Amicus Curiae Brief — Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Amarin Pharma, Inc., et al.
Supreme Court briefMar 20, 2025
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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 PETITION FOR WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
BRIEF OF 30 SCHOLARS OF LAW, ECONOMICS,
AND MEDICINE AS AMICI CURIAE IN SUPPORT
OF THE PETITION
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
Counsel for Amici Curiae
TABLE OF CONTENTS
TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . ii
INTEREST OF AMICI CURIAE . . . . . . . . . . . . . . 1
SUMMARY OF ARGUMENT . . . . . . . . . . . . . . . . 1
ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 4
I.
The Federal Circuit’s Decision Creates a Cloud of Liability over Product Equivalence Statements . . . . . 4
II. Liability Based on Product Equivalence Statements
Is Contrary to Law and Policy . . . . . . . . . . . . . . 6
A. The Federal Circuit’s Decision Renders Patent
Doctrine Inconsistent with Its Common Law
Basis . . . . . . . . . . . . . . . . . . . . . . . . . . 6
B.
Patent Liability Could Now Theoretically Run
Forever, Contrary to the Limited Patent Term . . 9
III. Impediments to Product Equivalence Statements
Would Cause Multiple Societal Harms . . . . . . . . . 12
A. Numerous Industries Beyond Pharmaceuticals
Depend on Equivalence Statements . . . . . . . . 13
B.
Equivalence Statements Are Necessary for Efficient Free-Market Competition . . . . . . . . . . 15
C.
Equivalence Statements Reduce Regulatory
Compliance Costs and Avoid Administrative
Waste . . . . . . . . . . . . . . . . . . . . . . . . . 18
D.
Equivalence Statements Protect Consumers
from Confusion . . . . . . . . . . . . . . . . . . . . 21
CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . 23
APPENDIX A: List of Academic Signatories . . . . . . . . 24
(i)
TABLE OF AUTHORITIES
CASES
Abbvie Inc. v. Mathilda & Terence Kennedy Institute,
764 F.3d 1366 (Fed. Cir. 2014) . . . . . . . . . . . . . . . 10
Alice Corp. Pty. Ltd. v. CLS Bank International,
573 U.S. 208 (2014) . . . . . . . . . . . . . . . . . . . . . . 15
Amarin Pharma v. Hikma Pharmaceuticals USA,
449 F. Supp. 3d 967 (D. Nev. 2020) . . . . . . . . . . . . . 11
Borden v. United States,
141 S. Ct. 1817 (2021) . . . . . . . . . . . . . . . . . . . . 7
Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
246 F.3d 1368 (Fed. Cir. 2001) . . . . . . . . . . . . . . . 10
Caraco Pharmaceutical Laboratories, Ltd.
v. Novo Nordisk A/S,
566 U.S. 399 (2012) . . . . . . . . . . . . . . . . . . . . . . 17
Commil USA, LLC v. Cisco Systems, Inc.,
575 U.S. 632 (2015) . . . . . . . . . . . . . . . . . . . . . 7–8
DSU Medical Corp. v. JMS Co., Ltd.,
471 F.3d 1293 (Fed. Cir. 2006) (en banc) . . . . . . . . . 5, 7
eBay Inc. v. MercExchange, LLC,
547 U.S. 388 (2006) . . . . . . . . . . . . . . . . . . . . . . 9
Eli Lilly & Co.
v. Board of Regents of the University of Washington,
334 F.3d 1264 (Fed. Cir. 2003) . . . . . . . . . . . . . . . 10
Ericsson, Inc. v. D-Link Systems, Inc.,
773 F.3d 1201 (Fed. Cir. 2014) . . . . . . . . . . . . . . . 13
Global-Tech Appliances, Inc. v. SEB SA,
563 U.S. 754 (2011) . . . . . . . . . . . . . . . . . . . . . . 7
(ii)
(iii)
Google LLC v. Oracle America, Inc.,
141 S. Ct. 1183 (2021) . . . . . . . . . . . . . . . . . . . . 13
Halo Electronics, Inc. v. Pulse Electronics, Inc.,
579 U.S. 93 (2016) . . . . . . . . . . . . . . . . . . . . . . 9
Hewlett-Packard Co. v. Bausch & Lomb Inc.,
909 F.2d 1464 (Fed. Cir. 1990) . . . . . . . . . . . . . . . 7
Highmark Inc.
