understanding the continuing impact of 101 on orange book ...€¦ · martin b. pavane shareholder...

#ACIPIV

11th Annual Paragraph IV Disputes

Moderator –

Martin B. Pavane

Shareholder

Cozen O’Connor

Understanding the Continuing Impact of

101 on Orange Book Listed-Method Claims

April 24-26, 2017

Speaker 4 –

Jason A. Wietjes

Shareholder

Polsinelli PC (Dallas, TX)

Speaker 5 -

Peter Waibel

Head, US Patent Litigation

Novartis Pharmaceuticals

Corporation (East

Hanover, NJ)

Tweeting about this conference?

Speaker 1 –

Bruce M. Wexler

Partner

Paul Hastings LLP (New

York, NY)

Speaker 3 –

Paul B. Sudentas

Attorney

Locke Lord LLP (New

York, NY)

Speaker 2 –

Dominic A. Conde

Partner

Fitzpatrick, Cella, Harper

& Scinto (New York, NY)

RECENT DECISIONS ON PATENT ELIGIBLE SUBJECT

MATTER

Bruce M. Wexler

David Chen

3THE § 101 TWO STEP

Two-step test for distinguishing claims to patent-ineligible concepts from claims to

patent-eligible applications

Step 1: Is the claim directed to a patent-ineligible concept?

Laws of nature, natural phenomena, and abstract ideas

Step 2: Do the additional elements, considered individually and as an ordered

combination, transform the claim into a patent-eligible application?

More is required than well-understood, routine, conventional activity already engaged in

by the scientific community

Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed. Cir. 2016)

Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375-76 (Fed. Cir. 2015)

4ARIOSA DIAGNOSTICS V. SEQUENOM

Claim 1: “A method for detecting a paternally inherited nucleic acid of fetal origin performed on a

maternal serum or plasma sample from a pregnant female, which method comprises

amplifying a paternally inherited nucleic acid from the serum or plasma sample and

detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.”

Sequenom, 788 F.3d at 1373-74.

Undisputed that existence of cffDNA in maternal blood is a natural phenomenon, none of the genetic code

of the cffDNA was created or altered, location of the nucleic acids existed in nature, and paternally

inherited cffDNA is a natural phenomenon.

Id. at 1376.

Methods of amplifying and detecting the cffDNA were “well-understood, routine, and conventional activity.”

Id. at 1377.

Held: Ineligible. “[T]he claims are directed to matter that is naturally occurring,” and the use of “known

laboratory techniques” fails to transform the claims into a patent-eligible application.

Id. at 1373, 1376, 1378.

5SEQUENOM’S RELIANCE ON MAYO

Mayo Claim 1 Sequenom Claim 1

“A method of optimizing therapeutic efficacy

for treatment of an immune-mediated

gastrointestinal disorder, comprising:

(a) administering a drug providing 6-

thioguanine to a subject having said immune-

mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in

said subject having said immune-mediated

gastrointestinal disorder,

wherein [certain concentrations indicate a

need to increase or decrease the amount of

drug subsequently administered].”

Mayo Collaborative Servs. v. Prometheus

Labs., Inc., 566 U.S. 66, 74-75 (2012).

“A method for detecting a paternally inherited

nucleic acid of fetal origin performed on a

maternal serum or plasma sample from a

pregnant female, which method comprises

amplifying a paternally inherited nucleic acid

from the serum or plasma sample and

detecting the presence of a paternally

inherited nucleic acid of fetal origin in the

sample.”

Sequenom, 788 F.3d at 1373-74.

“Like the patentee in Mayo, Sequenom contends that the claimed methods are patent

eligible applications of a natural phenomenon, specifically a method for detecting

paternally inherited cffDNA. Using methods like PCR to amplify and detect cffDNA was

well-understood, routine, and conventional activity in 1997. The method at issue here

amounts to a general instruction to doctors to apply routine, conventional techniques

when seeking to detect cffDNA. Because the method steps were well understood,

conventional and routine, the method of detecting paternally inherited cffDNA is not new

and useful.”

Sequenom, 788 F.3d at 1377.

