a sword and a shield:

A Sword and a Shield:

What Every Company Should Know about the

International Trade Commission (ITC) and

Section 337 Litigation

Thursday, January 7, 2016

PanelistsModerator/Panelist: Darren S. Cahr, Intellectual Property Partner, Drinker Biddle &

Reath LLP. Litigator; Chair of firm’s Advertising and Promotions practice; assists clients in

understanding the value of their intangible assets; Illinois Super Lawyer for IP since 2006;

member, US Legislation Subcommittee of the International Trademark Assoc.

2

Jeff L. Eichen: Intellectual Property Partner, Drinker Biddle & Reath LLP. Litigator;

USPTO, ITC, courts; draws on background in physics and electrical engineering to serve

clients in electronics, telecommunications, consumer products.

Lisa Kattan: Investigative Attorney, Office of Unfair Import Investigations at the U.S.

International Trade Commission. Litigator, USPTO. Previously patent litigator in private

practice. Cases involve telecommunications, pharmaceuticals, medical devices, and

consumer products.

Vaishali Udupa: Vice President, Associate General Counsel for IP Litigation, Hewlett-

Packard Enterprise. Manages IP lawsuits that are filed against HPE in the United States;

supports all intellectual property disputes worldwide; actively involved in patent reform

issues. 2015 Influential Women of Virginia; Corporate IP Star.

The views expressed during this presentation belong to the individual panelists and are not imputed to the U.S. International Trade Commission, the Office of Unfair Import Investigations, Hewlett-Packard or Drinker Biddle & Reath.

ACC Presentation: A Sword and A Shield (January 7, 2016)

3ACC Presentation: A Sword and A Shield (January 7, 2016)

The United States International Trade Commission (“ITC”) is a

federal agency located in Washington, DC.

Headed by six Commissioners appointed by the President and

approved by Senate.

Section 337 of the Tariff Act of 1930 (19 U.S.C. §1337, or just

“Section 337”) is a trade remedy administered by the ITC.

Under this statute, the ITC has jurisdiction to conduct

investigations into “unfair” trade practices and, if proven, to issue

“exclusion orders” barring the importation of infringing products.

What is the International Trade Commission (ITC)?


Infringement of a valid U.S. patent

Infringement of a valid U.S. copyright

Infringement of a valid U.S. trademark registration

Infringement of an unregistered or “common law” trademark.*

Infringement of a trade secret protected under state law*

Other “unfair” methods of competition or “unfair” acts*

* -- requires proof of “substantial injury” to domestic industry

What is an “unfair” trade practice under Section 337?


Number of ITC Investigations is Roughly Increasing with Time


Subject Matter of ITC Investigations, by Industry


Commission—composed of six Commissioners appointed by the

President; all Commission decisions are approved by majority

vote

General Counsel’s Office—the Commission’s “legal department”;

advises the Commission and represents the agency in appeals

Six Administrative Law Judges (“ALJs”)—hired by the

Commission and responsible for conducting hearings, finding

facts and preparing an “Initial Determination”

Office of Unfair Import Investigation (“OUII”)—represents the

public interest in Section 337 investigations

Key Players for Section 337 Investigations


ITC Administrative Law Judges

Chief ALJ Bullock ALJ Essex ALJ Pender

ALJ Lord ALJ Shaw


Not shown: ALJ McNamara

Detailed complaint (with lots of exhibits) is filed with the Commission, and

then the Commission decides, based on the allegations in the complaint,

whether to institute an investigation.

If the investigation is instituted, the Commission assigns the matter to one

of six Administrative Law Judges (“ALJs”).

The ALJ then schedules deadlines for discovery, motions, Markman briefs

and argument (in some cases), pretrial submissions and trial (called the

“hearing”).

After the hearing, the ALJ issues his or her decision, called an “Initial

Determination” or “ID”.

The ID is then reviewed by the Commission, which issues its own decision,

called a “Final Determination” or “FD”.

So what is a Section 337 Investigation?


Section 337 provides broad remedies that bar infringing

products from access to the United States market, but all of the

relief is prospective (aimed at future conduct):

- General exclusion orders: Directed to Customs to bar the importation of

infringing products made or sold by anyone, including non-parties! (CBP

can stop goods in violation of an ITC exclusion order at the border)

- Limited exclusion orders: Directed to Customs to bar the importation of

infringing products made or sold by the respondents.

- Cease and desist orders: Bars the sale or transfer of infringing products

already within the United States; statutory penalty of up to $100,000 or

twice the value of the infringing imports per day.

- No monetary damages can be awarded to the Complainant; no

remedies for past infringement; willfulness is not an issue.

Relief Available at the End of an Investigation


Sale for importation, importation or sale after importation of goods (section

337 is based on in rem jurisdiction, so proof of importation is significant)

Unfair act or method of competition—

- Includes infringement of U.S. patents among “statutory” unfair acts – direct,

contributory and/or inducing infringement are all “unfair” acts.

A “domestic industry” – which must exist or be in the process of being

established.

“Substantial injury” to domestic industry for non-statutory or common law

unfair acts, but no proof of injury required for statutory unfair acts (patent,

copyright, registered trademark infringement).

Public interest, which may or may not be delegated to ALJ for findings and

recommendation

Elements of a Section 337 Action


In a nutshell, the “domestic industry” element requires some

substantial activity in the United States relating to the practice or

exploitation of the asserted patent, copyright, trademark, etc.

For complaints based on statutory infringement, complainant

must show:

- Significant investment in plant and equipment in the United States (Prong

A);

- Significant employment of labor or capital in the United States

(Prong B); or

- Substantial investment in the United States in other exploitation of the

patent or other rights, including engineering, research and development

or licensing (Prong C).

What is the “Domestic Industry” Requirement?


Rules require fact pleading, not notice pleading (like

under the old Federal Rules), so complaints are fifty to

several hundred pages long and have dozens of

exhibits, declarations and other supporting document

attached.

For patent infringement, the complainant attaches claim

charts showing each element of one or more patent

claims found in both the infringing product and in the

complainant’s product (for proving domestic industry).

Draft complaint is usually submitted first to OUII for

informal review and comments

Investigation is Started by Filing a Complaint


Final complaint is filed with the Secretary.

Complaint may be amended at any time prior to institution of an investigation; requests for clarification and supplementation from OUII are common, and any supplementation may reset the 30 day clock for the Commission

Commission reviews and decides within 30 days whether to institute an investigation. Virtually every complaint filed (if technically sufficient) results in the institution of an investigation.

Once initiated, an answer must be filed in 20 days (up to 30 days for foreign respondents).

What Happens to the Complaint After Filing?


Within 45 days after institution of the investigation by

the Commission, the assigned ALJ issues an order

setting a target date for completion of the

investigation.

The target date is the date by which the Commission

must issue its final determination or decision on the

outcome of the investigation, and this date, in turn,

determines all the other deadlines in the matter.

The target date is typically 15 or 16 months after the

investigation is “instituted.”

Target Date for the Investigation


Example of an ITC Investigation Schedule


All relevant, unprivileged information is discoverable; no

“proportionality” requirement, like under the new Federal Rules

(although ALJ may limit requests in his or her discretion; there are

limits on ESI discovery)

Discovery can be served immediately—no Rule 26 conference is

required. Discovery period is limited to about 5 months, starting

immediately after the initiation of the investigation.

Responses to interrogatories and document requests are typically

due 10 days after service.

Response time for motions is typically 10 days.

The assigned staff attorney from the OUII also participates in

discovery.

Discovery in an ITC Investigation


The Commission has significant latitude in gaining access to

information held by foreign respondents because of its in rem

jurisdiction. (This may be a significant issue in choosing to bring

an ITC investigation versus traditional federal court action.)

Depositions in foreign countries are common.

Foreign plant inspections are obtainable.

The Commission can impose sanctions similar to those set forth

in Rule 37 of the Federal Rules of Civil Procedure for failure to

provide information.

Foreign Discovery in an ITC Investigation


Up to a few years ago, there were very few Section 337

investigations with separate Markman proceedings; instead, all

claim construction issues were briefed as part of the prehearing

process and claim construction would not be decided until the ID

was issued.

Now all ALJs have ground rules requiring the parties to present

their positions on claim construction early in the investigation;

some of the six ALJ also prefer an early Markman proceeding to

decide claim construction issues prior to the deadline for expert

reports

Claim construction can be reversed by the Commission or even

later on appeal.

Claim Construction in an ITC Investigation


Technical experts are retained by both complainant and

respondents—typically separate experts for infringement and

invalidity.

As in federal district court litigation, technical experts conduct

tests, issue reports, and provide deposition and hearing

testimony.

The ALJ usually gives experts broad latitude at the hearing to

educate and provide their opinion on any relevant topic. Experts

are typically the most important witnesses for each side’s case.

Role of Experts in an ITC Investigation


A party will be found in default if it fails to respond to the complaint

or notice of investigation and fails to show cause why it should not

be found in default.

‒ The ALJ shall issue an initial determination finding the respondent in default. Facts

alleged in the complaint are presumed to be true.

‒ Complainant can request entry of a limited exclusion order immediately, but general

exclusion orders must be established through substantial, reliable and probative

evidence, and only after consideration of public interest factors.

Summary determination is the Section 337 equivalent of summary

judgment under the Federal Rules.

‒ For uncontested matters (such as importation or, sometimes, domestic industry),

summary determination is commonly granted—and assists both sides by narrowing

the issues for hearing.

‒ For contested matters (such as infringement or invalidity) summary determination is

virtually never granted, although parties still file them anyway.

Defaults and Summary Determination


The hearing is held at the agency’s offices in Washington, DC.

Federal Rules of Evidence are not binding under the APA but

they are a source of guidance. In general, evidence presented

at the hearing is required to be “relevant, material and reliable”

to be admitted.

Hearing time is typically five to seven days.

To save time, direct testimony is usually presented in written

statements, followed by live cross-examination.

Hearing in an ITC Investigation


After the hearing, the parties are allowed a short period of time,

up to one month, to prepare final briefs for submission. The final

briefs incorporate all the evidence presented at the hearing

combined with each party’s arguments about how each of the

elements has or has not been proven.

The ALJ has approximately three (3) months following the

hearing in which to consider evidence presented at the hearing

and to prepare an Initial Determination (“ID”) for submission to

the Commission.

Post-Hearing Briefs and Initial Determination


The ALJ prepares an initial determination (ID) based on

evidence and argument presented at the hearing and in the

parties’ briefs. If the target date is 16 months or less from the

date of institution, the ID must be filed no later than 4 months

before the target date.

Parties may appeal the ALJ's ID by filing a “petition for review”

with the Commission. Sometimes all parties (complainant,

respondent and OUII) file petitions for review.

The Commission considers the ID and the petitions for review

and then, in some cases, poses additional written questions for

the parties to brief. The Commission then issues its final

determination (FD) on or before the target date.

Initial and Final Determination


If the Commission finds a violation, the President has sixty (60)

days to disapprove of the determination, for policy reasons, in

which case the Commission's action will have no force or effect.

This is exceptionally rare. A bond is typically required during

the Presidential review period.

Appeal of a final determination of the Commission may be taken

to the Court of Appeals for the Federal Circuit (“CAFC”).

At the CAFC, legal determinations are reviewed de novo; factual

determinations are reviewed for substantial evidence; the ITC’s

interpretation of Section 337 is given Chevron deference.

Presidential Review and Appeal to the CAFC


ITC Investigation Versus Federal Court Litigation

ITC INVESTIGATION FEDERAL COURT LITIGATION

No money damages, but an exclusion order may be even more valuable.

Money damages and at least the potential for injunctive relief.

Extremely fast procedure; speed favors the complainant and the well-prepared respondent.

Somewhere between slow and very slow; sluggish pace favors defendants.

Cases decided by ALJs and the Commission, both of whom know the difference between strong and weak cases.

Cases decided by juries, who generally do not know the difference between strong and weak cases.

ACC Presentation: A Sword and A Shield (January 7, 2016) 27

ITC Investigation Versus Federal Court Litigation (continued)


Wide latitude for foreign discovery from respondents, including plant tours.

Very limited opportunity for foreign discovery.

Domestic industry requirement is a significant additional burden.

No domestic industry proof required.

Reduced participation for in-house counsel because of confidentiality provisions.

Confidentiality provisions can be negotiated for each case, allowing in-house counsel some leeway to participate in review of opposing party’s documents.



No damages calculations; no lost profits or royalty analysis.

Damages calculations and discovery to support these calculations at trial.

ALJs are used to hearing testimony through translators or by written statements.

Juries are sometimes less inclined to side with foreign witnesses or parties.

No service of process issues. Service of process can be difficult, especially in China.




No delay as yet because of IPR proceedings.

Stay of litigation for IPR is common under AIA.

No counterclaims (but invalidity and unenforceability are always on the table).

Counterclaims allowed.

OUII provides an objective view of the case to counsel and ALJ.

Generally little or no control of counsel, except in the most extreme cases.

Advisory opinions available for potential infringers.

No advisory opinions, only “actual case or controversy” permitted.



Supplemental Materials

ITC Organizational Chart (attached)

The following are available on the flash drives and through

links on the ACC website:

- Section 337 Regulations

- Section 337 Statute

- Case Study: Complaint and Commission Opinion (Exclusion Order)


Organizational Chart for the ITC


PUBLIC VERSION

In the Matter of

CERTAIN SLEEP-DISORDEREDBREATHING I“”°s"g”“°“ N°' 337‘TA'89"TREATMENT SYSTEMS AND COMPONENTSTHEREOF

COMMISSION OPINION

This investigation is before the Commission for a final detennination on the issues under

review, remedy, the public interest, and bonding. The Commission has determined to affirm the

presiding administrative law judge’s (“ALJ”) initial detennination (“ID”) that Respondents,

BMC Medical Co., Ltd. of Beijing, China; 3B Medical, Inc. of Lake Wales, Florida; and 3B

Products, L.L.C., of Lake Wales, Florida (collectively “Respondents”), violated section 337 of

the TariffAct of 1930, as amended, 19 U.S.C. § 1337, in connection with claims 1, 9, 32, 89, and

92 ofU.S. Patent No. 7,178,527 (“the ’527 patent”); claims 19, 21, 32, and 36 ofU.S. Patent No.

7,950,392 (“the ’392 patent”); claims 32-34 and 53 of U.S. Patent No. 7,997,267 (“the ’267

patent”); claims 30, 37, and 38 of U.S. Patent No. 7,341,060 (“the ’O60patent”); and claims 1, 3,

5, 11, 28, 30, 31, and 56 ofU.S. Patent No. 8,312,883 (“the ’883 patent”). The Commission has

determined to reverse the ALJ’s detennination that Respondents violated section 337 in

connection with claim 2 of U.S. Patent No. RE 44,453 (“the ’453 patent”) and finds that prior art

renders the asserted claims of the ’453 patent invalid. The Commission has determined to affirm

the ALJ’s finding that Respondents have not violated section 337 in connection with claims 13,

51, 52, and 55 of U.S. Patent No. 7,926,487 (“the ’487 patent”) because, as all the parties agree,

Complainants, ResMed Corporation of San Diego, California; ResMed Incorporated of San

1

PUBLIC VERSION

Diego, California; and ResMed Limited of New South Wales, Australia (collectively, “ResMed”)

failed to establish the technical prong for domestic industry under the Commission’s construction

of the claim term “gas washout vent.”1 The Commission has determined to vacate the ID’s

finding and discussion that ResMed established a domestic industry under 19 U.S.C. '

§ 1337(a)(3)(C). The Commission adopts the ID to the extent it does not conflict with this

opinion.

Having found a violation of section 337 in this investigation, the Commission has

determined that the appropriate form of relief is: (1) a limited exclusion order prohibiting the

unlicensed entry of sleep-disordered breathing treatment systems and components thereof that

infringe one or more of claims 1, 9, 32, 89, and 92 of the ’527 patent; claims 19, 21, 29, 32, and

36 ofthe ’392 patent; claims 32, 33, 34, and 53 ofthe ’267 patent; claims 30, 37, and 38 of

the ’O60patent; and claims l, 3, 5, 11, 28, 30, 31, and 56 ofthe ’883 patent that are

manufactured by, or on behalf of, or are imported by or on behalf of BMC Medical Co., Ltd., 3B

Medical, Inc., or 3B Products L.L.C. or any of their affiliated companies, parents, subsidiaries,

agents, or other related business entities, or their successors or assigns, except for service and

replacement parts for customers that purchased their covered products prior to the date the

exclusion order becomes final; and (2) cease and desist orders prohibiting domestic respondents

BMC Medical Co., Ltd., 3B Medical, Inc. from conducting any of the following activities in the

United States: importing, selling, marketing, advertising, distributing, transferring (except for

exportation), and soliciting U.S. agents or distributors for, sleep-disordered breathing treatment

1ResMed states that it “would not contest a finding of no violation on the ’487 patentbased on the technical prong of domestic industry.” ResMed Motion to Withdraw ’487 Patent at1.

2

_ PUBLIC VERSION

systems and components thereof covered by claims l, 9, 32, 89, and 92 of the ’527 patent; claims

19, 21, 29, 32, and 36 of the ’392 patent; claims 32, 33, 34, and 53 of the ’267 patent; claims 30,

37, and 38 ofthe ’060 patent; and claims 1, 3, 5, 11, 28, 30, 31, and 56 of the ’883 patent. The

cease and desist orders include the following exemptions: (1) if in a written instrument, the

owner of the patents authorizes or licenses such specific conduct, or such specific conduct is

related to the importation or same of covered products by or for the United States; or (2) conduct

limited to the provision of service and replacement parts for customers that purchased their

covered products prior to the date this Order becomes final within the meaning of 19 U.S.C.

§ 1337(i)(4).

The Commission has also determined that the public interest factors enumerated in

section 337(d) and (f) (19 U.S.C. §§ l337(d) and (f)) do not preclude issuance of the limited

exclusion order or cease and desist orders. Finally, the Commission has determined that a bond

in the amount of 65 percent of entered value is required to permit temporary importation during

the period of Presidential review (19 U.S.C. § 1337(j)) of sleep-disordered breathing treatment

systems and components thereof that are subject to the limited exclusion order.

I. BACKGROUND

A. Procedural History t

The Commission instituted this investigation on August 23, 2013, based on a complaint

filed by ResMed. 78 Fed. Reg. 52564 (Aug. 23, 2013). The complaint alleged violations of

section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337) in the importation into the United States

the sale for importation, and the sale within the United States after importation of certain sleep

disordered breathing treatment systems and components thereof that infringe one or more of

3

PUBLIC VERSION

claims 32-37, 53, 79, 80, and 88 ofthe ’267 patent; claims 1-7 ofU.S. Patent No. 7,614,398

(“the ’398 Patent”); claim 1 of U.S. Patent No. 7,938,116 (the “’1 16 Patent”); claims 30, 37, and

38 ofthe ’060 patent; claims 1, 3, 5, 11, 28, 30, 31, and 56 ofthe ’883 patent; claims 1, 3, 6, 7, 9,

29, 32, 35, 40, 42, 45, 50, 51, 56, 59, 89, 92, 94, and 96 ofthe ’527 patent; claims 19-24, 26, 29

36, and 39-41 of the ’392 patent; and claims 13, 15, 16, 26-28, 51, 52, and 55 of the ’487 patent.

Id. The notice of investigation named the Respondents identified above. Id. The Office of

Unfair Import Investigations (“OUII”) was a named party to the investigation.

On January 9, 2014, the ALJ issued an ID, granting a motion by ResMed to amend the

complaint and notice of investigation to substitute the ’453 patent for the ’398 patent and to

terminate the investigation as to the ’398 patent. See Order No. 7 (Jan. 9, 2014). The

Commission detennined not to review the ID.2 On February 24, 2014, the ALJ issued an ID,

granting a motion by ResMed to withdraw its allegations with respect to the ’116 patent. See

Order No. 11 (Feb. 24, 2014). The Commission determined not to review the ID.3 On March 18

2014, the ALJ granted a motion by ResMed to terminate the investigation as to claims 26-28 of

the ’487 patent. See Order No. 20 (Mar 18, 2012). The Commission determined not to review

the 113.4

The ALJ held an evidentiary hearing on April 10, 2014, and April 11, 2014, and from

2See Notice of Commission Determination Not to Review an Initial DeterminationGranting the Complainants’ Motion to Amend the Complaint and Notice of Investigation (Feb.10, 2014); 79 Fed. Reg. 9000-01 (Feb. 14,2014).

3See Notice of Commission Determination Not to Review an Initial DeterminationGranting the Complainants’ Motion to Partially Terminate the Investigation by WithdrawingAllegations with Respect to U.S. Patent No. 7,938,116 (March 11, 2014).

4See Notice of Commission Determination Not to Review an Initial DeterminationGranting Complainants‘ Unopposed Motion for Partial Termination of the Investigation byWithdrawal of Claims 26-28 of U.S. Patent No. 7,926,487 (Apr. 29, 2014).

4

PUBLIC VERSION

April 14, 2014, through April 17, 2014, and thereafter received post-hearing briefing from the

parties.

On August 21, 2014, the ALJ issued his final ID, finding a violation of section 337 by

Respondents with respect to certain asserted claims of the ’392, ’267, ’060, ’883, and ’453

patents. The ALJ found no violation of section 337 with respect to the asserted claims of

the ’487 patent. Specifically, the ALJ found that the Commission has subject matter jurisdiction,

in rem jurisdiction over the accused products, and inpersonam jurisdiction over the respondents.

ID at 10-11. The parties stipulated to importation of the accused products and the ALJ found

that the importation requirement of section 337 (19 U.S.C. § l337(a)(l)(B)) has been satisfied.

Id. at 3. The ALJ found that the accused products infringe asserted claims 1, 9, 32, 89, and 92 of

the ’527 patent; asserted claims 19, 21, 29, 32, and 36 of the ’392 patent; asserted claims 32-34

and 53 of the ’267 patent; asserted claims 13, 51, 52, and 55 of the ’267 patent; asserted claims

30, 37, and 38 ofthe ’060 patent; asserted claims 1, 3, 5, 11, 28, 30, 31, and 56 ofthe ’883 patent

and asserted claim 2 of the ’453 patent. See ID at 23, 46, 57-58, 71-78, 95, 99, and 102. The

ALJ concluded that the accused products satisfy each limitation of claims 4 and 7 of the ’453

patent but found those claims invalid in view of the prior art. See id. at 103-139. The ALJ also

found that the accused products satisfy each limitation of asserted claims 13, 51, 52, and 55 of

the ’487 patent but found those claims invalid in view of the prior art. See id. at 78-92. The ALJ

found that Respondents failed to establish by clear and convincing evidence that the asserted

claims of the ’392, ’267, ’060, ’883, or claim 2 of the ’453 patents were invalid in light of the

cited prior art references. See id. at 25-45, 48-55, 96, and 100. The ALJ further found that

ResMed established the existence of a domestic industry that practices each of the asserted

5

PUBLIC VERSION

patents under 19 U.S.C. § 1337(a)(2). See ID at 139-188.

The ID included the ALJ’s recommended determination on remedy and bonding. The

ALJ recommended that in the event the Commission finds a violation of section 337, the

Commission should issue a limited exclusion order prohibiting the importation of infringing

sleep-disordered breathing treatment systems and components thereof imported by Respondents.

ID at 192. The ALJ also recommended issuance of cease and desist orders directed to

Respondents, finding that Respondents maintain commercially significant inventory of at least

some of the infringing products in the United States. Id. at 6. The ALJ noted the parties’

stipulation that a bond of 65 percent of entered value should be imposed during the period of

Presidential review, and recommended that the Commission set the bond in that amount. Id. at

194.

On September 3, 2014, Respondents filed a petition for review of the ID, challenging a

number of the ALJ’s findings. See Respondents’ Petition for Review of Initial Determination

(“Resp. Pet.”). Specifically, Respondents sought review of the ALJ’s construction of the claim

tenn “gas washout vent” recited in the asserted claims of the ’487 patent, the ALJ’s finding that

the accused products satisfy all the limitations of the asserted claims, and the ALJ’s finding that

the cited prior art does not anticipate the asserted claims. Respondents also challenged the ALJ’s

finding that the cited prior alt does not anticipate the asserted claims of the ’453 patent and does

not render asserted claim 2 of the patent obvious. Respondents further challenged the ALJ’s

construction of the claim term “base configured to retain a body liquid therein” and the

infringement finding based on that construction. Regarding the ’267 patent, Respondents

challenged the ALJ’s construction of certain claim tenns and the finding that the asserted claims

6

PUBLIC VERSION

are not obvious in view of the cited prior art references. Respondents also sought review of the

ALJ’s finding that ResMed established the economic prong of the domestic industry requirement

On September 3, 2014, the Commission investigative attomey (“IA”) also filed a petition

for review challenging the ALJ’s construction of the claim term “gas washout vent” recited in

the asserted claims of the ’487 patent as well as the ALJ’s infringement and invalidity findings

based on that constructions The IA also challenged the ALJ’s construction of the claim term

“retaining mechanism configured to secure the connecting structure to the CPAP apparatus”

recited in the asserted claims of the ’453 patent and the ALJ’s invalidity finding based on that

construction. That same day, complainant ResMed filed a contingent petition for review.“ On

September 11, 2014, the parties filed responses to the petitions for review.7

On October 16, 2014, the Commission detennined to review the final ID in part. 79 Fed.

Reg. 63163-65 (Oct. 22, 2014). Specifically, with respect to the ’487 patent, the Commission

determined to review the ALJ’s construction of the claim term “gas washout vent” and

simultaneously construed the limitation to mean “a vent comprising a thin air permeable

membrane extending across an opening for exhausting gas to the atmosphere.” As a result of the

new claim construction, the Commission detennined to review the ALJ’s findings on

infringement, invalidity, and the technical prong of the domestic industry requirement.

Regarding the ’453 patent, the Commission determined to review (1) the ALJ’s construction of

5See Office of Unfair Import Investigations’ Petition for Review of the InitialDetennination (“IA Pet.”).

6See The ResMed Complainants’ Contingent Petition for Review (“ResMed Pet.”). '7See Complainants’ Response to Respondents’ Petition for Review of Initial

Determination (ResMed Rep.); Respondents’ Opposition To ResMed’s Contingent Petition ForReview Of Initial Determination And Response To OUII’s Petition For Review Of InitialDetermination (“Resp. Rep.”); Office of Unfair Import Investigations’ Response to the Petitionsfor Review of the Initial Detennination (IA Rep.).

7

PUBLIC VERSION

the claim limitation “a retaining mechanism configured to secure the comrecting structure to the

CPAP apparatus” and struck the ID’s requirement that the claimed “retaining mechanism” must

include an arrangement of moving parts; (2) the ALJ’s finding that the prior art REMstar device

does not anticipate the asserted claims of the ’453 patent; and (3) the ALJ’s findings on

infringement and the technical prong of the domestic industry requirement. The Commission

also determined to review the ID’s findings and conclusions regarding the economic prong of the

domestic industry requirement under 19 U.S.C. § l337(a)(3)(C). In its notice of review, the

Commission asked the parties to brief the following issue:

The Commission has determined to revise the ALJ’s constructionof the claim limitation “a retaining mechanism” recited in theasserted claims of the ’453 patent and strike the requirement that itrequires an arrangement of moving parts. That is, the claimlimitation “a retaining mechanism configured to secure theconnecting structure to the CPAP apparatus” is construed to mean“one or more parts for holding in place the CPAP apparatus that isconfigured to attach the connecting structure to the CPAPapparatus.” See ID at 124. Please discuss whether the REMstardevice anticipates the asserted claims under the revised

'construction.

On October 31, 2014, the parties filed written submissions on the issues tmder review,

remedy, the public interest, and bonding.8 On November 7, 2014, the parties filed reply

submissions?

8See Respondents’ Brief in Response to Notice of Commission Determination to Reviewin Part a Final Initial Determination (“Resp Br.”); ResMed Complainants’ Written Submissionin Response to Commission Notice of Review (“ResMed Br.”) Office of Unfair ImportInvestigations’ Response to the Commission Question (“IA Br.”).

9See Respondents’ Reply Brief in Response to Notice of Commission Determination toReview in Part a Final Initial Determination; The ResMed Complainants’ Response toRespondents’ Brief in Response to Notice of Commission Determination to Review in Part aFinal Initial Determination; Office of Unfair Import Investigations’ Reply to the Private Parties’Responses to the Commission Question.

8

PUBLIC VERSION

B. Patents and Technology at Issue

The technology at issue in this investigation generally relates to the field of continuous

positive airway pressure (“CPAP”) devices used to treat sleep-disordered breathing problems,

particularly obstructive sleep apnea. See ID at 1.

The ’527 patent describes nasal mask cushions for sealing masks to a patient’s face

during CPAP therapy. ’527 patent (JX-1) at col. 1, ll. 23-25. These cushions are designed to

reduce mask-to-face pressure and fonn a more effective seal for greater patient comfort and a

reduction in the likelihood of skin irritation. Id. at col. 2, l. 34-col. 3, l. 44. ResMed owns the

patent and has asselted independent claims 1, 9, and 89 and dependent claims 32 and 92 in this

investigation.

Like the ’527 patent, the ’392 patent also describes design of a more comfortable nasal

mask used to treat obstructive sleep apnea. ’392 Patent (JX-5) at col. 2, l. 9-col. 3, l. 14.

ResMed owns the patent and has asserted independent claim l9 and dependent claims 21, 29, 32,

and 36 in this investigation.

The ’267 patent describes a respiratory mask assembly for delivering breathable gas to a

patient comprising a frame dimensioned to create an aperture to a nasal breathing cavity, and a

swivelable, quick-release elbow assembly that interfaces with the aperture. Id. at Abstract.

ResMed owns the patent and has asserted independent claims 32 and 53 and dependent claims 33

and 34 in this investigation.

The ’487 patent describes a respiratory mask for CPAP.treatment comprising a washout

vent assembly consisting of at least twenty (20) holes configured to reduce noise and gas jetting.

Id. at Abstract. ResMed owns the patent and has asserted independent claims 13 and 51 and

9

PUBLIC VERSION

dependent claims 52 and 55 in this investigation.

The ’060 patent describes a respiratory mask assembly for delivering breathable gas to a

patient, which includes a frame that can attach to cushions to protect a patient’s face, a rotatable

elbow that carries gas in and out of the mask, a headgear assembly that can be used to secure the

mask on the patient’s head, and connectors that attach these components together. ’060 patent,

col. 8, l. 4-col. 9,1. 33; col. 9, ll. 34-67; col. 10,11. 54-58; col. 17, l. 48-col. 18, 1.52; Figs 5 and 6

ResMed owns that patent and has asserted independent claim 30 and dependent claims 37 a.nd38

in this investigation.

The ’883 patent describes a nasal pillows mask with prongs that are generally cone

shaped to provide an effective seal without irritating the nostrils, and a base for the pillows to

rest on the upper lip. ’883 patent at col. 2, l. 36-col. 3, l. 24; col. 10, l. 66-col. 11, l. 54. ResMed

owns the patent and has asserted independent claims 1 and 31 and dependent claims 3, 5, 11, 28,

$0, and 56 in this investigation.

The reissue ’453 patent describes a humidifier for a CPAP apparatus that is adapted to

prevent liquid from undesirably exiting an inlet of the humidifier. ’453 patent (JX-8) at col. 1, ll.

53-56. ResMed owns the patent and has asserted dependent claims 2, 4, and 7 in this

investigation.

C. Products at Issue

The accused products include masks and humidifiers for CPAP therapy to treat breathing

problems such as sleep apnea. ID at 7 (citing Yerbury WS, CX-754C at 4-5, Q/A 18-21). For a

complete list of accused products, see ID at 8-9.

10

PUBLIC VERSION

II. ISSUES UNDER REVIEW

A. The ’487 Patent

ResMed has asserted independent claims 13 and 51 and dependent claims 52 and 55 of

the ’487 patent in this investigation. Claim 13 of the ’487 patent is illustrative and recites:

13. A respiratory mask comprising:

a cushion;

a breathable gas inlet to provide pressurized gas at a pressure elevated aboveatmospheric pressure to the patient via the cushion when the mask is in use;and

at least one gas washout vent to allow gas to exit from the mask, wherein thewashout vent has at least twenty through holes each having a length and adiameter that are selected to help eliminate or reduce noise while maintainingsufficient CO; washout during patient breathing, and

wherein each of the holes has a first end positioned on an inside surface of themask and a second end positioned on an outer surface of the mask, andwherein the first end has a diameter that is larger than a diameter of thesecond end.

’487 patent, col. 8, ll. 8-23 (claim 13) (emphasis added).

1. Construction of the Claim Term “Gas Washout Vent”

a. The ID

The ALJ construed the claim term “gas washout vent” to mean “vent for exhausting gas

to the atmosphere,” adopting the construction proposed by ResMed which purportedly applied

the claim term‘s plain and ordinary meaning. ID at 71 (citing Markman Order No. 8, at 37). The

ALJ rejected Respondents’ and the IA’s proposal to construe the claim term to mean “a vent

comprising a thin air permeable membrane extending across an opening for exhausting gas to the

atmosphere.” See Markman Order at 30. The IA and Respondents argued that the patent

disclosure limits the “gas washout vent” to the “thin air permeable membrane” disclosed in the

patent and that the patentees disclaimed any other scope of the claim term. Id. at 31.

11

PUBLIC VERSION

The ALJ, relying primarily on the doctrine of claim differentiation, adopted ResMed’s

proposed construction. Id. at 33. The ALJ found that references to membranes in dependent '

claims 34, 41, and 62 created a presumption that a membrane limitation is not present in the

independent claims. Id. The ALJ explained that claims 34 and 41 depend from independent

claims 26 and 39, respectively, and these independent claims refer to a “patient interface” with

“a gas washout vent having a plurality of holes,” “wherein each of the holes has a first end

positioned on an inside surface of the mask and a second end positioned on an outer surface of

the mask.” Id. (citing ’487 patent at col. 9, ll. 5-22; col. 10, ll. 8-24). The ALJ reasoned that

claims 26 and 39 “already require that the gas washout vent be ‘positioned’ on the “surface of

the mask” and that “[t]he only additional limitation added by claims 34 and 41 is that ‘the vent is

formed on a membrane.’” Id. (citing ’487 patent at col. 9, 11.47-49; col. 10, ll. 27-29).

Likewise, the ALJ found that independent claim 56 claims “a gas washout vent having an array

of through holes extending from an inside of the elbow to an outside of the elbow” and that

“[t]he only additional limitation added by claim 62 is that “the plurality of holes is formed on a

membrane.” Id. (citing ’487 patent at col. 11, ll. 31-50, 65-67). The ALJ concluded that because

“the sole difference between these independent and dependent claims is the ‘membrane’

limitation that Respondents and the Staff are proposing to read into the ‘gas washout vent’ term,

this is a situation where ‘the doctrine of claim differentiation is at its strongest.”’ Id. at 33-34

(citing SanDisk Corp. v. Kingston Technology C0., Inc., 695 F.3d 1348, 1361 (Fed. Cir. 2012)

(citing Liebel-Flarsheim C0. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004); Phillips v.

AWHCOrp., 415 F.3d 1303, 1315 (Fed. Cir. 2005)).

The ALJ recognized that the doctrine of claim differentiation only creates a rebuttable

12

PUBLIC VERSION

presumption which “will be overcome by a contrary construction dictated by the written

description or prosecution history.” Id. at 34 (citing Seachange 1nt’l, Inc. v. C-COR, Inc., 413

F.3d 1361, 1369 (Fed. Cir. 2005); Retractable Techs., Inc. v. Becton, Dickinson and Co., 653

F.3d 1296, 1305 (Fed. Cir. 2011); Kraft Foods, Inc. v. Int’! Trading Co., 203 F.3d 1362, 1368

(Fed. Cir. 2000). He found however, that the portions of the specification that the IA and

Respondents pointed to as establishing a disclaimer of claim scope “are not sufficient to rebut the

presumption of claim differentiation here.” ID at 35. The ALJ therefore declined to restrict “gas

washout vent” to a thin permeable membrane and assigned the claim tenn its plain and ordinary

meaning.

b. Respondents’ Petition

Respondents challenge the AL.I’sclaim construction and assert that the Commission has

already construed the claim term in a related patent, U.S. Patent No. 7,159,587 (“the ’587

patent”), which shares a common specification with the ’487 patent. Resp. Pet. 5. Respondents

point to the C01rnnission’sadvisory opinion issued on August 11, 2014, in Certain Sleep

Disordered Breathing Treatment Systems and Components Thereof, 337-TA-879 (“879 Advisory

Opinion”). Id. at 6. Respondents observe that in the 879 Advisory Opinion, the Commission

construed the claim term “gas washout vent portion” to mean “a vent comprising a thin air

permeable membrane extending across an opening for exhausting gas to the atmosphere,”

adopting the construction proposed by Respondents and the IA. Id. Respondents note that the

’487 patent is a continuation of the ’587 patent at issue in the 879 Advisory Opinion and that the

two patents have identical specifications in all relevant respects. Id. Thus, Respondents argue

that the statements from the ’587 patent that the Commission found limited gas washout vents to

13

PUBLIC VERSION

those having a thin air permeable membrane are also present in the specification of the ’487

patent. Id. Respondents assert that under controlling Federal Circuit precedent the same claim

term must be accorded the same meaning across a family of patents. Id at 10 (citing NTP, Inc. v.

Research in Motion, Ltd, 418 F.3d 1282, 1293 (Fed. Cir. 2005); In re Rambus Inc., 694 F.3d 42,

48 (Fed. Cir. 2012) (“unless otherwise compelled the same claim term in the same patent or

related patents carries the same construed meaning”)).

Respondents contend that the ALJ failed to construe the claim term “gas washout vent”

based on the patent application as-filed, and instead relied on the doctrine of claim differentiation

based upon dependent claims added after the ’487 patent application had been filed. Id. at 6.

According to Respondents, “the meaning of a claim term is determined as of the application’s

effective filing date, and subsequent actions or statements during prosecution may narrow, but

may not broaden, the meaning conveyed by the application as filed.” Id. at 6 (emphasis omitted),

ll(citing Retractable Techs., 653 F.3d at 1305; ATD Corp. v. Lydall, Inc., 159 F.3d 534, 541

(Fed. Cir. 1998) (“The doctrine of claim differentiation cannot broaden claims beyond the scope

that is supported by the specification. . . . The presumption that separate claims have different

scope ‘is a guide, not a rigid rule.”’).

c. The IA’s Petition

The IA also filed a petition challenging the ALJ’s construction of the claim term “gas

washout vent” for the same reasons. IA Pet. at 5. The IA states that the Commission based its

construction of the claim term in the 879 Advisory Opinion primanly on “ResMed‘s ‘repeated’

and ‘clear and unmistakable’ disavowal of gas washout vents that do not contain membranes.”

Id. at 6 (citing 879 Advisory Op. at 25).

14

PUBLIC VERSION

The IA notes that the Commission preliminarily suggested in the 879 Advisory Opinion

that its construction of “gas washout vent” did not appear inconsistent with the ALJ’s

construction in this investigation, but stated that “the Markman Order in the 890 investigation is

an interlocutory order that has not been subject to a Commission review.” Id. at 6-7. The IA

asserts that “the Commission now has the opportunity to review the full record in this

investigation, in light of its 879 advisory opinion,” and argues that the Commission should assign

the claim terms the same meaning because under existing law, the same claim term “in the same

or related patents carries the same construed meaning” “unless otherwise compelled.” Id. at 7

(citing In re Rambus, 694 F.3d at 48; Omega Eng ’g,Inc. v. Raytek C0rp., 334 F.3d 1314, 1334

(Fed. Cir. 2003)).

The IA contends that the ALJ erred by not giving ResMed’s disclaimers the same weight

as the Commission did. Id. (citing ID at 33-36). In tabular form the IA compares statements in

the specification of ’587 patent that the Commission found resulted in a disclaimer of claim

scope for the claim tenn “gas washout vent portion” to identical statements in the ’487 patent.

See IA Pet. at 8-12. Against this background, the IA contends that as the Commission found in

the 879 Advisory opinion, ResMed disclaimed gas washout vents that do not have membranes.

Id. at 12-13. The IA argues that the ALJ’s reliance on the doctrine of claim differentiation is

improper because the “the doctrine of claim differentiation cannot broaden claims beyond their

correct scope, determined in light of the specification and the prosecution history and any

relevant extrinsic evidence.” Id. at 12 (citing Multzform Desiccants, Inc. v. Medzam, Ltd., 133

F.3d 1473, 1480 (Fed. Cir. 1998)).

15

PUBLIC VERSION

d. ResMed’s Response

ResMed supports the ALJ’s construction of the claim term “gas washout vent” and

argues that “nothing in the specification dictates a construction for ‘gas washout vent’ that

departs from its plain and ordinary meaning, which is ‘vent for exhausting gas to the

atmosphere.’” ResMed Rep. at 7 (citing Markman Order No. 8 at 30-37). ResMed accuses

Respondents of concentrating on selected portions of the Commission’s findings in the 879

Advisory Opinion, while omitting portions Wherethe Commission “stat[ed] that ‘the presiding

ALJ’s construction [in the 879 Advisory Opinion] is not inconsistent with another ALJ’s

construction of the same term in a related child patent asserted in Inv. No. 337-TA-890/” Id. at

7-8 (citing Advisory Opinion at 30) (emphasis omitted). ResMed observes that the “Commission

went on to state that ‘the construction in the 890 investigation was based on claim differentiation

principles and different record evidence, which are not applicable here.”’ Id. at 3.

ResMed further accuses Respondents of ignoring portions of the intrinsic record that

support the ALJ’s construction, pointing out that “independent claims describe the ‘gas washout

vent’ assembly as a vent that “allo[w]s gas to exit from the mask . . . .” Id. (citing "487 patent at

col. 8, ll. 13-14 (claim 13); col. 9, ll. 12-13 (claim 26) (“allow gas to be exhausted from the

breathing cavity”); col. 11, ll. 8-9 (claim 51) (“allow gas to exit from the mask”). ResMed also

points to the following statements in the specification for support: that the “present invention

provides a vent assembly suitable for use with a respiratory mask of the type used in CPAP

treatment,” (’487 patent, abstract); that the assembly “vent[s] exhaled gases to the atmosphere”

(’487 patent at col. 1, ll. 62-63); and that “[t]he mask or nasal prongs or nasal pillows

incorporates, or has in close proximity, the gas washout vent for venting exhaled gases to the

16

PUBLIC VERSION

atmosphere” (’487 patent at col. 6, 1.66-col. 7, l. 2.). Id. at 8.

ResMed argues that the ’487 patent does not teach that the “gas washout vent” is limited

to “a thin air permeable membrane extending across an opening” but that the inventors drafted

some claims with a membrane limitation, and others without. Id ResMed points to independent

claim 26 and argues that it makes no mention of a membrane. Id ResMed explains that claim

34, which depends from claim 26, adds that requirement, requiring that the vent “is formed on a

membrane that is mounted to the patient interface.” Id. (citing ’487 patent at col.9, 11.47-49

(emphasis omitted). ResMed argues that “[i]ndependent claims 39 and 51 and their respective

dependent claims 41 and 62 have a similar structure” and contends that “when the inventors

wished to require the gas washout vent to include a ‘membrane,’ they specifically said so.” Id.

ResMed concludes that “[a]s a result, the term ‘gas washout vent’ cannot require a membrane

without rendering this other claim language redundant.” Id. (citing Phillips, 415 F.3d at 1315

(“The presence of a dependent claim that adds a particular limitation gives rise to a presmnption

that the limitation in question is not present in the independent claim.”). i

ResMed takes issue with Respondents’ argument that “there are other limitations in

dependent claims 34, 41, and 62 that differentiate them from the independent claims.” ResMed

explains that “independent claim 56 requires that the gas washout vent be on the elbow of the

patient interface, and dependent claim 62 adds “wherein the plurality of holes is formed on a

membrane attached to the elbow” and that “the only limitation added in dependent claim 62 is

that the gas washout vent must be formed on a membrane.” Id. (citing ’487 patent at col. 11, ll.

39-41 (claim 56); col. 11, ll. 65-67 (claim 62); IA Pet. at 15. ResMed makes the same argument

regarding independent claim 39 and dependent claim 41. ResMed Rep. at 9.

17

PUBLIC VERSION

ResMed further argues that Respondents’ proposed construction is inconsistent with the

testimony of inventor Joanne Drew, who testified that “putting vent holes directly in the frame,

as opposed to on an air permeable membrane, was part of the concept of the invention of the

’487 patent. Id at 11 (citing Drew Hearing Tr. at 193:4-6.) ResMed asserts that Respondents’

argument that the claims of the ’487 patent as filed did not contain the claims on which the

ALJ’s claim differentiation opinion was based should be rejected out of hand “because

Respondents cite nothing in the record to support it.” Id. at 11. According to ResMed, “the ’487

application as filed did contain claims that support the ALJ’s decision,” noting that “while

independent claims 15, 29, and 34 do not require an air permeable membrane, independent claim

24, as filed on April 28, 2006 (the filing date of the ‘487 patent) expressly requires the vent to

have an ‘air permeable portion.’” Id. (citing JX-0012 at 29-34).

ResMed states that “if the Commission chooses to alter the ALJ’s construction of “gas

washout vent,” it must also reverse the ALJ’s finding that the claims of the ’487 patent are

invalid as anticipated or obvious over the Kwok PCT because “there is no evidence in the record

that the Kwok PCT discloses a gas washout vent with a “thin air permeable membrane.” Id. at

12.

e. Analysis

The Commission determined to review the ALJ’s construction of the claim term “gas

washout vent” to mean “vent for exhausting gas to the atmosphere,” and simultaneously

construed the limitation to mean “a vent comprising a thin air permeable membrane extending

across an opening for exhausting gas to the atmosphere.” See 79 Fed. Reg. 63163-65 (Oct. 22,

2014). Significantly, the Commission has already construed the exact claim limitation in a

18

PUBLIC VERSION

related patent, the ’587 patent, which shares a common specification with the ’487 patent in all

relevant respects. 879 Advisory Op. at 25-28. Under Federal Circuit precedent the same claim

term must have the same meaning across a family of patents. In re Rambus, 694 F.3d at 48

(“unless otherwise compelled the same claim tenn in the same patent or related patents carries

the same construed meaning”).

In its 879 Advisory Opinion, the Commission affirmed the ALJ’s construction of the

claim limitation “gas washout vent portion” to mean “a vent comprising a thin air permeable

membrane extending across an opening for exhausting gas to the atmosphere,” finding that the

patentees made “repeated” and “clear and unmistakable” disavowal of gas washout vents that do

not contain membranes. 879 Advisory Op. at 25.

The ALJ purportedly assigned the claim tenn its plain and ordinary meaning. Order N0.

8, Markman Order, at 37. However, giving a claim term its plain and ordinary meaning is

appropriate only if the patentees have not disclaimed claim scope. See SciMed LzfizSys. Inc. v.

Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed. Cir. 2001) (“Where the

specification makes clear that the invention does not include a particular feature, that feature is

deemed to be outside the reach of the claims of the patent, even though the language of the

claims, read without reference to the specification, might be considered broad enough to

encompass the feature in question”). As detailed in the IA’s petition, the same statements the

Commission found resulted in a disclaimer of claim scope in the ’587 patent exist in the ’487

patent at issue in this investigation. The Commission made a determination that those passages

evinced disclaimer of claim scope in the ’587 patent and reaches the same determination here.

NTP, Inc., 418 F.3d at 1293.

19

PUBLIC VERSION

In this investigation, the ALJ relied on the doctrine of claim differentiation to overcome

the statements of disavowal in the patent. See ID at 33. Thus, a question remains as to whether

the doctrine of claim differentiation can be used to overcome an express disavowal. Under

Federal Circuit law, it cannot. “The doctrine of claim differentiation cannot broaden claims

beyond the scope that is supported by the specification.” ATD Corp, 159 F.3d at 541 (“The

presumption that separate claims have different scope ‘is a guide, not a rigid rule”); Multzform

Desiccants, 133 F.3d at 1480 (“the doctrine of claim differentiation cannot broaden claims

beyond their correct scope, determined in light of the specification and the prosecution history

and any relevant extrinsic evidence). Lnaddition, the Federal Circuit has made clear that claim

differentiation only creates a rebuttable presumption, which “will be overcome by a contrary

construction dictated by the written description or prosecution history.” See, e.g. , Seachange,

413 F.3d at 1369 (Fed. Cir. 2005); Retractable Techs., 653 F.3d at 1305; Kraft Foods, 203 F.3d

at 1368.

The ALJ found that “the evidence in the intrinsic record is not as strong” to overcome the

doctrine of claim differentiation. Markman Order No. 8 at 34. That is not the proper inquiry.

The inquiry is not whether the intrinsic evidence is strong enough to overcome claim

differentiation but whether claim differentiation can be used to negate express statements of

disavowal in a patent specification. Here, the Commission has fotmd the evidence strong enough

to establish disclaimer of clam scope. Curtiss- Wright Flow Control Corp. v. Velan, Ina, 438

F.3d 1374, 1381 (Fed Cir. 2006) (holding that claim differentiation cannot contradict the correct

meaning of the claim as defined by the “overall context of this invention and this field of art as

described in the specification”).

20

PUBLIC VERSION

In addition, we agree with Respondents that each of dependent claims 34, 41 and 62

define more specifically how and where the vent is formed and contain additional limitations not

found in the independent claims. As ResMed points out, the claims recite in their entirety:

34. A respiratory mask according to claim 26, wherein the vent is formed on amembranethat is mounted to thepatient interface.

41. A respiratory mask according to claim 39, wherein the vent is formed on amembranethat is mounted on the patient interface.

62. A respiratory mask according to claim 56, wherein the plurality of holes isformed on a membrane attached to the elbow.

’487 patent at col. 9, ll. 10 and ll (emphasis added).

2. ResMed’s Motion to Withdraw the ’487Patent or Alternatively to Find N0Violation with Regard to the ’487Patent Based on the Technical Prong ofDomesticIndustry

a. ResMed’s Motion

On November 7, 2014, ResMed moved to terminate the investigation as to the ’487

patent“) ResMed states that the “ALJ’s findings regarding infringement, validity and the

technical prong of domestic industry are not supported Lmderthe claim construction adopted by

the Commission in its Notice of Review.” ResMed Mot. at 1. ResMed contends, however, that

“because the requested relief sought by ResMed—exclusion of Respondents’ infringing

products~will not be impacted by the outcome of the Investigation regarding the ’487 patent,

there is good cause to terminate the investigation as to the ’487 patent rather than consume

additional resources of the Commission, the ALJ, the Staff, and the private parties by remanding

the Investigation for further proceedings.” Id. ResMed thus moves to withdraw the ’487 patent

and states that “pursuant to 2l0.21(a)(l), ResMed represents that there are no agreements,

'0 See The ResMed Complainants’ Motion to Withdraw the ’487 Patent or Alternativelyto Find No Violation with Regard to the ’487 Patent Based on the Technical Prong of DomesticIndustry. (“ResMed Mot”).

21

PUBLIC VERSION

written or oral, express or implied, between the parties conceming the subject matter of this

Investigation.” Id. As an alternative, ResMed asserts that “because the private parties agree that

the products ResMed identified for the domestic industry requirement for the ’487 patent do not

meet the limitation as construed by the Commission, ResMed would not contest a finding of no

violation on the ’487 patent based on the technical prong of domestic industry.” Id.

Regarding infringement and invalidity, ResMed argues that “[t]here is no expert

testimony applying the Commission’s construction to the Original iVolve N2 mask, or any other

mask,” and so a remand would be required to address those issues. Id. at 5. With respect to the

technical prong for domestic industry, however, ResMed states that “the parties agree that the

ResMed products identified for the ’487 patent do not have a ‘thin air permeable membrane’ as

required by the Commission’s construction.” Id. ResMed observes that “the ALJ’s finding of no

violation of Section 337 with respect to the ’487 patent has been effectively vacated by the

Cormnission’s new construction, which will require a remand and a new initial determination

with respect to the ’487 patent.” ResMed Mot. at 6-7.

ResMed requests that the Commission grant its motion to withdraw its allegations

relating to the ’487 patent, “rather than force the private parties, the ALJ, the Staff, and the

Commission to undergo a costly remand proceeding that will have virtually no impact on the

outcome of this Investigation.” Id. ResMed states that “[d]ue to the unique facts of this

Investigation, and pursuant to Commission Rule 201.4(b), ResMed additionally respectfully

requests the Commission to waive the requirement of Commission Rule 210.21(a) that a motion

to withdraw be filed ‘at any time prior to the issuance of an initial determination on violation of

section 337.”’ Id. As noted above, ResMed states that “should the Commission decide not to

22

PUBLIC VERSION

allow ResMed to withdraw its allegations regarding the ’487 patent at this stage, ResMed

respectfully suggests that the Commission can find no violation of the ’487 patent based on a

finding of lack of proof of the technical prong of the domestic industry requirement.” Id.

b. Respondents’ Response

Respondents argue that the Commission should deny ResMed’s motion to withdraw its

allegations pertaining to the ’487 patent at this late stage. See Respondents’ Response to

ResMed’s Motion to Withdraw the ’487 Patent (“Resp. Mot. Rep.”). According to Respondents,

“[b]ased on the evidence of record, Respondents are entitled to a decision finding that the

accused products do not infringe any of the asserted claims, that the asserted claims are invalid,

and that there is no domestic industry for the ’487 patent.” Id. at l. Respondents ‘arguethat

“ResMed’s motion to withdraw the ’487 patent from this investigation is an improper attempt to

avoid an adverse ruling on infringement and invalidity based on the Commission’s construction

of the ’487 patent.” Id.