v. Allcare Health Management System, Inc.,
572 U.S. 559 (2014) . . . . . . . . . . . . . . . . . . . . . . 9
Juhl v. Airington,
936 S.W.2d 640 (Tex. 1996) . . . . . . . . . . . . . . . . . 8
McNeil Nutritionals, LLC
v. Heartland Sweeteners, LLC,
511 F.3d 350 (3d Cir. 2007) . . . . . . . . . . . . . . . . . 14
Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.,
545 U.S. 913 (2005) . . . . . . . . . . . . . . . . . . . . 5, 7–9
National Presto Industries, Inc. v. West Bend Co.,
76 F.3d 1185 (Fed. Cir. 1996) . . . . . . . . . . . . . . . . 6
Oak Industries, Inc. v. Zenith Electronics Corp.,
697 F. Supp. 988 (N.D. Ill. 1988) . . . . . . . . . . . . . . 5
Prometheus Laboratories v. Roxane Laboratories,
805 F.3d 1092 (Fed. Cir. 2015) . . . . . . . . . . . . . . . 10
Russello v. United States,
464 U.S. 16 (1983) . . . . . . . . . . . . . . . . . . . . . . 21
Sims v. Western Steel Co.,
551 F.2d 811 (10th Cir. 1977) . . . . . . . . . . . . . . . . 6
Sindell v. Abbott Laboratories,
26 Cal. 3d 588 (Cal. 1980) . . . . . . . . . . . . . . . . . . 8
(iv)
SmithKline Beecham Corp. v. Apotex Corp.,
403 F.3d 1331 (Fed. Cir. 2005) . . . . . . . . . . . . . . . 19
Tubular Rivet & Stud Co. v. O’Brien,
93 F. 200 (C.C.D. Mass. 1989) . . . . . . . . . . . . . . . . 7
Twitter, Inc. v. Taamneh,
143 S. Ct. 1206 (2023) . . . . . . . . . . . . . . . . . . . . 8
United States v. Wong Kim Bo,
472 F.2d 720 (5th Cir. 1972) . . . . . . . . . . . . . . . . . 21
Wallace v. Holmes,
29 F. Cas. 74 (C.C.D. Conn. 1871) . . . . . . . . . . . . . 7
Warner Lambert Co. v. McCrory’s Corp.,
718 F. Supp. 389 (D.N.J. 1989) . . . . . . . . . . . . . . . 15
STATUTES AND REGULATIONS
35 U.S.C. § 102 . . . . . . . . . . . . . . . . . . . . . . . . . . 10
——— § 103 . . . . . . . . . . . . . . . . . . . . . . . . . . 10
——— § 271(b) . . . . . . . . . . . . . . . . . . . . . . . . 7
——— § 271(c) . . . . . . . . . . . . . . . . . . . . . . . . 7
46 C.F.R. § 175.540(b) . . . . . . . . . . . . . . . . . . . . . . 19
47 C.F.R. 73.682/d1 . . . . . . . . . . . . . . . . . . . . . . . 19
Federal Food, Drug, and Cosmetics Act (FFDCA)
§ 505(j)(2)(A)(iii)–(iv),
21 U.S.C. § 355 . . . . . . . . . . . . . . . . . . . . . . . . 18
——— § 505(j)(2)(A)(v) . . . . . . . . . . . . . . . . . 19
——— § 505(j)(2)(A)(viii) . . . . . . . . . . . . . . . . 17
Federal Food, Drug, and Cosmetics Act § 513(f)(1)(A)(ii),
21 U.S.C. § 360c . . . . . . . . . . . . . . . . . . . . . . . 18
(v)
Federal Insecticide, Fungicide, and Rodenticide Act
§ 3(c)(3)(B)(i)(I),
7 U.S.C. § 136a . . . . . . . . . . . . . . . . . . . . . . . . 19
Hatch–Waxman Act, Pub. L. No. 98-417, 98 STAT. 1585
(1984) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
OTHER SOURCES
Charles W. Adams, A Brief History of Indirect Liability
for Patent Infringement, 22 SANTA CLARA COMPUT.
& HIGH TECH. L.J. 369 (2006) . . . . . . . . . . . . . . . 6
Courtenay C. Brinckerhoff, Yes, You Can Patent Food
Products!, FOLEY & LARDNER LLP (Aug. 22, 2024),
https://www.foley.com/insights/publications/2024/08/
yes-you-can-patent-food-products/ . . . . . . . . . . . . 15
Michael A. Carrier, Unsettling Drug Patent Settlements:
A Framework for Presumptive Illegality, 108 MICH.