6RAPID LITIGATION V. CELLZDIRECT

Claim 1: “A method of producing a desired preparation of multi-cryopreserved hepatocytes . . . said

method comprising: (A) subjecting hepatocytes that have been frozen and thawed to density gradient

fractionation to separate viable hepatocytes from non-viable hepatocytes, (B) recovering the separated

viable hepatocytes, and (C) cryopreserving the recovered viable hepatocytes . . . “

Claim 5: “The method of claim 1, wherein said preparation comprises a pooled preparation of hepatocytes of

multiple sources.”

CellzDirect, 827 F.3d at 1046.

Prior art taught away from multiply freezing hepatocytes because of cell damage. Inventors discovered

that some fraction of hepatocytes were capable of surviving multiple freeze-thaw cycles. They developed

a multiple-freeze method that simplified preparation of pooled hepatocyte preparations and allowed

preserved hepatocyte preparations to be thawed and used later without unacceptable loss of viability.

Id. at 1045.

Held: Eligible. Claims are not directed to an ineligible law of nature, but are “directed to a new and useful

laboratory technique for preserving hepatocytes.”

If reached Step 2, would have been patent eligible despite the claims’ individual steps being known independently in

the art because “a process of preserving hepatocytes by repeating those steps was itself far from routine and

conventional” particularly in light of the prior art teaching away from repeating those steps.

Id. at 1048, 1050-51.

21 OfficesACROSS THE AMERICAS, ASIA,

AND EUROPE

1 Legal TeamTO INTEGRATE WITH THE STRATEGIC GOALS OF YOUR

BUSINESS

THE AMERICAS

Atlanta

Chicago

Houston

Los Angeles

New York

Orange County

Palo Alto

San Diego

San Francisco

São Paulo Washington,

D.C.

ASIA

Beijing

Hong Kong

Seoul

Shanghai

Tokyo

EUROPE

Brussels

Frankfurt

London

Milan

Paris

7

THE AMERICAS ASIA EUROPE

Atlanta

1170 Peachtree Street, N.E.

Suite 100

Atlanta, GA 30309

t: +1.404.815.2400

f: +1.404.815.2424

Chicago

71 S. Wacker Drive

Forty-fifth Floor

Chicago, IL 60606

t: +1.312.499.6000

f: +1.312.499.6100

Houston

600 Travis Street

Fifty-Eighth Floor

Houston, TX 77002

t: +1.713.860.7300

f: +1.713.353.3100

Los Angeles

515 South Flower Street

Twenty-Fifth Floor

Los Angeles, CA 90071

t: +1.213.683.6000

f: +1.213.627.0705

New York

200 Park Avenue

New York, NY 10166

t: +1.212.318.6000

f: +1.212.319.4090

Orange County

695 Town Center Drive

Seventeenth Floor

Costa Mesa, CA 92626

t: +1.714.668.6200

f: +1.714.979.1921

Palo Alto

1117 S. California Avenue

Palo Alto, CA 94304

t: +1.650.320.1800

f: +1.650.320.1900

San Diego

4747 Executive Drive

Twelfth Floor

San Diego, CA 92121

t: +1.858.458.3000

f: +1.858.458.3005

San Francisco

55 Second Street

Twenty-Fourth Floor

San Francisco, CA 94105

t: +1.415.856.7000

f: +1.415.856.7100

São Paulo

Rua Funchal, 418, 34º andar

Vila Olímpia

São Paulo - SP

Brazil

04551-060

Washington, D.C.

875 15th Street, N.W.

