Amicus Curiae Brief — Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Amarin Pharma, Inc., et al.
Supreme Court briefFeb 23, 2026
Ask Donna
What actually matters in this document.
Text
No. 24-889
IN THE
Supreme Court of the United States
HIKMA PHARMACEUTICALS USA INC.
AND HIKMA PHARMACEUTICALS PLC,
Petitioners,
v.
AMARIN PHARMA, INC., AMARIN PHARMACEUTICALS
IRELAND LTD., AND MOCHIDA PHARMACEUTICAL CO., LTD.,
Respondents.
ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
BRIEF OF 76 SCHOLARS OF LAW, BUSINESS,
ECONOMICS, AND MEDICINE AS AMICI CURIAE
IN SUPPORT OF PETITIONERS
MICHAEL A. CARRIER
RUTGERS LAW SCHOOL
217 North Fifth Street
Camden, NJ 08102
(856) 225-6380
mcarrier@law.rutgers.edu
S. SEAN TU
UNIVERSITY OF ALABAMA SCHOOL
OF LAW
101 Paul W. Bryant Drive East
Tuscaloosa, AL 35487
(352) 262-9531
sstu@law.ua.edu
CHARLES DUAN
Counsel of Record
AMERICAN UNIVERSITY
WASHINGTON COLLEGE OF LAW
4300 Nebraska Avenue NW
Washington, DC 20016
(202) 274-4124
supremecourt.gov@cduan.com
AARON S. KESSELHEIM
HARVARD MEDICAL SCHOOL
641 Huntington Ave., 2nd Floor
Boston, MA 02115
(617) 278-0930
akesselheim@bwh.harvard.edu
Counsel for Amici Curiae
TABLE OF CONTENTS
TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . ii
INTEREST OF AMICI CURIAE . . . . . . . . . . . . . . 1
SUMMARY OF ARGUMENT . . . . . . . . . . . . . . . . 1
ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 4
I.
Inducement of Patent Infringement Requires Specific, Unambiguous, and Affirmative Conduct . . . . . 4
II. The Conduct Requirement Promotes the Congressional Scheme for a Robust Generic Drug Market . . . 6
A. The Hatch–Waxman Act Is Intended to Facilitate Speedy Introduction of Generics . . . . . . . 7
B. The Section viii “Skinny Labeling” Pathway is
Critical to Effective Generic Entry . . . . . . . . . 10
C. The Conduct Requirement Avoids Circumvention of the Statutory Design . . . . . . . . . . . . . 13
III. The Conduct Requirement Promotes Innovation
and the Purposes of the Patent Act . . . . . . . . . . . 16
A. An Expanded Inducement Doctrine Interferes
with Competition and Regulatory Compliance . . 16
B.
Such Interference Distorts Incentives for Innovation, Contrary to Patent Law and Policy . . . . 20
C. The Conduct Requirement Avoids These Innovation and Competition Distortions . . . . . . . . 24
IV. Empirical Studies Show the Conduct Requirement’s
Importance to Patients and Public Health . . . . . . . 25
CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . 29
APPENDIX A: List of Academic Signatories . . . . . . . . 30
(i)
TABLE OF AUTHORITIES
CASES
Aro Manufacturing Co.
v. Convertible Top Replacement Co.,
365 U.S. 336 (1960) . . . . . . . . . . . . . . . . . . . . . . 4
A. Stucki Co. v. Worthington Industries, Inc.,
849 F.2d 593 (Fed. Cir. 1988) . . . . . . . . . . . . . . 4, 25
Beverly Hills Fan Co. v. Royal Sovereign Corp.,
21 F.3d 1558 (Fed. Cir. 1994) . . . . . . . . . . . . . . . . 5
Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,
489 U.S. 141 (1989) . . . . . . . . . . . . . . . . . . . . . . 20
Brenner v. Manson,
383 U.S. 519 (1966) . . . . . . . . . . . . . . . . . . . . . . 14
Caraco Pharmaceutical Laboratories, Ltd.
v. Novo Nordisk A/S,
566 U.S. 399 (2012) . . . . . . . . . . . . . . 11–12, 15, 17, 28
Carbice Corp. of America
v. America Patents Development Corp.,
283 U.S. 27 (1931) . . . . . . . . . . . . . . . . . . . . . . 5
Cox Communications, Inc.
v. Sony Music Entertainment,
No. 24-171 (U.S. argued Dec. 1, 2025) . . . . . . . . . . . 4
C.R. Bard, Inc. v. Advanced Cardiovascular Systems,
911 F.2d 670 (Fed. Cir. 1990) . . . . . . . . . . . . . . . . 5
DSU Medical Corp. v. JMS Co., Ltd.,
471 F.3d 1293 (Fed. Cir. 2006) (en banc) . . . . . . . . . . 4
Eli Lilly & Co. v. Board of Regents,
334 F.3d 1264 (Fed. Cir. 2003) . . . . . . . . . . . . . . . 5
(ii)
(iii)
Eli Lilly & Co. v. Medtronic, Inc.,
496 U.S. 661 (1990) . . . . . . . . . . . . . . . . . . . . . . 8
Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.,
845 F.3d 1357 (Fed. Cir. 2017) . . . . . . . . . . . . . . . 24
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA,
7 F.4th 1320 (Fed. Cir. 2021) (per curiam) . . 1, 3, 6, 13, 15,
19, 27–28
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA,
25 F.4th 949 (Fed. Cir. 2022) (per curiam) . . . . . . . 16, 28
Global-Tech Appliances, Inc. v. SEB SA,
563 U.S. 754 (2011) . . . . . . . . . . . . . . . . . . . . . 4–5
Henry v. A.B. Dick Co.,
224 U.S. 1 (1912) . . . . . . . . . . . . . . . . . . . . . . . 5
Hewlett-Packard Co. v. Bausch & Lomb Inc.,
909 F.2d 1464 (Fed. Cir. 1990) . . . . . . . . . . . . . . . 4
HZNP Medicines LLC v. Actavis Laboratories UT, Inc.,
940 F.3d 680 (Fed. Cir. 2019) . . . . . . . . . . . . . . . . 5
Janssen Pharmaceutica NV
v. Teva Pharmaceuticals USA, Inc.,
583 F.3d 1317 (Fed. Cir. 2009) . . . . . . . . . . . . . . . 14
Medtronic, Inc. v. Mirowski Family Ventures, LLC,
571 U.S. 191 (2014) . . . . . . . . . . . . . . . . . . . . . . 20
Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.,
545 U.S. 913 (2005) . . . . . . . . . . . . . . . . . . . . . . 6
Motion Picture Patents Co.
v. Universal Film Manufacturing Co.,
243 U.S. 502 (1917) . . . . . . . . . . . . . . . . . . . . . 5–6
Precision Instrument Manufacturing Co.
v. Automotive Maintenance Machinery Co.,
324 U.S. 806 (1945) . . . . . . . . . . . . . . . . . . . . . . 20
(iv)
Purepac Pharmaceutical Co. v. Thompson,
354 F.3d 877 (D.C. Cir. 2004) . . . . . . . . . . . . . . . . 13
SmithKline Beecham Consumer Healthcare, LP
v. Watson Pharmaceuticals, Inc.,
211 F.3d 21 (2d Cir. 2000) . . . . . . . . . . . . . . . . 18–19
Takeda Pharmaceuticals U.S.A., Inc.