L. REV. 37 (2009) . . . . . . . . . . . . . . . . . . . . . . 17
Andrew W. Coleman, National Brands, Private Labels
and Unfair Competition, 87 TRADEMARK REP. 79
(1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . 14–16
Jack A. Cook & Howard N. Bockbrader, An Industrial
Implementation of the Biopharmaceutics Classification System, DISSOLUTION TECHS., May 2002,
at 6, https://dissolutiontech.com/DTresour/0502art/
DTMay02_art1.htm . . . . . . . . . . . . . . . . . . . . . 20
Charles Duan, Internet of Infringing Things: The Effect
of Computer Interface Copyrights on Technology
Standards, 45 RUTGERS COMPUT. & TECH. L.J. 1
(2019) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
———, Mandatory Infringement, 75 FLA. L. REV. 219
(2023) . . . . . . . . . . . . . . . . . . . . . . . . . 12, 19–20
(vi)
Suzanne S. Dunne & Colum P. Dunne, What Do People
Really Think of Generic Medicines?, in 13 BMC MED.
no. 173 (2015), https://bmcmedicine.biomedcentral.
com/articles/10.1186/s12916-015-0415-3 . . . . . . . . . . 22
Alexander C. Egilman et al., Estimated Medicare Part
D Savings from Generic Drugs with a Skinny Label,
177 ANNALS INTERNAL MED. 833 (2024) . . . . . . . . . 18
———, Frequency of Approval and Marketing of
Biosimilars with a Skinny Label and Associated
Medicare Savings, 183 JAMA INTERNAL MED. 82
(2023) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
FOOD & DRUG ADMIN., APPROVED DRUG PRODUCTS
WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
(45th ed. 2025) . . . . . . . . . . . . . . . . . . . . . . . . 6
Eric Goldman, Brand Spillovers, 22 HARV. J.L. & TECH.
381 (2009) . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Daniel J. Hemel & Lisa Larrimore Ouellette, Innovation
Policy Pluralism, 128 YALE L.J. 544 (2019) . . . . . . . 12
INT’L ORG. FOR STANDARDIZATION, ISO 19005-1,
ELECTRONIC DOCUMENT FILE FORMAT FOR LONGTERM PRESERVATION—PART 1: USE OF PDF 1.4
(PDF/A-4) (2005) . . . . . . . . . . . . . . . . . . . . . . 13
Aaron S. Kesselheim et al., Variations in Patients’
Perceptions and Use of Generic Drugs, 31 J. GEN.
INTERNAL MED. 609 (2016), https://link.springer.
com/article/10.1007/s11606-016-3612-7 . . . . . . . . . . 22
Aaron S. Kesselheim & Jonathan J. Darrow, Hatch–
Waxman Turns 30: Do We Need a Re-Designed
Approach for the Modern Era?, 15 YALE J. HEALTH
POL’Y L. & ETHICS 293 (2015) . . . . . . . . . . . . . . . 22
(vii)
Charles E. Miller, Some Views on the Law of Patent
Infringement By Inducement, 53 J. PAT. OFF. SOC’Y
86 (1971) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Thomas J Moore et al., Estimated Costs of Pivotal
Trials for Novel Therapeutic Agents Approved by
the US Food and Drug Administration, 2015–2016,
178 JAMA INTERNAL MED. 1451 (Sept. 24, 2018),
https://pmc.ncbi.nlm.nih.gov/articles/PMC6248200/ . . . 20
Tejas N. Narechania, Certiorari, Universality, and a
Patent Puzzle, 116 MICH. L. REV. 1345 (2018) . . . . . . 9
Dylan Niederland, The Software Inducement Paradox,
AM. U. L. REV. (forthcoming Feb. 22, 2025), https://
papers.ssrn.com/sol3/papers.cfm?abstract_id=
5160166 . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 14
RESTATEMENT (SECOND) OF TORTS § 876(b) (AM. L.
INST. 1978) . . . . . . . . . . . . . . . . . . . . . . . . . . 8
RESTATEMENT (SECOND) OF TORTS § 876, cmt. d (AM. L.
INST. 1978) . . . . . . . . . . . . . . . . . . . . . . . . . . 8
REVISION OF TITLE 35, UNITED STATES CODE, HOUSE
REPORT NO. 82-1923 (1952) . . . . . . . . . . . . . . . . 7
T.A.B. Sanders et al., Effect on Blood Lipids and
Haemostasis of a Supplement of Cod-Liver Oil, Rich
in Eicosapentaenoic and Docosahexaenoic Acids, in
Healthy Young Men, 61 CLINICAL SCI. 317 (1981) . . . . 4
ANTONIN SCALIA & BRYAN A. GARNER, READING LAW:
THE INTERPRETATION OF LEGAL TEXTS (2012) . . . . . 21
AYLIN SERTKAYA ET AL., E. RSCH. GRP., INC., COST OF
GENERIC DRUG DEVELOPMENT AND APPROVAL (Dec.