Washington, D.C. 20005

t: +1.202.551.1700

f: +1.202.551.1705

Beijing

26/F Yintai Center Office Tower

2 Jianguomenwai Avenue

Chaoyang District

Beijing 100022, PRC

t: +86.10.8567.5300

f: +86.10.8567.5400

Hong Kong

21-22/F Bank of China Tower

1 Garden Road

Central Hong Kong

t: +852.2867.1288

f: +852.2526.2119

Seoul

33/F West Tower

Mirae Asset Center1

26, Eulji-ro 5-gil, Jung-gu,

Seoul, 04539, Korea

t: +82.2.6321.3800

f: +82.2.6321.3900

Shanghai

43/F Jing An Kerry Center Tower II

1539 Nanjing West Road

Shanghai 200040, PRC

t: +86.21.6103.2900

f: +86.21.6103.2990

Tokyo

Ark Hills Sengokuyama Mori Tower

40th Floor, 1-9-10 Roppongi

Minato-ku, Tokyo 106-0032

Japan

t: +81.3.6229.6100

f: +81.3.6229.7100

Brussels

Avenue Louise 480-5B

1050 Brussels

Belgium

t: +32.2.641.7460

f: +32.2.641.7461

Frankfurt

Siesmayerstrasse 21

D-60323 Frankfurt am Main

Germany

t: +49.69.907485.0

f: +49.69.907485.499

London

Ten Bishops Square

Eighth Floor

London E1 6EG

United Kingdom

t: +44.20.3023.5100

f: +44.20.3023.5109

Milan

Via Rovello, 1

20121 Milano

Italy

t: +39.02.30414.000

f: +39.02.30414.005

Paris

96, boulevard Haussmann

75008 Paris

France

t: +33.1.42.99.04.50

f: +33.1.45.63.91.49

For further information, you may visit our home page at

www.paulhastings.com or email us at [email protected]

www.paulhastings.com ©2016 Paul Hastings LLP

OUR OFFICES8

FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com

MacroPoint v. Fourkites

FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 10

• MacroPoint’s patents covered:

“a system for providing location information of a vehicle [that] includes a

communications interface and a correlation logic that correlates location information

of a communications device to location of the vehicle.”

• Basically a freight tracking system

• FourKites moved to dismiss

• Argued, based on Alice, patents invalid because they were drawn to an abstract idea.

MacroPoint v. Fourkites, No. 1:15 cv 1002 (N.D. Ohio Nov. 6, 2015)


• Court found claims directed to “abstract ideas tracking freight”:

“the claim discloses nothing more than a process for tracking freight, including

monitoring, locating and communicating regarding the location of the freight. These

ideas are all abstract in and of themselves.” (Id. at 6)

• Court distinguished other cases because MarcoPoint’s computer related claims were not

“rooted in computer technology to overcome a problem specifically arising in the realm

of computer networks.” (Id. at 7)

MacroPoint – Patent Ineligible?


• Claims covered “correlating the location information of a communications device with the

location of freight or a vehicle”

• MacroPoint asserted

• Claims solve the problem of “how to monitor the location of freight or vehicle by

technical means …”

• Claims allowed “tracking of freight without the use of a dedicated GPS receiver and

instead discerns the location through a location information provider”

MacroPoint – Inventive Concept?


• Court disagreed, alleged “inventive concepts” did not transform abstract ideas into

patent-eligible claims (Id. at 11)

• Claims instruct a computer to use preexisting technology to implement the correlation:

“transmitting and receiving data are basic and generic computer functions and these

claims do not solve any problem tethered to [computers.]” (Id.)

• Alleged technological improvement was lacking in the claim language itself. (Id.)

MacroPoint – Inventive Concept?


• Using the PTO Guidelines is not determinative:

“the fact that the PTO may have considered Alice-based guidelines before issuing the

patents-in-suit does not mandate a finding that the patents are valid.” (Id. at 7)

“Nor is the guidance put forth by the PTO conclusive on the issue of patent-eligible

subject matter. Regardless, other than a blanket statement that the Examiner

presumably applied the guidance, plaintiff offers no analysis on the issue.” (Id. n. 3).

• Claims invalid under§101; CAFC affirmed per curium

MacroPoint – PTO Guidelines


• Federal Circuit generally has not relied on the PTO Subject Matter Eligibility guidelines in

deciding patent eligibility

• Since 2014, CAFC decided 47 patent eligibility cases

• Only 2 mentioned the guidelines

• Neither case gave much, if any weight, to the PTO’s use of the guidelines

PTO Guidelines: Does the CAFC Care?