Respondents argue that under Commission rule l9 C.F.R. § 2lO.21(a)(2) motions to

withdraw may be filed only before the final ID issues, and not after issuance of the final ID. Id

at 5-6. Respondents further argue that the record evidence establishes that the accused products

do not infringe under the Commission’s construction and demonstrate that the asserted claims of

the 487 patent are invalid. Id. at 8-11.

Respondents agree with ResMed that ResMed’s domestic industry products do not meet

the “gas washout vent” limitation as construed by the Commission and that the Commission

should find that ResMed failed to meet the technical prong of the domestic industry requirement

with respect to the ’487 patent. Id. at 12.

23

PUBLIC VERSION

c. lA’s Response

The IA notes that ResMed admits that under the Commission’s construction of the “gas

washout vent” limitation, a finding of infringement would not be possible based on the current

record, and that a finding that ResMed’s domestic industry products practice the ’487 patent

would not be possible under the Cornmission’s claim construction even if the record were re

opened on remand to take further evidence.“ The IA agrees that “in order to grant ResMed the

relief it seeks, the Commission would be obligated to waive its Rule 2l0.2l(a)(l ), which requires

that a motion to withdraw be made before an initial detennination issues.” Id (citing 19 C.F.R.

§2Ol.4(b) and Align Tech, Inc. vi Int’l Trade Comm ‘n, --F.3d -- 2014 WL 5350419, at *8 (Fed.

Cir. 2014) (“Rule 201.4(b) gives [the Commission] broad authority to waive, suspend, or even

amend its rules”). The IA further agrees “with ResMed that in this circumstance, such an

exception would be appropriate.” Id. The IA submits that the most efficient way to dispose of

this matter is to grant ResMed’s motion to Withdrawthe patent and find the remainder of the

motion moot. Id. In the altemative, the IA does not oppose ResMed’s request that the

Commission determine that its products do not satisfy the technical prong of the domestic

industry requirement. Id.

d. Analysis

The Cormnission has determined to dispose of the ’487 patent Witha finding of no

violation based upon ResMed’s admitted failure to establish the technical prong for domestic

industry under the Comrnission’s construction of “gas washout vent.” The Cormnission takes no

H See Office of Unfair Import Investigations’ Response to ResMed’s Motion toWithdraw the ’487 Patent or Alternatively to Find No Violation with Regard to the ’487 PatentBased on the Technical Prong of Domestic Industry.

24

PUBLIC VERSION

position on infringement and validity of the patent.

ResMed, supported by the IA, moves to withdraw the ’487 patent. However, as both

ResMed and the IA note, the Commission would have to waive its rules to allow ResMed to

withdraw the patent at this late stage. Commission rules permit withdrawal of allegations only

prior to issuance of the final ID. See Commission Rule 2lO.2l(a)(l). While the Commission

can waive its rules to permit withdrawal of the ’487 patent in this investigation after issuance of

the final ID, the Cormnission declines to do so here.

ResMed states that “because the private parties agree that the products ResMed identified

for the domestic industry requirement for the ’487 patent do not meet the limitation [i.e., “gas

washout vent”] as construed by the Commission, ResMed would not contest a finding of no

violation on the ’487 patent based on the technical prong of domestic industry.” ResMed Mot. at

l. Respondents agree with ResMed that ResMed’s domestic industry products do not meet the

“gas washout vent” limitation as construed by the Commission and that the Commission should

find that ResMed failed to meet the technical prong of the domestic industry requirement with

respect to the ’487 patent. The IA “does not oppose ResMed’s request that the Commission

determine that its products do not satisfy the technical prong of the domestic industry

requirement due to a failure of proof.” That is, all the parties agree that there is no violation of

section 337 with respect to the ’487 patent because ResMed failed to show the existence of a

domestic industry that practices the patent.

Respondents argue that the record evidence supports a finding that the accused products

are not infringed and that the asserted claims are invalid. However, ResMed and the IA point out

that, because the investigation proceeded under the ALJ’s construction, there is no expert

25

PUBLIC VERSION

testimony or other evidence applying the Commission’s construction to the accused products and

so a remand would be required to address infringement and validity. Given the posture of this

investigation and the positions of the parties, a remand would not be an appropriate use of public

and private resources.

B. The ’453 Patent

ResMed has asserted the following claims of the ’453 patent in this investigation: claims

2, 4, and 7, which depend from independent claim l. Claim l recites:

1. A humidifier assembly for a CPAP apparatus, comprising

a humidifier including

a base configured to retain a body of liquid therein, at least a portion of thebase being constructed of a heat conducting material,

a top cover, and

a seal disposed between the top cover and the base; and

a cormecting structure configured to connect between the CPAP apparatusand humidifier and allow communication of an outlet of the CPAP apparatuswith an inlet of the humidifier, the cormecting structure including

a housing providing a base portion to support the humidifier thereon, and

a retaining mechanism configured to secure the connecting structure tothe CPAP apparatus,

i wherein the base portion includes a heating element in contact with the heatconducting material of the base of the humidifier.

’453 patent, col. ll, ll. 42-56 (claim 1) (emphasis added).

1. Construction of the Claim Term “A Retaining Mechanism Configured to Securethe Connecting Structure to the CPAP Apparatus”

a. The ID

The ALJ construed the claim term “retaining mechanism configured to secure” to require

“an arrangement of moving parts for holding in place a CPAP apparatus that is configured to

attach the connecting structure to the CPAP apparatus.” ID at 124-25. In construing the claim

26

PUBLIC VERSION

term, the ALJ began with a presumption that the claim Words “secure” and “retaining” should

have different meanings. Id. at 114 (citing Chicago Bd. Options Exchange, Inc, v. Int’l

Securities Exchange, LLC, 677 F.3d 1361, 1369 (Fed. Cir. 2012) (observing that there is a

presumption “that different claim terms have different meanings”). The ALJ found that the

specification “describes two structures for connecting the humidifier to the connecting structure:

a ‘retaining portion 108’ and a ‘securing mechanism 122;’ and one structure for connecting the

CPAP apparatus to the connecting structure: a ‘retaining mechanism l40.’” Id at 118. The ALJ

found “it notable that these structures are not all designated as ‘retaining mechanisms’ but are

instead uniquely identified with labels that reflect their specific functions.” Id. The ALJ

explained that “[t]he two structures on the humidifier side perfonn distinct and complementary

functions: the “retaining portion 108” holds the humidifier in the proper position and the

“securing mechanism 122” locks it in that position. Id. (citing ’453 patent (JX-8) at col. 9, 11.32

35; col. 9,1. 66-col. 10,1. 1).

The ALJ further explained that the “retaining portion alone would not provide a secure

lock, and the securing mechanism alone would not provide the support necessary to hold the

humidifier in position.” Id. According to the ALJ, “[t]he ‘retaining mechanism 140’ on the

CPAP side of the comiecting structure comprises structures that perfonn both of these functions,

including apertures that hold the CPAP apparatus in place by receiving prongs or tabs (the

4: 79‘retaining’ function) and locking members to lock the CPAP apparatus in position (the securing

function)” Id. (citing ’453 patent (JX-8) at col. 10, ll. 9-26). Based on the disclosure of the

different structures, the ALJ found that use of the tenn “retaining mechanism” in conjunction

with the phrase “secure to” suggests specific limitations in the context of the other “retaining”

27

PUBLIC VERSION

and “securing” structures in the specification. Id. at 118-19. Accordingly, the ALJ concluded

that the plain and ordinary meaning of “retaining mechanism configured to secure the connecting

structure to the CPAP apparatus” in claim 1 of the ’453 patent requires “an arrangement of

moving parts for holding in place the CPAP apparatus that is configured to attach the connecting

structure to the CPAP apparatus.” Id.

b. Commission Review

The Commission determined to review the ALJ’s construction of the claim limitation “a

retaining mechanism configured to secure the connecting structure to the CPAP apparatus” and

simultaneously construed the limitation to mean “one or more parts for holding in place the

CPAP apparatus that is configured to attach the connecting structure to the CPAP apparatus”

(See 79 Fed. Reg. 63163-65 (Oct. 22, 2014)), striking the ID’s requirement that the claimed

“retaining mechanism” must include an arrangement of moving parts. See ID at 124-25.

The ALJ based his construction largely on his view that the claimed “retaining

mechanism” must contain moving parts in order to distinguish it from the disclosed “retaining

portion” and “securing mechanism.” ID at 123. The ALJ sought to give the claim terms “secure”

and “retaining” different meanings in deference to the Federal Circuit’s statement “that different

claim terms have different meanings.” Id. (citing Chicago Bd. Options Exchange, Inc. , 677 F.3d

at 1369). However, in seeking to pay heed to the Federal Circuit, the ALJ improperly limited the

claim term to a disclosed embodiment, even though the specification makes clear that the

“securing mechanism” only may include moving parts. The patent, discussing Figure 17 of the

’453 patent, which depicts the only example in the specification of the “retaining mechanism 140

to secure the cormecting structure 100 to the CPAP apparatus,” states that

28

PUBLIC VERSION

The rearward side of the connecting structure 100 provides a retainingmechanism 140 to secure the connecting structure 100 to the CPAPapparatus. It is contemplated that the retaining mechanism 140 may includea series of apertures 142 within the rearward portion of the housing 102.The apertures 142 may receive therein, for example, prongs or tabs (notshown) provided by the CPAP apparatus.”

’453 patent, col. 10, ll. 7-13 (emphasis added). That is, while the “retaining mechanism” may

include moving parts, the “retaining mechanism” is not required to include moving parts.

Liebel-Flarsheim C0, 358 F.3d at 905-O6(“[T]his court has expressly rejected the contention that

if a patent describes only a single embodiment, the claims of the patent must be construed as

being limited to that embodiment.”).

The extrinsic evidence provides additional support. Respondents’ expert testified that

“retaining mechanism” has no special meaning with regard to CPAP devices that requires

moving parts and ResMed’s expert testified that “retaining mechanism” does not require moving

parts in all cases. Bordewick Tr. 790:3-12; 1291; Sheehan Tr. 17-1292:3 (“I’m not requiring

movement in every situation.”).

The IA noted that the three elements, “retaining portion,” “securing mechanism,” and

“retaining mechanism” have distinct features that distinguish them without resorting to

narrowing the construction of “retaining mechanism” to require moving parts. See IA Rep. at

20-21. For example, the patent discussing Figure 15, states that the “retaining portion 108”

“extends generally parallel to the base portion 106 and is spaced above the base portion.” ’453

patent col. 9, ll. 34-38. In addition, the patent also describes a “securing mechanism 122” in

Figure 16 that “includes a resiliently biased pull member 124 that includes one or more locking

lugs 126 extending generally downwardly therefrom.” ‘453 patent col. 9, ll. 45-47. That is, the

patent disclosure provides descriptions for the “retaining portion,” “securing mechanism,” and

29

PUBLIC VERSION

“retaining mechanism” that do not require the retaining mechanism to include moving parts. The

mere fact that the “retaining portion 108” and “securing mechanism 122” connect the humidifier

to the connecting structure does not mean that the “retaining mechanism 140,” which connects

the CPAP apparatus to the connecting structure must perform the functions of the “securing

mechanism” and “retaining mechanism” in the same manner. See 1Dat 118.

Accordingly the Commission determined to review the ID’s construction and struck its

requirement that the claimed “retaining mechanism” must include an arrangement of moving

parts.

2. Whether the REMstar DeviceAnticipates or Renders Obvious the AssertedClaims of the ’453 Patent

a. The ID

The ALJ concluded that the REMstar device does not anticipate the “retaining

mechanism” limitation of claim 1 of the ’453 Patent. ID at 125. The ALJ based his conclusion

on the finding that “[t]he pegs on the REMstar humidifier platform do not have moving parts and

are not a ‘mechanism’ within the context of the ’453 Patent.” Id. The ALJ further found that

“while the REMstar humidifier platfonn holds the REMstar CPAP apparatus in place, it does not

attach these components together because the apparatus can be removed from the platform by

simply lifting upwards.” Id. The ALJ explained that “[t]he connecting apparatus of the REMstar

humidifier platform is thus similar to the ‘retaining portion’ of the ’453 Patent specification,

which only secures the device ‘in position,’” noting his finding that the ’453 patent uses different

terms to describe a “retaining portion,” a “securing mechanism,” and the claimed “retaining

mechanism to secure the connecting structure to the CPAP apparatus.” Id.

30

PUBLIC VERSION

b. Commission Review

In light of the revised claim construction, the Commission determined to review the

ALJ’s finding that the prior art REMstar device does not anticipate the asserted claims of

the ’453 patent. As noted above, the Commission asked the parties to brief the following issue:

The Commission has determined to revise the ALJ’s constructionof the claim limitation “a retaining mechanism” recited in theasserted claims of the ’453 patent and strike the requirement that itrequires an arrangement of moving parts. That is, the claimlimitation “a retaining mechanism configured to secure theconnecting structure to the CPAP apparatus” is construed to mean“one or more parts for holding in place the CPAP apparatus that isconfigured to attach the connecting structure to the CPAPapparatus.” See ID at 124. Please discuss whether the REMstardevice anticipates the asserted claims under the revisedconstruction.

i. Respondents’ Response

Respondents note that the only limitation of claims 1, 2, 4 and 7 that the ALJ found not

anticipated by the REMstar device is the “retaining mechanism configured to secure” the

comiecting structure to the CPAP. Resp. Br. at 8 (citing ID at 127). Respondents argue that thus

if the REMstar device has a “retaining mechanism” U11Cl61‘the Commission’s construction then

the asserted claims are anticipated by the REMstar device. 12 Id.

Respondents contend that the REMstar device has a “retaining mechanism” under the

Commissi0n’s construction because “[t]he platform and CPAP of the REMstar device have peg

and apertures, as well as interlocking shaped parts that fit together like a puzzle" and that

“[t]hese configurations not only attach the CPAP and platform of the REMstar device in normal

12The Commission notes that ResMed did not petition for review of the ALJ’s findingthat asserted claims 1, 4, and 7 of the ’453 patent are anticipated by Schatzl German PatentApplication DE 199 36 499 A1. See ID at 131-132. Thus, the only claim of the ’453 patent thatremains in the investigation is dependent claim 2.

31

R PUBLIC VERSION

use, but even keep the CPAP attached to the platform when the REMstar device is tipped at

significant angles.” Id. Respondents assert that the undisputed evidence demonstrates that the

“REMstar device will keep the CPAP attached to the humidifier assembly during treatment.”

Resp. Pet. at 43. Respondents explain that the REMstar device has three components (shown

below), a humidifier, a platform, and a CPAP flow generator, and that the platform is the

connecting structure. Resp. Br. at 11 (citing Bordewick DWS, RX-2aC at Q/A 61-63).

According to Respondents, “the platform and CPAP apparatus have parts ‘configured to attach

the connecting structure [i.e., the platform] to the CPAP apparatus?” Id.

CPAP Device. \

/ /P|8tf0fm 1 R Humidifier Tank

Specifically, Respondents argue that the CPAP is attached to the platform of the REMstar

32

PUBLIC VERSION

device by pegs on the platform that fit within corresponding holes in the bottom of the CPAP

apparatus that prevent the outlet of the CPAP and the inlet to the humidifier from becoming

detached or moving out of alignment with one another.” Id. at 12 (citing Bordewick DWS, RX

2aC at Q/A 74; Bordewick, Tr. 789113-16; 801:10-802:4). Respondents contend that “[i]f the

CPAP apparatus is bumped in use, these pegs prevent the CPAP from moving so that the

connection between the CPAP and humidifier is preserved and air flow is not intermpted.” Id.

(citing Bordewick, Tr. 802:5-12; Goodman, Tr. 769:24770:6 (“the purpose of the pegs are [sic]

to hold the CPAP exactly in place on the humidifier stand, which is vital to the assured treatment

dLu'ingthe night.”). Respondents add that “the CPAP apparatus and connecting structure of the

REMstar device are shaped to fit together like puzzle pieces” and that the “shape further serves

to hold the CPAP apparatus in proper position on the comiecting structure so that the humidifier

inlet and CPAP apparatus outlet remain connected and air flow is not interrupted during

treatment.” Id. (citing Bordewick DWS, RX-2a(_Iat Q/A 70, 74-78).

Respondents argue that witnesses for ResMed testified that because of the “pegs/holes

and complementary shapes of the CPAP and platform of the REMstar device, the assembled

REMstar device is stably secured together in normal use. Id. at 13 (citing Sheehan RWS, CX

805aC at Q/A 39-42; Sheehan Tr. 1286115-128718;Virr Tr. 164:8-19). Respondents state that

“[t]he fact that the CPAP can be removed by lifting up when not in use has no bearing on

whether it is secure enough to maintain the connection between the CPAP and humidifier”

because “claim 1 does not require that the retaining mechanism lock the CPAP to the connecting

structure.” Resp. Pet. at 44; Resp. Br. at 17-18. Respondents assert that the claimed “retaining

mechanism configured to secure the CPAP to the connecting structure” is met by “one which can

33

PUBLIC VERSION

hold the CPAP sufficiently securely that the humidifier inlet and CPAP outlet remain aligned.”

Id. Respondents state that “[t]he pegs and shape of the REMstar device additionally keep the

CPAP outlet and htunidifier inlet securely aligned and connected during treatment” and as such

constitute a “retaining mechanism configured to secure the connecting structure to the CPAP

apparatus” as required by claim l. Id at 45.

ii. The IA’s Response

The IA argues that the REMStar device anticipates claim l because it has “one or more

parts for holding in place the CPAP apparatus that is configured to attach the connecting

structure to the CPAP apparatus.” IA Br. at 3. The IA contends that “the REMStar’s base (the

‘comiecting structure’) has two pegs that protrude from the end of the base opposite from the

humidifier’s Waterchamber, and that the base of the REMStar CPAP has corresponding holes

which fit over the two pegs. Id at 3-4 (citing RX-002aC (Bordewick WS) at Q/A 74, citing

RDX-0022 (from RX-802 (showing RPX-079)) and RDX-0023 (from RX-790 (showing RPX

081)); ID at 104-05, citing RX-210 (REMStar User Manual) at 3-4; See RX-002aC (Bordewick

WS) at Q/A 74. The IA contends that the pegs and holes are configured to hold the CPAP in

place. Id. (citing Bordewick Tr. at 1015124-lOl6:9) (testifying that the pegs help to constrain

“lateral left to right movement of the CPAP relative to the connecting structure, and the rearward

lateral movement of the CPAP relative to the connecting structure”). The IA further points to

the testimony of John Goodman, the President and CEO of U.S. Expediters (a seller of the

REMStar device), who testified that “the purpose of the pegs [on the REMStar] are to hold the

CPAP exactly in place on the humidifier stand, which is vital to the assured treatment during the

night. And it makes it also sure that the patient, when they’re thinking about other things and

34

PUBLIC VERSION

ready to go to sleep, would be able to hook up the humidifier easily.” Hearing Tr. at 769224

770-6; RX-08 (Goodman WS) at Q/A 7-15, 164-66.

The IA also argues that the “REMStar’s base has cutout geometry next to where the

humidifier’s water chamber is placed, which “fit[s] like a puzzle piece into a correspondingly

shaped portion of the CPAP unit.” Id at 5 (citing RX-002aC (Bordewick WS) at Q/A 75.);

RDX-024 (from RX-119 (RPX-79)) and RDX-025 (from RX-0116 (RPX-0079 and RPX-0081).

The IA notes the testimony of Respondents’ expert that “the negative and positive geometry of

connecting structure and CPAP “interl0ck[] from the front of the CPAP at this point and renders

the CPAP and connecting structure secure with one another in this lateral position, forward,

backward, side to side.” Id. (citing Bordewick Tr. 801110-802:4 (Bordewick). The IA adds that

“[t]hus, the geometry on the base, and the corresponding negative geometry on the CPAP, are

parts that are configured to hold the CPAP in place.” Id. The IA further argues that “the

REMStar’s humidifier chamber also helps to hold the CPAP in place. Id. at 6 (citing Bordewick

Tr. at l0l7:2-10 (“You would be adding an additional stability element with the coupling of the

inlet of the humidifier chamber to the outlet of the CPAP. And so you would get some

constrained movement relative to the forward position and side to side, left to right, lateral, and

vertical movement”). The IA concludes that “the clear and convincing evidence showed that the

REMStar has several parts, both on the base and on the CPAP itself, that hold the CPAP

apparatus in place.” Id. at 7.

iii. ResMed’s Response

ResMed argues that “[t]here is no dispute that the pegs and shaped portion of the

REMstar platform do not ‘attach’ the CPAP device to the platfonn” but that “the pegs and cutout

35

PUBLIC VERSION

serve only to loosely position the CPAP device on the docking station in the horizontal plane.”

ResMed Br. at 9 (citing Sheehan Hearing Tr. at 1286215-1287:4; Bordewick Hearing Tr. at

917:l7-918:6, 919:3-18, 948:l7-25, 951:1-23; Sheehan Hearing Tr. at l237:l6-123812; CX

0805aC at 6-7, Q/A 39-40; Virr Hearing Tr. at 164:8-19). ResMed explains that “[w]hen the

REMstar CPAP device is placed on top of the platform, the round holes and shaped portion on

the bottom of the CPAP device align with the pegs and shaped portion of the platfonn” and that

“the round holes in the bottom of the REMstar CPAP device have a larger diameter than the pegs

of the REMstar platform.” Id. (citing RPX-0079; RPX-0081). ResMed states that consequently,

“when the CPAP is in place on the platform, the pegs fit loosely in the holes and the CPAP can

easily be displaced by jostling.” Id. (citing Virr Hearing Tr. at 164:8-19; Hearing Tr. (Sheehan)

at 1286:15- l287:4; Hearing Tr. (Bordewick) at 917117-918:6, 919:3-18, 948:l7-25, 95 1I1-23;

see also Hearing Tr. (Sheehan) at 1237:17-l238:2; Hearing Tr. at 1092119-109315.) ResMed

adds that “the CPAP device can be removed entirely simply by lifting the CPAP device up fi'om

the platform” and that “the corporate representative from Respironics—the third-party

manufacturer of the REMstar device—testified that ‘gravity’ is the only thing keeping the

REMstar CPAP device on the platform.” Id. (citing JX-0035C at 206:1-3). ResMed adds that

“[t]he pegs of the REMstar platform do not interact with the holes on the bottom of the REMstar

CPAP device in a way that prevents removal: there is no press fit or friction fit between the pegs

and the apertures—the fit is loose” and that there is no locking mechanism to hold the CPAP

securely in place. Id. (citing Sheehan Hearing Tr. l286:l5-1287:4; Hearing Tr. 1094:5-17; see

also Hearing Tr. (Virr) 181:5-12.)

ResMed further argues that the claim language requires “more from the retaining

36

PUBLIC VERSION

mechanism than just aligning the CPAP apparatus with the humidifier,” requiring that the

retaining mechanism “secure the CPAP to the connecting structure.” Id. According to ResMed,

the plain and ordinary meaning of “secure to” is that two objects are attached to or fastened to

each other, and that in normal use, a person would not use the term “secured to” to refer to

something that can be easily displaced or removed or to something that falls off if it is jostled or

tipped. ResMed states that given the plain and ordinary meaning, the AL] correctly found that

“in the context of the phrase ‘secure the comiecting structure to the CPAP apparatus,’ I find that

‘secure . . . to’ connotes attachment, in accordance with its ordinary meaning.” Id. (citing ID at

124-25.). ResMed contends that the ALJ’s conclusion is supported by the record. Id. (citing

(Hearing Tr. (Virr) at 118:9-120:l6, 125:3-126:2, l32:l7-l33:10, 160:16-l6l:l7; Hearing Tr.

(Sheehan) at 1232:6-15.) ResMed asserts that the claim language requiring the CPAP to be

“secured to” the connecting structure must mean something more than just “retained,” because

different terms used in the same claim limitation are to be given different meanings. Id. (citing

CAE Screen Plates Inc. v. Heinrich Fiedler GmbH & C0. KG, 224 F.3d 1308, 1317 (Fed. Cir.

2000); Bicon, Inc. v. Straumann C0., 441 F.3d 945, 950 (Fed. Cir. 2006) (“claims are interpreted

with an eye toward giving effect to all tenns in the claim”).

ResMed further argues that the specification also supports the ALJ’s construction that the

limitation requires that the CPAP device be attached to the connecting structure. Id. (citing ID at

115-119.) ResMed contends that the specification of the ’453 patent contains one example of the

claimed “retaining mechanism configured to secure the connecting structure to the CPAP

apparatus,” and it is the embodiment developed by the inventors and commercialized as

ResMed’s S7/H2i system. (JX-0008 at 10:6-26, Figs. 17 and 18). Specifically, ResMed argues

37

PUBLIC VERSION

that “the ’453 specification provides that the CPAP apparatus has prongs that engage with

apertures on the connecting structure (Id. at 10:6-13.)” and “indicates that the apertures on the

connecting structure have locking mechanisms that engage with the prongs on the CPAP

apparatus, thereby ‘securing’ the connecting structure ‘to’ the CPAP apparatus.” Id. ResMed

points to the disclosure that “[i]t is contemplated that the tabs or prongs on the CPAP apparatus

are provided with a groove therein such that when positioned within the apertures, the locking

members engage within respective grooves to thereby securely and detachably retain the

connecting structure to the CPAP apparatus.” Id. (citing ’453 patent, col. 10, ll. 6-26.)

According to ResMed, “this description demonstrates that the inventors used the term “secure to”

in accordance with its plain and ordinary meaning, i.e., one in which the CPAP apparatus is

fastened or attached to the connecting structure.” Id.

iv. Analysis

The ALJ’s finding that REMstar does not meet the “secure” limitation because it does not

attach or fasten the components together is in error. Accordingly, the Commission has

determined to reverse the ALJ’s finding that the REMstar device does not invalidate the asserted

claims of the ’453 patent.

Claim l recites in relevant part:

a connecting structure configured to connect between the CPAP apparatusand humidifier and allow communication of an outlet of the CPAP apparatuswith an inlet of the humidifier, the connecting structure including

a housing providing a base portion to support the humidifier thereon, and

a retaining mechanism configured to secure the connecting structure tothe CPAP apparatus

’453 patent, col. ll, ll. 47-53. That is, the purpose of the connecting structure, which includes

the “secure” limitation, is to connect the CPAP apparatus to the humidifier to allow

38

PUBLIC VERSION

communication of an outlet of the CPAP apparatus with an inlet of the humidifier. See ’453

patent, col. 9, ll. 25-35. The record evidence shows that the REMstar device has a connecting

structure on which the humidifier and CPAP apparatus are positioned. This connecting structure

has pegs that fit within corresponding holes in the bottom of the CPAP apparatus and prevent the

outlet of the CPAP and the inlet to the humidifier from becoming detached or moving out of

alignment with one another. Bordewick, Tr. 789:l3-16; 80l:10-802:4; Bordewick, Tr. 802:5-12;

Goodman, Tr. 769:24770:6 (“the purpose of the pegs are [sic] to hold the CPAP exactly in place

9on the htunidifier stand, which is vital to the assured treatment during the night. ’). The pegs

provided on the base of the REMstar are shown in the picture below:

See RX-002aC (Bordewick WS) at Q/A 74. The corresponding holes on the base of the

REMStar CPAP that fit over the pegs are shown below:

39

PUBLIC VERSION

See RX-OO2aC(Bordewick WS) at Q/A 74.

The evidence further shows that the CPAP apparatus and connecting structure of the

REMStar device are shaped to fit together like puzzle pieces (shown below) and that shape

“serves to hold the CPAP apparatus in a proper position on the connecting structure so that the

humidifier inlet and CPAP apparatus outlet are connected during use.” Bordewick Tr. 789213

16; 801:10-802:12; RX-002 (Bordewick WS) at Q/A 74-78; ID at 105, 109.

40

PUBLIC VERSION

See RX-002aC (Bordewick WS) at Q/A 75.

u The ALJ found that the REMstar does not meet the “secure” limitation because it does

not attach or fasten the components together. ID at 125. While the ALJ’s construction used the

word “attach,” the ALJ apparently required some kind of locked attachment and excluded

attachments that are not locking from the scope of the construction. See id. The patent, however,

does not require the components to be locked or fastened. The patentee used a broad term

“secm'e,” which in our view encompasses the pegs that fit within corresponding holes in the

bottom of the CPAP apparatus that prevent the outlet of the CPAP and the inlet to the humidifier

from becoming detached or moving out of alignment with one another. See Bordewick Tr. "

789:13-16; 801:10-802212; RX-002 (Bordewick WS) at Q/A 74-78; ID at 105, 109. Indeed, the

undisputed evidence showsthat the REMStar device stays attached when assembled for normal .

41

PUBLIC VERSION

operation, and remains in place even when tipped up to angles of about 45 degrees. See

Bordewick Hearing Tr. 9l7:17-918:6; 948:17-25; 951:1-23.

ResMed supports the ALJ’s understanding and states that the REMstar’s connecting

structure does not interact “in a way that prevents removal: there is no press fit or friction fit

between the pegs and the apertures.” ResMed Br. at 9-10. Unlike other claims in the asserted

patent, however, the “retaining mechanism” in claim 1 is not limited to a locking mechanism. In

contrast, the patent specifically claims locking mechanisms in unasserted claims 29, 30, 58, 59,

81 and 82. See JX-08 (‘453 patent) at 14:4-12, 15:66-16:7, and 17:41-49.

In addition, the specification teaches that use of a locking member is optional, stating:

FIG. 17 shows a rearward side of the connecting structure 100. The rearward sideof the connecting structure 100 provides a retaining mechanism 140 to secure theconnecting structure 100 to the CPAP apparatus. It is contemplated that theretaining mechanism 140 may include a series of apertures 142 within therearward portion of the housing 102. The apertures 142 may receive therein, forexample prongs or tabs (not shown) provided by the CPAP apparatus. As shownin FIG 18, within each aperture 142, a locking member 144 may be provided thatis resiliently biased toward a position that partially encloses the respectiveaperture 142.

’453 patent, col. 10, ll. 6-16 (emphasis added). FIGs 17 and 18 are shown below:

42

PUBLIC VERSION

OFIG. 17

E

@: e». ..'

@

I

. -- -' ,,_ ._%"'_

106 ‘,1

@ W --»_\ @5142 14{~@ _

102

142 1_ 7| 1 s _M4 % V a

140 142 §@"@ 1M;}®3 V ' .-—~

% J_._- _>_/',‘i6 __ .,

FIG. 18

As can be seen, while the embodiment described in FIG 18 shows apertures 142 includmg

43

104

_/-loo

\

/

PUBLIC VERSION

locking members 144, the embodiment described in FIG 17 depicts apertures 142 without

locking member 144, confirming the specification’s disclosure that locking members are optional

and not required components. See Bordewick Tr. at 896:7-897:6 (Bordewick) (claim 1 does not

require a locking mechanism); Tr. l293:l5-18 (Sheehan) (“I’m not requiring the claims of the

patent to have a locking member”).

At bottom, the ALJ found, and ResMed contends, that the connection disclosed in the

REMstar device is not secure enough to disclose the level of security required by the asserted

claims. See ID at 125; ResMed Rep at 30-31. The asserted claims, however, do not indicate the

level or degree of how secure the connection must be but simply require that the connection

allow for communication of an outlet of the CPAP apparatus with an inlet of the htunidifier.

There is no credible dispute that the REMstar discloses this feature. Accordingly, we reverse the

ID’s finding that the REMstar device does not anticipate the asserted claims of the ’453 patent.

3. The ALJ’s Findings on Infringement and Technical Prong of DomesticIndustryfor the ’453Patent

The ID’s findings on infringement and the technical prong of the domestic industry

requirement regarding the ’453 patent are also under review. See 79 Fed. Reg. 63163-65 (Oct.

22, 2014). Because the Commission’s construction of the claim term of the ’453 patent that was

reviewed is broader than the construction in the ID, the ALJ’s findings that the accused devices

infringe the asserted claims of the ’453 patent and that the domestic industry products practice

the ’453 patent are still valid under the Commission’s construction. Indeed, Respondents do not

contest the ALJ’s findings in light of the Commission’s construction of the “retaining

mechanism” limitation. See Resp. Rep. 19.

44

PUBLIC VERSION

C. Economic Prong of Domestic Industry Under 19 U.S.C. § 1337(a)(3)(C)

The Commission also determined to review the ID’s findings and conclusions regarding

the economic prong of the domestic industry requirement under 19 U.S.C. § 1337(a)(3)(C). 79

Fed. Reg. 63163-65 (Oct. 22, 2014). On review, the Commission has determined to vacate the

ALJ’s finding and discussion that ResMed established a domestic industry under 19 U.S.C.

§ 1337(a)(3)(C).13

V. REMEDY

A. Limited Exclusion Order

1. Summary of the Issue and Parties’ Arguments

The ID included the ALJ’s recommended determination on remedy and bonding. The

ALJ recommended that in the event the Commission finds a violation of section 337, the

Commission should issue a limited exclusion order directed to the respondents, including their

principals, stockholders, officers, directors, employees, agents, licensees, distributors, controlled

and/or majority-owned business entities and their employees and agents, successors and assigns.

ID at 194-95 (citing Certain Electronic Devices, Including Mobile Phones and Tablet Computers,

and Components Thereofl lnv. No. 337-TA-847, Recommended Determination at 220

(September 23, 2013) (recormnending limited exclusion order to cover all infringing articles and

applying the order to “affiliated companies, parents, subsidiaries, or other related business

entities, ortheir successors or assigns.”)). I

The IA and ResMed support the ALJ’s recommendation that the Commission should

issue a limited exclusion order directed to Respondents. See IA Br. at 11; ResMed Br at 29-30.

13The Commission determined not to review the ALJ’s finding that ResMed establishedthe existence of a domestic industry under 19 U.S.C. §§ 1337(a)(3)(A) and (B).

45

PUBLIC VERSION

Respondents argue that any remedial orders should be limited to products covered by the claims

of any patents found to be valid and infringed. Resp Br. at 26. Respondents further argue that

“any orders should permit the Respondents to repair, service or provide customer assistance as to

any humidifiers on CPAP devices that have already been sold to customers” and that “[i]f

Respondents are not permitted to service and repair CPAP devices that have already been sold by

Respondents, U.S. consumers and the public interest will be detrimentally affected.” Id. at 26

27. Respondents also argue that “any order should be limited to the named parties and should

not extend to “agents, licensees, and distributors,”'because those entities are not parties to the

investigation and that “Complainants have not provided any justification for including them in

any orders to be issued by the Commission.” Id. ‘

In response, the IA does not oppose Respondents’ request that they should be allowed to

repair, service and provide customer assistance as to any humidifiers on CPAP devices that have

already been sold to customers. The IA, however, opposes Respondents’ request that any

remedial order exclude Respondents’ agents, licensees, and distributors. The IA observes that

“such entities are part of the Cornmission’s standard language for remedial orders, which is

intended to prevent circumvention of such orders. .

2. Analysis

Section 337(d)(1) requires that “[i]f the Commission detennines, as a result of an

investigation under this section, that there is a violation of this section, it shall direct that the

articles concerned, imported by any person violating the provision of this section, be excluded

from entry into the United States . ..” 19 U.S.C. § 1337 (d)(l). As discussed above, we agree

with the ALJ that a violation of section 337 has occurred with respect to certain asserted claims.

46

PUBLIC VERSION

Thus, the Commission agrees with the ALJ’s recommendation and issues a limited exclusion

order directed to Respondents’ products that infringe those claims. The Commission also agrees

with the ALJ and IA and continues its practice of extending the exclusion order to Respondents’

and their affiliates. See ID at 194-95. Respondents do not present a persuasive argument for

deviating from normal Commission practice.

The Conunission includes an exemption for service and replacement parts for customers

that purchased their covered products prior to the date this Order becomes final. As

Respondents’ argue, such an exemption is in keeping with Commission precedent. See Resp Br.

at 26-27.

B. Cease and Desist Orders

1. Summary of the Issue and Parties’ Arguments

The ALJ also recommended issuance of cease and desist orders. The ALJ found that the

evidence shows that there are commercially significant inventories of at least some of the

infringing products, noting that cease and desist orders are not product-specific. ID at 195-96

(citing Certain Kinesiotherapy Devices and Components Thereofl Inv. No. 337-TA-823,

Corrected Order to Cease and Desist (February 7, 2014))

The IA agrees with the ALJ that cease and desist orders should issue, but only as to those

claims for which ResMed has established that commercially significant inventory of infringing

products exists domestically. IA Br. at ll-l3. In that regard, the IA argues that cease and desist

orders should be directed to Respondents 3B Medical, Inc. and 3B Products, LLC, targeting

products covered by claims 30 and 37-38 of the ’060 patent; claims 1, 3, 5, 11, 28, 30, 31, and 56

of the ’883 patent; and claims 32-34 of the ’267 patent. The IA argues, however, that the cease

47

PUBLIC VERSION

and desist orders should not be directed towards products that are covered by the asserted claims

of the ’527 and ’392 patents and claim 53 of the ’267 patent because the only products asserted

to infringe these claims are the redesigned iVolve products, of which there is allegedly no

evidence of commercially significant inventory in the United States. Ia’.(citing ID at 8, 23, 46,

57-58). The IA thus argues that the Commission should limit the cease and desist orders to only

those patent claims for which ResMed has established that commercially significant inventory of

infringing products exists in the United States. See IA Br. at 11-13.

Respondents argue that cease and desist orders should not issue because their “US

inventories are not commercially significant compared to either ResMed’s sales or the industry

in general.” Resp. Br. at 28. Respondents further argue that “any orders should permit the

Respondents to repair, service or provide customer assistance as to any humidifiers on CPAP

devices that have already been sold to customers.” Id. at 26.

2. Analysis

As recommended by the ALJ, the Commission has detennined to issue cease and desist

orders under 19 U.S.C. §1337(t) directed to Respondents 3B Medical, Inc. and 3B Products,

LLC.

The Commission generally issues cease and desist orders “when there is a commercially

significant amount of infringing imported product in the United States that could be sold so as to

undercut the remedy provided by an exclusion order.” Certain Protective Cases and

Components Thereoj‘, Inv. No. 337-TA—78O,Comm’n Op. (Pub. Version) at 28 (Nov. 19, 2012)

(quoting Certain Laser Bar Code Scanners and Scan Engines, Components Thereof and

Products Containing Same, Inv. No. 337-TA-551, Com1n’n Op. (Pub. Version) at 22 (June 14,

48

PUBLIC VERSION

2007)). Complainants bear the burden of proving that respondents have commercially

significant inventories of infringing products in the United States. Certain Integrated Repeaters,

Switches, Transceivers, and Products Containing Same, lnv. No. 337-TA-435, Comrn’n Op. at

27 (Aug. 16, 2002). The record evidence shows that Respondents 3B Medical, Inc. and 3B

Products, LLC have commercially significant inventories of infringing products in the United

States. Vander Veen DWS, CX-765aC at Q/A 119-124; CX-154C; CX-333C; CDX-l2.59aC.

Thus, cease and desist orders are warranted.

The Commission declines to restrict issuance of cease and desist orders to only the patent

claims for which it was established that commercially significant inventory of infringing

products exists in the United States.'4 In this investigation, the undisputed evidence shows that

there is commercially significant inventory of certain accused products in the United States.

Accordingly, the Commission determines that issuance of cease and desist orders directed to all

asserted patent claims is warranted.

VI. THE PUBLIC INTEREST

Sections 337(d) and (f) of the Tariff Act of 1930, as amended, direct the Commission to

consider certain public interest factors before issuing a remedy. These public interest factors

H Commissioner Johanson is of the view that the cease and desist orders againstRespondents 3B Medical, Inc. and 3B Products, LLC should not be directed to the assertedclaims of the ’527 and ’392 patents, as well as claim 53 of the ’267. The Complainant has failedto demonstrate that the Respondents maintain a commercially significant inventory of the iVolveproducts (i.e., the only “covered” products folmd to infringe the asserted claims of the ’527and ’392 patents, as well as claim 53 of the ’267). Thus, there is insufficient evidence thatdomestic inventory of the iVo1veif sold would undercut the remedy provided by the exclusionorder issued in this investigation. See Protective Cases and Components Thereof, Inv. No. 337TA-780, Con1m’n Op. (Pub. Version) at 28 (Nov. 19, 2012); see also Certain CrystallineCefadroxil Monohydrate, Inv. No. 337-TA-293, Comm’n Op., 1990 WL 10008086, at *14-*15(Mar. 21, 1990).

49

PUBLIC VERSION

include the effect of any remedial order on the “public health and welfare, competitive

conditions in the United States economy, the production of like or directly competitive articles in

the United States, and United States consumers." 19 U.S.C. §§ l337(d) and (f).

The IA and ResMed argue that the public interest factors are not implicated in this

investigation and that a limited exclusion order directed to Respondents’ infringing products

would not be contrary to the public interest. IA Br. at 10-11. The IA points to evidence showing

that ResMed has a large share of the market in every product category at issue, and that there are

multiple manufacturers besides ResMed and BMC in all of the accused product categories. Id

(citing Yerbury Tr. at 16:9-17:5 (full face mask Mirage Quattro has [ ] market share), id. at

25:1-4 (ResMed has [ ] of nasal pillows market), id. at 65:15-17 (ResMed’s market share in

the three categories of masks and pillows totals [ ]); id. at 65:22-25 (ResMed is market leader

for masks); CX-266C (U.S. Sleep Market Dashboard) at 24-28, 31, 32, 34, 38, 41, 42, and 45).

The IA argues that in contrast, Respondents’ inventory in the United States is quite small relative

to ResMed’s U.S. sales and so exclusion of their accused products would not significantly affect

competitive conditions in the U.S. CPAP or CPAP mask markets, the production of like or

directly competitive articles in the U.S., or U.S. consumers. Id. (citing CX-765C (Vander Veen

WS) at Q/A 120; CX-154C (Respondent 3B Medical inventory report showing between [ ]

and [ ] units of accused products); at Q/A 27 ([ ] units of S9 flow generator with

H5i humidifier sold by ResMed in 2013) and id. at Q/A 35 (showing ResMed’s 2013 sales of

domestic industry masks was greater than [ ] units).

Respondents argue that the industry for CPAP devices and interfaces has few suppliers.

According to Respondents, they provide “high quality products at a significantly lower cost to

50

PUBLIC VERSION

the government, and the exclusion of their products could undennine the Affordable Care Act’s

competitive bidding program’s mission.” Resp Br. at 30. Respondents note that they do not

contend that relief should be denied in this investigation based on the public interest, if the

Commission finds a violation, but that given the important public interest involved in sleep

apnea treatment, any remedial orders should be carefully and narrowly crafted.

The Commission agrees with the IA and ResMed that the public interest factors do not

weigh against issuance of the above-described remedial orders in this investigation.

Significantly, the evidence shows that United States demand for CPAP devices and interfaces

can be met by ResMed and non-infringing models offered by others. While Respondents

contend that “the exclusion of their products could undermine the Affordable Care Act’s

competitive bidding program’s mission,” and that their products are of high quality, Respondents

do not substantiate these assertions with any evidence or explanation of how the public interest

considerations would be adversely impacted. Accordingly, the Commission finds that the public

interest factors set out in section 337(d) and (f) do not preclude issuance of the orders.

Moreover, the Commission has determined to mitigate any potential impact on

consumers who have already purchased Respondents’ products prior to the date of this order by

exempting from the scope of the orders products used for service and repair of devices that are in

consumers’ hands as of the date of this order.

VII. BOND

During the 60-day period of Presidential review, imported articles otherwise subject to

remedial orders are entitled to conditional entry under bond. 19 U.S.C. § 1337(j)(3). The amount

of the bond is specified by the Commission and must be an amount sufficient to protect the

51

PUBLIC VERSION

complainant from any injury. Id.; 19 C.F.R. § 2lO.50(a)(3).

The AL] observed that the private parties stipulated to a bond amount of 65% of the

entered value of products imported during the period of Presidential review, and the IA agreed

that that rate would be appropriate. ID at 196. The ALJ found no reason to alter the stipulated

rate and recommended that the Commission set a bond in the amount of 65% of the entered

value of products imported during the period of Presidential review.

Accordingly, the Commission has determined to set a bond of 65% of the entered value

of infringing products imported during the period of Presidential review.

By order of the Commission. 7%Lisa R. BartonSecretary to the Commission

Issued: January 16, 2015

52

CERTAIN SLEEP-DISORDERED BREATHING Inv. N0. 337-TA-890TREATMENT SYSTEMS AND COMPONENTS THEREOF

PUBLIC CERTIFICATE OF SERVICE

I, Lisa R. Barton, hereby certify that the attached COMMISSION NOTICE has beenserved by hand upon the Commission Investigative Attorney, Lisa M. Kattan, Esq., and thefollowing parties as indicated, on January 20, 2015.%

Lisa R. Barton, SecretaryU.S. International Trade Commission500 E Street, SW, Room 112Washington, DC 20436

On Behalf of Complainants ResMed Corporation. ResMedIncorporated, and ResMed Limited:

Thomas S. Fusco, Esq.FISH & RICHARDSON P.C.1425 K Street, NW, 11th FloorWashington, DC 20005

El Via Hand DeliveryEl Via Express DeliveryVia First Class Mai]l:l Other:

On Behalf of Respondents BMC Medical C0.. Ltd., 3BMedical. Inc.. and 3B Products. LLC:

Gary M. Hnath, Esq.MAYER BROWN LLP1999 K Street, NWWashington, DC 20006

U Via Hand Deliveryl:l Via Express DeliveryVia First Class MailEl Other:

Frederick P. Fish185$-I950

WK Richardson18ssH9s1

fitATLANTA

AUSTIN

BOSTON

DALLAS

DELAWARE

NEW YORK

SAN DIEGO

SILICON VALLEY

TWIN CITIES

WASHINGTOK DC

FISH at RICHARDSON P.C.14.2; K STREET,N.W.urn FLOORWasnmcrou, DC 20005

-\--r

Telephone

_ 3C.K:=

CB‘ ' g 8 NuMEER

l I g _ .—¥ 202. 783-5070

i Facsimilezoz 783-2331VIA HAND DELIVERY

____________________________________ Web Site

Olfice of the ""“"”-fr-°°"1

July 19, 2013 Secmaw. 1 r| r a- ‘ "

The Honorable Lisa R. Barton n ra LCommlssmn

Acting SecretaryU.S. Intemational Trade Commission500 E Street, S.W.Washington, D.C. 20436

Re: Certain Sleep-Disordered Breathing Treatment Systems And ComponentsThereof, Inv. No. 337-TA-___

Dear Secretary Barton:

Enclosed for filing on behalf of ResMed Corp., ResMed Inc., and ResMed Ltd(collectively “ResMed”), are the following documents in support of Complainant’srequest that the Commission commence an investigation pursuant to the provisions ofSection 337 of the Tariff Act of I930, as amended, 19 U.S.C. §1337. Please note thatConfidential Exhibits 92, 93 and 94 to the Complaint contain Confidential BusinessInformation and pursuant to the Commission’s Rules of Practice and Procedure, arequest for confidential treatment of the infonnation in those exhibits accompaniesthis filing. Accordingly, Complainant submits the following:

1. One original and eight (8) paper copies of Comp1ainant’s NonConfidential Verified Complaint and the Public Interest Statement(original unbound); one (1) CD of the Non-Confidential Exhibits, and one(1) CD of the Confidential Exhibits (Commission Rules 201.6(0),2l0.4(f)(2) and 2l0.8(a)(l)(i) and 20l.8(b));

2. Three (3) additional copies of the Verified Non-Confidential Complaint,the Public Interest Statement, and three (3) CDs of the Non-ConfidentialExhibits for service upon each proposed respondent (Commission Rules2l0.8(a)(l)(iii) and 210.11(a));

3. Three (3) additional copies of the Confidential Exhibits on CD, one foreach proposed respondent (Commission Rules 210.8(a)(l)(iii) and210.1 1(a));

4. One (1) additional copy of the Non-Confidential Verified Complaint forservice upon the Embassy of China (Commission Rules 210.8(a)(1)(iv)and 210.1 l(a)(1)(ii));

FISH at RICHARDSON P.C.

The Honorable Lisa R. BartonJuly 19, 2013Page 2

One (l) certified copy of each of the following asserted United StatesPatents: U.S. Patent No. 7,938,116 (“the ’116 patent”), identified asExhibit 3 in the Complaint, U.S. Patent No. 7,341,060 (“the ’060 patent”),identified as Exhibit 5 in the Complaint, U.S. Patent No. 8,312,883 (“the’883 patent”), identified as Exhibit 4 in the Complaint, U.S. Patent No.7,178,527 (“the ’527 patent”), identified as Exhibit 6 in the Complaint,U.S. Patent No. 7,950,392 (“the ’392 patent”), identified as Exhibit 7 inthe Complaint, and U.S. Patent No. 7,926,487 (“the ’487 patent”),identified as Exhibit 8 in the Complaint. Certified copies of U.S. PatentNo. 7,997,267 (“the ’267 patent”), identified as Exhibit l in theComplaint, and U.S. Patent No. 7,614,398 (“the ’398 patent”), identifiedas Exhibit 2 in the Complaint, will be submitted upon receipt;

One (1) copy of the assignments for the ’267 patent identified as Exhibit10 in the Complaint. A certified copy will be submitted upon receipt;

One (1) copy of the assigmnents for the ’398 patent identified as Exhibitll in the Complaint. A certified copy will be submitted upon receipt;

One (1) certified copy of the assignments for the ’l l6 patent identified asExhibit 12 in the Complaint;

One (1) certified copy of the assignments for the ”883 patent identified asExhibit 13 in the Complaint;

One (1) certified copy of the assignments for the ’060 patent identified asExhibit 14 in the Complaint;




One (1) copy of the prosecution history of the ’267 patent identified asAppendix A in the Complaint and four (4) additional copies on separateCD5. (Commission Rules 2l0.l2(c)( 1)). A certified copy will be submittedupon receipt;

Frsn 81 RICHARDSON r>.c.


l5. One (1) copy of the prosecution history of the ’398 patent identified asAppendix B in the Complaint and four (4) additional copies on separateCDs. (Commission Rules 2l0.l2(c)(1)). A certified copy will be submittedupon receipt;

16. One (l) certified copy of the prosecution history of the ’116 patentidentified as Appendix C in the Complaint and four (4) additional copieson separate CDs. (Commission Rules 2l0.l2(c)(l));

One (1) certified copy of the prosecution history of the ’060 patentidentified as Appendix D in the Complaint and four (4) additional copieson separate CDs. (Commission Rules 2l0.l2(c)(l));

One (1) certified copy of the prosecution history of the ’883 patentidentified as Appendix E in the Complaint and four (4) additional copieson separate CDs. (Commission Rules 2l0.l2(c)(l));

One (1) copy of the prosecution history of the ’527 patent identified asAppendix F in the Complaint and four (4) additional copies on separateCDs. (Commission Rules 2l0.l2(c)(1)). A certified copy will be submittedupon receipt;

One (1) copy of the prosecution history of the ’392 patent identified asAppendix G in the Complaint and four (4) additional copies on separateCDs. (Commission Rules 2l0.l2(c)( 1)). A certified copy will be submittedupon receipt;

One (1) copy of the prosecution history of the ’487 patent identified asAppendix H in the Complaint and four (4) additional copies on separateCDs. (Commission Rules 2l0.l2(c)( 1)). A certified copy will be submittedupon receipt;

Four (4) copies of each relevant cited reference identified in theprosecution histories of the asserted patents, identified as Appendices l-Pin the Complaint (Commission Rule 210.l2(c)(2));

23. Physical samples of: the ResMed Quattro FX Full Face Mask, identified asExhibit Pl; the ResMed Mirage Quattro Full Face Mask, identified asExhibit P2; the ResMed Mirage Activa LT Nasal Mask, identified asExhibit P3; the ResMed S9 Series CPAP identified as Exhibit P4; and theBMC and 3B RESMart Auto-CPAP, identified as Exhibit P5; and

FISH st RICHARDSON P.C.


24.

13

A letter of certification pursuant to Commission Rules 201.6(b) and21O.5(d)requesting confidential treatment of information appearing inConfidential Exhibits 92, 93 and 94 to the verified Complaint.

