Patent Infringement After Duncan Parking

TechnologiesDoctrine of Equivalents, Too-Narrow Claim Construction, and Prosecution Impact

on Litigation Outcomes

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5

35 U.S.C. §271

• (a) Except as otherwise provided in this title, whoever without authority

makes, uses, offers to sell, or sells any patented invention, within the

United States, or imports into the United States any patented invention

during the term of the patent therefor, infringes the patent.

• (b) Whoever actively induces infringement of a patent shall be liable as

an infringer.

• (c) Whoever offers to sell or sells within the United States or imports into

the United States a component of a patented machine, manufacture,

combination, or composition, or a material or apparatus for use in

practicing a patented process, constituting a material part of the

invention, knowing the same to be especially made or especially adapted

for use in an infringement of such patent, and not a staple article or

commodity of commerce suitable for substantial noninfringing use, shall

be liable as a contributory infringer.

Direct infringement

Induced infringement

Contributory

infringement

6

Infringement

• Direct infringement generally requires a single actor to practice

every element of a patent claim.― When more than one actor practices every element, direct

infringement is still possible if all steps are attributable to one person.

• Indirect infringement requires a showing of underlying direct

infringement.

― Induced infringement – one actor induces another to practice

the claimed invention.

― Contributory infringement – one actor contributes a material

part of the claimed invention to be used by another.

• Divided infringement: Combined actions of multiple parties (as

compared to a single party satisfying all elements of the claim).

7

Divided Infringement

• Divided infringement: claimed steps performed by multiple actors.

― A form of infringement in which elements of a claim are collectively

performed or used by multiple actors, but all performance or use is

attributable to a single actor.

• Divided infringement is a form of direct infringement under 35

U.S.C. § 271(a), which unlike indirect infringement under § 271(b)

or (c), does not require proof of knowledge or intent.

8

• Limelight Networks, Inc. v. Akamai Technologies, Inc., 134 S.Ct. 2111 (U.S., June 2,

2014)

― Issue: Did the Federal Circuit err in holding that a defendant may be

held liable for inducing patent infringement under 35 U.S.C. §271(b)

even though no one person has committed direct infringement under

§271(a)

― Supreme Court unanimously reversed.

― [I]nducement liability may arise ‘if, but only if, [there is] ... direct

infringement.’”

― Direct infringement requires one actor to perform all the claimed steps.

― Limelight cannot be liable for inducing infringement because no single

actor performed all of the claimed steps—no direct infringement.

Akamai: Setting the Stage for

Expanded Direct Infringement Liability

9

• Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020

(Fed. Cir. 2015)(en banc)

• On remand to Federal Circuit― “Where more than one actor is involved in practicing the steps, a court must

determine whether the acts of one are attributable to the other such that a

single entity is responsible for the infringement.”

― “We will hold an entity responsible for others' performance of method steps in

two sets of circumstances:

― (1) where that entity directs or controls others' performance, and

― (2) where the actors form a joint enterprise.”

• Federal Circuit reversed district court’s grant of JMOL of non-

infringement.

Akamai: Setting the Stage for

Expanded Direct Infringement Liability

10

• Joint enterprise requires proof four elements:― (1) an agreement, express or implied, among members of the group;

― (2) a common purpose to be carried out by the group;

― (3) a community of pecuniary interest in that purpose, among the

members; and

― (4) an equal right to a voice in the direction of the enterprise, which

gives an equal right of control.

• Direction and control is satisfied when the single actor ― (1) “conditions participate in an activity or receipt of a benefit upon

performance of a step,” and

― (2) “establishes the manner or timing of that performance.”

Akamai: Setting the Stage for

Expanded Direct Infringement Liability

11

Travel Sentry, Inc. v. Tropp,

877 F.3d 1370 (Fed. Cir. 2017)

• Travel Sentry and its licensees

sought summary judgment of no

direct infringement of Tropp’s

patents.

• Patents directed to methods of

improving airline luggage

inspection through the use of

dual-access locks.

― Travel Sentry sells a special lock for a

customer’s luggage that can be opened by

TSA using a master lock provided by

Travel Sentry pursuant to a MOU.

12

Travel Sentry

• Representative Claim: A method of improving airline luggage inspection by a luggage

screening entity, comprising:

[a] making available to consumers a special lock [designed for luggage] having a

combination lock portion and a master key lock portion, [and] an identification structure

…,

[b] marketing the special lock to the consumers in a manner that conveys to the

consumers that the special lock will be subjected by the luggage screening entity to the

special procedure,

[c] the identification structure signaling to a luggage screener … that the luggage

screening entity has agreed to subject the special lock … to the special procedure and that

the luggage screening entity has a master key that opens the special lock, and

[d] the luggage screening entity acting pursuant to a prior agreement to look for [and]

upon finding said identification structure …, to use the master key … to, if necessary, open

the … luggage.

13

Travel Sentry

• The actors:

[a] Travel Sentry makes the special lock available to consumers,

[b] Travel Sentry markets the special lock to the consumers,

[c] the luggage screener is signaled by the identification structure that

there is a special screening procedure and master key, and

[d] the luggage screener acts pursuant to a prior agreement to look for

the identification structure and to use the master key to open the luggage,

if necessary.

14

Travel Sentry

• District Court: Summary judgment of no direct infringement of method claims.

• Travel Sentry did not control or influence or “mastermind” TSA’s performance of last two steps.

― TSA was under no obligation to use the master keys at all,

― MOU absolves TSA of liability for damaged locks,

― No consequences to TSA for failure to comply with the screening process,

― Either party can terminate unilaterally.

• Absent direct infringement, there can be no indirect infringement.

15

Travel Sentry

• Federal Circuit: Vacate and remand.

― Genuine disputes of material fact remain regarding whether Travel

Sentry directs or controls the performance of certain steps of the

claimed methods.

― Noted that where divided infringement exists, the court must

determine whether the acts of one are attributable to the other

such that a single entity is responsible for the infringement.

― Applied the 2-prong Akamai framework for directing or controlling

another:

1) Did one actor condition participation in activity or receipt of a

benefit upon another’s performance of a claimed step?

2) Did one actor establish the manner or timing of performance?

16

Travel Sentry

• Federal Circuit:

• “[A] reasonable jury could conclude that TSA's performance of the final

two claim steps is attributable to Travel Sentry such that Travel Sentry is

liable for direct infringement under § 271(a).”

• Common thread in conditions-participation/receipt-of-benefit cases:

“evidence that a third party hoping to obtain access to certain benefits

can only do so if it performs certain steps identified by the defendant,

and does so under the terms prescribed by the defendant.”

17

Travel Sentry

• Federal Circuit acknowledged that, in Akamai, it

‘broaden[ed] the circumstances in which others'

acts may be attributed to an accused infringer to

support direct-infringement liability for divided

infringement, relaxing the tighter constraints on

such attribution reflected in our earlier precedents

and in the three previous rulings for Limelight on

direct infringement.’”

18

Travel SentryAkamai test

elementWhat it is What it is not

activity

Screening luggage under the Travel Sentry system:• Identifying the special locks• Opening special locks with a passkey

Screening luggage as per Congressional mandate

benefit

• More efficient screening of luggage with the special locks

• Ability to open locks with master key• Not having to break open locks• Fewer customer complaints• Improvement in employee health• Better PR

Screening luggage as per Congressional mandate

conditionsObtain the benefit by performing the claimed steps

Legal or contractual obligation

Establish manner/timing of performance

• Instruct the TSA how to perform the steps• Provide the TSA with the tools they need to

perform the steps• Control whether they can or cannot perform

the claimed steps

Mastermind

19

Implications of Travel Sentry

• Conditions an activity upon the performance of a claimed step.― Defined by the terms of agreement between the parties.

― Defined with reference to the patent. ― “These two [claimed] steps define the relevant activity in this case.”

• Conditions receipt of a benefit upon the performance of a

claimed step.― Expansive view of what constitutes a benefit.

― Intangible benefits qualify.

― Benefits may be recited in the patent specification.

• Conditions an activity or receipt of a benefit upon performance

of a claimed step.― If you perform the claimed steps, you get the benefit.

20

Implications of Travel Sentry

• Establish the manner/timing of another’s performance of

the claimed steps.

• Instructions;

• No obligation required;

• Control.

21

Inducement:

Basic Requirements

• To prove induced infringement, the patent owner must show that:

(i) there is direct infringement;

(ii) the accused infringer induced the infringement; and

(iii) the accused infringer knew or should have known that its actions would induce actual infringement.

• The required knowledge/scienter can be satisfied by either (i) actual knowledge of a patent or (ii) willful blindness to the existence of a patent.

