Nos. 19-1434, -1452, and -1458
`
`IN THE
`Supreme Court of the United States
`
`UNITED STATES OF AMERICA, Petitioner,
`v.
`ARTHREX, INC., ET AL.
`
`SMITH & NEPHEW, INC. AND
`ARTHROCARE CORP., Petitioners,
`v.
`ARTHREX, INC. AND THE
`UNITED STATES OF AMERICA.
`
`ARTHREX, INC., Petitioner,
`v.
`SMITH & NEPHEW, INC., ARTHROCARE CORP.,
`AND THE UNITED STATES OF AMERICA.
`
`ON WRITS OF CERTIORARI
`TO THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`BRIEF OF THE COALITION AGAINST PATENT
`ABUSE AS AMICUS CURIAE IN SUPPORT OF NO
`PARTY
`
`CHARLES DUAN
`Counsel of Record
`1801 Columbia Road, Suite 101
`Washington DC 20009
`(202) 713-5799
`supremecourt.gov@cduan.com
`
`Counsel for amicus curiae
`
`
`
`IN THE
`Supreme Court of the United States
`
`UNITED STATES OF AMERICA, Petitioner,
`v.
`ARTHREX, INC., ET AL.
`
`SMITH & NEPHEW, INC. AND
`ARTHROCARE CORP., Petitioners,
`v.
`ARTHREX, INC. AND THE
`UNITED STATES OF AMERICA.
`
`ARTHREX, INC., Petitioner,
`v.
`SMITH & NEPHEW, INC., ARTHROCARE CORP.,
`AND THE UNITED STATES OF AMERICA.
`
`ON WRITS OF CERTIORARI
`TO THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`BRIEF OF THE COALITION AGAINST PATENT
`ABUSE AS AMICUS CURIAE IN SUPPORT OF NO
`PARTY
`
`CHARLES DUAN
`Counsel of Record
`1801 Columbia Road, Suite 101
`Washington DC 20009
`(202) 713-5799
`supremecourt.gov@cduan.com
`
`Counsel for amicus curiae
`
`
`
`TABLE OF CONTENTS
`
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`TABLE OF AUTHORITIES .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`INTEREST OF AMICUS CURIAE .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`SUMMARY OF ARGUMENT .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`ARGUMENT .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`I. The Patent Trial and Appeal Board Has Proven Its
`Merit in Reviewing Patents That Wrongfully Raise
`Drug Prices and Harm American Consumers .
`.
`.
`A. Alzheimer’s Disease .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`B. Opioid Addiction .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`C.
`Insulin .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`D. Prostate Cancer .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`E. Ulcerative Colitis .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`F. Heart Disease .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`G. Anemia .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`II. The Appointments Clause Should Not Undermine
`the Impartiality and Objectivity of the Board .
`.
`.
`A. The Board Is and Ought to Be Structured
`to Minimize Political Actors’ Influence over
`Patent Decisions .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`B. What the Federal Circuit Thought the Appoint-
`ments Clause Requires, This Court’s Justices
`Have Vigorously Denounced .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`C. Courts, Not Political Officers, Supervise Board
`Decisions That Are Largely Matters of Pure
`Law .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`D. To Ensure the Board’s Impartiality, This Court
`Should Find It Constitutional or Apply a Mini-
`mally Disruptive Remedy .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`CONCLUSION .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`.
`.
`.
`
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`ii
`.
`. 1
`. 1
`. 4
`
`. 4
`. 9
`. 11
`. 13
`. 16
`. 17
`. 19
`. 20
`
`. 21
`
`.
`
`. 22
`
`.
`
`. 23
`
`.
`
`. 26
`
`.
`.
`
`. 30
`. 32
`
`(i)
`
`
`
`TABLE OF AUTHORITIES
`
`CASES AND ADMINISTRATIVE DECISIONS
`
`Accord Healthcare Inc. v. Daiichi Sankyo Co.,
`No. IPR2015-00864 (P.T.A.B. Sept. 12, 2016) (final
`written decision) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`Alappat, In re,
`33 F.3d 1526 (Fed. Cir. 1994) (en banc)
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019)
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 20
`
`. 24
`
`. 23, 30
`
`BioDelivery Sciences International, Inc.
`v. RB Pharmaceuticals Ltd.,
`667 F. App’x 997 (Fed. Cir. 2016) .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 13
`
`BioDelivery Sciences International, Inc.
`v. RB Pharmaceuticals Ltd.,
`No. IPR2014-00325 (P.T.A.B. June 30, 2015) (final
`written decision) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`. 13
`
`BTG International Ltd.
`v. Amneal Pharmaceuticals LLC,
`923 F.3d 1063 (Fed. Cir. 2019)
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 16–17
`
`Cleveland Clinic Foundation
`v. True Health Diagnostics LLC,
`760 F. App’x 1013 (Fed. Cir. 2019) .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 27
`
`Consumer Watchdog
`v. Wisconsin Alumni Research Foundation,
`753 F.3d 1258 (Fed. Cir. 2014)
`.