Respectfully submitted,

/2 E%@/’Thomas S. Fusco

Counsel for ResMed Corp., ResMed Inc., and ResMed Ltd

Enclosures

Frederick P. Fish

1855-1930

WK. Richardson1859-1951

6*ATLANTA

AUSTIN

BOSTON

DALLAS

DELAWARE

NEW YORK

SAN DIEGO

SILICON VALLEY

TWIN CITIES

WASHINGTON DC

FISH at RICHARDSON P.C.1425 K STREET,N.\V.rm-1 FLooR

WASHINGTON,DC 20005

Telephone202 783-5070

Facsimile

303 783-3331

Web Sitewww.fr.comJuly 19, 2013

The Honorable Lisa R. BartonActing SecretaryU.S. International Trade Commission500 E Street, S.W.Washington, D.C. 20436

Re: Certain Sleep-Disordered Breathing Treatment Systems And ComponentsThereof, Inv. No. 337-TA-_

Dear Secretary Barton:

In accordance with 19 C.F.R. §§ 201.8(g) and 210.5, ResMed Corp., ResMedInc., and ResMed Ltd, (collectively “ResMed”) request confidential treatment for thebusiness information contained in Confidential Exhibits 92, 93, and 94.

The information for which confidential treatment is sought is proprietarycommercial infonnation not otherwise publicly available. Specifically, ConfidentialExhibit 92 contains proprietary information regarding Complainants’ domesticindustry, including information relating to the financial performance and commercialoperations of Complainants, sales and marketing information, inventories, and otherinformation of commercial value to Complainants. Exhibits 93 and 94 similarlycontain proprietary commercial information regarding Complainant’s licensing of theasserted patents.

The information described above qualifies as confidential businessinformation pursuant to Rule 201.6(a) because:

l. It is not publicly available ;

2. Unauthorized disclosure of such information could cause substantial harmto the competitive position of ResMed; and

3. The disclosure of such infonnation could impair the Commission’s abilityto obtain information necessary to perform its statutory function.

F151-I at RICHARDSON P.C.


Please contact me if you have any questions about this request, or if this request is notgranted in full.

Respectfully submitted,/Z %/ m %.Cr’Thomas S. Fusco

Counsel for ResMed Corp., ResMed Inc., and ResMed Ltd

Enclosures

UNITED STATES INTERNATIONAL TRADE COMMISSIONWASHINGTON, D.C. 20436

In the Matter of

CERTAIN SLEEP-DISORDERED Investigation No. 337-TABREATHING TREATMENT SYSTEMSAND COMPONENTS THEREOF

RESMED COMPLAINANTS’ STATEMENTON THE PUBLIC INTEREST

Pursuant to U.S. Intemational Trade Commission (“Commission”) Rule § 2l0.8(b),

Complainants ResMed Corp., ResMed Inc., and ResMed Ltd (“ResMed” or “Complainants”)

submit this Statement on the Public Interest with respect to the remedial orders it seeks against

Respondents BMC Medical Co., 3B Medical, Inc., and 3B Products, L.L.C. (collectively,

“Respondents”).

ResMed seeks a limited exclusion order specifically directed to each named Respondent

excluding from entry into the United States certain sleep disordered breathing treatment systems

and components thereof that infringe U.S. Patent No. 7,997,267, “Ergonomic And Adjustable

Respiratory Mask Assembly With Elbow Assembly,” (“the ’267 patent”), U.S. Patent No.

7,614,398, “Humidifier With Structure To Prevent Backflow Of Liquid Through The Humidifier

Inlet,” (“the ’398 patent”), U.S. Patent No. 7,938,116, “Ergonomic And Adjustable Respiratory

Mask Assembly With Headgear Assembly,” (“the ’l 16 patent”), U.S. Patent No. 7,341,060,

“Ergonomic And Adjustable Respiratory Mask Assembly With Headgear Assembly,” (“the ’O6O

patent”), U.S. Patent No. 8,312,883, “Nasal Assembly,” (“the ’883 patent”), U.S. Patent No.

7,178,527, entitled “Nasal Mask And Mask Cushion Therefor,” (“the ‘S27 patent”), U.S. Patent

No. 7,950,392, entitled “Cushion And Mask Therefor,” (“the ’392 patent”), or U.S. Patent No.

1

7,926,487, entitled “Respiratory Mask Having Gas Washout Vent And Gas Washout Vent

Assembly For A Respiratory Mask,” (“the ’487 patent”) (collectively, “the Asserted Patents” or

“the ResMed Patents”). ResMed also seeks a pennanent cease and desist order, pursuant to

Section 337(1),halting the importation, sale, offer for sale, marketing, advertising, or soliciting

of sleep disordered breathing treatment systems and components thereof by Respondents and

their related companies that infringe one or more of the Asserted Patents. Issuance of the relief

requested will not adversely impact the public health, safety, or welfare conditions in the United

States, competitive conditions in the United States economy, the production of like or directly

competitive articles in the United States, or United States consumers. Thus, this Investigation

does not present an instance where the Commission, the parties, and the public should be

required to undergo the time and expense of discovery and trial for a Recommended

Determination by the ALJ on the public interest.

Issuance of the requested remedial orders will provide effective relief in the face of

ongoing and open patent infringement in the United States by the proposed Respondents.

Protecting ResMed’s intellectual property rights and associated domestic industry in the United

States through the requested remedial orders will accordingly serve the public interest while

having little or no adverse effect on the public interest. In fact, the public interest is served by

granting the requested remedial orders.

I. THE REQUESTED REMEDIAL ORDERS ARE IN ACCORD WITH THEPUBLIC INTEREST

There is a strong public interest in protecting intellectual property rights. Certain

Baseband Processor Chips and Chipsets, Transmitter and Receiver (Radio) Chip, Power Control

Chips, Inv. No. 337-TA-543, USITC Pub. 4258 (Nov. 2011) (“Baseband Processor Chips”). In

this case, the requested remedial orders are in accord with the public interest for at least the

2

following reasons: (l) exclusion of the accused products will not have an adverse effect on the

public health or welfare, as those issues are defined by the Commission; (2) ResMed’s sleep

disordered breathing treatment systems a.ndcomponents thereof directly compete with, and are

substitutes for, Respondents’ infringing products in the United States; (3) only a small subset of

the industry selling or offering for sale certain sleep-disordered breathing treatment systems and

components thereof in the United States would be barred; and (4) ResMed and third parties will

be in a position to fill any void in the market caused by the requested remedial orders. As such,

the public interest in protecting ResMed’s intellectual property rights outweighs any potentially

adverse impact on the public.

A. How the articles potentially subject to the remedial orders are used in theUnited States

The accused products at issue in this Investigation are certain sleep-disordered breathing

treatment systems and components thereof. The accused products are used primarily in the

treatment of obstructive sleep apnea by delivering pressurized air to the user in a way that keeps

the user’s breathing passages open during sleep. The accused products are commonly referred to

as “CPAP” systems, an acronym that stands for “continuous positive airway pressure.” CPAP

systems generally consist of a flow generator, a flexible com1ectorsuch as a hose, an interface

such as a mask for delivering the pressurized air to the user, and an optional humidifier.

Each of the accused products infringes ResMed’s patent rights. The infringing products

are imported into, sold for importation into, and/or sold alter importation in the United States by

or on behalf of the Respondents identified in the Complaint.

B. Identification of any public health, safety, or welfare concerns in the UnitedStates relating to the requested remedial orders

The issuance of the requested remedial orders would not adversely affect the public

health, safety, or welfare in the United States. While Respondents’ products are used in the

3

treatment of obstructive sleep apnea, their products represent a small portion of the market. The

number of patients who would be affected by remedial orders directed to Respondents’

infringing products is relatively small, and ResMed is more than capable of supplying substitutes

for Respondents’ excluded products, thus overriding any concerns regarding whether the

remedial orders would adversely affect the public health. Moreover, because the infringing

sleep-disordered breathing treatment systems and components thereof represent a relatively small

amount of the U.S. market, any remedial orders will not have a significant effect on the market

for such products as products are otherwise available from ResMed and other sources.

C. Identification of like or directly competitive articles that ResMed, itslicensees,or third parties make which could replace the subject articles ifthey were excluded

The accused products in this Investigation are certain sleep-disordered breathing

treatment systems and components thereof. There are directly competitive products that could

replace the accused products if the accused products were excluded from the United States,

including, but not limited to, ResMed’s Quattro FX, Quattro FX For Her, Mirage Vista, Mirage

Quattro, Mirage Micro, Mirage FX, Mirage FX For Her, Mirage Liberty, Swift 1, Swift II, Swift

LT, Swift LT for Her, and Mirage Activa LT masks; the S9 and other models of flow generators;

and the H5i and other models of heated humidifiers.

D. ResMed, its licensees, and/or third parties will be in a position to replace thevolume of articles subject to the requested remedial orders in a commerciallyreasonable time in the United States

ResMed and/or other manufacturers, some of whom are large companies, have sold and

continue to sell competitive sleep-disordered breathing treatment systems and components

thereof in the United States that are similar to the infringing products that are the subject of the

Complaint. Therefore, ResMed-and/or other manufacturers will be able to replace the infringing

4

products subject to the requested remedial orders within a commercially reasonable time in the

United States.

E. The requested remedial orders will not adversely impact U.S. consumers

The issuance of exclusion and cease and desist orders in this Investigation banning the

accused products will not adversely impact consumers in the United States. ResMed will be able

to adequately supply and meet the demand of the United States market. In addition, there are

other third parties that supply competitive products to the United States market. Even if the

remedial orders caused a slight increase in the price of certain sleep-disordered breathing

treatment systems and components thereof, a price increase alone is insufficient to warrant

preclusion of a remedial order. See Certain Lens-Fitted Film Packages ("LFFPs ”), Inv. No.

337-TA-406, Comm’n. Op., 1999 ITC LEXIS 202 at *4O(June 28, 1999) (finding that some

price increase “does not justify a detennination that the public interest in protecting intellectual

property rights is in any way outweighed”). Given that there would be no unfilled void because

there are substitute products, including those made and sold by ResMed and other parties that

could replace the volume of the excluded articles, any impact to the public interest by the

exclusion of Respondents’ infringing products will be minimal.

II. CONCLUSION

If the Commission grants the requested remedial orders, the public interest will be served.

Exclusion of the accused products will not adversely affect the public health or welfare, and an

adequate supply of substitute devices will be available through at least ResMed and other parties.

As such, the strong public interest in protecting ResMed’s valid intellectual property rights

outweighs any adverse impact on the public.

5

Dated: July 18, 2013


FISH & RICHARDSON P.C.

Roger DenningSeth M. SproulScott PennerFISH & RICHARDSON P.C.12390 El Camino RealSan Diego, CA 92130Telephone: (858) 678-5070Facsimile: (858) 678-5099

Thomas “Monty” FuscoW. Peter GuarnieriFISH & RICHARDSON P.C.1425 K Street, N.W., 11°“FloorWashington, D.C. 20005Telephone: (202) 783-5070Facsimile: (202) 783-2331

Frank E. ScherkenbachFISH & RICHARDSON P.C.One Marina Park DriveBoston, MA 02210-1878Telephone: (617) 542-5070Facsimile: (617) 542-8906

Michael J. KaneFISH & RICHARDSON P.C.3200 RBC Plaza60 South Sixth StreetMinneapolis, MN 55402Telephone: (612) 335-5070Facsimile: (612)288-9696

Counselfor ComplainantsResMed C0rp., ResMed Ina,and ResMedLtd

UNITED STATES INTERNATIONAL TRADE COMMISSIONWASHINGTON, D.C. 20436

In the Matter of

CERTAIN SLEEP-DISORDERED Investigation N0. 337-TABREATHING TREATMENT SYSTEMSAND COMPONENTS THEREOF

COMPLAINT OF RESMED LTD, RESMED INC., AND RESMED CORPUNDER SECTION 337 OF THE TARIFF ACT OF 1930, AS AMENDED

COMPLAINANTS

ResMed Corp9001 Spectrum Center DriveSan Diego, CA 92123USATelephone: (858)-836-5000

ResMed Inc.9001 Spectrum Center DriveSan Diego, CA 92123USATelephone: (858)-836-5000

ResMed Ltd1 Elizabeth Macarthur DriveBella Vista NSW 2153AustraliaTelephone: +61 (2) 8884 1000

COUNSEL FOR COMPLAINANT

Roger DenningScott PennerFISH & RICHARDSON P.C.12390 El Camino Real

San Diego, CA 92130

PROPOSED RESPONDENTS

BMC Medical Co., Ltd.5/F Main Building,No.19 Gucheng Street WestShijingshan, Beijing 100043China

3B Medical, Inc.21301 US Highway 27Lake Wales, FL 33859USA

3B Products, L.L.C.21301 US Highway 27Lake Wales, FL 33859USA

Telephone: (858)-678-5070Fax: (858)-678-5099

Thomas “Monty” FuscoW. Peter GuarnieriFISH & RICHARDSON P.C.1425 K Street, N.W., 11th FloorWashington, D.C. 20005Telephone: (202) 783-5070Fax: (202) 783-2331

Frank E. ScherkenbachFISH & RICHARDSON P.C.One Marina Park DriveBoston, MA 02210-1878Telephone: (617)-542-5070Fax: (617)-542-8906

Michael J. KaneFISH & RICHARDSON P.C.3200 RBC Plaza60 South Sixth StreetMinneapolis, MN 55402Telephone: (612)-335-5070Fax: (612)-288-9696

III

IV

VI

INTRODUCTION ................................................................... ..

COMPLAINANTS .................................................................. ..

. PROPOSED RESPONDENTS ................................................ ..

. PRODUCTS AND TECHNOLOGY AT ISSUE .................... ..

THE ASSERTED PATENTS .................................................. ..

A.

1

2

3

B.

1

2

3

C.

:<BbJ!\)>—~

D.

1

2

3

E.

1

2

3

4

A.

TABLE OF CONTENTS

U.S. Patent N0. 7,997,267 ................................................. ..

Identification of the Patents and Ownership by ResMed

Non-TechnicalDescriptionof the PatentedInventionForeign Counterparts to the ’267 Patent.........................

U.S. Patent No. 7,614,398 ................................................. ..

Identification of the Patent and Ownership by ResMed.

Non-TechnicalDescriptionof the PatentedInventionForeign Counterparts to the ’398 Patent ....................... ..

U.S. Patent Nos. 7,938,116 and 7,341,060 ....................... ..


Non-TechnicalDescriptionof the PatentedInventionForeign Counterparts to the ’116 Patent ........................ ..

Foreign Counterparts to the ’060 Patent ........................ ..

U.S. Patent No. 8,312,883 ................................................. ..

Identification of the Patent and Ownership by ResMed..

Non-TechnicalDescriptionof the PatentedInventionForeign Counterparts to the ’883 Patent.........................

U.S. Patent No. 7,926,487 ................................................. ..

Identification of the Patent and Ownership by ResMed ..

Non-TechnicalDescriptionof the PatentedInventionForeign Counterparts to the ’487 Patent ........................ ..

F. U.S. Patent Nos. 7,178,527 and 7,950,392 ........................... ..


Non-Technical Description of the Patented Invention

Foreign Counterparts to the ’527 Patent..........................

Foreign Counterparts to the ’392 Patent ........................ ... THE DOMESTIC INDUSTRY ............................................... ..

Technical Prong................................................................. ..

3

B. Economic Prong ................................................................................ ..VII. UNLAWFUL AND UNFAIR ACTS OF PROPOSED RESPONDENTS

VIII.SPECIFIC INSTANCESOF UNFAIR IMPORTATIONAND SALE

A. BMC and 3B...................................................................................... ..

B. HTSUS .............................................................................................. ..

IX. LICENSEES ............................................................................................ ..

X. RELATED LITIGATION ....................................................................... ..

XI. REQUESTED RELIEF ............................................................................ ..

4

LIST OF EXHIBITS

,_i

§?.'§-3,» M-1* - - - - . ~52"

Copy of U.S. Patent No. 7,997,267

l\J

Copy of U.S. Patent No. 7,614,398

U)

Certified Copy of U.S. Patent No. 7,938,116

-B


LII


O'\


\l


00


NO

RESERVED

>—AC

Assigmnent Documents for U.S. Patent No. 7,997,267

,_.>-a

Assignment Documents for U.S. Patent No. 7,614,39812 Certified Assignment Documents for U.S. Patent No. 7,938,11613 Certified Assignment Documents for U.S. Patent No. 8,312,88314 Certified Assignment Documents for U.S. Patent No. 7,341,06015 Assignment Documents for U.S. Patent No. 7,178,52716 Assignment Documents for U.S. Patent No. 7,950,39217 Assignment Dociunents for U.S. Patent No. 7,926,48718 RESERVED

19 A List of All Foreign Patents and All Foreign Patent ApplicationsCorresponding to U.S. Patent No. 7,997,267

20 A List of All Foreign Patents and A11Foreign Patent ApplicationsCorresponding to U.S. Patent N0. 7,614,398






26 Photographs of the ResMed Mirage Activa LT27 Photographs of the ResMed Liberty28 Photographs of the ResMed Mirage Micro29 Photographs of the ResMed Mirage Quattro

5

$2-Z“

"'""“it-7%.;.'":r»'w;,;gg§;-;,f..',;,q;, ExU'm\4I|4\,<|54,Iv;,7%»~}4vV|>!U/1%:L._<3;;»<_,1,/n.r>1n>€;fi£"$1.22"."L‘5&r2:.“:“?"“--"""“' , .a.a,n,...,r.~..n;,,.,“V ~ ~ .=>5:;__ M g V,;~_~_-;w‘1?\ Es“ E Jsm_wzvs

Photograph of the ResMed Mirage Vista

Photographs of the ResMed Quattro FX and Quattro FX For Her

Photographs of the ResMed S9 Autoset and H5i

Photographs of the ResMed Swifi LT

Photographs of the ResMed Swift LT for Her

Photographs of the ResMed Mirage Swift IIRESERVED

User Manuals for the ResMed Mirage Activa LT

User Manuals for the ResMed Mirage Liberty

User Manuals for the ResMed Mirage Micro

User Manuals for the ResMed Mirage Quattro

User Manuals for the ResMed Mirage Vista

User Manuals for the ResMed Quattro FX and Quattro FX For HerUser Manuals for the ResMed S9 Autoset and H5i

User Manuals for the ResMed Swift LT

User Manuals for the ResMed Swifl LT for Her

User Manuals for the ResMed Mirage Swift IIRESERVED

Exemplary Claim Chart Comparing the Claims of the ’267 patent to theResMed Mirage Activa LT

Exemplary Claim Chart Comparing the Claims of the ’267 patent to theResMed Mirage Micro

Exemplary Claim Chart Comparing the Claims of the ’267 patent to theResMed Mirage Quattro

Exemplary Claim Chart Comparing the Claims of the ’267 patent to theResMed Mirage Vista

Exemplary Claim Chart Comparing the Claims of the ’267 patent to theResMed Quattro FX and Quattro FX For Her

Exemplary Claim Chart Comparing the Claims of the ’398 patent to theResMed H5i heated humidifier.

RESERVED

Exemplary Claim Chart Comparing the Claims of the ’116 patent to theResMed Swifi LT

Exemplary Claim Chart Comparing the Claims of the ’l 16patent to theResMed Vista

6

fie»

WW

rm

=1“ M' M »~1 W w. L"'*"‘"‘"-"*':“:,$-x‘"..;*?.€ Elia e"ii YE, i; 1 “M z:a-::>-;sE;;§g;1;;_-m-Sim -§ 1“;-,'»;;;-,-.;‘ x "*“*""".”.i%“_ l’ 'n__WWW , M __W___ \'_~,)_<)0,‘>r-y;:;v,:|4lg”é‘:‘:\f'/_,a,.,,.W,.,,_,.,,,,,__,_“ " " " -»-»»~~»»-I * mi-.t<':zi»a£':?i§.4¥z._i.' ' -11' mm -»-W“-*.. W

Exemplary Claim Chart Comparing the Claims of the ’883 patent to theResMed Swift II

Exemplary Claim Chart Comparing the Claims of the ’883 patent to theResMed Swift LT

Exemplary Claim Chart Comparing the Claims of the ’O6Opatent to theResMed Swift II

Exemplary Claim Chart Comparing the Claims of the ’O6Opatent to theResMed Swift LT

Exemplary Claim Chart Comparing the Claims of the ’O6Opatent to theResMed Vista


RESERVED


RESERVED

Exemplary Claim Chart Comparing the Claims of the ’487 patent to theResMed Mirage Quattro

RESERVED

Photographs of the BMC and 3B Willow

Photographs of the BMC and 3B iVolve

Photographs of the BMC and 3B RESmart CPAP and RESmart AutoCPAP

User Manual for the BMC and 3B Willow

Sales sheet for the BMC and 3B Willow

User Manual for the BMC and 3B RESmart CPAP and RESmart AutoCPAP

RESERVED

Exemplary Claim Chart Comparing the Claims of the ’267 patent to theBMC and 3B Willow

7

76 Exemplary Claim Chart Comparing the Claims of the ’267 patent to theBMC and 3B iVolve

Exemplary Claim Chart Comparing the Claims of the ’398 patent to the77 BMC and 3B RESmart CPAP and RESmart Auto-CPAP.

Exemplary Claim Chart Comparing the Claims of the ‘I 16 patent to theBMC and 3B Willow



78

79

80

Exemplary Claim Chart Comparing the Claims of the ’527 patent to the81 BMC and 3B iV0lve

Exemplary Claim Chart Comparing the Claims of the ’392 patent to the82 BMC and 313iVolve

Exemplary Claim Chart Comparing the Claims of the ’487 patent to the83 BMC and 313iVolve

Exemplary Claim Chart Comparing the Claims of the ’487 patent to the84 BMC and 313Willow

85 Photographs of the Product Packaging for the BMC and 3B Willow

86 Photographs of the Product Packaging for the BMC RESmart CPAP

87 Photographs of the Product Packaging for the BMC RESmart Auto-CPAP

Photographs of package containing a BMC and 3B Willow, RESmart88 CPAP, and RESmart Auto-CPAP.

89 3B website Willow product page at http://3bproducts.com/willow.html

BMC website FeaLite product page at http://en.bmc90 medical.com/products_detail/&productId=eda3 2f48-5d22-4dd3 -b517

3b3a65685352.ht1nl

Unopposed Motion ofN0n-Parties BMC Medical C0. Ltd, 3B MedicalInc., and 3B Products, LLC to Intervene for the Limited Purpose ofResponding to ResMed's Motion to Amend the Complaint and Notice ofInvestigation, Inv. 337-TA-879 (June 12, 2013)

91

92 CONFIDENTIAL EXHIBIT: Declaration of Ben Cheah

93 CONFIDENTIAL EXHIBIT: Copies of ResMed Inc. and ResMed Corp.Licenses of Asserted Patents

8

f I.. eRe‘ .,Patents

95 Declaration of Michael J. Rider

96 ResMed Inc.’s Annual Report and Fonn 10-K

9

LIST OF APPENDICES

A Copy of the File History for U.S. Patent No. 7,999,267

f t» VW w- . . .. . ~ 4-,L M e,@.¢;.,=,;;1§ti:-E ti: ‘" " ' ' F , 5:2 " " :e::s.'.;.':.;::z'.--::::.::--:::

B Copy of the File History for U.S. Patent No. 7,614,398

C Certified Copy of the File History for U.S. Patent No. 7,938,116

D Certified Copy of the File History for U.S. Patent No. 7,341,060

E Certified Copy of the File History for U.S. Patent No. 8,312,883

F Copy of the File History for U.S. Patent No. 7,178,527

G Copy of the File History for U.S. Patent No. 7,950,392

H Copy of the File History for U.S. Patent No. 7,926,487

I Relevant Technical References Cited in U.S. Patent No. 7,999,267

J Relevant Technical References Cited in U.S. Patent No. 7,614,398

K Relevant Technical References Cited in U.S. Patent No. 7,938,l 16

L Relevant Technical References Cited in U.S. Patent No. 7,341,060

M Relevant Technical References Cited in U.S. Patent No. 8,312,883

N Relevant Technical References Cited in U.S. Patent No. 7,l78,52 7

O Relevant Technical References Cited in U.S. Patent No. 7,950,392

P Relevant Technical References Cited in U.S. Patent No. 7,926,487

10

I. INTRODUCTION

1.1 ResMed Corp., ResMed Inc., and ResMed Ltd (sometimes collectively referred to

as “ResMed” or “Complainants”) request that the United States International Trade Commission

commence an investigation pursuant to Section 337 of the Tariff Act of 1930, as amended, 19

U.S.C. § 1337 (“Section 337”), to remedy the unlawful importation into the United States, sale

for importation into the United States, and/or sale within the United States after importation by

the owner, importer, or consignee, of certain sleep-disordered breathing treatment systems and

components thereof (collectively referred to as “the accused products”), that infringe valid and

enforceable United States patents owned by ResMed Ltd, and licensed to ResMed Inc. and

ResMed Corp.

1.2 This Complaint is based on Proposed Respondents’ unlawful and unauthorized

importation into the United States, sale for importation, and/or sale within the United States after

importation, of certain sleep-disordered breathing treatment systems and components thereof.

Respondents’ products infringe at least one or more claims of U.S. Patent No. 7,997,267,

“Ergonomic:And Adjustable Respiratory Mask Assembly With Elbow Assembly,” (“the ’267

patent”), U.S. Patent No. 7,614,398, “Humidifier With Structure To Prevent Backflow Of Liquid

Through The Humidifier Inlet,” (“the ’398 patent”), U.S. Patent No. 7,938,116, “Ergonomic And

Adjustable Respiratory Mask Assembly With Headgear Assembly,” (“the ’ll6 patent”), U.S.

Patent No. 7,341,060, “Ergonomic And Adjustable Respiratory Mask Assembly With Headgear

Assembly,” (“the ’060 patent”), U.S. Patent No. 8,312,883, “Nasal Assembly,” (“the ’883

patent”), U.S. Patent No. 7,178,527, entitled “Nasal Mask And Mask Cushion Therefor,” (“the

’527 patent”), U.S. Patent No. 7,950,392, entitled “Cushion And Mask Therefor,” (“the ’392

patent”), and U.S. Patent No. 7,926,487, entitled “Respiratory Mask Having Gas Washout Vent

And Gas Washout Vent Assembly For A Respiratory Mask,” (“the ’487 patent”) (collectively,

11

“the Asserted Patents” or “the ResMed Patents”). The ResMed Patents are valid and enforceable

United States Patents, the entire right, title, and interest in and to which ResMed Ltd owns by

assignment.

1.3 ResMed asserts that the accused products infringe claims 32, 33, 34, 35, 36, 37,

53, 79, 80, and 88 of the ’267 patent; claims 1, 2, 3, 4, 5, 6 and 7 of the ’398 patent; claim 1 of

the ’l 16 patent; claims 30, 37, and 38 ofthe ’060 patent; claims 1,3,5, 11, 28, 30, 31, and 56 of

the ’883 patent; claims 1, 3, 6, 7, 9, 29,32, 35, 40, 42, 45, 50, 51, 56, 59, 89, 92, 94, and 96 of

the ’527 patent; claims 19, 20,21, 22, 23, 24, 26, 29, 30, 31, 32, 33, 34, 35, 36, 39,40, and 41 of

the ’392 patent; and claims 13, 15, 16, 26, 27, 28, 51, 52, and 55 of the ’487 patent (collectively,

“the asserted claims”). In summary, Proposed Respondents infringe at least the patents and

claims listed in the chart below (dependent claims are contained in parentheses).

U.S Patent No. Asserted Claims

’267 patent: 32 (33, 34, 35, 36, 37); 53; 79 (80, 88)

’398 patent 1 (2, 3, 4, 5, 6, 7)

’ 116 patent 1

’060 patent 30 (37, 38)

’883 patent 1 (3, 5, 11); 28; 30; 31 (56)

’527 patent 1; 3 (6); 7; 9; 29 (32, 35); 40 (42, 45, 50);51 (56, 59); 89 (92, 94, 96)

’392 patent 19 (20, 21, 22, 23, 24, 26, 29, 30, 31, 32,33, 34, 35, 36, 39, 40, 41)

’487 patent 13 (15, 16); 26 (27, 28); 51 (52, 55)

1.4 Proposed Respondents’ activities with respect to the importation into the United

States, the sale for importation into the United States, and/or the sale within the United States

12

after importation of certain sleep-disordered breathing treatment systems and components

thereof, described more fully, infra, are unlawful under 19 U.S.C. § 1337(a)(l)(B)(i), in that these

systems are protected by one or more claims of the valid and enforceable ResMed Patents.

1.5 Certified copies of the Asseited Patents accompany this Complaint as Exhibits l

8 respectively.1 ResMed Ltd owns by assigmnent the entire right, title, and interest in and to

these patents. A certified copy of each of the recorded assignments accompanies this Complaint

as Exhibits 10-17.2 Each of the Asserted Patents is licensed to ResMed Inc. and sublicensed to

ResMed Corp.

1.6 As required by Section 337(a)(2) and defined in Section 337(a)(3), an industry in

the United States exists relating to articles protected by the Asserted Patents.

1.7 ResMed seeks relief from the Commission in the fonn of a permanent limited

exclusion order, pursuant to Section 337(d), excluding from entry into the United States

Proposed Respondents’ accused products that infringe one or more claims of the Asserted

Patents. ResMed also seeks a permanent cease and desist order, pursuant to Section 337(f),

halting the importation, sale, offer for sale, marketing, advertising, or soliciting of sleep

disordered breathing treatment systems and components thereof by Proposed Respondents and

their related companies that infringe ResMed’s valid and enforceable United States patents.

II. COMPLAINANTS

2.1 Complainant ResMed Ltd is a corporation organized under the laws of Australia,

having its principal place of business in Bella Vista, New South Wales, Australia. ResMed Ltd

1ResMed notes that Exhibits 1-2 are un-certified copies of the ‘Z67 and ’398, patents. At the time of filing of thiscomplaint, certified copies of these patents had been ordered. In accordance with Rule 210(a)(9)(i), certified copiesof the patents will be filed with the Commission when received by Complainants.2 ResMed notes that Exhibits 10-11, and 15-17 are un-certified copies of the ’267, ’398, ’527, ‘$92, and ’487assignment records. At the time of filing of this complaint, certified copies of these assignment records had beenordered. In accordance with Rule 210(a)(9)(i), certified copies of the assignment records will be filed with theCommission when received by Complainants.

13

owns the patents at issue in this complaint. Complainant ResMed Corp. is a corporation

organized under the laws of the state of Minnesota with its principal place of business in San

Diego, California. Complainant ResMed Inc. is a corporation organized under the laws of the

state of Delaware with its principal place of business in San Diego, California. ResMed Ltd

licenses the patents at issue to ResMed Inc. which in tum licenses them to ResMed Corp. The

Complainants are sometimes collectively referred to as “ResMed” herein. ResMed Corp. and

ResMed Ltd are, respectively, direct and indirect subsidiaries of ResMed Inc.

2.2 ResMed is a leading developer, manufacturer and distributor of medical

equipment for treating, diagnosing, and managing sleep-disordered breathing and other

respiratory disorders. The company is dedicated to developing innovative products to improve

the lives of those who suffer from these conditions and to increasing awareness among patients

and healthcare professionals of the potentially serious health consequences of untreated sleep

disordered breathing (sometimes referred to as “SDB”). Since its founding in 1989, ResMed has

focused on developing and commercializing systems for the treatment of obstructive sleep apnea

(“OSA”), a major subset of SDB. ResMed’s development of innovative therapies for the

treatment of OSA has resulted in over 3,000 patents granted or pending worldwide, and its

product line incorporates technology that is a highly effective and proven way to treat OSA.

2.3 ResMed was originally founded in Australia, but is now a U.S. corporation with

its parent, ResMed lnc., incorporated in Delaware and headquartered in San Diego. ResMed Ltd

is principally responsible for ResMed’s research and manufacturing operations, which are

located in various places around the world. ResMed Inc.’s principal Americas sales subsidiary,

ResMed Corp., is co-located in San Diego with the parent company. ResMed Motor

Technologies is a wholly owned subsidiary of ResMed Inc., and is responsible for research,

14

development and manufacturing of the motors that are used in ResMed’s flow generators - the

principal device used in the SDB systems that ResMed Ltd makes and ResMed Corp. sells.

2.4 ResMed Ltd has invested hundreds of millions of dollars in research and

development. It has been estimated that SDB in general, and OSA in particular, affects

approximately 20% of the adult population, making it as widespread as diabetes or asthma.

However, awareness of OSA is relatively low; one study in 2002 concluded that about 90% of

people with OSA remain undiagnosed and untreated. Therefore, ResMed Corp., in particular,

has made substantial investments directed to increasing education and awareness of the health

consequences of untreated SDB among both the general public and physicians.

III. PROPOSED RESPONDENTS

3.1 On infonnation and belief, proposed Respondent BMC Medical Co., Ltd.

(“BMC”) is a corporation organized under the laws of the country of China with its principal

place of business at 5/F Main Building, No.19 Gucheng Street West, Shijingshan, Beijing

100043, China. On information and belief, proposed Respondent 3B Medical, Inc. (“3B

Medical”) is the U.S. subsidiary of BMC. See Exhibit 91, Unopposed Motion of Non-Parties

BMC Medical Co. Ltd, 3B Medical Inc., and 3B Products, LLC to Intervene for the Limited

Purpose of Responding to ResMed’s Motion to Amend the Complaint and Notice of

Investigation, Inv. 337-TA-879 (June 12, 2013), BMC Opposition, Ex. 1, Declaration of Mr.

Alex Lucio at 111 [hereinafter “Lucio Declaration”] (stating that “3B Medical is associated with

BMC Medical Co., Ltd.”). 3B Medical is a corporation organized under the laws of the state of

Florida with its principal place of business at 21301 US Highway 27, Lake Wales, FL 33859.

On information and belief, proposed Respondent 3B Products, L.L.C. (“3B Products”) is a

limited liability company organized under the laws of the state of Florida with its principal place

of business at 21301 US Highway 27, Lake Wales, FL 33859. 3B Products and 3B Medical are

15

collectively referred to as “3B.” On information and belief, proposed Respondent 3B Products is

affiliated with BMC?

3.2 As detailed below, on information and belief, BMC and 3B are manufacturers and

distributors of durable medical equipment, including systems and components thereof for the

treatment of sleep-disordered breathing, such as obstructive sleep apnea. See Lucio Declaration,

at 1]2 (“BMC is a new entrant into the U.S. market for sleep disordered breathing systems. BMC

first began selling sleep disordered breathing equipment, including CPAP machines and

breathing masks in the United States in October 2012”).

3.3 BMC and 3B develop, manufacture, and market sleep-disordered breathing

treatment systems and components thereof that infringe one or more claims of the Asserted

Patents. On information and belief, BMC and 3B’s sleep-disordered breathing treatment systems

and components thereof are manufactured, assembled, packaged, and/or tested outside of the

United States. On information and belief, BMC, 3B, and/or others then import the accused

sleep-disordered breathing treatment systems, and components thereof into the United States, sell

them for importation, or sell them in the United States after importation. See Exhibit 91,

Unopposed Motion of Non-Parties BMC Medical Co. Ltd, 3B Medical Inc., and 3B Products,

LLC to Intervene for the Limited Purpose of Responding to ResMed‘s Motion to Amend the

Complaint and Notice of Investigation, Inv. 337-TA-879 (June 12, 2013), Memorandum Of

Points And Authorities In Support Of Non-Parties BMC Medicial Co., Ltd., 3B Medical Inc.,

And 3B Products, LLC’s Motion To Intervene For The Limited Purpose Of Responding To

3For example, 3B Products’ website, believed to be located at http://3bproducts.com/, shows BMC’s logo as well asa 3B logo. Similarly, the website bears a message near the bottom of the main page reading “All Rights Reserved3B Products, LLC 201 1, Flex-Lite and Innovations in Sleep Therapy are trademarks of 3B Products, LLC,Willow, iVolve, iCode, RESmart, and RESlex are trademarks of BMC Medical Co., Ltd.” Seehttp://3bproducts.com.

16

ResMed’s Motion To Amend The Complaint And Notice Of Investigation, at p. 6 (“The

allegations could impair BMC’s ability to import its sleep-disordered products - but should not

because BMC does not violate Section 337.”) [hereinafter “BMC Motion to Intervene”].

IV. PRODUCTS AND TECHNOLOGY AT ISSUE

4.1 The products at issue are medical systems used in the treatment of sleep

disordered breathing (“SDB”), particularly obstructive sleep apnea (“OSA”). As the name

implies, a person with OSA will experience obstructed breathing while sleeping as throat

muscles relax and close off the breathing passage. After a period as long as ten seconds, the

person will reopen the breathing passage by expelling air, only to have the passage close again as

the throat muscles relax again, a cycle which may repeat itself several hundred times in the

course of a night. The disrupted sleep pattern that results from having OSA not only causes the

person to feel unrested after sleeping, but can cause a drop in blood oxygen levels, placing a

strain on the person’s overall respiratory and circulatory systems.

4.2 In the l980’s, Professor Colin Sullivan at Royal Prince Alfred Hospital in

Sydney, Australia and Dr. George Gregory at the University of California, San Francisco began

devising methods of treating OSA through the use of continuous positive airway pressure, or

“CPAP.” CPAP therapy involves the use of mild air pressure to keep the patient’s airway open

during sleep. A CPAP therapy system consists of three main elements working together: 1) a

flow generator for creating the flow of air, 2) a conduit, usually a flexible tube, for carrying the

flow of air to the patient, and 3) an interface (usually a facial mask or a pair of “nasal pillows”

that are inserted into the nasal cavities) that provides a connection to the patient’s airway. The

continuous flow of air prevents the airway from collapsing during sleep and thus disrupts the

OSA cycle described above, leading the patient to a good night's sleep uninterrupted by apneas.

l7

ResMed CPAP Machine in Use

4.3 The success of CPAP therapy in the treatment of OSA has been widely

recognized. Indeed, the University of Maryland Medical Center describes CPAP as the “first

line treatment for mild-to-moderate or severe obstructive sleep apnea.”4

4.4 The mask (or pair of nasal pillows) is a critical element of any CPAP therapy

system. The mask must maintain an effective seal against the patient’s face since air leakage can

significantly reduce the therapeutic effects of the CPAP system. At the same time, if the mask is

uncomfortable or constricting, the patient may find the system difficult to use and cease using the

system altogether. Indeed, patient noncompliance with therapy because of mask discomfort is a

major concem in the administration of CPAP therapy. This was pointed out in a study published

in the journal Sleep Science in which it was reported that the most common side effects of CPAP

therapy that influence adherence to the treatment are related to nasal complaints, masks, and

pressures.5

4

http://wvvw.umm.edu/patiented/articles/continuous_positive_airflowJJressure_cp11p_devices_used sleep apnea 000065 8.htm (accessed February 28, 2013)

A.D. Rueda et al., “Improving CPAP Compliance by a Basic Educational Program with NurseSupport for Obstructive Sleep Apnea Syndrome Patients,” Sleep Science, 2009 2(1): 8-13

18

4.5 ResMed offers a range of flow generators and masks designed to maximize the

efficacy of the CPAP therapy delivered. A complete depiction of ResMed’s products, designed

to treat OSA in a myriad of patient types across the population, can be found at

http://www.resmed.com/products.

4.6 The accused BMC and 3B masks are sold under the brand names “iVolve” and

“Willow” or “FeaLite.”6 The iVolve is a nasal mask intended to cover only the nose, while the

Willow/FeaLite uses nasal pillows. The accused BMC and 3B flow generators are sold under the

brand name “RESmart.”

V. THE ASSERTED PATENTS

5.1 At issue in this investigation is Proposed Respondents’ infringement of eight

United States patents: the ’267, ’398, ’ll6, ’060, ’883, ’527, ’392, and ’487 patents. ResMed

summarizes the general technology of all the inventions as well as each patent below.

A. General Background

5.2 As noted previously, sleep-disordered breathing (“SDB”), particularly obstructive

sleep apnea (“OSA”), can lead to serious and harmful effects on a person’s overall respiratory

and circulatory systems. One manner of treating these disorders is through the use of Continuous

Positive Airway Pressure (“CPAP”) treatments. During CPAP treatment air is continually

supplied into a patient’s airways at pressures above the ambient atmospheric pressure while the

patient sleeps. This higher pressure air helps keep the patient’s airways open, thereby ensuring a

steady supply of oxygen and helping a patient achieve a more restful and healthy sleep. Various

different types of CPAP treatment may involve different cycles or levels of pressure during the

cotu'se of a single treatment (i.e. over the course of single sleeping period). The air is supplied

° On information and belief, and as described in more detail in Section VII, the Willow and FeaLite are the sameproducts sold under different brand names by 3B and BMC respectively.

19

by an air flow generator, through an air conduit, and into a patient interface that generally

consists of a mask. Other examples of patient interfaces include a full face mask and nasal

prongs or pillows.

5.3 The innovative construction and design of masks used to deliver air during CPAP

and related treatments are one subject of the patents-in-suit. The masks generally consist of a

mask shell attached to a conduit of some kind, with for example an elbow joint:

so/MD un

% if10

\ 12a H8 W,.» -ias ./ / ‘E .

Q\

as» '

HI150M” <;<.--~

. _\ » /1tea L ‘ "T qg ;

_..~— 4v » a

2°?* '\ ‘B\~ .

I80’! Q/ -— jg »=»on 3 \

5!! “’ - *1 . M1 / 5ELI

314) 74

FIG. l

See e.g. Exhibit 1, ’267 patent, at Fig. 1

5.4 The mask shell includes a cushion or padding so that it rests comfortably on a

patient’s face when in contact with the patient’s nose and mouth. The mask may be secured onto

a patient’s head with a harness consisting of straps. It may also include other support structures,

such as a forehead pad to comfortably brace the mask against the patient’s forehead. The mask

will also generally include a vent for exhaling exhaust gas when a patient breathes out; this vent

will usually be located on or near the mask shell itself.

5.5 As previously noted, air is provided to the patient by a flow generator. The flow

generator generally uses an electric motor driving a fan or turbine to create the high pressure air

20

that is supplied to the mask. ResMed’s patented inventions involve an innovative housing and

mounting body for the flow generator. This mounting body helps to minimize the noise

produced by the generator while still being economic to manufacture and service. Additionally,

because some patients prefer to use humidified air during CPAP treatment, ResMed’s patented

inventions also involve the design of humidifiers to humidify the air supplied to the mask.

5.6 Descriptions of the patents asserted in this complaint are set forth in the remainder

of this section. The contents of this Complaint, including the subsections entitled “Non

Technical Description of the Patented Invention”, does not, and is not intended to, construe

either the specification or claims of the patents asserted herein.

A. U.S. Patent N0. 7,997,267

1. Identification of the Patents and Ownership by ResMed

5.7 ResMed Ltd owns by assignment the entire right, title, and interest in the ’267

patent entitled “Ergonomic And Adjustable Respiratory Mask Assembly With Elbow

Assembly,” which issued August 16, 2011. The ’267 patent issued from U.S. Patent Application

Serial No. 12/368,545, filed on February 10, 2009. The ’267 patent is a continuation of U.S.

Patent Application Serial No. 10/390,720, filed on March 19, 2003, now U.S. Patent No.

7,487,772. ResMed Inc. is the exclusive licensee of the ’267 patent and has sublicensed the

patent to ResMed Corp., the U.S. sales subsidiary.

5.8 The inventors of the ’267 patent, Anthony M. Ging, Saad Nasr, Rachael E.

Moore, and Andrew M. Price, assigned to ResMed Ltd all rights, title, and interest in the

invention ultimately disclosed and claimed in the ’267 patent. See Exhibit 10. The ’267 patent

is valid, enforceable, and is currently in full force and effect. A copy of the ’267 patent is

attached as Exhibit 1.

21

5.9 Pursuant to Rule 2l0.l2(c) of the Commission's Rules of Practice and Procedure,

this Complaint is accompanied by Appendices A and I. Appendix A contains four copies of the

prosecution history of the ’267 patent; Appendix I contains four copies of each reference

mentioned in that prosecution history.7 i

2. Non-Technical Description of the Patented Invention

5.10 The ’267 patent generally discloses a respiratory mask assembly for delivering

breathable air to a patient. See Exhibit 1, ’267 Patent, at Abstract. An embodiment of the

invention is pictured in Figure l:

no/l38no /

IU

\ ma we MO

as " $7"

B5

M” i Va W I50

Tl‘ /— '1

1;‘ 1’, 1- > ‘~10

an j; W w\u;:;J10 :"‘<'

FIG. l

\ E 2 5‘H\\IIl@/~,

/a1 g

See id. at Fig. l

5.11 The frame includes both a front surface, as well as a rear surface adapted to face

the patient. See id. at Abstract. A main body of the frame includes an opening for breathable gas

to flow through and be introduced into the patient’s nasal cavity. See id. The mask assembly

also includes an elbow assembly comiected to the front surface of the frame by a connector. See

7At the time of filing of this complaint, a certified copy of the ’267 file history had been ordered. In accordancewith Rule 2l0(a)(9)(i), the certified file history will be filed with the Commission when received by Complainants.

22

id The elbow assembly is connected to the front surface in a way that allows it to swivel by

using a swivel elbow. See id. Additionally, the swivel elbow has an air intake port and can have

an air exhaust port, the two ports separated by a baffle. See id.

3. Foreign Counterparts to the ’267Patent

5.12 The foreign counterparts to the ’267 patent are listed in Exhibit 19. No other

foreign patents or patent applications corresponding to the ’267 patent have been filed,

abandoned, withdrawn or rejected.

B. U.S. Patent N0. 7,614,398

1. Identification of the Patent and Ownership by ResMed


patent entitled “Humidifier With Structure To Prevent Backflow Of Liquid Through The

Humidifier Inlet,” which issued on November 10, 2009. The ‘398 patent issued from U.S. Patent

Application Serial No. 11/181,807, filed on July 15, 2005, and is a continuation of application

U.S. Patent Application Serial No. 10/467,382, filed as Application No. PCT/AU02/00155 on

Feb. 14, 2002, now U.S. Patent No. 6,935,337. ResMed Inc. is the exclusive licensee of the ’398

patent and has sublicensed the patent to ResMed Corp., the U.S. sales subsidiary.

5.14 The inventors of the ’398 patent, Alexander Virr, Ian M. Smith, Peny D.

Lithgow, Richard L. Jones, and Andrew Cheung, assigned to ResMed Ltd all rights, title, and

interest in the invention ultimately disclosed and claimed in the ’398 patent. See Exhibit 11.

The’398 patent is valid, enforceable, and is currently in full force and effect. A copy of the ’398

patent is attached as Exhibit 2.

5.15 Pursuant to Rule 210. 12(c) of the Commission's Rules of Practice and Procedure,

this Complaint is accompanied by Appendices B, and J. Appendix B contains four copies of the

23

prosecution history of the ’398 patent; Appendix J contains four copies of each reference

mentioned in that prosecution history.8


5.16 The ’398 patent generally discloses a humidifier for humidifying air in a CPAP

system. See Exhibit 2, ’398 Patent, at Abstract. An embodiment of the invention is pictured in

Figures 6 and 7:

so

Q2

' Q Y‘?

70\,’See id. at Fig. 6. See id.at Fig. 7

5.17 The humidifier of the invention has a top cover attached to a base, with a seal

between the two; a part of the base can be made of a heat conducting material. See Exhibit 2,

’398 Patent, at Abstract. The top cover has an inlet and an outlet that communicate with the

3At the time of filing of this complaint, a certified copy of the ’398 file history had been ordered. In accordancewith Rule 210(a)(9)(i), the certified file history will be filed with the Commission when received by Complainants

24

base. See id. Air coming in through the inlet port is humidified by the liquid in the humidifier,

and subsequently exits the humidifier through an outlet port. See id.





C. U.S. Patent Nos. 7,938,116 and 7,341,060

1. Identification of the Patents and Ownership by ResMed

5.19 ResMed Ltd owns by assigmnent the entire right, title, and interest in the ’116

patent entitled “Ergonomic And Adjustable Respiratory Mask Assembly With Headgear

Assembly,” which issued May 10, 2011. The ’116 patent issued from U.S. Patent Application

Serial No. 11/390,239, filed on March 28, 2006. The ’116 patent is a continuation of application

No. l 1/124,251, filed on May 9, 2005, now U.S. Patent No. 7,047,972, which is a continuation

of application No. 10/390,681, filed on March 19, 2003, now U.S. Patent No. 6,907,882.

ResMed Ltd further owns by assignment the entire right, title, and interest in the ’060 patent

entitled “Ergonomic And Adjustable Respiratory Mask Assembly With Headgear Assembly,”

which issued on March 11, 2008. The ’060 patent issued from U.S. Patent Application Serial

No. 11/698,066, filed on January 26, 2007. The ’060 patent is a continuation the ’116 patent.

ResMed Inc. is the exclusive licensee of the ’116 and ’060 patents and has sublicensed the

patents to ResMed Corp., the U.S. sales subsidiary.

5.20 The inventors of both the ’116 and ’060 patents, Anthony M. Ging and Saad Nasr,

assigned to ResMed Ltd all rights, title, and interest in the invention ultimately disclosed and

claimed in both the ’116 and ’606 patents. See Exhibits 12 and 14. The ’116 and ’060 patents

25

are valid, enforceable, and are currently in full force and effect. A certified copy of the ’116

patent is attached as Exhibit 3, and a certified copy of the ’060 patent is attached as Exhibit 5.

5.21 Pursuant to Rule 2l0.12(c) of the Commission's Rules of Practice and Procedure,

this Complaint is accompanied by Appendices C, D, K, and L. Appendix C contains one

certified copy and three additional copies of the prosecution history of the ’116 patent; Appendix

K contains four copies of each reference mentioned in that prosecution history. Appendix D

contains one certified copy and three additional copies of the prosecution history of the ’060

patent; Appendix L contains four copies of each reference mentioned in that prosecution history.


5.22 The ’116 and ’060 patents generally disclose a respiratory mask assembly

including a frame for delivering breathable air to a patient. See Exhibit 3, ’116 Patent, at

Abstract, and Exhibit 5, ’060 patent, at Abstract. An embodiment of the invention is pictured in

Figures 1 and 10e:

80/14¢ we\ _ ‘- /Q \ B4

\ W, Z; we \ 92 82ea ~ /~’- J “\ ‘i \.\ » . \ \ _ Z. 12¢%} 2 \_ ,1 l r A

// \ " /if // as’ ‘ /

‘I6

1

._7~.____‘h_

\____'

\L/‘-_

' _ F5\ 1,.2.

...rs.

~_._,..,-’

as- if

~ 1.. %

q\

/"/\§% 3 n g \\\ Rrinflkfi\ I

\*\/‘L ..l

1/ >\.,_‘*”,, 5 \_..

\\

'\

\

E .

5aw

m‘7'hI\? 1.no/if / U ,

\ ms

“it” WHG -I 1Oe 315

See id. at Figs. l and l0e

26

5.23 The frame has a main body with side frame members on each lateral side of the

main body. See id. at Abstract. The side frame members each include connector portions. See

id. A headgear assembly is included, and can be removably attached to the frame. See id. The

headgear assembly includes comiector portions that are adapted to be connected to the connector

portions on the frame. See id. The connector portions on the headgear assembly can be manually

moved to a releasing position in order to detach the headgear from the frame. See id.

Additionally, the headgear assembly can be adjustably rotated with respect to the frame. See id.


5.24 The foreign counterparts to the ’l16 patent are listed in Exhibit 21. No other

foreign patents or patent applications corresponding to the ‘116 patent have been filed,

abandoned, withdrawn or rejected. V





D. U.S. Patent No. 8,312,883



patent entitled “Nasal Assembly,” which issued on November 20, 2012. The ’883 patent issued

from U.S. Patent Application Serial No. 11/967,346, filed on December 31, 2007. The ’883

patent is a continuation of application No. l0l781,929, filed on Feb. 20, 2004, now U.S. Patent

No. 7,318,437. ResMed Inc. is the exclusive licensee of the ’883 patent and has sublicensed the

patent to ResMed Corp., the U.S. sales subsidiary.

27

5.27 The inventors of the ’883 patent, Michael K. Gunaratnam, Philip R. Kwok, Robin

G. Hitchcock, Lee J. Veliss, Memduh Guney, Richard Sokolov, Perry D. Lithgow, Donald

Darkin, and Susan R. Lynch., assigned to ResMed Ltd all rights, title, and interest in the

invention ultimately disclosed and claimed in the ’883 patent. See Exhibit 13. The ’883 patent

is valid, enforceable, and is currently in full force and effect. A certified copy of the ’883 patent

is attached as Exhibit 4.

5.28 Pursuant to Rule 210.l2(c) of the Commission's Rules of Practice and Procedure,

this Complaint is accompanied by Appendices E and M. Appendix E contains a certified copy

and three additional copies of the prosecution history of the ’883 patent; Appendix M contains

four copies of each reference mentioned in that prosecution history.


5.29 The ’883 patent generally discloses a nasal assembly for delivering air to a

patient. See Exhibit 4, ’883 Patent, at Abstract. Figure 38 of the ’883 patent depicts one

embodiment of this nasal assembly:

3953w\\ “fig1.

