Amicus Curiae Brief — Mylan Pharmaceuticals Inc., et al., Petitioners v. UCB, Inc., et al.

No. 18-692

IN THE

Supreme Court of the United States

____________________

MYLAN PHARMACEUTICALS INC., et al,

Petitioners,

v.

UCB, INC., et al.,

Respondents.

____________________

On Petition for Writ of Certiorari

to the United States Court of Appeals

for the Federal Circuit

____________________

BRIEF OF

AMERICA’S HEALTH INSURANCE PLANS

AS AMICUS CURIAE

IN SUPPORT OF PETITIONERS

____________________

JULIE SIMON MILLER

MICHAEL S. SPECTOR

AMERICA’S HEALTH

INSURANCE PLANS

601 Pennsylvania Ave., NW

Washington, DC 20004

ANNA-ROSE MATHIESON

Counsel of Record

SUSAN YORKE

CALIFORNIA APPELLATE

LAW GROUP LLP

96 Jessie Street

San Francisco, CA 94105

(415) 649-6700

annarose@calapplaw.com

i

TABLE OF CONTENTS

Page

INTEREST OF AMICUS CURIAE........................... 1

SUMMARY OF ARGUMENT ................................... 3

ARGUMENT ............................................................. 5

I.

The Constitution, Congress, and this

Court all prohibit obvious patents. ............... 5

A. The Federal Circuit’s use of

artificially rigid tests departs from

constitutional and statutory

directives and flouts this Court’s

precedent. ............................................. 5

B. This case illustrates how the

application of rigid legal tests can

protect duplicative patents. ............... 10

II. Duplicative patents contribute to rising

drug prices and harm American

consumers. ................................................... 12

A. Patents on prescription drugs

significantly and directly affect

consumer costs. .................................. 13

B. Some brand-name companies use

duplicative or obvious patents to

artificially prolong their

monopolies on lucrative drugs. .......... 16

C. Duplicative patents threaten the

delicate balance between spurring

innovation and enabling public

access to inventions. .......................... 21

CONCLUSION ........................................................ 23

ii

TABLE OF AUTHORITIES

Page

CASES

Graham v. John Deere Co. of Kansas City,

383 U.S. 1 (1966) ...................................... 6, 10, 11

Great Atl. & Pac. Tea Co. v. Supermarket

Equip. Corp.,

340 U.S. 147 (1950) ............................................ 10

KSR Int’l Co. v. Teleflex Inc.,

550 U.S. 398 (2007) .................................. 6, 7, 8, 9

Oil States Energy Servs., LLC v. Greene’s

Energy Grp., LLC,

138 S. Ct. 1365 (2018) .................................. 12, 17

Otsuka Pharm. Co., Ltd. v. Sandoz, Inc.,

678 F.3d 1280 (Fed. Cir. 2012) ............................ 8

Scott Paper Co. v. Marcalus Mfg. Co.,

326 U.S. 249 (1945) ............................................ 20

CONSTITUTIONS & STATUTES

35 U.S.C. § 103 ...................................................... 6, 9

U.S. Const. art. I, § 8, cl. 8 ........................................ 5

OTHER AUTHORITIES

Altarum Center for Value in

Healthcare, Health Sector Economic

Indicators: Insights from Monthly

National Health Spending Data

through February 2018 (April 13,

2018), available at https://

altarum.org/sites/default/

files/uploaded-related-files/SHSSSpending-Brief_April_2018.pdf ................... 13, 14

iii

TABLE OF AUTHORITIES

(continued)

Page

Altarum Institute, Center for

Sustainable Health Spending,

Insights from Monthly National

Health Spending Data Through

December 2015 1 (Feb. 16, 2016),

available at https://altarum.org/

sites/default/files/uploaded-relatedfiles/CSHS-Spending-Brief_

February_2016.pdf ............................................. 13

Briana Barron, Structural Uncertainty:

Understanding the Federal Circuit’s

Lead Compound Analysis, 16 Marq.

Intell. Prop. L. Rev. 401 (Summer

2012) ................................................................. 8, 9

Board of Governors of the Federal

Reserve System, Report on the

Economic Well-Being of U.S.

Households in 2016 (May 2017),

available at https://www.

federalreserve.gov/publications/

files/2016-report-economic-wellbeing-us-households-201705.pdf ....................... 21

Amy Brown, Evaluate Grp., EP Vantage

2017 Preview (Dec. 2016), available

at http://info.evaluategroup.com/rs/

607-YGS-364/images/EPV2017

Prev.pdf .............................................................. 18

Dan L. Burk & Mark A. Lemley,

Biotechnology’s Uncertainty

Principle, 54 Case W. Res. L. Rev.

691 (Spring 2004) ............................................... 11

iv

TABLE OF AUTHORITIES

(continued)

Page

Centers for Medicare & Medicaid

Services, NHE Fact Sheet, https://

www.cms.gov/Research-StatisticsData-and-Systems/StatisticsTrends-and-Reports/National

HealthExpendData/NHE-FactSheet.html (last visited Dec. 19,

2018) ................................................................... 13

Jessie Cheng, An Antitrust Analysis of

Product Hopping in the

Pharmaceutical Industry, 108

Colum. L. Rev. 1471 (Oct. 2008) .................. 19, 20

Mildred K. Cho et al., Effects of Patents

and Licenses on the Provision of

Clinical Genetic Testing Services, 5

J. MOLECULAR DIAGNOSTICS 3 (Feb.

2003), available at https://www.

ncbi.nlm.nih.gov/pmc/articles/

PMC1907368/#__ffn_sectitle ............................. 22

Roger Collier, Drug Patents: The

Evergreening Problem, 185 Can.

Med. Ass’n J. E385 (June 11, 2013),

available at https://www.ncbi.

nlm.nih.gov/pmc/articles/

PMC3680578/ ..................................................... 17

Chester Davis, Jr., CEO of Ass’n for

Accessible Medicines, Statement to

the Senate Health, Education, Labor

and Pensions Committee: The Cost

of Prescription Drugs: How the Drug

Delivery System Affects What

Patients Pay (Oct. 17, 2017),

available at https://www.help.

senate.gov/imo/media/doc/Davis6.pdf ................ 22

v

TABLE OF AUTHORITIES

(continued)

Page

John F. Duffy, Inventing Invention: A

Case Study of Legal Innovation, 86

Tex. L. Rev. 1 (Nov. 2007)................................ 6, 7

Alfred B. Engelberg, Aaron S.