v. West-Ward Pharmaceutical Corp.,
785 F.3d 625 (Fed. Cir. 2015) . . . . . . . . . . . . . . 5, 25
Tegal Corp. v. Tokyo Electron Co., Ltd.,
248 F.3d 1376 (Fed. Cir. 2001) . . . . . . . . . . . . . . . 5
Teva Pharmaceuticals USA, Inc. v. Sebelius,
595 F.3d 1303 (D.C. Cir. 2010) . . . . . . . . . . . . . . . . 12
TorPharm, Inc. v. Thompson,
260 F. Supp. 2d 69 (D.D.C. 2003) . . . . . . . . . . . . . . 13
Twitter, Inc. v. Taamneh,
143 S. Ct. 1206 (2023) . . . . . . . . . . . . . . . . . . . . 6
Vita-Mix Corp. v. Basic Holding, Inc.,
581 F.3d 1317 (Fed. Cir. 2009) . . . . . . . . . . . . . . . 4
Wallace v. Holmes,
29 F. Cas. 74 (C.C.D. Conn. 1871) . . . . . . . . . . . . . 5
Warner-Lambert Co. v. Apotex Corp.,
316 F.3d 1348 (Fed. Cir. 2003) . . . . . . . . . . . . . 4, 14
Warner Lambert Co. v. McCrory’s Corp.,
718 F. Supp. 389 (D.N.J. 1989) . . . . . . . . . . . . . . . 17
CONSTITUTIONAL PROVISION
U.S. Const. art. I, § 8, cl. 8 . . . . . . . . . . . . . . . . . . . 20
(v)
STATUTES AND REGULATIONS
21 C.F.R. § 201.57(c)(15) . . . . . . . . . . . . . . . . . . . . 19
——— § 314.127(a)(7) . . . . . . . . . . . . . . . . . . 17, 19
21 U.S.C. § 353d(a)(3) . . . . . . . . . . . . . . . . . . . . . . 17
35 U.S.C. § 156(c), (g)(6) . . . . . . . . . . . . . . . . . . . . . 8
——— § 271 . . . . . . . . . . . . . . . . . . . . . . . . . . 13
——— § 271(a) . . . . . . . . . . . . . . . . . . . . . . . . 14
——— § 271(b) . . . . . . . . . . . . . . . 4, 6, 13–14, 17, 24
——— § 271(c) . . . . . . . . . . . . . . . . . . . . . . . . 14
——— § 271(e) . . . . . . . . . . . . . . . . . . . . . . . . 14
——— § 271(e)(1) . . . . . . . . . . . . . . . . . . . . . . . 9
——— § 271(e)(2) . . . . . . . . . . . . . . . . . . . . . . . 10
——— § 271(f)–(g) . . . . . . . . . . . . . . . . . . . . . . 14
42 U.S.C. ch. 7, subch. XVIII, pt. D . . . . . . . . . . . . . . 26
Drug Price Competition and Patent Term Restoration
Act of 1984 (Hatch–Waxman Act), Pub. L. No. 98-417,
98 Stat. 1585 . . . . . . . . . . . . 7–9, 11, 13–16, 18–19, 24
Federal Food, Drug, and Cosmetics Act (FFDCA)
§ 505(b)(1)(A)(viii),
21 U.S.C. § 355 . . . . . . . . . . . . . . . . . . . . . . . . 9
——— § 505(j) . . . . . . . . . . . . . . . . . . . . . . . 9
——— § 505(j)(2)(A)(v) . . . . . . . . . . . . . . . 14, 17
——— § 505(j)(2)(A)(viii) . . . . . . . . . . 10–11, 14, 19
——— § 505(j)(2)(A)(vii)(IV) . . . . . . . . . . . . . . 10
(vi)
Federal Food, Drug, and Cosmetics Act (FFDCA)
§ 505(j)(2)(iv),
21 U.S.C. § 355 . . . . . . . . . . . . . . . . . . . . . . . . 9
——— § 505(j)(4)(G) . . . . . . . . . . . . . . . . . . . 18
——— § 505(j)(5)(B) . . . . . . . . . . . . . . . . . . . 9
——— § 505(j)(5)(B)(iii) . . . . . . . . . . . . . 9–10, 12
——— § 505(j)(5)(B)(iv) . . . . . . . . . . . . . . . . . 10
——— § 505(j)(5)(F)(ii) . . . . . . . . . . . . . . . . . . 8
OTHER SOURCES
John R. Allison & Mark A. Lemley, Empirical Evidence
on the Validity of Litigated Patents, 26 AIPLA Q.J.
185 (1998) . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Am. Intell. Prop. L. Ass’n, Report of the Economic
Survey (2023) . . . . . . . . . . . . . . . . . . . . . . . . 10
Roger D. Blair & Thomas F. Cotter, Intellectual Property: Economic and Legal Dimensions of Rights and
Remedies (2005) . . . . . . . . . . . . . . . . . . . . . . . 21
Doni Bloomfield et al., Prescription Drug Method-of-Use
Patent Protection, 1991–2018, 41 J. Gen. Internal
Med. 261 (2026) . . . . . . . . . . . . . . . . . . . . . . . 26
Brief of a Professor of Patent Law as Amicus Curiae,
Cox Commc’ns, Inc. v. Sony Music Ent., No. 24-171
(U.S. Sept. 4, 2025) . . . . . . . . . . . . . . . . . . . . . 4
Michael A. Carrier, Skinny Labels’ Importance for Drug
Competition, Wis. L. Rev. Forward (forthcoming
2026), https://ssrn.com/abstract=6082609 . . . . . . . 10–11
———, Unsettling Drug Patent Settlements, 108 Mich. L.
Rev. 37 (2009) . . . . . . . . . . . . . . . . . . . . . . . 7–8
(vii)
Bernard Chao, Horizontal Innovation and Interface
Patents, 2016 Wis. L. Rev. 287 . . . . . . . . . . . . . . . 21
Congressional Record . . . . . . . . . . . . . . . . . . . . . 7–8
Ctr. for Drug Evaluation & Rsch., FDA, ANDA
Submissions—Refuse-to-Receive Standards (2d
rev. Dec. 2016), https://www.fda.gov/media/86660/
download . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Charles Duan, Licensing Patents, but Not by Choice,
18 Landslide 7 (Sept.–Oct. 2025), https://ssrn.com/
abstract=5707406 . . . . . . . . . . . . . . . . . . . . . . 21
———, Mandatory Infringement, 75 Fla. L. Rev. 219
(2023) . . . . . . . . . . . . . . . . . . . . . . . . . 18–19, 21
———, The Importance of Being Equivalent, 17 Am. U.
Intell. Prop. Brief (forthcoming 2026), https://ssrn.
com/abstract=6290459 . . . . . . . . . . . . . . . . . 17, 22
John W. Egan et al., Economics of the Pharmaceutical
Industry (1982) . . . . . . . . . . . . . . . . . . . . . . . 7
Alexander C. Egilman et al., Estimated Medicare Part
D Savings from Generic Drugs with a Skinny Label,
177 Annals Internal Med. 833 (2024) . . . . . . . . . 25–26
———, Frequency of Approval and Marketing of
Biosimilars with a Skinny Label and Associated
Medicare Savings, 183 JAMA Internal Med. 82
(2023) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
P.J. Federico, Commentary on the New Patent Act, 75 J.
Pat. & Trademark Off. Soc’y 161 (1993) . . . . . . . . . . 6
Fed. Trade Comm’n, The Evolving IP Marketplace
(2011) . . . . . . . . . . . . . . . . . . . . . . . . . . . 20–21
(viii)
Food & Drug Admin., Approved Drug Products with
Therapeutic Equivalence Evaluations (45th ed.
2025) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Daniel J. Hemel & Lisa Larrimore Ouellette, Innovation
Policy Pluralism, 128 Yale L.J. 544 (2019) . . . . . . . . 20
C. Scott Hemphill & Bhaven Sampat, Drug Patents at
the Supreme Court, 339 Science 1386 (2013) . . . . . . . 27
Caroline Horrow et al., Patent Portfolios Protecting
10 Top-Selling Prescription Drugs, 2024 JAMA
Internal Med. 810 . . . . . . . . . . . . . . . . . . . . . . 9
House Report No. 98-857 (1984) . . . . . . . . . . . . . . . . 8
Justification of Estimates for Appropriations Committees (Food & Drug Admin. 2024), https://www.fda.
gov/media/166182/download . . . . . . . . . . . . . . . . 28
Jonathan Kahn, Race in a Bottle: The Story of BiDil and
Racialized Medicine in a Post-Genomic Age (2013) . . 23
Mark A. Lemley, Inducing Patent Infringement, 39 U.C.
Davis L. Rev. 225 (2005) . . . . . . . . . . . . . . . . 4, 24
Peter Loftus, Pfizer, Takeda to Get $2.15 Billion
Settlement, Wall St. J., June 12, 2013 . . . . . . . . . . . 12
Maureen S. May et al., New Drug Development During
and After a Period of Regulatory Change, 33 Clin.
Pharm. Ther. 691 (1983) . . . . . . . . . . . . . . . . . . 7
Kimberly A. Moore, Judges, Juries, and Patent Cases—
An Empirical Peek Inside the Black Box, 99 Mich. L.
Rev. 365 (2000) . . . . . . . . . . . . . . . . . . . . . . . . 27
Nat’l Rsch. Council, A Patent System for the 21st
Century (2004), https://www.nationalacademies.org/
read/10976 . . . . . . . . . . . . . . . . . . . . . . . . . . 12
(ix)
Dylan Niederland, The Software Inducement Paradox,
75 Am. U. L. Rev. 307 (2025) . . . . . . . . . . . . . . . . 17
Jin Park et al., Overlapping Method of Use Patents to
Prevent Generic Entry, 53 J.L. Med. & Ethics 577
(2025) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Giles S. Rich, Infringement Under Section 271 of the
Patent Act of 1952, 21 Geo. Wash. L. Rev. 521 (1953) . . 6
David A. Simon, Off-Label Innovations, 56 Ga. L. Rev.