`.
`.
`.
`.
`.
`.
`.
`
`Cuozzo Speed Technologies, LLC v. Lee,
`136 S. Ct. 2131 (2016) .
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`Daiichi Sankyo Co. v. Accord Healthcare Inc.,
`706 F. App’x 679 (Fed. Cir. 2017) .
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 29
`
`. 28
`
`. 20
`
`(ii)
`
`
`
`(iii)
`
`Dr. Falk Pharma GmbH v. GeneriCo, LLC,
`No. 17-2312 (Fed. Cir. June 12, 2019) (nonpreceden-
`tial)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 18
`
`Edmond v. United States,
`520 U.S. 651 (1997) .
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 26, 28
`
`Free Enterprise Fund
`v. Public Co. Accounting Oversight Board,
`561 U.S. 477 (2010) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`Freytag v. Commissioner,
`501 U.S. 868 (1991) .
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`General Electric Co. v. United Technologies Corp.,
`928 F.3d 1349 (Fed. Cir. 2019)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`GeneriCo, LLC v. Dr. Falk Pharma GmbH,
`No. IPR2016-00297 (P.T.A.B. May 19, 2017) (final
`written decision) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 26
`
`. 28
`
`. 29
`
`. 18–19
`
`.
`
`.
`
`. 26
`
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`Great Atlantic & Pacific Tea Co.
`v. Supermarket Equipment Corp.,
`340 U.S. 147 (1950) .
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Hospira, Inc. v. Janssen Pharmaceuticals, Inc.,
`No. IPR2013-00365 (P.T.A.B. Oct. 24, 2013)
`
`.
`
`Indivior Inc. v. Dr. Reddy’s Laboratories, SA,
`930 F.3d 1325 (Fed. Cir. 2019)
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Lantus Direct Purchaser Antitrust Litigation, In re,
`950 F.3d 1 (1st Cir. 2020)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 26
`
`. 20
`
`. 13
`
`. 15
`
`. 28
`
`. 27
`
`
`
`(iv)
`
`Morrison v. Olson,
`487 U.S. 654 (1988) .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 28
`
`Mylan Pharmaceuticals Inc.
`v. Sanofi-Aventis Deutschland GmbH,
`No. IPR2018-01678 (P.T.A.B. May 29, 2020) (final
`written decision) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 14–15
`
`Nidec Motor Corp.
`v. Zhongshan Broad Ocean Motor Co.,
`868 F.3d 1013 (Fed. Cir. 2017)
`.
`.
`.
`.
`.
`
`.
`
`.
`
`Novartis AG v. Noven Pharmaceuticals Inc.,
`853 F.3d 1289 (Fed. Cir. 2017)
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 24
`
`. 9–11
`
`Novartis Pharmaceuticals Corp.
`v. Par Pharmaceutical, Inc.,
`48 F. Supp. 3d 733 (D. Del. 2015) .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 10–11
`
`Novartis Pharmaceuticals Corp.
`v. Watson Laboratories, Inc.,
`611 F. App’x 988 (Fed. Cir. 2015) (nonpreceden-
`tial)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 10–11
`
`Oil States Energy Services, LLC
`v. Greene’s Energy Group, LLC,
`138 S. Ct. 1365 (2018) .
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Rivastigmine Patent Litigation, In re,
`No. 1:05-md-1551 (S.D.N.Y. Sept. 22, 2005) .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 24–25
`
`.
`
`.
`
`. 9
`
`Sanofi-Aventis Deutschland GmbH
`v. Mylan Pharmaceuticals Inc.,
`No. 20-1871 (Fed. Cir. June 10, 2020)
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 14
`
`Sanofi-Aventis Deutschland GmbH
`v. Mylan Pharmaceuticals Inc.,
`No. 2012-1368, -1369 (Fed. Cir. Nov. 19, 2019)
`(nonprecedential)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`. 14
`
`
`
`(v)
`
`Seila Law LLC
`v. Consumer Financial Protection Bureau,
`140 S. Ct. 2183 (2020) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.,
`135 S. Ct. 831 (2015) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`Thryv, Inc. v. Click-to-Call Technologies, LP,
`140 S. Ct. 1367 (2020) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 30
`
`. 27
`
`. 24, 29
`
`United States v. Indivior Solutions, Inc.,
`No. 1:19-cr-16 (W.D. Va. dismissed Nov. 12, 2020) .
`
`Wi-Fi One, LLC v. Broadcom Corp.,
`878 F.3d 1364 (Fed. Cir. 2018) (en banc) .
`
`Winans v. New York & Erie Railroad Co.,
`62 U.S. (21 How.) 88 (1858) .