Kesselheim, & Jerry Avorn,

Balancing Innovation, Access, and

Profits — Market Exclusivity for

Biologics, 361 New Eng. J. Med.

1917 (Nov. 12, 2009), available at

http://www.nejm.org/doi/full/

10.1056/NEJMp0908496#t=article ................... 17

Scott Gottlieb, Commissioner of Food

and Drugs, Speech at

Pharmaceutical Care Management

Association PBM Policy Forum

(April 19, 2018), available at

https://www.fda.gov/NewsEvents/

Speeches/ucm605143.htm ................................. 22

Divya Grover, Costly Drugs to Weigh on

U.S. Employers’ Expenses in 2018:

Survey, REUTERS (Sept. 18, 2017),

http://www.reuters.com/article/ususa-healthcare-survey/costly-drugsto-weigh-on-u-s-employers-expensesin-2018-survey-idUSKCN1BT1FR .................... 15

Katherine M. L. Hayes, Three Years

Post-KSR: A Practitioner’s Guide to

“Winning” Arguments on

Obviousness and a Look at What

May Lay Ahead, 9 Nw. J. Tech. &

Intell. Prop. 243 (Fall 2010) ................................ 9

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TABLE OF AUTHORITIES

(continued)

Page

Michael A. Heller & Rebecca S.

Eisenberg, Can Patents Deter

Innovation? The Anticommons in

Biomedical Research, 280 SCIENCE

698 (May 1, 1998), available at

http://science.sciencemag.org/

content/280/5364/698.full .................................. 22

Cynthia M. Ho, Should All Drugs Be

Patentable?: A Comparative

Perspective, 17 Vand. J. Ent. & Tech.

L. 295 (Winter 2015) .................................... 19, 20

I-Mak, Overpatented, Overpriced: How

Excessive Pharmaceutical Patenting

Is Extending Monopolies and

Driving up Drug Prices (2018),

available at http://www.i-mak.org/

wp-content/uploads/2018/08/I-MAKOverpatented-Overpriced-Report.pdf ................ 13

IMS Institute for Healthcare

Informatics, Global Medicines Use in

2020: Outlook and Implications

(Nov. 2015), available at https://

s3.amazonaws.com/assets.fiercemar

kets.net/public/005-LifeSciences/

imsglobalreport.pdf ........................................ 3, 14

Judith A. Johnson, FDA Regulation of

Follow-On Biologics (Cong. Research

Serv., Apr. 26, 2010), https://

primaryimmune.org/wp-content/

uploads/2014/05/Biosimilars_Congre

ssional_Research_Service_Report.

pdf ................................................................ 16, 18

vii

TABLE OF AUTHORITIES

(continued)

Page

Linda A. Johnson & Nicky Forster, AP

Investigation: Drug Prices Continue

to Rise Despite Trump Promise, NBC

7 San Diego (Sept. 25, 2018), https://

www.nbcsandiego.com/news/health/

AP-Investigation-Drug-PricesGoing-Up-Despite-Trump-Promise494246131.html?_osource=taboolarecirc................................................................... 15

Aaron S. Kesselheim, Jerry Avorn, &

Ameet Sarpatwari, The High Cost of

Prescription Drugs in the United

States: Origins and Prospects for

Reform, 316 JAMA 858 (Aug. 2016) .......... passim

Mark A. Lemley, Expecting the

Unexpected, 92 Notre Dame L. Rev.

1369 (Jan. 2017) ................................................... 6

Anne B. Martin et al., National Health

Spending: Faster Growth in 2015 as

Coverage Expands and Utilization

Increases, 36 HEALTH AFFAIRS 166

(Jan. 2017) ................................................... 14, 15

Medicaid and CHIP Payment and

Access Commission, Report to

Congress on Medicaid and CHIP

(June 2016), available at https://

www.macpac.gov/wp-content/

uploads/2016/06/June-2016-Reportto-Congress-on-Medicaid-andCHIP.pdf ............................................................ 13

viii

TABLE OF AUTHORITIES

(continued)

Page

Mercer, Mercer Survey Finds Employers

Hold Health Benefit Cost Increases

to 4.3%, Maintaining Stable Growth

(Sept. 18, 2017), https://www.

mercer.us/our-thinking/healthcare/

mercer-survey-finds-employers-holdhealth-benefit-cost-increases-to-43maintaining-stable-growth.html ....................... 15

Jon F. Merz, Disease Gene Patents:

Overcoming Unethical Constraints

on Clinical Laboratory Medicine, 45

CLINICAL CHEMISTRY 324 (March

1999), available at http://

clinchem.aaccjnls.org/content/45/3/

324.full ............................................................... 23

J. Duncan Moore Jr. & Kristen

Schorsch, How AbbVie Has Won the

Humira Fight—So Far, Crain’s

Chicago Business (Nov. 5, 2016),

http://www.chicagobusiness.com/

article/20161105/ISSUE01/

311059994/how-abbvie-has-won-thehumira-fight-so-far ............................................ 19

Office of the Assistant Secretary for

Planning and Evaluation,

Department of Health & Human

Services, Observations on Trends in

Prescription Drug Spending (Mar. 8,

2016), available at https://aspe.hhs.

gov/pdf-report/observations-trendsprescription-drug-spending ............................... 14

ix

TABLE OF AUTHORITIES

(continued)

Page

Dotan Oliar, Making Sense of the

Intellectual Property Clause:

Promotion of Progress as a

Limitation on Congress’s Intellectual

Property Power, 94 Geo. L.J. 1771

(Aug. 2006) ........................................................... 5

Andrew Pollack, New Patents Aim to

Delay Generics of Biologics, N.Y.