• Requires knowledge that the induced acts constitute patent infringement and intent to cause that infringement

22

22

Contributory Infringement:

Basic Requirements

• To prove contributory infringement, the patent owner must show that:

(i) there is direct infringement;

(ii) the accused infringer provides a component of a patented invention, or a material or apparatus for use in practicing a patented process which constitutes a material part of the invention;

(iii) the accused infringer knows the component is especially made or adapted for use for infringing the patent;

(iv) the component is not a staple article or commodity of commerce suitable for substantial noninfringing use; and

(iii) the accused infringer knew that its actions would cause infringement.

• Does not require intent to cause that infringement

23

23

The Role Of A Reasonable Belief

As A Defense

Commil USA, LLC v. Cisco Systems, Inc., 135 S.Ct.

1920 (U.S. May 26, 2015)

• A reasonable belief of non-infringement is a defense to claims

of inducement, but a good faith belief that a patent is invalid is

not a defense to a charge of induced or contributory

infringement.

24

• “Accordingly, we now hold that induced infringement

under §271(b) requires knowledge that the induced acts

constitute patent infringement.” Global-Tech Appl., Inc. v.

SEB S.A., 563 U.S. 754 (U.S. May 31, 2011).

• Patentee must show accused infringer knew of the patent.

• Patentee must show accused infringer intended its actions to

cause direct infringement.

Proving Induced

Infringement

25

• Global-Tech Appliances v. SEB S.A., 563 U.S. 754 (2011)

• Willful blindness can substitute for actual knowledge.

― “Given the long history of willful blindness and its wide acceptance in

the Federal Judiciary, we can see no reason why the doctrine should

not apply in civil lawsuits for induced patent infringement….”

• Two basic requirements: (1) the defendant must subjectively believe that there

is a high probability that a fact exists and (2) the defendant must take deliberate

actions to avoid learning of that fact.

Willful Blindness

26

Intent In

Hatch-Waxman Act Cases

• Knowledge of the patent. • Easily shown by the patents listed in the Orange Book and

the generic manufacturer’s paragraph IV certification.

• Knowledge that accused infringer intended its actions to cause direct infringement.

• May be established by the instructions and information in a drug label.

27

Carve-outs In Hatch-Waxman Cases

• The “Skinny viii” Option

― An ANDA filer can omit, or “carve out,” a patented indication

from its labeling to avoid having to file a paragraph IV

certification on the patent(s) that cover that indication.

― 21 U.S.C. § 355(j)(2)(A)(viii) allows ANDA applicant to

submit, in lieu of a paragraph IV certification, a certification

that an Orange Book listed patent does not claim an

indication for which the ANDA applicant seeks FDA approval.

• Does the labeling still encourage, recommend, or promote

the allegedly carved-out use?

28

Matching Label To Claim

• Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017)

• Claim 1. A method of administering pemetrexed disodium to a patient in need thereof comprising

― administering an effective amount of folic acid and an effective amount of

[vitamin B12]

― followed by administering an effective amount of pemetrexed disodium ….

29

Steps

PhysicianAdministers B12 & pemetrexed

PatientSelf-administers folic acid

TevaSupplies the pemetrexed

30

DIRECT INFRINGEMENT

REQUIRED

• District Court: Claims valid and infringed.― No single actor performs all steps of the asserted claims --

actions of both physicians and patients are required.

― But all steps of the asserted claims are attributable to

physicians, so court found direct infringement attributable to

physicians.

• Federal Circuit: Affirmed.― “Where, as here, no single actor performs all steps of a

method claim, direct infringement only occurs if ‘the acts of

one are attributable to the other such that a single entity is

responsible for the infringement.” Akamai V, 797 F.3d at

1022. The performance of method steps is attributable to a

single entity in two types of circumstances: when that entity

‘directs or controls’ others’ performance, or when the

actors ‘form a joint enterprise.’”

31

Must Also Show Specific Intent For Induced

Infringement

• District Court: Induced infringement.– “Defendants induce physicians’ infringement because physicians act ‘‘in

accordance with Defendants’ proposed labeling.’’

• FC: Affirmed. – “[T]he intent for inducement must be with respect to the actions of the underlying

direct infringer, here physicians.”

– “When the alleged inducement relies on a drug label’s instructions, ‘[t]he question

is not just whether [those] instructions describ[e] the infringing mode, … but

whether the instructions teach an infringing use such that we are willing to infer

from those instructions an affirmative intent to infringe the patent.’ … ‘The label

must encourage, recommend, or promote infringement.’”

– In this case, “[t]he instructions are unambiguous on their face and encourage or

recommend infringement.”

32

Lessons Learned From

Eli Lilly

• Inducement and divided infringement can live together happily

ever after.

• Accused infringer can instruct direct infringer to infringe, who in turn

directs another actor to carry out some of the infringing steps.

• Accused infringer intends to cause direct infringer to perform acts

that are known to infringe.

• Attribution of all method steps to the direct infringer.

33

Lessons Learned From

Eli Lilly

• In Hatch-Waxman cases relying on the ANDA filer’s proposed

labeling to show inducement, the issue of specific intent often

turns on whether the proposed labeling instructs users to

perform the patented method.

• The labeling must encourage, recommend, or promote

infringement.

― Even where the labeling does not explicitly recite the claim

limitations, instructions that inevitably lead some users to practice

the claimed method is sufficient evidence of specific intent.

34

Induced Infringement

● Sanofi v. Watson, 875 F.3d 636 (Fed. Cir. 2017)

● An example of why patent holders should pursue claim language that

mirrors an FDA drug label, particularly regarding clinical trials, provide

that clinical trial information in a patent application, set forth that

clinical trial information in the label, and reference that clinical trial

information in the Indications and Usage Section of the label.

● Multaq® is the brand name version of dronedarone, an antiarrhythmic

agent directed towards the treatment of heart rhythm problems in

patients with atrial fibrillation.

● However, dronedarone also has the risk of doubling mortality rates in

patients who have severe heart failure (NYHA Class IV or Class III with a

recent hospitalization for heart failure).

35

● Initial ‘167 Application Claim 1 (Filed Apr. 16, 2009):

● No reference of clinical trials.

● No indication of any contraindicated symptoms.

● No definition of severe heart failure dangers.

● No description of patient cardiovascular risk factors.

● Such information appeared in issued claims of the ‘167 patent, as seen on the next

page, and that information was found in the specification of the ‘167 patent.

Sanofi v. Watson (con’t)

36

● Final Version of Claim 1 in ’167 Patent: A method of decreasing a risk of

cardiovascular hospitalization in a patient, said method comprising

administering to said patient an effective amount of dronedarone or a

pharmaceutically acceptable salt thereof, twice a day with a morning and

an evening meal, wherein said patient does not have severe heart

failure, (i) wherein severe heart failure is indicated by: a) NYHA Class IV

heart failure or b) hospitalization for heart failure within the last month;

and (ii) wherein said patient has a history of, or current, paroxysmal or

persistent non-permanent atrial fibrillation or flutter; and (iii) wherein the

patient has at least one cardiovascular risk factor selected from the group

consisting of:I. an age greater than or equal to 75;

II. hypertension;

III. diabetes;

IV. a history of cerebral stroke or of systemic embolism;

V. a left atrial diameter greater than or equal to 50mm; and

VI. a left ventricular ejection fraction less than 40%.

Sanofi v. Watson (con’t)

37

Sanofi v. Watson (con’t)

Original Approved Label (07/01/2009):

Currently Approved Label (03/31/2014):

38

Sanofi v. Watson (con’t)Section 14

14 CLINICAL STUDIES

14.1 ATHENA

14.2 EURIDIS and ADONIS

14.3 ANDROMEDA

14.4 PALLAS

● “The reference to the Clinical Studies section (14) of the label

expressly directs the reader to that section for elaboration of the

class of patients for whom the drug is indicated to achieve the

stated objective, i.e. reduced hospitalization.” Sanofi v. Watson

Labs. Inc., 875 F.3d 636, 645 (Fed. Cir. 2017)○ “Section 14 leads with and features a subsection on the ATHENA study, which sets forth the

positive results, relating to reduced hospitalization, for patients having the risk factors

written into the '167 patent. And it is only the ATHENA subsection—not any of the three

other brief subsections—that identifies a class of patients as having been shown to achieve

reduced hospitalization from use of dronedarone...The label thus directs medical providers

to information identifying the desired benefit for only patients with the patent-claimed

risk factors.” Id.

39

Sanofi v. Watson (con’t)

● DC: Patents valid and labels induced infringement.

● FC: Affirmed.

● “The label thus directs medical providers to information identifying the desired benefit for only patients with the patent-claimed risk factors.”

● “There was considerable testimony that this label encourages— and would be known by Watson and Sandoz to encourage—administration of the drug to those patients, thereby causing infringement.” The label demonstrate specific intent to encourage physicians to infringe.

● “The content of the label in this case permits the inference of specific intent to encourage the infringing use.”

● Can’t avoid infringement by pointing out that there are substantial non-infringing uses.

40

Sanofi: Why Did It Matter?

Can You Say 10 More Years?