K i ‘ 394

/éxlfll\ "7~3‘/4;3 V ,. 3 1‘-;~"\{' /;:‘::':-~ //.»’;'‘ / ;5"” / \

i‘ 14 $93“ /3;?/I/j

ti‘ 0:-‘QM :92/1%319/’ ,::j --:=..’ K 370 l

75%?33/ i

FIG 38

F 1 \,z

/< N

28

See id. at Fig. 38.

5.30 The nasal assembly includes a frame with a pair of connector portions. See id.

The invention also includes a nozzle assembly with a base portion and a pair of nozzles. See id.

An inlet conduit is structured to deliver breathable air into the frame and nozzle assembly for the

patient to breath. See id A second pair of connector portions are removably and rotatably

cormected to the first pair of connector portions on the frame, and are in communication with the

inlet conduits. See id. The invention further includes a headgear assembly that can be

removably connected to the second pair of connector portions, so that the patient can adjust the

frame and nozzle assembly to a desirable position on their face. See id.





E. U.S. Patent No. 7,926,487



patent entitled “Respiratory Mask Having Gas Washout Vent And Gas Washout Vent Assembly

For Respiratory Mask,” which issued on April 19, 2011. The ’487 patent issued from U.S.

Patent Application Serial No. 11/413,080, filed on April 28, 2006. The ’487 is a continuation of

U.S. Patent Application Serial No. 10/976,874, filed on Nov. 1, 2004, now U.S. Patent No.

7,159,587, which is a continuation of U.S. Patent Application Serial No. 10/377,110, filed on

Mar. 3, 2003, now U.S. Patent No. 6,823,865, which is a continuation of U.S. Patent Application

Serial No. 09/570,907, filed on May 15, 2000, now U.S. Patent No. 6,581,594. ResMed Inc. is

29

the exclusive licensee of the ’587 patent and has sublicensed the patent to ResMed Corp., the

U.S. sales subsidiary.

5.33 The inventors of the ’487 patent, Joanne Drew, Alexander Virr, and Geoffrey

Crumblin, assigned to ResMed Ltd all rights, title, and interest in the invention ultimately

disclosed and claimed in the ’487 patent. See Exhibit 17. The ’487 patent is valid, enforceable,

and is currently in full force and effect. A certified copy of the ’487 patent is attached as Exhibit

8.

5.34 Pursuant to Rule 2l0.l2(c) of the Commission's Rules of Practice and Procedure,

this Complaint is accompanied by Appendices H and P. Appendix H contains four copies of the

prosecution history of the ’487 patent. Appendix P contains four copies of each reference

mentioned in that prosecution history?


5.35 The ’487 patent generally discloses a vent assembly for use with a respiratory

mask of the type used in a CPAP machine. See Exhibit 8, ’487 Patent at Abstract. Figure l of

the ’487 patent depicts one embodiment of this vent assembly included on a respiratory mask:

9At the time of filing of this complaint, a certified copy of the ’487 file history had been ordered. In accordancewith Rule 2 l0(a)(9)(i), the certified file history will be filed with the Commission when received by Complainants.

30

6

( “‘°\\ \\ l5

l

7

~,/ Q324 l

[W 1° no.1Z2

See id. at Fig. l

5.36 In one embodiment of the invention, the vent contained on the vent assembly is

made of a thin air permeable membrane, generally thinner than 0.5 mm. See id at Abstract. The

membrane may be made of a material such as polytetrafluoroethylene (PTFE) or expanded

PTFE, which expanded PTFE is mounted on a polypropylene scrim. See id. Altematively, the

vent may be made of stainless steel. See id. Additionally, the vent assembly may consist of a

membrane attached to the vent frame in such a way that it forms an insert that can be removed or

attached from a mask frame. See id.

3. Foreign Counterparts to the ’487 Patent

5.37 N0 foreign patents or patent applications corresponding to the ’487 patent have

been filed, abandoned, withdrawn or rejected.

F. U.S. Patent Nos. 7,178,527 and 7,950,392

1. Identification of the Patents and Ownership.by ResMed


patent entitled “Nasal Mask And Mask Cushion Therefor,” which issued on February 20, 2007.

The ’527 patent issued from U.S. Patent Application Serial No. 10/068,963, filed on February

31

11, 2002. The ’527 is a continuation of U.S. Patent Application Serial No. 09/230,491, filed as

application No. PCT/AU97/00450 on Jul. 16, 1997, now U.S. Patent No. 6,357,441. ResMed

Ltd further owns by assignment the entire right, title, and interest in the ’392 patent entitled

“Cushion And Mask Therefor,” which issued on May 31, 2011. The ’392 patent issued from

U.S. Patent Application Serial No. 11/826,267, filed on July 13, 2007. The ’392 is a

continuation of U.S. Patent Application Serial No. 10/934,402, filed on Sep. 7, 2004, now U.S.

Patent No. 7,243,651, which is a continuation of U.S. Patent Application Serial No. 10/004,428,

filed on Dec. 6, 2001, now U.S. Patent No. 6,871,649, which is a division of U.S. Patent

Application Serial N0. 09/566,806, filed on May 8, 2000, now U.S. Patent No. 6,634,358, which

is a continuation of U.S. Patent Application Serial No. 08/791,212, filed on Jan. 31, 1997, now

U.S. Patent No. 6,112,746. ResMed Inc. is the exclusive licensee of the ’527 and ’392 patents

and has sublicensed the patents to ResMed C0rp., the U.S. sales subsidiary.

5.39 The inventors of the ’527 and ’392 patents, Philip R. Kwok and Robert E. Styles,

assigned to ResMed Ltd all rights, title, and interest in the invention ultimately disclosed and

claimed in the ’527 and ’392 patents. See Exhibits 15-16. The ’527 and ’392 patents are valid,

enforceable, and are currently in full force and effect. A certified copy of the ’527 patent is

attached as Exhibit 6. A certified copy of the ’392 patent is attached as Exhibit 7.

5.40 Pursuant to Rule 210.12(c) of the Commission's Rules of Practice and Procedure,

this Complaint is accompanied by Appendices F, G, N, and O. Appendix F contains four copies

of the prosecution history of the ’527 patent. Appendix N contains four copies of each reference

mentioned in that prosecution history/0 Appendix G contains four copies of the prosecution

'0At the time of filing of this complaint, a certified copy of the ’527 file history had been ordered. In accordancewith Rule 210(a)(9)(i), the certified file history will be filed with the Commission when received by Complainants.

32

history of the ’392 patent. Appendix O contains four copies of each reference mentioned in that

prosecution history. H

' ' tion of the Patented Invention2. Non-Technical Descrlp

rally disclose a nasal cushion and a nasal mask.5.41 The ’527 and ’392 patents gene

t. Figures 6 and 4 of the7 ’392 Patent at AbstracSee Exhibit 6, ‘S27 Patent at Abstract; Exhibit ,

' ' bodiments of the nasal cushion and nasal mask:es ectively, depicts em

W 57

’527 and ’392 patents r p ..\\ TI i ‘ 72 \5, <".lI\~.§~_ "

rift.‘ ., ~» $8 ‘=v /_\_

g I .so 52

__-;_-J 421’ _

as i 3

:‘\\\;6 3 2O\

9, S

, AH? Q

13” *

. x\Fig. 4

A F .

See Exhibit 7, ’392 Patent at Fig. 4See Exhibit 6, ’527 Patent at Fig. 6

5.42 In one embodiment of the invention, the nasal cushion has a triangular frame with

' t Abstract; Exhibit 7, ’392 Patent ata membrane extending from it. See Exhibit 6, ’527 Patent a

Abstract. The membrane has an opening into which the patient inserts their nose, with respective

notches to receive the bridge of the patient’s nose. See id. The membrane is spaced away from

the rim of the mask frame. See id. The seal between the patient’s nose and the mask is in contact

histo had been ordered. In accordancela‘ ants

f this complaint, a certified copy of the ’392 file ryfled with the Commission when received by Comp II1

“ At the time of filing 0with Rule 2l0(a)(9)(i), the certified file history will be 1

33

with the patient’s upper lip, sides of the nose, and bridge of the nose. See id. The shape of the

seal is effective to seal the crease between the sides of the patient’s nose and their face. See id.









VI. THE DOMESTIC INDUSTRY

6.1 A domestic industry exists as defined by 19 U.S.C. §§ 1337(a)(2)—(3)relating to

ResMed’s significant investment in plant and equipment; significant employment of labor or

capital; and substantial investment in exploitation of the patents, including a variety of technical

support, field training and professional clinical education, customer support, and service and

repair activities with respect to ResMed’s domestic industry sleep-disordered breathing treatment

systems and components thereof. While a portion of the manufacturing of ResMed’s domestic

industry products occurs outside of the United States, ResMed’s activities in the United States

with respect to these products constitutes a domestic industry for purposes of Section 337. In

addition, ResMed’s domestic industry products are protected by at least one claim of one or more

of the Asserted Patents.

A. Technical Prong

6.2 ResMed manufactures, assembles, and sells sleep-disordered breathing treatment

systems and components thereof. As set forth in more detail herein, ResMed’s sleep-disordered

34

breathing treatment systems and components thereof incorporate the inventions claimed in one or

more of the Asserted Patents.

6.3 At least the following components of ResMed SDB treatment systems are

protected by the ’267 patent: Quattro FX, Quattro FX For Her, Mirage Vista, Mirage Quattro,

Mirage Micro, Mirage Liberty, and Mirage Activa LT. Photographs of these ResMed products

are attached as Exhibits 26-31. Copies of the user manuals for these ResMed Products are

attached as Exhibits 37-42. Claim charts demonstrating how representative ResMed products are

protected by an exemplary claim of the ’267 patent are attached as Exhibits 48-52. C

6.4 At least the following component of the ResMed SDB treatment systems is

protected by the ’398 patent: the H5i heated humidifier. Photographs of the H5i heated

humidifier are attached as Exhibit 32. A copy of the user manual for the H5i is attached as

Exhibit 43. A claim chart demonstrating how the H5i heated hmnidifier is protected by an

exemplary claim of the ’398 patent is attached as Exhibit 53.


protected by the ’1l6 patent: Swift LT, Swift LT for Her, and the Mirage Vista. Photographs of

these ResMed products are attached as Exhibits 33-34. Copies of the user manuals for these

ResMed Products are attached as Exhibits 44-45. Claim charts demonstrating how

representative ResMed products are protected by an exemplary claim of the ’116 patent are

attached as Exhibits 55-56.


protected by the ’O60patent: Swift II, Swift LT, Swift LT for Her, and the Mirage Vista.

Photographs of these ResMed products are attached as Exhibits 30 and 33-35. Copies of the user

manuals for these ResMed Products are attached as Exhibits 41 and 44-46. Claim charts

35

demonstrating how representative ResMed products are protected by an exemplary claim of the

’060 patent are attached as Exhibits 59-61.


protected by the ’883 patent: Swift II, Swift LT and Swift LT for Her. Photographs of these

ResMed products are attached as Exhibits 33-35. Copies of the user manuals for these ResMed

Products are attached as Exhibits 44-46. Claim charts demonstrating how representative

ResMed products are protected by an exemplary claim of the ’883 patent are attached as Exhibits

57-58.


protected by the ’487 patent: Mirage FX, Quattro, Quattro FX, Swift II, Swift LT, Swift FX,

Swift FX for Her, Swift FX Bella, Mirage Liberty. Photographs of a selection of these ResMed

products are attached as Exhibits 27, 29, 31, and 35. Copies of the user manuals for a selection

of these ResMed Products are attached as Exhibits 38, 40, 42, 44, and 46. A claim chart

demonstrating how a representative ResMed product is protected by an exemplary claim of the

’487 patent is attached as Exhibit 66.


protected by the ’527 patent: Mirage Micro, Mirage Quattro, Activa, Activa LT, Mirage Vista.

Photographs of a selection of these ResMed products are attached as Exhibits 26 and 28-30.

Copies of the user manuals for a selection of these ResMed Products are attached as Exhibits 37

and 39-41. A claim chart demonstrating how a representative ResMed product is protected by an



protected by the ’392 patent: Mirage Micro, Mirage Quattro, Activa, Activa LT, Mirage Vista.

36

Photographs of a selection of these ResMed products are attached as Exhibits 26 and 28-30.

Copies of the user manuals for a selection of these ResMed Products are attached as Exhibits 37

and 39-41. A claim chart demonstrating how a representative ResMed product is protected by an


B. Economic Prong

6.11 ResMed conducts significant domestic industry activities in the United States

relating to products protected by one or more claims of the Asserted Patents. These activities

include the research and development and manufacturing of electronic motors (the key

component in the ResMed flow generators contained in ResMed’s sleep-disordered breathing

treatment systems), the packaging of these systems, sales of the sleep-disordered breathing

treatment systems, and other activities designed to exploit the patents at issue such as customer

support, warranty and repair services, and clinical educational and training activities. ResMed’s

investment in plant and equipment, employment of labor and capital, and substantial investment

in the exploitation of the Asserted Patents and the investments in these activities is set forth in a

confidential declaration attached to this complaint. See Confidential Exhibit 92. A copy of

ResMed Inc.’s Form 10-K and Annual Report for the fiscal year ending Jtme 30, 2012 is attached

as Exhibit 96.

6.12 ResMed has made and continues to make significant investment in facilities and

equipment in the United States dedicated to the research and development, manufacture,

assembly, product support, testing and quality management, and warranty and repair services for

products protected by the Asserted Patents. The plant facilities and equipment used in

connection with ResMed’s products are located in Califomia and South Carolina. ResMed’s

investment in plant and equipment is set forth in Confidential Exhibit 92.

37

6.13 ResMed has employed and continues to employ a significant number of

employees in the above-mentioned facilities that devote substantial personnel-hours toward the

manufacture, assembly, customer and product support, testing and quality management, and

warranty and repair services for products protected by the Asserted Patents. Additionally,

ResMed employees conduct clinical education sessions to educate clinical professionals on the

use of products protected by the Asserted Patents. Confidential Exhibit 92 describes this labor

investment.

6.14 ResMed has invested and continues to invest significant capital in its domestic

facilities toward customer and product support, testing and quality management, clinical

education, and warranty and repair services for products protected by the Asserted Patents.

Confidential Exhibit 92 describes the capital ResMed has expended towards these activities.

VII. UNLAWFUL AND UNFAIR ACTS OF PROPOSED RESPONDENTS

7.1 Upon infonnation and belief, Proposed Respondents’ accused products directly

infringe at least: claims 32, 33, 34, 35, 36, 37, 53, 79, 80, and 88 ofthe ’267 patent; claims 1, 2,

3, 4, 5, 6 and 7 ofthe ’398 patent; claim 1 of the ’116 patent; claims 30, 37, and 38 ofthe ’06()

patent; claims 1, 3, 5, ll, 28, 30, 31, and 56 ofthe ’883 patent; claims 1, 3, 6, 7, 9, 29, 32, 35, 40,

42, 45, 50, 51, 56, 59, 89, 92, 94, and 96 ofthe ’527 patent; claims 19, 20, 21, 22, 23, 24, 26, 29,

30, 31, 32,33, 34, 35, 36, 39, 40, and 41 ofthe ’392 patent; and claims 13, 15, 16, 26, 27, 28, 51,

52, and 55 of the ’487 patent. On information and belief, the accused products are manufactured,

assembled, packaged, and/or tested overseas, specifically, at least in China. On information and

belief, these same products are then imported into the United States, sold for importation into the

United States, and/or sold after importation into the United States by Proposed Respondents.

Ftuther discovery may reveal that Proposed Respondents infringe additional claims of the

Asserted Patents.

38

7.1 On information and belief, BMC and 3B’s Willow and iVolve infringe the

asserted claims of the ’267 patent. Further discovery may reveal additional infringing BMC and

3B products and/or models. Photographs of a representative BMC and 3B Willow and a

representative iVolve are attached to this Complaint as Exhibit 68 and Exhibit 69, respectively.

A copy of the user manual for the representative Willow is attached to this Complaint as Exhibit

71. Claim charts demonstrating how the asserted independent claims of the ’267 patent are

infringed by the representative accused products are attached as Exhibit 75 and Exhibit 76.

7.2 On information and belief, BMC and 3B’s RESmart CPAP and RESmart Auto

CPAP infringe the asserted claims of the ’398 patent. Further discovery may reveal additional

infringing BMC and 3B products and/or models. Photographs of a representative BMC and 3B

RESmart CPAP and a RESmart Auto-CPAP are attached to this Complaint as Exhibit 70. A

copy of the user manual for the representative RESmart CPAP and RESmart Auto-CPAP is

attached to this Complaint as Exhibit 73. A claim chart demonstrating how the asserted

independent claims of the ’398 patent are infringed by the representative accused product is

attached as Exhibit 77

7.3 On information and belief, BMC and 3B’s Willow infringes the asserted claim of

the ’116 patent. Further discovery may reveal additional infringing BMC and 3B products

and/or models. Photographs of a representative BMC and 3B Willow are attached to this

Complaint as Exhibit 68. A copy of the user manual for the representative Willow is attached to

this Complaint as Exhibit 71. A claim chart demonstrating how the asserted independent claim

of the ’l l6 patent is infringed by the representative accused products is attached as Exhibit 78.

7.4 On information and belief, BMC and 3B’s Willow infringes the asserted claims of

the ’O6Opatent. Ftnther discovery may reveal additional infringing BMC and 3B products

39

and/or models. Photographs of a representative BMC and 3B Willow are attached to this

Complaint as Exhibit 68. A copy of the user brochure for the representative Willow is attached

to this Complaint as Exhibit 71. A claim chart demonstrating how the asserted independent

claim of the ’060 patent is infringed by the representative accused product is attached as Exhibit

80.

7.5 On information and belief, BMC and 3B’s Willow infringes the asserted claims of


and/or models. Photographs of a representative BMC and 3B Willow is attached to this

Complaint as Exhibit 68. A copy of the user brochure for the representative Willow is attached

to this Complaint as Exhibit 71. A claim chart demonstrating how the asserted independent

claims of the ’883 patent are infringed by the representative accused products is attached as

Exhibit 79.

7.6 On infonnation and belief, BMC and 3B’s Willow and iVolve infringe the

asserted claims of the ’487 patent. Further discovery may reveal additional infringing BMC and

3B products and/or models. Photographs of a representative BMC and 3B Willow and a

representative iVolve are attached to this Complaint as Exhibit 68 and Exhibit 69, respectively.

A copy of the user manual for the representative Willow is attached to this Complaint as Exhibit

71. Claim charts demonstrating how the asserted independent claims of the ’487 patent are

infringed by the representative accused products are attached as Exhibit 83 and Exhibit 84.

7.7 On information and belief, BMC and 3B’s iVolve infringes the asserted claims of


and/or models. Photographs of a representative BMC and 3B iVolve are attached to this

40

Complaint as Exhibit 69. A claim chart demonstrating how the asserted independent claims of

the ’527 patent are infringed by the representative accused product is attached as Exhibit 81.

7.8 On information and belief, BMC and 3B’s iVolve infringes the asserted claims of


and/or models. Photographs of a representative BMC and 3B iVo1veare attached to this

Complaint as Exhibit 69. A claim chart demonstrating how the asserted independent claim of the

’392 patent is infringed by the representative accused product is attached as Exhibit 82.

7.9 On information and belief, the 3B Willow and BMC FeaLite are the same

products with different branding. On information and belief, BMC manufacturers the nasal

pillow patient interface with the brand name “FeaLite.” 3B, the U.S. subsidiary of BMC,

imports the FeaLite into the United States and sells it under the brand name “Willow.” For

example, a comparison of pictures of the FeaLite and Willow, taken from their respective

websites, show that they are the same product, merely with different labels:

41

.;,n “Q

Pictures of the 3B Willow”

7.10 Additio

and BMC Fe

nally, the Sales S

shows an i

I

‘/

W’ “’*~+5»

aLitel3

heet for the 3B Willow, available from 3B’s

mage that is identical to the image of the BMC FeaLite pictured on the BM

‘ZSee Exhibit 89, 3B’s websi" See Exhibit 9

te, Willow0, BMC’s

medicalcoI4

product page, at http://3bproducts.com/wi11ow,html.website, FeaLite product page, at http://en.bmc

m/products_detail/&pr0ductId=eda32f48-5d22-4dd3-b5 l 7-3b32165See http://3bpr0ducts.c0m/patient_p011al.html

685352.html.

42

website, '4

C website

1

"5 /

4.“

it» ‘“

” 5

Pictures of the 3B Willow” and BMC FeaLitel6

7.11 Therefore, because the BMC FeaLite a.nd‘3BWillow are the same products with

different brand names, BMC’s FeaLite infringes the asserted claims of the ’267, ’487, ’O60,

’1l6, and ’883 patents for the reasons described previously with respect to the 3B Willow, and in

the associated claim charts. Further discovery may reveal additional infringing 3B and BMC

products and/or models.

VIII. SPECIFIC INSTANCES OF UNFAIR IMPORTATION AND SALE

A. BMC and 3B

8.1 According to the sworn declaration of Alex Lucio, Vice President of 3B Medical,

“BMC first began selling sleep disordered breathing equipment, including CPAP machines and

breathing masks in the United States in October 2012.” See Exhibit 91, Lucio Declaration, at ‘[1

2. Further, according to Mr. Lucio, “[t]he Willow nasal pillow and RESmart CPAP and Auto

15See Exhibit 72, Sales sheet for the BMC and 3B Willow, at 1.1‘See Exhibit 90, BMC’s website, FeaLite product page, at http://en.bmcmedical.com/products_detail/&productId=eda32f48-5d22-4dd3-b517-3b3a65685352.html.

43

CPAP machines have been available in the United States at least as early as October 20l2.” See

id. at 114. Additionally, Mr. Lucio states that “[t]he Willow nasal pillow and RESmart CPAP

and Auto CPAP were displayed at HME conferences at least as early as October 2012.” See id. at

1]5. Mr. Lucio also states that “BMC’s products, the Willow nasal pillow, iVolve maks, and

RESmart CPAP and Auto CPAP devices have been or are currently being evaluated by the FDA

for approval to distribute in the United States. The iVolve is pending FDA approval.” See id. at

114.

8.2 BMC has also previously stated that “ResMed’s motion alleges that BMC imports

and sells certain sleep-disordered products and that BMC should be added as a respondent to the

ongoing investigation. BMC has an interest responding to these allegations. The allegations

could impair BMC’sability to import its sleep-disordered products - but should not because

BMC does not violate Section 337.” See Exhibit 91, BMC Motion to Intervene, Memorandiun

Of Points And Authorities In Support Of Non-Parties BMC Medicial Co., Ltd., 3B Medical Inc.,

And 3B Products, LLC’s Motion To Intervene For The Limited Pmpose Of Responding To

ResMed’s Motion To Amend The Complaint And Notice Of Investigation, at p. 6 (emphasis

added). BMC and 3B have therefore admitted to importing their “sleep-disordered products.”

8.3 Additionally, on information and belief, ResMed tmderstands that the BMC and

3B iVolve has been imported into the United States for the purpose of display at a trade show. A

ResMed representative attended the Medtrade Spring trade show in Las Vegas, Nevada, on

March 20, 2013, and observed a Willow, RESma1t, and iVolve on display at the BMC and 3B

booth. See Exhibit 95, Declaration of Michael J. Rider, at 11112-4. Furthermore, on information

and belief, BMC and 3B plans to, or already has begtm, selling the iVolve in the United States.

See id.

44

8.4 Complainants purchased a representative BMC and 3B Willow, RESmart CPAP,

and RESmart Auto-CPAP in the United States. Attached as Exhibit 88 are photographs showing

the box in which the BMC and 3B Willow, RESmart CPAP, and RESmart Auto-CPAP were

shipped, showing that the products were shipped from 3B Medical in the United States. Labels

on the device and/or product packaging for representative BMC and 3B devices indicate that the

accused products were manufactured in China. Attached as Exhibits 85-87 are photographs of

the product packaging for the BMC and 3B Willow, RESmart CPAP, and RESmart Auto—CPAP,

reflecting that they were made in China.

B. HTSUS

8.5 The accused products are believed to fall within at least the following

classifications of the Harmonized Tariff Schedules of the United States: 9019.20.00, and

9817.00.96. This classification is intended for illustrative purposes only and is not intended to

restrict the scope or type of accused product.

IX. LICENSEES

9.1 ResMed has licensed one or more of the Asserted Patents. Pursuant to

Commission Rule 210.12, ResMed states that for all of the Asserted Patents ResMed Ltd has

granted ResMed Inc. an exclusive license with the right to sublicense. ResMed Inc. has granted

an exclusive license to all the asserted patents to ResMed Corp. Copies of these licenses can be

found in Confidential Exhibit 93. A list of all licensees can be found in Confidential Exhibit 94.

X. RELATED LITIGATION

10.1 On March 28, 2013, ResMed filed a complaint with ITC requesting that the ITC

institute an investigation against Apex Medical Corp., Apex Medical USA Corp. (collectively

“Apex”), and Medical Depot, Inc., d/b/a Drive Medical (“Drive”), alleging infringement of some

of the same patents asserted in this Investigation. See Certain Sleep-Disordered Breathing

45

Treatment Systems Ana’Components Thereoj’,Inv. No. 337-TA-879, Complaint Of ResMed Ltd,

ResMed Inc., And ResMed Corp. Under Section 337 Of The Tariff Act Of 1930, As Amended

(March 28, 2013). The Commission instituted the Investigation as Investigation No. 337-TA

879 (“the 879 Investigation”) on May 1, 2013. See 78 Fed. Reg. 25475 (May 1, 2013). ALJ

Gildea issued an initial detennination terminating the 879 Investigation as to Drive Medical on

the basis of a consent order on June 26, 2013. See Certain Sleep-Disordered Breathing

Treatment Systems And Components Thereoy’,Inv. No. 337-TA-879, Order No. 8 (Jun. 26, 2013).

10.2 On March 28, 2013, ResMed filed a complaint in District Court in the Central

District of California, alleging infringement of some of the same patents asserted in this

Investigation. See ResMed Inc., et. al. v. Apex Medical Corp., et. al., Case No. SACV-13-00498

(C.D. Cal., filed Mar. 28, 2013). ResMed filed a first amended complaint on April 8, 2013. See

id., Dkt. No. 6. On May 10, 2013, pursuant to a stipulation and 28 U.S.C. § 1659, the action was

stayed pending final resolution of the 879 Investigation.

10.3 On May 29, 2013, ResMed filed suit against BMC and 3B in District Court in the

Southern District of Califomia, alleging infringement of many of the same patents asserted in

this Investigation. See ResMed Inc., et. al. v. BMC Medical C0., Ltd., et. al., Case No. 3:13-cv

01246-MMA-WMC (S.D. Cal., filed May 29, 2013).

10.4 On February 13, 2007, the University of Sydney initiated a complaint in the

Federal Court of Australia against ResMed for patent infringement and contract claims involving

some of the patents asserted in this Investigation. See University of Sydney v ResMed Limited,

NSD 200/2007 (Federal Court of Australia, filed Feb. 13, 2007). The case was settled in June of

2013.

46

10.5 In October of 2002, ResMed filed suit against Respironics, Inc. in District Court

in the Southern District of Califomia, alleging infringement of patents related to patents asserted

in this Investigation. See ResMed Corp, et. al. v. Respironics Inc., Case No. 3:O2cv2021 (S.D.

Cal., filed Oct. 11, 2002). The case (and other cases related thereto) was settled by the parties in

September of 2003.

10.6 There has been no other foreign or domestic court or agency litigation involving

any of the Asserted Patents, or the subject matter thereof.

XI. REQUESTED RELIEF

11.1 WHEREFORE, by reason of the foregoing, ResMed requests that the United

States International Trade Commission:

(a) Institute an immediate Investigation, pursuant to Section 337 of the Tariff Act of

1930, as amended, 19 U.S.C. § 1337, with respect to violations of Section 337 based on

the proposed Respondent’s unlawful importation into the United States, sale for

importation into the United States, and/or sale within the United States after importation

of certain sleep-disordered breathing treatment systems and components thereof, which

infringe one or more claims of United States Patent Nos. 7,997,267; 7,614,398;

7,938,116; 7,341,060; 8,312,883; 7,178,527; 7,950,392; or 7,926,487;

(b) Schedule and conduct a hearing on the unlawful acts and, following the hearing,

determine that there has been a violation of Section 337;

(c) Issue a pennanent limited exclusion order, pursuant to Section 337(d) of the Tariff

Act of 1930, as amended, excluding from entry into the United States all of the proposed

Respondent’s sleep-disordered breathing treatment systems and components thereof

which infringe one or more claims of United States Patent Nos. 7,997,267; 7,614,398;

7,938,116; 7,341,060; 8,312,883; 7,178,527; 7,950,392; or 7,926,487;

47

(d) Issue a permanent cease and desist order, pursuant to Section 337(f) of the Tariff Act

of 1930, as amended, directing the proposed Respondents to cease and desist from the

importation, marketing, advertising, demonstrating, warehousing inventory for

distribution, sale and use of certain sleep-disordered breathing treatment systems and

components thereof that infringe one or more claims of United States Patent Nos.

7,997,267; 7,614,398; 7,938,116; 7,341,060; 8,312,883; 7,178,527; 7,950,392; or

7,926,487; and 2

(e) Grant such other and further relief as the Commission deems just and proper based on

the facts determined by the Investigation and the authority of the Commission.

48


FISH & RICHARDSON P.C.

Dated July19 2013 Z 6%‘?

Roger DemlingSeth M. SproulScott PennerFISH & RICHARDSON P.C.12390 El Camino Real

San Diego, CA 92130Telephone: (858)-678-5070Fax: (858)-678-5099

Thomas “Monty” FuscoW. Peter GuamieriFISH & RICHARDSON P.C.1425 K Street, N.W., 11"‘FloorWashington, D.C. 20005Telephone: (202) 783-5070Facsimile: (202) 783-2331

Frank E. ScherkenbachFISH & RICHARDSON P.C.One Marina Park DriveBoston, MA 02210-1878Telephone: (617)-542-5070Fax: (617)-542-8906

Michael J. KaneFISH & RICHARDSON P.C.3200 RBC Plaza60 South Sixth StreetMinneapolis, MN 55402Telephone: (612)-335-5070Fax: (612)-288-9696

Counselfor Complainants ResMed Ltd,ResMedIna, and ResMed Corp.

.VERIFICATION OF COMPLAINT

I, Benjamin Cheah, declare under the penalty of perjury under the laws of the United

States of America, and in accordance with 19 C.F.R. §§ 210.4 and 2l0.l2(a), that the following

is true and correct: - ,

1. I am currently the Vice President, Customer Service, of ResMcd Corp and have been

with ResMed Corp for more than 9 years. I am duly authorized to verify this

complaint on behalf of ResMed Corp, ResMed Inc. and ResMed Ltd.

2. I have read the Complaint and I am aware of its contents; '

3. The Complaint is not being presented for any improper purpose, such as to harass or

to cause unnecessary delay or needlessly increase the cost of Litigation;

4. To the best of my knowledge, information and belief founded upon reasonable

inquiry, the claims and legal contentions of this complaint are warranted by existing

law or a good faith argument for the extension, modification or reversal of existing

law; »

5. To the best of my knowledge, information and belief founded upon reasonable

inquiry, the allegations and other factual contentions in the complaint have

evidentiary support or are likely to have evidentiary support afier a reasonable

opportunity for further investigation or discovery. I

_ .-,.__.§§?E‘}§€§.P“l?l¥ .................... ....................... o o.. Benjamin Cheah V

Copy of rules from eCFR.gov, as revised June 20, 2013.

This version incorporates the text of 78 Fed. Reg. 23474 (April 19, 2013) and 78 Fed. Reg. 29618 (May 21, 2013). See also, Commission Notice dated June 4, 2013.

Note: This version is unofficial. The official text is the text of the original Federal Register notices.

Title 19: Customs Duties

PART 201—RULES OF GENERAL APPLICATION

§ 201.16 Service of process and other documents.

(a) By the Commission. Except when service by another method shall be specifically ordered by the Commission, the service of a process or other document of the Commission shall be served by anyone duly authorized by the Commission and be effected—

(1) By mailing or delivering a copy of the document to the person to be served, to a member of the partnership to be served, to the president, secretary, other executive officer, or member of the board of directors of the corporation, association, or other organization to be served, or, if an attorney represents any of the above before the Commission, by mailing or delivering a copy to such attorney; or

(2) By leaving a copy thereof at the principal office of such person, partnership, corporation, association, or other organization, or, if an attorney represents any of the above before the Commission, by leaving a copy at the office of such attorney.

(3) By using an express delivery service to send a copy of the document to the principal office of such person, partnership, corporation, association, or other organization, or, if an attorney represents any of the above before the Commission, by serving the attorney by express delivery.

(4) When service is by mail, it is complete upon mailing of the document. When service is by an express service, service is complete upon submitting the document to the express delivery service or depositing it in the appropriate container for pick-up by the express delivery service.

(b) By a party other than the Commission. Except when service by another method shall be specifically ordered by the Commission, the service of a document of a party shall be effected:

(1) By mailing or delivering a copy of a nonconfidential version of the document to each party, or, if the party is represented by an attorney before the Commission, by mailing or delivering a nonconfidential version thereof to such attorney; or

(2) By leaving a copy thereof at the principal office of each other party, or, if a party is represented by an attorney before the Commission, by leaving a copy at the office of such attorney.

(3) When service is by mail, it is complete upon mailing of the document.

(4) When service is by mail, it shall be by first class mail, postage prepaid. In the event the addressee is outside the United States, service shall be by first class airmail, postage prepaid.

(c) Proof of service; certificate. (1) Each document filed with the Secretary to the Commission by a party in the course of an investigation (as provided in § 201.8 of this part) shall be served on each other party to the investigation (as provided in § 210.4(i) of this chapter for investigations under 19 U.S.C. 1337).

(2) Each document served by a party shall include a certificate of service, setting forth the manner and date of such service. The certificate of service shall be deemed proof of service of the document. In the event a document is not accompanied by a certificate of service, the Secretary shall not accept such document for filing and shall promptly notify the submitter.

(d) Additional time after service by mail. Whenever a party or Federal agency or department has the right or is required to perform some act or take some action within a prescribed period after the service of a document upon it and the document is served upon it by mail, three (3) calendar days shall be added to the prescribed period, except that when mailing is to a person located in a foreign country, ten (10) calendar days shall be added to the prescribed period.

(e) Additional time after service by express delivery. Whenever a party or Federal agency or department has the right or is required to perform some act or take some action within a prescribed period after the service of a document upon it and the document is served by express delivery, one (1) day shall be added to the prescribed period if the service is to a destination in the United States, and five (5) days shall be added to the prescribed period if the service is to a destination outside the United States. “Service by express delivery” refers to a method that would provide delivery by the next business day within the United States and refers to the equivalent express delivery service when the delivery is to a foreign location.

(f) Electronic service. Parties may serve documents by electronic means in all matters before the Commission. Parties may effect such service on any party, unless that party has, upon notice to the Secretary and to all parties, stated that it does not consent to electronic service. If electronic service is used, no additional time is added to the prescribed period. However, any dispute that arises among parties regarding electronic service must be resolved by the parties themselves, without the Commission's involvement.

(19 U.S.C. 1335 and the Administrative Procedure Act, 5 U.S.C. 551, et seq. )

[41 FR 17711, Apr. 27, 1976, as amended at 47 FR 6190, Feb. 10, 1982; 47 FR 33682, Aug. 4, 1982; 49 FR 32571, Aug. 15, 1984; 67 FR 68037, Nov. 8, 2002; 73 FR 38320, July 7, 2008; 76 FR 61942, Oct. 6, 2011; 78 FR 23840, Apr. 19, 2013]

PART 210—ADJUDICATION AND ENFORCEMENT

AUTHORITY: 19 U.S.C. 1333, 1335, and 1337.

SOURCE: 59 FR 39039, Aug. 1, 1994, unless otherwise noted.

Subpart A—Rules of General Applicability § 210.1 Applicability of part.

The rules in this part apply to investigations under section 337 of the Tariff Act of 1930 and related proceedings. These rules are authorized by sections 333, 335, or 337 of the Tariff Act of 1930 (19 U.S.C. §§ 1333, 1335, and 1337) and sections 2 and 1342(d)(1)(B) of the Omnibus Trade and Competitiveness Act of 1988, Pub. L. No. 100-418, 102 Stat. 1107 (1988).

§ 210.2 General policy.

It is the policy of the Commission that, to the extent practicable and consistent with requirements of law, all investigations and related proceedings under this part shall be conducted expeditiously. The parties, their attorneys or other representatives, and the presiding administrative law judge shall make every effort at each stage of the investigation or related proceeding to avoid delay.

§ 210.3 Definitions.

As used in this part—

Administrative law judge means the person appointed under section 3105 of title 5 of the United States Code who presides over the taking of evidence in an investigation under this part. If the Commission so orders or a section of this part so provides, an administrative law judge also may preside over stages of a related proceeding under this part.

Ancillary proceeding has the same meaning as related proceeding.

Commission investigative attorney means a Commission attorney designated to engage in investigatory activities in an investigation or a related proceeding under this part.

Complainant means a person who has filed a complaint with the Commission under this part, alleging a violation of section 337 of the Tariff Act of 1930.

Intervenor means a person who has been granted leave by the Commission to intervene as a party to an investigation or a related proceeding under this part.

Investigation means a formal Commission inquiry instituted to determine whether there is a violation of section 337 of the Tariff Act of 1930. An investigation is instituted upon publication of a notice in the FEDERAL REGISTER. The investigation entails postinstitution adjudication of the complaint. An investigation can also involve the processing of one or more of the following: A motion to amend the complaint and notice of investigation; a motion for temporary relief; a motion to designate “more complicated” the temporary relief stage of the investigation; an interlocutory appeal of an administrative law judge's decision on a particular matter; a motion for sanctions for abuse of process, abuse of discovery, or failure to make or cooperate in discovery, which if granted, would have an impact on the adjudication of the merits of the complaint; a petition for

reconsideration of a final Commission determination; a motion for termination of the investigation in whole or part; and procedures undertaken in response to a judgment or judicial order issued in an appeal of a Commission determination or remedial order issued under section 337 of the Tariff Act of 1930.

Party means each complainant, respondent, intervenor, or the Office of Unfair Import Investigations.

Proposed intervenor means any person who has filed a motion to intervene in an investigation or a related proceeding under this part.

Proposed respondent means any person named in a complaint filed under this part as allegedly violating section 337 of the Tariff Act of 1930.

Related proceeding means preinstitution proceedings, sanction proceedings (for the possible issuance of sanctions that would not have a bearing on the adjudication of the merits of a complaint or a motion under this part), bond forfeiture proceedings, proceedings to enforce, modify, or revoke a remedial or consent order, or advisory opinion proceedings.

Respondent means any person named in a notice of investigation issued under this part as allegedly violating section 337 of the Tariff Act of 1930.

U.S. Customs Service means U.S. Customs and Border Protection.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67626, Dec. 30, 1994; 73 FR 38320, July 7, 2008; 76 FR 24363, May 2, 2011; 78 FR 23840, Apr. 19, 2013]

§ 210.4 Written submissions; representations; sanctions.

(a) Caption; names of parties. The front page of every written submission filed by a party or a proposed party to an investigation or a related proceeding under this part shall contain a caption setting forth the name of the Commission, the title of the investigation or related proceeding, the docket number or investigation number, if any, assigned to the investigation or related proceeding, and in the case of a complaint, the names of the complainant and all proposed respondents.

(b) Signature. Every pleading, written motion, and other paper of a party or proposed party who is represented by an attorney in an investigation or a related proceeding under this part shall be signed by at least one attorney of record in the attorney's individual name. A party or proposed party who is not represented by an attorney shall sign, or his duly authorized officer or agent shall sign, the pleading, written motion, or other paper. Each paper shall state the signer's address and telephone number, if any. Pleadings, written motions, and other papers need not be under oath or accompanied by an affidavit, except as provided in § 210.12(a)(1), § 210.13(b), § 210.18, § 210.52(d), § 210.59(b), or another section of this part or by order of the administrative law judge or the Commission. If a pleading, motion, or other paper is not signed, it shall be stricken unless it is signed promptly after omission of the signature is called to the attention of the submitter.

(c) Representations. By presenting to the presiding administrative law judge or the Commission (whether by signing, filing, submitting, or later advocating) a pleading, written motion, or other paper, an attorney or unrepresented party or proposed party is certifying that to the best of the person's knowledge, information, and belief, formed after an inquiry reasonable under the circumstances—

(1) It is not being presented for any improper purpose, such as to harass or to cause unnecessary delay or needless increase in the cost of the investigation or related proceeding;

(2) The claims, defenses, and other legal contentions therein are warranted by existing law or by a nonfrivolous argument for the extension, modification, or reversal of existing law or the establishment of new law;

(3) The allegations and other factual contentions have evidentiary support or, if specifically so identified, are likely to have evidentiary support after a reasonable opportunity for further investigation or discovery; and

(4) The denials of factual contentions are warranted on the evidence or, if specifically so identified, are reasonably based on a lack of information or belief.

(d) Sanctions. If, after notice and a reasonable opportunity to respond (see paragraphs (d)(1) (i) and (ii) of this section and § 210.25), the presiding administrative law judge or the Commission determines that paragraph (c) of this section has been violated, the administrative law judge or the Commission may, subject to the conditions stated below and in § 210.25, impose an appropriate sanction upon the attorneys, law firms, or parties that have violated paragraph (c) or are responsible for the violation. A representation need not be frivolous in its entirety in order for the administrative law judge or the Commission to determine that paragraph (c) has been violated. If any portion of a representation is found to be false, frivolous, misleading, or otherwise in violation of paragraph (c), a sanction may be imposed. In determining whether paragraph (c) has been violated, the administrative law judge or the Commission will consider whether the representation or disputed portion thereof was objectively reasonable under the circumstances.

(1) How initiated —(i) By motion. A motion for sanctions under this section shall be made separately from other motions or requests and shall describe the specific conduct alleged to violate paragraph (c). It shall be served as provided in paragraph (g) of this section, but shall not be filed with or presented to the presiding administrative law judge or the Commission unless, within seven days after service of the motion (or such other period as the administrative law judge or the Commission may prescribe), the challenged paper, claim, defense, contention, allegation, or denial is not withdrawn or appropriately corrected. See also § 210.25 (a) through (c). If warranted, the administrative law judge or the Commission may award to the party or proposed party prevailing on the motion the reasonable expenses and attorney's fees incurred in presenting or opposing the motion. Absent exceptional circumstances, a law firm shall be held jointly responsible for violations committed by its partners, associates, and employees.

(ii) On the administrative law judge's or the Commission's initiative. The administrative law judge or the Commission may enter an order sua sponte describing the specific conduct that appears to violate paragraph (c) of this section and directing an attorney, law firm, party, or proposed party to show cause why it has not violated paragraph (c) with respect thereto.

(2) Nature of sanctions; limitations. A sanction imposed for violation of paragraph (c) of this section shall be limited to what is sufficient to deter repetition of such conduct or comparable conduct by others similarly situated. Subject to the limitations in paragraphs (d)(2) (i) through (iv) of this section, the sanction may consist of, or include, directives of a nonmonetary nature, an order to pay a penalty, or, if imposed on motion and warranted for effective deterrence, an order directing payment to the movant of some or all of the reasonable attorney's fees and other expenses incurred as a direct result of the violation.

(i) Monetary sanctions shall not be imposed under this section against the United States, the Commission, or a Commission investigative attorney.

(ii) Monetary sanctions may not be awarded against a represented party or proposed party for a violation of paragraph (c)(2) of this section.

(iii) Monetary sanctions may not be imposed on the administrative law judge's or the Commission's initiative unless—

(A) The Commission or the administrative law judge issues an order to show cause before the investigation or related proceeding is terminated, in whole or in relevant part, as to the party or proposed party which is, or whose attorneys are, to be sanctioned; and

(B) Such termination is the result of—

( 1 ) A motion to withdraw the complaint, motion, or petition that was the basis for the investigation or related proceeding;

( 2 ) A settlement agreement;

( 3 ) A consent order agreement; or

( 4 ) An arbitration agreement.

(iv) Monetary sanctions imposed to compensate the Commission for expenses incurred by a Commission investigative attorney or the Commission's Office of Unfair Import Investigations will include reimbursement for some or all costs reasonably incurred as a direct result of the violation, but will not include attorney's fees.

(3) Order. When imposing sanctions, the administrative law judge or the Commission shall describe the conduct determined to constitute a violation of this rule and explain the basis for the sanction imposed. See also § 210.25(d)-(f).

(e) Inapplicability to discovery. Paragraphs (c) and (d) of this section do not apply to discovery requests, responses, objections, and motions that are subject to provisions of §§ 210.27 through 210.34.

(f) Filing of documents. (1) Written submissions that are addressed to the Commission during an investigation or a related proceeding shall comply with the Commission's Handbook on Filing Procedures, which is issued by and available from the Secretary and posted on the Commission's Electronic Document Information System Web site at https://edis.usitc.gov. Failure to comply with the requirements of this chapter and the Handbook on Filing Procedures in the filing of a document may result in the rejection of the document as improperly filed.

(2) A complaint, petition, or request, and supplements and amendments thereto, filed under § 210.8, § 210.75, § 210.76, or § 210.79 shall be filed in paper form. An original and eight (8) true paper copies shall filed. All exhibits, appendices, and attachments to the document shall be filed in electronic form on one CD-ROM, DVD, or other portable electronic media approved by the Secretary. Sections 210.8 and 210.12 set out additional requirements for a complaint filed under § 210.8. Additional requirements for a petition or request filed under § 210.75, § 210.76, or § 210.79 are set forth in those sections. Submitted media will be retained by the Commission, except that media may be returned to the submitter if a document is not accepted for filing.

(3) Responses to a complaint, briefs, comments and responses thereto, compliance reports, motions and responses or replies thereto, petitions and replies thereto, prehearing statements, and proposed findings of fact and conclusions of law and responses thereto provided for under §§

210.4(d), 210.13, 210.8, 210.14, 210.15, 210.16, 210.17, 210.18, 210.19, 210.20, 210.21, 210.23, 210.24, 210.25, 210.26, 210.33, 210.34, 210.35, 210.36, 210.38, 210.40, 210.43, 210.45, 210.46, 210.47, 210.50, 210.52, 210.53, 210.57, 210.59, 210.66, 210.70, or 210.71; and submissions filed with the Secretary pursuant to an order of the presiding administrative law judge shall be filed electronically, and true paper copies of such submissions shall be filed by 12 noon, eastern time, on the next business day.

(4) Except for the documents listed in paragraphs (f)(2) and (f)(3) of this section, all other documents shall be filed electronically, and no paper copies will be required.

(5) If paper copies are required under this section, the required number of paper copies shall be governed by paragraph (f)(6) of this section. A paper copy provided for in this section must be a true copy of the electronic version of the document, i.e., a copy that is identical in all possible respects.

(6) Unless the Commission or this part specifically states otherwise:

(i) Two (2) true paper copies of each submission shall be filed if the investigation or related proceeding is before an administrative law judge; and

(ii) Eight (8) true paper copies of each submission shall be filed if the investigation or related proceeding is before the Commission.

(7)(i) If a complaint, a supplement or amendment to a complaint, a motion for temporary relief, or the documentation supporting a motion for temporary relief contains confidential business information as defined in § 201.6(a) of this chapter, the complainant shall file nonconfidential copies of the complaint, the supplement or amendment to the complaint, the motion for temporary relief, or the documentation supporting the motion for temporary relief concurrently with the requisite confidential copies, as provided in § 210.8(a). A nonconfidential copy of all exhibits, appendices, and attachments to the document shall be filed in electronic form on one CD-ROM, DVD, or other portable electronic media approved by the Secretary, separate from the media used for the confidential version.

(ii)(A) Persons who file the following submissions that contain confidential business information covered by an administrative protective order, or that are the subject of a request for confidential treatment, must file nonconfidential copies and serve them on the other parties to the investigation or related proceeding within 10 calendar days after filing the confidential version with the Commission:

( 1 ) A response to a complaint and all supplements and exhibits thereto;

( 2 ) All submissions relating to a motion to amend the complaint or notice of investigation; and

( 3 ) All submissions addressed to the Commission.

(B) Other sections of this part may require, or the Commission or the administrative law judge may order, the filing and service of nonconfidential copies of other kinds of confidential submissions. If the submitter's ability to prepare a nonconfidential copy is dependent upon receipt of the nonconfidential version of an initial determination, or a Commission order or opinion, or a ruling by the administrative law judge or the Commission as to whether some or all of the information at issue is entitled to confidential treatment, the nonconfidential copies of the submission must be filed within 10 calendar days after service of the Commission or

administrative law judge document in question. The time periods for filing specified in this paragraph apply unless the Commission, the administrative law judge, or another section of this part specifically provides otherwise.

(8) The Secretary may provide for exceptions and modifications to the filing requirements set out in this chapter. A person seeking an exception should consult the Handbook on Filing Procedures.

(9) Where to file; date of filing. Documents shall be filed at the Office of the Secretary of the Commission in Washington, DC. Such documents, if properly filed within the hours of operation specified in § 201.3(c), will be deemed to be filed on the date on which they are actually received in the Commission.

(10) Conformity with rules. Each document filed with the Commission for the purpose of initiating any investigation shall be considered properly filed if it conforms with the pertinent rules prescribed in this chapter. Substantial compliance with the pertinent rules may be accepted by the Commission provided good and sufficient reason is stated in the document for inability to comply fully with the pertinent rules.

(11) During any period in which the Commission is closed, deadlines for filing documents electronically and by other means are extended so that documents are due on the first business day after the end of the closure.

(g) Cover Sheet. When making a paper filing, parties must complete the cover sheet online at http://edis.usitc.gov and print out the cover sheet for submission to the Office of the Secretary with the paper filing. The party submitting the cover sheet is responsible for the accuracy of all information contained in the cover sheet, including, but not limited to, the security status and the investigation number, and must comply with applicable limitations on disclosure of confidential information under § 210.5.

(h) Specifications. (1) Each document filed under this chapter shall be double-spaced, clear and legible, except that a document of two pages or less in length need not be double-spaced. All submissions shall be in letter-sized format (8.5 × 11 inches), except copies of documents prepared for another agency or a court (e.g., patent file wrappers or pleadings papers), and single sided. Typed matter shall not exceed 6.5 × 9.5 inches using 11-point or larger type and shall be double-spaced between each line of text using the standard of 6 lines of type per inch. Text and footnotes shall be in the same size type. Quotations more than two lines long in the text or footnotes may be indented and single-spaced. Headings and footnotes may be single-spaced.

(2) The administrative law judge may impose any specifications he deems appropriate for submissions that are addressed to the administrative law judge.

(i) Service. Unless the Commission, the administrative law judge, or another section of this part specifically provides otherwise, every written submission filed by a party or proposed party shall be served on all other parties in the manner specified in § 201.16(b) of this chapter.

[59 FR 39039, Aug. 1, 1994; 59 FR 64286, Dec. 14, 1994, as amended at 59 FR 67626, Dec. 30, 1994; 60 FR 32443, June 22, 1995; 68 FR 32978, June 3, 2003; 73 FR 38320, July 7, 2008; 76 FR 61944, Oct. 6, 2011; 78 FR 23840, Apr. 19, 2013]

§ 210.5 Confidential business information.

(a) Definition and submission. Confidential business information shall be defined and identified in accordance with § 201.6 (a) and (c) of this chapter. Unless the Commission, the

administrative law judge, or another section of this part states otherwise, confidential business information shall be submitted in accordance with § 201.6(b) of this chapter. In the case of a complaint, any supplement to the complaint, and a motion for temporary relief filed under this part, the number of nonconfidential copies shall be prescribed by § 210.8(a) of this part.

(b) Restrictions on disclosure. Information submitted to the Commission or exchanged among the parties in connection with an investigation or a related proceeding under this part, which is properly designated confidential under paragraph (a) of this section and § 201.6(a) of this chapter, may not be disclosed to anyone other than the following persons without the consent of the submitter:

(1) Persons who are granted access to confidential information under § 210.39(a) or a protective order issued pursuant to § 210.34(a);

(2) An officer or employee of the Commission who is directly concerned with—

(i) Carrying out or maintaining the records of the investigation or related proceeding for which the information was submitted;

(ii) The administration of a bond posted pursuant to subsection (e), (f), or (j) of section 337 of the Tariff Act of 1930;

(iii) The administration or enforcement of an exclusion order issued pursuant to subsection (d), (e), or (g), a cease and desist order issued pursuant to subsection (f), or a consent order issued pursuant to subsection (c) of section 337 of the Tariff Act of 1930; or

(iv) Proceedings for the modification or rescission of a temporary or permanent order issued under subsection (d), (e), (f), (g), or (i) of section 337 of the Tariff Act of 1930, or a consent order issued under section 337 of the Tariff Act of 1930;

(3) An officer or employee of the United States Government who is directly involved in a review conducted pursuant to section 337(j) of the Tariff Act of 1930; or

(4) An officer or employee of the United States Customs Service who is directly involved in administering an exclusion from entry under section 337 (d), (e), or (g) of the Tariff Act of 1930 resulting from the investigation or related proceeding in connection with which the information was submitted.