Times, July 15, 2016, at B1,

available at https://www.nytimes.

com/2016/07/16/business/makers-ofhumira-and-enbrel-using-new-drugpatents-to-delay-generic-versions.

html?mcubz=1 .................................................... 18

Douglas L. Rogers, Federal Circuit’s

Obviousness Test for New

Pharmaceutical Compounds:

Gobbledygook? 14 Chi.-Kent J.

Intell. Prop. 49 (Fall 2014) ........................ 8, 9, 12

S&P Dow Jones Indices, Healthcare

Expenditures for Commercial Plans

up 3.2% in the Year to February

2014: S&P Healthcare Claims

Indices (June 30, 2014), available at

http://press.spglobal.com/2014-0630-Healthcare-Expenditures-forCommercial-Plans-up-3-2-in-theYear-to-February-2014-S-PHealthcare-Claims-Indices?

asPDF=1 ............................................................ 15

x

TABLE OF AUTHORITIES

(continued)

Page

Mari Serebrov, Amgen-Abbvie

Agreement Erases Uncertainty for

Humira Biosimilar, BioWorld,

http://www.bioworld.com/content/

amgen-abbvie-agreement-erasesuncertainty-humira-biosimilar-0

(last visited Dec. 18, 2018) ................................. 19

Dan Stanton, AbbVie: Humira’s Patent

Maze Will Keep US Biosimilars

Away Until at Least 2022,

BioPharma Reporter (Nov. 3, 2015),

http://www.biopharma-reporter.com/

Markets-Regulations/AbbVieHumira-s-patent-maze-to-keep-USbiosimilars-at-bay-until-2022 ............................ 18

The Street, AbbVie (ABBV) Earnings

Report: Q3 2015 Conference Call

Transcript (Oct. 30, 2015), available

at https://s.t.st/media/xtranscript/

2015/Q4/13346337.pdf ....................................... 19

David Tseng, Not All Patents Are

Created Equal: Bias Against

Predictable Arts Patents in the PostKSR Landscape 13 Chi.-Kent J.

Intell. Prop. 16 (Fall 2013) .................................. 9

U.S. Food & Drug Administration, FDA

Approves Amjevita, a Biosimilar to

Humira (Sept. 23, 2016), https://

www.fda.gov/newsevents/newsroom/

pressannouncements/

ucm522243.htm ................................................. 18

xi

TABLE OF AUTHORITIES

(continued)

Page

U.S. Food & Drug Administration,

Frequently Asked Questions About

Therapeutic Biological Products,

https://www.fda.gov/drugs/

developmentapprovalprocess/

howdrugsaredevelopedandapproved/

approvalapplications/therapeuticbiol

ogicapplications/ucm113522.htm

(last visited Dec. 17, 2018) ................................... 4

Nancy L. Yu, Preston Atteberry, &

Peter B. Bach, Spending on

Prescription Drugs in the U.S.:

Where Does All the Money Go?,

Health Affairs Blog (Jul. 31, 2018),

https://www.healthaffairs.org/do/10.

1377/hblog20180726.670593/full/?ut

m_source=newsletter&utm_medium

=email&utm_campaign=newsletter_

axiosvitals&stream=top-stories......................... 17

BRIEF OF AMERICA’S HEALTH

INSURANCE PLANS AS AMICUS CURIAE

IN SUPPORT OF PETITIONERS

The undersigned respectfully submits this amicus

curiae brief in support of petitioners.1

INTEREST OF AMICUS CURIAE

America’s Health Insurance Plans (AHIP) is a national association whose members provide coverage

for health care and related services to millions of

Americans every day. These services improve and

protect the health and financial security of consumers, families, businesses, communities, and the nation. AHIP advocates for public policies that expand

access to affordable health care coverage through a

competitive marketplace that fosters choice, quality,

and innovation.

Increases in prescription drug costs are a leading

driver of rising health care costs. AHIP is committed

to practical solutions that reduce consumer costs and

increase patient access to needed medication, so

AHIP has a strong interest in ensuring that claims of

patent invalidity are resolved efficiently and effectively. To that end, AHIP has filed amicus briefs in

other significant cases bearing on issues of drug patents, including Oil States Energy Servs., LLC v.

Greene’s Energy Grp., LLC, 138 S. Ct. 1365 (2018);

1 No counsel for any party authored this brief in whole or in

part, and no person other than amicus or its counsel have made

any monetary contribution intended to fund the preparation or

submission of this brief. All parties to this case received timely

notice under Rule 37.2(a) of amicus’s intent to file this brief, and

all parties consented to the filing of this brief.

2

Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131

(2016); and Saint Regis Mohawk Tribe v. Mylan

Pharm. Inc., 896 F.3d 1322 (2018).

3

SUMMARY OF ARGUMENT

Patents are available only for true innovations—

those acts of creativity that add to the sum of useful

knowledge. Duplicative or obvious products should

not be rewarded with a grant of monopoly power. To

distinguish novel inventions from obvious ones, this

Court has made clear that only a flexible, expansive

approach will suffice.

But the Federal Circuit continues to apply rigid legal rules when assessing the obviousness of pharmaceutical compounds. Its cramped analysis impermissibly elevates the showing required to prove obviousness. That heightened standard makes it more difficult for generic drug companies to combat gamesmanship by brand-name manufacturers, and it encourages the grant of more duplicative patents in the first

place.

This abstract legal error causes very real harm.

Prescription drug prices spiral up at ever-increasing

rates, and drugs protected by patent monopolies

cause the bulk of this price growth.2 While brandname drugs comprise only 10% of all dispensed prescriptions in the United States, they account for 72%

of drug spending.3

2 IMS Institute for Healthcare Informatics, Global Medicines

Use in 2020: Outlook and Implications 9, 13 (Nov. 2015), available at https://s3.amazonaws.com/assets.fiercemarkets.net/public/005-LifeSciences/imsglobalreport.pdf.

3 Aaron S. Kesselheim, Jerry Avorn, and Ameet Sarpatwari,

The High Cost of Prescription Drugs in the United States: Origins

and Prospects for Reform, 316 JAMA 858, 860 (Aug. 2016).