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 12
`
`. 25
`
`. 27
`
`Yissum Research Development Co. of the Hebrew
`University of Jerusalem v. Sony Corp.,
`626 F. App’x 1006 (Fed. Cir. 2015) (affirmed without
`opinion) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 24
`
`CONSTITUTIONAL PROVISIONS
`
`U.S. CONST. art. II, § 2, cl. 2 .
`
`——— art. III .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 3, 21, 23, 25–27, 31
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 11, 25, 29
`
`STATUTES
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 23
`
`35 U.S.C. § 3(a)(2)(A)
`
`——— § 6(a) .
`
`——— § 6(c) .
`
`——— § 102 .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 8, 22
`
`. 22–24
`
`.
`
`.
`
`. 26
`
`
`
`(vi)
`
`35 U.S.C. § 103 .
`
`.
`
`——— § 311(b)
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 26
`
`. 27
`
`——— § 314(b)
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 23, 26
`
`OTHER SOURCES
`
`Abiraterone Acetate, 10 DRUGS R & D 261 (2010) .
`
`.
`
`.
`
`.
`
`.
`
`. 16
`
`A New Way to Treat Prostate Cancer: The Story of
`Abiraterone, INST. CANCER RES. (May 26, 2011),
`https://www.icr.ac.uk/news-features/latest-features/
`a-new-way-to-treat-prostate-cancer-the-story-of-
`abiraterone .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`. 16
`
`ASS’N FOR ACCESSIBLE MEDS., GENERIC DRUG AC-
`CESS & SAVINGS IN THE U.S. (2017), https://
`accessiblemeds.org/resources/blog/2017-generic-
`drug-access-and-savings-us-report .
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`. 5
`
`Reed F. Beall & Aaron S. Kesselheim, Tertiary Patenting
`on Drug–Device Combination Products in the United
`States, 36 NATURE BIOTECHNOLOGY 142 (2018) .
`.
`.
`
`.
`
`. 14
`
`Jacob Bell, Pfizer Launches Biosimilar Version of
`Amgen’s Epogen, BIOPHARMA DIVE (Nov. 14,
`2018), https://www.biopharmadive.com/news/pfizer-
`launches-biosimilar-version-of-amgens-epogen/
`542282/
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`. 21
`
`Matthew Bultman, Hedge Fund Drug Patent Challenges
`in Doubt After Bass’ Test, LAW360 (Mar. 31, 2017),
`https://www.sternekessler.com/sites/default/files/
`2018-01/Hedge_Fund_Drug_Patent_Challenges_In_
`Doubt_After_Bass_Test.pdf .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 7
`
`
`
`(vii)
`
`COAL. AGAINST PATENT ABUSE & MORNING CONSULT,
`REFORMING THE PATENT SYSTEM (Nov. 2020),
`https://www.capanow.org/wp-content/uploads/2020/
`11/CAPA_Memo_MC.pdf .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`. 4, 6
`
`COMPETITION DIR.-GEN., EUROPEAN COMM’N, PHAR-
`MACEUTICAL SECTOR INQUIRY: FINAL REPORT
`(July 8, 2009), https://ec.europa.eu/competition/
`sectors/pharmaceuticals/inquiry/staff_working_
`paper_part1.pdf .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`. 7–8
`
`RYAN CONRAD & RANDALL LUTTER, U.S. FOOD & DRUG
`ADMIN., GENERIC COMPETITION AND DRUG PRICES:
`NEW EVIDENCE LINKING GREATER GENERIC
`COMPETITION AND LOWER GENERIC DRUG PRICES
`(Dec. 2019), https://www.fda.gov/media/133509/
`download .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 5, 9
`
`.
`
`.
`
`Frank B. Cross & Emerson H. Tiller, Judicial Partisan-
`ship and Obedience to Legal Doctrine: Whistleblow-
`ing on the Federal Courts of Appeals, 107 YALE L.J.
`2155 (1998) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 22
`
`CTRS. FOR MEDICARE & MEDICAID SERVS., METHODOL-
`OGY FOR CALCUL ATING THE NATIONAL AVERAGE
`DRUG ACQUISITION COST (NADAC) FOR MEDI-
`CAID COVERED OUTPATIENT DRUGS (Nov. 2013),
`https://www.medicaid.gov/medicaid-chip-program-
`information/by-topics/prescription-drugs/ful-nadac-
`downloads/nadacmethodology.pdf .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`Jonathan J. Darrow et al., The Generic Drug Industry
`Embraces a Faster, Cheaper Pathway for Challeng-
`ing Patents, 17 APPLIED HEALTH ECON. & HEALTH
`POL’Y 47 (2018) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 6
`
`.
`
`. 7
`
`
`
`(viii)
`
`John E. Dicken, U.S. Gov’t Accountability Office, Letter
`to Orrin G. Hatch, U.S. Senate, GAO-12-371R:
`Savings from Generic Drug Use (Jan. 31, 2012),
`https://www.gao.gov/assets/590/588064.pdf
`.