(c) Transmission of certain records to district court. Notwithstanding paragraph (b) of this section, confidential business information may be transmitted to a district court and be admissible in a civil action, subject to such protective order as the district court determines necessary, pursuant to 28 U.S.C. 1659.

(d) Confidentiality determinations in preinstitution proceedings. After a complaint is filed under section 337 of the Tariff Act of 1930 and before an investigation is instituted by the Commission, confidential business information designated confidential by the supplier shall be submitted in accordance with § 201.6(b) of this chapter. The Secretary shall decide, in accordance with § 201.6(d) of this chapter, whether the information is entitled to confidential treatment. Appeals from the ruling of the Secretary shall be made to the Commission as set forth in § 201.6(e) and (f) of this chapter.

(e) Confidentiality determinations in investigations and other related proceedings. (1) If an investigation is instituted or if a related proceeding is assigned to an administrative law judge, the

administrative law judge shall set the ground rules for the designation, submission, and handling of information designated confidential by the submitter. When requested to do so, the administrative law judge shall decide whether information in a document addressed to the administrative law judge, or to be exchanged among the parties while the administrative law judge is presiding, is entitled to confidential treatment. The administrative law judge shall also decide, with respect to all orders, initial determinations, or other documents issued by the administrative law judge, whether information designated confidential by the supplier is entitled to confidential treatment. The supplier of the information or the person seeking the information may, with leave of the administrative law judge, request an appeal to the Commission of the administrative law judge's unfavorable ruling on this issue, under § 210.24(b)(2).

(2) The Commission may continue protective orders issued by the administrative law judge, amend or revoke those orders, or issue new ones. All submissions addressed to the Commission that contain information covered by an existing protective order will be given confidential treatment. (See also § 210.72.) New information that is submitted to the Commission, designated confidential by the supplier, and not covered by an existing protective order must be submitted to the Secretary with a request for confidential treatment in accordance with § 201.6(b) and (c) of this chapter. The Secretary shall decide, in accordance with § 201.6(d) of this chapter, whether the information is entitled to confidential treatment. Appeals from the ruling of the Secretary shall be made to the Commission as provided in § 201.6(e) and (f) of this chapter. The Commission shall decide, with respect to all orders, notices, opinions, and other documents issued by or on behalf of the Commission, whether information designated confidential by the supplier is entitled to confidential treatment.

(f) When the Commission or the administrative law judge issues a confidential version of an order, initial determination, opinion, or other document, the Commission, or the presiding administrative law judge if the administrative law judge has issued the confidential version, shall issue any public version of the document within 30 days, unless good cause exists to extend the deadline. An administrative law judge or the Commission may extend this time by order. Upon request by the Commission, or the administrative law judge if the administrative law judge has issued the confidential version, parties must provide support in the record for their claim of confidentiality, pursuant § 201.6 of this chapter and § 210.4 of this subpart for any proposed redactions that parties may submit to the Commission or the administrative law judge for the preparation of any public version.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67626, Dec. 30, 1994; 60 FR 32444, June 22, 1995; 78 FR 23840, Apr. 19, 2013]

§ 210.6 Computation of time, additional hearings, postponements, continuances, and extensions of time.

(a) Unless the Commission, the administrative law judge, or this or another section of this part specifically provides otherwise, the computation of time and the granting of additional hearings, postponements, continuances, and extensions of time shall be in accordance with §§ 201.14 and 201.16(d) and (e) of this chapter.

(b) Whenever a party has the right or is required to perform some act or to take some action within a prescribed period after service of a document upon it, and the document was served by mail, the deadline shall be computed by adding to the end of the prescribed period the additional time allotted under § 201.16(d), unless the Commission, the administrative law judge, or another section of this part specifically provides otherwise.

(c) Whenever a party has the right or is required to perform some act or to take some action within a prescribed period after service of a Commission document upon it, and the document was served by express delivery, the deadline shall be computed by adding to the end of the

prescribed period the additional time allotted under § 201.16(e), unless the Commission, the administrative law judge, or another section of this part specifically provides otherwise.

[78 FR 23840, Apr. 19, 2013]

§ 210.7 Service of process and other documents; publication of notices.

(a) Manner of service. (1) The service of process and all documents issued by or on behalf of the Commission or the administrative law judge—and the service of all documents issued by parties under §§ 210.27 through 210.34 of this part—shall be in accordance with § 201.16 of this chapter, unless the Commission, the administrative law judge, or this or another section of this part specifically provides otherwise.

(2) The service of all initial determinations as defined in § 210.42, all cease and desist orders as set forth in § 210.50(a)(1), and all documents containing confidential business information as defined in § 201.6(a), issued by or on behalf of the Commission or the administrative law judge on a private party, shall be effected by serving a copy of the document by express delivery, as defined in § 201.16(e), on the person to be served, on a member of the partnership to be served, on the president, secretary, other executive officer, or member of the board of directors of the corporation, association, or other organization to be served, or, if an attorney represents any of the above in connection with an investigation under this subtitle, by serving a copy by express delivery on such attorney.

(3) Whenever the Commission effects service of documents issued by or on behalf of the Commission or the administrative law judge upon the private parties by overnight delivery, service upon the Office of Unfair Import Investigations shall also be deemed to have occurred by overnight delivery.

(b) Designation of a single attorney or representative for service of process. The service list prepared by the Secretary for each investigation will contain the name and address of no more than one attorney or other representative for each party to the investigation. In the event that two or more attorneys or other persons represent one party to the investigation, the party must select one of their number to be the lead attorney or representative for service of process. The lead attorney or representative for service of process shall state, at the time of the filing of its entry of appearance with the Secretary, that it has been so designated by the party it represents. (Only those persons authorized to receive confidential business information under a protective order issued pursuant to § 210.34(a) are eligible to be included on the service list for documents containing confidential business information.)

(c) Publication of notices. (1) Notice of action by the Commission or an administrative law judge will be published in the FEDERAL REGISTER only as specifically provided in § 201.10, paragraph (c)(2) of this section, by another section in this chapter, or by order of an administrative law judge or the Commission.

(2) When an administrative law judge or the Commission determines to amend or supplement a notice published in accordance with paragraph (c)(1) of this section, notice of the amendment will be published in the FEDERAL REGISTER .

[60 FR 53119, Oct. 12, 1995, as amended at 72 FR 13960, Mar. 23, 2007; 73 FR 38320, July 7, 2008; 78 FR 23840, Apr. 19, 2013]

Subpart B—Commencement of Preinstitution Proceedings and Investigations § 210.8 Commencement of preinstitution proceedings.

A preinstitution proceeding is commenced by filing with the Secretary a signed original complaint and the requisite number of true copies.

(a)(1) A complaint filed under this section shall be filed in paper form with the Secretary as follows.

(i) An original and eight (8) true paper copies of the nonconfidential version of the complaint shall be filed. All exhibits, appendices, and attachments to this version of the complaint shall be filed in electronic form on CD-ROM, DVD, or other portable electronic media approved by the Secretary.

(ii) An original and eight (8) true paper copies of the confidential version of the complaint shall be filed. All exhibits, appendices, and attachments to this version of the complaint shall be filed in electronic form on CD-ROM, DVD, or other portable electronic media approved by the Secretary.

(iii) For each proposed respondent, one true copy of the nonconfidential version of the complaint and one true copy of the confidential version of the complaint, if any, along with one true copy of the nonconfidential exhibits and one true copy of the confidential exhibits shall be filed, and

(iv) For the government of the foreign country in which each proposed respondent is located as indicated in the complaint, one true copy of the nonconfidential version of the complaint shall be filed.

NOTE TO PARAGRAPH ( a )(1): The same requirements apply for the filing of a supplement or amendment to the complaint.

(2) If the complainant is seeking temporary relief, the complainant must also file:

(i) An original and eight (8) true paper copies of the nonconfidential version of the motion for temporary relief. All exhibits, appendices, and attachments to this version of the motion shall be filed in electronic form on CD-ROM, DVD, or other portable electronic media approved by the Secretary.

(ii) An original and eight (8) true paper copies of the confidential version of the motion for temporary relief. All exhibits, appendices, and attachments to this version of the motion shall be filed in electronic form on CD-ROM, DVD, or other portable electronic media approved by the Secretary; and

(iii) For each proposed respondent, one true copy of the nonconfidential version of the motion and one true copy of the confidential version of the motion along with one true copy of the nonconfidential exhibits and one true copy of the confidential exhibits filed with the motion.

NOTE TO PARAGRAPH ( a )(2): The same requirements apply for the filing of a supplement or amendment to the complaint or a supplement to the motion for temporary relief.

(b) Provide specific information regarding the public interest. Complainant must file, concurrently with the complaint, a separate statement of public interest, not to exceed five pages, inclusive of attachments, addressing how issuance of the requested relief, i.e., a general exclusion order, a limited exclusion order, and/or a cease and desist order, in this investigation could affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers. If the complainant files a confidential version of its submission on public interest, it shall file a public version of the submission no later than one business day after the deadline for filing the submission. In particular, the submission should:

(1) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

(2) Identify any public health, safety, or welfare concerns relating to the requested remedial orders;

(3) Identify like or directly competitive articles that complainant, its licensees, or third parties make which could replace the subject articles if they were to be excluded;

(4) Indicate whether the complainant, its licensees, and/or third parties have the capacity to replace the volume of articles subject to the requested remedial orders in a commercially reasonable time in the United States; and

(5) State how the requested remedial orders would impact consumers.

(c) Publication of notice of filing. (1) When a complaint is filed, the Secretary to the Commission will publish a notice in the FEDERAL REGISTER inviting comments from the public and proposed respondents on any public interest issues arising from the complaint and potential exclusion and/or cease and desist orders. In response to the notice, members of the public and proposed respondents may provide specific information regarding the public interest in a written submission not to exceed five pages, inclusive of attachments, to the Secretary to the Commission within eight (8) calendar days of publication of notice of the filing of a complaint. Comments that substantively address allegations made in the complaint will not be considered. Members of the public and proposed respondents may address how issuance of the requested exclusion order and/or a cease and desist order in this investigation could affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers. If a member of the public or proposed respondent files a confidential version of its submission, it shall file a public version of the submission no later than one business day after the deadline for filing the submission. Submissions should:

(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

(ii) Identify any public health, safety, or welfare concerns relating to the requested remedial orders;

(iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make which could replace the subject articles if they were to be excluded;

(iv) Indicate whether the complainant, its licensees, and/or third parties have the capacity to replace the volume of articles subject to the requested remedial orders in a commercially reasonable time in the United States; and

(v) State how the requested remedial orders would impact consumers.

(2) Complainant may file a reply to any submissions received under paragraph (c)(1) of this section not to exceed five pages, inclusive of attachments, to the Secretary to the Commission within three (3) calendar days following the filing of the submissions. If the complainant files a confidential version of its submission, it shall file a public version of the submission no later than one business day after the deadline for filing the submission.

(d) Upon the initiative of the Commission. The Commission may upon its initiative commence a preinstitution proceeding based upon any alleged violation of section 337 of the Tariff Act of 1930.

[59 FR 39039, Aug. 1, 1994, as amended at 60 FR 32444, June 22, 1995; 68 FR 32978, June 3, 2003; 73 FR 38320, July 7, 2008; 76 FR 61945, Oct. 6, 2011; 76 FR 64808, Oct. 19, 2011; 78 FR 23841, Apr. 19, 2013]

§ 210.9 Action of Commission upon receipt of complaint.

Upon receipt of a complaint alleging violation of section 337 of the Tariff Act of 1930, the Commission shall take the following actions:

(a) Examination of complaint. The Commission shall examine the complaint for sufficiency and compliance with the applicable sections of this chapter.

(b) Informal investigatory activity. The Commission shall identify sources of relevant information, assure itself of the availability thereof, and, if deemed necessary, prepare subpoenas therefore, and give attention to other preliminary matters.

§ 210.10 Institution of investigation.

(a)(1) The Commission shall determine whether the complaint is properly filed and whether an investigation should be instituted on the basis of the complaint. That determination shall be made within 30 days after the complaint is filed, unless—

(i) Exceptional circumstances preclude adherence to a 30-day deadline;

(ii) Additional time is allotted under other sections of this part in connection with the preinstitution processing of a motion by the complainant for temporary relief;

(iii) The complainant requests that the Commission postpone the determination on whether to institute an investigation; or

(iv) The complainant withdraws the complaint.

(2) If exceptional circumstances preclude Commission adherence to the 30-day deadline for determining whether to institute an investigation on the basis of the complaint, the determination will be made as soon after that deadline as possible.

(3) If additional time is allotted in connection with the preinstitution processing of a motion by the complainant for temporary relief, the Commission will determine whether to institute an investigation and provisionally accept the motion within 35 days after the filing of the complaint or by a subsequent deadline computed in accordance with § 210.53(a), § 210.54, § 210.55(b), § 210.57, or § 210.58 as applicable.

(4) If the complainant desires to have the Commission postpone making a determination on whether to institute an investigation in response to the complaint, the complainant must file a written request with the Secretary. If the request is granted, the determination will be rescheduled for whatever date is appropriate in light of the facts.

(5)(i) The complainant may withdraw the complaint as a matter of right at any time before the Commission votes on whether to institute an investigation. To effect such withdrawal, the complainant must file a written notice with the Commission.

(ii) If a motion for temporary relief was filed in addition to the complaint, the motion must be withdrawn along with the complaint, and the complainant must serve copies of the notice of withdrawal on all proposed respondents and on the embassies that were served with copies of the complaint and motion pursuant to § 210.54.

(b) An investigation shall be instituted by the publication of a notice in the FEDERAL REGISTER. The notice will define the scope of the investigation and may be amended as provided in § 210.14(b) and (c). The Commission may order the administrative law judge to take evidence and to issue a recommended determination on the public interest based generally on the submissions of the parties and the public under § 210.8(b) and (c). If the Commission orders the administrative law judge to take evidence with respect to the public interest, the administrative law judge will limit public interest discovery appropriately, with particular consideration for third parties, and will ensure that such discovery will not delay the investigation or be used improperly. Public interest issues will not be within the scope of discovery unless the administrative law judge is specifically ordered by the Commission to take evidence on these issues.

(c) If the Commission determines not to institute an investigation on the basis of the complaint, the complaint shall be dismissed, and the complainant and all proposed respondents will receive written notice of the Commission's action and the reason(s) therefor.

[59 FR 39039, Aug. 1, 1994, as amended at 73 FR 38321, July 7, 2008; 76 FR 64809, Oct. 19, 2011; 76 FR 71248, Nov. 17, 2011]

§ 210.11 Service of complaint and notice of investigation.

(a)(1) Unless the Commission institutes temporary relief proceedings, upon institution of an investigation, the Commission shall serve:

(i) Copies of the nonconfidential version of the complaint, the nonconfidential exhibits, and the notice of investigation upon each respondent; and

(ii) Copies of the nonconfidential version of the complaint and the notice of investigation upon the embassy in Washington, DC of the country in which each proposed respondent is located as indicated in the Complaint.

(2) If the Commission institutes temporary relief proceedings, upon institution of an investigation, the Commission shall serve:

(i) Copies of the nonconfidential version of the complaint and the notice of investigation upon each respondent; and

(ii) A copy of the notice of investigation upon the embassy in Washington, DC of the country in which each proposed respondent is located as indicated in the Complaint.

(3) All respondents named after an investigation has been instituted and the governments of the foreign countries in which they are located as indicated in the complaint shall be served as soon as possible after the respondents are named.

(4) The Commission shall serve copies of the notice of investigation upon the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service, and such other agencies and departments as the Commission considers appropriate.

(b) With leave from the presiding administrative law judge, a complainant may attempt to effect personal service of the complaint and notice of investigation upon a respondent, if the Secretary's efforts to serve the respondent have been unsuccessful. If the complainant succeeds in serving the respondent by personal service, the complainant must notify the administrative law judge and file proof of such service with the Secretary.

[73 FR 38321, July 7, 2008]

Subpart C—Pleadings § 210.12 The complaint.

(a) Contents of the complaint. In addition to conforming with the requirements of §§ 210.4 and 210.5 of this part, the complaint shall—

(1) Be under oath and signed by the complainant or his duly authorized officer, attorney, or agent, with the name, address, and telephone number of the complainant and any such officer, attorney, or agent given on the first page of the complaint, and include a statement attesting to the representations in § 210.4(c)(1) through (3);

(2) Include a statement of the facts constituting the alleged unfair methods of competition and unfair acts;

(3) Describe specific instances of alleged unlawful importations or sales, and shall provide the Tariff Schedules of the United States item number(s) for importations occurring prior to January 1, 1989, and the Harmonized Tariff Schedule of the United States item number(s) for importations occurring on or after January 1, 1989;

(4) State the name, address, and nature of the business (when such nature is known) of each person alleged to be violating section 337 of the Tariff Act of 1930;

(5) Include a statement as to whether the alleged unfair methods of competition and unfair acts, or the subject matter thereof, are or have been the subject of any court or agency litigation, and, if so, include a brief summary of such litigation;

(6)(i) If the complaint alleges a violation of section 337 based on infringement of a U.S. patent, or a federally registered copyright, trademark, mask work, or vessel hull design, under section 337(a)(1) (B), (C), (D), or (E) of the Tariff Act of 1930, include a statement as to whether an alleged domestic industry exists or is in the process of being established as defined in section 337(a)(2), and include a detailed description of the relevant domestic industry as defined in section 337(a)(3) that allegedly exists or is in the process of being established ( i.e., for the former, facts showing significant/substantial investment and employment, and for the latter, facts showing complainant is actively engaged in the steps leading to the exploitation of its intellectual property rights, and that there is a significant likelihood that an industry will be established in the

future), and including the relevant operations of any licensees.Relevant information includes but is not limited to:

(A) Significant investment in plant and equipment;

(B) Significant employment of labor or capital; or

(C) Substantial investment in the exploitation of the subject patent, copyright, trademark, mask work, or vessel hull design, including engineering, research and development, or licensing; or

(ii) If the complaint alleges a violation of section 337 of the Tariff Act of 1930 based on unfair methods of competition and unfair acts in the importation or sale of articles in the United States that have the threat or effect of destroying or substantially injuring an industry in the United States or preventing the establishment of such an industry under section 337(a)(1)(A)(i) or (ii), include a detailed statement as to whether an alleged domestic industry exists or is in the process of being established ( i.e., for the latter, facts showing that there is a significant likelihood that an industry will be established in the future), and include a detailed description of the domestic industry affected, including the relevant operations of any licensees; or

(7) Include a description of the complainant's business and its interests in the relevant domestic industry or the relevant trade and commerce. For every intellectual property based complaint (regardless of the type of intellectual property right involved), include a showing that at least one complainant is the owner or exclusive licensee of the subject intellectual property; and

(8) If the alleged violation involves an unfair method of competition or an unfair act other than those listed in paragraph (a)(6)(i) of this section, state a specific theory and provide corroborating data to support the allegation(s) in the complaint concerning the existence of a threat or effect to destroy or substantially injure a domestic industry, to prevent the establishment of a domestic industry, or to restrain or monopolize trade and commerce in the United States. The information that should ordinarily be provided includes the volume and trend of production, sales, and inventories of the involved domestic article; a description of the facilities and number and type of workers employed in the production of the involved domestic article; profit-and-loss information covering overall operations and operations concerning the involved domestic article; pricing information with respect to the involved domestic article; when available, volume and sales of imports; and other pertinent data.

(9) Include, when a complaint is based upon the infringement of a valid and enforceable U.S. patent—

(i) The identification of each U.S. patent and a certified copy thereof (a legible copy of each such patent will suffice for each required copy of the complaint);

(ii) The identification of the ownership of each involved U.S. patent and a certified copy of each assignment of each such patent (a legible copy thereof will suffice for each required copy of the complaint);

(iii) The identification of each licensee under each involved U.S. patent;

(iv) A copy of each license agreement (if any) for each involved U.S. patent that complainant relies upon to establish its standing to bring the complaint or to support its contention that a domestic industry as defined in section 337(a)(3) exists or is in the process of being established as a result of the domestic activities of one or more licensees;

(v) When known, a list of each foreign patent, each foreign patent application (not already issued as a patent) and each foreign patent application that has been denied, abandoned or withdrawn corresponding to each involved U.S. patent, with an indication of the prosecution status of each such patent application;

(vi) A nontechnical description of the invention of each involved U.S. patent;

(vii) A reference to the specific claims in each involved U.S. patent that allegedly cover the article imported or sold by each person named as violating section 337 of the Tariff Act of 1930, or the process under which such article was produced;

(viii) A showing that each person named as violating section 337 of the Tariff Act of 1930 is importing or selling the article covered by, or produced under the involved process covered by, the above specific claims of each involved U.S. patent. The complainant shall make such showing by appropriate allegations, and when practicable, by a chart that applies each asserted independent claim of each involved U.S. patent to a representative involved article of each person named as violating section 337 of the Tariff Act or to the process under which such article was produced;

(ix) A showing that an industry in the United States, relating to the articles protected by the patent exists or is in the process of being established. The complainant shall make such showing by appropriate allegations, and when practicable, by a chart that applies an exemplary claim of each involved U.S. patent to a representative involved domestic article or to the process under which such article was produced; and

(x) Drawings, photographs, or other visual representations of both the involved domestic article or process and the involved article of each person named as violating section 337 of the Tariff Act of 1930, or of the process utilized in producing the imported article, and, when a chart is furnished under paragraphs (a)(9)(viii) and (a)(9)(ix) of this section, the parts of such drawings, photographs, or other visual representations should be labeled so that they can be read in conjunction with such chart; and

(10) Include, when a complaint is based upon the infringement of a federally registered copyright, trademark, mask work, or vessel hull design—

(i) The identification of each licensee under each involved copyright, trademark, mask work, and vessel hull design;

(ii) A copy of each license agreement (if any) that complainant relies upon to establish its standing to bring the complaint or to support its contention that a domestic industry as defined in section 337(a)(3) exists or is in the process of being established as a result of the domestic activities of one or more licensees.

(11) Contain a request for relief, including a statement as to whether a limited exclusion order, general exclusion order, and/or cease and desist orders are being requested, and if temporary relief is requested under section 337(e) and/or (f) of the Tariff Act of 1930, a motion for such relief shall accompany the complaint as provided in § 210.52(a) or may follow the complaint as provided in § 210.53(a).

(12) Contain a clear statement in plain English of the category of products accused. For example, the caption of the investigation might refer to “certain electronic devices,” but the complaint would provide a further statement to identify the type of products involved in plain English such as mobile devices, tablets, or computers.

(b) Submissions of articles as exhibits. At the time the complaint is filed, if practicable, the complainant shall submit both the domestic article and all imported articles that are the subject of the complaint.

(c) Additional material to accompany each patent-based complaint. There shall accompany the submission of the original of each complaint based upon the alleged unauthorized importation or sale of an article covered by, or produced under a process covered by, the claims of a valid U.S. patent the following:

(1) One certified copy of the U.S. Patent and Trademark Office prosecution history for each involved U.S. patent, plus three additional copies thereof; and

(2) Four copies of each patent and applicable pages of each technical reference mentioned in the prosecution history of each involved U.S. patent.

(d) Additional material to accompany each registered trademark-based complaint. There shall accompany the submission of the original of each complaint based upon the alleged unauthorized importation or sale of an article covered by a federally registered trademark, one certified copy of the Federal registration and three additional copies, and one certified copy of the prosecution history for each federally registered trademark.

(e) Additional material to accompany each complaint based on a non-Federally registered trademark. There shall accompany the submission of the original of each complaint based upon the alleged unauthorized importation or sale of an article covered by a non-Federally registered trademark the following:

(1) A detailed and specific description of the alleged trademark;

(2) Information concerning prior attempts to register the alleged trademark; and

(3) Information on the status of current attempts to register the alleged trademark.

(f) Additional material to accompany each copyright-based complaint. There shall accompany the submission of the original of each complaint based upon the alleged unauthorized importation or sale of an article covered by a copyright one certified copy of the Federal registration and three additional copies;

(g) Additional material to accompany each registered mask work-based complaint. There shall accompany the submission of the original of each complaint based upon the alleged unauthorized importation or sale of a semiconductor chip in a manner that constitutes infringement of a Federally registered mask work, one certified copy of the Federal registration and three additional copies;

(h) Additional material to accompany each vessel hull design-based complaint. There shall accompany the submission of the original of each complaint based upon the alleged unauthorized importation or sale of an article covered by a vessel hull design, one certified copy of the Federal registration (including all deposited drawings, photographs, or other pictorial representations of the design), and three additional copies;

(i) Initial disclosures. Complainant shall serve on each respondent represented by counsel who has agreed to be bound by the terms of the protective order one copy of each document submitted with the complaint pursuant to § 210.12(c) through (h) within five days of service of a notice of appearance and agreement to be bound by the terms of the protective order; and

(j) Duty to supplement complaint. Complainant shall supplement the complaint prior to institution of an investigation if complainant obtains information upon the basis of which he knows or reasonably should know that a material legal or factual assertion in the complaint is false or misleading.

[59 FR 39039, Aug. 1, 1994; 59 FR 64286, Dec. 14, 1994; 73 FR 38321, July 7, 2008; 78 FR 23841, Apr. 19, 2013]

§ 210.13 The response.

(a) Time for response. Except as provided in § 210.59(a) and unless otherwise ordered in the notice of investigation or by the administrative law judge, respondents shall have 20 days from the date of service of the complaint and notice of investigation, by the Commission under § 210.11(a) or by a party under § 210.11(b), within which to file a written response to the complaint and the notice of investigation. When the investigation involves a motion for temporary relief and has not been declared “more complicated,” the response to the complaint and notice of investigation must be filed along with the response to the motion for temporary relief—i.e., within 10 days after service of the complaint, notice of investigation, and the motion for temporary relief by the Commission under § 210.11(a) or by a party under § 210.11(b). (See § 210.59.)

(b) Content of the response. In addition to conforming to the requirements of §§ 210.4 and 210.5 of this part, each response shall be under oath and signed by respondent or his duly authorized officer, attorney, or agent with the name, address, and telephone number of the respondent and any such officer, attorney, or agent given on the first page of the response. Each respondent shall respond to each allegation in the complaint and in the notice of investigation, and shall set forth a concise statement of the facts constituting each ground of defense. There shall be a specific admission, denial, or explanation of each fact alleged in the complaint and notice, or if the respondent is without knowledge of any such fact, a statement to that effect. Allegations of a complaint and notice not thus answered may be deemed to have been admitted. Each response shall include, when available, statistical data on the quantity and value of imports of the involved article. Respondents who are importers must also provide the Harmonized Tariff Schedule item number(s) for importations of the accused imports occurring on or after January 1, 1989, and the Tariff Schedules of the United States item number(s) for importations occurring before January 1, 1989. Each response shall also include a statement concerning the respondent's capacity to produce the subject article and the relative significance of the United States market to its operations. Respondents who are not manufacturing their accused imports shall state the name and address of the supplier(s) of those imports. Affirmative defenses shall be pleaded with as much specificity as possible in the response. When the alleged unfair methods of competition and unfair acts are based upon the claims of a valid U.S. patent, the respondent is encouraged to make the following showing when appropriate:

(1) If it is asserted in defense that the article imported or sold by respondents is not covered by, or produced under a process covered by, the claims of each involved U.S. patent, a showing of such noncoverage for each involved claim in each U.S. patent in question shall be made, which showing may be made by appropriate allegations and, when practicable, by a chart that applies the involved claims of each U.S. patent in question to a representative involved imported article of the respondent or to the process under which such article was produced;

(2) Drawings, photographs, or other visual representations of the involved imported article of respondent or the process utilized in producing such article, and, when a chart is furnished under paragraph (b)(1) of this section, the parts of such drawings, photographs, or other visual representations, should be labeled so that they can be read in conjunction with such chart; and

(3) If the claims of any involved U.S. patent are asserted to be invalid or unenforceable, the basis for such assertion, including, when prior art is relied on, a showing of how the prior art

renders each claim invalid or unenforceable and a copy of such prior art. For good cause, the presiding administrative law judge may waive any of the substantive requirements imposed under this paragraph or may impose additional requirements.

(c) Submission of article as exhibit. At the time the response is filed, if practicable, the respondent shall submit the accused article imported or sold by that respondent, unless the article has already been submitted by the complainant.

[59 FR 39039, Aug. 1, 1994, as amended at 73 FR 38322, July 7, 2008; 78 FR 23841, Apr. 19, 2013]

§ 210.14 Amendments to pleadings and notice; supplemental submissions; counterclaims; consolidation of investigations.

(a) Preinstitution amendments. The complaint may be amended at any time prior to the institution of the investigation. If, prior to institution, the complainant seeks to amend a complaint to add a respondent or to assert an additional unfair act not in the original complaint, including asserting a new patent or patent claim, then the complaint shall be treated as if it had been filed on the date the amendment is filed for purposes of §§ 210.8(b) and (c), 210.9, and 210.10(a).

(b) Postinstitution amendments generally. (1) After an investigation has been instituted, the complaint or notice of investigation may be amended only by leave of the Commission for good cause shown and upon such conditions as are necessary to avoid prejudicing the public interest and the rights of the parties to the investigation. A motion for amendment must be made to the presiding administrative law judge. A motion to amend the complaint and notice of investigation to name an additional respondent after institution shall be served on the proposed respondent. If the proposed amendment of the complaint would require amending the notice of investigation, the presiding administrative law judge may grant the motion only by filing with the Commission an initial determination. All other dispositions of such motions shall be by order.

(2) If disposition of the issues in an investigation on the merits will be facilitated, or for other good cause shown, the presiding administrative law judge may allow appropriate amendments to pleadings other than complaints upon such conditions as are necessary to avoid prejudicing the public interest and the rights of the parties to the investigation.

(c) Postinstitution amendments to conform to evidence. When issues not raised by the pleadings or notice of investigation, but reasonably within the scope of the pleadings and notice, are considered during the taking of evidence by express or implied consent of the parties, they shall be treated in all respects as if they had been raised in the pleadings and notice. Such amendments of the pleadings and notice as may be necessary to make them conform to the evidence and to raise such issues shall be allowed at any time, and shall be effective with respect to all parties who have expressly or impliedly consented.

(d) Supplemental submissions. The administrative law judge may, upon reasonable notice and on such terms as are just, permit service of a supplemental submission setting forth transactions, occurrences, or events that have taken place since the date of the submission sought to be supplemented and that are relevant to any of the issues involved.

(e) Counterclaims. At any time after institution of the investigation, but not later than ten business days before the commencement of the evidentiary hearing, a respondent may file a counterclaim at the Commission in accordance with section 337(c) of the Tariff Act of 1930. Counterclaims shall be filed in a separate document. A respondent who files such a counterclaim shall immediately file a notice of removal with a United States district court in which venue for any of the counterclaims raised by the respondent would exist under 28 U.S.C. 1391.

(f) Respondent submissions on the public interest. When the Commission has ordered the administrative law judge to take evidence with respect to the public interest under § 210.50(b)(1), respondents must submit a statement concerning the public interest, including any response to the issues raised by the complainant pursuant to § 210.8(b) and (c)(2), at the same time that their response to the complaint is due. This submission must be no longer than five pages, inclusive of attachments.

(g) Consolidation of investigations. The Commission may consolidate two or more investigations. If the investigations are currently before the same presiding administrative law judge, he or she may consolidate the investigations. The investigation number in the caption of the consolidated investigation will include the investigation numbers of the investigations being consolidated. The investigation number in which the matter will be proceeding (the lead investigation) will be the first investigation number named in the consolidated caption.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67627, Dec. 30, 1994; 76 FR 64809, Oct. 19, 2011; 78 FR 23841, Apr. 19, 2013]

Subpart D—Motions § 210.15 Motions.

(a) Presentation and disposition. (1) During the period between the institution of an investigation and the assignment of the investigation to a presiding administrative law judge, all motions shall be addressed to the chief administrative law judge. During the time that an investigation or related proceeding is before an administrative law judge, all motions therein shall be addressed to the administrative law judge.

(2) When an investigation or related proceeding is before the Commission, all motions shall be addressed to the Chairman of the Commission. All motions shall be filed with the Secretary and shall be served upon each party.

(b) Content. All written motions shall state the particular order, ruling, or action desired and the grounds therefor.

(c) Responses to motions. Within 10 days after service of any written motions, or within such longer or shorter time as may be designated by the administrative law judge or the Commission, a nonmoving party, or in the instance of a motion to amend the complaint or notice of investigation to name an additional respondent after institution, the proposed respondent, shall respond or he may be deemed to have consented to the granting of the relief asked for in the motion. The moving party shall have no right to reply, except as permitted by the administrative law judge or the Commission.

(d) Motions for extensions. As a matter of discretion, the administrative law judge or the Commission may waive the requirements of this section as to motions for extension of time, and may rule upon such motions ex parte.

[59 FR 39039, Aug. 1, 1994, as amended at 78 FR 23842, Apr. 19, 2013

§ 210.16 Default.

(a) Definition of default. (1) A party shall be found in default if it fails to respond to the complaint and notice of investigation in the manner prescribed in § 210.13 or § 210.59(c), or otherwise fails to answer the complaint and notice, and fails to show cause why it should not be found in default.

(2) A party may be found in default as a sanction for abuse of process, under § 210.4(c), or failure to make or cooperate in discovery, under § 210.33(b).

(b) Procedure for determining default. (1)(i) If a respondent has failed to respond or appear in the manner described in paragraph (a)(1) of this section, a party may file a motion for, or the administrative law judge may issue upon his own initiative, an order directing respondent to show cause why it should not be found in default.

(ii) If the respondent fails to make the necessary showing pursuant to paragraph (b)(1)(i) of this section, the administrative law judge shall issue an initial determination finding the respondent in default. An administrative law judge's decision denying a motion for a finding of default under paragraph (a)(1) of this section shall be in the form of an order.

(2) Any party may file a motion for issuance of, or the administrative law judge may issue on his own initiative, an initial determination finding a party in default for abuse of process under § 210.4(c) or failure to make or cooperate in discovery. A motion for a finding of default as a sanction for abuse of process or failure to make or cooperate in discovery shall be granted by initial determination or denied by order.

(3) If a proposed respondent has not filed a response to the complaint and notice of investigation pursuant to § 210.13 or § 210.59(c) of this chapter, the proposed respondent may file a notice of intent to default under this section. The filing of a notice of intent to default does not require the administrative law judge to issue the show-cause order of paragraph (b)(1) of this section. The administrative law judge shall issue an initial determination finding the proposed respondent in default upon the filing of a notice of intent to default. Such default will be treated in the same manner as any default under this section.

(4) A party found in default shall be deemed to have waived its right to appear, to be served with documents, and to contest the allegations at issue in the investigation.

(c) Relief against a respondent in default —(1) Types of relief available. After a respondent has been found in default by the Commission, the complainant may file with the Commission a declaration that it is seeking immediate entry of relief against the respondent in default. The facts alleged in the complaint will be presumed to be true with respect to the defaulting respondent. The Commission may issue an exclusion order, a cease and desist order, or both, affecting the defaulting respondent only after considering the effect of such order(s) upon the public health and welfare, competitive conditions in the U.S. economy, the production of like or directly competitive articles in the United States, and U.S. consumers, and concluding that the order(s) should still be issued in light of the aforementioned public interest factors.

(2) General exclusion orders. In any motion requesting the entry of default or the termination of the investigation with respect to the last remaining respondent in the investigation, the complainant shall declare whether it is seeking a general exclusion order. The Commission may issue a general exclusion order pursuant to section 337(g)(2) of the Tariff Act of 1930, regardless of the source or importer of the articles concerned, provided that a violation of section 337 of the Tariff Act of 1930 is established by substantial, reliable, and probative evidence and that the other requirements of 19 U.S.C. 1337(d)(2) are satisfied, and only after considering the aforementioned public interest factors and the requirements of § 210.50(c).

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67627, Dec. 30, 1994; 78 FR 23482, Apr. 19, 2013]

§ 210.17 Other failure to act and default.

Failures to act other than the defaults listed in § 210.16 may provide a basis for the presiding administrative law judge or the Commission to draw adverse inferences and to issue findings of fact, conclusions of law, determinations (including a determination on violation of section 337 of the Tariff Act of 1930), and orders that are adverse to the party who fails to act. Such failures include, but are not limited to:

(a) Failure to respond to a motion that materially alters the scope of the investigation or a related proceeding;

(b) Failure to respond to a motion for temporary relief pursuant to § 210.59;

(c) Failure to respond to a motion for summary determination under § 210.18;

(d) Failure to appear at a hearing before the administrative law judge after filing a written response to the complaint or motion for temporary relief, or failure to appear at a hearing before the Commission;

(e) Failure to file a brief or other written submission requested by the administrative law judge or the Commission during an investigation or a related proceeding;

(f) Failure to respond to a petition for review of an initial determination, a petition for reconsideration of an initial determination, or an application for interlocutory review of an administrative law judge's order; and

(g) Failure to participate in temporary relief bond forfeiture proceedings under § 210.70.

(h) Default by notice. If a respondent has filed a response to the complaint or notice of investigation under § 210.13 of this chapter, the respondent may still file a notice of intent to default with the presiding administrative law judge at any time before the filing of the final initial determination. The administrative law judge shall issue an initial determination finding the respondent in default upon the filing of a notice of intent to default. Such default will be treated in the same manner as any other failure to act under this section. The filing of a notice of intent to default does not require the administrative law judge to issue an order to show cause as to why the respondent should not be found in default.

The presiding administrative law judge or the Commission may take action under this rule sua sponte or in response to the motion of a party.

[59 FR 39039, Aug. 1, 1994, as amended at 78 FR 23842, Apr. 19, 2013]

§ 210.18 Summary determinations.

(a) Motions for summary determinations. Any party may move with any necessary supporting affidavits for a summary determination in its favor upon all or any part of the issues to be determined in the investigation. Counsel or other representatives in support of the complaint may so move at any time after 20 days following the date of service of the complaint and notice instituting the investigation. Any other party or a respondent may so move at any time after the date of publication of the notice of investigation in the FEDERAL REGISTER. Any such motion by any party in connection with the issue of permanent relief, however, must be filed at least 60 days before the date fixed for any hearing provided for in § 210.36(a)(1). Notwithstanding any other rule, the deadline for filing summary determinations shall be computed by counting backward at

least 60 days including the first calendar day prior to the date the hearing is scheduled to commence. If the end of the 60 day period falls on a weekend or holiday, the period extends until the end of the next business day. Under exceptional circumstances and upon motion, the presiding administrative law judge may determine that good cause exists to permit a summary determination motion to be filed out of time.

(b) Opposing affidavits; oral argument; time and basis for determination. Any nonmoving party may file opposing affidavits within 10 days after service of the motion for summary determination. The administrative law judge may, in his discretion or at the request of any party, set the matter for oral argument and call for the submission of briefs or memoranda. The determination sought by the moving party shall be rendered if pleadings and any depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a summary determination as a matter of law.

(c) Affidavits. Supporting and opposing affidavits shall be made on personal knowledge, shall set forth such facts as would be admissible in evidence, and shall show affirmatively that the affiant is competent to testify to the matters stated therein. Sworn or certified copies of all papers or parts thereof referred to in an affidavit shall be attached thereto or served therewith. The administrative law judge may permit affidavits to be supplemented or opposed by depositions, answers to interrogatories, or further affidavits. When a motion for summary determination is made and supported as provided in this section, a party opposing the motion may not rest upon the mere allegations or denials of the opposing party's pleading, but the opposing party's response, by affidavits, answers to interrogatories, or as otherwise provided in this section, must set forth specific facts showing that there is a genuine issue of fact for the evidentiary hearing under § 210.36(a)(1) or (2). If the opposing party does not so respond, a summary determination, if appropriate, shall be rendered against the opposing party.

(d) Refusal of application for summary determination; continuances and other orders. Should it appear from the affidavits of a party opposing the motion that the party cannot, for reasons stated, present by affidavit facts essential to justify the party's opposition, the administrative law judge may refuse the application for summary determination, or may order a continuance to permit affidavits to be obtained or depositions to be taken or discovery to be had or may make such other order as is appropriate, and a ruling to that effect shall be made a matter of record.

(e) Order establishing facts. If on motion under this section a summary determination is not rendered upon the whole case or for all the relief asked and a hearing is necessary, the administrative law judge, by examining the pleadings and the evidence and by interrogating counsel if necessary, shall if practicable ascertain what material facts exist without substantial controversy and what material facts are actually and in good faith controverted. The administrative law judge shall thereupon make an order specifying the facts that appear without substantial controversy and directing such further proceedings in the investigation as are warranted. The facts so specified shall be deemed established.

(f) Order of summary determination. An order of summary determination shall constitute an initial determination of the administrative law judge.

[59 FR 39039, Aug. 1, 1994, as amended at 73 FR 38322, July 7, 2008]

§ 210.19 Intervention.

Any person desiring to intervene in an investigation or a related proceeding under this part shall make a written motion. The motion shall have attached to it a certificate showing that the

motion has been served upon each party to the investigation or related proceeding in the manner described in § 201.16(b) of this chapter. Any party may file a response to the motion in accordance with § 210.15(c) of this part, provided that the response is accompanied by a certificate confirming that the response was served on the proposed intervenor and all other parties. The Commission, or the administrative law judge by initial determination, may grant the motion to the extent and upon such terms as may be proper under the circumstances.

§ 210.20 Declassification of confidential information.

(a) Any party may move to declassify documents (or portions thereof) that have been designated confidential by the submitter but that do not satisfy the confidentiality criteria set forth in § 201.6(a) of this chapter. All such motions, whether brought at any time during the investigation or after conclusion of the investigation shall be addressed to and ruled upon by the presiding administrative law judge, or if the investigation is not before a presiding administrative law judge, by the chief administrative law judge or such administrative law judge as he may designate.

(b) Following issuance of a public version of the initial determination on whether there is a violation of section 337 of the Tariff Act of 1930 or an initial determination that would otherwise terminate the investigation (if adopted by the Commission), the granting of a motion, in whole or part, to declassify information designated confidential shall constitute an initial determination, except as to that information for which no submissions in opposition to declassification have been filed.

§ 210.21 Termination of investigations.

(a) Motions for termination. (1) Any party may move at any time prior to the issuance of an initial determination on violation of section 337 of the Tariff Act of 1930 to terminate an investigation in whole or in part as to any or all respondents, on the basis of withdrawal of the complaint or certain allegations contained therein, or for good cause other than the grounds listed in paragraph (a)(2) of this section. A motion for termination of an investigation based on withdrawal of the complaint, or for good cause, shall contain a statement that there are no agreements, written or oral, express or implied between the parties concerning the subject matter of the investigation, or if there are any agreements concerning the subject matter of the investigation, all such agreements shall be identified, and if written, a copy shall be filed with the Commission along with the motion. If the agreement contains confidential business information within the meaning of § 201.6(a) of this chapter, at least one copy of the agreement with such information deleted shall accompany the motion, in addition to a copy of the confidential version. On motion for good cause shown, the administrative law judge may limit service of the agreements to the settling parties and the Commission investigative attorney. The presiding administrative law judge may grant the motion in an initial determination upon such terms and conditions as he deems proper.

(2) Any party may move at any time to terminate an investigation in whole or in part as to any or all respondents on the basis of a settlement, a licensing or other agreement, including an agreement to present the matter for arbitration, or a consent order, as provided in paragraphs (b), (c) and (d) of this section.

(b) Termination by settlement. (1) An investigation before the Commission may be terminated as to one or more respondents pursuant to section 337(c) of the Tariff Act of 1930 on the basis of a licensing or other settlement agreement. The motion for termination by settlement shall contain copies of the licensing or other settlement agreements, any supplemental agreements, any documents referenced in the motion or attached agreements, and a statement that there are no other agreements, written or oral, express or implied between the parties

concerning the subject matter of the investigation. If the licensing or other settlement agreement contains confidential business information within the meaning of § 201.6(a) of this chapter, a copy of the agreement with such information deleted shall accompany the motion. On motion for good cause shown, the administrative law judge may limit the service of the agreements to the settling parties and the Commission investigative attorney.

(2) The motion and agreement(s) shall be certified by the administrative law judge to the Commission with an initial determination if the motion for termination is granted. If the licensing or other agreement or the initial determination contains confidential business information, copies of the agreement and initial determination with confidential business information deleted shall be certified to the Commission simultaneously with the confidential versions of such documents. Notice of the initial determination and the agreement shall be provided to the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service, and such other departments and agencies as the Commission deems appropriate. If the Commission's final disposition of the initial determination results in termination of the investigation in its entirety, a notice will be published in the FEDERAL REGISTER. Termination by settlement need not constitute a determination as to violation of section 337 of the Tariff Act of 1930.

(c) Termination by entry of consent order. An investigation before the Commission may be terminated pursuant to section 337(c) of the Tariff Act of 1930 on the basis of a consent order. Termination by consent order need not constitute a determination as to violation of section 337. A motion for termination by consent order shall contain copies of any licensing or other settlement agreement, any supplemental agreements, and a statement that there are no other agreements, written or oral, express or implied between the parties concerning the subject matter of the investigation. If the licensing or other settlement agreement contains confidential business information within the meaning of § 201.6(a) of this chapter, a copy of the agreement with such information deleted shall accompany the motion. On motion for good cause shown, the administrative law judge may limit service of the agreements to the settling parties and the Commission investigative attorney. If there are no additional agreements, the moving parties shall certify that there are no additional agreements.

(1) Opportunity to submit proposed consent order —(i) Prior to institution of an investigation. Where time, the nature of the proceeding, and the public interest permit, any person being investigated pursuant to section 603 of the Trade Act of 1974 (19 U.S.C. § 2482) shall be afforded the opportunity to submit to the Commission a proposal for disposition of the matter under investigation in the form of a consent order stipulation that incorporates a proposed consent order executed by or on behalf of such person and that complies with the requirements of paragraph (c)(3) of this section.

(ii) Subsequent to institution of an investigation. In investigations under section 337 of the Tariff Act of 1930, a proposal to terminate by consent order shall be submitted as a motion to the administrative law judge with a stipulation that incorporates a proposed consent order. If the stipulation contains confidential business information within the meaning of § 201.6(a) of this chapter, a copy of the stipulation with such information deleted shall accompany the motion. The stipulation shall comply with the requirements of paragraph (c)(3) of this section. At any time prior to commencement of the hearing, the motion may be filed by one or more respondents, and may be filed jointly with other parties to the investigation. Upon request and for good cause shown, the administrative law judge may consider such a motion during or after a hearing. The filing of the motion shall not stay proceedings before the administrative law judge unless the administrative law judge so orders. The administrative law judge shall promptly file with the Commission an initial determination regarding the motion for termination if the motion is granted. If the initial determination contains confidential business information, a copy of the initial determination with such information deleted shall be filed with the Commission simultaneously with the filing of the confidential version of the initial determination. Pending disposition by the Commission of a

consent order stipulation, a party may not, absent good cause shown, withdraw from the stipulation once it has been submitted pursuant to this section.

(2) Commission disposition of consent order. (i) If an initial determination granting the motion for termination based on a consent order stipulation is filed with the Commission, notice of the initial determination and the consent order stipulation shall be provided to the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service, and such other departments and agencies as the Commission deems appropriate.

(ii) The Commission, after considering the effect of the settlement by consent order upon the public health and welfare, competitive conditions in the U.S. economy, the production of like or directly competitive articles in the United States, and U.S. consumers, shall dispose of the initial determination according to the procedures of §§ 210.42 through 210.45. If the Commission's final disposition of the initial determination results in termination of the investigation in its entirety, a notice will be published in the FEDERAL REGISTER. Termination by consent order need not constitute a determination as to violation of section 337. Should the Commission reverse the initial determination, the parties are in no way bound by their proposal in later actions before the Commission.

(3) Contents of consent order stipulation. (i) Every consent order stipulation shall contain, in addition to the proposed consent order, the following:

(A) An admission of all jurisdictional facts;

(B) A statement identifying the asserted patent claims, copyright, trademark, mask work, boat hull design, or unfair trade practice, and whether the stipulation calls for cessation of importation, distribution, sale, or other transfers (other than exportation) of subject articles in the United States and/or specific terms relating to the disposition of existing U.S. inventories of subject articles.

(C) An express waiver of all rights to seek judicial review or otherwise challenge or contest the validity of the consent order;

(D) A statement that the signatories to the consent order stipulation will cooperate with and will not seek to impede by litigation or other means the Commission's efforts to gather information under subpart I of this part;

(E) A statement that the enforcement, modification, and revocation of the consent order will be carried out pursuant to subpart I of this part, incorporating by reference the Commission's Rules of Practice and Procedure;

(F) A statement that the signing thereof is for settlement purposes only and does not constitute admission by any respondent that an unfair act has been committed, if applicable; and

(G) A statement that the consent order shall have the same force and effect and may be enforced, modified, or revoked in the same manner as is provided in section 337 of the Tariff Act of 1930 and this part for other Commission actions, and the Commission may require periodic compliance reports pursuant to subpart I of this part to be submitted by the person entering into the consent order stipulation.

(ii) In the case of an intellectual property-based investigation, the consent order stipulation shall also contain—

(A) A statement that the consent order shall not apply with respect to any claim of any intellectual property right that has expired or been found or adjudicated invalid or unenforceable by the Commission or a court or agency of competent jurisdiction, provided that such finding or judgment has become final and nonreviewable;

(B) A statement that each signatory to the stipulation who was a respondent in the investigation will not seek to challenge the validity of the intellectual property right(s), in any administrative or judicial proceeding to enforce the consent order

(4) Contents of consent order. The Commission will not issue consent orders with terms beyond those provided for in this section, and will not issue consent orders that are inconsistent with this section. The consent order shall contain:

(i) A statement of the identity of complainant, the respondent, and the subject articles, and a statement of any allegation in the complaint that the respondents sell for importation, import, or sell after importation the subject articles in violation of section 337 by reason of asserted patent claims, copyright, trademark, mask work, boat hull design, or unfair trade practice;

(ii) A statement that the respondents have executed a consent order stipulation (but the consent order shall not contain the terms of the stipulation);

(iii) A statement that the respondent shall not sell for importation, import, or sell after importation the subject articles, directly or indirectly, and shall not aid, abet, encourage, participate in, or induce the sale for importation, the importation, or the sale after importation except under consent, license from the complainant, or to the extent permitted by the settlement agreement between complainant and respondent;

(iv) A statement, if applicable, regarding the disposition of existing U.S. inventories of the subject articles.

(v) A statement, if applicable, whether the respondent would be ordered to cease and desist from importing and distributing articles covered by the asserted patent claims, copyright, trademark, mask work, boat hull design, or unfair trade practice;

(vi) A statement that respondent shall be precluded from seeking judicial review or otherwise challenging or contesting the validity of the Consent Order;

(vii) A statement that respondent shall cooperate with and shall not seek to impede by litigation or other means the Commission's efforts to gather information under subpart I of the Commission's Rules of Practice and Procedure, 19 CFR part 210;

(viii) A statement that Respondent and its officers, directors, employees, agents, and any entity or individual acting on its behalf and with its authority shall not seek to challenge the validity or enforceability of the claims of the asserted patent claims, copyright, trademark, mask work, boat hull design, or unfair trade practice in any administrative or judicial proceeding to enforce the Consent Order;

(ix) A statement that when the patent, copyright, trademark, mask work, boat hull design, or unfair trade practice expires the Consent Order shall become null and void as to such;

(x) A statement that if any claim of the patent, copyright, trademark, mask work, boat hull design, or other unfair trade practice is held invalid or unenforceable by a court or agency of competent jurisdiction or as to any articles that has been found or adjudicated not to infringe the

asserted right in a final decision, no longer subject to appeal, this Consent Order shall become null and void as to such invalid or unenforceable claim; and

(xi) A statement that the investigation is hereby terminated with respect to the respondent; provided, however, that enforcement, modification, or revocation of the Consent Order shall be carried out pursuant to Subpart I of the Commission's Rules of Practice and Procedure, 19 CFR part 210.

(5) Effect, interpretation, and reporting. The consent order shall have the same force and effect and may be enforced, modified, or revoked in the same manner as is provided in section 337 of the Tariff Act of 1930 and this part for other Commission actions. The Commission will not enforce consent order terms beyond those provided for in this section. The Commission may require periodic compliance reports pursuant to subpart I of this part to be submitted by the person entering into the consent order stipulation.

(d) Termination based upon arbitration agreement. Upon filing of a motion for termination with the administrative law judge or the Commission, a section 337 investigation may be terminated as to one or more respondents pursuant to section 337(c) of the Tariff Act of 1930 on the basis of an agreement between complainant and one or more of the respondents to present the matter for arbitration. The motion and a copy of the arbitration agreement shall be certified by the administrative law judge to the Commission with an initial determination if the motion for termination is granted. If the agreement or the initial determination contains confidential business information, copies of the agreement and initial determination with confidential business information deleted shall be certified to the Commission with the confidential versions of such documents. A notice will be published in the FEDERAL REGISTER if the Commission's final disposition of the initial determination results in termination of the investigation in its entirety. Termination based on an arbitration agreement does not constitute a determination as to violation of section 337 of the Tariff Act of 1930.