701 (2022) . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Ziaurrehman Tanoli et al., Computational Drug Repurposing, 24 Nature Revs. Drug Discovery 521
(2025) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Errol B. Taylor & Fredrick M. Zullow, Focusing Only on
Active Ingredient Patents Ignores Case Law Success
Rates, Pharm. L. & Indus. Rep. (BNA), Oct. 28, 2011 . . 27
Theodore W. Teng et al., Tertiary Patents on Drugs
Approved by the FDA, 2026 JAMA Health F. 1 . . . . . 9
S. Sean Tu & Charles Duan, Pharmaceutical Patent
Two-Step: The Adverse Advent of Amarin v. Hikma
Type Litigation, 12 N.Y.U. J. Intell. Prop. & Ent. L. 1
(2022) . . . . . . . . . . . . . . . . . . . . . . . . . . . 22, 26
S. Sean Tu & Ameet Sarpatwari, A “Method of Use”
to Prevent Generic and Biosimilar Entry, 388 New
Eng. J. Med. 483 (2023) . . . . . . . . . . . . . . . . . 22, 26
Shashank Upadhye, Generic Pharmaceutical Patent
and FDA Law (2024) . . . . . . . . . . . . . . . . . . . . 12
U.S. Patent No. 8,399,446 (issued Mar. 19, 2013) . . . . . . . 22
U.S. Patent No. 9,700,537 (issued July 11, 2017) . . . . . . . 22
U.S. Patent No. 12,171,738 (issued Dec. 24, 2024) . . . . . . 22
(x)
Bryan S. Walsh et al., Frequency of First Generic Drug
Approvals with “Skinny Labels” in the United States,
181 JAMA Internal Med. 995 (2021) . . . . . . . . . . . . 27
James J. Wheaton, Generic Competition and Pharmaceutical Innovation, 35 Cath. U. L. Rev. 433
(1986) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Therese J. Ziaks et al., Frequency of First Generic Drugs
Approved Through “Skinny Labeling,” 2021 to 2023,
31 J. Managed Care & Specialty Pharmacy 343 (2025) . . 27
INTEREST OF AMICI CURIAE
Amici curiae1 are scholars of law, business, economics,
and medicine, listed in Appendix A. Their interest is in
the proper development of patent law in ways that best
promote access to innovation and the public interest.
SUMMARY OF ARGUMENT
I. For a century and a half, the doctrine of inducement of patent infringement has required an act that is
specific, unambiguous, and affirmative. Conduct that (1)
does not specifically encourage infringement, (2) is ambiguous as to infringing or noninfringing behavior, or (3)
is an omission has long been insufficient for patent inducement liability.
In this case, the Federal Circuit disregarded these
principles. The court held that inducement liability could
arise based on speculative inferences from general marketing statements and mandatory drug labeling text—
statements that bore no specificity to the patented methods of use at issue. That holding followed the court’s 2021
decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, which also expanded patent inducement beyond its historic bounds.
Such expansion is not just wrong on the law—it
threatens the statutory scheme for generic drug competition, the innovation economy, the patent system’s
foundational principles, and patient health and welfare.
This Court should return inducement law to its wellestablished roots.
1
Pursuant to Rule 37.6, no counsel for a party authored this brief
in whole or in part. No person or entity, other than amici, their members, or their counsel, made a monetary contribution to the preparation or submission of this brief.
1
2
II. Expanded inducement frustrates generic drug
competition legislation. In 1984, Congress enacted a comprehensive scheme for generic drugs to obtain regulatory
approval and reach the market. Of particular relevance
here, when patents on a drug compound have expired but
some methods of using the drug are patented, Congress
created the “section viii carve-out” pathway for generic
entry. Using this pathway, a generic drug manufacturer
removes specific references to the patented uses from
its official labeling, and the drug is approved for the unpatented uses.
The Federal Circuit’s expansion of patent inducement
contravenes this scheme. Congress created the section
viii pathway against the backdrop of inducement law.
Yet it provided no explicit guidance for dealing with potential inducement in the regulatory approval process.
Nor did it provide mechanisms for resolving inducement
disputes. Congress knew how to do these, and indeed
offered detailed guidance and mechanisms for handling
other patent issues relating to generic drugs. So the
section viii pathway’s simplicity demonstrates a congressional understanding that avoidance of patent inducement is a simple, clear, easily determined matter. That
view is at odds with the fact-specific, indeterminate, inferential theories of inducement that the Federal Circuit
embraced. A return to the longstanding conduct requirement of patent inducement best renders patent law consistent with that congressional understanding.
III. The expansion of patent inducement also harms
competition and innovation. Under the Federal Circuit’s
decision, ordinary statements about product equivalence
and comparative marketing could plausibly give rise to
inducement liability. The resulting liability cloud over
3
truthful advertising stymies competition. Even more concerning, the Federal Circuit has now twice—in this case
and GlaxoSmithKline—suggested that inducement liability can be premised on statements required by law,
like mandatory drug labeling. This creates an impossible double-bind: the generic firm cannot comply with its
regulatory obligations without the risk of inducing patent
infringement.
These impairments to regulation and competition distort incentives to innovate. If even the most low-value
patents can block competitors from advertising their
products or complying with regulatory requirements, innovators will prefer to invest in those low-value patents
instead of breakthrough innovation. That goes directly
against the heart of the patent system—promoting innovation for the benefit of the public. Restoring the traditional requirements of patent inducement will avoid these
incentive distortions.
IV. Concerns about an expanded patent inducement
doctrine are not mere theory. The section viii carve-out
was measurably effective at fostering generic competition and lower prices. The Federal Circuit’s decisions,
however, have already started to discourage use of this
essential pathway. Exacerbated by the rapid growth in
the number of patents on methods of drug use, the current state of the law is empirically problematic. Restoration of the inducement doctrine to its traditional bounds is
necessary to maintain the benefits of generic competition
for generations of patients to come.
ARGUMENT
I.
INDUCEMENT OF PATENT INFRINGEMENT
REQUIRES SPECIFIC, UNAMBIGUOUS, AND
AFFIRMATIVE CONDUCT
Under 35 U.S.C. § 271(b), “[w]hoever actively induces
infringement of a patent shall be liable as an infringer.”
This requires (1) direct infringement, Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 341 (1960),
and (2) knowledge thereof, see Glob.-Tech Appliances,
Inc. v. SEB SA, 563 U.S. 754, 766 (2011). But it also
demands, through the phrase “actively induces,” (3) an
act that is specific, unambiguous, and affirmative with
respect to the patented invention. Id. at 760; accord
Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d
1464, 1469 (Fed. Cir. 1990) (same). See generally Mark A.
Lemley, Inducing Patent Infringement, 39 U.C. Davis L.
Rev. 225, 228–35 (2005).2
First, the act of inducement must be specific: intentionally and directly encouraging or causing infringing
conduct, without need for “speculation.” A. Stucki Co. v.
Worthington Indus., Inc., 849 F.2d 593, 597 (Fed. Cir.
1988); see Warner-Lambert Co. v. Apotex Corp., 316 F.3d
1348, 1364 (Fed. Cir. 2003) (“[S]pecific intent and action
to induce infringement must be proven . . . .”); Vita-Mix
Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1329 n.2
(Fed. Cir. 2009) (instructions must “teach an infringing
use,” not merely “lead to infringing uses”); DSU Med.
Corp. v. JMS Co., Ltd., 471 F.3d 1293, 1306 (Fed. Cir.
2
For additional treatment of this statutory analysis, see Brief of a
Professor of Patent Law as Amicus Curiae at 10–15, Cox Commc’ns,
Inc. v. Sony Music Ent., No. 24-171 (U.S. Sept. 4, 2025).
4
5
2006) (en banc) (“[I]nducement requires evidence of culpable conduct, directed to encouraging another’s infringement . . . .”); Tegal Corp. v. Tokyo Electron Co., Ltd., 248
F.3d 1376, 1379 (Fed. Cir. 2001) (act must “in fact cause[],
or urge[], or aid[] another to infringe a patent”).
Second, it must be unambiguous: not “vague” or
amenable to multiple interpretations, some of which are
connected with noninfringing conduct. Takeda Pharms.
U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 632
(Fed. Cir. 2015); C.R. Bard, Inc. v. Advanced Cardiovascular Sys., 911 F.2d 670, 675 (Fed. Cir. 1990) (no inducement where acts are “at best ambiguous”); HZNP Meds.
LLC v. Actavis Lab’ys UT, Inc., 940 F.3d 680, 702 (Fed.
Cir. 2019) (no inducement where drug label notes possibility of performing a patented method but “does not
require” those steps); Eli Lilly & Co. v. Bd. of Regents,
334 F.3d 1264, 1369 (Fed. Cir. 2003) (inducement may be
found based on instructions that “are unambiguous on
their face”).
Third, it must be affirmative: an act of “commission,”
not omission. Glob.-Tech, 563 U.S. at 760 (“[I]nducement
must involve the taking of affirmative steps . . . .”); Beverly Hills Fan Co. v. Royal Sovereign Corp., 21 F.3d 1558,
1568 (Fed. Cir. 1994); see also Tegal, 248 F.3d at 1378.
This conduct requirement of induced infringement is
the product of a century and a half of precedent of this
Court and others. See Wallace v. Holmes, 29 F. Cas. 74,
80 (C.C.D. Conn. 1871) (requiring “actual concert with others”); Motion Picture Pats. Co. v. Universal Film Mfg.