`.
`.
`
`.
`
`.
`
`Eli Lilly & Co., Annual Report (Form 10-K) (Feb. 21,
`2017)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`Robin Feldman, May Your Drug Price Be Evergreen, 5
`J.L. & BIOSCIENCES 590 (2018) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`. 5–6
`
`.
`
`.
`
`. 19
`
`. 8
`
`John M. Golden, PTO Panel Stacking: Unblessed by the
`Federal Circuit and Likely Unlawful, 104 IOWA L.
`REV. 2447 (2019) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`. 25
`
`Rebecca L. Haffajee & Richard G. Frank, Generic Drug
`Policy and Suboxone to Treat Opioid Use Disorder,
`. 12–13
`47 J.L. MED. & ETHICS 43 (2019)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`C. Scott Hemphill & Bhaven N. Sampat, When Do
`Generics Challenge Drug Patents?, 8 J. EMPIRICAL
`LEGAL STUD. 613 (2011)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`C. Scott Hemphill & Bhaven Sampat, Drug Patents at
`the Supreme Court, 339 SCIENCE 1386 (2013)
`.
`.
`.
`
`HOUSE OF REPRESENTATIVES REPORT NO. 96-1307
`(1980) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`HOUSE OF REPRESENTATIVES REPORT NO. 112-98
`(2011) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 8
`
`. 7
`
`. 22
`
`. 4
`
`Amy Kapczynski et al., Polymorphs and Prodrugs
`and Salts (Oh My!): An Empirical Analysis of
`“Secondary” Pharmaceutical Patents, 7 PLOS ONE
`No. e49470 (2012), https://journals.plos.org/plosone/
`article?id=10.1371/journal.pone.0049470 .
`.
`.
`.
`.
`.
`
`.
`
`.
`
`. 8
`
`A.K. Azad Khan et al., An Experiment to Determine
`the Active Therapeutic Moiety of Suphasalazine, 310
`LANCET 892 (1977)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 17
`
`
`
`(ix)
`
`Ashley Kirzinger et al., KFF Health Tracking Poll—
`February 2019: Prescription Drugs, KAISER FAM.
`FOUND. (Mar. 1, 2019), https://www.kff.org/health-
`costs/poll-finding/kff-health-tracking-poll-february-
`2019-prescription-drugs/
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 4–6
`
`Lewis A. Kornhauser & Lawrence G. Sager, Unpacking
`the Court, 96 YALE L.J. 82 (1986)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 22
`
`Joe Matal, A Guide to the Legislative History of the
`America Invents Act: Part II of II, 21 FED. CIR. B.J.
`539 (2012) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 4
`
`John Mayberry, The History of 5-ASA Compounds
`and Their Use in Ulcerative Colitis—Trailblazing
`Discoveries in Gastroenterology, 22 J. GASTROIN-
`TESTINAL & LIVER DISEASES 375 (2013) .
`.
`.
`.
`.
`.
`
`.
`
`.
`
`. 17
`
`Andrew C. Michaels, Retroactivity and Appointments,
`52 LOY. U. CHI. L.J. (forthcoming 2020), https://
`papers.ssrn.com/sol3/papers.cfm?abstract_id=
`3650166 .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`Andrew Michaels, How Much Deference Courts Owe
`to USPTO Guidance, LAW360 (June 20, 2019),
`https://www.law360.com/articles/1171217/how-
`much-deference-courts-owe-to-uspto-guidance .
`
`.
`
`.
`
`Takaji Miyake et al., Purification of Human Erythropoi-
`etin, 252 J. BIOLOGICAL CHEMISTRY 5558 (1977) .
`.
`.
`
`Oral Argument, Yissum Research Dev. Co. of the Hebrew
`Univ. of Jerusalem v. Sony Corp., 626 F. App’x 1006
`(Fed. Cir. Dec. 7, 2015) (No. 2015-1343) (affirmed
`without opinion) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`Oral Argument, Wi-Fi One, LLC v. Broadcom Corp.,
`878 F.3d 1364 (Fed. Cir. May 4, 2017) (No. 2015-1944,
`-1945, -1946) (en banc) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 25
`
`.
`
`. 31
`
`.
`
`.
`
`. 27
`
`. 20
`
`.
`
`. 24
`
`
`
`(x)
`
`PATENT TRIAL & APPEAL BD., STANDARD OPERAT-
`ING PROCEDURE 2 (10th rev. ed. Sept. 20, 2018),
`https://www.uspto.gov/sites/default/files/documents/
`SOP2%20R10%20FINAL.pdf .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 23
`
`Plea Agreement, United States v. Indivior Sols., Inc.,
`No. 1:19-cr-16 (W.D. Va. July 27, 2020) (Doc. No.