41

Takeaways From Sanofi

● The “see Clinical Studies” language, included in the FDA drug label, was an

extremely important factor that helped Sanofi prove induced infringement in both

cases.

● Safety/Efficacy of drug led to specific patient population with patent-claimed risk

factors. ○ Consider drafting claims based on a specification reporting results of clinical trials that match those set

forth in the label.

○ Avoid waiting too long to file application such that the clinical trial results become prior art against the

claims (the results of the ATHENA trials post-dated the critical prior art date).

● Method-of-treatment claims that appear to be very narrow can sound the death knell

for generic manufacturers where the claim limitations closely correspond with

generic label language, relying in the Indications and Usage section of the label on

critical clinical trial results that find their way into the patent specification.

● But see Indications and Usage section of “Labeling for Human Prescription Drugs and

Biologicals Products – Content and Format, Draft Guidance for Industry, FDA July

2018, For Comment Purposes Only”

42

• U.S. Patent 8,586,610

• A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of: determining whether the patient is a CYP2D6 poor metabolizer by: obtaining or having obtained a biological sample from the patient; and performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day, wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/ day.

VANDA PHARM., INC. v. WEST-WARD PHARM. INT’L LTD.,

887 F. 3d 1117 (Fed. Cir. 2018), pet. for cert. filed on §101 issue

43

Label

44

Induced Infringement

• DC: West-Ward’s proposed products induce infringement.

• Federal Circuit: Affirmed.

• “the proposed label ‘recommends’ that physicians perform the claimed steps, …and its analysis of the proposed label to assess potential direct infringement by physicians was proper under our precedent.”

• “Even if not every practitioner will prescribe an infringing dose, that the target dose range ‘instructs users to perform the patented method’ is sufficient to ‘provide evidence of [West-Ward’s] affirmative intent to induce infringement.’”

• “even if the proposed ANDA product has ‘substantial noninfringing uses,’ West-Ward may still be held liable for induced infringement. ‘‘Section 271(b), on inducement, does not contain the ‘substantial noninfringing use’ restriction of section 271(c), on contributory infringement.”

45

Injunctive Relief

46

Granted injunction

Pursuant to § 271(e)(4)

Strategic Considerations:

Label Language

• Consider drafting labeling to align with patent claim limitations.• What can you include?• Will an alleged infringer be able to carve it out?• Are there sections of the labeling that will support a claim of infringement

for all claimed indications?• Can you include instructions to help with attribution of all claimed method

steps?

• Carefully draft use codes to comply with FDA standards.• Marshal support from the entire labeling—not just the indications and

usage section—to support the use code.• If the use code is challenged, keep infringement in mind when you

characterize the scope of the patent.

47

No Infringement If Activity Within §271(e)

(“safe harbor”)

• (e)(1) It shall not be an act of infringement to

make, use, offer to sell, or sell within the United

States or import into the United States a

patented invention … solely for uses reasonably

related to the development and submission of

information under a Federal law which

regulates the manufacture, use, or sale of drugs

or veterinary biological products.

48

§271(f)

• (f)(1) Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

• (2) Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

49

§271(f)

• Life Tech v. Promega, 137 S.Ct. 734 (U.S. Feb. 22, 2017)

― Patented kit includes five components, including a polymerase enzyme.

― Life Tech manufactured the polymerase enzyme in the U.S., shipped it to the UK,

assembled kit, and sold worldwide.

― Federal Circuit, 773 F.3d 1338 (2014): Infringement, the polymerase enzyme was

“a substantial component.”

― USSC: Reversed.

― Liability under § 271(f)(1) requires more than one component part of a

multicomponent patented invention to be shipped abroad for assembly, no matter

how important or critical that one component may be.”

― “substantial” is best understood in a purely quantitative sense.

― “substantial” must be more than one; a single component can never trigger

liability under § 271 (f)(1).

50

271(f) Post-Promega

• Claim 1. Element A including ingredients a, b and c; and element B including

ingredients m and n.

― Does the patented invention include 2 components (A+B)? or 5

(A+a+b+c+B+m+n)? or 4 (A+m+n or a+b+c+B)?

― Under Promega’s quantitative approach, § 271(f)(1) liability would

differ.

― What if Claim 1 further includes Element C which forms an aggregate

with element A for an added function - should element A together

with element C be considered the single component?

• Claim 2. Element E including a, b, c and d.

― Is this a single component? Or is any combination of a, b, c and d a

single component?

51

271(f) and Damages

• WesternGeco, LLC v. ION Geophysical Corp., 138 S.Ct. 2129 (U.S., June 22, 2018)

• FC: vacated award of lost foreign profits to WesternGeco.

• USSC: Reversed, 7-2. ― presumption against extraterritoriality did not apply because the “conduct

relevant to the statutory focus was domestic.”

― The infringement at issue, ION’s exportation of components from the U.S. for assembly abroad, occurred within the U.S., and “the lost-profits damages that were awarded to WesternGeco were a domestic application of § 284.”

― The patentee proved the acts of domestic infringement caused the foreign lost profits.

52

35 U.S.C. §271(g)

• [w]hoever without authority imports into the United States or offers to sell, sells or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. . . . A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—

1. it is materially changed by subsequent processes; or2. it becomes a trivial and nonessential component of another

product.

53

Patent Claim Drafting Considerations

• Consider where infringement will occur to avoid extra-

territoriality.

• Try to draft claims that will be directly and literally infringed in

the U.S. by competitors.

• Try to draft claims that will be directly and literally infringed in

the U.S. by one actor.

• Avoid divided infringement issue.

• A method step performed outside the U.S. may mean no direct

infringement.

54

Example

• A method comprising reacting A with B to form C

and then reacting C with D to form E.

• What if A with B to form C is performed outside of

the U.S.?

• Does 35 USC §271(g) apply?

55

Consider

• A method for reacting D with C to form E, with

production of C being enabled in the specification.

• A method for reacting A with B to form C, with

subsequent production of E being enabled in the

specification.

• A method of forming E or C, with appropriate

enablement in the specification.

56

• Uniloc’s ’216 patent is directed to a

software registration system to deter

“casual copying” of software.

• Uniloc’s system allows full use of the

software (in “use mode”) only if the

software installation is legitimate;

otherwise, the software runs in a

demonstration mode.

Uniloc v. Microsoft,

632 F.3d 1292 (Fed. Cir. 2010)

Example Of Claim Drafted

To Avoid Extraterritoriality

57

• Claim 19:• A remote registration station incorporating remote licensee unique ID generating means,

• said station forming part of a registration system for licensing execution of digital data in a use mode, said digital data executable on a platform, said system including local licensee unique ID generating means, said system further including mode switching means operable on said platform which permits use of said digital data in said use mode on said platform only if a licensee unique ID generated by said local licensee unique ID generating means has matched a licensee unique ID generated by said remote licensee unique ID generating means; and wherein said remote licensee unique ID generating means comprises software executed on a platform which includes the algorithm utilized by said local licensee unique ID generating means to produce said licensee unique ID.

Example Of Claim Drafted

To Avoid ExtraterritorialityAccused

registration station located

in U.S.

No joint infringement defense for claim 19.

Uniloc drafted claim to capture infringement by a single party - focuses exclusively on the ‘remote registration station,’ and defines the environment in which that registration station must function.

58

Doctrine Of Equivalents

Literal scope of claimEquivalents given

to patentee

59

Graver Tank & Mfg. Co. v. Linde Air Products

Co., 339 U.S. 605 (1950)

• Claim: a welding flux containing essentially a combination of alkaline earth

metal silicate and calcium fluoride.

• Accused product substituted silicates of manganese, not an alkaline earth

metal, for silicates of magnesium, an alkaline earth metal used in the

patentee's product.

• USSC: infringement can be found when the accused product “performs

substantially the same function in substantially the same way to obtain the

same result.”

• The accused flux containing manganese silicates infringed under the

doctrine of equivalents; the manganese silicates performed substantially

the same function as the magnesium silicates in substantially the same

way to obtain substantially the same result.

60

Warner-Jenkinson Co. v. Hilton-Davis Chem. Co.,

520 U.S. 17 (1997)

• Claim limitation: “at a pH from approximately 6.0 to 9.0”

• Upper limitation included to avoid prior art.

• Parties disagreed why lower limitation added.

• Accused process had pH of 5.0.

• Jury and CAFC found infringement under DOE.

• USSC: Reversed and remanded.

• “The determination of equivalence should be applied as an objective inquiry on an

element-by-element basis. Prosecution history estoppel continues to be available as a

defense to infringement, but if the patent holder demonstrates that an amendment

required during prosecution had a purpose unrelated to patentability, a court must consider

that purpose in order to decide whether an estoppel is precluded. Where the patent holder

is unable to establish such a purpose, a court should presume that the purpose behind the

required amendment is such that prosecution history estoppel would apply.”

61

•DC: No DOE infringement.

• FC: Affirmed – SMC’s aluminum sleeve was a foreseeable equivalent, so PHEapplies.