• Federal Circuit has stated that PTO rules are not binding:

As the Interim Eligibility Guidance itself states, it is not intended to create any right

or benefit, substantive or procedural, enforceable by any party against the Office.

Rejections will continue to be based upon the substantive law, and it is these

rejections that are appealable. … [W]e have previously determined that such

Guidance is not binding on this Court.

In re Smith (Fed. Circ. 2016) (emphasis added)



• In a concurrence, Judge Mayer stated no presumption of validity should apply:

The rationale for the presumption of validity is that the [PTO], “in its expertise, has

approved the claim…” That rationale, however, is “much diminished” in situations in

which the PTO has not properly considered an issue… Because the PTO has for

many years applied an insufficiently rigorous subject matter eligibility standard,

no presumption of eligibility should attach when assessing whether claims meet the

demands of section 101.

Ultramercial, Inc. v. Hulu, LLC, (Fed. Circ. 2014)(emphasis added)


FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com

NEW YORK

1290 Avenue of the Americas

New York, NY 10104-3800

212.218.2100

WASHINGTON

975 F Street, NW

Washington, DC 20004-1462

202.530.1010

CALIFORNIA

650 Town Center Drive, Suite 1600

Costa Mesa, CA 92626-7130

714.540.8700

THANK YOU.

Boehringer Ingelheim Pharms., Inc., et al.

v.

HEC Pharm Co., Ltd., et al.,

Paul B. Sudentas

April 24, 2017

What’s Happening in D.N.J.?

C.A. No. 15-5982, 2016 WL 7177704

(D.N.J. Dec. 7, 2016) (Sheridan, U.S.D.J.)

20

■ Motion to dismiss (Rule 12(c)) for invalidity under

§ 101

■ Δ’s argument – claims recite a natural law directed to pharmacokinetic observations of

diabetic patients

■ Π’s argument –claims recited methods of using non-naturally existing compounds (DPP-

IV inhibitors), which alter the state of the body in a new and useful way

Boehringer Ingelheim Pharms., Inc., et al. v.

HEC Pharm Co., Ltd., et al.

■ U.S. Patent No. 8,853,156, claim 1:

A method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising

orally administering to the patient a DPP-IV inhibitor

wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary

galactose intolerance

21



22

Step 1

■ Is the single claimed step (“orally administering”) an abstract idea? YES

■ Single instruction vs. series of steps: Claim 1 provides a single instruction- “orally administering”

a DPP-IV inhibitor to a targeted patient population rather than a series of steps tied to tangible

embodiments

■ Claim 1 provides “no contribution over conventional knowledge of administering DPP-IV

inhibitors.”

■ Claim1 does not require any prior determination that the natural body levels have changed or

altered before performing the “orally administering step” abstract idea.



23

Step 2

■ Does the claim recite an inventive concept (i.e., add “significantly more” to the abstract idea)? NO

■ The preamble and body are simply “additional features [that] recite well-understood, routine, and

conventional activity.” The ‘156 patent specification indicates that the inventor recognized that

side effect issues with antiglycemic agents “were known and well-understood in the scientific

community.”

■ “[C]laim 1 of the ‘156 patent does not amount to significantly more than an abstract idea of

providing an instruction for a medical care professional who is treating the targeted patient

population. The instruction of claim 1 can be conducted via mental processes, which is not tied to

any tangible embodiment.”



24

■ Summary

■ The claimed methods recite only a single step not tied to a tangible

embodiment

■ Compare with CellzDirect which disclosed series of steps tied to

tangible embodiments

■ There was nothing in the preamble or body that added substantially

more to convert the abstract idea into patent eligible subject

■ Specifying amounts of the DPP-IV inhibitor or a particular DPP-

IV inhibitor also did not amount to substantially more than the

abstract idea

■ If appealed, will it be affirmed?