`427-5) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 12–13
`
`Press Release, Mylan N.V., Mylan and Biocon Biologics
`Announce Launch of Semglee (insulin glargine
`injection) in the U.S. to Expand Access for Pa-
`tients Living with Diabetes (Aug. 31, 2020), http://
`newsroom.mylan.com/2020-08-31-Mylan-and-Biocon-
`Biologics-Announce-Launch-of-Semglee-TM-insulin-
`glargine-injection-in-the-U-S-to-Expand-Access-for-
`Patients-Living-with-Diabetes
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`Press Release, U.S. Dep’t of Justice, Justice Department
`Obtains $1.4 Billion from Reckitt Benckiser Group
`in Largest Recovery in a Case Concerning an Opioid
`Drug in United States History (July 11, 2019),
`https://www.justice.gov/opa/pr/justice-department-
`obtains-14-billion-reckitt-benckiser-group-largest-
`recovery-case .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`. 15
`
`.
`
`. 13
`
`Jason Rantanen et al., Federal Circuit Statistics
`Update—September 2020, PATENTLY-O (Sept. 15,
`2020), https://patentlyo.com/patent/2020/09/federal-
`statistics-september.html
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`. 8, 15
`
`RECKITT BENCKISER GRP. PLC, ANNUAL REPORT AND
`FINANCIAL STATEMENTS 2008 (Mar. 2009) .
`.
`.
`.
`.
`. 11–12
`
`KEVIN T. RICHARDS ET AL., CONG. RESEARCH SERV.,
`REPORT NO. R46221, DRUG PRICING AND PHARMA-
`CEUTICAL PATENTING PRACTICES (Feb. 11, 2020),
`https://www.everycrsreport.com/reports/R46221.
`html .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`. 7
`
`
`
`(xi)
`
`SANOFI-AVENTIS U.S. LLC, HOW MUCH SHOULD I
`EXPECT TO PAY FOR LANTUS? (Oct. 2019), https://
`www.lantus.com/-/media/EMS/Conditions/Diabetes/
`Brands/Lantus2/Consumer/Lantus-Pricing.pdf .
`.
`.
`
`.
`
`. 15
`
`The Patent Trial and Appeal Board and the Ap-
`pointments Clause: Implications of Recent Court
`Decisions: Hearing Before the H. Comm. on the
`Judiciary, 116th Cong. (Nov. 19, 2019) (testimony
`of Professor Arti Rai), https://docs.house.gov/
`meetings/JU/JU03/20191119/110260/HHRG-116-
`JU03-Wstate-RaiA-20191119.pdf
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`. 30
`
`Transcript of Argument, Oil States Energy Servs.,
`LLC v. Greene’s Energy Grp., LLC, 138 S. Ct. 1365
`(Nov. 27, 2017) (No. 16-712) .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`. 25
`
`U.S. GOV’T ACCOUNTABILITY OFFICE, GAO-18-40,
`DRUG INDUSTRY: PROFITS, RESEARCH AND DEVEL-
`OPMENT SPENDING, AND MERGER AND ACQUISITION
`DEALS (Nov. 2017), https://www.gao.gov/assets/690/
`688472.pdf
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`U.S. Patent No. 6,316,023 (issued Nov. 13, 2001) .
`
`U.S. Patent No. 6,335,031 (issued Jan. 1, 2002) .
`
`U.S. Patent No. 6,746,002 (issued June 8, 2004)
`
`.
`
`.
`
`U.S. Patent No. 8,865,688 (issued Oct. 21, 2014) .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 5–6
`
`.
`
`.
`
`.
`
`. 9
`
`. 9
`
`. 20
`
`.
`
`.
`
`.
`
`. 17–18
`
`Saurabh Vishnubhakat, Arti K. Rai & Jay P. Kesan,
`Strategic Decision Making in Dual PTAB and
`District Court Proceedings, 31 BERKELEY TECH. L.J.
`45 (2016)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`. 22
`
`Saurabh Vishnubhakat, Disguised Patent Policymak-
`ing, 76 WASH. & LEE L. REV. 1667 (2019)
`.
`.
`.
`.
`.
`
`. 24–25
`
`
`
`(xii)
`
`Christopher J. Walker & Melissa F. Wasserman, The
`New World of Agency Adjudication, 107 CAL. L.
`REV. 141 (2019)
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`. 25
`
`WORLD HEALTH ORG., MODEL LIST OF ESSENTIAL
`MEDICINES (21st ed. 2019), https://apps.who.int/iris/
`bitstream/handle/10665/325771/WHO-MVP-EMP-
`IAU-2019.06-eng.pdf
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`XCENDA AMERSOURCEBERGEN, MODELING THE POPU-
`LATION OUTCOMES OF COST-RELATED NONADHER-
`ENCE: MODEL REPORT (2020), https://www.cidsa.