Co., 243 U.S. 502, 516 (1917) (overruling Henry v. A.B.
Dick Co., 224 U.S. 1 (1912), which had approved of indirect patent liability despite ambiguity in the relevant
act); see also Carbice Corp. of Am. v. Am. Pats. Dev.
6
Corp., 283 U.S. 27, 32 (1931) (explaining Motion Picture
Patents as limiting contributory infringement); Giles S.
Rich, Infringement Under Section 271 of the Patent Act
of 1952, 21 Geo. Wash. L. Rev. 521, 542 (1953) (describing
how § 271(b) arose out of these common-law precedents);
P.J. Federico, Commentary on the New Patent Act, 75 J.
Pat. & Trademark Off. Soc’y 161, 214 (1993) (same).
Moreover, the conduct requirement squares with
copyright law, which requires “clear expression or other
affirmative steps” to promote infringement. See MetroGoldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S.
913, 937 (2005). And it is consistent with aiding and abetting under tort law, which requires “conscious, voluntary, and culpable participation in another’s wrongdoing.”
Twitter, Inc. v. Taamneh, 143 S. Ct. 1206, 1223 (2023).
Here, the Federal Circuit has strayed from these core
requirements of § 271(b). The court allowed for liability
based on speculative inferences from truthful, and sometimes legally mandatory, statements about general features of a drug—statements that are neither specific nor
unambiguous. Pet. App. 6–7a. And it allowed a generic
company’s non-removal of text from statutorily required
drug labeling—an omission—to be a basis for inducement
liability. Id. at 17a; see also GlaxoSmithKline LLC v.
Teva Pharms. USA, 7 F.4th 1320, 1328–29 (Fed. Cir. 2021)
(per curiam). These deviations from longstanding precedent require reversal and clarification from this Court.
II.
THE CONDUCT REQUIREMENT PROMOTES
THE CONGRESSIONAL SCHEME FOR A ROBUST
GENERIC DRUG MARKET
Patent inducement’s requirement of specific, unambiguous, and affirmative conduct is not only correct on
7
the law, but also critical to the proper functioning of the
statutory scheme for generic drugs.
A.
THE HATCH–WAXMAN ACT IS INTENDED
TO FACILITATE SPEEDY INTRODUCTION OF
GENERICS
Four decades ago, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984
(“Hatch–Waxman Act”), a carefully crafted statute fostering an equilibrium between brand-firm innovation and
generic competition. Pub. L. No. 98-417, 98 Stat. 1585.
At the time that Congress took up the issue, the need
for such an equilibrium was well-known. Evidence suggested a decline in regulatory approval of new drugs
between the late 1950s and 1970s, particularly with respect to new compounds, dosage forms, and domestic research. See Maureen S. May et al., New Drug Development During and After a Period of Regulatory Change,
33 Clin. Pharm. Ther. 691, 691 (1983); John W. Egan et
al., Economics of the Pharmaceutical Industry 105–06
(1982). According to the drug industry, one factor leading to this situation was the decline in the period between
U.S. Food and Drug Administration (“FDA”) approval
and patent expiration, which had fallen from nearly 17
years in the early 1960s to under seven years by the early
1980s. James J. Wheaton, Generic Competition and Pharmaceutical Innovation, 35 Cath. U. L. Rev. 433, 451–
52 (1986). See generally Michael A. Carrier, Unsettling
Drug Patent Settlements, 108 Mich. L. Rev. 37, 43–44
(2009) [hereinafter Carrier, Unsettling].
At the same time, Congress recognized an urgent
need to ensure the provision of “low-cost, generic drugs
for millions of Americans.” 130 Cong. Rec. 24427 (1984)
8
(statement of Rep. Henry Waxman). Generic competition would save consumers, as well as the federal and
state governments, millions of dollars each year. And it
would “do more to contain the cost of elderly care than
perhaps anything else this Congress has passed.” Id.
(statement of Rep. Waxman). See generally Carrier, Unsettling, supra, at 42.
The major hold-up for generic entry was that the
costs of FDA approval were often prohibitive for generic
drug manufacturers, especially those anticipating vigorous competition. See Eli Lilly & Co. v. Medtronic,
Inc., 496 U.S. 661, 676 (1990). And the drafters of the
Hatch–Waxman Act lamented the “practical extension”
of the patentee’s “monopoly position” beyond the ordinary patent term. H.R. Rep. No. 98-857, pt. 2, at 4 (1984).
The Hatch–Waxman Act’s drafters, in particular Representative Waxman, repeatedly underscored the “fundamental balance of the bill” between the rights of patent
owners and the interests of generic competitors. 130
Cong. Rec. 24425; see also H.R. Rep. No. 98-857, supra,
pt. 1, at 28 (describing bill as “fairly balanced”); id. pt. 2,
at 30 (asserting that the bill will “balance the need to stimulate innovation against the goal of furthering the public interest”). In that spirit of compromise, the Hatch–
Waxman Act offered benefits to both patent-holding
brand manufacturers and generic firms.
For patent holders, the statute first allowed for the
extension of the patent term for key drug patents to
compensate partially for time in FDA review. 35 U.S.C.
§ 156(c), (g)(6). Second, it provided for FDA market
exclusivity periods not based on patents, for example
on a drug with a new active ingredient. Federal Food,
Drug, and Cosmetics Act (FFDCA) § 505(j)(5)(F)(ii), 21
9
U.S.C. § 355. Third, it granted to brand manufacturers an automatic 30-month stay of FDA approval of any
generic equivalent during the pendency of certain patent
litigation—effectively an automatic preliminary injunction against generic competitors without the ordinary equitable safeguards such as likelihood of success and irreparable harm. FFDCA § 505(j)(5)(B)(iii).
For generic firms, the centerpiece of the legislation
was an expedited pathway for the approval of generic
drugs. See id. § 505(j). Rather than needing to
present a full application with efficacy and safety evidence, a generic manufacturer under the Hatch–Waxman
Act could file an Abbreviated New Drug Application
(“ANDA”) based on a showing of bioequivalence between
the generic and a previously approved drug. See FFDCA
§ 505(j)(2)(iv). The Hatch–Waxman Act also allowed
generics a limited exception to patent infringement to facilitate bioequivalency testing. 35 U.S.C. § 271(e)(1).
As a further dimension of the legislative compromise,
the Hatch–Waxman Act added a key limitation on the expedited ANDA pathway. Most brand-name drugs are
patented, and there are often multiple patents on one
drug—up to 17 per drug by one measure.3 If a drug manufacturer notifies the FDA about patents associated with
its product, FFDCA § 505(b)(1)(A)(viii), then the Hatch–
Waxman Act prohibits the agency from approving generics of that drug unless the generic manufacturer can overcome each of the patents. FFDCA § 505(j)(5)(B). The
generic firm has two options for doing so.
3
Caroline Horrow et al., Patent Portfolios Protecting 10 TopSelling Prescription Drugs, 2024 JAMA Internal Med. 810 (17
patents, figures from small-molecule setting); see also Theodore W.
Teng et al., Tertiary Patents on Drugs Approved by the FDA, 2026
JAMA Health F. 1, 4 (7 patents).
10
The first option is a “paragraph IV” certification,
which allows a generic to certify that the patent “is invalid or will not be infringed.” Id. § 505(j)(2)(A)(vii)(IV).
The mere filing of a paragraph IV certification is treated
as an artificial act of infringement, which allows the brand
firm to immediately file suit even before the generic enters the market. 35 U.S.C. § 271(e)(2).
Although generics often use the paragraph IV route,
it has major disadvantages. See generally Michael A.
Carrier, Skinny Labels’ Importance for Drug Competition, Wis. L. Rev. Forward (forthcoming 2026) [hereinafter Carrier, Importance], available online.4 Most
notably, it tends to be lengthy and costly. A survey of
patent lawyers reveals that for pharmaceutical litigation
with more than $25 million at risk, the average litigation
costs are $6.2 million. Am. Intell. Prop. L. Ass’n, Report of the Economic Survey I-158 (2023). Plus, as noted
above, the brand firm, merely by filing a lawsuit, automatically obtains an effective preliminary injunction in
the form of a 30-month stay of generic approval. FFDCA
§ 505(j)(5)(B)(iii).5
B.
THE SECTION viii “SKINNY LABELING”
PATHWAY IS CRITICAL TO EFFECTIVE
GENERIC ENTRY
The alternative to paragraph IV litigation is called the
“carve-out,” the “skinny label,” or by reference to the relevant part of the statute, section viii. Id. § 505(j)(2)(A)(viii).
4
Locations of authorities available online are shown in the Table
of Authorities.
5
Additionally, the first generic to file an ANDA with a paragraph
IV certification receives a 180-day period of marketing exclusivity.
FFDCA § 505(j)(5)(B)(iv).
11
This option exists because, as this Court has explained,
“a single drug may have multiple methods of use, only
one or some of which a patent covers.” Caraco Pharm.
Lab’ys, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 414 (2012).