•“foreseeability does not require the applicant to be aware that a particular equivalent would satisfy the insubstantial differences test or the function/way/result test with respect to the claim as amended.”

•“foreseeability [is tied] to whether the applicant would have been expected to know of, and thus properly claim, the proposed equivalent at the time of amendment.”

•“an alternative is foreseeable if it is disclosed in the pertinent prior art in the field of the invention. In other words, an alternative is foreseeable if it is known in the field of the invention as reflected in the claim scope before amendment”

Festo v. SMC, 493 F.3d 1368

(Fed. Cir. 2007)

62

USSC: Criteria For Showing

No Surrender Under Festo

“unforeseeable at the time

of the amendment

and thus beyond a

fair interpretation of

what was surrendered.”

“the rationale

underlying the

narrowing

amendment [bore]

no more than a

tangential relation

to the equivalent

in question.”

“some other reason suggesting that

the patentee could not reasonably be

expected to have described the

insubstantial substitute in question.”

63

Operation Of W-J and Festo PHE PresumptionsDid the amendment

narrow the literal

scope of the claim?

NO NO PHE

YES

For a substantial reason

relating to patentability? NO NO PHE

Rebuttal evidence

restricted to

prosecution history

NO REASON SHOWN

Warner-Jenkinson presumption

that reason related to patentability

YES

Scope of subject

matter

surrendered?

1

2

3

64

Operation Of W-J and Festo PHE

Presumptions

Scope of subject

matter surrendered?3Festo presumption that

patentee surrendered

all territory between

original claim limitation

and amended claim

limitation

NOT REBUTTED

PHE bars patentee

from relying on

DOE for accused

element

REBUTTED

No PHE and

equivalency

of accused

element reached

on merits

Show no

surrender of

particular

equivalent

according to

criteria

65

Limitations On DOE

• Prosecution history estoppel

• Prior Art

• Narrow Claiming

• All-Limitations Rule

• Unclaimed but disclosed is dedicated to public

• Insubstantial Difference Test

• Narrowing Statements in the Specification and Prosecution History

66

Acts Giving Rise To

Prosecution History Estoppel

• Remarks made after allowance.

― Hormone Research Found. v. Genentech, Inc., 904 F.2d at 1564 n.9 (Fed.Cir. 1990)

• Multiple arguments to overcome prior art may or may not create separateestoppels.

• Representations to foreign patent offices.

― Tanabe Seiyaku Co., Ltd. v. USITC, 109 F.3d 726 (Fed. Cir. 1997)

― Caterpillar Tractor Co. v. Berco, S.p.A., 714 F.2d 1110 (Fed. Cir. 1983)

• Failure to continue prosecution.

― Merck & Co. v. Mylan Pharmaceuticals, Inc., 190 F.3d 1335 (Fed. Cir. 1999)(by limiting claims to single species without pursuing broader polymerclaims, patentee surrendered other subject matter disclosed)

67

Acts Giving Rise To PHE

• Criticizing the prior art in the specification.

• Retractable Technologies, Inc. v. Becton, Dickinson and Co., 653 F.3d 1296 (Fed. Cir. 2011)

― RTI argued DOE infringement by BD’s 3 mL syringes.

― FC: RTI precluded from asserting DOE infringement because the specifications expressly criticized prior art syringes similar to BD’s:

• “It is well settled that “when a specification excludes certain prior art alternatives from the literal scope of the claims and criticizes those prior art alternatives, the patentee cannot then use the doctrine of equivalents to capture those alternatives.” [citation omitted].

68

“About” Makes Equivalents

Within Literal Scope Of Claim

• Cohesive Technologies, Inc. v. Waters Corp., 543 F.3d 1351

(Fed. Cir. 2008)• DC: Granted SJ of no infringement under the doctrine of equivalents.

• FC: Affirmed, but for different reason.

― “about 30 μm” encompasses particle diameters that perform the same

function, in the same way, with the same result as the 30 μm particles, as

long as those diameters are within the range left open by the specific

disclosures of the specification. Thus, by electing to include the broadening

word “about” in the claim, the patentee has in this case already captured

what would otherwise be equivalents within the literal scope of the claim.

― “Where, as here, a patentee has brought what would otherwise be

equivalents of a limitation into the literal scope of the claim, the doctrine of

equivalents is unavailable to further broaden the scope of the claim.”

69

Estoppel Applies To

• Claims in same patent.

• Claims in related patent(s).― Southwall Technologies, Inc. v. Cardinal IG Co., 54 F.3d 1570 (Fed.

Cir. 1995)

― Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973 (Fed. Cir. 1999)

― Biovail Corp. Int'l v. Andrx Pharms., Inc., 239 F.3d 1297 (Fed. Cir.

2001)

― Abbott Laboratories v. Dey, L.P., 287 F.3d 1097 (Fed. Cir. 2002)

― Merck & Co. Inc. v. Teva Pharmaceuticals USA Inc., 347 F.3d 1367

(Fed. Cir. 2003)

• On same claims prosecuted by different counsel?― Yes: Nikken USA, Inc. v. Robinsons-May, Inc., 2002 WL 31664765, 65

U.S.P.Q.2d 1611 (Fed. Cir. November 20, 2002) (unpublished)70

Ensnarement

• Subject matter that is in the prior art or

that would have been unpatentable over

the prior art cannot infringe under the

doctrine of equivalents.

―Wilson Sporting Goods Co. v. David

Geoffrey & Assoc., 904 F.2d 677 (Fed.

Cir. 1990) (disapproved on other grounds by Cardinal

Chemical Co. v. Morton Intern., Inc., 113 S.Ct. 1967 (U.S., May 17,

1993)

71

Hypothetical Claim Analysis

• Claim 1. A golf ball having a spherical surface with a plurality of dimples formed therein and six great circle paths which do not intersect any di[m]ples, the dimples being arranged by dividing the spherical surface into twenty spherical triangles corresponding to the faces of a regular icosahedron, …

• “The accused balls …have dimples which are arranged in an icosahedral pattern having six great circles, but the six great circles are not dimple-free as the claims literally require.”

• “it may be helpful to conceptualize the limitation on the scope of equivalents by visualizing a hypothetical patent claim, sufficient in scope to literally cover the accused product. The pertinent question then becomes whether that hypothetical claim could have been allowed by the PTO over the prior art. If not, then it would be improper to permit the patentee to obtain that coverage in an infringement suit under the doctrine of equivalents. If the hypothetical claim could have been allowed, then prior art is not a bar to infringement under the doctrine of equivalents.”

• “to allow the patent to reach Dunlop's balls under the doctrine of equivalents would improperly ensnare the prior art[.]”

72

Ensnarement

• Janssen Biotech Inc. v. Celltrion Healthcare Co. Ltd., 17-cv-

11008 (D. Mass. July 30, 2018)― Janssen product Remicade (infliximab).

― Celltrion biosimilar products Inflectra and Remsima.

― Janssen sued for infringement under the doctrine of equivalents for the

process of making the biosimilar products.

― The accused media contain all 52 ingredients required by claim 1, but

several are present in concentrations outside the claimed ranges.

― Celltrion moved for summary judgment of noninfringement because

Janssen’s asserted scope of equivalents would ensnare the prior art.

― DC: granted Celltrion’s motion for summary judgment of noninfringement.

― Janssen’s proposed hypothetical claims would have been obvious

(“ensnared by the prior art”).

73

Ensnarement

• “[T]here can be no infringement if the asserted scope of equivalency of what is literally claimed would encompass the prior art.” Wilson Sporting Goods Co. v. David Geoffrey & Assocs., 904 F.2d 677, 683 (Fed. Cir. 1990).

• Burden is on patent owner to show that theory of infringement does not ensnare the prior art.

• “prove that if … the expanded hypothetical claims [were submitted] to the PTO [when the issued claims were filed], the PTO would have found the claims … patentable[.]”

• Framework for decision is hypothetical claim analysis:

1) “the patentee must ‘construct a hypothetical claim that literally covers the accused device,’ which involves expanding the claim limitations to encompass the features of the accused product”; and

2) “prior art introduced by the accused infringer is assessed to determine whether the patentee has carried its burden of persuading the court that the hypothetical claim is

patentable over the prior art.”

74

Ensnarement

• Janssen (con’t)― The hypothetical claims included all ingredients listed in claim 1 with the

claimed concentration ranges extended to match the concentrations used in

the Celltrion media.

― DC: “it is most appropriate to analyze the obviousness of the hypothetical

media under the principles applicable to combinations of known elements[.]”

― GSK reference “combined 50 of 52 ingredients required by the hypothetical claims,

and for those 50 shared ingredients, the concentration ranges disclosed in GSK

partially overlap with the concentration ranges in the hypothetical claims.”

― Life Techs reference “combined 47 of 52 ingredients required by the hypothetical

claims, and for those 47 shared ingredients, 46 have partially overlapping

concentration ranges.”