`org/publications/xcenda-summary .
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`. 17
`
`.
`
`. 5
`
`
`
`INTEREST OF AMICUS CURIAE
`The Coalition Against Patent Abuse1 is a coalition of
`healthcare providers, consumer groups, patient advocacy
`organizations, free market advocates, employers, and
`others fighting abuses of the patent system that can ex-
`tend government-granted monopolies that illegitimately
`keep drug prices high for years, or even decades. CAPA
`produces research and analysis on patents and drug costs
`aimed at educating lawmakers and policy experts on
`issues vital to American health care.2
`
`SUMMARY OF ARGUMENT
`Perhaps unexpectedly, a case on the constitutionality
`of the Patent Trial and Appeal Board has major signifi-
`cance to the pressing policy crisis of drug prices in the
`United States. Erroneously issued patents monopolize
`medical therapies, making them unaffordable or inacces-
`sible to numerous Americans. The inter partes review
`proceedings that the Board conducts have repeatedly and
`successfully overcome such patents, enabling competi-
`tion and dramatically lowering prices. This Court should
`ensure the continued viability of the Board and of inter
`
`1Pursuant to Supreme Court Rule 37.3(a), all parties received
`appropriate notice of this brief and granted blanket consent for the
`filing of briefs of amici curiae. Pursuant to Rule 37.6, no counsel for a
`party authored this brief in whole or in part, and no counsel or party
`made a monetary contribution intended to fund the preparation or
`submission of the brief. No person or entity, other than amicus,
`its members, or its counsel, made a monetary contribution to the
`preparation or submission of this brief.
`2A list of CAPA members may be found on the website https://
`www.capanow.org/. Opinions expressed herein reflect the views of
`the coalition but not necessarily those of the individual members.
`
`1
`
`
`
`2
`
`partes review, by preserving the Board’s objectivity and
`independence from executive branch political influence.
`1.
`In the eight years that it has been in effect, inter
`partes review and related patent challenge proceedings
`have proven effective in overcoming abuse of patents
`that improperly block competition, raise prices, and stifle
`future innovation. That critical role is plainly observable
`in the context of drug patents, where infirmities in patent
`examination allow pharmaceutical firms to obtain ques-
`tionable patents that wrongly block generic competition
`and cost Americans hundreds of millions of dollars every
`year. Inter partes review has successfully distinguished
`patents representing genuine innovation from those that
`serve largely to preserve pharmaceutical monopoly prof-
`its without concomitant public benefit.
`Case studies of key inter partes reviews on drug
`patents reveal the effectiveness and value of those
`proceedings and the Board that conducts them. The
`case studies show that patents declared erroneous
`in those proceedings are manifestly uninventive “sec-
`ondary” patents designed to extend monopoly prices
`beyond the congressionally specified patent term. They
`show that cancellation of those patents can lower drug
`prices by 98%, because they enable multiple competi-
`tors, even ones beyond the firms bringing the patent
`challenges, to compete vigorously on prices. And they
`show why the Board has proven to be an effective venue
`for such challenges: because the administrative patent
`judges on the Board have the qualifications to understand
`complex technological facts in patent cases and apply
`patent law to those facts objectively, such that judicial
`review affirms the Board over 80% of the time.
`
`
`
`3
`
`Impartiality is key to why the Board succeeds.
`2.
`Congress structured the Board to conduct inter partes
`reviews impartially based on the law,
`largely free of
`political pressures from powerful lobbies such as the phar-
`maceutical industry. Indeed, members of this Court have
`already vigorously denounced attempts by the Director
`of the U.S. Patent and Trademark Office to manipulate
`the Board’s outcomes through a practice called “panel
`stacking.”
`Yet as important as impartiality is to fair adjudication,
`the Federal Circuit read the Appointments Clause to
`encourage—even require—executive power to meddle
`with Board decisions on patentability. The Constitution
`does not demand that level of political influence. Indeed,
`heavyhanded Director oversight of the Board is superflu-
`ous given that the Board’s patentability decisions, being
`almost entirely matters of law, are already rigorously
`reviewed by the federal judiciary.
`Impartiality and objectivity of the Board should lead
`this Court to approve the structure that Congress de-
`signed. In the alternative, should this Court find that
`some structural remedy is required, that remedy should
`impose minimal political interference upon the Board, to
`ensure that its decisions on patentability remain credible,
`reliable, and impartial. Furthermore, the Court should
`disapprove the Federal Circuit’s improper remanding of
`all pending decisions, which wastefully unsettles expec-
`tations of competitive drug companies and patients who
`depend on them. In a case with widespread implications
`for the health of all Americans, this Court should apply
`to inter partes review that classic principle of medicine:
`first, do no harm.