(e) Effect of termination. Termination issued by the administrative law judge shall constitute an initial determination.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67627, Dec. 30, 1994; 60 FR 53120, Oct. 12, 1995; 73 FR 38322, July 7, 2008; 78 FR 23482, Apr. 19, 2013]

§ 210.22 [Reserved]

§ 210.23 Suspension of investigation.

Any party may move to suspend an investigation under this part, because of the pendency of proceedings before the Secretary of Commerce or the administering authority pursuant to section 337(b)(3) of the Tariff Act of 1930. The administrative law judge or the Commission also may raise the issue sua sponte. An administrative law judge's decision granting a motion for suspension shall be in the form of an initial determination.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67627, Dec. 30, 1994]

§ 210.24 Interlocutory appeals.

Rulings by the administrative law judge on motions may not be appealed to the Commission prior to the administrative law judge's issuance of an initial determination, except in the following circumstances:

(a) Appeals without leave of the administrative law judge. The Commission may in its discretion entertain interlocutory appeals, except as provided in § 210.64, when a ruling of the administrative law judge:

(1) Requires the disclosure of Commission records or requires the appearance of Government officials pursuant to § 210.32(c)(2); or

(2) Denies an application for intervention under § 210.19. Appeals from such rulings may be sought by filing an application for review, not to exceed 15 pages, with the Commission within five days after service of the administrative law judge's ruling. An answer to the application for review may be filed within five days after service of the application. The application for review should specify the person or party taking the appeal, designate the ruling or part thereof from which appeal is being taken, and specify the reasons and present arguments as to why review is being sought. The Commission may, upon its own motion, enter an order staying the return date of an order issued by the administrative law judge pursuant to § 210.32(c)(2) or may enter an order placing the matter on the Commission's docket for review. Any order placing the matter on the Commission's docket for review will set forth the scope of the review and the issues that will be considered and will make provision for the filing of briefs if deemed appropriate by the Commission.

(b) Appeals with leave of the administrative law judge. (1) Except as otherwise provided in paragraph (a) of this section, § 210.64, and paragraph (b)(2) of this section, applications for review of a ruling by an administrative law judge may be allowed only upon request made to the administrative law judge and upon determination by the administrative law judge in writing, with justification in support thereof, that the ruling involves a controlling question of law or policy as to which there is substantial ground for difference of opinion, and that either an immediate appeal from the ruling may materially advance the ultimate completion of the investigation or subsequent review will be an inadequate remedy.

(2) Applications for review of a ruling by an administrative law judge under § 210.5(e)(1) as to whether information designated confidential by the supplier is entitled to confidential treatment under § 210.5(b) may be allowed only upon request made to the administrative law judge and upon determination by the administrative law judge in writing, with justification in support thereof.

(3) A written application for review under paragraph (b)(1) or (b)(2) of this section shall not exceed 15 pages and may be filed within five days after service of the administrative law judge's determination. An answer to the application for review may be filed within five days after service of the application for review. Thereupon, the Commission may, in its discretion, permit an appeal. Unless otherwise ordered by the Commission, Commission review, if permitted, shall be confined to the application for review and answer thereto, without oral argument or further briefs.

(c) Investigation not stayed. Application for review under this section shall not stay the investigation before the administrative law judge unless the administrative law judge or the Commission shall so order.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67627, Dec. 30, 1994]

§ 210.25 Sanctions.

(a)(1) Any party may file a motion for sanctions for abuse of process under § 210.4(d)(1), abuse of discovery under § 210.27(d)(3), failure to make or cooperate in discovery under § 210.33 (b) or (c), or violation of a protective order under § 210.34(c). A motion alleging abuse of process should be filed promptly after the requirements of § 210.4(d)(1)(i) have been satisfied. A

motion alleging abuse of discovery, failure to make or cooperate in discovery, or violation of a protective order should be filed promptly after the allegedly sanctionable conduct is discovered.

(2) The administrative law judge (when the investigation or related proceeding is before him) or the Commission (when the investigation or related proceeding is before it) also may raise the sanction issue sua sponte. (See also §§ 210.4(d)(1)(ii), 210.27(d)(3), 210.33(c), and 210.34(c).)

(b) A motion for sanctions shall be addressed to the presiding administrative law judge, if the allegedly sanctionable conduct occurred and is discovered while the administrative law judge is presiding in an investigation or in a related proceeding. During an investigation, the administrative law judge's ruling on the motion shall be in the form of an order, if it is issued before or concurrently with the initial determination concerning violation of section 337 of the Tariff Act of 1930 or termination of the investigation. In a related proceeding, the administrative law judge's ruling shall be in the form of an order, regardless of the point in time at which the order is issued.

(c) A motion for sanctions shall be addressed to the Commission, if the allegedly sanctionable conduct occurred while the Commission is presiding or is filed after the subject investigation or related proceeding is terminated. The Commission may assign the motion to an administrative law judge for issuance of a recommended determination. The deadlines and procedures that will be followed in processing the recommended determination will be set forth in the Commission order assigning the motion to an administrative law judge.

(d) If an administrative law judge's order concerning sanctions is issued before the initial determination concerning violation of section 337 of the Tariff Act of 1930 or termination of the investigation, it may be appealed under § 210.24(b)(1) with leave from the administrative law judge, if the requirements of that section are satisfied. If the order is issued concurrently with the initial determination, the order may be appealed by filing a petition meeting the requirements of § 210.43(b). The periods for filing such petitions and responding to the petitions will be specified in the Commission notice issued pursuant to § 210.42(i), if the initial determination has granted a motion for termination of the investigation, or in the Commission notice issued pursuant to § 210.46(a), if the initial determination concerns violation of section 337. The Commission will determine whether to adopt the order after disposition of the initial determination concerning violation of section 337 or termination of the investigation.

(e) If the administrative law judge's ruling on the motion for sanctions is in the form of a recommended determination pursuant to paragraph (c) of this section, the deadlines and procedures for parties to contest the recommended determination will be set forth in the Commission order assigning the motion to an administrative law judge.

(f) If a motion for sanctions is filed with the administrative law judge during an investigation, he may defer his adjudication of the motion until after he has issued a final initial determination concerning violation of section 337 of the Tariff Act of 1930 or termination of investigation. If the administrative law judge defers his adjudication in such a manner, his ruling on the motion for sanctions must be in the form of a recommended determination and shall be issued no later than 30 days after issuance of the Commission's final determination on violation of section 337 or termination of the investigation. To aid the Commission in determining whether to adopt a recommended determination, any party may file written comments with the Commission 14 days after service of the recommended determination. Replies to such comments may be filed within seven days after service of the comments. The Commission will determine whether to adopt the recommended determination after reviewing the parties' arguments and taking any other steps the Commission deems appropriate.


§ 210.26 Other motions.

Motions pertaining to discovery shall be filed in accordance with § 210.15 and the pertinent provisions of subpart E of this part (§§ 210.27 through 210.34). Motions pertaining to evidentiary hearings and prehearing conferences shall be filed in accordance with § 210.15 and the pertinent provisions of subpart F of this part (§§ 210.35 through 210.40). Motions for temporary relief shall be filed as provided in subpart H of this part (see §§ 210.52 through 210.57).

Subpart E—Discovery and Compulsory Process § 210.27 General provisions governing discovery.

(a) Discovery methods. The parties to an investigation may obtain discovery by one or more of the following methods: depositions upon oral examination or written questions; written interrogatories; production of documents or things or permission to enter upon land or other property for inspection or other purposes; and requests for admissions.

(b) Scope of discovery. Regarding the scope of discovery for the temporary relief phase of an investigation, see § 210.61. For the permanent relief phase of an investigation, unless otherwise ordered by the administrative law judge, a party may obtain discovery regarding any matter, not privileged, that is relevant to the following:

(1) The claim or defense of the party seeking discovery or to the claim or defense of any other party, including the existence, description, nature, custody, condition, and location of any books, documents, or other tangible things;

(2) The identity and location of persons having knowledge of any discoverable matter;

(3) The appropriate remedy for a violation of section 337 of the Tariff Act of 1930 (see § 210.42(a)(1)(ii)(A)); or

(4) The appropriate bond for the respondents, under section 337(j)(3) of the Tariff Act of 1930, during Presidential review of the remedial order (if any) issued by the Commission (see § 210.42(a)(1)(ii)(B)).

It is not grounds for objection that the information sought will be inadmissible at the hearing if the information sought appears reasonably calculated to lead to the discovery of admissible evidence. All discovery is subject to the limitations of paragraph (d) of this section.

(c) Specific limitations on electronically stored information. A person need not provide discovery of electronically stored information from sources that the person identifies as not reasonably accessible because of undue burden or cost. The party seeking the discovery may file a motion to compel discovery pursuant to § 210.33(a). In response to the motion to compel discovery, or in a motion for a protective order filed pursuant to § 210.34, the person from whom discovery is sought must show that the information is not reasonably accessible because of undue burden or cost. If that showing is made, the administrative law judge may order discovery from such sources if the requesting party shows good cause, considering the limitations found in paragraph (d) of this section. The administrative law judge may specify conditions for the discovery.

(d) General limitations on discovery. In response to a motion made pursuant to §§ 210.33(a) or 210.34 or sua sponte, the administrative law judge must limit by order the frequency or extent of discovery otherwise allowed in this subpart if the administrative law judge determines that:

(1) The discovery sought is unreasonably cumulative or duplicative, or can be obtained from some other source that is more convenient, less burdensome, or less expensive;

(2) The party seeking discovery has had ample opportunity to obtain the information by discovery in the investigation;

(3) The responding person has waived the legal position that justified the discovery or has stipulated to the particular facts pertaining to a disputed issue to which the discovery is directed; or

(4) The burden or expense of the proposed discovery outweighs its likely benefit, considering the needs of the investigation, the importance of the discovery in resolving the issues to be decided by the Commission, and matters of public concern.

(e) Claiming privilege or work product protection. (1) When, in response to a discovery request made under this subpart, a person withholds information otherwise discoverable by claiming that the information is privileged or subject to protection as attorney work product, the person must:

(i) Expressly make the claim when responding to a relevant question or request; and

(ii) Within 10 days of making the claim produce to the requester a privilege log that describes the nature of the information not produced or disclosed, in a manner that will enable the requester to assess the claim without revealing the information at issue. The privilege log must separately identify each withheld document, communication, or item, and to the extent possible must specify the following for each entry:

(A) The date the information was created or communicated;

(B) The author(s) or speaker(s);

(C) All recipients;

(D) The employer and position for each author, speaker, or recipient, including whether that person is an attorney or patent agent;

(E) The general subject matter of the information; and

(F) The type of privilege or protection claimed.

(2) If a document produced in discovery is subject to a claim of privilege or of protection as attorney work product, the person making the claim may notify any person that received the document of the claim and the basis for it.

(i) The notice shall identify the information in the document subject to the claim, preferably using a privilege log as defined under paragraph (e)(1) of this section. After being notified, a person that received the document must do the following:

(A) Within 7 days of service of the notice return, sequester, or destroy the specified document and any copies it has;

(B) Not use or disclose the document until the claim is resolved; and

(C) Within 7 days of service of the notice take reasonable steps to retrieve the document if the person disclosed it to others before being notified.

(ii) Within 7 days of service of the notice, the claimant and the parties shall meet and confer in good faith to resolve the claim of privilege or protection. Within 5 days after the conference, a party may file a motion to compel the production of the document and may, in the motion to compel, use a description of the document from the notice produced under this paragraph. In connection with the motion to compel, the party may submit the document in camera for consideration by the administrative law judge. The person that produced the document must preserve the document until the claim of privilege or protection is resolved.

(3) Parties may enter into a written agreement to waive compliance with paragraph (e)(1) of this section for documents, communications, and items created or communicated within a time period specified in the agreement. The administrative law judge may decline to entertain any motion based on information claimed to be subject to the agreement. If information claimed to be subject to the agreement is produced in discovery then the administrative law judge may determine that the produced information is not entitled to privilege or protection.

(4) For good cause, the administrative law judge may order a different period of time for compliance with any requirement of this section. Parties may enter into a written agreement to set a different period of time for compliance with any requirement of this section without approval by the administrative law judge unless the administrative law judge has ordered a different period of time for compliance, in which case the parties' agreement must be approved by the administrative law judge.

(f) Supplementation of responses. (1) A party who has responded to a request for discovery with a response is under a duty to supplement or correct the response to include information thereafter acquired if ordered by the administrative law judge or the Commission or in the following circumstances: A party is under a duty seasonably to amend a prior response to an interrogatory, request for production, or request for admission if the party learns that the response is in some material respect incomplete or incorrect and if the additional or corrective information has not otherwise been made known to the other parties during the discovery process or in writing.

(2) A duty to supplement responses also may be imposed by agreement of the parties, or at any time prior to a hearing through new requests for supplementation of prior responses.

(g) Signing of discovery requests, responses, and objections. (1) The front page of every request for discovery or response or objection thereto shall contain a caption setting forth the name of the Commission, the title of the investigation or related proceeding, and the docket number or investigation number, if any, assigned to the investigation or related proceeding.

(2) Every request for discovery or response or objection thereto made by a party represented by an attorney shall be signed by at least one attorney of record in the attorney's individual name, whose address shall be stated. A party who is not represented by an attorney shall sign the request, response, or objection and shall state the party's address. The signature of the attorney or party constitutes a certification that to the best of the signer's knowledge, information, and belief formed after a reasonable inquiry, the request, objection, or response is:

(i) Consistent with § 210.5(a) (if applicable) and other relevant provisions of this chapter, and warranted by existing law or a good faith argument for the extension, modification, or reversal of existing law;

(ii) Not interposed for any improper purpose, such as to harass or to cause unnecessary delay or needless increase in the cost of litigation; and

(iii) Not unreasonable or unduly burdensome or expensive, given the needs of the case, the discovery already had in the case, and the importance of the issues at stake in the litigation.

If a request, response, or objection is not signed, it shall be stricken unless it is signed promptly after the omission is called to the attention of the party making the request, response, or objection, and a party shall not be obligated to take any action with respect to it until it is signed.

(3) If without substantial justification a request, response, or objection is certified in violation of paragraph (d)(2) of this section, the administrative law judge or the Commission, upon motion or sua sponte under § 210.25 of this part, may impose an appropriate sanction upon the person who made the certification, the party on whose behalf the request, response, or objection was made, or both.

(4) An appropriate sanction may include an order to pay to the other parties the amount of reasonable expenses incurred because of the violation, including a reasonable attorney's fee, to the extent authorized by Rule 26(g) of the Federal Rules of Civil Procedure. Monetary sanctions shall not be imposed under this section against the United States, the Commission, or a Commission investigative attorney.

(5) Monetary sanctions may be imposed under this section to reimburse the Commission for expenses incurred by a Commission investigative attorney or the Commission's Office of Unfair Import Investigations. Monetary sanctions will not be imposed under this section to reimburse the Commission for attorney's fees.

[59 FR 39039, Aug. 1, 1994, as amended at 78 FR 29623, May 21, 2013]

§ 210.28 Depositions.

(a) When depositions may be taken. Following publication in the FEDERAL REGISTER of a Commission notice instituting the investigation, any party may take the testimony of any person, including a party, by deposition upon oral examination or written questions. The presiding administrative law judge will determine the permissible dates or deadlines for taking such depositions. Without stipulation of the parties, the complainants as a group may take a maximum of five fact depositions per respondent or no more than 20 fact depositions whichever is greater, the respondents as a group may take a maximum of 20 fact depositions total, and if the Commission investigative attorney is a party, he or she may take a maximum of 10 fact depositions and is permitted to participate in all depositions taken by any parties in the investigation. Each notice for a corporation to designate deponents only counts as one deposition and includes all corporate representatives so designated to respond, and related respondents are treated as one respondent for purposes of determining the number of depositions. The presiding administrative law judge may increase the number of depositions on written motion for good cause shown.

(b) Persons before whom depositions may be taken. Depositions may be taken before a person having power to administer oaths by the laws of the United States or of the place where the examination is held.

(c) Notice of examination. A party desiring to take the deposition of a person shall give notice in writing to every other party to the investigation. The administrative law judge shall determine the appropriate period for providing such notice. A party upon whom a notice of deposition is served may make objections to a notice of deposition and state the reasons therefor

within ten days of service of the notice of deposition. The notice shall state the time and place for taking the deposition and the name and address of each person to be examined, if known, and, if the name is not known, a general description sufficient to identify him or the particular class or group to which he belongs. A notice may provide for the taking of testimony by telephone, but the administrative law judge may, on motion of any party, require that the deposition be taken in the presence of the deponent. The parties may stipulate in writing, or the administrative law judge may upon motion order, that the testimony at a deposition be recorded by other than stenographic means. If a subpoena duces tecum is to be served on the person to be examined, the designation of the materials to be produced as set forth in the subpoena shall be attached to or included in the notice.

(d) Taking of deposition. Each deponent shall be duly sworn, and any adverse party shall have the right to cross-examine. Objections to questions or documents shall be in short form, stating the grounds of objections relied upon. Evidence objected to shall be taken subject to the objections, except that privileged communications and subject matter need not be disclosed. The questions propounded and the answers thereto, together with all objections made, shall be reduced to writing, after which the deposition shall be subscribed by the deponent (unless the parties by stipulation waive signing or the deponent is ill or cannot be found or refuses to sign) and certified by the person before whom the deposition was taken. If the deposition is not subscribed by the deponent, the person administering the oath shall state on the record such fact and the reason therefor. When a deposition is recorded by stenographic means, the stenographer shall certify on the transcript that the witness was sworn in the stenographer's presence and that the transcript is a true record of the testimony of the witness. When a deposition is recorded by other than stenographic means and is thereafter transcribed, the person transcribing it shall certify that the person heard the witness sworn on the recording and that the transcript is a correct writing of the recording. Thereafter, upon payment of reasonable charges therefor, that person shall furnish a copy of the transcript or other recording of the deposition to any party or to the deponent. See paragraph (i) of this section concerning the effect of errors and irregularities in depositions.

(e) Depositions of nonparty officers or employees of the Commission or of other Government agencies. A party desiring to take the deposition of an officer or employee of the Commission other than the Commission investigative attorney, or of an officer or employee of another Government agency, or to obtain documents or other physical exhibits in the custody, control, and possession of such officer or employee, shall proceed by written motion to the administrative law judge for leave to apply for a subpoena under § 210.32(c). Such a motion shall be granted only upon a showing that the information expected to be obtained thereby is within the scope of discovery permitted by § 210.27(b) or § 210.61 and cannot be obtained without undue hardship by alternative means.

(f) Service of deposition transcripts on the Commission staff. The party taking the deposition shall promptly serve one copy of the deposition transcript on the Commission investigative attorney.

(g) Admissibility of depositions. The fact that a deposition is taken and served upon the Commission investigative attorney as provided in this section does not constitute a determination that it is admissible in evidence or that it may be used in the investigation. Only such part of a deposition as is received in evidence at a hearing shall constitute a part of the record in such investigation upon which a determination may be based. Objections may be made at the hearing to receiving in evidence any deposition or part thereof for any reason that would require exclusion of the evidence if the witness were then present and testifying.

(h) Use of depositions. A deposition may be used as evidence against any party who was present or represented at the taking of the deposition or who had reasonable notice thereof, in accordance with any of the following provisions:

(1) Any deposition may be used by any party for the purpose of contradicting or impeaching the testimony of a deponent as a witness;

(2) The deposition of a party may be used by an adverse party for any purpose;

(3) The deposition of a witness, whether or not a party, may be used by any party for any purposes if the administrative law judge finds—

(i) That the witness is dead; or

(ii) That the witness is out of the United States, unless it appears that the absence of the witness was procured by the party offering the deposition; or

(iii) That the witness is unable to attend or testify because of age, illness, infirmity, or imprisonment; or

(iv) That the party offering the deposition has been unable to procure the attendance of the witness by subpoena; or

(v) Upon application and notice, that such exceptional circumstances exist as to make it desirable in the interest of justice and with due regard to the importance of presenting the oral testimony of witnesses at a hearing, to allow the deposition to be used.

(4) If only part of a deposition is offered in evidence by a party, an adverse party may require him to introduce any other part that ought in fairness to be considered with the part introduced, and any party may introduce any other parts.

(i) Effect of errors and irregularities in depositions —(1) As to notice. All errors and irregularities in the notice for taking a deposition are waived unless written objection is promptly served upon the party giving notice.

(2) As to disqualification of person before whom the deposition is to be taken. Objection to taking a deposition because of disqualification of the person before whom it is to be taken is waived unless made before the taking of the deposition begins or as soon thereafter as the disqualification becomes known or could be discovered with reasonable diligence.

(3) As to taking of depositions. (i) Objections to the competency of a witness or the competency, relevancy, or materiality of testimony are not waived by failure to make them before or during the deposition, unless the ground of the objection is one which might have been obviated or removed if presented at that time.

(ii) Errors and irregularities occurring at the oral examination in the manner of taking the deposition, in the form of the questions or answers, in the oath or affirmation, or in the conduct of parties, and errors of any kind which might be obviated, removed, or cured if promptly presented, are waived unless seasonable objection thereto is made at the taking of the deposition.

(iii) Objections to the form of written questions submitted under this section are waived unless served in writing upon the party propounding them. The presiding administrative law judge shall set the deadline for service of such objections.

(4) As to completion and return of deposition. Errors and irregularities in the manner in which the testimony is transcribed or the deposition is prepared, signed, certified, sealed, indorsed, transmitted, served, or otherwise dealt with by the person before whom it is taken are

waived unless a motion to suppress the deposition or some part thereof is made with reasonable promptness after such defect is, or with due diligence might have been, ascertained.


§ 210.29 Interrogatories.

(a) Scope; use at hearing. Any party may serve upon any other party written interrogatories to be answered by the party served. Interrogatories may relate to any matters that can be inquired into under § 210.27(b) or § 210.61, and the answers may be used to the extent permitted by the rules of evidence. Absent stipulation of the parties, any party may serve upon any other party written interrogatories not exceeding 175 in number including all discrete subparts. Related respondents are treated as one entity. The presiding administrative law judge may increase the number of interrogatories on written motion for good cause shown.

(b) Procedure. (1) Interrogatories may be served upon any party after the date of publication in the FEDERAL REGISTER of the notice of investigation.

(2) Parties answering interrogatories shall repeat the interrogatories being answered immediately preceding the answers. Each interrogatory shall be answered separately and fully in writing under oath, unless it is objected to, in which event the reasons for objection shall be stated in lieu of an answer. The answers are to be signed by the person making them, and the objections are to be signed by the attorney making them. The party upon whom the interrogatories have been served shall serve a copy of the answers and objections, if any, within ten days of service of the interrogatories or within the time specified by the administrative law judge. The party submitting the interrogatories may move for an order under § 210.33(a) with respect to any objection to or other failure to answer an interrogatory.

(3) An interrogatory otherwise proper is not necessarily objectionable merely because an answer to the interrogatory involves an opinion or contention that relates to fact or the application of law to fact, but the administrative law judge may order that such an interrogatory need not be answered until after designated discovery has been completed or until a prehearing conference or a later time.

(c) Option to produce records. When the answer to an interrogatory may be derived or ascertained from the records of the party upon whom the interrogatory has been served or from an examination, audit, or inspection of such records, or from a compilation, abstract, or summary based thereon, and the burden of deriving or ascertaining the answer is substantially the same for the party serving the interrogatory as for the party served, it is a sufficient answer to such interrogatory to specify the records from which the answer may be derived or ascertained and to afford to the party serving the interrogatory reasonable opportunity to examine, audit, or inspect such records and to make copies, compilations, abstracts, or summaries. The specifications provided shall include sufficient detail to permit the interrogating party to locate and to identify, as readily as can the party served, the documents from which the answer may be ascertained.


§ 210.30 Requests for production of documents and things and entry upon land.

(a) Scope. Any party may serve on any other party a request:

(1) To produce and permit the party making the request, or someone acting on his behalf, to inspect and copy any designated documents (including writings, drawings, graphs, charts, photographs, and other data compilations from which information can be obtained), or to inspect

and copy, test, or sample any tangible things that are in the possession, custody, or control of the party upon whom the request is served; or

(2) To permit entry upon designated land or other property in the possession or control of the party upon whom the request is served for the purpose of inspecting and measuring, surveying, photographing, testing, or sampling the property or any designated object or operation thereon, within the scope of § 210.27(b).

(b) Procedure. (1) The request may be served upon any party after the date of publication in the FEDERAL REGISTER of the notice of investigation. The request shall set forth the items to be inspected, either by individual item or by category, and describe each item and category with reasonable particularity. The request shall specify a reasonable time, place, and manner of making the inspection and performing the related acts.

(2) The party upon whom the request is served shall serve a written response within 10 days or the time specified by the administrative law judge. The response shall state, with respect to each item or category, that inspection and related activities will be permitted as requested, unless the request is objected to, in which event the reasons for objection shall be stated. If objection is made to part of any item or category, the part shall be specified. The party submitting the request may move for an order under § 210.33(a) with respect to any objection to or other failure to respond to the request or any part thereof, or any failure to permit inspection as requested. A party who produces documents for inspection shall produce them as they are kept in the usual course of business or shall organize and label them to correspond to the categories in the request.

(c) Persons not parties. This section does not preclude issuance of an order against a person not a party to permit entry upon land.


§ 210.31 Requests for admission.

(a) Form, content, and service of request for admission. Any party may serve on any other party a written request for admission of the truth of any matters relevant to the investigation and set forth in the request that relate to statements or opinions of fact or of the application of law to fact, including the genuineness of any documents described in the request. Copies of documents shall be served with the request unless they have been otherwise furnished or are known to be, and in the request are stated as being, in the possession of the other party. Each matter as to which an admission is requested shall be separately set forth. The request may be served upon a party whose complaint is the basis for the investigation after the date of publication in the FEDERAL REGISTER of the notice of investigation. The administrative law judge will determine the period within which a party may serve a request upon other parties.

(b) Answers and objections to requests for admissions. A party answering a request for admission shall repeat the request for admission immediately preceding his answer. The matter may be deemed admitted unless, within 10 days or the period specified by the administrative law judge, the party to whom the request is directed serves upon the party requesting the admission a sworn written answer or objection addressed to the matter. If objection is made, the reason therefor shall be stated. The answer shall specifically deny the matter or set forth in detail the reasons why the answering party cannot truthfully admit or deny the matter. A denial shall fairly meet the substance of the requested admission, and when good faith requires that a party qualify his answer or deny only a part of the matter as to which an admission is requested, he shall specify so much of it as is true and qualify or deny the remainder. An answering party may not give lack of information or knowledge as a reason for failure to admit or deny unless he states

that he has made reasonable inquiry and that the information known to or readily obtainable by him is insufficient to enable him to admit or deny. A party who considers that a matter as to which an admission has been requested presents a genuine issue for a hearing may not object to the request on that ground alone; he may deny the matter or set forth reasons why he cannot admit or deny it.

(c) Sufficiency of answers. The party who has requested the admissions may move to determine the sufficiency of the answers or objections. Unless the objecting party sustains his burden of showing that the objection is justified, the administrative law judge shall order that an answer be served. If the administrative law judge determines that an answer does not comply with the requirements of this section, he may order either that the matter is admitted or that an amended answer be served. The administrative law judge may, in lieu of these orders, determine that final disposition of the request be made at a prehearing conference or at a designated time prior to a hearing under this part.

(d) Effect of admissions; withdrawal or amendment of admission. Any matter admitted under this section may be conclusively established unless the administrative law judge on motion permits withdrawal or amendment of the admission. The administrative law judge may permit withdrawal or amendment when the presentation of the issues of the investigation will be subserved thereby and the party who obtained the admission fails to satisfy the administrative law judge that withdrawal or amendment will prejudice him in maintaining his position on the issue of the investigation. Any admission made by a party under this section is for the purpose of the pending investigation and any related proceeding as defined in § 210.3 of this chapter.


§ 210.32 Subpoenas.

(a) Application for issuance of a subpoena —(1) Subpoena ad testificandum. An application for issuance of a subpoena requiring a person to appear and depose or testify at the taking of a deposition or at a hearing shall be made to the administrative law judge.

(2) Subpoena duces tecum. An application for issuance of a subpoena requiring a person to appear and depose or testify and to produce specified documents, papers, books, or other physical exhibits at the taking of a deposition, at a prehearing conference, at a hearing, or under any other circumstances, shall be made in writing to the administrative law judge and shall specify the material to be produced as precisely as possible, showing the general relevancy of the material and the reasonableness of the scope of the subpoena.

(3) The administrative law judge shall rule on all applications filed under paragraph (a)(1) or (a)(2) of this section and may issue subpoenas when warranted.

(b) Use of subpoena for discovery. Subpoenas may be used by any party for purposes of discovery or for obtaining documents, papers, books or other physical exhibits for use in evidence, or for both purposes. When used for discovery purposes, a subpoena may require a person to produce and permit the inspection and copying of nonprivileged documents, papers, books, or other physical exhibits that constitute or contain evidence relevant to the subject matter involved and that are in the possession, custody, or control of such person.

(c) Application for subpoenas for nonparty Commission records or personnel or for records and personnel of other Government agencies —(1) Procedure. An application for issuance of a subpoena requiring the production of nonparty documents, papers, books, physical exhibits, or other material in the records of the Commission, or requiring the production of records or personnel of other Government agencies shall specify as precisely as possible the material to be

produced, the nature of the information to be disclosed, or the expected testimony of the official or employee, and shall contain a statement showing the general relevancy of the material, information, or testimony and the reasonableness of the scope of the application, together with a showing that such material, information, or testimony or their substantial equivalent could not be obtained without undue hardship or by alternative means.

(2) Ruling. Such applications shall be ruled upon by the administrative law judge, and he may issue such subpoenas when warranted. To the extent that the motion is granted, the administrative law judge shall provide such terms and conditions for the production of the material, the disclosure of the information, or the appearance of the official or employee as may appear necessary and appropriate for the protection of the public interest.

(3) Application for subpoena grounded upon the Freedom of Information Act. No application for a subpoena for production of documents grounded upon the Freedom of Information Act (5 U.S.C. § 552) shall be entertained by the administrative law judge.

(d) Motion to limit or quash. Any motion to limit or quash a subpoena shall be filed within such time as the administrative law judge may allow.

(e) Ex parte rulings on applications for subpoenas. Applications for the issuance of the subpoenas pursuant to the provisions of this section may be made ex parte, and, if so made, such applications and rulings thereon shall remain ex parte unless otherwise ordered by the administrative law judge.

(f) Witness Fees —(1) Deponents and witnesses. Any person compelled to appear in person to depose or testify in response to a subpoena shall be paid the same mileage as are paid witnesses with respect to proceedings in the courts of the United States; provided, that salaried employees of the United States summoned to depose or testify as to matters related to their public employment, irrespective of the party at whose instance they are summoned, shall be paid in accordance with the applicable Federal regulations.

(2) Responsibility. The fees and mileage referred to in paragraph (f)(1) of this section shall be paid by the party at whose instance deponents or witnesses appear. Fees due under this paragraph shall be tendered no later than the date for compliance with the subpoena issued under this section. Failure to timely tender fees under this paragraph shall not invalidate any subpoena issued under this section.

(g) Obtaining judicial enforcement. In order to obtain judicial enforcement of a subpoena issued under paragraphs (a)(3) or (c)(2) of this section, the administrative law judge shall certify to the Commission, on motion or sua sponte, a request for such enforcement. The request shall be accompanied by copies of relevant papers and a written report from the administrative law judge concerning the purpose, relevance, and reasonableness of the subpoena. If the request, relevant papers, or written report contain confidential business information, the administrative law judge shall certify nonconfidential copies along with the confidential versions. The Commission will subsequently issue a notice stating whether it has granted the request and authorized its Office of the General Counsel to seek such enforcement.


§ 210.33 Failure to make or cooperate in discovery; sanctions.

(a) Motion for order compelling discovery. A party may apply to the administrative law judge for an order compelling discovery upon reasonable notice to other parties and all persons affected thereby.

(b) Non-monetary sanctions for failure to comply with an order compelling discovery. If a party or an officer or agent of a party fails to comply with an order including, but not limited to, an order for the taking of a deposition or the production of documents, an order to answer interrogatories, an order issued pursuant to a request for admissions, or an order to comply with a subpoena, the administrative law judge, for the purpose of permitting resolution of relevant issues and disposition of the investigation without unnecessary delay despite the failure to comply, may take such action in regard thereto as is just, including, but not limited to the following:

(1) Infer that the admission, testimony, documents, or other evidence would have been adverse to the party;

(2) Rule that for the purposes of the investigation the matter or matters concerning the order or subpoena issued be taken as established adversely to the party;

(3) Rule that the party may not introduce into evidence or otherwise rely upon testimony by the party, officer, or agent, or documents, or other material in support of his position in the investigation;

(4) Rule that the party may not be heard to object to introduction and use of secondary evidence to show what the withheld admission, testimony, documents, or other evidence would have shown;

(5) Rule that a motion or other submission by the party concerning the order or subpoena issued be stricken or rule by initial determination that a determination in the investigation be rendered against the party, or both; or

(6) Order any other non-monetary sanction available under Rule 37(b) of the Federal Rules of Civil Procedure. Any such action may be taken by written or oral order issued in the course of the investigation or by inclusion in the initial determination of the administrative law judge. It shall be the duty of the parties to seek, and that of the administrative law judge to grant, such of the foregoing means of relief or other appropriate relief as may be sufficient to compensate for the lack of withheld testimony, documents, or other evidence. If, in the administrative law judge's opinion such relief would not be sufficient, the administrative law judge shall certify to the Commission a request that court enforcement of the subpoena or other discovery order be sought.

(c) Monetary sanctions for failure to make or cooperate in discovery. (1) If a party or an officer, director, or managing agent of the party or person designated to testify on behalf of a party fails to obey an order to provide or permit discovery, the administrative law judge or the Commission may make such orders in regard to the failure as are just. In lieu of or in addition to taking action listed in paragraph (b) of this section and to the extent provided in Rule 37(b)(2) of the Federal Rules of Civil Procedure, the administrative law judge or the Commission, upon motion or sua sponte under § 210.25, may require the party failing to obey the order or the attorney advising that party or both to pay reasonable expenses, including attorney's fees, caused by the failure, unless the administrative law judge or the Commission finds that the failure was substantially justified or that other circumstances make an award of expenses unjust. Monetary sanctions shall not be imposed under this section against the United States, the Commission, or a Commission investigative attorney.

(2) Monetary sanctions may be imposed under this section to reimburse the Commission for expenses incurred by a Commission investigative attorney or the Commission's Office of Unfair Import Investigations. Monetary sanctions will not be imposed under this section to reimburse the Commission for attorney's fees.

§ 210.34 Protective orders; reporting requirement; sanctions and other actions.

(a) Issuance of protective order. Upon motion by a party or by the person from whom discovery is sought or by the administrative law judge on his own initiative, and for good cause shown, the administrative law judge may make any order that may appear necessary and appropriate for the protection of the public interest or that justice requires to protect a party or person from annoyance, embarrassment, oppression, or undue burden or expense, including one or more of the following:

(1) That discovery not be had;

(2) That the discovery may be had only on specified terms and conditions, including a designation of the time or place;

(3) That discovery may be had only by a method of discovery other than that selected by the party seeking discovery;

(4) That certain matters not be inquired into, or that the scope of discovery be limited to certain matters;

(5) That discovery be conducted with no one present except persons designated by the administrative law judge;

(6) That a deposition, after being sealed, be opened only by order of the Commission or the administrative law judge;

(7) That a trade secret or other confidential research, development, or commercial information not be disclosed or be disclosed only in a designated way; and

(8) That the parties simultaneously file specified documents or information enclosed in sealed envelopes to be opened as directed by the Commission or the administrative law judge. If the motion for a protective order is denied, in whole or in part, the Commission or the administrative law judge may, on such terms and conditions as are just, order that any party or person provide or permit discovery. The Commission also may, upon motion or sua sponte, issue protective orders or may continue or amend a protective order issued by the administrative law judge.

(b) Unauthorized disclosure, loss, or theft of information. If confidential business information submitted in accordance with the terms of a protective order is disclosed to any person other than in a manner authorized by the protective order, lost, or stolen, the party responsible for the disclosure, or subject to the loss or theft, must immediately bring all pertinent facts relating to such incident to the attention of the submitter of the information and the administrative law judge or the Commission, and, without prejudice to other rights and remedies of the submitter of the information, make every effort to prevent further mishandling of such information by the party or the recipient of such information.

(c) Violation of protective order. (1) The issue of whether sanctions should be imposed may be raised on a motion by a party, the administrative law judge's own motion, or the Commission's own initiative in accordance with § 210.25(a)(2). Parties, including the party that identifies an alleged breach or makes a motion for sanctions, and the Commission shall treat the identity of the alleged breacher as confidential business information unless the Commission issues a public sanction. The identity of the alleged breacher means the name of any individual against whom allegations are made. The Commission or administrative law judge shall allow the parties to make

written submissions and, if warranted, to present oral argument bearing on the issues of violation of a protective order and sanctions therefor.

(2) If the breach occurs while the investigation is before an administrative law judge, any determination on sanctions of the type enumerated in paragraphs (c)(3)(i) through (iv) of this section shall be in the form of a recommended determination. The Commission may then consider both the recommended determination and any related orders in making a determination on sanctions. When the motion is addressed to the administrative law judge for sanctions of the type enumerated in paragraph (c)(3)(v) of this section, he shall grant or deny a motion by issuing an order.

(3) Any individual who has agreed to be bound by the terms of a protective order issued pursuant to paragraph (a) of this section, and who is determined to have violated the terms of the protective order, may be subject to one or more of the following:

(i) An official reprimand by the Commission;

(ii) Disqualification from or limitation of further participation in a pending investigation;

(iii) Temporary or permanent disqualification from practicing in any capacity before the Commission pursuant to § 201.15(a) of this chapter;

(iv) Referral of the facts underlying the violation to the appropriate licensing authority in the jurisdiction in which the individual is licensed to practice;

(v) Sanctions of the sort enumerated in § 210.33(b), or such other action as may be appropriate.

(d) Reporting requirement. Each person who is subject to a protective order issued pursuant to paragraph (a) of this section shall report in writing to the Commission immediately upon learning that confidential business information disclosed to him or her pursuant to the protective order is the subject of:

(1) A subpoena;

(2) A court or an administrative order (other than an order of a court reviewing a Commission decision);

(3) A discovery request;

(4) An agreement; or

(5) Any other written request, if the request or order seeks disclosure, by him or any other person, of the subject confidential business information to a person who is not, or may not be, permitted access to that information pursuant to either a Commission protective order or § 210.5(b).

NOTE TO PARAGRAPH ( d ): This reporting requirement applies only to requests and orders for disclosure made for use of confidential business information in non-Commission proceedings.

(e) Sanctions and other actions. After providing notice and an opportunity to comment, the Commission may impose a sanction upon any person who willfully fails to comply with paragraph (d) of this section, or it may take other action.


Subpart F—Prehearing Conferences and Hearings § 210.35 Prehearing conferences.

(a) When appropriate. The administrative law judge in any investigation may direct counsel or other representatives for all parties to meet with him for one or more conferences to consider any or all of the following:

(1) Simplification and clarification of the issues;

(2) Negotiation, compromise, or settlement of the case, in whole or in part;

(3) Scope of the hearing;

(4) Necessity or desirability of amendments to pleadings subject, however, to the provisions of § 210.14 (b) and (c);

(5) Stipulations and admissions of either fact or the content and authenticity of documents;

(6) Expedition in the discovery and presentation of evidence including, but not limited to, restriction of the number of expert, economic, or technical witnesses; and

(7) Such other matters as may aid in the orderly and expeditious disposition of the investigation including disclosure of the names of witnesses and the exchange of documents or other physical exhibits that will be introduced in evidence in the course of the hearing.

(b) Subpoenas. Prehearing conferences may be convened for the purpose of accepting returns on subpoenas duces tecum issued pursuant to § 210.32(a)(3).

(c) Reporting. In the discretion of the administrative law judge, prehearing conferences may or may not be stenographically reported and may or may not be public.

(d) Order. The administrative law judge may enter in the record an order that recites the results of the conference. Such order shall include the administrative law judge's rulings upon matters considered at the conference, together with appropriate direction to the parties. The administrative law judge's order shall control the subsequent course of the hearing, unless the administrative law judge modifies the order.


§ 210.36 General provisions for hearings.

(a) Purpose of hearings. (1) An opportunity for a hearing shall be provided in each investigation under this part, in accordance with the Administrative Procedure Act. At the hearing, the presiding administrative law judge will take evidence and hear argument for the purpose of determining whether there is a violation of section 337 of the Tariff Act of 1930, and for the purpose of making findings and recommendations, as described in § 210.42(a)(1)(ii), concerning the appropriate remedy and the amount of the bond to be posted by respondents during Presidential review of the Commission's action, under section 337(j) of the Tariff Act.

(2) An opportunity for a hearing in accordance with the Administrative Procedure Act shall also be provided in connection with every motion for temporary relief filed under this part.

(b) Public hearings. All hearings in investigations under this part shall be public unless otherwise ordered by the administrative law judge.

(c) Expedition. Hearings shall proceed with all reasonable expedition, and, insofar as practicable, shall be held at one place, continuing until completed unless otherwise ordered by the administrative law judge.

(d) Rights of the parties. Every hearing under this section shall be conducted in accordance with the Administrative Procedure Act (i.e., 5 U.S.C. §§ 554 through 556). Hence, every party shall have the right of adequate notice, cross-examination, presentation of evidence, objection, motion, argument, and all other rights essential to a fair hearing.

(e) Presiding official. An administrative law judge shall preside over each hearing unless the Commission shall otherwise order.

§ 210.37 Evidence.

(a) Burden of proof. The proponent of any factual proposition shall be required to sustain the burden of proof with respect thereto.

(b) Admissibility. Relevant, material, and reliable evidence shall be admitted. Irrelevant, immaterial, unreliable, or unduly repetitious evidence shall be excluded. Immaterial or irrelevant parts of an admissible document shall be segregated and excluded as far as practicable.

(c) Information obtained in investigations. Any documents, papers, books, physical exhibits, or other materials or information obtained by the Commission under any of its powers may be disclosed by the Commission investigative attorney when necessary in connection with investigations and may be offered in evidence by the Commission investigative attorney.

(d) Official notice. When any decision of the administrative law judge rests, in whole or in part, upon the taking of official notice of a material fact not appearing in evidence of record, opportunity to disprove such noticed fact shall be granted any party making timely motion therefor.

(e) Objections. Objections to evidence shall be made in timely fashion and shall briefly state the grounds relied upon. Rulings on all objections shall appear on the record.

(f) Exceptions. Formal exception to an adverse ruling is not required.

(g) Excluded evidence. When an objection to a question propounded to a witness is sustained, the examining party may make a specific offer of what he expects to prove by the answer of the witness, or the administrative law judge may in his discretion receive and report the evidence in full. Rejected exhibits, adequately marked for identification, shall be retained with the record so as to be available for consideration by any reviewing authority.

§ 210.38 Record.

(a) Definition of the record. The record shall consist of all pleadings, the notice of investigation, motions and responses, all briefs and written statements, and other documents and things properly filed with the Secretary, in addition to all orders, notices, and initial determinations

of the administrative law judge, orders and notices of the Commission, hearing and conference transcripts, evidence admitted into the record (including physical exhibits), and any other items certified into the record by the administrative law judge or the Commission.

(b) Reporting and transcription. Hearings shall be reported and transcribed by the official reporter of the Commission under the supervision of the administrative law judge, and the transcript shall be a part of the record.

(c) Corrections. Changes in the official transcript may be made only when they involve errors affecting substance. A motion to correct a transcript shall be addressed to the administrative law judge, who may order that the transcript be changed to reflect such corrections as are warranted, after consideration of any objections that may be made. Such corrections shall be made by the official reporter by furnishing substitute typed pages, under the usual certificate of the reporter, for insertion in the transcript. The original uncorrected pages shall be retained in the files of the Commission.

(d) Certification of record. The record, including all physical exhibits entered into evidence or such photographic reproductions thereof as the administrative law judge approves, shall be certified to the Commission by the administrative law judge upon his filing of an initial determination or at such earlier time as the Commission may order.


§ 210.39 In camera treatment of confidential information.

(a) Definition. Except as hereinafter provided and consistent with §§ 210.5 and 210.34, confidential documents and testimony made subject to protective orders or orders granting in camera treatment are not made part of the public record and are kept confidential in an in camera record. Only the persons identified in a protective order, persons identified in § 210.5(b), and court personnel concerned with judicial review shall have access to confidential information in the in camera record. The right of the administrative law judge and the Commission to disclose confidential data under a protective order (pursuant to § 210.34) to the extent necessary for the proper disposition of each proceeding is specifically reserved.

(b) Transmission of certain Commission records to district court. (1) In a civil action involving parties that are also parties to a proceeding before the Commission under section 337 of the Tariff Act of 1930, at the request of a party to a civil action that is also a respondent in the proceeding before the Commission, the district court may stay, until the determination of the Commission becomes final, proceedings in the civil action with respect to any claim that involves the same issues involved in the proceeding before the Commission under certain conditions. If such a stay is ordered by the district court, after the determination of the Commission becomes final and the stay is dissolved, the Commission shall certify to the district court such portions of the record of its proceeding as the district court may request. Notwithstanding paragraph (a) of this section, the in camera record may be transmitted to a district court and be admissible in a civil action, subject to such protective order as the district court determines necessary, pursuant to 28 U.S.C. 1659.

(2) To facilitate timely compliance with any court order requiring the Commission to transmit all or part of the record of its section 337 proceedings to the court, as described in paragraph (b)(1) of this section, a party that requests the court to issue an order staying the civil action or an order dissolving the stay and directing the Commission to transmit all or part of the record to the court must file written notice of the issuance or dissolution of a stay with the Commission Secretary within 10 days of the issuance or dissolution of a stay by the district court.

(c) In camera treatment of documents and testimony. The administrative law judge shall have authority to order documents or oral testimony offered in evidence, whether admitted or rejected, to be placed in camera.

(d) Part of confidential record. In camera documents and testimony shall constitute a part of the confidential record of the Commission.

(e) References to in camera information. In submitting proposed findings, briefs, or other papers, counsel for all parties shall make an attempt in good faith to refrain from disclosing the specific details of in camera documents and testimony. This shall not preclude references in such proposed findings, briefs, or other papers to such documents or testimony including generalized statements based on their contents. To the extent that counsel consider it necessary to include specific details of in camera data in their presentations, such data shall be incorporated in separate proposed findings, briefs, or other papers marked “Business Confidential,” which shall be placed in camera and become a part of the confidential record.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67627, Dec. 30, 1994; 73 FR 38324, July 7, 2008]

§ 210.40 Proposed findings and conclusions and briefs.

At the time a motion for summary determination under § 210.18(a) or a motion for termination under § 210.21(a) is made, or when it is found that a party is in default under § 210.16, or at the close of the reception of evidence in any hearing held pursuant to this part (except as provided in § 210.63), or within a reasonable time thereafter fixed by the administrative law judge, any party may file proposed findings of fact and conclusions of law, together with reasons therefor. When appropriate, briefs in support of the proposed findings of fact and conclusions of law may be filed with the administrative law judge for his consideration. Such proposals and briefs shall be in writing, shall be served upon all parties in accordance with § 210.4(g), and shall contain adequate references to the record and the authorities on which the submitter is relying.

Subpart G—Determinations and Actions Taken § 210.41 Termination of investigation.

Except as provided in § 210.21 (b)(2), (c), and (d), an order of termination issued by the Commission shall constitute a determination of the Commission under § 210.45(c). The Commission shall publish in the FEDERAL REGISTER notice of each Commission order that terminates an investigation in its entirety.

[60 FR 53120, Oct. 12, 1995]

§ 210.42 Initial determinations.

(a)(1)(i) On issues concerning violation of section 337. Unless otherwise ordered by the Commission, the administrative law judge shall certify the record to the Commission and shall file an initial determination on whether there is a violation of section 337 of the Tariff Act of 1930 in an original investigation no later than 4 months before the target date set pursuant to § 210.51(a)(1).

(ii) Recommended determination on issues concerning permanent relief, bonding, and the public interest. Unless the Commission orders otherwise, within 14 days after issuance of the initial determination on violation of section 337 of the Tariff Act of 1930, the administrative law

judge shall issue a recommended determination containing findings of fact and recommendations concerning—

(A) The appropriate remedy in the event that the Commission finds a violation of section 337, and

(B) The amount of the bond to be posted by the respondents during Presidential review of Commission action under section 337(j) of the Tariff Act.

(C) The public interest under sections 337(d)(1) and (f)(1) in investigations where the Commission has ordered the administrative law judge under § 210.50(b)(1) to take evidence with respect to the public interest.

(2) On certain motions to declassify information. The decision of the administrative law judge granting a motion to declassify information, in whole or in part, shall be in the form of an initial determination as provided in § 210.20(b).

(b) On issues concerning temporary relief or forfeiture of temporary relief bonds. Certification of the record and the disposition of an initial determination concerning a motion for temporary relief are governed by §§ 210.65 and 210.66. The disposition of an initial determination concerning possible forfeiture or return of a complainant's temporary relief bond, in whole or in part, is governed by § 210.70.

(c) On other matters. (1) The administrative law judge shall grant the following types of motions by issuing an initial determination or shall deny them by issuing an order: a motion to amend the complaint or notice of investigation pursuant to § 210.14(b); a motion for a finding of default pursuant to §§ 210.16 and 210.17; a motion for summary determination pursuant to § 210.18; a motion for intervention pursuant to § 210.19; a motion for termination pursuant to § 210.21; a motion to suspend an investigation pursuant to § 210.23; or a motion to set a target date for an original investigation exceeding 16 months pursuant to § 210.51(a)(1); or a motion to set a target date for a formal enforcement proceeding exceeding 12 months pursuant to § 210.51(a)(2).

(2) The administrative law judge shall grant or deny the following types of motions by issuing an initial determination: a motion for forfeiture or return of respondents' bonds pursuant to § 210.50(d) or a motion for forfeiture or return of a complainant's temporary relief bond pursuant to § 210.70.

(d) Contents. The initial determination shall include: an opinion stating findings (with specific page references to principal supporting items of evidence in the record) and conclusions and the reasons or bases therefor necessary for the disposition of all material issues of fact, law, or discretion presented in the record; and a statement that, pursuant to § 210.42(h), the initial determination shall become the determination of the Commission unless a party files a petition for review of the initial determination pursuant to § 210.43(a) or the Commission, pursuant to § 210.44, orders on its own motion a review of the initial determination or certain issues therein.

(e) Notice to and advice from other departments and agencies. Notice of each initial determination granting a motion for termination of an investigation in whole or part on the basis of a consent order or a settlement, licensing, or other agreement pursuant to § 210.21 of this part, and notice of such other initial determinations as the Commission may order, shall be provided to the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service, and such other departments and agencies as the Commission deems appropriate. The Commission shall consider comments, limited to issues raised by the record, the initial determination, and the petitions for review, received from such

agencies when deciding whether to initiate review or the scope of review. The Commission shall allow such agencies 10 days after the service of an initial determination to submit their comments.

(f) Initial determination made by the administrative law judge. An initial determination under this section shall be made and filed by the administrative law judge who presided over the investigation, except when that person is unavailable to the Commission and except as provided in § 210.20(a).

(g) Reopening of proceedings by the administrative law judge. At any time prior to the filing of the initial determination, the administrative law judge may reopen the proceedings for the reception of additional evidence.

(h) Effect. (1) An initial determination filed pursuant to § 210.42(a)(2) shall become the determination of the Commission 45 days after the date of service of the initial determination, unless the Commission has ordered review of the initial determination or certain issues therein, or by order has changed the effective date of the initial determination.

(2) An initial determination under § 210.42(a)(1)(i) shall become the determination of the Commission 60 days after the date of service of the initial determination, unless the Commission within 60 days after the date of such service shall have ordered review of the initial determination or certain issues therein or by order has changed the effective date of the initial determination. The findings and recommendations made by the administrative law judge in the recommended determination issued pursuant to § 210.42(a)(1)(ii) will be considered by the Commission in reaching determinations on remedy and bonding by the respondents pursuant to § 210.50(a).

(3) An initial determination filed pursuant to § 210.42(c) shall become the determination of the Commission 30 days after the date of service of the initial determination, except as provided for in paragraph (h)(5) and paragraph (h)(6) of this section, § 210.50(d)(3), and § 210.70(c), unless the Commission, within 30 days after the date of such service shall have ordered review of the initial determination or certain issues therein or by order has changed the effective date of the initial determination.

(4) The disposition of an initial determination granting or denying a motion for temporary relief is governed by § 210.66.

(5) The disposition of an initial determination concerning possible forfeiture of a complainant's temporary relief bond is governed by § 210.70(c).