― “As the Supreme Court explained in KSR, ‘[t]he proper question’ is not ‘whether a

[POSA] writing on a blank slate’ would necessarily have chosen GSK and Life Techs

over another medium for further development, but whether he or she ‘would have

seen a benefit’ to modifying the teachings of GSK or Life Techs to achieve the

claimed compositions.”75

Ensnarement• Janssen (con’t)

― “partially overlapping concentration ranges establish a p.f. case of

obviousness.”

― “a POSA would have had a motivation, based on these problems known in the

field and the teachings of other references, to produce variations of GSK and

Life Techs that supplied the same active ingredients in different salt forms and

concentrations.”

― “With respect to the ingredients required by the hypothetical claims that are

not disclosed in the GSK and Life Techs media, it is undisputed that the GSK

and Life Techs media contain alternative, previously-known ingredients that

were known to provide the same active components as the claimed

ingredients[.]”

― Objective evidence of copying did not outweigh strong case of obviousness.

76

• DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567

F.3d 1314 (Fed. Cir. 2009)

• Jury: Infringement under the doctrine of equivalents.

• Medtronic: asserted scope of equivalency would “ensnare” the

prior art.

― Prior art would have rendered obvious a “hypothetical” version of

claim 1 in which alleged equivalent “conically-shaped” is

substituted for the actual claim term “spherically-shaped.”

• DC: Denied Medtronic’s ensnarement defense.

• FC: Affirmed.

― Hypothetical claim did not ensnare prior art.

― Prior art actually taught away from a rigid pedicle screw encompassed by

the hypothetical claim.

Ensnarement

77

All-Limitations Rule

• Each and every element of the claimed invention must be met

literally or by an equivalent for there to be infringement.

• All-Limitations Rule not vitiated just because two elements of

the accused device perform single function.

• “one-to-one correspondence of components is not required.”

78

All-Limitations Rule

• Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (Fed. Cir. 2006)― Claim term: “at least the luminal portion of the tunica mucosa”

― DC: infringement.

― Broad enough to include compositions that contained tissues other than submucosa.

― FC: Reversed.

― Accused product contains tissue layers expressly excluded by the claim terms as the

patentees have defined them.

― “A claim that specifically excludes an element cannot through a theory of

equivalence be used to capture a composition that contains that expressly excluded

element without violating the ‘all limitations rule.’ Permitting appellees to assert

such a theory of equivalence would effectively remove the requirement that the

urinary bladder submucosa be delaminated from ‘the luminal portion of the tunica

mucosa.’”

79

Vitiate Claim Limitation

• Akzo Nobel Coatings, Inc. v. Dow Chemical Co., 811 F.3d 1334 (Fed. Cir. 2016)

― Claim: 1. A process for producing a dispersion of a polymer in an

aqueous medium …in an extruder having an outlet …maintaining the

pressure above atmospheric for the extruder at the outlet with a

pressurized collection vessel and… wherein the aqueous dispersion

enters the outlet and pressurized collection vessel at a pressure

above atmospheric ….

― Dow's process: dispersion exits the extruder, passes through a valve

located at the extruder's outlet, and then continuously travels

through a series of pipes and heat exchangers.

― Dow’s process infringe under the doctrine of equivalents?

80

Vitiate Claim Limitation

• Akzo (con’t)

―DC: Granted summary judgment of no infringement. •Construed “pressurized collection vessel” to require accumulation within the vessel. •The lack of accumulation in Dow’s process “precluded a finding of infringement under the doctrine of equivalents.”

•“would vitiate the claim limitation that the ‘pressurized collection vessel’ be a ‘container where the desired material accumulates.’ ”

―FC: Affirmed.•“saying that a claim element would be vitiated is akin to saying that there is no equivalent to the claim element in the accused device …”•“Akzo failed to … show that a valve and a series of pipes and heat exchangers, wherein the dispersion flows continuously, generate backpressure in the extruder in substantially the same way to increase the boiling point of the carrier fluid. It did not do so.”

81

DOE Infringement

• Intendis GmbH v. Glenmark Pharms., Inc., USA, 822 F.3d 1355 (Fed. Cir. 2016)

― ANDA litigation over Finacea® Gel.

― Claim 1. A composition that comprises:

― (i) azelaic acid as a therapeutically active ingredient in a concentration

of 5 to 20% by weight,

― (iii) at least one triacylglyceride in a concentration of 0.5 to 5% by

weight,

― (iv) propylene glycol, and― (v) at least one polysorbate, in an aqueous phase that further comprises water

and salts, and the composition further comprises

― (ii) at least one polyacrylic acid, and

― (vi) lecithin,

― wherein the composition is in the form of a hydrogel.

― DC: DOE infringement, judgment in favor of Intendis.

― FC: Affirmed.

82

DOE Infringement

• Intendis (con’t)

― Proposed generic product substituted isopropyl myristate

for the claimed triglyceride and lecithin.

― FC: “To be clear, we are not presented with the issue of

the substantiality of the differences between the

chemical structures of isopropyl myristate, triglyceride,

and lecithin. This appeal is limited to whether the district

court clearly erred when it determined that triglyceride

and lecithin function as penetration enhancers in the

claimed compounds.”

83

DOE Infringement

• Intendis (con’t)― FC: (con’t)

― isopropyl myristate “performs substantially the same function as the claimed excipients”

• Expert testimony;• Glenmark’s ANDA included repeated statements that both

Glenmark’s excipient and the claimed excipients function as penetration enhancers.

• “Glenmark ‘should not be permitted to liken their product to the claimed composition to support their bid for FDA approval, yet avoid the consequences of such a comparison for purposes of infringement.’”

― isopropyl myristate “performed in substantially the same way as the claimed excipients.”

― Expert testimony; and scientific literature.

― isopropyl myristate “obtained substantially the same result as the claimed excipients.”

― Data from the ′070 patent; Glenmark’s own patent application; a skin penetration study; and and a clinical trial.

84

DOE Infringement

• Intendis (con’t)

― FC: (con’t)

― “Glenmark is wrong to the extent that it argues that a determination

of the claimed element’s function is limited to a review of the

intrinsic record. The relevant inquiry is what the claim element’s

function in the claimed composition is to one of skill in the art, and a

fact finder may rely on extrinsic evidence in making this factual

determination.”

― Glenmark argued that its statements in its ANDA about the claimed

excipients (triglyceride and lecithin) functioning as penetration

enhancers should be rejected as a “guess” and “wrong.”

― Did not persuade FC of any clear error in the district court’s decision.

85

More DOE Infringement

• Mylan Institutional LLC v. Aurobindo Pharma Ltd. 857 F.3d 858 (Fed. Cir. 2017)

― Claim: A compound N-[4-[[4-(diethylamino)phenyl] (2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium, sodium salt having a purity of at least 99.0% by HPLC.

― Claim: A process of preparing N-[4-[[4-(diethyl-amino)phenyl] (2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium, sodium salt comprising combining a suspension of isoleuco acid of the formula… in a polar solvent with silver oxide, recovering isosulfan blue acid, and treating the isosulfan blue acid with a sodium solution.

― Aurobindo used manganese dioxide and then preparatory HPLC to achieve an ISB purity of greater than 99.5%.

― Issue: equivalency of manganese dioxide and silver oxide.

― DC: granted preliminary injunction (used function-way-result test).

― Mylan was likely to prove infringement under the doctrine of equivalents for both the ISB compound and the process of making claims (3 patents).

86

DOE

• Mylan (con’t)

― FC: Upheld for compound claims (1 patent), but not process of making

claims (2 patents).

― “the law on the doctrine of equivalents as applied to chemical

materials is not clear, and its misapplication can lead to unsound

results. This appears to be such a case.”

― “the district court conducted an incomplete F-W-R analysis while

essentially bypassing the substantial differences test, in a situation

where the latter test might seemingly be more appropriate.”

― Full trial on the merits to consider whether the “substantiality of the

differences” test is more appropriate for the chemical process claims

than the “function, way, result” test.

87

DOE

• Mylan (con’t)

― FC (con’t)

― “Especially when evaluating an equivalents dispute dealing with chemical compositions having many components, … it is often not clear what the ‘function’ or ‘way’ is for each claim limitation. How a particular component of a composition, or substituent of a compound, functions in a human or animal body, or in what way, may not be known or even knowable (although, as technology evolves, that may change). And precedent requires that, for infringement under the doctrine of equivalents, each limitation must satisfy an equivalence test. …The ‘result’ of using a claimed compound may be more easily evaluated, as the structure and uses of one compound may be directly compared with those of another. But, as indicated above, that is not how infringement under FWR is determined. It must be determined on a limitation-by-limitation basis. See id.Similarly, in the case of a chemical process claim, as in this case, the ‘result’ of a process producing a chemical compound may be clear—why else would a claim for infringement of a process claim be brought if the claimed result is not obtained? But the ‘function’ and ‘way’ of a particular limitation of a chemical process claim may remain vague and often overlap. In some cases, ‘way’ and ‘function’ may be synonymous.”