The View From Delaware

Endo v. Actavis

Endo Pharmaceuticals Inc., et al. v. Actavis Inc., et al., No. 14-1381 (2015)

– Judge Andrews order adopting report of Magistrate Judge Thynge

– Judge Thynge determined that U.S. Pat. No. 8,808,737 was facially invalid under §101

– Her report emphasized the factual similarity between representative claim 1 of the ’737 patent and a representative Mayo claim

Endo v. Actavis

The ’737 patent

– Method of Treating Pain Utilizing Controlled Release Oxymorphone Pharmaceutical Compositions and Instruction on Dosing for Renal Impairment

Endo v. Actavis

The ’737 patent v. Mayo

Mayo patent claim 1

indicates a need to [increase/decrease] the amount of said drug subsequently administered to said subject

’737 patent claim 1

orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief

Endo v. Actavis

Endo’s arguments

1. The claimed method is directed to a new and useful treatment regimen providing a practical, tangible benefit (pain relief) in a particular patient population.

2. The ’737 claim requires a tangible action or application of the method, i.e. lower dose administration.

Endo v. Actavis

Endo’s arguments

3. Judge Thynge failed to apply the Classen decision.

4. The ’737 patent claims a previously unknown relationship.

5. Policy argument that the report in effect invalidates all pharmaceutical method-of-treatment patents using an existing, well-known compound.

Endo v. Actavis

Judge Andrews’s analysis

– “Plaintiffs’ argument that the ’737 patent does not claim a law of nature, but instead a ‘new and useful process,’ is thoroughly unconvincing.”

– In comparing the representative claims: “[N]either formulation provides any sort of ‘inventive concept’ to suggest that more than just the natural law is being claimed.”

Endo v. Actavis

Judge Andrews’s analysis

– After Mayo, Classen holds no precedential value.

– “This case is hardly the poster child for a policy argument on the wide-ranging implications of a § 101 rejection of a pharmaceutical method patent.”

Vanda v. Roxane

Vanda Pharmaceuticals Inc., et al. v. Roxane Laboratories, Inc., Nos. 13-1973, 14-757 (2016)

– Judge Sleet opinion

– U.S. Pat. No. 8,586,610 found to be patent eligible

Vanda v. Roxane

The ’610 patent

– Methods for the Administration of Iloperidone

– The CYP2D6 Reaction

Vanda v. Roxane

Roxane’s arguments

– The ’610 patent embodies two laws of nature:

1. that mutations in the CYP2D6 genes can alter enzymatic activity; and

2. that a patient’s CYP2D6 enzymatic activity affects metabolism of iloperidone.

Vanda v. Roxane

Roxane’s arguments

– All of the method-of-treatment claims depend on natural processes.

– Vanda merely adds a dose adjustment to reduce the risk of a routine side effect.

– A person of ordinary skill in the art would discover the invention in performing FDA-mandated studies.

Vanda v. Roxane

Judge Sleet’s opinion

– The asserted claims depend on laws of nature.

– Specifically, the claims depend on the relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation.

Vanda v. Roxane

Judge Sleet’s opinion

– Issue:

• Whether the claims incorporate some additional, transformative step sufficient to make them valid.

– The Court found it persuasive that the dosage step doesn’t apply to all patients, but only a specific patient population based on genetic composition based on applying genetic tests in a highly specified way.

#ACIPIV

11th Annual Paragraph IV Disputes

Moderator –

Martin B. Pavane

Shareholder

Cozen O’Connor

Understanding the Continuing Impact of

101 on Orange Book Listed-Method Claims

April 24-26, 2017

Speaker 4 –

Jason A. Wietjes

Shareholder

Polsinelli PC (Dallas, TX)

Speaker 5 -

Peter Waibel

Head, US Patent Litigation

Novartis Pharmaceuticals

Corporation (East

Hanover, NJ)

Tweeting about this conference?

Speaker 1 –

Bruce M. Wexler

Partner

Paul Hastings LLP (New

York, NY)

Speaker 3 –

Paul B. Sudentas

Attorney

Locke Lord LLP (New

York, NY)

Speaker 2 –

Dominic A. Conde

Partner

Fitzpatrick, Cella, Harper

& Scinto (New York, NY)

understanding the continuing impact of 101 on orange book ...€¦ · martin b. pavane shareholder...

Documents