(6) The disposition of an initial determination filed pursuant to § 210.42(c) which grants a motion for summary determination that would terminate the investigation in its entirety if it were to become the Commission's final determination, shall become the final determination of the Commission 45 days after the date of service of the initial determination, unless the Commission has ordered review of the initial determination or certain issues therein, or by order has changed the effective date of the initial determination.

(i) Notice of determination. A notice stating that the Commission's decision on whether to review an initial determination will be issued by the Secretary and served on the parties. Notice of the Commission's decision will be published in the FEDERAL REGISTER if the decision results in termination of the investigation in its entirety, if the Commission deems publication of the notice to be appropriate under § 201.10 of subpart B of this part, or if publication of the notice is required under § 210.49(b) of this subpart or § 210.66(f) of subpart H of this part.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67628, Dec. 30, 1994; 60 FR 53120, Oct. 12, 1995; 73 FR 38324, July 7, 2008; 76 FR 64809, Oct. 19, 2011; 78 FR 23484, Apr. 19, 2013]

§ 210.43 Petitions for review of initial determinations on matters other than temporary relief.

(a) Filing of the petition. (1) Except as provided in paragraph (a)(2) of this section, any party to an investigation may request Commission review of an initial determination issued under § 210.42(a)(1) or (c), § 210.50(d)(3), § 210.70(c), or § 210.75(b)(3) by filing a petition with the Secretary.A petition for review of an initial determination issued under § 210.42(a)(1) must be filed within 12 days after service of the initial determination. A petition for review of an initial determination issued under § 210.42(c) that terminates the investigation in its entirety on summary determination, or an initial determination issued under § 210.50(d)(3), § 210.70(c) or § 210.75(b)(3), must be filed within 10 days after service of the initial determination. Petitions for review of all other initial determinations under § 210.42(c) must be filed within five (5) business days after service of the initial determination. A petition for review of an initial determination issued under § 210.50(d)(3) or § 210.70(c) must be filed within 10 days after service of the initial determination.

(2) A party may not petition for review of any issue as to which the party has been found to be in default. Similarly, a party or proposed respondent who did not file a response to the motion addressed in the initial determination may be deemed to have consented to the relief requested and may not petition for review of the issues raised in the motion.

(b) Content of the petition. (1) A petition for review filed under this section shall identify the party seeking review and shall specify the issues upon which review of the initial determination is sought, and shall, with respect to each such issue, specify one or more of the following grounds upon which review is sought:

(i) That a finding or conclusion of material fact is clearly erroneous;

(ii) That a legal conclusion is erroneous, without governing precedent, rule or law, or constitutes an abuse of discretion; or

(iii) That the determination is one affecting Commission policy.

(2) The petition for review must set forth a concise statement of the facts material to the consideration of the stated issues, and must present a concise argument providing the reasons that review by the Commission is necessary or appropriate to resolve an important issue of fact, law, or policy. If a petition filed under this paragraph exceeds 50 pages in length, it must be accompanied by a summary of the petition not to exceed ten pages. Petitions for review may not exceed 100 pages in length, exclusive of the summary and any exhibits. Petitions for review may not incorporate statements, issues, or arguments by reference. Any issue not raised in a petition for review will be deemed to have been abandoned by the petitioning party and may be disregarded by the Commission in reviewing the initial determination (unless the Commission chooses to review the issue on its own initiative under § 210.44), and any argument not relied on in a petition for review will be deemed to have been abandoned and may be disregarded by the Commission.

(3) Any petition designated by the petitioner as a “contingent” petition for review shall be deemed to be a petition under paragraph (a)(1) of this section and shall be processed accordingly. In order to preserve an issue for review by the Commission or the U.S. Court of Appeals for the Federal Circuit that was decided adversely to a party, the issue must be raised in

a petition for review, whether or not the Commission's determination on the ultimate issue, such as a violation of section 337, was decided adversely to the party.

(4) A party's failure to file a petition for review of an initial determination shall constitute abandonment of all issues decided adversely to that party in the initial determination.

(5) Service of petition. All petitions for review of an initial determination shall be served on the other parties by messenger, overnight delivery, or equivalent means.

(c) Responses to the petition. Any party may file a response within eight (8) days after service of a petition of a final initial determination under § 210.42(a)(1), and within five (5) business days after service of all other types of petitions, except that a party who has been found to be in default may not file a response to any issue as to which the party has defaulted. If a response to a petition for review filed under this paragraph exceeds 50 pages in length, it must be accompanied by a summary of the response not to exceed ten pages. Responses to petitions for review may not exceed 100 pages in length, exclusive of the summary and any exhibits. Responses to petitions for review may not incorporate statements, issues, or arguments by reference. Any argument not relied on in a response will be deemed to have been abandoned and may be disregarded by the Commission.

(d) Grant or denial of review. (1) The Commission shall decide whether to grant, in whole or in part, a petition for review of an initial determination filed pursuant to § 210.42(a)(1) within 60 days of the service of the initial determination on the parties, or by such other time as the Commission may order. The Commission shall decide whether to grant, in whole or in part, a petition for review of an initial determination filed pursuant to § 210.42(a)(2) or § 210.42(c), which grants a motion for summary determination that would terminate the investigation in its entirety if it becomes the final determination of the Commission, § 210.50(d)(3), or § 210.70(c) within 45 days after the service of the initial determination on the parties, or by such other time as the Commission may order. The Commission shall decide whether to grant, in whole or in part, a petition for review of an initial determination filed pursuant to § 210.42(c), except as noted above, within 30 days after the service of the initial determination on the parties, or by such other time as the Commission may order.

(2) The Commission shall decide whether to grant a petition for review, based upon the petition and response thereto, without oral argument or further written submissions unless the Commission shall order otherwise. A petition will be granted and review will be ordered if it appears that an error or abuse of the type described in paragraph (b)(1) of this section is present or if the petition raises a policy matter connected with the initial determination, which the Commission thinks it necessary or appropriate to address.

(3) The Commission shall grant a petition for review and order review of an initial determination or certain issues therein when at least one of the participating Commissioners votes for ordering review. In its notice, the Commission shall establish the scope of the review and the issues that will be considered and make provisions for filing of briefs and oral argument if deemed appropriate by the Commission. If the notice solicits written submissions from interested persons on the issues of remedy, the public interest, and bonding in addition to announcing the Commission's decision to grant a petition for review of the initial determination, the notice shall be served by the Secretary on all parties, the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service, and such other departments and agencies as the Commission deems appropriate.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67628, Dec. 30, 1994; 60 FR 53120, Oct. 12, 1995; 73 FR 38325, July 7, 2008; 78 FR 23484, Apr. 19, 2013]

§ 210.44 Commission review on its own motion of initial determinations on matters other than temporary relief.

Within the time provided in § 210.43(d)(1), the Commission on its own initiative may order review of an initial determination, or certain issues in the initial determination, when at least one of the participating Commissioners votes for ordering review. A self-initiated Commission review of an initial determination will be ordered if it appears that an error or abuse of the kind described in § 210.43(b)(1) is present or the initial determination raises a policy matter which the Commission thinks is necessary or appropriate to address.

§ 210.45 Review of initial determinations on matters other than temporary relief.

(a) Briefs and oral argument. In the event the Commission orders review of an initial determination pertaining to issues other than temporary relief, the parties may be requested to file briefs on the issues under review at a time and of a size and nature specified in the notice of review. The parties, within the time provided for filing the review briefs, may submit a written request for a hearing to present oral argument before the Commission, which the Commission in its discretion may grant or deny. The Commission shall grant the request when at least one of the participating Commissioners votes in favor of granting the request.

(b) Scope of review. Only the issues set forth in the notice of review, and all subsidiary issues therein, will be considered by the Commission.

(c) Determination on review. On review, the Commission may affirm, reverse, modify, set aside or remand for further proceedings, in whole or in part, the initial determination of the administrative law judge. In addition, the Commission may take no position on specific issues or portions of the initial determination of the administrative law judge. The Commission also may make any findings or conclusions that in its judgment are proper based on the record in the proceeding. If the Commission's determination on review terminates the investigation in its entirety, a notice will be published in the FEDERAL REGISTER .

[59 FR 39039, Aug. 1, 1994, as amended at 60 FR 53120, Oct. 12, 1995; 73 FR 38235, July 7, 2008]

§ 210.46 Petitions for and sua sponte review of initial determinations on violation of section 337 or temporary relief.

(a) Violation of section 337. An initial determination issued under § 210.42(a)(1)(i) on whether respondents have violated section 337 of the Tariff Act of 1930 will be processed as provided in § 210.42(e), (h)(2), and (i) and §§ 210.43 through 210.45. The Commission will issue a notice setting deadlines for written submissions from the parties, other Federal agencies, and interested members of the public on the issues of remedy, the public interest, and bonding by the respondents. In those submissions, the parties may assert their arguments concerning the recommended determination issued by the administrative law judge pursuant to § 210.42(a)(ii) on the issues of remedy and bonding by respondents.

(b) Temporary relief. Commission action on an initial determination concerning temporary relief is governed by § 210.66.

§ 210.47 Petitions for reconsideration.

Within 14 days after service of a Commission determination, any party may file with the Commission a petition for reconsideration of such determination or any action ordered to be taken thereunder, setting forth the relief desired and the grounds in support thereof. Any petition filed under this section must be confined to new questions raised by the determination or action

ordered to be taken thereunder and upon which the petitioner had no opportunity to submit arguments. Any party desiring to oppose such a petition shall file an answer thereto within five days after service of the petition upon such party. The filing of a petition for reconsideration shall not stay the effective date of the determination or action ordered to be taken thereunder or toll the running of any statutory time period affecting such determination or action ordered to be taken thereunder unless specifically so ordered by the Commission.

§ 210.48 Disposition of petitions for reconsideration.

The Commission may affirm, set aside, or modify its determination, including any action ordered by it to be taken thereunder. When appropriate, the Commission may order the administrative law judge to take additional evidence.

§ 210.49 Implementation of Commission action.

(a) Service of Commission determination upon the parties. A Commission determination pursuant to § 210.45(c) or a termination on the basis of a licensing or other agreement, a consent order or an arbitration agreement pursuant to § 210.21(b), (c) or (d), respectively, shall be served upon each party to the investigation.

(b) Publication and transmittal to the President. A Commission determination that there is a violation of section 337 of the Tariff Act of 1930 or that there is reason to believe that there is a violation, together with the action taken relative to such determination under § 210.50(a) or § 210.50(d) of this part, or the modification or rescission in whole or in part of an action taken under § 210.50(a), shall promptly be published in the FEDERAL REGISTER. It shall also be promptly transmitted to the President or an officer assigned the functions of the President under 19 U.S.C. 1337(j)(1)(B), 1337(j)(2), and 1337(j)(4), together with the record upon which the determination and the action are based.

(c) Enforceability of Commission action. Unless otherwise specified, any Commission action other than an exclusion order or an order directing seizure and forfeiture of articles imported in violation of an outstanding exclusion order shall be enforceable upon receipt by the affected party of notice of such action. Exclusion orders and seizure and forfeiture orders shall be enforceable upon receipt of notice thereof by the Secretary of the Treasury.

(d) Finality of affirmative Commission action. If the President does not disapprove the Commission's action within a 60-day period beginning the day after a copy of the Commission's action is delivered to the President, or if the President notifies the Commission before the close of the 60-day period that he approves the Commission's action, such action shall become final the day after the close of the 60-day period or the day the President notifies the Commission of his approval, as the case may be.

(e) Duration. Final Commission action shall remain in effect as provided in subpart I of this part.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67628, Dec. 30, 1994; 73 FR 38325, July 7, 2008]

§ 210.50 Commission action, the public interest, and bonding by respondents.

(a) During the course of each investigation under this part, the Commission shall—

(1) Consider what action (general or limited exclusion of articles from entry or a cease and desist order, or exclusion of articles from entry under bond or a temporary cease and desist order), if any, it should take, and, when appropriate, take such action;

(2) Consult with and seek advice and information from the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service, and such other departments and agencies as it considers appropriate, concerning the subject matter of the complaint and the effect its actions (general or limited exclusion of articles from entry or a cease and desist order, or exclusion of articles from entry under bond or a temporary cease and desist order) under section 337 of the Tariff Act of 1930 shall have upon the public health and welfare, competitive conditions in the U.S. economy, the production of like or directly competitive articles in the United States, and U.S. consumers;

(3) Determine the amount of the bond to be posted by a respondent pursuant to section 337(j)(3) of the Tariff Act of 1930 following the issuance of temporary or permanent relief under section 337(d), (e), (f), or (g) of the Tariff Act of 1930, taking into account the requirement of section 337(e) and (j)(3) that the amount of the bond be sufficient to protect the complainant from any injury.

(4) Receive submissions from the parties, interested persons, and other Government agencies and departments with respect to the subject matter of paragraphs (a)(1), (a)(2), and (a)(3) of this section. After a recommended determination on remedy is issued by the presiding administrative law judge, the parties are requested to submit to the Commission, within 30 days from service of the recommended determination, any information relating to the public interest, including any updates to the information requested by §§ 210.8(b) and (c) and 210.14(f). Submissions by the parties under this paragraph in response to the recommended determination are limited to 5 pages, inclusive of attachments.

(i) When the matter under consideration pursuant to paragraph (a)(1) of this section is whether to grant some form of permanent relief, the submissions described in paragraph (a)(4) of this section shall be filed by the deadlines specified in the Commission notice issued pursuant to § 210.46(a).

(ii) When the matter under consideration is whether to grant some form of temporary relief, such submissions shall be filed by the deadlines specified in § 210.67(b), unless the Commission orders otherwise.

(iii) Any submission from a party shall be served upon the other parties in accordance with § 210.4(g). The parties' submissions, as well as any filed by interested persons or other agencies shall be available for public inspection in the Office of the Secretary. If a party, interested person, or agency files a confidential version of its submission, it shall file a public version of the submission no later than one business day after the deadline for filing the submission.

(iv) The Commission will consider motions for oral argument or, when necessary, a hearing with respect to the subject matter of this section, except that no hearing or oral argument will be permitted in connection with a motion for temporary relief.

(b)(1) With respect to an administrative law judge's authorization to take evidence or other information and to hear arguments from the parties and other interested persons on the issues of appropriate Commission action, the public interest, and bonding by the respondents for purposes of an initial determination on temporary relief, see §§ 210.61, 210.62, and 210.66(a). For purposes of the recommended determination required by § 210.42(a)(1)(ii), an administrative law judge shall take evidence or other information and hear arguments from the parties and other interested persons on the issues of appropriate Commission action and bonding by the

respondents upon order of the Commission. Unless the Commission orders otherwise, and except as provided for in paragraph (b)(2) of this section, an administrative law judge shall not take evidence on the issue of the public interest for purposes of the recommended determination under § 210.42(a)(1)(ii).

(2) Regarding terminations by settlement agreement, consent order, or arbitration agreement under § 210.21 (b), (c) or (d), the parties may file statements regarding the impact of the proposed termination on the public interest, and the administrative law judge may hear argument, although no discovery may be compelled with respect to issues relating solely to the public interest. Thereafter, the administrative law judge shall consider and make appropriate findings in the initial determination regarding the effect of the proposed settlement on the public health and welfare, competitive conditions in the U.S. economy, the production of like or directly competitive articles in the United States, and U.S. consumers.

(c) No general exclusion from entry of articles shall be ordered under paragraph (a)(1) of this section unless the Commission determines that—

(1) Such exclusion is necessary to prevent circumvention of an exclusion order limited to products of named persons; or

(2) There is a pattern of violation of section 337 of the Tariff Act of 1930 and it is difficult to identify the source of infringing products.

(d) Forfeiture or return of respondents' bonds. (1)(i) If one or more respondents posts a bond pursuant to 19 U.S.C. 1337(e)(1) or 1337(j)(3), proceedings to determine whether a respondent's bond should be forfeited to a complainant in whole or part may be initiated upon the filing of a motion, addressed to the administrative law judge who last presided over the investigation, by a complainant within 90 days after the expiration of the period of Presidential review under 19 U.S.C. 1337(j), or if an appeal is taken from the determination of the Commission, within 30 days after the resolution of the appeal. If that administrative law judge is no longer employed by the Commission, the motion shall be addressed to the chief administrative law judge.

(ii) A respondent may file a motion addressed to the administrative law judge who last presided over the investigation for the return of its bond within 90 days after the expiration of the Presidential review period under 19 U.S.C. 1337(j), or if an appeal is taken from the determination of the Commission, within 30 days after the resolution of the appeal. If that administrative law judge is no longer employed by the Commission, the motion shall be addressed to the chief administrative law judge.

(2) Any nonmoving party may file a response to a motion filed under paragraph (d)(1) of this section within 15 days after filing of the motion, unless otherwise ordered by the administrative law judge.

(3) A motion for forfeiture or return of a respondent's bond in whole or part will be adjudicated by the administrative law judge in an initial determination with a 45-day effective date, which shall be subject to review under the provisions of §§ 210.42 through 210.45. In determining whether to grant the motion, the administrative law judge and the Commission will be guided by practice under Rule 65 of the Federal Rules of Civil Procedure (taking into account that the roles of the parties are reversed in this instance).

(4) If the Commission determines that a respondent's bond should be forfeited to a complainant, and if the bond is being held by the Secretary of the Treasury, the Commission Secretary shall promptly notify the Secretary of the Treasury of the Commission's determination.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67628, Dec. 30, 1994; 73 FR 38326, July 7, 2008; 76 FR 64809, Oct. 19, 2011; 78 FR 23484, Apr. 19, 2013]

§ 210.51 Period for concluding investigation.

(a) Permanent relief. Within 45 days after institution of an original investigation on whether there is a violation of section 337, or an investigation which is a formal enforcement proceeding, the administrative law judge shall issue an order setting a target date for completion of the investigation. After the target date has been set, it can be modified by the administrative law judge for good cause shown before the investigation is certified to the Commission or by the Commission after the investigation is certified to the Commission.

(1) Original investigations. If the target date does not exceed 16 months from the date of institution of an original investigation, the order of the administrative law judge shall be final and not subject to interlocutory review. If the target date exceeds 16 months, the order of the administrative law judge shall constitute an initial determination. Any extension of the target date beyond 16 months, before the investigation is certified to the Commission, shall be by initial determination.

(2) Formal enforcement proceedings. If the target date does not exceed 12 months from the date of institution of the formal enforcement proceeding, the order of the administrative law judge shall be final and not subject to interlocutory review. If the target date exceeds 12 months, the order of the administrative law judge shall constitute an initial determination. Any extension of the target date beyond 12 months, before the formal enforcement proceeding is certified to the Commission, shall be by initial determination.

(b) Temporary relief. The temporary relief phase of an investigation shall be concluded and a final order issued no later than 90 days after publication of the notice of investigation in the FEDERAL REGISTER, unless the temporary relief phase of the investigation has been designated “more complicated” by the Commission or the presiding administrative law judge pursuant to § 210.22(c) and § 210.60. If that designation has been made, the temporary relief phase of the investigation shall be concluded and a final order issued no later than 150 days after publication of the notice of investigation in the FEDERAL REGISTER.

(c) Computation of time. In computing the deadlines imposed in paragraph (b) of this section, there shall be excluded any period during which the investigation is suspended pursuant to § 210.23.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67629, Dec. 30, 1994; 61 FR 43432, Aug. 23, 1996; 73 FR 38326, July 7, 2008; 78 FR 23484, Apr. 19, 2013]

Subpart H—Temporary Relief § 210.52 Motions for temporary relief.

Requests for temporary relief under section 337 (e) or (f) of the Tariff Act of 1930 shall be made through a motion filed in accordance with the following provisions:

(a) A complaint requesting temporary relief shall be accompanied by a motion setting forth the complainant's request for such relief. In determining whether to grant temporary relief, the Commission will apply the standards the U.S. Court of Appeals for the Federal Circuit uses in determining whether to affirm lower court decisions granting preliminary injunctions. The motion

for temporary relief accordingly must contain a detailed statement of specific facts bearing on the factors the Federal Circuit has stated that a U.S. District Court must consider in granting a preliminary injunction.

(b) The motion must also contain a detailed statement of facts bearing on:

(1) Whether the complainant should be required to post a bond as a prerequisite to the issuance of temporary relief; and

(2) The appropriate amount of the bond, if the Commission determines that a bond will be required.

(c) In determining whether to require a bond as a prerequisite to the issuance of temporary relief, the Commission will be guided by practice under Rule 65 of the Federal Rules of Civil Procedure.

(d) The following documents and information also shall be filed along with the motion for temporary relief:

(1) A memorandum of points and authorities in support of the motion;

(2) Affidavits executed by persons with knowledge of the facts asserted in the motion; and

(3) All documents, information, and other evidence in complainant's possession that complainant intends to submit in support of the motion.

(e) If the complaint, the motion for temporary relief, or the documentation supporting the motion for temporary relief contains confidential business information as defined in § 201.6(a) of this chapter, the complainant must follow the procedure outlined in §§ 210.4(a), 210.5(a), 201.6 (a) and (c), 210.8(a), and 210.55 of this part.

[59 FR 39039, Aug. 1, 1994, as amended at 59 FR 67629, Dec. 30, 1994; 60 FR 32444, June 22, 1995]

§ 210.53 Motion filed after complaint.

(a) A motion for temporary relief may be filed after the complaint, but must be filed prior to the Commission determination under § 210.10 on whether to institute an investigation. A motion filed after the complaint shall contain the information, documents, and evidence described in § 210.52 and must also make a showing that extraordinary circumstances exist that warrant temporary relief and that the moving party was not aware, and with due diligence could not have been aware, of those circumstances at the time the complaint was filed. When a motion for temporary relief is filed after the complaint but before the Commission has determined whether to institute an investigation based on the complaint, the 35-day period allotted under § 210.58 for review of the complaint and informal investigatory activity will begin to run anew from the date on which the motion was filed.

(b) A motion for temporary relief may not be filed after an investigation has been instituted.

§ 210.54 Service of motion by the complainant.

>Notwithstanding the provisions of § 210.11 regarding service of the complaint by the Commission upon institution of an investigation, on the day the complainant files a complaint and motion for temporary relief, if any, with the Commission (see § 210.8(a)(1) and (a)(2) of subpart B

of this part), the complainant must serve non-confidential copies of both documents (as well as non-confidential copies of all materials or documents attached thereto) on all proposed respondents and on the embassy in Washington, DC of the country in which each proposed respondent is located as indicated in the Complaint. If a complainant files any supplemental information with the Commission prior to institution, nonconfidential copies of that supplemental information must be served on all proposed respondents and on the embassy in Washington, DC of the country in which each proposed respondent is located as indicated in the complaint. The complaint, motion, and supplemental information, if any, shall be served by messenger, overnight delivery, or equivalent means. A signed certificate of service must accompany the complaint and motion for temporary relief. If the certificate does not accompany the complaint and the motion, the Secretary shall not accept the complaint or the motion and shall promptly notify the submitter. Actual proof of service on each respondent and embassy (e.g., certified mail return receipts, messenger, or overnight delivery receipts, or other proof of delivery)—or proof of a serious but unsuccessful effort to make such service—must be filed within 10 days after the filing of the complaint and motion. If the requirements of this section are not satisfied, the Commission may extend its 35-day deadline under § 210.58 for determining whether to provisionally accept the motion for temporary relief and institute an investigation on the basis of the complaint.

[73 FR 38326, July 7, 2008, as amended at 78 FR 23484, Apr. 19, 2013]

§ 210.55 Content of service copies.

(a) Any purported confidential business information that is deleted from the nonconfidential service copies of the complaint and motion for temporary relief must satisfy the requirements of § 201.6(a) of this chapter (which defines confidential information for purposes of Commission proceedings). For attachments to the complaint or motion that are confidential in their entirety, the complainant must provide a nonconfidential summary of what each attachment contains. Despite the redaction of confidential material from the complaint and motion for temporary relief, the nonconfidential service copies must contain enough factual information about each element of the violation alleged in the complaint and the motion to enable each proposed respondent to comprehend the allegations against it.

(b) If the Commission determines that the complaint, motion for temporary relief, or any exhibits or attachments thereto contain excessive designations of confidentiality that are not warranted under § 201.6(a) of this chapter, the Commission may require the complainant to file and serve new non-confidential versions of the aforesaid submissions in accordance with § 210.54 and may determine that the 35-day period under § 210.58 for deciding whether to institute an investigation and to provisionally accept the motion for temporary relief for further processing shall begin to run anew from the date the new non-confidential versions are filed with the Commission and served on the proposed respondents in accordance with § 210.54.


§ 210.56 Notice accompanying service copies.

(a) Each service copy of the complaint and motion for temporary relief shall be accompanied by a notice containing the following text:

Notice is hereby given that the attached complaint and motion for temporary relief will be filed with the U.S. International Trade Commission in Washington, DC on ____, 20_. The filing of the complaint and motion will not institute an investigation on that date, however, nor will it begin the period for filing responses to the complaint and motion pursuant to 19 CFR 210.13 and 210.59.

Upon receipt of the complaint, the Commission will examine the complaint for sufficiency and compliance with 19 CFR 210.4, 210.5, 210.8, and 210.12. The Commission's Office of Unfair Import

Investigations will conduct informal investigatory activity pursuant to 19 CFR 210.9 to identify sources of relevant information and to assure itself of the availability thereof. The motion for temporary relief will be examined for sufficiency and compliance with 19 CFR 201.8, 210.4, 210.5, 210.52, 210.53(a) (if applicable), 210.54, 210.55, and 210.56, and will be subject to the same type of preliminary investigative activity as the complaint.

The Commission generally will determine whether to institute an investigation on the basis of the complaint and whether to provisionally accept the motion for temporary relief within 35 days after the complaint and motion are filed or, if the motion is filed after the complaint, within 35 days after the motion is filed—unless the 35-day deadline is extended pursuant to 19 CFR 210.53, 210.54, 210.55(b), 210.57, or 210.58. If the Commission determines to institute an investigation and provisionally accept the motion, the motion will be assigned to a Commission administrative law judge for issuance of an initial determination in accordance with 19 CFR 210.66. See 19 CFR 210.10 and 210.58.

If the Commission determines to conduct an investigation of the complaint and motion for temporary relief, the investigation will be formally instituted on the date the Commission publishes a notice of investigation in the FEDERAL REGISTER pursuant to 19 CFR 210.10(b). If an investigation is instituted, copies of the complaint, the notice of investigation, and the Commission's Rules of Practice and Procedure (19 CFR Part 210) will be served on each respondent by the Commission pursuant to 19 CFR 210.11(a). Responses to the complaint, the notice of investigation, and the motion for temporary relief must be filed within 10 days after Commission service thereof, and must comply with 19 CFR 201.8, 210.4, 210.5, 210.13, and 210.59. See also 19 CFR 201.14 and 210.6 regarding computation of the 10-day response period.

If, after reviewing the complaint and motion for temporary relief, the Commission determines not to institute an investigation, the complaint and motion will be dismissed and the Commission will provide written notice of that decision and the reasons therefor to the complainant and all proposed respondents pursuant to 19 CFR 210.10.

For information concerning the filing and processing of the complaint and its treatment, and to ask general questions concerning section 337 practice and procedure, contact the Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Room 401, Washington, DC 20436, telephone 202-205-2560. Such inquiries will be referred to the Commission investigative attorney assigned to the complaint. (See also the Commissions's Rules of Practice and Procedure set forth in 19 CFR Part 210.)

To learn the date that the Commission will vote on whether to institute an investigation and the publication date of the notice of investigation (if the Commission decides to institute an investigation), contact the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., room 112, Washington, DC 20436, telephone 202-205-2000.

This notice is being provided pursuant to 19 CFR 210.56.

(b) In the event that the complaint and motion for temporary relief are filed after the date specified in the above notice, the complainant must serve a supplementary notice to all proposed respondents and embassies stating the correct filing date. The supplementary notice shall be served by messenger, overnight delivery, or equivalent means. The complainant shall file a certificate of service and a copy of the supplementary notice with the Commission.


§ 210.57 Amendment of the motion.

A motion for temporary relief may be amended at any time prior to the institution of an investigation. All material filed to amend the motion (or the complaint) must be served on all proposed respondents and on the embassies in Washington, DC, of the foreign governments that they represent, in accordance with § 210.54. If the amendment expands the scope of the motion or changes the complainant's assertions on the issue of whether a bond is to be required as a

prerequisite to the issuance of temporary relief or the appropriate amount of the bond, the 35-day period under § 210.58 for determining whether to institute an investigation and provisionally accept the motion for temporary relief shall begin to run anew from the date the amendment is filed with the Commission. A motion for temporary relief may not be amended to expand the scope of the temporary relief inquiry after an investigation is instituted.

§ 210.58 Provisional acceptance of the motion.

The Commission shall determine whether to accept a motion for temporary relief at the same time it determines whether to institute an investigation on the basis of the complaint. That determination shall be made within 35 days after the complaint and motion for temporary relief are filed, unless the 35-day period is restarted pursuant to § 210.53(a), § 210.54, § 210.55, or § 210.57, or exceptional circumstances exist which preclude adherence to the prescribed deadline. (See § 210.10(a)(1).) Before the Commission determines whether to provisionally accept a motion for temporary relief, the motion will be examined for sufficiency and compliance with §§ 210.52, 210.53(a) (if applicable), 210.54 through 210.56, as well as §§ 210.4 and 210.5. The motion will be subject to the same type of preliminary investigatory activity as the complaint. (See § 210.9(b).) Acceptance of a motion pursuant to this paragraph constitutes provisional acceptance for referral of the motion to the chief administrative law judge, who will assign the motion to a presiding administrative law judge for issuance of an initial determination under § 210.66(a). Commission rejection of an insufficient or improperly filed complaint will preclude acceptance of a motion for temporary relief. Commission rejection of a motion for temporary relief will not preclude institution of an investigation of the complaint.


§ 210.59 Responses to the motion and the complaint.

(a) Any party may file a response to a motion for temporary relief. Unless otherwise ordered by the administrative law judge, a response to a motion for temporary relief in an ordinary investigation must be filed not later than 10 days after service of the motion by the Commission. In a “more complicated” investigation, the response shall be due within 20 days after such service, unless otherwise ordered by the presiding administrative law judge.

(b) The response must comply with the requirements of §§ 210.4 and 210.5 of this part, and shall contain the following information:

(1) A statement that sets forth with particularity any objection to the motion for temporary relief;

(2) A statement of specific facts concerning the factors the U.S. Court of Appeals for the Federal Circuit would consider in determining whether to affirm lower court decisions granting or denying preliminary injunctions;

(3) A memorandum of points and authorities in support of the respondent's response to the motion;

(4) Affidavits, where possible, executed by persons with knowledge of the facts specified in the response. Each response to the motion must address, to the extent possible, the complainant's assertions regarding whether a bond should be required and the appropriate amount of the bond. Responses to the motion for temporary relief also may contain counter-proposals concerning the amount of the bond or the manner in which the bond amount should be calculated.

(c) Each response to the motion for temporary relief must also be accompanied by a response to the complaint and notice of investigation. Responses to the complaint and notice of investigation must comply with §§ 210.4 and 210.5 of this part, and any protective order issued by the administrative law judge under § 210.34 of this part.


§ 210.60 Designating the temporary relief phase of an investigation more complicated for the purpose of adjudicating a motion for temporary relief.

(a) At the time the Commission determines to institute an investigation and provisionally accepts a motion for temporary relief pursuant to § 210.58, or at any time thereafter, the Commission may designate the temporary relief phase of an investigation “more complicated” pursuant to § 210.60(b) for the purpose of obtaining up to 60 additional days to adjudicate the motion for temporary relief. In the alternative, after the motion for temporary relief is referred to the administrative law judge for an initial determination under § 210.66(a), the administrative law judge may issue an order, sua sponte or on motion, designating the temporary relief phase of the investigation “more complicated” for the purpose of obtaining additional time to adjudicate the motion for temporary relief. Such order shall constitute a final determination of the Commission, and notice of the order shall be published in the FEDERAL REGISTER. As required by section 337(e)(2) of the Tariff Act of 1930, the notice shall state the reasons that the temporary relief phase of the investigation was designated “more complicated.” The “more complicated” designation may be conferred by the Commission or the presiding administrative law judge pursuant to this paragraph on the basis of the complexity of the issues raised in the motion for temporary relief or the responses thereto, or for other good cause shown.

(b) A temporary relief phase is designated more complicated owing to the subject matter, difficulty in obtaining information, the large number of parties involved, or other significant factors.


§ 210.61 Discovery and compulsory process.

The presiding administrative law judge shall set all discovery deadlines. The administrative law judge's authority to compel discovery includes discovery relating to the following issues:

(a) Any matter relevant to the motion for temporary relief and the responses thereto, including the issues of bonding by the complainant; and

(b) The issues the Commission considers pursuant to sections 337 (e)(1), (f)(1), and (j)(3) of the Tariff Act of 1930, viz.,

(1) The appropriate form of relief (notwithstanding the form requested in the motion for temporary relief),

(2) Whether the public interest precludes that form of relief, and

(3) The amount of the bond to be posted by the respondents to secure importations or sales of the subject imported merchandise while the temporary relief order is in effect. The administrative law judge may, but is not required to, make findings on the issues specified in sections 337 (e)(1), (f)(1), or (j)(3) of the Tariff Act of 1930. Evidence and information obtained through discovery on those issues will be used by the parties and considered by the Commission

in the context of the parties' written submissions on remedy, the public interest, and bonding by respondents, which are filed with the Commission pursuant to § 210.67(b).

§ 210.62 Evidentiary hearing.

An opportunity for a hearing in accordance with the Administrative Procedure Act and § 210.36 of this part will be provided in connection with every motion for temporary relief. If a hearing is conducted, the presiding administrative law judge may, but is not required to, take evidence concerning the issues of remedy, the public interest, and bonding by respondents under section 337 (e)(1), (f)(1), and (j)(3) of the Tariff Act of 1930.

§ 210.63 Proposed findings and conclusions and briefs.

The administrative law judge shall determine whether and, if so, to what extent the parties shall be permitted to file proposed findings of fact, proposed conclusions of law, or briefs under § 210.40 concerning the issues involved in adjudication of the motion for temporary relief.

§ 210.64 Interlocutory appeals.

There will be no interlocutory appeals to the Commission under § 210.24 on any matter connected with a motion for temporary relief that is decided by an administrative law judge prior to the issuance of the initial determination on the motion for temporary relief.

§ 210.65 Certification of the record.

When the administrative law judge issues an initial determination concerning temporary relief pursuant to § 210.66(a), he shall also certify to the Commission the record upon which the initial determination is based.

§ 210.66 Initial determination concerning temporary relief; Commission action thereon.

(a) On or before the 70th day after publication of the notice of investigation in an ordinary investigation, or on or before the 120th day after such publication in a “more complicated” investigation, the administrative law judge will issue an initial determination concerning the issues listed in §§ 210.52 and 210.59. If the 70th day or the 120th day is a Saturday, Sunday, or Federal holiday, the initial determination must be received in the Office of the Secretary no later than 12:00 noon on the first business day after the 70-day or 120-day deadline. The initial determination may, but is not required to, address the issues of remedy, the public interest, and bonding by the respondents pursuant under sections 337 (e)(1), (f)(1), and (j)(3) of the Tariff Act of 1930.

(b) If the initial determination on temporary relief is issued on the 70-day or 120-day deadline imposed in paragraph (a) of this section, the initial determination will become the Commission's determination 20 calendar days after issuance thereof in an ordinary case, and 30 calendar days after issuance in a “more complicated” investigation, unless the Commission modifies, reverses, or sets aside the initial determination in whole or part within that period. If the initial determination on temporary relief is issued before the 70-day or 120-day deadline imposed in paragraph (a) of this section, the Commission will add the extra time to the 20-day or 30-day deadline to which it would otherwise have been held. In computing the deadlines imposed by this paragraph, intermediary Saturdays, Sundays, and Federal holidays shall be included. If the last day of the period is a Saturday, Sunday, or Federal holiday as defined in § 201.14(a) of this chapter, the effective date of the initial determination shall be extended to the next business day.

(c) The Commission will not modify, reverse, or set aside an initial determination concerning temporary relief unless the Commission finds that a finding of material fact is clearly erroneous, that the initial determination contains an error of law, or that there is a policy matter warranting discussion by the Commission. All parties may file written comments concerning any clear error of material fact, error of law, or policy matter warranting such action by the Commission. Such comments must be limited to 35 pages in an ordinary investigation and 45 pages in a “more complicated” investigation. The comments must be filed no later than seven calendar days after issuance of the initial determination in an ordinary case and 10 calendar days after issuance of the initial determination in a “more complicated” investigation. In computing the aforesaid 7-day and 10-day deadlines, intermediary Saturdays, Sundays, and Federal holidays shall be included. If the initial determination is issued on a Friday, however, the filing deadline for comments shall be measured from the first business day after issuance. If the last day of the filing period is a Saturday, Sunday, or Federal holiday as defined in § 201.14(a) of this chapter, the filing deadline shall be extended to the next business day. The parties shall serve their comments on other parties by messenger, overnight delivery, or equivalent means.

(d) Notice of the initial determination shall be served on the other agencies listed in § 210.50(a)(2). Those agencies will be given 10 calendar days from the date of service of the notice to file comments on the initial determination.

(e)(1) Each party may file a response to each set of comments filed by another party. All such reply comments must be filed within 10 calendar days after issuance of the initial determination in an ordinary case and within 14 calendar days after issuance of an initial determination in a “more complicated” investigation. The deadlines for filing reply comments shall be computed in the manner described in paragraph (c) of this section, except that in no case shall a party have fewer than two calendar days to file reply comments.

(2) Each set of reply comments will be limited to 20 pages in an ordinary investigation and 30 pages in a “more complicated” case.

(f) If the Commission determines to modify, reverse, or set aside the initial determination, the Commission will issue a notice and, if appropriate, a Commission opinion. If the Commission does not modify, reverse, or set aside the administrative law judge's initial determination within the time provided under paragraph (b) of this section, the initial determination will automatically become the determination of the Commission. Notice of the Commission's determination concerning the initial determination will be issued on the statutory deadline for determining whether to grant temporary relief, or as soon as possible thereafter, and will be served on the parties. Notice of the determination will be published in the FEDERAL REGISTER if the Commission's disposition of the initial determination has resulted in a determination that there is reason to believe that section 337 has been violated and a temporary remedial order is to be issued. If the Commission determines (either by reversing or modifying the administrative law judge's initial determination, or by adopting the initial determination) that the complainant must post a bond as a prerequisite to the issuance of temporary relief, the Commission may issue a supplemental notice setting forth conditions for the bond if any (in addition to those outlined in the initial determination) and the deadline for filing the bond with the Commission.

[59 FR 39039, Aug. 1, 1994, as amended at 60 FR 53121, Oct. 12, 1995; 73 FR 38326, July 7, 2008]

§ 210.67 Remedy, the public interest, and bonding.

The procedure for arriving at the Commission's determination of the issues of the appropriate form of temporary relief, whether the public interest factors enumerated in the statute preclude such relief, and the amount of the bond under which respondents' merchandise will be

permitted to enter the United States during the pendency of any temporary relief order issued by the Commission, is as follows:

(a) While the motion for temporary relief is before the administrative law judge, he may compel discovery on matters relating to remedy, the public interest and bonding (as provided in § 210.61). The administrative law judge also is authorized to make findings pertaining to the public interest, as provided in § 210.66(a). Such findings may be superseded, however, by Commission findings on that issue as provided in paragraph (c) of this section.

(b) On the 65th day after institution in an ordinary case or on the 110th day after institution in a “more complicated” investigation, all parties shall file written submissions with the Commission addressing those issues. The submissions shall refer to information and evidence already on the record, but additional information and evidence germane to the issues of appropriate relief, the statutory public interest factors, and bonding by respondents may be provided along with the parties' submissions. Pursuant to § 210.50(a)(4), interested persons may also file written comments, on the aforesaid dates, concerning the issues of remedy, the public interest, and bonding by the respondents.

(c) On or before the 90-day or 150-day statutory deadline for determining whether to order temporary relief under section 337 (e)(1) and/or (f)(1) of the Tariff Act of 1930, the Commission will determine what relief is appropriate in light of any violation that appears to exist, whether the public interest factors enumerated in the statute preclude the issuance of such relief, and the amount of the bond under which the respondents' merchandise will be permitted to enter the United States during the pendency of any temporary relief order issued by the Commission. In the event that Commission's findings on the public interest pursuant to this paragraph are inconsistent with findings made by the administrative law judge in the initial determination pursuant to § 210.66(a), the Commission's findings are controlling.


§ 210.68 Complainant's temporary relief bond.

(a) In every investigation under this part involving a motion for temporary relief, the question of whether the complainant shall be required to post a bond as a prerequisite to the issuance of such relief shall be addressed by the parties, the presiding administrative law judge, and the Commission in the manner described in §§ 210.52, 210.59, 210.61, 210.62, and 210.66. If the Commission determines that a bond should be required, the bond may consist of one or more of the following:

(1) The surety bond of a surety or guarantee corporation that is licensed to do business with the United States in accordance with 31 U.S.C. 9304-9306 and 31 CFR parts 223 and 224;

(2) The surety bond of an individual, a trust, an estate, or a partnership, or a corporation, whose solvency and financial responsibility will be investigated and verified by the Commission; or

(3) A certified check, a bank draft, a post office money order, cash, a United States bond, a Treasury note, or other Government obligation within the meaning of 31 U.S.C. 9301 and 31 CFR part 225, which is owned by the complainant and tendered in lieu of a surety bond, pursuant to 31 U.S.C. 9303(c) and 31 CFR part 225.

The same restrictions and requirements applicable to individual and corporate sureties on Customs bonds, which are set forth in 19 CFR part 113, shall apply with respect to sureties on bonds filed with the Commission by complainants as a prerequisite to a temporary relief under

section 337 of the Tariff Act of 1930. If the surety is an individual, the individual must file an affidavit of the type shown in appendix A to § 210.68. Unless otherwise ordered by the Commission, while the bond of the individual surety is in effect, an updated affidavit must be filed every four months (computed from the date on which the bond was approved by the Secretary or the Commission).

(b) The bond and accompanying documentation must be submitted to the Commission within the time specified in the Commission notice, order, determination, or opinion requiring the posting of a bond, or within such other time as the Commission may order. If the bond is not submitted within the specified period (and an extension of time has not been granted), temporary relief will not be issued.

(c) The corporate or individual surety on a bond or the person posting a certified check, a bank draft, a post office money order, cash, a United States bond, a Treasury note, or other Government obligation in lieu of a surety bond must provide the following information on the face of the bond or in the instrument authorizing the Government to collect or sell the bond, certified check, bank draft, post office money order, cash, United States bond, Treasury note, or other Government obligation in response to a Commission order requiring forfeiture of the bond pursuant to § 210.70:

(1) The investigation caption and docket number;

(2) The names, addresses, and seals (if appropriate) of the principal, the surety, the obligee, as well as the “attorney in fact” and the registered process agent (if applicable) (see Customs Service regulations in 19 CFR part 113 and Treasury Department regulations in 31 CFR parts 223, 224, and 225);

(3) The terms and conditions of the bond obligation, including the reason the bond is being posted, the amount of the bond, the effective date and duration of the bond (as prescribed by the Commission order, notice, determination, or opinion requiring the complainant to post a bond); and

(4) A section at the bottom of the bond or other instrument for the date and authorized signature of the Secretary to reflect Commission approval of the bond.

(d) Complainants who wish to post a certified check, a bank draft, a post office money order, cash, a United States bond, a Treasury note, or other Government obligation in lieu of a surety bond must notify the Commission in writing immediately upon receipt of the Commission document requiring the posting of a bond, and must contact the Secretary to make arrangements for Commission receipt, handling, management, and deposit of the certified check, bank draft, post office money order, cash, United States bond, Treasury note, or other Government obligation tendered in lieu of a surety bond, in accordance with 31 U.S.C. § 9303, 31 CFR parts 202, 206, and 225 and other governing Treasury regulations and circular(s). If required by the governing Treasury regulations and circular, a certified check, a bank draft, a post office money order, cash, a United States bond, a Treasury note, or other government obligation tendered in lieu of a surety bond may have to be collateralized. See, e.g., 31 CFR 202.6 and the appropriate Treasury Circular.

APPENDIX A TO § 210.68—AFFIDAVIT BY INDIVIDUAL SURETY

United States International Trade Commission Affidavit by Individual Surety 19 CFR 210.68

State of

County

SS:

I, the undersigned, being duly sworn, depose and say that I am a citizen of the United States, and of full age and legally competent; that I am not a partner in any business of the principal on the bond or bonds on which I appear as surety; and that the information herein below furnished is true and complete to the best of my knowledge. This affidavit is made to induce the United States International Trade Commission to accept me as surety on the bond(s) filed or to be filed with the United States International Trade Commission pursuant to 19 CFR 210.68. I agree to notify the Commission of any transfer or change in any of the assets herein enumerated.

1. Name (First, Middle, Last)

2. Home Address

3. Type & Duration of Occupation

4. Name of Employer (If Self-Employed)

5. Business Address

6. Telephone No.

Home Business

7. The following is a true representation of my assets, liabilities, and net worth and does not include any financial interest I have in the assets of the principal on the bond(s) on which I appear as surety.

a. Fair value of solely owned real estate *

b. All mortgages or other encumbrances on the real estate included in Line a

c. Real estate equity (subtract Line b from Line a)

d. Fair value of all solely owned property other than real estate

e. Total of the amounts on Lines c and d

f. All other liabilities owing or incurred not included in Line b

g. Net worth (subtract Line f from Line e)

*Do not include property exempt from execution and sale for any reason. Surety's interest in community property may be included if not so exempt.

8. LOCATION AND DESCRIPTION OF REAL ESTATE OF WHICH I AM SOLE OWNER, THE VALUE OF WHICH IS IN LINE a, ITEM 7 ABOVE 1

Amount of assessed value of above real estate for taxation purposes:

9. DESCRIPTION OF PROPERTY INCLUDED IN LINE d, ITEM 7 ABOVE (List the value of each category of property separately) 2

10. ALL OTHER BONDS ON WHICH I AM SURETY (State character and amount of each bond; if none, so state) 3

11. SIGNATURE

12. BOND AND COMMISSION INVESTIGATION TO WHICH THIS AFFIDAVIT RELATES

SUBSCRIBED AND SWORN TO BEFORE ME AS FOLLOWS:

DATE OATH ADMINISTERED

MONTH DAY YEAR

CITY STATE (Or Other Jurisdiction)

NAME & TITLE OF OFFICIAL

ADMINISTERING OATH SIGNATURE MY COMMISSION EXPIRES

INSTRUCTIONS

1. Here describe the property by giving the number of the lot and square or block, and addition or subdivision, if in a city, and, if in the country, after showing state, county, and township, locate the property by metes and bounds, or by part of section, township, and range, so that it may be identified.

2. Here describe the property by name so that it can be identified—for example “Fifteen shares of the stock of the “National Metropolitan Bank, New York City,” or “Am. T. & T. s. f.5's 60.”

3. Here state what other bonds the affiant has already signed as surety, giving the name and address of the principal, the date, and the amount and character of the bond.

[59 FR 39039, Aug. 1, 1994; 59 FR 64286, Dec. 14, 1994]

§ 210.69 Approval of complainant's temporary relief bond.

(a) In accordance with 31 U.S.C. § 9304(b), all bonds posted by complainants must be approved by the Commission before the temporary relief sought by the complainant will be issued. See also 31 U.S.C. § 9303(a) and 31 CFR 225.1 and 225.20. The Commission's bond approval officer for purposes of those provisions shall be the Secretary.

(b) The bond approval process may entail investigation by the Secretary or the Commission's Office of Investigations to determine the veracity of all factual information set forth in the bond and the accompanying documentation (e.g., powers of attorney), as well as any additional verification required by 31 CFR parts 223, 224, or 225. The Secretary may reject a bond on one or more of the following grounds:

(1) Failure to comply with the instructions in the Commission determination, order, or notice directing the complainant to post a bond;

(2) Failure of the surety or the bond to provide information or supporting documentation required by the Commission, the Secretary, § 210.68 of this part, 31 CFR parts 223 or 224, or other governing statutes, regulations, or Treasury circulars, or because of a limitation prescribed in a governing statute, regulation, or circular;

(3) Failure of an individual surety to execute and file with the bond, an affidavit of the type shown in appendix A to § 210.68, which sets forth information about the surety's assets, liabilities, net worth, real estate and other property of which the initial surety is the sole owner, other bonds

on which the individual surety is a surety (and which must be updated at 4-month intervals while the bond is in effect, measured from the date on which the bond is approved by the Secretary on behalf of the Commission or by the Commission);

(4) Any question about the solvency or financial responsibility of the surety, or any question of fraud, misrepresentation, or perjury which comes to light as a result of the verification inquiry during the bond approval process; and

(5) Any other reason deemed appropriate by the Secretary.

(c) If the complainant believes that the Secretary's rejection of the bond was erroneous as a matter of law, the complainant may appeal the Secretary's rejection of the bond by filing a petition with the Commission in the form of a letter to the Chairman, within 10 days after service of the rejection letter.

(d) After the bond is approved and temporary relief is issued, if any question concerning the continued solvency of the individual or the legality or enforceability of the bond or undertaking develops, the Commission may take the following action(s), sua sponte or on motion;

(1) Revoke the Commission approval of the bond and require complainant to post a new bond; or

(2) Revoke or vacate the temporary remedial order for public interest reasons or changed conditions of law or fact (criteria that are the basis for modification or rescission of final Commission action pursuant to § 210.76(a)(1) and (b)); or

(3) Notify the Treasury Department if the problem involves a corporate surety licensed to do business with the United States under 31 U.S.C. §§ 9303-9306 and 31 CFR parts 223 and 224; or

(4) Refer the matter to the U.S. Department of Justice if there is a suggestion of fraud, perjury, or related conduct.

§ 210.70 Forfeiture or return of complainant's temporary relief bond.

(a)(1) If the Commission determines that one or more of the respondents whose merchandise was covered by the temporary relief order has not violated section 337 of the Tariff Act of 1930 to the extent alleged in the motion for temporary relief and provided for in the temporary relief order, proceedings to determine whether the complainant's bond should be forfeited to one or more respondents in whole or part may be initiated upon the filing of a motion by a respondent within 30 days after filing of the aforesaid Commission determination on violation.

(2) A complainant may file a motion for the return of its bond.

(b) Any nonmoving party may file a response to a motion filed under paragraph (a) of this section within 15 days after filing of the motion, unless otherwise ordered by the administrative law judge.

(c) A motion for forfeiture or return of a complainant's temporary relief bond in whole or part will be adjudicated by the administrative law judge in an initial determination with a 45-day effective date, which shall be subject to review under the provisions of §§ 210.42 through 210.45.

In determining whether to grant the motion, the administrative law judge and the Commission will be guided by practice under Rule 65 of the Federal Rules of Civil Procedure.

[59 FR 67629, Dec. 30, 1994]

Subpart I—Enforcement Procedures and Advisory Opinions § 210.71 Information gathering.

(a) Power to require information. (1) Whenever the Commission issues an exclusion order, the Commission may require any person to report facts available to that person that will help the Commission assist the U.S. Customs Service in determining whether and to what extent there is compliance with the order. Similarly, whenever the Commission issues a cease and desist order or a consent order, it may require any person to report facts available to that person that will aid the Commission in determining whether and to what extent there is compliance with the order or whether and to what extent the conditions that led to the order are changed.

(2) The Commission may also include provisions that exercise any other information-gathering power available to the Commission by law, regardless of whether the order at issue is an exclusion order, a cease and desist order, or a consent order. The Commission may at any time request the cooperation of any person or agency in supplying it with information that will aid the Commission or the U.S. Customs Service in making the determinations described in paragraph (a)(1) of this section.

(b) Form and detail of reports. Reports under paragraph (a) of this section are to be in writing, under oath, and in such detail and in such form as the Commission prescribes.

(c) Power to enforce informational requirements. Terms and conditions of exclusion orders, cease and desist orders, and consent orders for reporting and information gathering shall be enforceable by the Commission by a civil action under 19 U.S.C. 1333, or, at the Commission's discretion, in the same manner as any other provision of the exclusion order, cease and desist order, or consent order is enforced.

(d) Term of reporting requirement. An exclusion order, cease and desist order, or consent order may provide for the frequency of reporting or information gathering and the date on which these activities are to terminate. If no date for termination is provided, reporting and information gathering shall terminate when the exclusion order, cease and desist order, or consent order or any amendment to it expires by its own terms or is terminated.


§ 210.72 Confidentiality of information.

Confidential information (as defined in § 201.6(a) of this chapter) that is provided to the Commission pursuant to exclusion order, cease and desist order, or consent order will be received by the Commission in confidence. Requests for confidential treatment shall comply with § 201.6 of this chapter. The restrictions on disclosure and the procedures for handling such information (which are set out in §§ 210.5 and 210.39) shall apply and, in a proceeding under § 210.75 or § 210.76, the Commission or the presiding administrative law judge may, upon motion or sua sponte, issue or continue appropriate protective orders.