Aug. 1, 2017, district court order granted joint motion to dismiss with prejudice.

88

DOE

• Eli Lilly & Co. v. Dr. Reddy’s Labs. Ltd., No. 1:16-cv-00308 (S.D. Ind. June 25, 2018), appeal pending

― U.S. 7,772,209 Claim 12 comprises

― a) administration of between 3500 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;

― b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and

― c) administration of pemetrexed disodium.

― ALIMTA® uses pemetrexed disodium.

― DRL’s ANDA product uses pemetrexed ditromethamine.

89

DOE

• Lilly v. DRL (con’t)

― District court: infringement under doctrine of equivalents (DOE)

― Applied “insubstantial differences” test for DOE because the “case is based on chemical

properties[.]”

― “Under the relevant context that the claim relates to medical treatment, pemetrexed ditromethamine treats the

patient’s cancer in exactly the same way as pemetrexed disodium. … [I]n aqueous solution, the two products will be

identical. … Recognizing these similarities, Dr. Reddy’s relied on Lilly’s clinical trials of pemetrexed disodium, in

demonstrating the safety and efficacy of its product, when it told the FDA that the salt form does not matter when it

comes to treating the patient to support approval of its NDA product. … It is undisputed that the products are

bioequivalent; however, the parties disagree on whether there is patent equivalence in the context of the claimed

method. … The differences in the chemical properties between pemetrexed disodium and pemetrexed

ditromethamine with regards to solubility, stability, pH, and buffering capacity are irrelevant in the context of the

claimed method including this Court’s claim construction. …Additionally, the theoretical phenomenon of the

difference of salting out between the two products is irrelevant, as ALIMTA®’s label “requires the solution to be clear

prior to administration and specifically instructs physicians not to administer it if any particulate matter is observed.”

… Lilly does not dispute that there are differences when the products are in solid form, instead Lilly argues that the

differences are insubstantial. … The Court agrees. The differences are irrelevant in the context of the claimed

method which is a liquid administration of pemetrexed sodium. … The products are identical in liquid form as

pemetrexed is the active moiety in both Dr. Reddy’s and Lilly’s products dissolved in solution.”

90

Duncan Parking Technologies, Inc. v. IPS Group, Inc.,

914 F.3d 1347 (Fed. Cir. 2019)

• DC: Granted summary judgment of noninfringement of

the 8,595,054 patent.― The entire lower portion of the accused device is not

“receivable within” its housing base.

• DC: Granted summary judgment of noninfringement

of the 7,854,310 patent.― The accused device cover panel did not include a

“plurality of buttons.”

91

Claims

• ‘054 Claim 1. A parking meter device

that is receivable within a housing base

of a single space parking meter, the

parking meter device including:

• a timer;

• a payment facilitating arrangement …;

• a display …;

• a power management facility …;

• a wireless communications subsystem …;

• a keypad sensor …;

• a coin slot …; and

• a lower portion and an upper portion;

• wherein … the lower portion of the

parking meter device is configured to

have a shape and dimensions such that

the lower portion is receivable within

the housing base of the single space

parking meter; and ….

• ‘310 Claim 9. A parking meter comprising:

• a housing comprising an intermediate panel set

and a cover panel, the cover panel being

movably attached to the intermediate panel set,

…, the first surface of the cover panel having a

first window and a plurality of buttons that

operate the parking meter upon manipulation by

a user, …; a module … comprising …, and

• (c) an electronic device electrically connected to

the sensor and the reader so as to receive

information electronically therefrom, the

electronic device comprising …,

• (iii) a rechargeable battery electrically coupled

to provide power to the reader, the sensor, and

the electronic device, and

• (iv) a solar cell operatively coupled with the

rechargeable battery to charge the rechargeable

batter[y], ….

92

No Literal Infringement

• FC: Affirmed grant of summary judgment of no

infringement of the ‘310 patent.

• Reviewed only independent claims 1 and 9 and agreed with the

district court’s claim construction.

― “we need not separately address the additional limitations of the

remaining dependent claims 6 and 11, which IPS has not specifically

argued…. We therefore will only review the infringement arguments

relating to claim 9, which IPS has indicated is exemplary.”

― “See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9

(Fed. Cir. 1989) (“One who does not infringe an independent claim

cannot infringe a claim dependent on (and thus containing all the

limitations of) that claim.”

93

No Literal Infringement

• FC: Affirmed grant of summary judgment of no

infringement of the ‘310 patent.

• IPS argued that the district court construction of “cover panel”

as “the upper structural component of the exterior casing” was

too narrow, restricted to the preferred embodiment and the

figures; limited to a cover panel that swings open, as in Figure 4.

The ‘310 specification also discloses “slidably attached” to the

housing as an alternative cover panel mechanism.

94

No Literal Infringement

• FC (con’t):

• “The Liberty Meter’s keypad is an extension of its device, and construing

part of the device as the cover panel is inconsistent with the claims of the

’310 patent. …The specification is equally clear that the cover panel is a

part of the housing and does not include the device. …. DPT is also correct

that the cover panel is described as a singular component…. Nor is the

Liberty Meter’s keypad “attached” to an intermediate panel set, as

required by the ’310 patent claims, simply by virtue of making contact

with its housing. The word “attach” is never used in so broad a sense in

the ’310 patent. IPS has not presented any argument that a person of skill

in the art would understand the term more broadly than its ordinary

meaning of “to fasten or join.” …Liberty Meter does not meet the

limitation of a “cover panel movably attached to the intermediate panel

set ... [with] a plurality of buttons,” and the district court therefore did

not err by granting summary judgment of noninfringement of the ’310

patent claims.

95

No DOE Infringement

• FC: Affirmed grant of summary judgment of no

infringement of the ‘310 patent.

• According to IPS, changing the location of the buttons from

the cover panel to the device itself is an insubstantial

change, and thus the case should not have been resolved

on summary judgment.

• No DOE infringement because the allegedly infringing

device did not work in the same way as the claimed

invention.

96

No DOE Infringement

• FC (con’t):

• Also, noted that application of the doctrine of equivalents

would “essentially read out” and “essentially void” at least

one claim limitation, incorrectly “vitiating a claim

limitation.”

― “the claim limitation requiring buttons to be located on the

cover panel, which is a part of the housing, not the device.”

― “Allowing IPS to greatly expand the scope of the ’310 patent

claims, to cover a parking meter with buttons located nearly

anywhere on the outside of the meter, would disserve

members of the public who seek to avoid infringing those

claims.”

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Proving Infringement

98

Drafting And Prosecution:

Keep Enforcement In Mind When Drafting

Claims

• Consider who will infringe the claims and how

infringement will be proven.

• Goal: claims that will be directly and literally

infringed by competitors.

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Consider How Infringement

Will Be Proven

• Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003)

― Claim: A having a property which differs from that of A1.

― Specification taught three measurement methods, but failed to limit

“which differs” to particular method.

― DC: Invalid and no infringement.― Patent failed to identify a single standard by which the “difference”

could be measured, so patent invalid for failure to satisfy §112 and

no infringement.

― FC: Affirmed because claims indefinite. ― “One cannot logically determine whether an accused product comes

within the bounds of a claim of unascertainable scope.”

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Patent Claim Drafting Considerations

• Why is the goal to draft claims that will be directly and

literally infringed by competitors?

• Avoid difficulties of proving infringement under doctrine of equivalents.

• Deny your competitor the additional defenses to induced and

contributory infringement (knowledge, intent, etc.).

• Avoid having to take extensive third party discovery, especially of your

own customers or prospective customers.

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Drafting And Prosecution

Tips For Orange-Book Listed Patents

• Coordinate patent, regulatory and clinical personnel early.

• Maintain consistency between claims and likely or actual label

language.

• Maintain the coordination referenced above throughout the U.S.

patent prosecution and label negotiation with FDA. See Sanofi v.

Watson, discussed earlier.

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Divided Infringement

• Consider drafting claims so that one party infringes claims (e.g., one party performs all recited steps).

• Consider obtaining a noninfringement opinion to show good-faith belief of noninfringement.

• Opinion of counsel concluding that the patent in question is invalid will not be relevant to induced infringement allegation.

• Consider explicitly pleading indirect infringement and knowledge of the patent prior to the complaint.

103

Product Must Meet Claim Limitations To

Be Infringing• Brigham and Women’s Hospital, Inc. v. Perrigo Co. (Fed. Cir. Feb.

28, 2019)(non-precedential)

• Claim 1. A method of providing immediate and sustained relief from pain, discomfort

and/or symptoms associated with episodic heartburn in a human, said method

comprising: orally administering to a human together or substantially together an

antacid in an amount effective to substantially neutralize gastric acid and a histamine

H2-receptor antagonist in an amount effective to substantially inhibit or block gastric

acid secretion for providing the human with immediate and sustained relief from pain,

discomfort and/or symptoms associated with episodic heartburn, the immediate and

sustained relief provided lasting longer in duration than when the human is orally

treated with only the antacid and the immediate and sustained relief provided being

faster than and lasting at least about as long in duration as when the human is orally

treated with only the histamine H2-receptor antagonist.