But method-of-use patents can be applied for—and thus
expire—years (or even decades) after the drug compound
itself is off-patent and legitimately open to generic competition. If the Hatch–Waxman Act precluded the FDA
from approving a generic drug on account of method-ofuse patents, then generic competition could be delayed
indefinitely.
Section viii deals specifically with method-of-use
patents and overcomes this hurdle by permitting a
generic firm to seek approval for only unpatented uses.
The firm carves out the patented uses from its labeling to produce a skinny label, and includes in its ANDA
“a statement that the method of use patent does not
claim” the uses for which approval is sought. FFDCA
§ 505(j)(2)(A)(viii). Through this procedure, the Hatch–
Waxman Act “authorize[s] the FDA to approve the marketing of a generic drug for particular unpatented uses;
and section viii provides the mechanism for a generic company to identify those uses, so that a product with a label
matching them can quickly come to market.” Caraco, 566
U.S. at 415. In other words, section viii ensures “that one
patented use will not foreclose marketing a generic drug
for other unpatented ones.” Id.
While a generic firm could theoretically use a paragraph IV certification for a method-of-use patent, section viii provides unique advantages. See Carrier, Importance, supra. Because a section viii statement does not
require the same notification to patent holders as does a
paragraph IV certification, litigation is “not usually trig-
12
ger[ed].” Shashank Upadhye, Generic Pharmaceutical
Patent and FDA Law § 26:11 (2024).
In addition, drug applications based on a section viii
statement are not subject to the 30-month stay, ensuring
faster FDA final approval so generics can more quickly
enter the market. See FFDCA § 505(j)(5)(B)(iii). With
paragraph IV litigation, the generic must wait during the
30-month stay, paying the costs of litigation all the while,
before getting final FDA approval to enter the market.
Even after that, to market its less expensive drug, the
generic often must launch “at risk” because the patent
litigation typically extends beyond the 30-month stay.
Launching at risk exposes the generic to potentially substantial lost-profit damages since the brand product sells
at a much higher price than the generic. Teva Pharms.
USA, Inc. v. Sebelius, 595 F.3d 1303, 1305 (D.C. Cir. 2010);
see Peter Loftus, Pfizer, Takeda to Get $2.15 Billion Settlement, Wall St. J., June 12, 2013.
The advantages of the section viii carve-out over paragraph IV litigation are compounded by the fact that
method-of-use patents, the focus of skinny labels, are especially questionable as to validity. See infra pp. 26–
27. There are multiple reasons why patents are often
overturned in court, including limited time for examination, incentives to grant patents, and the ex parte nature of the patent acquisition process. See, e.g., Nat’l
Rsch. Council, A Patent System for the 21st Century
47–48 (2004), available online. But to the extent that
such patents are granted and are associated with drug
products—the FDA exercises only a “ministerial” role
over those associations, Caraco, 566 U.S. at 407—generic
competitors must deal with these questionable patents,
13
either through the simplicity of a section viii carve-out or
in costly paragraph IV litigation.
For these reasons, courts have recognized that section viii is “an attractive route for generic manufacturers,” Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 880
(D.C. Cir. 2004), and a pathway with “a diminished set
of . . . risks,” TorPharm, Inc. v. Thompson, 260 F. Supp.
2d 69, 73–74 (D.D.C. 2003). The skinny labeling pathway
provides certainty, efficiency, cost savings, and simplicity for both generic firms applying for approval and the
FDA reviewing ANDAs. And it does this without harming innovation, as brand manufacturers can still patent
new methods of use and compel generics to carve out
those uses. It is a central part of the design of the Hatch–
Waxman Act.
C.
THE CONDUCT REQUIREMENT AVOIDS
CIRCUMVENTION OF THE STATUTORY DESIGN
Twice now, the Federal Circuit has allowed generic
firms to be haled into an induced infringement lawsuit
based, at least in part, on the very actions those generics
took to comply with the section viii carve-out pathway.
See Pet. App. 17a; see also GlaxoSmithKline, 7 F.4th at
1328–29. Doing so depended on an expansionist view of
inducement that ensnared acts that were not specific, unambiguous, or affirmative. The text and structure of the
Hatch–Waxman Act carve-out, however, show that the
Federal Circuit’s expansion of inducement under § 271(b)
is in error.
As an initial matter, section viii is closely tied to inducement. No other form of liability under § 271 could
logically attach to a generic firm based on a method-of-use
patent covering an otherwise off-patent drug. A generic
14
firm cannot directly infringe under § 271(a) because a
mere seller of a drug performs no methods of using it.
Contributory infringement under § 271(c) is avoided because an off-patent drug has “substantial noninfringing
uses,” namely those first identified when the drug was
discovered.6 Importation and exportation under § 271(f)–
(g) are presumably not at issue, and § 271(e) applies only
to Paragraph IV certifications, not section viii. WarnerLambert, 316 F.3d at 1362. Inducement under § 271(b) is
all that is left.
Given that the drafters of the Hatch–Waxman Act
were keenly aware of patent law, the section viii carveout undoubtedly reflects how Congress understood inducement under § 271(b). The legislature’s understanding conflicts with that of the Federal Circuit in at least
two ways.
First, the statutory text suggests that carve-outs
should be simple. Section viii says nothing about how
to carve out a method of use from generic labeling. See
FFDCA § 505(j)(2)(A)(viii). Indeed, the generic’s labeling must be “the same” as the brand-name product’s except for deviations irrelevant to patents. See id.
§ 505(j)(2)(A)(v). If § 271(b) required detailed labeling
revisions to avoid even speculative inferences of inducement, then generic companies would need guidance on
permissible labeling revisions, and the FDA would need
authorization to accept them. The lack of guidance and
authorization shows that the carved-out text must be so
obviously removable that the resulting labeling remains
6
Patent law’s utility requirement ensures that, at the time the
first patent application covering a drug is filed, at least one use of the
drug is known. Janssen Pharmaceutica NV v. Teva Pharms. USA,
Inc., 583 F.3d 1317, 1324 (Fed. Cir. 2009) (discussing Brenner v. Manson, 383 U.S. 519, 534–35 (1966)).
15
“the same,” at least with respect to the unpatented methods of use.
Second, section viii’s simplicity suggests that
Congress viewed avoidance of inducement liability as so
straightforward that an agency without patent expertise,
like the FDA, could administer it. As this Court has
observed, the basic premise of the Hatch–Waxman Act
is that “the FDA cannot authorize a generic drug that
would infringe a patent.” Caraco, 566 U.S. at 405. If
inducement were as expansive as the Federal Circuit
deemed it to be, then Congress would have devised
some mechanism to determine whether labeling induces
infringement—litigation procedures like paragraph IV,
perhaps, or at least a protest opportunity for the patent
holder. Section viii has no such mechanism. Congress
therefore must have found that determining whether
a label induces infringement requires no speculation,
patent expertise, or detailed fact-finding—the opposite
of how the Federal Circuit has characterized inducement.
See GlaxoSmithKline, 7 F.4th at 1330–31.
Patent inducement’s historic requirement of specific,
unambiguous, and affirmative conduct is consistent with
these consequences of the statutory text. Specific and
unambiguous language of inducement is easy enough to
identify that the FDA, even in its traditional ministerial
role, can do it. Such language can be excised from the
labeling without intricate or detailed edits, allowing the
remainder of the label to remain “the same.”
That makes the historic requirement consistent with
the statute’s motivating principle—congressional intent
to facilitate generic entry. Federal Circuit Judge Prost
has explained, “if playing by the skinny-label rules
doesn’t give generics some security from label-based li-
16
ability,” they “simply won’t play” because “[t]he risk is
too great.” GlaxoSmithKline LLC v. Teva Pharms. USA
(“GlaxoSmithKline II”), 25 F.4th 949, 955 (Fed. Cir. 2022)
(per curiam) (Prost, J., dissenting from denial of petition
for rehearing en banc). The historic requirement gives
generics that certainty and security, and thus effectuates
the legislative scheme.
III.
THE CONDUCT REQUIREMENT PROMOTES
INNOVATION AND THE PURPOSES OF THE
PATENT ACT
The Federal Circuit’s failure to adhere to the specific, unambiguous, and affirmative conduct requirement
frustrates not only the Hatch–Waxman Act, but also the
patent system as a whole. It allows a method-of-use
patent to distort legitimate competition, misaligns incentives for innovation, and potentially allows patent protection to run indefinitely rather than for a limited term.
A.
AN EXPANDED INDUCEMENT DOCTRINE
INTERFERES WITH COMPETITION AND
REGULATORY COMPLIANCE
The expansion of patent inducement opens the door
to anticompetitive behavior and regulatory manipulation.
To see why, consider the four acts upon which the Federal
Circuit relied in this case to infer possible inducement:
(1) the text of the generic drug label, (2) descriptions of
the generic drug as “AB-rated,” (3) statements that the
generic was a “generic version,” and (4) investor press
releases reciting the total sales of the brand-name drug.