§ 210.73 Review of reports.

(a) Review to insure compliance. The Commission, through the Office of Unfair Import Investigations, will review reports submitted pursuant to any exclusion order, cease and desist order, or consent order and conduct such further investigation as it deems necessary to insure compliance with its orders.

(b) Extension of time. The Director of the Office of Unfair Import Investigations may, for good cause shown, extend the time in which reports required by exclusion orders, cease and desist orders, and consent orders may be filed. An extension of time within which a report may be filed, or the filing of a report that does not evidence full compliance with the order, does not in any circumstances suspend or relieve a respondent from its obligation under the law with respect to compliance with such order.

§ 210.74 Modification of reporting requirements.

(a) Exclusion and cease and desist orders. The Commission may modify reporting requirements of exclusion and cease and desist orders as necessary:

(1) To help the Commission assist the U.S. Customs Service in ascertaining that there has been compliance with an outstanding exclusion order;

(2) To help the Commission ascertain that there has been compliance with a cease and desist order;

(3) To take account of changed circumstances; or

(4) To minimize the burden of reporting or informational access.

An order to modify reporting requirements shall identify the reports involved and state the reason or reasons for modification. No reporting requirement will be suspended during the pendency of such a modification unless the Commission so orders. The Commission may, if the public interest warrants, announce that a modification of reporting is under consideration and ask for comment, but it may also modify any reporting requirement at any time without notice, consistent with the standards of this section.

(b) Consent orders. Consistent with the standards set forth in paragraph (a) of this section, the Commission may modify reporting requirements of consent orders. The Commission shall serve notice of any proposed change, together with the reporting requirements to be modified and the reasons therefor, on each party subject to the consent order. Such parties shall be given the opportunity to submit briefs to the Commission, and the Commission may hold a hearing on the matter. Notice of any proposed change in the reporting requirements will be published in the FEDERAL REGISTER if the Commission determines to solicit public comment on the proposed change.

[59 FR 39039, Aug. 1, 1994, as amended at 60 FR 53121, Oct. 12, 1995]

§ 210.75 Proceedings to enforce exclusion orders, cease and desist orders, consent orders, and other Commission orders.

(a) Informal enforcement proceedings. Informal enforcement proceedings may be conducted by the Commission, through the Office of Unfair Import Investigations, with respect to any act or omission by any person in possible violation of any provision of an exclusion order, cease and desist order, or consent order. Such matters may be handled by the Commission through correspondence or conference or in any other way that the Commission deems

appropriate. The Commission may issue such orders as it deems appropriate to implement and insure compliance with the terms of an exclusion order, cease and desist order, or consent order, or any part thereof. Any matter not disposed of informally may be made the subject of a formal proceeding pursuant to this subpart.

(b) Formal enforcement proceedings. (1) The Commission may institute an enforcement proceeding at the Commission level upon the filing by the complainant in the original investigation or his successor in interest, by the Office of Unfair Import Investigations, or by the Commission of a complaint setting forth alleged violations of any exclusion order, cease and desist order, or consent order. If a proceeding is instituted, the complaint shall be served upon the alleged violator and a notice of institution published in the FEDERAL REGISTER. Within 15 days after the date of service of such a complaint, the named respondent shall file a response to it. Responses shall fully advise the Commission as to the nature of any defense and shall admit or deny each allegation of the complaint specifically and in detail unless the respondent is without knowledge, in which case its answer shall so state and the statement shall operate as a denial. Allegations of fact not denied or controverted may be deemed admitted. Matters alleged as affirmative defenses shall be separately stated and numbered. These proceedings are authorized under section 337(b) as investigations on whether there is a violation of section 337 in the same manner as original investigations, and are conducted in accordance with the laws for original investigations as set forth in section 1337 of title 19 and sections 554, 555, 556, 557, and 702 of title 5 of the United States Code and the rules of this part.

(2) Upon the failure of a respondent to file and serve a response within the time and in the manner prescribed herein the Commission, in its discretion, may find the facts alleged in the complaint to be true and take such action as may be appropriate without notice or hearing, or, in its discretion, proceed without notice to take evidence on the allegations set forth in the complaint, provided that the Commission (or administrative law judge, if one is appointed) may permit late filings of an answer for good cause shown.

(3) The Commission, in the course of a formal enforcement proceeding under this section, may hold a public hearing and afford the parties to the enforcement proceeding the opportunity to appear and be heard. The Commission may delegate the hearing to the chief administrative law judge for designation of a presiding administrative law judge, who shall certify an initial determination to the Commission. A presiding administrative law judge shall certify the record and issue the enforcement initial determination to the Commission no later than three months before the target date for completion of a formal enforcement proceeding. Parties may file petitions for review, and responses thereto, in accordance with § 210.43 of this part. The enforcement initial determination shall become the determination of the Commission 45 days after the date of service of the enforcement initial determination, unless the Commission, within 45 days after the date of such service, shall have ordered review of the enforcement initial determination on certain issues therein, or by order shall have changed the effective date of the enforcement initial determination.

(4) Upon conclusion of a formal enforcement proceeding under this section, the Commission may:

(i) Modify a cease and desist order, consent order, and/or exclusion order in any manner necessary to prevent the unfair practices that were originally the basis for issuing such order;

(ii) Bring civil actions in a United States district court pursuant to paragraph (c) of this section (and section 337(f)(2) of the Tariff Act of 1930) to recover for the United States the civil penalty accruing to the United States under that section for the breach of a cease and desist order or a consent order, and to obtain a mandatory injunction incorporating the relief the Commission deems appropriate for enforcement of the cease and desist order or consent order; or

(iii) Revoke the cease and desist order or consent order and direct that the articles concerned be excluded from entry into the United States.

(5) Prior to effecting any modification, revocation, or exclusion under this section, the Commission shall consider the effect of such action upon the public health and welfare, competitive conditions in the U.S. economy, the production of like or directly competitive articles in the United States, and U.S. consumers.

(6) In lieu of or in addition to taking the action provided for in paragraph (b)(1) of this section, the Commission may issue, pursuant to section 337(i) of the Tariff Act of 1930, an order providing that any article imported in violation of the provisions of section 337 of the Tariff Act of 1930 and an outstanding final exclusion order issued pursuant to section 337(d) of the Tariff Act of 1930 be seized and forfeited to the United States, if the following conditions are satisfied:

(i) The owner, importer, or consignee of the article (or the agent of such person) previously attempted to import the article into the United States;

(ii) The article previously was denied entry into the United States by reason of a final exclusion order; and

(iii) Upon such previous denial of entry, the Secretary of the Treasury provided the owner, importer, or consignee of the article (or the agent of such person) with written notice of the aforesaid exclusion order and the fact that seizure and forfeiture would result from any further attempt to import the article into the United States.

(c) Court enforcement. To obtain judicial enforcement of an exclusion order, a cease and desist order, a consent order, or a sanctions order, the Commission may initiate a civil action in the U.S. district court. In a civil action under section 337(f)(2) of the Tariff Act of 1930, the Commission may seek to recover for the United States the civil penalty accruing to the United States under that section for the breach of a cease and desist order or a consent order, and may ask the court to issue a mandatory injunction incorporating the relief the Commission deems appropriate for enforcement of the cease and desist order or consent order. The Commission may initiate a proceeding to obtain judicial enforcement without any other type of proceeding otherwise available under section 337 or this subpart or without prior notice to any person, except as required by the court in which the civil action is initiated.


§ 210.76 Modification or rescission of exclusion orders, cease and desist orders, and consent orders.

(a) Petitions for modification or rescission of exclusion orders, cease and desist orders, and consent orders. (1) Whenever any person believes that changed conditions of fact or law, or the public interest, require that an exclusion order, cease and desist order, or consent order be modified or set aside, in whole or in part, such person may file with the Commission a petition requesting such relief. The Commission may also on its own initiative consider such action. The petition shall state the changes desired and the changed circumstances warranting such action, shall include materials and argument in support thereof, and shall be served on all parties to the investigation in which the exclusion order, cease and desist order, or consent order was issued. Any person may file an opposition to the petition within 10 days of service of the petition.

(2) If the petitioner previously has been found by the Commission to be in violation of section 337 of the Tariff Act of 1930 and if its petition requests a Commission determination that the petitioner is no longer in violation of that section or requests modification or rescission of an order issued pursuant to section 337 (d), (e), (f), (g), or (i) of the Tariff Act of 1930, the burden of proof in any proceeding initiated in response to the petition pursuant to paragraph (b) of this section shall be on the petitioner. In accordance with section 337(k)(2) of the Tariff Act, relief may be granted by the Commission with respect to such petition on the basis of new evidence or evidence that could not have been presented at the prior proceeding or on grounds that would permit relief from a judgment or order under the Federal Rules of Civil Procedure.

(b) Commission action upon receipt of petition. The Commission may thereafter institute a proceeding to modify or rescind the exclusion order, cease and desist order, or consent order by issuing a notice. The Commission may hold a public hearing and afford interested persons the opportunity to appear and be heard. After consideration of the petition, any responses thereto, and any information placed on the record at a public hearing or otherwise, the Commission shall take such action as it deems appropriate. The Commission may delegate any hearing under this section to the chief administrative law judge for designation of a presiding administrative law judge, who shall certify a recommended determination to the Commission.

(c) Comments. Parties may submit comments on the recommended determination within 10 days from the service of the recommended determination. Parties may submit responses thereto within 5 business days from service of any comments.

[59 FR 39039, Aug. 1, 1994, as amended at 61 FR 43433, Aug. 23, 1996; 78 FR 23486, Apr. 19, 2013]

§ 210.77 Temporary emergency action.

(a) Whenever the Commission determines, pending a formal enforcement proceeding under § 210.75(b), that without immediate action a violation of an exclusion order, cease and desist order, or consent order will occur and that subsequent action by the Commission would not adequately repair substantial harm caused by such violation, the Commission may immediately and without hearing or notice modify or revoke such order and, if it is revoked, replace the order with an appropriate exclusion order.

(b) Prior to taking any action under this section, the Commission shall consider the effect of such action upon the public health and welfare, competitive conditions in the U.S. economy, the production of like or directly competitive articles in the United States, and U.S. consumers. The Commission shall, if it has not already done so, institute a formal enforcement proceeding under § 210.75(b) at the time of taking action under this section or as soon as possible thereafter, in order to give the alleged violator and other interested parties a full opportunity to present information and views regarding the continuation, modification, or revocation of Commission action taken under this section.

§ 210.78 Notice of enforcement action to Government agencies.

(a) Consultation. The Commission may consult with or seek information from any Government agency when taking any action under this subpart.

(b) Notification of Treasury. The Commission shall notify the Secretary of the Treasury of any action under this subpart that results in a permanent or temporary exclusion of articles from entry, or the revocation of an order to such effect, or the issuance of an order compelling seizure and forfeiture of imported articles.

§ 210.79 Advisory opinions.

(a) Advisory opinions. Upon request of any person, the Commission may, upon such investigation as it deems necessary, issue an advisory opinion as to whether any person's proposed course of action or conduct would violate a Commission exclusion order, cease and desist order, or consent order. The Commission will consider whether the issuance of such an advisory opinion would facilitate the enforcement of section 337 of the Tariff Act of 1930, would be in the public interest, and would benefit consumers and competitive conditions in the United States, and whether the person has a compelling business need for the advice and has framed his request as fully and accurately as possible. Advisory opinion proceedings are not subject to sections 554, 555, 556, 557, and 702 of title 5 of the United States Code.

(b) Revocation. The Commission may at any time reconsider any advice given under this section and, where the public interest requires, revoke its prior advice. In such event the person will be given notice of the Commission's intent to revoke as well as an opportunity to submit its views to the Commission. The Commission will not proceed against a person for violation of an exclusion order, cease and desist order, or consent order with respect to any action that was taken in good faith reliance upon the Commission's advice under this section, if all relevant facts were accurately presented to the Commission and such action was promptly discontinued upon notification of revocation of the Commission's advice.


Appendix A to Part 210—Adjudication and Enforcement

Initial determination concerning:

Petitions for review due:

Response to petitions due:

Commission deadline for determining whether to review the initial determination:

1. Violation § 210.42(a)(1) 12 days from service of the initial determination

8 days from service of any petition

60 days from service of the initial determination (on private parties).

2. Summary initial determination that would terminate the investigation if it became the Commission's final determination § 210.42(c)

10 days from service of the initial determination

5 business days from service of any petition


3. Other matters § 210.42(c) 5 business days from service of the initial determination



4. Forfeiture or return of respondents' bond § 210.50(d)(3)




5. Forfeiture or return of complainant's temporary relief bond § 210.70(c)




6. Formal enforcement proceedings § 210.75(b)

10 days from service of the enforcement initial determination

5 business days from service of any

45 days from service of the enforcement initial determination (on private

petition parties).

[78 FR 23486, Apr. 19, 2013]

Appendix B to Part 210-Adjudication and Enforcement

Recommended determination concerning: Comments due:

Response to comments due:

Modification or Rescission § 210.76(a)(1)

10 days from service of the recommended determination

5 business days from service of any comments.

[78 FR 23486, Apr. 19, 2013]

19 U.S.C. United States Code, 2010 EditionTitle 19 - CUSTOMS DUTIESCHAPTER 4 - TARIFF ACT OF 1930SUBTITLE II - SPECIAL PROVISIONSPart II - United States International Trade CommissionSec. 1337 - Unfair practices in import tradeFrom the U.S. Government Printing Office, www.gpo.gov

§1337. Unfair practices in import trade(a) Unlawful activities; covered industries; definitions

(1) Subject to paragraph (2), the following are unlawful, and when found by the Commission to exist shall be dealt with, in addition to any other provision of law, as provided in this section:

(A) Unfair methods of competition and unfair acts in the importation of articles (other than articles provided for in subparagraphs (B), (C), (D), and (E)) into the United States, or in the sale of such articles by the owner, importer, or consignee, the threat or effect of which is—

(i) to destroy or substantially injure an industry in the United States;(ii) to prevent the establishment of such an industry; or(iii) to restrain or monopolize trade and commerce in the United States.

(B) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that—

(i) infringe a valid and enforceable United States patent or a valid and enforceable United States copyright registered under title 17; or

(ii) are made, produced, processed, or mined under, or by means of, a process covered by the claims of a valid and enforceable United States patent.

(C) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that infringe a valid and enforceable United States trademark registered under the Trademark Act of 1946 [15 U.S.C. 1051 et seq.].

(D) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of a semiconductor chip product in a manner that constitutes infringement of a mask work registered under chapter 9 of title 17.

(E) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consigner, of an article that constitutes infringement of the exclusive rights in a design protected under chapter 13 of title 17.

(2) Subparagraphs (B), (C), (D), and (E) of paragraph (1) apply only if an industry in the United States, relating to the articles protected by the patent, copyright, trademark, mask work, or design concerned, exists or is in the process of being established.

(3) For purposes of paragraph (2), an industry in the United States shall be considered to exist if there is in the United States, with respect to the articles protected by the patent, copyright, trademark, mask work, or design concerned—

(A) significant investment in plant and equipment;(B) significant employment of labor or capital; or(C) substantial investment in its exploitation, including engineering, research and development,

or licensing.

Page 1 of 12U.S.C. Title 19 - CUSTOMS DUTIES

1/6/2016https://www.gpo.gov/fdsys/pkg/USCODE-2010-title19/html/USCODE-2010-title19-chap4-...

(4) For the purposes of this section, the phrase “owner, importer, or consignee” includes any agent of the owner, importer, or consignee.(b) Investigation of violations by Commission

(1) The Commission shall investigate any alleged violation of this section on complaint under oath or upon its initiative. Upon commencing any such investigation, the Commission shall publish notice thereof in the Federal Register. The Commission shall conclude any such investigation and make its determination under this section at the earliest practicable time after the date of publication of notice of such investigation. To promote expeditious adjudication, the Commission shall, within 45 days after an investigation is initiated, establish a target date for its final determination.

(2) During the course of each investigation under this section, the Commission shall consult with, and seek advice and information from, the Department of Health and Human Services, the Department of Justice, the Federal Trade Commission, and such other departments and agencies as it considers appropriate.

(3) Whenever, in the course of an investigation under this section, the Commission has reason to believe, based on information before it, that a matter, in whole or in part, may come within the purview of part II of subtitle IV of this chapter, it shall promptly notify the Secretary of Commerce so that such action may be taken as is otherwise authorized by such part II. If the Commission has reason to believe that the matter before it (A) is based solely on alleged acts and effects which are within the purview of section 1671 or 1673 of this title, or (B) relates to an alleged copyright infringement with respect to which action is prohibited by section 1008 of title 17, the Commission shall terminate, or not institute, any investigation into the matter. If the Commission has reason to believe the matter before it is based in part on alleged acts and effects which are within the purview of section 1671 or 1673 of this title, and in part on alleged acts and effects which may, independently from or in conjunction with those within the purview of such section, establish a basis for relief under this section, then it may institute or continue an investigation into the matter. If the Commission notifies the Secretary or the administering authority (as defined in section 1677(1) of this title) with respect to a matter under this paragraph, the Commission may suspend its investigation during the time the matter is before the Secretary or administering authority for final decision. Any final decision by the administering authority under section 1671 or 1673 of this title with respect to the matter within such section 1671 or 1673 of this title of which the Commission has notified the Secretary or administering authority shall be conclusive upon the Commission with respect to the issue of less-than-fair-value sales or subsidization and the matters necessary for such decision.(c) Determinations; review

The Commission shall determine, with respect to each investigation conducted by it under this section, whether or not there is a violation of this section, except that the Commission may, by issuing a consent order or on the basis of an agreement between the private parties to the investigation, including an agreement to present the matter for arbitration, terminate any such investigation, in whole or in part, without making such a determination. Each determination under subsection (d) or (e) of this section shall be made on the record after notice and opportunity for a hearing in conformity with the provisions of subchapter II of chapter 5 of title 5. All legal and equitable defenses may be presented in all cases. A respondent may raise any counterclaim in a manner prescribed by the Commission. Immediately after a counterclaim is received by the Commission, the respondent raising such counterclaim shall file a notice of removal with a United States district court in which venue for any of the counterclaims raised by the party would exist under section 1391 of title 28. Any counterclaim raised pursuant to this section shall relate back to the date of the original complaint in the proceeding before the Commission. Action on such counterclaim shall not delay or affect the proceeding under this section, including the legal and equitable defenses that may be raised under this subsection. Any person adversely affected by a final



determination of the Commission under subsection (d), (e), (f), or (g) of this section may appeal such determination, within 60 days after the determination becomes final, to the United States Court of Appeals for the Federal Circuit for review in accordance with chapter 7 of title 5. Notwithstanding the foregoing provisions of this subsection, Commission determinations under subsections (d), (e), (f), and (g) of this section with respect to its findings on the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, the amount and nature of bond, or the appropriate remedy shall be reviewable in accordance with section 706 of title 5. Determinations by the Commission under subsections (e), (f), and (j) of this section with respect to forfeiture of bonds and under subsection (h) of this section with respect to the imposition of sanctions for abuse of discovery or abuse of process shall also be reviewable in accordance with section 706 of title 5.(d) Exclusion of articles from entry

(1) If the Commission determines, as a result of an investigation under this section, that there is a violation of this section, it shall direct that the articles concerned, imported by any person violating the provision of this section, be excluded from entry into the United States, unless, after considering the effect of such exclusion upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, it finds that such articles should not be excluded from entry. The Commission shall notify the Secretary of the Treasury of its action under this subsection directing such exclusion from entry, and upon receipt of such notice, the Secretary shall, through the proper officers, refuse such entry.

(2) The authority of the Commission to order an exclusion from entry of articles shall be limited to persons determined by the Commission to be violating this section unless the Commission determines that—

(A) a general exclusion from entry of articles is necessary to prevent circumvention of an exclusion order limited to products of named persons; or

(B) there is a pattern of violation of this section and it is difficult to identify the source of infringing products.

(e) Exclusion of articles from entry during investigation except under bond; procedures applicable; preliminary relief(1) If, during the course of an investigation under this section, the Commission determines that

there is reason to believe that there is a violation of this section, it may direct that the articles concerned, imported by any person with respect to whom there is reason to believe that such person is violating this section, be excluded from entry into the United States, unless, after considering the effect of such exclusion upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, it finds that such articles should not be excluded from entry. The Commission shall notify the Secretary of the Treasury of its action under this subsection directing such exclusion from entry, and upon receipt of such notice, the Secretary shall, through the proper officers, refuse such entry, except that such articles shall be entitled to entry under bond prescribed by the Secretary in an amount determined by the Commission to be sufficient to protect the complainant from any injury. If the Commission later determines that the respondent has violated the provisions of this section, the bond may be forfeited to the complainant.

(2) A complainant may petition the Commission for the issuance of an order under this subsection. The Commission shall make a determination with regard to such petition by no later than the 90th day after the date on which the Commission's notice of investigation is published in the Federal Register. The Commission may extend the 90-day period for an additional 60 days in a case it designates as a more complicated case. The Commission shall publish in the Federal Register its reasons why it designated the case as being more complicated. The Commission may require the complainant to post a bond as a prerequisite to the issuance of an order under this subsection. If the



Commission later determines that the respondent has not violated the provisions of this section, the bond may be forfeited to the respondent.

(3) The Commission may grant preliminary relief under this subsection or subsection (f) of this section to the same extent as preliminary injunctions and temporary restraining orders may be granted under the Federal Rules of Civil Procedure.

(4) The Commission shall prescribe the terms and conditions under which bonds may be forfeited under paragraphs (1) and (2).(f) Cease and desist orders; civil penalty for violation of orders

(1) In addition to, or in lieu of, taking action under subsection (d) or (e) of this section, the Commission may issue and cause to be served on any person violating this section, or believed to be violating this section, as the case may be, an order directing such person to cease and desist from engaging in the unfair methods or acts involved, unless after considering the effect of such order upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, it finds that such order should not be issued. The Commission may at any time, upon such notice and in such manner as it deems proper, modify or revoke any such order, and, in the case of a revocation, may take action under subsection (d) or (e) of this section, as the case may be. If a temporary cease and desist order is issued in addition to, or in lieu of, an exclusion order under subsection (e) of this section, the Commission may require the complainant to post a bond, in an amount determined by the Commission to be sufficient to protect the respondent from any injury, as a prerequisite to the issuance of an order under this subsection. If the Commission later determines that the respondent has not violated the provisions of this section, the bond may be forfeited to the respondent. The Commission shall prescribe the terms and conditions under which the bonds may be forfeited under this paragraph.

(2) Any person who violates an order issued by the Commission under paragraph (1) after it has become final shall forfeit and pay to the United States a civil penalty for each day on which an importation of articles, or their sale, occurs in violation of the order of not more than the greater of $100,000 or twice the domestic value of the articles entered or sold on such day in violation of the order. Such penalty shall accrue to the United States and may be recovered for the United States in a civil action brought by the Commission in the Federal District Court for the District of Columbia or for the district in which the violation occurs. In such actions, the United States district courts may issue mandatory injunctions incorporating the relief sought by the Commission as they deem appropriate in the enforcement of such final orders of the Commission.(g) Exclusion from entry or cease and desist order; conditions and procedures applicable

(1) If—(A) a complaint is filed against a person under this section;(B) the complaint and a notice of investigation are served on the person;(C) the person fails to respond to the complaint and notice or otherwise fails to appear to answer

the complaint and notice;(D) the person fails to show good cause why the person should not be found in default; and(E) the complainant seeks relief limited solely to that person;

the Commission shall presume the facts alleged in the complaint to be true and shall, upon request, issue an exclusion from entry or a cease and desist order, or both, limited to that person unless, after considering the effect of such exclusion or order upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, the Commission finds that such exclusion or order should not be issued.

(2) In addition to the authority of the Commission to issue a general exclusion from entry of articles when a respondent appears to contest an investigation concerning a violation of the



provisions of this section, a general exclusion from entry of articles, regardless of the source or importer of the articles, may be issued if—

(A) no person appears to contest an investigation concerning a violation of the provisions of this section,

(B) such a violation is established by substantial, reliable, and probative evidence, and(C) the requirements of subsection (d)(2) of this section are met.

(h) Sanctions for abuse of discovery and abuse of processThe Commission may by rule prescribe sanctions for abuse of discovery and abuse of process to

the extent authorized by Rule 11 and Rule 37 of the Federal Rules of Civil Procedure.(i) Forfeiture

(1) In addition to taking action under subsection (d) of this section, the Commission may issue an order providing that any article imported in violation of the provisions of this section be seized and forfeited to the United States if—

(A) the owner, importer, or consignee of the article previously attempted to import the article into the United States;

(B) the article was previously denied entry into the United States by reason of an order issued under subsection (d) of this section; and

(C) upon such previous denial of entry, the Secretary of the Treasury provided the owner, importer, or consignee of the article written notice of—

(i) such order, and(ii) the seizure and forfeiture that would result from any further attempt to import the article

into the United States.

(2) The Commission shall notify the Secretary of the Treasury of any order issued under this subsection and, upon receipt of such notice, the Secretary of the Treasury shall enforce such order in accordance with the provisions of this section.

(3) Upon the attempted entry of articles subject to an order issued under this subsection, the Secretary of the Treasury shall immediately notify all ports of entry of the attempted importation and shall identify the persons notified under paragraph (1)(C).

(4) The Secretary of the Treasury shall provide—(A) the written notice described in paragraph (1)(C) to the owner, importer, or consignee of any

article that is denied entry into the United States by reason of an order issued under subsection (d) of this section; and

(B) a copy of such written notice to the Commission.(j) Referral to President

(1) If the Commission determines that there is a violation of this section, or that, for purposes of subsection (e) of this section, there is reason to believe that there is such a violation, it shall—

(A) publish such determination in the Federal Register, and(B) transmit to the President a copy of such determination and the action taken under subsection

(d), (e), (f), (g), or (i) of this section, with respect thereto, together with the record upon which such determination is based.

(2) If, before the close of the 60-day period beginning on the day after the day on which he receives a copy of such determination, the President, for policy reasons, disapproves such determination and notifies the Commission of his disapproval, then, effective on the date of such notice, such determination and the action taken under subsection (d), (e), (f), (g), or (i) of this section with respect thereto shall have no force or effect.

(3) Subject to the provisions of paragraph (2), such determination shall, except for purposes of subsection (c) of this section, be effective upon publication thereof in the Federal Register, and the action taken under subsection (d), (e), (f), (g), or (i) of this section, with respect thereto shall be



effective as provided in such subsections, except that articles directed to be excluded from entry under subsection (d) of this section or subject to a cease and desist order under subsection (f) of this section shall, until such determination becomes final, be entitled to entry under bond prescribed by the Secretary in an amount determined by the Commission to be sufficient to protect the complainant from any injury. If the determination becomes final, the bond may be forfeited to the complainant. The Commission shall prescribe the terms and conditions under which bonds may be forfeited under this paragraph.

(4) If the President does not disapprove such determination within such 60-day period, or if he notifies the Commission before the close of such period that he approves such determination, then, for purposes of paragraph (3) and subsection (c) of this section such determination shall become final on the day after the close of such period or the day on which the President notifies the Commission of his approval, as the case may be.(k) Period of effectiveness; termination of violation or modification or rescission of exclusion or

order(1) Except as provided in subsections (f) and (j) of this section, any exclusion from entry or order

under this section shall continue in effect until the Commission finds, and in the case of exclusion from entry notifies the Secretary of the Treasury, that the conditions which led to such exclusion from entry or order no longer exist.

(2) If any person who has previously been found by the Commission to be in violation of this section petitions the Commission for a determination that the petitioner is no longer in violation of this section or for a modification or rescission of an exclusion from entry or order under subsection (d), (e), (f), (g), or (i) of this section—

(A) the burden of proof in any proceeding before the Commission regarding such petition shall be on the petitioner; and

(B) relief may be granted by the Commission with respect to such petition—(i) on the basis of new evidence or evidence that could not have been presented at the prior

proceeding, or(ii) on grounds which would permit relief from a judgment or order under the Federal Rules

of Civil Procedure.(l) Importation by or for United States

Any exclusion from entry or order under subsection (d), (e), (f), (g), or (i) of this section, in cases based on a proceeding involving a patent, copyright, mask work, or design under subsection (a)(1) of this section, shall not apply to any articles imported by and for the use of the United States, or imported for, and to be used for, the United States with the authorization or consent of the Government. Whenever any article would have been excluded from entry or would not have been entered pursuant to the provisions of such subsections but for the operation of this subsection, an owner of the patent, copyright, mask work, or design adversely affected shall be entitled to reasonable and entire compensation in an action before the United States Court of Federal Claims pursuant to the procedures of section 1498 of title 28.(m) “United States” defined

For purposes of this section and sections 1338 and 1340 1 of this title, the term “United States” means the customs territory of the United States as defined in general note 2 of the Harmonized Tariff Schedule of the United States.(n) Disclosure of confidential information

(1) Information submitted to the Commission or exchanged among the parties in connection with proceedings under this section which is properly designated as confidential pursuant to Commission rules may not be disclosed (except under a protective order issued under regulations of the Commission which authorizes limited disclosure of such information) to any person (other than a person described in paragraph (2)) without the consent of the person submitting it.



(2) Notwithstanding the prohibition contained in paragraph (1), information referred to in that paragraph may be disclosed to—

(A) an officer or employee of the Commission who is directly concerned with—(i) carrying out the investigation or related proceeding in connection with which the

information is submitted,(ii) the administration of a bond posted pursuant to subsection (e), (f), or (j) of this section,(iii) the administration or enforcement of an exclusion order issued pursuant to subsection

(d), (e), or (g) of this section, a cease and desist order issued pursuant to subsection (f) of this section, or a consent order issued pursuant to subsection (c) of this section,

(iv) proceedings for the modification or rescission of a temporary or permanent order issued under subsection (d), (e), (f), (g), or (i) of this section, or a consent order issued under this section, or

(v) maintaining the administrative record of the investigation or related proceeding,

(B) an officer or employee of the United States Government who is directly involved in the review under subsection (j) of this section, or

(C) an officer or employee of the United States Customs Service who is directly involved in administering an exclusion from entry under subsection (d), (e), or (g) of this section resulting from the investigation or related proceeding in connection with which the information is submitted.

(June 17, 1930, ch. 497, title III, §337, 46 Stat. 703; Proc. No. 2695, July 4, 1946, 11 F.R. 7517, 60 Stat. 1352; Pub. L. 85–686, §9(c)(1), Aug. 20, 1958, 72 Stat. 679; Pub. L. 93–618, title III, §341(a), Jan. 3, 1975, 88 Stat. 2053; Pub. L. 96–39, title I, §106(b)(1), title XI, §1105, July 26, 1979, 93 Stat. 193, 310; Pub. L. 96–417, title VI, §604, Oct. 10, 1980, 94 Stat. 1744; Pub. L. 97–164, title I, §§160(a)(5), 163(a)(4), Apr. 2, 1982, 96 Stat. 48, 49; Pub. L. 98–620, title IV, §413, Nov. 8, 1984, 98 Stat. 3362; Pub. L. 100–418, title I, §§1214(h)(3), 1342(a), (b), Aug. 23, 1988, 102 Stat. 1157, 1212, 1215; Pub. L. 100–647, title IX, §9001(a)(7), (12), Nov. 10, 1988, 102 Stat. 3807; Pub. L. 102–563, §3(d), Oct. 28, 1992, 106 Stat. 4248; Pub. L. 103–465, title II, §261(d)(1)(B)(ii), title III, §321(a), Dec. 8, 1994, 108 Stat. 4909, 4943; Pub. L. 104–295, §20(b)(11), (12), (c)(2), Oct. 11, 1996, 110 Stat. 3527, 3528; Pub. L. 106–113, div. B, §1000(a)(9) [title V, §5005(b)], Nov. 29, 1999, 113 Stat. 1536, 1501A–594; Pub. L. 108–429, title II, §2004(d)(5), Dec. 3, 2004, 118 Stat. 2592.)

REFERENCES IN TEXTThe Trademark Act of 1946, referred to in subsec. (a)(1)(C), is act July 5, 1946, ch. 540, 60 Stat. 427, as

amended, also popularly known as the Lanham Act, which is classified generally to chapter 22 (§1051 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1051 of Title 15 and Tables.

The Federal Rules of Civil Procedure, referred to in subsecs. (e)(3), (h), and (k)(2)(B)(ii), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

Section 1340 of this title, referred to in subsec. (m), was omitted from the Code.The Harmonized Tariff Schedule of the United States, referred to in subsec. (m), is not set out in the Code.

See Publication of Harmonized Tariff Schedule note set out under section 1202 of this title.

CODIFICATIONThe reference to the Philippine Islands, formerly contained in subsec. (k), was omitted because of

independence of the Philippines proclaimed by the President of the United States in Proc. No. 2695, issued pursuant to section 1394 of Title 22, Foreign Relations and Intercourse, and set out as a note thereunder.

PRIOR PROVISIONSProvisions similar to those in this section were contained in act Sept. 21, 1922, ch. 356, title III, §316, 42

Stat. 943. That section was superseded by section 337 of act June 17, 1930, comprising this section, and repealed by section 651(a)(1) of the 1930 act.

AMENDMENTS



2004—Subsec. (a)(1)(E). Pub. L. 108–429, §2004(d)(5)(A), realigned margins.Subsec. (a)(2). Pub. L. 108–429, §2004(d)(5)(B), substituted “(D), and (E)” for “and (D)”.1999—Subsec. (a)(1)(A). Pub. L. 106–113, §1000(a)(9) [title V, §5005(b)(1)(A)(i)], substituted “(D), and

(E)” for “and (D)”.Subsec. (a)(1)(E). Pub. L. 106–113, §1000(a)(9) [title V, §5005(b)(1)(A)(ii)], added subpar. (E).Subsec. (a)(2), (3). Pub. L. 106–113, §1000(a)(9) [title V, §5005(b)(1)(B)], substituted “mask work, or

design” for “or mask work”.Subsec. (l). Pub. L. 106–113, §1000(a)(9) [title V, §5005(b)(2)], substituted “mask work, or design” for “or

mask work” in two places.1996—Subsec. (b)(3). Pub. L. 104–295, §20(c)(2), amended Pub. L. 103–465, §321(a)(1)(C)(i). See 1994

Amendment note below.Pub. L. 104–295, §20(b)(12), struck out “such section and” before “such part II” in first sentence.Pub. L. 104–295, §20(b)(11), amended Pub. L. 103–465, §261(d)(1)(B)(ii)(I). See 1994 Amendment note

below.1994—Subsec. (b). Pub. L. 103–465, §321(a)(1)(A), struck out “; time limits” after “Commission” in

heading.Subsec. (b)(1). Pub. L. 103–465, §321(a)(1)(B), substituted third and fourth sentences for “The

Commission shall conclude any such investigation, and make its determination under this section, at the earliest practicable time, but not later than one year (18 months in more complicated cases) after the date of publication of notice of such investigation. The Commission shall publish in the Federal Register its reasons for designating any investigation as a more complicated investigation. For purposes of the one-year and 18-month periods prescribed by this subsection, there shall be excluded any period of time during which such investigation is suspended because of proceedings in a court or agency of the United States involving similar questions concerning the subject matter of such investigation.”

Subsec. (b)(3). Pub. L. 103–465, §321(a)(1)(C)(ii), struck out after fourth sentence “For purposes of computing the 1-year or 18-month periods prescribed by this subsection, there shall be excluded such period of suspension.”

Pub. L. 103–465, §321(a)(1)(C)(i), as amended by Pub. L. 104–295, §20(c)(2), in first sentence, made technical amendment to reference in original act which appears in text as reference to “such part II”.

Pub. L. 103–465, §261(d)(1)(B)(ii)(II)–(V), in second sentence, struck out “1303,” after “purview of section” and comma after “1671” and made technical amendment to references to sections 1671 and 1673 of this title to correct references to corresponding sections of original act, in third sentence, substituted “1671” for “1303, 1671,”, and in last sentence, struck out “of the Secretary under section 1303 of this title or” after “Any final decision” and substituted “1671 or” for “1303, 1671, or”.

Pub. L. 103–465, §261(d)(1)(B)(ii)(I), as amended by Pub. L. 104–295, §20(b)(11), in first sentence, struck out reference to section 1303 of this title after “within the purview” and made technical amendment to reference to part II of subtitle IV of this chapter by substituting in the original “of subtitle B of title VII of this Act” for “of section 303 or of subtitle B of title VII of the Tariff Act of 1930”.

Subsec. (c). Pub. L. 103–465, §321(a)(2), in first sentence, substituted “an agreement between the private parties to the investigation, including an agreement to present the matter for arbitration” for “a settlement agreement”, inserted after third sentence “A respondent may raise any counterclaim in a manner prescribed by the Commission. Immediately after a counterclaim is received by the Commission, the respondent raising such counterclaim shall file a notice of removal with a United States district court in which venue for any of the counterclaims raised by the party would exist under section 1391 of title 28. Any counterclaim raised pursuant to this section shall relate back to the date of the original complaint in the proceeding before the Commission. Action on such counterclaim shall not delay or affect the proceeding under this section, including the legal and equitable defenses that may be raised under this subsection.”, and inserted at end “Determinations by the Commission under subsections (e), (f), and (j) of this section with respect to forfeiture of bonds and under subsection (h) of this section with respect to the imposition of sanctions for abuse of discovery or abuse of process shall also be reviewable in accordance with section 706 of title 5.”

Subsec. (d). Pub. L. 103–465, §321(a)(5)(A), designated existing provisions as par. (1), substituted “there is a violation” for “there is violation” in first sentence, and added par. (2).

Subsec. (e)(1). Pub. L. 103–465, §321(a)(3)(A), in last sentence, substituted “prescribed by the Secretary in an amount determined by the Commission to be sufficient to protect the complainant from any injury. If the Commission later determines that the respondent has violated the provisions of this section, the bond may be forfeited to the complainant.” for “determined by the Commission and prescribed by the Secretary.”



Subsec. (e)(2). Pub. L. 103–465, §321(a)(3)(B), inserted at end “If the Commission later determines that the respondent has not violated the provisions of this section, the bond may be forfeited to the respondent.”

Subsec. (e)(4). Pub. L. 103–465, §321(a)(3)(C), added par. (4).Subsec. (f)(1). Pub. L. 103–465, §321(a)(4), inserted at end “If a temporary cease and desist order is issued

in addition to, or in lieu of, an exclusion order under subsection (e) of this section, the Commission may require the complainant to post a bond, in an amount determined by the Commission to be sufficient to protect the respondent from any injury, as a prerequisite to the issuance of an order under this subsection. If the Commission later determines that the respondent has not violated the provisions of this section, the bond may be forfeited to the respondent. The Commission shall prescribe the terms and conditions under which the bonds may be forfeited under this paragraph.”

Subsec. (g)(2)(C). Pub. L. 103–465, §321(a)(5)(B), added subpar. (C).Subsec. (j)(3). Pub. L. 103–465, §321(a)(6), substituted “shall, until such determination becomes final, be

entitled to entry under bond prescribed by the Secretary in an amount determined by the Commission to be sufficient to protect the complainant from any injury. If the determination becomes final, the bond may be forfeited to the complainant. The Commission shall prescribe the terms and conditions under which bonds may be forfeited under this paragraph.” for “shall be entitled to entry under bond determined by the Commission and prescribed by the Secretary until such determination becomes final.”

Subsec. (l). Pub. L. 103–465, §321(a)(8), substituted “Court of Federal Claims” for “Claims Court”.Subsec. (n)(2)(A). Pub. L. 103–465, §321(a)(7)(A), amended subpar. (A) generally. Prior to amendment,

subpar. (A) read as follows: “an officer or employee of the Commission who is directly concerned with carrying out the investigation in connection with which the information is submitted,”.

Subsec. (n)(2)(C). Pub. L. 103–465, §321(a)(7)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “an officer or employee of the United States Customs Service who is directly involved in administering an exclusion from entry under this section resulting from the investigation in connection with which the information is submitted.”

1992—Subsec. (b)(3). Pub. L. 102–563 amended second sentence generally. Prior to amendment, second sentence read as follows: “If the Commission has reason to believe the matter before it is based solely on alleged acts and effects which are within the purview of section 1303, 1671, or 1673 of this title, it shall terminate, or not institute, any investigation into the matter.”

1988—Subsec. (a). Pub. L. 100–418, §1342(a)(1), amended subsec. (a) generally. Prior to amendment, subsec. (a) read as follows: “Unfair methods of competition and unfair acts in the importation of articles into the United States, or in their sale by the owner, importer, consignee, or agent of either, the effect or tendency of which is to destroy or substantially injure an industry, efficiently and economically operated, in the United States, or to prevent the establishment of such an industry, or to restrain or monopolize trade and commerce in the United States, are declared unlawful, and when found by the Commission to exist shall be dealt with, in addition to any other provisions of law, as provided in this section.”

Subsec. (b)(2). Pub. L. 100–418, §1342(b)(1)(A), substituted “Department of Health and Human Services” for “Department of Health, Education, and Welfare”.

Subsec. (b)(3). Pub. L. 100–418, §1342(b)(1)(B), substituted “Secretary of Commerce” for “Secretary of the Treasury”.

Subsec. (c). Pub. L. 100–418, §1342(a)(2), inserted before period at end of first sentence “, except that the Commission may, by issuing a consent order or on the basis of a settlement agreement, terminate any such investigation, in whole or in part, without making such a determination”.

Pub. L. 100–418, §1342(b)(2), inserted reference to subsec. (g) in two places.Subsec. (e). Pub. L. 100–418, §1342(a)(3), designated existing provisions as par. (1) and added pars. (2)

and (3).Subsec. (f)(1). Pub. L. 100–418, §1342(a)(4)(A), substituted “In addition to, or in lieu of,” for “In lieu of”.Subsec. (f)(2). Pub. L. 100–418, §1342(a)(4)(B), substituted “$100,000 or twice” for “$10,000 or”.Subsecs. (g) to (i). Pub. L. 100–418, §1342(a)(5), added subsecs. (g) to (i). Former subsecs. (g) to (i)

redesignated (j) to (l), respectively.Subsec. (j). Pub. L. 100–418, §1342(a)(5)(A), redesignated former subsec. (g) as (j). Former subsec. (j)

redesignated (m).Subsec. (j)(1)(B), (2), (3). Pub. L. 100–418, §1342(b)(3), inserted reference to subsecs. (g) and (i).Subsec. (k). Pub. L. 100–418, §1342(b)(4), which directed the substitution “(j)” for “(g)” was executed by

making that substitution in par. (1) and not in par. (2), as added by Pub. L. 100–418, §1342(a)(6), to reflect the probable intent of Congress.



Pub. L. 100–418, §1342(a)(6), as amended by Pub. L. 100–647, §9001(a)(7), designated existing provisions as par. (1) and added par. (2).

Pub. L. 100–418, §1342(a)(5)(A), redesignated former subsec. (h) as (k).Subsec. (l). Pub. L. 100–418, §1342(b)(5), inserted reference to subsecs. (g) and (i).Pub. L. 100–418, §1342(a)(7), substituted “a proceeding involving a patent, copyright, or mask work under

subsection (a)(1)” for “claims of United States letters patent” and “an owner of the patent, copyright, or mask work” for “a patent owner”.

Pub. L. 100–418, §1342(a)(5)(A), redesignated former subsec. (i) as (l).Subsec. (m). Pub. L. 100–418, §1342(a)(5)(A), redesignated former subsec. (j) as (m).Pub. L. 100–418, §1214(h)(3), substituted “general note 2 of the Harmonized Tariff Schedule of the United

States” for “general headnote 2 of the Tariff Schedules of the United States”.Subsec. (n). Pub. L. 100–418, §1342(a)(8), added subsec. (n).Subsec. (n)(2)(B). Pub. L. 100–647, §9001(a)(12), substituted “subsection (j)” for “subsection (h)”.1984—Subsec. (c). Pub. L. 98–620 inserted “, within 60 days after the determination becomes final,” after

“appeal such determination”.1982—Subsec. (c). Pub. L. 97–164, §163(a)(4), substituted “Court of Appeals for the Federal Circuit” for

“Court of Customs and Patent Appeals”.Subsec. (i). Pub. L. 97–164, §160(a)(5), substituted “United States Claims Court” for “Court of Claims”.1980—Subsec. (c). Pub. L. 96–417 provided that the appeal of determinations to the United States Court of

Customs and Patent Appeals be reviewed in accordance with chapter 7 of title 5 and substituted provision that review of findings concerning the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, the amount and nature of bond, or the appropriate remedy, be in accordance with section 706 of title 5 for provision giving such court jurisdiction to review determinations in same manner and subject to same limitations and conditions as in case of appeals from decisions of the United States Customs Court.

1979—Subsec. (b)(3). Pub. L. 96–39, §1105(a), substituted “a matter, in whole or in part,” for “the matter” and inserted provisions relating to matters based solely or in part on alleged acts and effects within the purview of section 1303, 1671, or 1673 of this title.

Pub. L. 96–39, §106(b)(1), substituted “part II of subtitle IV of this chapter” for “the Antidumping Act, 1921”.

Subsec. (c). Pub. L. 96–39, §1105(c), substituted “Any person adversely affected by a final determination of the Commission under subsection (d), (e), or (f) of this section” for “Any person adversely affected by a final determination of the Commission under subsection (d) or (e) of this section”.

Subsec. (f). Pub. L. 96–39, §1105(b), designated existing provisions as par. (1) and added par. (2).1975—Subsec. (a) Pub. L. 93–618 substituted “Commission” for “President” and “as provided in this

section” for “as hereinafter provided”.Subsec. (b). Pub. L. 93–618 designated existing provisions as first sentence of par. (1), substituted “The

Commission shall investigate any alleged violation of this section” for “To assist the President in making any decisions under this section the commission is authorized to investigate any alleged violation hereof” in first sentence of par. (1) as so designated, and added remainder of par. (1) and pars. (2) and (3).

Subsec. (c). Pub. L. 93–618 substituted provisions covering determinations by the Commission and appeals to the United States Court of Customs and Patent Appeals for provisions covering all aspects of hearings and review as part of investigations of unfair practices in import trade.

Subsec. (d). Pub. L. 93–618 substituted provisions covering the exclusion of articles from entry, formerly covered in subsec. (e), for provisions directing that final findings of the Commission be transmitted with the record to the President, covered by subsec. (g).

Subsec. (e). Pub. L. 93–618 substituted provisions covering the entry of articles under bond during investigation, formerly covered in subsec. (f), for provisions covering the exclusion of articles from entry, covered by subsec. (d).

Subsec. (f). Pub. L. 93–618 added subsec. (f). Provisions of former subsec. (f) covering entry of articles under bond are covered by subsec. (e).

Subsec. (g). Pub. L. 93–618 substituted provisions covering referral to the President, formerly covered by subsec. (d), for provisions covering the continuance of exclusion, covered by subsec. (h).

Subsec. (h). Pub. L. 93–618 substituted provisions covering the period of effectiveness, formerly covered by subsec. (g), for provisions defining “United States”, covered by subsec. (j).

Subsec. (i). Pub. L. 93–618 added subsec. (i).



Subsec. (j). Pub. L. 93–618 added subsec. (j) defining “United States”, formerly covered by subsec. (h).1958—Subsec. (c). Pub. L. 85–686 struck out “under and in accordance with such rules as it may

promulgate” after “commission shall make such investigation”. See section 1335 of this title.

EFFECTIVE DATE OF 1994 AMENDMENTAmendment by section 261(d)(1)(B)(ii) of Pub. L. 103–465 effective on effective date of title II of Pub. L.

103–465, Jan. 1, 1995, see section 261(d)(2) of Pub. L. 103–465, set out as a note under section 1315 of this title.

Section 322 of title III of Pub. L. 103–465 provided that: “The amendments made by this subtitle [subtitle C (§§321, 322) of title III of Pub. L. 103–465, enacting sections 1368 and 1659 of Title 28, Judiciary and Judicial Procedure, and amending this section and section 1446 of Title 28] apply—

“(1) with respect to complaints filed under section 337 of the Tariff Act of 1930 [19 U.S.C. 1337] on or after the date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], or

“(2) in cases under such section 337 in which no complaint is filed, with respect to investigations initiated under such section on or after such date.”

EFFECTIVE DATE OF 1988 AMENDMENTSAmendment by Pub. L. 100–647 applicable as if such amendment took effect on Aug. 23, 1988, see section

9001(b) of Pub. L. 100–647, set out as an Effective and Termination Dates of 1988 Amendments note under section 58c of this title.

Amendment by section 1214(h)(3) of Pub. L. 100–418 effective Jan. 1, 1989, and applicable with respect to articles entered on or after such date, see section 1217(b)(1) of Pub. L. 100–418, set out as an Effective Date note under section 3001 of this title.

Section 1342(d) of Pub. L. 100–418 provided that:“(1)(A) Subject to subparagraph (B), the amendments made by this section [amending this section and

repealing section 1337a of this title] shall take effect on the date of the enactment of this Act [Aug. 23, 1988].“(B) The United States International Trade Commission is not required to apply the provision in section

337(e)(2) of the Tariff Act of 1930 [19 U.S.C. 1337(e)(2)] (as amended by subsection (a)(3) of this section) relating to the posting of bonds until the earlier of—

“(i) the 90th day after such date of enactment; or“(ii) the day on which the Commission issues interim regulations setting forth the procedures relating

to such posting.“(2) Notwithstanding any provision of section 337 of the Tariff Act of 1930, the United States International

Trade Commission may extend, by not more than 90 days, the period within which the Commission is required to make a determination in an investigation conducted under such section 337 if—

“(A) the Commission would, but for this paragraph, be required to make such determination before the 180th day after the date of enactment of this Act; and

“(B) the Commission finds that the investigation is complicated.”

EFFECTIVE DATE OF 1982 AMENDMENTAmendment by Pub. L. 97–164 effective Oct. 1, 1982, see section 402 of Pub. L. 97–164, set out as a note

under section 171 of Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1980 AMENDMENTAmendment by Pub. L. 96–417 applicable with respect to civil actions commenced on or after Nov. 1,

1980, see section 701(b)(2) of Pub. L. 96–417, set out as a note under section 251 of Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1979 AMENDMENTAmendment by section 106(b)(1) of Pub. L. 96–39 effective Jan. 1, 1980, see section 107 of Pub. L. 96–39,

set out as an Effective Date note under section 1671 of this title.Amendment by section 1105 of Pub. L. 96–39 effective July 26, 1979, see section 1114 of Pub. L. 96–39,

set out as an Effective Date note under section 2581 of this title.

EFFECTIVE DATE OF 1975 AMENDMENT



Section 341(c) of Pub. L. 93–618 provided that: “The amendments made by this section [amending this section and section 1337 of this title] shall take effect on the 90th day after the date of the enactment of this Act [Jan. 3, 1975], except that, for purposes of issuing regulations under section 337 of the Tariff Act of 1930 [this section], such amendments shall take effect on the date of the enactment of this Act [Jan. 3, 1975]. For purposes of applying section 337(b) of the Tariff Act of 1930 [subsec. (b) of this section] (as amended by subsection (a) [as amended by section 341(a) of Pub. L. 93–618]) with respect to investigations being conducted by the International Trade Commission under section 337 of the Tariff Act [this section] on the day prior to the 90th day after the date of the enactment of this Act [Jan. 3, 1975], such investigations shall be considered as having been commenced on such 90th day.”

TRANSFER OF FUNCTIONSFor transfer of functions, personnel, assets, and liabilities of the United States Customs Service of the

Department of the Treasury, including functions of the Secretary of the Treasury relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections 203(1), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

CONGRESSIONAL FINDINGS AND PURPOSES RESPECTING PART 3 OF PUB. L. 100–418Section 1341 of Pub. L. 100–418 provided that:“(a) FINDINGS.—The Congress finds that—

“(1) United States persons that rely on protection of intellectual property rights are among the most advanced and competitive in the world; and

“(2) the existing protection under section 337 of the Tariff Act of 1930 [this section] against unfair trade practices is cumbersome and costly and has not provided United States owners of intellectual property rights with adequate protection against foreign companies violating such rights.“(b) PURPOSE.—The purpose of this part [part 3 (§§1341, 1342) of subtitle C of title I of Pub. L. 100–418,

amending this section, repealing section 1337a of this title, and enacting provisions set out as a note above] is to amend section 337 of the Tariff Act of 1930 to make it a more effective remedy for the protection of United States intellectual property rights.”

ASSIGNMENT OF CERTAIN FUNCTIONSMemorandum of President of the United States, July 21, 2005, 70 F.R. 43251, provided:Memorandum for the United States Trade RepresentativeBy the authority vested in me by the Constitution and the laws of the United States of America, including

section 301 of title 3, United States Code, I hereby assign to you the functions of the President under section 337(j)(1)(B), section 337(j)(2), and section 337(j)(4) of the Tariff Act of 1930, as amended (19 U.S.C. 1337(j)(1), (j)(2), and (j)(4)).

You are authorized and directed to publish this memorandum in the Federal Register.GEORGE W. BUSH.

1 See References in Text note below.