4

As a recent article from the Journal of the American Medical Association explains, “[t]he only form of

competition that consistently and substantially decreases prescription drug prices occurs with the availability of generic drugs, which emerge after the monopoly period ends.”4 Yet drug makers have significant incentives to maximize their market exclusivity

period by seeking duplicative patents in order to block

generic entry for as long as possible.5

The costs and delays caused by these duplicative

and improper patents cause significant harms to

American citizens. They mean that consumers must

pay higher prices, both through direct payments for

prescription medications and through increased insurance premiums. For those who cannot afford expensive branded medications, these delays may mean

no access at all to needed treatments.

This case presents an ideal opportunity for this

Court to clarify that rigid legal tests for obviousness

are as unwelcome in the realm of pharmaceutical

compounds as they are in the sphere of mechanical

patents. By doing so, the Court can reaffirm the basic

constitutional and statutory principles underlying the

4 Id. at 861.

5 References to “prescription drugs” or “drugs” in this brief

include biologics, complex medications that “are generally derived from living material—human, animal, or microorganism.”

U.S. Food & Drug Administration, Frequently Asked Questions

About Therapeutic Biological Products, https://www.fda.gov/

drugs/developmentapprovalprocess/howdrugsaredeveloped

andapproved/approvalapplications/therapeuticbiologicapplications/ucm113522.htm (last visited Dec. 19, 2018). References to

“generics” include biosimilars.

5

patent power, encourage innovation, and protect patients and consumers.

ARGUMENT

I.

The Constitution, Congress, and this

Court all prohibit obvious patents.

When functioning properly, the patent system

serves the public good. It spurs important research

by offering inventors limited-term monopolies on

their products, in return for public access to those discoveries upon expiration of that limited term. But

that careful balance can only be maintained when patents are novel, non-obvious, and for a properly limited term. For duplicative or obvious patents, consumers are saddled with the costs of a patent monopoly without any corresponding benefits.

A.

The Federal Circuit’s use of artificially rigid tests departs from constitutional and statutory directives

and flouts this Court’s precedent.

The federal patent power derives from Article I,

section 8, of the Constitution, which authorizes Congress “[t]o promote the Progress of * * * useful Arts,

by securing for limited Times to * * * Inventors the

exclusive Right to their * * * Discoveries.” U.S. Const.

art. I, § 8, cl. 8.6 That provision “is both a grant of

6 See generally Dotan Oliar, Making Sense of the Intellectual

Property Clause: Promotion of Progress as a Limitation on Congress’s Intellectual Property Power, 94 Geo. L.J. 1771, 1800-01

(Aug. 2006) (explaining that the Framers drafted the Patent

Clause against an “anti-monopolistic background” that included

concerns about “governmental favoritism” and England’s oppressive use of exclusive commercial arrangements).

6

power and a limitation.” Graham v. John Deere Co.

of Kansas City, 383 U.S. 1, 5 (1966).

Based on the constitutional language, this Court

has long held that Congress may not “enlarge the patent monopoly without regard to the innovation, advancement or social benefit gained thereby.” Id. at 6.

Nor may it “authorize the issuance of patents whose

effects are to remove existent knowledge from the

public domain, or to restrict free access to materials

already available.” Id.

In keeping with that constitutional mandate—and

in an effort to codify this Court’s early jurisprudence

on the issue—Congress enacted the Patent Act of

1952. Id. at 3-4, 14-15. Under 35 U.S.C. § 103, a patent for a claimed invention may not be obtained “if

the differences between the claimed invention and the

prior art are such that the claimed invention as a

whole would have been obvious before the effective filing date of the claimed invention to a person having

ordinary skill in the art to which the claimed invention pertains.” When correctly applied, the provision

serves a crucial purpose: it screens out trivial inventions that merely combine known art to predictable

success. See KSR Int’l Co. v. Teleflex Inc., 550 U.S.

398, 416 (2007).

The non-obviousness requirement “is the ‘ultimate

condition’ of patentability—the single most significant doctrine dividing those ideas worth granting a

patent on from run-of-the-mill work that does not deserve a patent.”7 It is thus of paramount importance

7 Mark A. Lemley, Expecting the Unexpected, 92 Notre Dame

L. Rev. 1369, 1371 (Jan. 2017); see also John F. Duffy, Inventing

7

that lower courts—and initial patent reviewers—

have a clear understanding of how to assess obviousness.

The Federal Circuit misunderstood that inquiry

here, applying an artificially rigid test that cabined

its analysis. And not for the first time. In KSR, this

Court reversed a similar decision of the Federal Circuit, emphasizing that artificially rigid legal tests are

contrary to a proper understanding of obviousness.

KSR dealt with the validity of the teaching, suggestion, or motivation (TSM) test, a legal framework created by the Federal Circuit to guide its obviousness

inquiry. KSR, 550 U.S. at 407. Under that test, “a

patent claim is only proved obvious if ‘some motivation or suggestion to combine the prior art teachings’

can be found in the prior art, the nature of the problem, or the knowledge of a person having ordinary

skill in the art.” Id.

In unanimously rejecting “the rigid approach of

the Court of Appeals,” the Court explained that

“[t]hroughout this Court’s engagement with the question of obviousness, our cases have set forth an expansive and flexible approach * * * .” Id. at 415. The

Court acknowledged that the principle underlying the

TSM test, that the existence of a known reason to

combine the prior art can bear on obviousness, was a

Invention: A Case Study of Legal Innovation, 86 Tex. L. Rev. 1, 2

(Nov. 2007) (The obviousness doctrine “is widely understood to

be so fundamental to the proper functioning of the patent system

that it can be accurately described as the ‘final gatekeeper of the

patent system,’ the ‘ultimate condition of patentability,’ and ‘the

heart of the patent law.’” (Footnotes omitted.)).

8

“helpful insight.” Id. at 418. But helpful insights, the

Court cautioned, “need not become rigid and mandatory formulas.” Id. at 419. Indeed, when a helpful

insight is applied rigidly, it demonstrates a fundamental misunderstanding of the concept of obviousness. Id. at 422; see also id. at 421 (“Rigid preventative rules that deny factfinders recourse to common

sense, however, are neither necessary under our case

law nor consistent with it.”).