Pet. App. 16–18a.
Many of these actions are standard tropes of comparative marketing. Generic cereals, sodas, car parts,
17
and other products regularly compare themselves to
“the leading brand” and may even reference the leading brand’s sales. Charles Duan, The Importance of Being Equivalent, 17 Am. U. Intell. Prop. Brief (forthcoming 2026) [hereinafter Duan, Equivalent] (manuscript at
sec. I.A), available online. Computer products advertise
compatibility with information technologies like Wi-Fi or
USB—a claim that the product is “equivalent” to other
compatible systems. Id.; see Dylan Niederland, The Software Inducement Paradox, 75 Am. U. L. Rev. 307 (2025).
In all these fields, truthful advertising enables fair
competition. Equivalence statements allow new entrants
to attract customers away from incumbents. See Warner
Lambert Co. v. McCrory’s Corp., 718 F. Supp. 389, 399–
400 (D.N.J. 1989) (observing ubiquity of “compare and
save” advertisements for generic products); Duan, Equivalent, supra, sec. I.B. They are also a commonplace of
discourse, both in the industry and outside. The words
“generic version,” which the Federal Circuit would proscribe as inducement, are how doctors, pharmacists, patients, and even Congress and this Court describe generic
drugs. 21 U.S.C. § 353d(a)(3); Caraco, 566 U.S. at 415.
If § 271(b) could ensnare truthful statements of comparative advertising, it would impede legitimate competition,
boosting dominant firms for no good reason.
Due to conflicts with regulatory requirements, inducement based on the drug label and AB-rating statements
is even more pernicious. A generic drug may be approved
only if the generic’s labeling is “the same as the labeling approved for” the brand equivalent. See FFDCA
§ 505(j)(2)(A)(v); accord 21 C.F.R. § 314.127(a)(7). And
the “AB” rating is an assigned FDA determination based
on the generic’s therapeutic equivalence. See Food &
18
Drug Admin., Approved Drug Products with Therapeutic Equivalence Evaluations xiii–xiv (45th ed. 2025). If
statements in drug labeling or a government-issued rating can induce infringement, then the generic company is
thrust into an impossible double-bind of being required
by regulation to violate a patent—what one might call
“mandatory infringement.” See generally Charles Duan,
Mandatory Infringement, 75 Fla. L. Rev. 219 (2023)
[hereinafter Duan, Mandatory Infringement].
The copyright case of SmithKline Beecham Consumer Healthcare, LP v. Watson Pharmaceuticals, Inc.
illustrates this double-bind. A generic manufacturer
sought to market an off-patent nicotine chewing gum. 211
F.3d 21, 23 (2d Cir. 2000). Complying with the Hatch–
Waxman Act’s same-labeling requirement, the generic
used the same labeling as the brand-name gum, and the
brand-name manufacturer sued for copyright infringement. SmithKline, 211 F.3d at 23–24. When the generic
tried to rewrite its labeling, the FDA refused it, requiring the generic “to copy verbatim substantially all of the
text.” See id. at 24. The district court asked the FDA to
“revisit” its refusal, but the agency responded, correctly
under the law, that the agency had no authority to consider copyright issues in its approval of labeling. See id.;
FFDCA § 505(j)(4)(G) (prohibiting FDA from approving
an ANDA absent same-labeling).
As SmithKline recognized, the situation produced “a
conflict between two statutes”—copyright law prohibits
what regulation requires. 211 F.3d at 28. Left unresolved,
this conflict would mean that a generic firm “cannot realistically use the ANDA process to sell its generic” products. Id. By the same token, if the required labeling or
regulatory designations of generic drugs could give rise
19
to patent inducement, then generic drugs could not be realistically marketed without an ongoing threat of liability.
See Duan, Mandatory Infringement, supra, at 238–40.7
The section viii carve-out does offer a limited degree
of flexibility from the same-labeling requirement, authorizing generics to carve out patented methods of use.
See FFDCA § 505(j)(2)(A)(viii); 21 C.F.R. § 314.127(a)(7).
But that minimal flexibility provides little help in this
setting. Consistent with its statutory duties, the FDA
will only allow patent-accommodating deviations from
the same-label requirement if those deviations “do not
render the proposed drug product less safe or effective.”
21 C.F.R. § 314.127(a)(7); see Ctr. for Drug Evaluation
& Rsch., FDA, ANDA Submissions—Refuse-to-Receive
Standards 12 (2d rev. Dec. 2016), available online (disallowing “differences in . . . labeling . . . that may be associated with safe/effective use of the drug product”).
At odds with this mandate, the Federal Circuit has
been willing to find plausible inducement allegations
based on labeling text in, among other places, the “Clinical Study” and “Dosage and Administration” sections of
a drug label. GlaxoSmithKline, 7 F.4th at 1329. These
are sections where the FDA would likely refuse revisions.
See 21 C.F.R. § 201.57(c)(15) (Clinical Studies section describes “how to use the drug safely and effectively”). Minor flexibility under section viii cannot resolve the conflict between the Hatch–Waxman Act and the Federal
Circuit’s expansive theories of inducement.
7
The court in SmithKline resolved the problem by inserting an
implicit exception into the Copyright Act. There is no need to do the
same here because the statutory conflict disappears under a proper
construction of inducement.
20
B.
SUCH INTERFERENCE DISTORTS INCENTIVES
FOR INNOVATION, CONTRARY TO PATENT LAW
AND POLICY
It is problematic enough that the Federal Circuit’s expansion of inducement creates a statutory conflict. But
the problems run deeper, as this conflict undermines the
reason for the very existence of the patent system.
Patents are granted “to promote the progress of science and useful arts.” U.S. Const. art. I, § 8, cl. 8. As a
form of temporary exclusivity over an invention, a patent
offers incentives to invent, to disclose inventions, and
to commercialize them. See, e.g., Bonito Boats, Inc. v.
Thunder Craft Boats, Inc., 489 U.S. 141, 150–51 (1989).
But these incentives must be calibrated—the patent’s private value to the inventor ought generally to correlate
with the patented technology’s public value. Too little reward and inventors may opt out of inventing; too much
reward and inventors may focus on rent-seeking rather
than research. See id. at 146–47. As a result, there is
a “paramount interest in seeing that patent monopolies
are kept within their legitimate scope.” Medtronic, Inc. v.
Mirowski Family Ventures, LLC, 571 U.S. 191, 203 (2014)
(quoting Precision Instrument Mfg. Co. v. Auto. Maint.
Mach. Co., 324 U.S. 806, 816 (1945)).
This calibration ought to happen naturally through
the “market-set reward” nature of patents. See Daniel
J. Hemel & Lisa Larrimore Ouellette, Innovation Policy
Pluralism, 128 Yale L.J. 544, 553–54 (2019). A patent’s exclusivity over an invention has value only to “the extent
to which consumers prefer it over alternatives and prior
technology.” Fed. Trade Comm’n, The Evolving IP Marketplace 138 (2011). In an ideal world, marginal improvements would command little or no price increase, while
21
substantial improvements would lead to larger returns
to the patent holder. As a result, “a well-functioning market incentivizes inventors to pursue those inventions that
are more likely to be valued by consumers.” Id. at 140
(citing Roger D. Blair & Thomas F. Cotter, Intellectual
Property: Economic and Legal Dimensions of Rights
and Remedies 16–17 (2005)).
But where market competition is distorted, for example by an overbroad patent inducement doctrine, the incentive structure of patents is also upended. See generally Duan, Mandatory Infringement, supra, at 256–
58; Bernard Chao, Horizontal Innovation and Interface
Patents, 2016 Wis. L. Rev. 287, 295–307. This is because
the market-distortive effects described above do not depend on the value of the patent causing the distortion.
Consider again the four types of non-specific statements about product equivalence and regulatory compliance discussed above. See supra p. 16. Any methodof-use patent on the relevant drug could rope a generic
firm into protracted inducement litigation based on those
statements, regardless of whether that patent helps five
million patients or five. See Duan, Mandatory Infringement, supra, at 257. A rational drug developer, looking
to exploit method-of-use patents to stymie generic competition, would rationally pursue the cheapest, least innovative methods of use to do so.
This upside-down incentives phenomenon can occur
in many industries, such as pharmaceuticals, agriculture,
and communication technologies. See Charles Duan, Licensing Patents, but Not by Choice, 18 Landslide 7, 8–10
(Sept.–Oct. 2025), available online. But it is especially
acute for methods of drug uses. New drug development
is expensive in part because of the extensive clinical trial
22
data that the drug developer must generate. Once that
data is generated, though, it is merely a matter of statistical analysis to find another correlation or patient subpopulation that reacts differently to the drug, which can
be patented as a method of use. See Jin Park et al., Overlapping Method of Use Patents to Prevent Generic Entry, 53 J.L. Med. & Ethics 577, 578–79 (2025) (reviewing
method-of-use patent portfolios of this type).8 Indeed,
nothing stops a drug patent holder from “discovering” a
new method of use every twenty years, thereby generating generic-blocking patents theoretically forever. See
Duan, Equivalent, supra, sec. III.B.