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Product Must Meet Claim Limitations To

Be Infringing

• Brigham and Women’s (con’t)

― Specification definition:

It should therefore be appreciated that by the term “immediate and sustained relief,”

it means herein immediate, temporary and sustained relief which starts within about

5-10 minutes following ingestion of the active ingredients and continues and remains

constant for at least about 4-6 hours after ingestion of the active ingredients; the

actual ingredients being an antacid and a histamine H2-receptor antagonist.

― To show infringement by generic product, B and W submitted clinical data to

show that branded product provided immediate relief.

― “since Perrigo’s generic product has the same active ingredients and dosages as

Pepcid Complete®, Perrigo’s generic product must also provide immediate relief.”

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Product Must Meet Claim Limitations To

Be Infringing

• Brigham and Women’s (con’t)― But the clinical data did not show relief starting in about 5-10 minutes.

― Data showed “adequate relief” at 15 minutes. (Different parameter)

― DC: No infringement.

― “Brigham’s evidence was insufficient to show immediate relief as

claimed[.]”

― “At most, the study suggests that Pepcid Complete® might provide

immediate and sustained relief; such speculative data, however, cannot

sustain Brigham’s burden of proof.”

― “[The studies] did not measure the result that Brigham claimed in the

’137 patent[.]”

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Drafting Claims And Specification

107

AIA or pre-AIA, the task of preparing a patentapplication disclosure is not an easy one:“There are few, if any, legal documents more difficult to craft, more fraught

with pitfalls than patent applications[.]”Circuit Judge Newman dissenting in Energizer Holdings, Inc. v. International Trade Commission, 2008 WL 1791980, *10 (Fed. Cir. April 21, 2008)(not published).

Study relating patent prosecution to patent validity found that:“More than a quarter of the patents held invalid in the data set sufferedfrom drafting problems, which generally reflect a failure to include aspecification that adequately describes and enables an invention that isdelineated with definiteness in the claims.”Mann, Ronald J. & Marian Underweiser, A New Look at Patent Quality: Relating Patent Prosecution to Validity, 9 J. EMPIRICAL LEGALSTUD. 1 (2012). The Mann Study comprised appeals from the district courts 2003 - 2009.

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• “The specification is always highly relevant to claim construction and is the

single best guide to the meaning of a claim term in dispute.”

• Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)(en banc)

• PTAB relying on dictionary definitions when cannot find guidance in

spec.

Why Is Careful Attention To Drafting So Important?

Disclosure Provides Framework For Claim Construction

Who do you want to decide?You?

Or a district court judge or PTAB panel influenced by opposing counsel?

109

Patent Profanity: What Is It?

• Words of characterization

• Chief, Majority

• Vital

• Critical, Essential, Necessary

• Fundamental

• Solely, Only, Is

• Important

• Main

• Principal

• Significant

– Surprising– Unexpected (?)– All (?)– Only (?)– Each (?)– “The invention is…” or “This

invention…”

110

“Invention Is…”

• C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858 (Fed. Cir. 2004)

• Claimed plug for hernias, but no claim language about plug surface.

• Specification “consistently described as having pleats”

• Summary of Invention, Abstract

• DC: No infringement.― Claim construed to require pleated plug.

• FC: Affirmed -> no infringement by plugs without pleats.

― “because the patent globally defined the plug as having a pleated surface, the

term "pleated" need not be repeated each time a term describing some other

aspect of the plug is used.”

― Statements of general applicability clearly define the claimed plug as "having" or

"includ[ing] a pleated surface."

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“Invention Is…”

• C.R. Bard (con’t)

• FC: Explicitly relied on statements in the “Summary of the

Invention” and the Abstract for its claim construction:

― “Statements that describe the invention as a whole, rather than statements that

describe only preferred embodiments, are more likely to support a limiting

definition of a claim term. [citation omitted] …Accordingly, other things being

equal, certain sections of the specification [such as the Summary and Abstract]

are more likely to contain statements that support a limiting definition of a claim

term than other sections…. In this case, the plug claimed by the '432 patent is

defined globally as requiring a pleated surface, which limits claim 20.”

― See also, Edwards Life Sciences v. Cook, Inc., 582 F.3d 1322 (Fed. Cir. 2009)(“specification

frequently describes an ‘intraluminal graft’ as ‘the present invention’ or ‘this invention,’

indicating an intent to limit the invention to intraluminal devices.”) ; Regents of University of

Minnesota v. AGA Medical Corp., 717 F.3d 929 (Fed. Cir. 2013)

112

• Claim = “at least one of a W, a X, a Y, and a Z”

•Does the phrase mean at least one W and at least one X and at least one Y and at least one Z?

• Likely, yes

•“at least one of” modifies each category in the criteria list

• “and” connotes a conjunctive list

• see Superguide Corp. v. DirecTV Enterprises, Inc, 358 F.3d 870 (Fed. Cir. 2004)

CLAIM DRAFTING:

ORDINARY WORDS: “AT LEAST ONE”

113

• “at least one of a W, a X, a Y, and/or a Z” • Creates unnecessary ambiguity?

• Try using “at least one ____ (needs to be a noun such as polymer) chosen from a and b,” clearly covers “and/or” but it more clear.

•What about the phrase “A and/or B” ?•Try “at least one A chosen from …” or “at least one B chosen from ….”

•But if on Track I, that spends two independent claims.

What If End List With “And/Or”?

114

Use Different Types Of Claims To Cover

Subject Matter

Method of making

Product-by-process

Compound

Composition/

Formulation

Downstream claims

Method of treatment

Means-plus-function

Invention

115

• Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371 (Fed. Cir. 2004)

•Claim process for baking dough by “heating the . . . dough to a temperature in the range of about 400 degrees F. to 850 degrees F.”• If dough were heated to the temperature specified in the claim, “it would be burned to a crisp.”• Expert declaration that one skilled in the art reading the claim would believe temperature range referred to temperature of oven, not dough.• Patent gives two examples, each stating that the dough product is placed in a multi-layered convection oven and baked “at temperatures” or “at a temperature” of 680° F to 850° F.

•DC: Construed claim to mean temperature of dough -> no infringement.

• FC: Affirmed. “courts may not redraft claims.” • Could have chosen “at a temperature”, but didn’t.

Note: pre-Phillips (2005)

Claim Drafting:

Ordinary Words: “To”

116

Principles In Tension

• “[A] court may not read into a claim a limitation from a preferred embodiment, if that limitation is not present in the claim itself.” Bayer AG v. Biovail Corp., 279 F.3d 1340, 1348 (Fed. Cir. 2002)

• "When the preferred embodiment is described in the specification as the invention itself, the claims are not necessarily entitled to a scope broader than that embodiment." SciMed Life Sys. v. Advanced Cardiovascular Sys., 242 F.3d 1337 (Fed. Cir. 2001), quoting ModineMfg. Co. v. United States Int'l Trade Comm'n, 75 F.3d 1545, 1551 (Fed. Cir. 1996).

117

• Honeywell Int’l, Inc. v. ITT Industrials, Inc., 452 F.3d 1312 (Fed.

Cir. 2006)― Limitation: “fuel system component.”

― DC: SJ of noninfringement

― Claim scope limited to a fuel filter only because the written description expressly

refers to the filter as “this invention.”

― FC: Affirmed

― Cited Phillips.

― Construction based on language in specification: “the written description uses

language that leads us to the conclusion that a fuel filter is the only ‘fuel

injection system component’ that the claims cover, and that a fuel filter was not

merely discussed as a preferred embodiment. On at least four occasions, the

written description refers to the fuel filter as ‘this invention’ or ‘the present

invention’”

― “No other fuel injection system component with the claimed limitations is

disclosed or suggested.”

Describing In Only One Way May Mean

Limited To One Embodiment

118

“Clear Disavowal”

• As a general rule, the ordinary and customary meaning

controls unless “a patentee sets out a definition and acts as

his own lexicographer, or ... the patentee disavows the full

scope of a claim term either in the specification or during

prosecution.” Thorner v. Sony Comput. Entm’t Am. LLC, 669

F.3d 1362, 1365 (Fed. Cir. 2012).

119

Clear Disavowal

• Poly-America, L.P. v. API Industries, Inc., 839 F.3d 1131 (Fed. Cir.

2016)― Claim 10. An elastic drawstring trash bag comprising:

― a polymeric bag comprised of a first panel and a second panel, the first panel

and the second panel joined at a first side, a second side, and a bottom,

― a first hem …,

― a second hem …,

― the first panel, the first elastic drawstring, the second panel, and the second

elastic drawstring inseparably joined together at a first short seal and at a

second short seal, and

― a first access cutout along the upper edge of the first panel and a second

access cutout along the upper edge of the second panel, ….