The lead compound test applied by the Federal

Circuit here thwarts the directives laid out by this

Court in KSR. Like the test in KSR, the lead compound test imposes an inflexible threshold requirement, which must be met before the court can proceed

to the flexible, multi-factor analysis articulated in

Graham and reaffirmed by this Court in KSR.8 See,

e.g., Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d

1280, 1291 (Fed. Cir. 2012) (describing its obviousness analysis as a “two-part inquiry,” with satisfying

the lead compound test as the first, essential, step to

demonstrating obviousness). The lead compound test

is thus “exactly the type of rigid application that [this]

Court warned against in KSR v. Teleflex.”9

8 The lead compound test “requires a challenger to show that

elements in prior art identified (i) the lead compound, (ii) each

individual step thereafter and (iii) the resulting invention, even

though the lead compound was not part of the patent claim.”

Douglas L. Rogers, Federal Circuit’s Obviousness Test for New

Pharmaceutical Compounds: Gobbledygook? 14 Chi.-Kent J. Intell. Prop. 49, 54 (Fall 2014).

9 Briana Barron, Structural Uncertainty: Understanding the

Federal Circuit’s Lead Compound Analysis, 16 Marq. Intell.

Prop. L. Rev. 401, 416 (Summer 2012). Numerous academics

9

There are minor differences between this case and

KSR, most notably the fact that KSR involved a patent for a mechanical invention, while the lead compound test applies to chemical compounds.10 The underlying principles governing the obviousness inquiry, however, remain the same regardless of the nature of the patented art. Put simply, the meaning of

the word “obvious” in 35 U.S.C. § 103 should not differ

depending on the context.11

In sum, the test applied by the Federal Circuit in

this case cannot be squared with this Court’s directives in KSR and artificially limits the courts’ review

of challenged patents. In granting review, this Court

would provide invaluable guidance to the lower

courts—and to the patent office—by affirming that

have observed that the lead compound test is plainly inconsistent with the principles articulated in KSR. See, e.g., Rogers,

Federal Circuit’s Obviousness Test, supra note 8, at 54 (explaining that “the Federal Circuit developed [the lead compound] test

before KSR and continues to apply essentially the same test now,

even though it is inconsistent with KSR”); David Tseng, Not All

Patents Are Created Equal: Bias Against Predictable Arts Patents in the Post-KSR Landscape 13 Chi.-Kent J. Intell. Prop.

165, 179 (Fall 2013) (“The lead compound analysis appears to be

in stark contradiction to the Supreme Court’s disapproval of the

rigid application of rules to determine obviousness.”); Barron,

Structural Uncertainty, supra, at 423 (explaining that the lead

compound test is inconsistent with KSR).

10 See Katherine M. L. Hayes, Three Years Post-KSR: A Prac-

titioner’s Guide to “Winning” Arguments on Obviousness and a

Look at What May Lay Ahead, 9 Nw. J. Tech. & Intell. Prop. 243,

244 (Fall 2010) (“KSR’s impact has differed based on the patented art. While KSR has only tweaked chemical patent inquiries, its effect on mechanical patent validity has been substantial.”).

11 Barron, Structural Uncertainty, supra note 9, at 423.

10

the basic principles governing obviousness apply with

equal force regardless of the nature of the art at issue.

B.

This case illustrates how the application of rigid legal tests can protect duplicative patents.

Not only does the application of artificially rigid

tests directly contravene this Court’s precedent, it

also leads to bad results. The non-obviousness requirement is fundamental to ensuring that patents

serve their most basic purpose: “to add to the sum of

useful knowledge.” Great Atl. & Pac. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152 (1950).

But when, as here, the Federal Circuit erects rigid

barriers to proving obviousness for pharmaceutical

compounds, more improper patents survive, and consumers suffer.

This case provides a good example of how the application of the lead compound test can undermine the

basic premise of the patent system. Through the application of that rigid standard, respondents have

been permitted to obtain and defend multiple patents

on the same antiepileptic drug. If left unchecked,

they will have successfully secured a monopoly on

that drug for more than a quarter century.

And because respondents have simply built upon

prior art without significant additional innovation,

their later patents have added little, if anything, to

the sum of useful knowledge. Any rigid test that permits such evergreen monopolies—without requiring

true invention in the interim—cannot stand because

it does not serve the basic constitutional principles on

which the patent system is founded. See Graham, 383

U.S. at 6 (“Innovation, advancement, and things

11

which add to the sum of useful knowledge are inherent requisites in a patent system which by constitutional command must ‘promote the Progress of * * *

useful Arts.’ This is the standard expressed in the

Constitution and it may not be ignored.”)

The flaws inherent in the lead compound test not

only insulate bad patents from review, they also flow

upstream, encouraging the grant of more duplicative

patents. That is so because, as this Court has observed, there should be a “close[] concurrence” between the standards articulated in judicial precedent

and those applied by the administrative body in

granting patents. See id. at 18-19 (“While we have

focused attention on the appropriate standard to be

applied by the courts, it must be remembered that the

primary responsibility for sifting out unpatentable

material lies in the Patent Office.”).

Accordingly, the Federal Circuit’s application of

artificial constraints on obviousness likely makes it

easier to obtain a duplicative pharmaceutical patent

at the outset.12

Moreover, the cost and difficulty of litigation—

combined with the discouraging rigidity of the current

legal standards—mean that duplicative pharmaceuti-

12 Cf. Dan L. Burk & Mark A. Lemley, Biotechnology’s Uncertainty Principle, 54 Case W. Res. L. Rev. 691, 741 n.214

(Spring 2004) (“Strengthening the obviousness standard will

make it harder to extend patent life through double-patenting * * * .”).

12

cal patents, once issued, may be more likely to survive.13 In placing a heavy threshold burden on patent

challengers seeking to demonstrate obviousness, the

lead compound test may discourage challenges to bad

patents and force settlements that deprive consumers

of access to generic medicines for years or even decades.

As discussed below, the evergreening of pharmaceutical patents causes real harm to consumers. By

allowing duplicative patents for chemical compounds,

the lead compound test contributes to skyrocketing

costs for essential drugs and limits patients’ access to

needed medicine. It also discourages true innovation

by rewarding companies for rehashing timeworn

pharmaceutical technology that should have long

since entered the public domain. Those results are

flatly at odds with the fundamental goals of the patent system.