Consistent with this theory, firms are taking increased advantage of method-of-use patents today. See S.
Sean Tu & Ameet Sarpatwari, A “Method of Use” to Prevent Generic and Biosimilar Entry, 388 New Eng. J. Med.
483, 485 & fig. (2023). Indeed, many of the method-of-use
patents held by the respondents are simple variations on
a theme, covering methods of using icosapent ethyl on different patient populations based on cholesterol levels.9
See generally S. Sean Tu & Charles Duan, Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin v.
Hikma Type Litigation, 12 N.Y.U. J. Intell. Prop. & Ent.
L. 1, 14 (2022).
8
This is sometimes called “in silico” or “computational drug repurposing.” See, e.g., Ziaurrehman Tanoli et al., Computational Drug
Repurposing, 24 Nature Revs. Drug Discovery 521 (2025). FDA approval of a drug’s new use may require clinical trials or other studies,
but those are not required for patenting the new use.
9
See, e.g., U.S. Patent No. 9,700,537 cl. 1 (issued July 11,
2017) (claiming treatment of patients with triglycerides of at least
150mg/dl); U.S. Patent No. 8,399,446 cl. 1 (issued Mar. 19, 2013) (500
to 1500mg/dl); U.S. Patent No. 12,171,738 cl. 1 (issued Dec. 24, 2024)
(200 to 500mg/dl).
23
The infamous patent on the use of the drug BiDil on
African-American patients also fits this cheap-innovation
pattern precisely. See Jonathan Kahn, Race in a Bottle:
The Story of BiDil and Racialized Medicine in a PostGenomic Age 48–49 (2013). Knowing that its general
patent on BiDil would expire soon, the developer of the
drug hastily reexamined its existing clinical trial data to
find a race-based statistical correlation—apparently, one
that was “weak at best.” Id. at 59. The developer then
obtained a method-of-use patent on the correlation, delaying generic competition for thirteen additional years.
See id. at 49.
To be sure, new uses of known drugs can be valuable,
and inventors of new uses arguably face some difficulties
exploiting their patents. This is a consequence of complex interactions among doctors’ prescription practices,
pharmacy substitution laws, and a lack of policies regarding off-label uses. See David A. Simon, Off-Label Innovations, 56 Ga. L. Rev. 701, 730–33 (2022).
As the Solicitor General observed, these difficulties
were a trade-off that Congress “presumably understood.”
Br. United States as Am. Cur. 12, Dec. 5, 2025. Furthermore, the proper solution to any such difficulties is specific policy targeted to this particular interaction. See,
e.g., Simon, supra, at 749–50. It is not to foreclose the market for generics by expanding the scope of inducement liability to sweep in ordinary and mandatory acts of drug
marketing. Swinging the pendulum so far in the direction
of expanded liability would encourage the development of
only the cheapest methods of use. Such a result would be
at cross-purposes with the patent system.
24
C.
THE CONDUCT REQUIREMENT AVOIDS THESE
INNOVATION AND COMPETITION DISTORTIONS
Avoiding these systemic harms to competition, regulation, and innovation is a simple matter of returning to the
standard that the Federal Circuit abandoned: the longstanding requirement of a specific, unambiguous, and affirmative act.
Under that standard, generalized comparative advertising or statements of product equivalence generally do
not induce infringement, as long as the advertising or
statements do not identify the specific patented method
of use. In particular, assuming that the product in question has noninfringing uses, any such nonspecific marketing claim would be ambiguous at best.
Applied to the marketing statements in the present
case, for example, the description of generic icosapent
ethyl as a “generic version” and “AB rated” are not specific to any particular use of the drug, and they are ambiguous insofar as icosapent ethyl has noninfringing uses.
Similarly, the press releases describing brand-name sales
of Vascepa do not specifically encourage any particular
use, and are ambiguous in that the sales numbers cover
multiple uses of Vascepa. Interpreted this way, § 271(b)
would “avoid imposing liability on those who participate
in the stream of lawful commerce merely because their
products can be misused.” Lemley, supra, at 228.
The specific, unambiguous, and affirmative act requirement also resolves the conflict with the Hatch–
Waxman Act. If a generic drug’s labeling specifically
and unambiguously encourages a patented use of a drug,
then that text would likely induce infringement. See Eli
Lilly & Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357,
1369 (Fed. Cir. 2017). But labeling that generally char-
25
acterizes the safety, dosage, or clinical trial characteristics of a drug would likely be nonspecific and ambiguous with respect to a patented use. See, e.g., Takeda,
785 F.3d at 631–32. It would not induce infringement
and thus would avoid any need for labeling modifications
that would subvert the FDA’s safety and efficacy mandate. A generic firm’s declining to speculate about how
doctors interpret ambiguous labeling text also would not
induce infringement because the omission would not be
affirmative. Cf. Worthington Indus., 849 F.2d at 597
(no inducement where “no document exists which states”
inducement-relevant conduct).
Accordingly, the historic rule that inducement of infringement requires a specific, unambiguous, and affirmative act preserves competitive markets while also avoiding unnecessary conflicts with the regulatory system.
IV. EMPIRICAL STUDIES SHOW THE CONDUCT
REQUIREMENT’S IMPORTANCE TO PATIENTS
AND PUBLIC HEALTH
The harms of expanding patent inducement liability
are not mere theory, but borne out through numerous empirical studies.
Skinny labeling has resulted in proven benefits for
access to medicines and competitive drug pricing. One
study identified 15 brand-name drugs for which the first
generic competition between 2015 and 2019 occurred via
a skinny-label entrant and found that skinny labels resulted in generic entry a median of 2.5 years earlier.
Alexander C. Egilman et al., Estimated Medicare Part
D Savings from Generic Drugs with a Skinny Label, 177
Annals Internal Med. 833 (2024). Competition from these
15 drugs alone saved the Medicare Part D $14.6 billion
26
from 2015 to 2021 and increased use of the drugs, which
“suggest[ed] improved patient access.” Id. at 835.10
Over the last few decades, though, brand-name manufacturers have increasingly been building up stockpiles
of method-of-use patents on their drugs. See Doni Bloomfield et al., Prescription Drug Method-of-Use Patent Protection, 1991–2018, 41 J. Gen. Internal Med. 261, 261–62
(2026); see also Tu & Sarpatwari, supra (finding sixfold increase in registration of “use codes,” which correlate with
method-of-use patents).
For example, in 2012, the FDA originally approved
Amarin’s Vascepa for severe hypertriglyceridemia,
which is characterized by triglyceride levels of at least
500 milligrams per deciliter. This indication is now
unpatented. See Tu & Duan, supra, at 21–22. But in
2019, Amarin received FDA approval for Vascepa to
treat cardiovascular risk in patients with triglyceride
levels of at least 150 milligrams per deciliter, with patent
protection lasting until 2033. As of 2024, respondents’
product Vascepa was associated with 67 patents with
expiration dates ranging from May 31, 2027 to June 28,
2033. Id. at 19–20.
Perhaps connected to the problems of incentives for
low-value innovation described above, the evidence also
suggests that method-of-use patents are often of questionable validity. One study found that the Federal Circuit upheld method-of-use patents only 29% of the time
10
Medicare Part D provides prescription drug coverage. 42 U.S.C.
ch. 7, subch. XVIII, pt. D. For similar findings for biologics in the context of Medicare, see Alexander C. Egilman et al., Frequency of Approval and Marketing of Biosimilars with a Skinny Label and Associated Medicare Savings, 183 JAMA Internal Med. 82 (2023) (finding
$1.5 billion in savings and 2.5 years of earlier entry on five biologics
between 2015 and 2020).
27
(as compared to 75% for active ingredient patents). Errol
B. Taylor & Fredrick M. Zullow, Focusing Only on Active Ingredient Patents Ignores Case Law Success Rates,
Pharm. L. & Indus. Rep. (BNA), Oct. 28, 2011.
Similarly, another study found that while patents covering a drug’s active ingredient are almost always (92%)
upheld in court, those involving secondary patents covering “ancillary aspects of drug innovation” are upheld
in only 32% of the cases. C. Scott Hemphill & Bhaven
Sampat, Drug Patents at the Supreme Court, 339 Science
1386, 1386–87 (2013).11
Growing stockpiles of method-of-use patents and an
expanded inducement doctrine appear to have led to declining use of the skinny-label pathway. Between 2015
and 2022, the number of drugs approved using the skinnylabel pathway was roughly 40 to 50%. See Bryan S. Walsh
et al., Frequency of First Generic Drug Approvals with
“Skinny Labels” in the United States, 181 JAMA Internal
Med. 995 (2021) (2015–2019 period); Therese J. Ziaks et
al., Frequency of First Generic Drugs Approved Through
“Skinny Labeling,” 2021 to 2023, 31 J. Managed Care &
Specialty Pharmacy 343 (2025) (2021–2022 period).