`
`
`
`ARGUMENT
`I. THE PATENT TRIAL AND APPEAL BOARD HAS
`PROVEN ITS MERIT IN REVIEWING PATENTS
`THAT WRONGFULLY RAISE DRUG PRICES AND
`HARM AMERICAN CONSUMERS
`When it created the Patent Trial and Appeal Board
`in 2011 to adjudicate inter partes review proceedings,
`Congress hoped to overcome serious and systematic
`flaws in the American patent system that enabled wrong-
`fully issued patents to block competition and injure the
`American public.3
`In the context of pharmaceutical
`patents,4 the Board and inter partes review have been
`invaluable to approaching the United States drug pricing
`crisis.
`Skyrocketing drug prices today certainly merit the
`term “crisis.” Eight in ten surveyed Americans describe
`the cost of prescription drugs as “unreasonable,”5 and
`the “rising price of prescription drugs was an important
`factor” to a majority of voters of all parties.6 Unaf-
`
`3See H.R. REP. NO. 112-98, at 46–48 (2011); Joe Matal, A Guide to
`the Legislative History of the America Invents Act: Part II of II, 21
`FED. CIR. B.J. 539, 600–02 (2012).
`4For simplicity, this brief throughout uses the terms “pharma-
`ceuticals” and “drugs” to refer to the broad class of chemical thera-
`peutic medicines, and “generics” to refer to subsequent competitive
`products that are roughly market substitutes. In industry parlance,
`those terms refer only to small-molecule products, while large-
`molecule therapeutics are analogously designated “biologics” and
`“biosimilars”; the differences are immaterial to this case.
`5See Ashley Kirzinger et al., KFF Health Tracking Poll—
`February 2019: Prescription Drugs, KAISER FAM. FOUND. (Mar. 1,
`2019), available online. Locations of authorities available online are
`shown in the Table of Authorities.
`6COAL. AGAINST PATENT ABUSE & MORNING CONSULT, RE-
`FORMING THE PATENT SYSTEM 1 (Nov. 2020), available online.
`
`4
`
`
`
`5
`
`fordability has harmed Americans, with nearly a third
`of surveyed adults reported not taking medicines as
`prescribed because of costs, and 29% of them reportedly
`became sicker as a result.7 Indeed, researchers attribute
`between 112,000 and 125,000 deaths a year to patients
`who fail to take necessary medications because they
`cannot afford them.8
`The most straightforward approach to overcoming
`this drug pricing problem is competition.9 Having mul-
`tiple firms selling a drug can cut prices tremendously—
`over 95% in some cases, a U.S. Food and Drug Adminis-
`tration study finds.10 The Government Accountability Of-
`fice similarly concludes that generics cost on average 75%
`less than the brand-name equivalent, and substitution of
`generic drugs between 1999 and 2010 saved Americans
`more than $1 trillion.11 Because patents by definition are
`government-granted privileges to escape competition,
`multiple surveys find that Americans overwhelmingly
`
`7See Kirzinger et al., supra note 5.
`8See XCENDA AMERSOURCEBERGEN, MODELING THE POPULA-
`TION OUTCOMES OF COST-RELATED NONADHERENCE: MODEL RE-
`PORT 13 tbl.6 (2020), available online; ASS’N FOR ACCESSIBLE MEDS.,
`GENERIC DRUG ACCESS & SAVINGS IN THE U.S. 26 (2017), available
`online.
`9See U.S. GOV’T ACCOUNTABILITY OFFICE, GAO-18-40, DRUG
`INDUSTRY: PROFITS, RESEARCH AND DEVELOPMENT SPENDING,
`AND MERGER AND ACQUISITION DEALS 47–50 (Nov. 2017), available
`online (citing studies).
`10RYAN CONRAD & RANDALL LUTTER, U.S. FOOD & DRUG AD-
`MIN., GENERIC COMPETITION AND DRUG PRICES: NEW EVIDENCE
`LINKING GREATER GENERIC COMPETITION AND LOWER GENERIC
`DRUG PRICES 3 (Dec. 2019), available online.
`11See Letter from John E. Dicken, U.S. Gov’t Accountability Office,
`to Orrin G. Hatch, U.S. Senate, GAO-12-371R: Savings from Generic
`Drug Use (Jan. 31, 2012), available online.
`
`
`
`6
`
`blame pharmaceutical patents and the firms that hold
`them for the unreasonable costs of drugs.12
`Inter partes reviews conducted by the Board have
`played a key role in stemming these harms. The case
`studies that follow were gathered by correlating drug
`patent inter partes review outcomes where all patent
`claims were canceled, against Medicaid and other data on
`drug prices.13 Several key features of the Board emerge
`from this study, pointing to inter partes review being a
`strong mechanism for overcoming the ongoing problems
`of skyrocketing drug prices.