II.

Duplicative patents contribute to rising

drug prices and harm American consumers.

As this Court is well aware, patents represent

grants of “‘public rights.’” Oil States Energy Servs.,

LLC v. Greene’s Energy Grp., LLC, 138 S. Ct. 1365,

1374 (2018). Congress designed the patent system to

spur innovation through a limited period of monopoly,

and then provide greater consumer access and decreased costs when competitors enter the market.

13 See Rogers, Federal Circuit’s Obviousness Test, supra note

8, at 54 (explaining that the lead compound test for pharmaceutical compounds “generally makes it more difficult than under

KSR to prove obviousness”).

13

Duplicative patents thwart this plan, stifling innovation and driving up costs. And the harms of improper

patents are particularly acute in the pharmaceutical

context.14

A.

Patents on prescription drugs significantly and directly affect consumer costs.

Rising prescription drug prices are a serious problem for our nation and economy. The United States

spends 18% of its gross domestic product on health

care, up from just 7% in 1970. 15 A significant portion

of that health care spending goes toward prescription

drugs.16 As of February 2018, the nation spent approximately $354 billion annually on prescription

14 I-Mak, Overpatented, Overpriced: How Excessive Pharma-

ceutical Patenting Is Extending Monopolies and Driving up Drug

Prices 11 (2018), available at http://www.i-mak.org/wp-content/

uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf.

15 Altarum Institute, Center for Sustainable Health Spending, Insights from Monthly National Health Spending Data

Through December 2015 1 (Feb. 16, 2016), available at https://altarum.org/sites/default/files/uploaded-related-files/CSHSSpending-Brief_February_2016.pdf; Medicaid and CHIP Payment and Access Commission, Report to Congress on Medicaid

and CHIP 3 (June 2016), available at https://www.macpac.gov/

wp-content/uploads/2016/06/June-2016-Report-to-Congress-onMedicaid-and-CHIP.pdf; Centers for Medicare & Medicaid Services, NHE Fact Sheet, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet.html (last visited

Dec. 19, 2018).

16 See Altarum Center for Value in Health Care, Health Sec-

tor Economic Indicators: Insights from Monthly National Health

14

drugs.17 That represents a 4.2% increase over 2017,18

and drug prices continue to increase both nationally

and globally.19

Patented drugs cause the bulk of this spiraling

price growth. Although brand-name drugs represent

only 10% of all dispensed prescriptions in the United

States, they account for 72% of drug spending.20 Between 2008 and 2015, prices for the most commonly

used brand-name drugs increased by 164%, far in excess of the 12% increase in the consumer price index.21

In 2015, prices for existing brand-name drugs reached

a double-digit growth rate for the fourth consecutive

year, while prices for generic drugs increased less

than 1%.22 More recently, over the first seven months

Spending Data through February 2018 2 (April 13, 2018), available at https://altarum.org/sites/default/files/uploaded-relatedfiles/SHSS-Spending-Brief_April_2018.pdf.

17 Id.

18 Id. at 3.

19 See Office of the Assistant Secretary for Planning and

Evaluation, Department of Health & Human Services, Observations on Trends in Prescription Drug Spending 7 (Mar. 8, 2016),

available at https://aspe.hhs.gov/pdf-report/observations-trendsprescription-drug-spending (“Expenditures on prescription

drugs are rising and are projected to continue to rise in the coming years as a share of total health care spending.”); IMS Institute for Healthcare Informatics, Global Medicines Use in 2020,

supra note 2, at 1, 16.

20 Kesselheim, et al., High Cost of Prescription Drugs, supra

note 3, at 860.

21 Id.

22 Anne B. Martin et al., National Health Spending: Faster

Growth in 2015 as Coverage Expands and Utilization Increases,

15

of 2018, there were 96 price increases on brand-name

drugs for every price cut.23 And experts expect the

upward trend on drug spending to continue.24

As noted earlier, “[t]he only form of competition

that consistently and substantially decreases prescription drug prices occurs with the availability of generic drugs, which emerge after the monopoly period

ends.”25 Typically, the presence of generic medications can cut branded drug prices by half or even

36 Health Affairs 166, 174-75 (Jan. 2017). In 2014, brand-name

drug prices grew by 15.4% while prices for generics grew by only

0.2%. S&P Dow Jones Indices, Healthcare Expenditures for

Commercial Plans up 3.2% in the Year to February 2014: S&P

Healthcare Claims Indices (June 30, 2014), available at http://

press.spglobal.com/2014-06-30-Healthcare-Expenditures-forCommercial-Plans-up-3-2-in-the-Year-to-February-2014-S-PHealthcare-Claims-Indices?asPDF=1.

23 Linda A. Johnson & Nicky Forster, AP Investigation: Drug

Prices Continue to Rise Despite Trump Promise, NBC 7 San Diego (Sept. 25, 2018), https://www.nbcsandiego.com/news/health/

AP-Investigation-Drug-Prices-Going-Up-Despite-Trump-Promise-494246131.html?_osource=taboola-recirc.

24 Divya Grover, Costly Drugs to Weigh on U.S. Employers’

Expenses in 2018: Survey, Reuters (Sept. 18, 2017), http://

www.reuters.com/article/us-usa-healthcare-survey/costlydrugs-to-weigh-on-u-s-employers-expenses-in-2018-surveyidUSKCN1BT1FR (citing Mercer, Mercer Survey Finds Employers Hold Health Benefit Cost Increases to 4.3%, Maintaining Stable Growth (Sept. 18, 2017), https://www.mercer.us/our-thinking/healthcare/mercer-survey-finds-employers-hold-health-benefit-cost-increases-to-43-maintaining-stable-growth.html).

25 Kesselheim et al., High Cost of Prescription Drugs, supra

note 3, at 861.