In 2023, however, the number of drugs using the pathway fell to 20%, likely due to the Federal Circuit’s first
expansion of inducement, GlaxoSmithKline, two years
earlier. See Ziaks et al., supra, at 346–47. This appears
to confirm Judge Prost’s prediction that generics “simply won’t play” absent certainty from the skinny-labeling
11
For oft-cited general studies, see John R. Allison & Mark A. Lemley, Empirical Evidence on the Validity of Litigated Patents, 26
AIPLA Q.J. 185, 194, 205 (1998) (courts invalidated 46% of patents);
Kimberly A. Moore, Judges, Juries, and Patent Cases—An Empirical Peek Inside the Black Box, 99 Mich. L. Rev. 365, 384–85 (2000)
(alleged infringers prevailed in 42% of patent cases).
28
pathway. GlaxoSmithKline II, 25 F.4th at 955 (in dissent).
These concerns led the FDA to include in its 2024 legislative proposals a safe harbor for skinny labeling. Justification of Estimates for Appropriations Committees 38–
39 (Food & Drug Admin. 2024), available online. In particular, the agency asked Congress to “exclud[e] such labeling from the evidence that can be used to support a
claim of patent infringement” and “clarify[] that statements regarding therapeutic equivalence cannot be used
as evidence to support an infringement claim.” Id. at 39.
The FDA was “concerned” that the GlaxoSmithKline decision “imperils an important statutory marketing pathway that allows earlier generic drug market entry for
conditions of use of a drug not protected by a patent.”
Justification of Estimates for Appropriations Committees, supra, at 39. And it worried that “[w]ithout this
change, . . . [the] decision could significantly impact the
timely availability of generic drugs.” Id.
Congress designed the section viii pathway to enable the speedy introduction of generic drugs in settings
where patents cover some but not all uses of those drugs.
See Caraco, 566 U.S. at 414–15. The evidence shows that
it has worked—up until the Federal Circuit expanded the
patent inducement doctrine to reach beyond its proper
bounds. Restoring the requirement of a specific, unambiguous, and affirmative act would return inducement
doctrine to its common law roots while having measurable impacts on the health and welfare of all Americans.
CONCLUSION
For the foregoing reasons, the decision of the Court of
Appeals should be reversed.
Respectfully submitted,
MICHAEL A. CARRIER
RUTGERS LAW SCHOOL
217 North Fifth Street
Camden, NJ 08102
(856) 225-6380
mcarrier@law.rutgers.edu
S. SEAN TU
UNIVERSITY OF ALABAMA
SCHOOL OF LAW
101 Paul W. Bryant Drive East
Tuscaloosa, AL 35487
(352) 262-9531
sstu@law.ua.edu
CHARLES DUAN
Counsel of Record
AMERICAN UNIVERSITY
WASHINGTON COLLEGE OF
LAW
4300 Nebraska Avenue NW
Washington, DC 20016
(202) 274-4124
supremecourt.gov@cduan.com
AARON S. KESSELHEIM
HARVARD MEDICAL SCHOOL
641 Huntington Ave., 2nd Floor
Boston, MA 02115
(617) 278-0930
akesselheim@bwh.harvard.edu
Counsel for Amici Curiae
February 2026
29
APPENDIX A
LIST OF ACADEMIC SIGNATORIES
The brief presents the views of the individual signers.
Institutions are listed for identification purposes only.
Professor GERARD ANDERSON, Johns Hopkins
Bloomberg School of Public Health
Professor REED BEALL, University of Calgary
Cumming School of Medicine
Professor JEREMY BOCK, Tulane University Law School
Professor Emeritus TIMOTHY F. BRESNAHAN, Stanford
Department of Economics
Professor JEREMY I. BULOW, Stanford Business School
Professor DARREN BUSH, University of Houston Law
Center
Professor MICHAEL A. CARRIER, Rutgers Law School
Professor MICHAEL W. CARROLL, American University
Washington College of Law
Professor Emeritus PETER CARSTENSEN, University of
Wisconsin Law School
Professor BERNARD CHAO, University of Denver Sturm
College of Law
Professor THOMAS CHENG, University of Hong Kong,
Faculty of Law
Professor Emeritus RALPH D. CLIFFORD, University of
Massachusetts School of Law
Professor JORGE L. CONTRERAS, University of Utah S.J.
Quinney College of Law
Professor Emerita ROCHELLE DREYFUSS, New York
University School of Law
30
31
Professor CHARLES DUAN, American University
Washington College of Law
Professor MICHAEL DUBE, University of New
Hampshire Franklin Pierce School of Law
Professor STACIE B. DUSETZINA, Vanderbilt University
Medical Center
Professor WILLIAM FELDMAN, UCLA David Geffen
School of Medicine
Professor H.E. FRECH, III, University of California,
Santa Barbara, Department of Economics
Professor ERIN C. FUSE BROWN, Brown University
School of Public Health
Professor MICHAL S. GAL, University of Haifa, Faculty
of Law
Professor JON M. GARON, Nova Southeastern
University Shepard Broad College of Law
Professor SHUBHA GHOSH, Syracuse University College
of Law
Professor HIBA HAFIZ, Boston College Law School
Professor Emerita BRONWYN H. HALL, University of
California, Berkeley, Department of Economics
Professor (former) JEFFREY HARRISON, University of
Florida Levin College of Law
Professor YANIV HELED, Georgia State University
College of Law
Professor CHRISTINA S. HO, Rutgers Law School
Professor CYNTHIA M. HO, Loyola University Chicago
School of Law
Professor TIM HOLBROOK, University of Denver Sturm
College of Law
32
Professor ERIK HOVENKAMP, Cornell Law School
Professor MICHAEL J. HUTTER, Albany Law School
Professor AARON S. KESSELHEIM, Harvard Medical
School
Professor SHWETA KUMAR, University of Kentucky J.
David Rosenberg College of Law
Professor AMY LANDERS, Drexel University Thomas R.
Kline School of Law
Professor STACEY M. LANTAGNE, Suffolk University
Law School
Professor MARK A. LEMLEY, Stanford Law School
Professor JACK I. LERNER, University of California,
Irvine School of Law
Professor CHRISTOPHER R. LESLIE, University of
California, Irvine School of Law
Professor YVETTE JOY LIEBESMAN, Saint Louis
University School of Law
Professor DARYL LIM, Penn State Dickinson Law
Professor ORLY LOBEL, University of San Diego School
of Law
Professor Emeritus LEE ANN WHEELIS LOCKRIDGE,
Louisiana State University Law Center
Professor BRIAN LOVE, Santa Clara University School
of Law
Professor DUNCAN MATTHEWS, Queen Mary
University of London, School of Law
Professor MARK P. MCKENNA, UCLA School of Law
Professor Emerita FRANCES MILLER, Boston
University Law School
33
Professor CHRISTOPHER J. MORTEN, New York
University School of Law
Professor Emeritus ROGER NOLL, Stanford University,
Department of Economics
Professor TYLER T. OCHOA, Santa Clara University
School of Law
Professor (former) LUIGI PALOMBI, University of
Sydney
Professor JORDAN PARADISE, Loyola University
Chicago School of Law
Professor STEPHANIE PLAMONDON, Brigham Young
University J. Reuben Clark Law School
Professor SRIVIDHYA RAGAVAN, Texas A&M University
School of Law
Professor ZIA RAHMAN, Sidney Kimmel Medical
College at Thomas Jefferson University
Professor ARTI K. RAI, Duke Law School
Professor JASON REINECKE, University of Wisconsin
Law School
Professor CHRISTOPHER ROBERTSON, Boston
University Law School
Professor BENJAMIN N. ROME, Harvard Medical School
Professor JOSEPH ROSS, Yale School of Medicine
Professor ANA SANTOS RUTSCHMAN, Villanova
University Charles Widger School of Law
Professor WILLIAM SAGE, Texas A&M University
School of Law and College of Medicine
Professor JOSHUA D. SARNOFF, DePaul College of Law
Professor AMEET SARPATWARI, Harvard Medical
School
34
Professor KURT SAUNDERS, California State
University, Northridge, David Nazarian College of
Business and Economics
Professor FIONA M. SCOTT MORTON, Yale School of
Management and Yale Law School
Professor STEVEN SEMERARO, Thomas Jefferson School
of Law
Professor MICHAEL S. SINHA, Saint Louis University
School of Law
Professor ARAM SINNREICH, American University
School of Communication
Professor KATHERINE J. STRANDBURG, New York
University School of Law
Professor HANNIBAL TRAVIS, Florida International
University College of Law
Professor S. SEAN TU, University of Alabama School of
Law
Professor H.H.B. VEDDER, University of Gronigen,
Faculty of Law
Professor LIZA VERTINSKY, University of Maryland
Francis King Carey School of Law
Professor REBECCA E. WOLITZ, The Ohio State
University, Mortiz College of Law
Professor OLIVIER WOUTERS, Brown University School
of Public Health
Rev. b3258e32
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.