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Clear Disavowal

• Poly-America (con’t)

― DC: Construed “short seals” as required to extend inwardly.

― No infringement because API's accused bags are conventional drawstring trash

bags with short seals that are substantially aligned with the side seal.

― FC: Affirmed. Based on statements in abstract, background, summary, and

description of invention.

― “clear and unequivocal statements that the inventor intended to limit the

claimed invention to a trash bag with ‘short seals’ at its upper corners that

extend inwardly to narrow the bag’s upper opening.”

― Also during prosecution, argued patentability based on narrower upper opening.

― “Disavowal can be effectuated by language in the specification or the

prosecution history. …In either case, the standard for disavowal is exacting,

requiring clear and unequivocal evidence that the claimed invention includes or

does not include a particular feature.”

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Clear Disavowal

• Poly-America (con’t)

― FC:

― “While disavowal must be clear and unequivocal, it need not be explicit.

…For example, an inventor may disavow claims lacking a particular feature

when the specification describes “the present invention” as having that

feature. …Here, the specification states that: ‘In looking at both FIG. 1 and

FIG 2, it is important to note that one of the characteristics of the present

invention is a reduction in upper width ... resulting from the extended

short seals.’ …Directing the reader to figures one and two, which

demonstrate the extended short seal feature, does not limit the import of

this clear statement that describes a characteristic feature of the

invention.”

― “Every embodiment described in the specification has inwardly extended

short seals and every section of the specification indicates the importance

of inwardly extended short seals. These two facts provide together a proper

reason to limit the claims in this way.”

122

Clear Disavowal From Statements

In IPR• Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353 (Fed. Cir. 2017)

― After PTAB denied IPR on claims 2, 4, 21, and 23 of ‘412 patent, Aylus filed

notice of voluntary dismissal in district court as to all asserted claims except 2

and 21.

― DC: Granted summary judgment of no infringement.

― Claim limitation “wherein the CPP logic is invoked to negotiate media content

delivery between the MS and the MR” not present in accused method.

― Construed to “require that only the CPP logic is invoked to negotiate media content

delivery between the MS and the MR” (not both the CP and CPP).

― “relied on statements made by Aylus in its preliminary responses to Apple’s

petitions for IPR of the ’412 patent, finding the statements ‘akin to

prosecution disclaimer.’”

• “Aylus’s repeated statements that claims 2 and 21 ‘require that . . . only the control point proxy logic[] be invoked,’”

123

Clear Disavowal From Statements

In IPR

• Aylus (con’t)

― FC: Affirmed.

― “statements made by a patent owner during an IPR proceeding can

be relied on to support a finding of prosecution disclaimer during

claim construction.”

― “Extending the prosecution disclaimer doctrine to IPR proceedings

will ensure that claims are not argued one way in order to maintain

their patentability and in a different way against accused

infringers.

― “Aylus’s statements in the IPR proceeding are a clear and

unmistakable surrender of methods invoking the CP logic in claims

2 and 21, and based on these disclaiming statements, we see no

error in the district court’s claim construction or its grant of

summary judgment of noninfringement.”

124

• Cultor Corp. v. A.E. Staley Mfg. Co., 224 F.3d 1328 (Fed. Cir. 2000)

― Claim: "polydextrose composition substantially free of bitter-tasting residual compounds made by the process consisting essentially of" 3 steps, but did not specify in the claims a citric acid catalyst.”

― Specifications read: the expression "water-soluble polydextrose" (also known as polyglucose or poly-D-glucose) specifically refers to the water-soluble polydextrose prepared by melting and heating dextrose (also known as glucose or D-glucose), preferably with about 5-15% by weight of sorbitolpresent, in the presence of a catalytic amount (about 0.5 to 3.0 mol %) of citric acid.

― Yikes: compare with no comma: preferably with about 5-15% by weight of sorbitol present in the presence of a catalytic amount (about 0.5 to 3.0 mol %) of citric acid.

Narrow Construction Of Claim Based On

Specification: Killed By A Profanity And A Comma

125

• Cultor (con’t)

― Cultor: "polydextrose" in its ordinary meaning, to persons of skill in

the art, is not encumbered by the nature of the catalyst, and thus is

not limited to the specific acid catalyst actually used in its

production.

― FC: Construed "water-soluble polydextrose" as limited to polydextrose

produced with citric acid as a catalyst, both for literal infringement

and for infringement under the doctrine of equivalents. Clearly, that

was based on the unfortunate “comma”: noted on the previous

slide.

Narrow Construction Of Claim

Based On Specification

126

Prosecution History In

Claim Construction

• Viskase Corp. v. American National Can Co., 261 F.3d 1316 (Fed. Cir. 2001)

• Claim term = “density below about 0.91 g/cm3”

• Accused films either 0.912 g/cm3 or 0.908 g/cm3

• DC: means densities between 0.905 and 0.914, based on the convention that numbers in this range would be rounded to 0.91.

• FC: means "below about 0.910 g/cm3” because once during prosecution, Viskase used 0.91 with a zero in the third decimal place to distinguish a prior art copolymer “having a density range of "0.910 to 0.940 g/cm3.“

― Interpreted such use as indicating Viskase treated 0.91 as if it were 0.910

― “clear that the prosecution argument to distinguish Shibata was presented as necessary to draw a line in this crowded field of technology, and that Viskase drew the line between ‘very low density’ and other polyethylenes at 0.910 g/cm3”

127

• Test by analyzing “design around” possibilities from viewpoint of infringer.

• Determine necessity of each term.― Make sure that each independent claim recites clearly ONLY that which is required.

• Identify where each term is defined in specification.

• Identify ambiguity and eliminate it!― Ascertain whether an infringer could “misconstrue” the applicant’s intended

meaning of any term.

• Is every term used consistently?

• The mantra: Necessary, clearly defined, and consistently used

Choose Claim Terms Carefully

128

§112 Claim Drafting Considerations

• More than one type of claim may be used in an application

• No matter what type, the claim should be supported in the specification, self-contained in the body of the claim, and, most importantly, complete

• Allen Engineering Corp. v. Bartell Indus., 299 F.3d 1336 (Fed. Cir. 2002)

― FC: claim ending in the middle of a limitation (“coupled to said gearbox means by rigid…”) is indefinite because it is impossible to discern the scope of such a truncated limitation.

• Note: Smart Wearable v. Microsoft, 2017 WL448616 (W.D. Va Jan. 1, 2017) – it still happens!

129

• Allen (con’t)

― Claims read: "its gear box only in a plane perpendicular to said

biaxial plane.“

― However specification described structure as "gearbox … cannot

pivot in a plane perpendicular to the biaxial plane."

― Allen argued that one of skill in the art would understand that the

term "perpendicular" in the claim should be read to mean "parallel."

― FC: “Allen stretches the law too far.”

§112 Claim Drafting Considerations

130

• Focus on objective of literal infringement (by single actor).

― Specification acts as a dictionary for the claim terminology.

― If broad meaning for a term intended, set forth a broad definition in the

specification.

― Alternatively, consider embodiments with narrower definitions.

― Consider crafting definitions to address concerns about related prior art.

― Use specification to eliminate uncertainty.― Athletic Alternatives, Inc. v. Prince Manufacturing, Inc., 73 F.3d 1573, 1581 (Fed. Cir. 1996): when there is an equal choice between a broad and a narrow meaning of a claim, the public notice function is better served by interpreting the claim more narrowly.

― Use specification to describe how claims will be infringed.

Drafting Specification

131

• Try to cover variations and permutations of each

claim element (e.g., reverse order).

• Draft claim with separate elements.• Separate elements with semicolons and paragraphs.

• Increase the number of elements in a claim.

• If have to amend, can make it clear relates to only one

element.• Can focus comments.

• Can limit prosecution history estoppel to a single element.

Tips

132

Tips

• Be cautious about leaving information out of the specification.

• Be diligent about trying to draft the patent so that the claim terms will be construed as desired, whether broadly or narrowly.

• To the maxim of patent law that “claims are construed in light of the specification, and are not limited to a designated ‘preferred embodiment’," the practitioner should be cautioned, “unless that embodiment is in fact the entire invention presented.” (Vulcan Eng'g Co. v. Fata Aluminum, Inc., 278 F.3d 1366 (Fed. Cir. 2002).

133

Thank You!

Contact Information:

Adriana L. Burgy

Finnegan Henderson Farabow Garrett & Dunner

adriana.burgy@finnegan.com

Mark J. Feldstein, Ph.D.

Finnegan Henderson, Farabow Garrett & Dunner

mark.feldstein@finnegan.com

Doris J. Hines

Finnegan Henderson, Farabow Garrett & Dunner

dori.hines@finnegan.com

Tom Irving

Finnegan Henderson Farabow Garrett & Dunner

tom.irving@finnegan.com

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