16

more.26 “Drug prices decline to approximately 55% of

brand-name drug prices with 2 generic manufacturers making the product, 33% with 5 manufacturers,

and 13% with 15 manufacturers.”27 And a 2012 government

study

estimated

that

“generic

drugs * * * saved the US health care system $1 trillion during the previous decade.”28

While the patent system has benefits, the existence of a patent monopoly for a prescription drug

comes at a heavy price for patients who cannot afford

life-saving medications, consumers and businesses

who pay higher and higher premiums because of rising drug prices, and hardworking taxpayers who fund

public programs like Medicaid and Medicare.

B.

Some brand-name companies use

duplicative or obvious patents to artificially prolong their monopolies

on lucrative drugs.

Manufacturers of name-brand pharmaceuticals

reap huge benefits from patents; these grants of public rights give them a period of monopoly on the drugs

they develop and allow them to extract from the pub-

26 Judith A. Johnson, FDA Regulation of Follow-On Biologics

2 (Cong. Research Serv., Apr. 26, 2010), https://primaryimmune.org/wp-content/uploads/2014/05/Biosimilars_Congressional_Research_Service_Report.pdf.

27 Kesselheim et al., High Cost of Prescription Drugs, supra

note 3, at 861.

28 Id.

17

lic the maximum possible returns on their investments.29 See Oil States Energy Servs., 138 S. Ct. at

1373-74. Because the monopoly power of a patent

confers huge benefits, companies do everything they

can to retain that power. Those efforts may include

“seeking and obtaining many patents of questionable

validity” and “engaging in frequent and costly patent

litigation” for improper purposes.30

Respondents’ conduct in attempting to obtain duplicative patents for their lucrative drug is hardly

unique—indeed, such attempts to “evergreen” a patent are a key part of the business strategy of many

name-brand drug manufacturers.31 Consider, for example, the medication Humira (adalimumab), which

29 See id. at 860 (“Drug prices are higher in the United States

than in the rest of the industrialized world because, unlike that

in nearly every other advanced nation, the US health care system allows manufacturers to set their own price for a given product.”) In 2016, total U.S. expenditures on pharmaceutical drugs

were $480 billion. Two-thirds of this total ($323 billion) was captured by drug manufacturers in the form of net revenues. Nancy

L. Yu, Preston Atteberry, & Peter B. Bach, Spending on Prescription Drugs in the U.S.: Where Does All the Money Go?, Health

Affairs Blog (Jul. 31, 2018), https://www.healthaffairs.org/do/

10.1377/hblog20180726.670593/full/?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top-stories.

30 Alfred B. Engelberg, Aaron S. Kesselheim, & Jerry Avorn,

Balancing Innovation, Access, and Profits — Market Exclusivity

for Biologics, 361 New Eng. J. Med. 1917, 1919 (Nov. 12, 2009),

available

at

http://www.nejm.org/doi/full/10.1056/NEJMp

0908496#t=article.

31 Roger Collier, Drug Patents: The Evergreening Problem,

185 Can. Med. Ass’n J. E385, E385 (June 11, 2013), available at

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3680578/.

18

costs over $50,000/year and is the top selling medication in the world.32 The original patent on Humira

expired in 2016, and the FDA has already approved a

biosimilar (generic) version.33 Yet the company that

owns Humira has acquired a web of over 70 other ancillary patents to protect Humira, the “‘vast majority’”

of which it obtained within the last two years before

its original patent expired.34

32 Johnson, FDA Regulation of Follow-On Biologics, supra

note 26, at 1; Amy Brown, Evaluate Grp., EP Vantage 2017 Preview 5 (Dec. 2016), available at http://info.evaluategroup.com/

rs/607-YGS-364/images/EPV2017Prev.pdf.

33 U.S.

Food & Drug Administration, FDA Approves Amjevita, a Biosimilar to Humira (Sept. 23, 2016), https://

www.fda.gov/newsevents/newsroom/pressannouncements/

ucm522243.htm. Humira is a “biologic,” which as explained

above is a relatively new category of high-priced specialty medications made from living material. See supra note 5.

34 Dan Stanton, AbbVie: Humira’s Patent Maze Will Keep US

Biosimilars Away Until at Least 2022, BioPharma Reporter

(Nov. 3, 2015), https://www.biopharma-reporter.com/Article/2015/11/03/AbbVie-Humira-s-patent-maze-to-keep-US-biosimilars-at-bay-until-2022; see also Andrew Pollack, New Patents Aim to Delay Generics of Biologics, N.Y. Times, July 15,

2016, at B1, available at https://www.nytimes.com/2016/07/

16/business/makers-of-humira-and-enbrel-using-new-drug-patents-to-delay-generic-versions.html?mcubz=1. The follow-on

patents AbbVie obtained for Humira include 22 patents for

method of treatment (e.g., giving Humira to patients by injection), and 24 patents on different ways to make Humira. Stanton, Humira’s Patent Maze, supra.

19

The company that owns Humira is attempting to

use these patents to “cocoon Humira by tying up competitors in expensive and lengthy court battles.”35 As

the CEO told investors on an earnings report conference call, “[a]ny company seeking to market a biosimilar version of Humira will have to contend with this

extensive patent estate, which [we] intend[] to enforce

vigorously.”36 “[W]e believe the litigation process and

our intellectual property estate will protect Humira

from biosimilar entry until 2022.”37

Another classic example of evergreening involves

the heartburn treatment, Prilosec.38 Prilosec was the

world’s best-selling pharmaceutical drug in 2001.39

35 J. Duncan Moore Jr. & Kristen Schorsch, How AbbVie Has

Won the Humira Fight—So Far, Crain’s Chicago Business (Nov.

5, 2016), http://www.chicagobusiness.com/article/20161105/ISSUE01/311059994/how-abbvie-has-won-the-humira-fight-sofar. Or, as a recent article put it, “Abbvie has built a thick patent

fence around its cash cow.” Mari Serebrov, Amgen-Abbvie Agreement Erases Uncertainty for Humira Biosimilar, BioWorld,

http://www.bioworld.com/content/amgen-abbvie-agreementerases-uncertainty-humira-biosimilar-0 (last visited Dec. 18,

2018).

36 The

Street, AbbVie (ABBV) Earnings Report: Q3 2015

Conference Call Transcript 9 (Oct. 30, 2015), available at https://

s.t.st/media/xtranscript/2015/Q4/13346337.pdf.