`1. Most obviously, the effect of inter partes review
`on questionable drug patents is to lower prices—often
`dramatically. Cancellation of erroneous patents on a
`drug opens the door to generic competition, and that
`competition brings prices down on average 75%, saving
`American consumers over $100 billion a year according
`to the Government Accountability Office.14 The case
`studies repeatedly show competition following rapidly
`after a Board decision in inter partes review, with almost
`immediate savings of up to 93%.
`2. Monopoly drug prices might be tolerable if the
`patents backing those prices represented genuine in-
`novation, but the patents that the Board has declared
`
`12See COAL. AGAINST PATENT ABUSE & MORNING CONSULT,
`supra note 6, at 1; Kirzinger et al., supra note 5.
`13Specifically, this analysis uses National Average Drug Acqui-
`sition Cost (NADAC) weekly reference data, which is based on
`monthly pharmacy surveys and other data. See CTRS. FOR MEDI-
`CARE & MEDICAID SERVS., METHODOLOGY FOR CALCUL ATING
`THE NATIONAL AVERAGE DRUG ACQUISITION COST (NADAC) FOR
`MEDICAID COVERED OUTPATIENT DRUGS 20 (Nov. 2013), available
`online.
`14See Dicken, supra note 11; U.S. GOV’T ACCOUNTABILITY OFFICE,
`supra note 9, at 47–50.
`
`
`
`7
`
`erroneous do not. Instead, the case studies reflect bald
`manipulation of the patent system to extend monopoly
`control over drugs that ought to be open to competition.15
`The challenged patents involve mere combinations of
`well-known drugs, predictable dosage adjustments, and
`trivial modifications to drug delivery. These “inventions”
`offered insignificant benefits or even caused harm, in
`one case being the centerpiece of a drug company’s
`fraudulent scheme that led to a $1.7 billion fine.
`These “follow-on” or “secondary” patents, so called
`because they are directed not to the active ingredient
`of a drug but to uses or formulations,16 regularly fail in
`litigation against generics17 and are often described as
`as “weak” or “less solid” even by the very companies ob-
`
`15By contrast, there is no evidence of the Board being overbearing
`on legitimately issued patents. A study of inter partes reviews
`between 2012 and 2017 found that only 7 out of 198 challenged
`drug patents were directed to active ingredients, with only 2 such
`challenges successful in canceling all disputed patent claims. See
`Jonathan J. Darrow et al., The Generic Drug Industry Embraces
`a Faster, Cheaper Pathway for Challenging Patents, 17 APPLIED
`HEALTH ECON. & HEALTH POL’Y 47, 51 (2018). Moreover, while
`there were some initial concerns about abuse of inter partes review
`to manipulate drug companies’ stock prices, those practices were
`apparently “a complete failure” and now are largely “all but over.”
`Matthew Bultman, Hedge Fund Drug Patent Challenges in Doubt
`After Bass’ Test, LAW360 (Mar. 31, 2017), available online.
`16On secondary patents, see generally KEVIN T. RICHARDS ET AL.,
`CONG. RESEARCH SERV., REPORT NO. R46221, DRUG PRICING AND
`PHARMACEUTICAL PATENTING PRACTICES 9, 16–19 (Feb. 11, 2020),
`available online.
`17See, e.g., C. Scott Hemphill & Bhaven Sampat, Drug Patents at
`the Supreme Court, 339 SCIENCE 1386, 1387 (2013); COMPETITION
`DIR.-GEN., EUROPEAN COMM’N, PHARMACEUTICAL SECTOR IN-
`QUIRY: FINAL REPORT para. 501, at 191 (July 8, 2009), available
`online.
`
`
`
`8
`
`taining them.18 Nevertheless, the number of secondary
`patents is large and growing,19 with pharmaceutical firms
`acknowledging that those patents have the intended
`purpose of “extending the term of the existing compound
`patent.”20
`3. Why the Board is especially important in over-
`coming improper secondary drug patents is another in-
`sight to be gleaned from these case studies. Members
`of the Board are required to have “competent legal
`knowledge and scientific ability,”21 and that expertise
`has proven valuable to the correct disposition of drug
`patent cases that can involve difficult scientific facts. On
`at least one occasion the appellate court praised the
`Board for providing “ample” evidence in support of its
`conclusions; the fact that the Board is affirmed on appeal
`more frequently than the district courts further confirms
`its competence.22
`4. The case studies further show that the outcome
`of inter partes review is not just that the challenger may
`enter the market, but that other generic manufacturers
`
`18COMPETITION DIR.-GEN., EUROPEAN COMM’N, supra note 17,
`para. 504, at 192 (quoting pharmaceutical firm); see C. Scott Hemphill
`& Bhaven N. Sampat, When Do Generics Challenge Drug Patents?,
`8 J. EMPIRICAL LEGAL STUD. 613, 644 (2011).
`19See Robin Feldman, May Your Drug Price Be Evergreen, 5 J.L.
`& BIOSCIENCES 590, 630 & tb
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