37 Id. at 11.

38 Cynthia M. Ho, Should All Drugs Be Patentable?: A Com-

parative Perspective, 17 Vand. J. Ent. & Tech. L. 295, 315 (Winter 2015); see also Jessie Cheng, An Antitrust Analysis of Product

Hopping in the Pharmaceutical Industry, 108 Colum. L. Rev.

1471, 1489-91 (Oct. 2008).

39 Ho, Should All Drugs Be Patentable?, supra note 38, at

318.

20

The patent on the active ingredient for that drug expired in 2001, but the manufacturer obtained additional patents, such as a patent for the internal coating on Prilosec pills, in an effort to delay generic entry

into the market.40 The manufacturer also patented a

minor variation of the chemical compound in Prilosec

and marketed it as a new and ostensibly improved

drug, Nexium.41

It then strategically released

Nexium one month before Prilosec’s patent was set to

expire—and before any generics could enter the market—and withdrew Prilosec from the prescription

pharmaceutical market.42 That strategy was “highly

successful in prompting most consumers to switch

from Prilosec to Nexium” and enabled the manufacturer to largely maintain its monopoly over prescription heartburn medication.43

This Court has long made clear that “any attempted reservation or continuation in the patentee

or those claiming under him of the patent monopoly,

after the patent expires, whatever the legal device

employed, runs counter to the policy and purpose of

the patent laws.” Scott Paper Co. v. Marcalus Mfg.

Co., 326 U.S. 249, 256 (1945). Yet, as the examples

above and this case illustrate, companies with valuable patents are throwing research and development

funding into gaining ancillary patents that they can

use to protect their lucrative brand-name drugs even

40 Id. at 315.

41 Id. at 318; see also Cheng, An Antitrust Analysis of Product

Hopping, supra note 38, at 1490 n.112.

42 Ho, Should All Drugs Be Patentable?, supra note 38, at

319.

43 Id. at 318.

21

after the original patent expires. Artificially rigid

tests shield those duplicative patents from challenge

and improperly extend monopoly power, contributing

to rising drug prices and harming the public.

C.

Duplicative patents threaten the

delicate balance between spurring

innovation and enabling public access to inventions.

The existence of duplicative patents drives up

costs for consumers, insurance companies, and the

government. When a patent issues inappropriately or

a monopoly is improperly prolonged, prices for the patented technology remain artificially high.

In addition to increasing costs, high drug prices

limit patients’ access to needed medicine. High drug

prices limit access both directly, through increased

out-of-pocket costs, and indirectly, by raising health

insurance premiums for everyone. This, in turn, may

force some patients to rely on less effective over-thecounter medicine or simply forgo treatment all together. Indeed, in 2016, 11% of Americans went without a needed prescription medicine because they

could not afford it.44 And patients are nearly three

times more likely to abandon their prescription for a

44 Board of Governors of the Federal Reserve System, Report

on the Economic Well-Being of U.S. Households in 2016 28 (May

2017), available at https://www.federalreserve.gov/publications/

files/2016-report-economic-well-being-us-households201705.pdf.

22

brand-name drug than for a generic one.45 Prescription abandonment, in turn, can negatively impact patient health and may, in some cases, lead to hospitalization or death.46

The existence of improper patents can also stifle

innovation. Scientists may be chilled from cuttingedge research for fear of legal issues created by the

invalid patents. In a survey of clinical laboratory directors, more than half reported deciding not to develop a new clinical genetic test because of concern

about an existing patent or license, and a quarter reported that they had stopped performing a genetic

test because of a patent or license.47 Even the

“knowledge that a patent application has been filed

45 Chester Davis, Jr., CEO of Ass’n for Accessible Medicines,

Statement to the Senate Health, Education, Labor and Pensions

Committee: The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay 6 (Oct. 17, 2017), available

at https://www.help.senate.gov/imo/media/doc/Davis6.pdf.

46 Id.;

see also Scott Gottlieb, Commissioner of Food and

Drugs, Speech at Pharmaceutical Care Management Association

PBM Policy Forum (April 19, 2018), available at

https://www.fda.gov/NewsEvents/Speeches/ucm605143.htm

(“High prices at the pharmacy counter can lead to patients abandoning prescriptions, worsening health outcomes, and raising

overall health care costs.”).

47 Mildred K. Cho et al., Effects of Patents and Licenses on

the Provision of Clinical Genetic Testing Services, 5 J. Molecular

Diagnostics 3, 7 (Feb. 2003), available at https://www.ncbi.nlm.

nih.gov/pmc/articles/PMC1907368/#__ffn_sectitle; see also Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Sci. 698

(May 1, 1998), available at http://science.sciencemag.org/content/280/5364/698.full.

23

can influence the decision to spend the time and resources to develop a clinical test because of the uncertain risk that a patent holder will later prevent the

laboratory from continuing to provide this service.”48

Duplicative patents impose real burdens on Americans and subvert the goals of the patent system.

And, in the pharmaceutical context, improperly extending a patent monopoly can have life-or-death repercussions. This case provides an ideal opportunity

for the Court to correct the Federal Circuit’s misunderstanding of the law, enforce the constitutional

text, and protect American consumers from rising

drug prices.

CONCLUSION

Amicus respectfully urges this Court to grant the

petition for certiorari.

48 Jon F. Merz, Disease Gene Patents: Overcoming Unethical

Constraints on Clinical Laboratory Medicine, 45 Clinical Chemistry 324, 327 (March 1999), available at http://clinchem.aaccjnls.org/content/45/3/324.full.pdf.

24

Respectfully submitted,

JULIE SIMON MILLER

MICHAEL S. SPECTOR

AMERICA’S HEALTH

INSURANCE PLANS

601 Pennsylvania Ave., NW

Washington, DC 20004

December 2018

ANNA-ROSE MATHIESON

Counsel of Record

SUSAN YORKE

CALIFORNIA APPELLATE

LAW GROUP LLP

96 Jessie Street

San Francisco, CA 94105

(415) 649-6700

annarose@calapplaw.com