31, 2021), https://aspe.hhs.gov/sites/default/files/
documents/20e14b66420440b9e726c61d281cc5a5/
cost-of-generic-drugs-erg.pdf . . . . . . . . . . . . . . . 20
(viii)
Ed Silverman, FDA Scolds Drugmaker over Promotion
That Touts “Misleading” Comparison with Generics,
STAT NEWS (Mar. 4, 2005), https://www.statnews.
com/pharmalot/2025/03/04/fda-myeloma-promotionmisleading-edenbridge-dexcel/ . . . . . . . . . . . . . . 22
SUP. CT. OF THE U.S., ELECTRONIC FILING SYSTEM
USER GUIDE (Nov. 2017), https://www.supremecourt.
gov/filingandrules/electronic_filing_filer_user_guide.
pdf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Francesco Trebbi & Miao Ben Zhang, The Cost of
Regulatory Compliance in the United States (Nat’l
Bureau of Econ. Rsch., Working Paper 30691, Nov.
2022), https://www.nber.org/papers/w30691 . . . . . . . 20
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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
S. Sean Tu & Aaron S. Kesselheim, Preserving Timely
Generic Drug Competition with Legislation on
“Skinny Labeling,” 115 CLINICAL PHARMACOLOGY
& THERAPEUTICS 22 (2024) . . . . . . . . . . . . . . . . 10
S. Sean Tu & Ameet Sarpatwari, A “Method of Use” to
Prevent Generic and Biosimilar Entry, 388 NEW
ENG. J. MED. 483 (2023) . . . . . . . . . . . . . . . . . . . 12
U.S. Patent No. 7,431,955 (issued Oct. 7, 2008) . . . . . . . . 15
U.S. Patent No. 8,399,446 (issued Mar. 19, 2013) . . . . . . . 11
U.S. Patent No. 9,700,537 (issued July 11, 2017) . . . . . . . 11
U.S. Patent No. 12,171,738 (issued Dec. 24, 2024) . . . . . . 11
W. KIP VISCUSI ET AL., ECONOMICS OF REGULATION
AND ANTITRUST (4th ed. 2005) . . . . . . . . . . . . . . 16
(ix)
Jesse C. Vivian, Generic-Substitution Laws, 33 US
PHARMACIST 30 (2008), https://www.uspharmacist.
com/article/generic-substitution-laws . . . . . . . . . . . 17
Bryan S. Walsh et al., Frequency of First Generic Drug
Approvals with “Skinny Labels” in the United States,
181 JAMA INTERNAL MED. 995 (2021) . . . . . . . . . . 17
INTEREST OF AMICI CURIAE
Amici curiae1 are scholars of law, economics, and
medicine, listed in the Appendix. Their interest is in the
proper development of patent law in ways that best promote the interests of innovation access and the public interest.
SUMMARY OF ARGUMENT
Any well-stocked grocery store sells Kellogg’s brand
Rice Krispies beside a house-brand puffed rice cereal. No
surprise: Patents on puffed rice cereals expired a century
ago, enabling classic competition. Kellogg’s may patent
new uses for its cereal—binding with melted marshmallows to form bar-shaped treats, for example. But these
new-use patents ought not force the house brand off the
shelves. Future patents on novel cereal uses cannot foreclose competition over the market for cereal eating.
Yet the Federal Circuit here held that a generic may
be liable under new-use patents, and might even be
forced off the shelves, based on the routine additional act
of truthfully characterizing the generic as a generic equivalent. This conflicts with basic principles of law, is contrary to patent policy, and injures competition, consumer
protection, and efficient government. Certiorari is warranted to reverse this decision and restore the proper balance between patent law and competitive markets.
1
Pursuant to Supreme Court Rule 37.2(a), all parties received
timely notice of intention to file this brief. 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 amici, their members, or their counsel, made a monetary contribution to the preparation or submission of this brief.
1
2
I. To reach this remarkable result, the Federal Circuit relied on the doctrine of patent inducement, which
imposes liability on one who actively encourages others
to infringe. The patent here covers a new use of an otherwise off-patent drug compound to treat certain cardiovascular risks. The allegedly inducing acts were press releases characterizing a generic version of that drug as a
“generic version,” in combination with factual statements
about the overall sales of the brand-name product—akin
to the advertising trope “just like the leading brand.”
A mere descriptive statement about a product’s equivalence, however, “actively encourages” nothing. To turn
generalized equivalence statements into specific acts of
encouragement, the Federal Circuit heaped inference
upon inference: that (1) describing a drug as a “generic
version” implies that the drug is equivalent for all known
uses; and (2) relevant consumers would voluntarily research and perform the specific, patented use as a result.
It was this tenuously connected theory of inferential reasoning that sufficed, in the Federal Circuit’s view, to force
the generic drug manufacturer through full-blown litigation over patent inducement.
II. This vague conception of patent inducement is
contrary to law and policy. Patent inducement is not a
sui generis form of liability, but rather derives from the
common law of inchoate crimes and secondary tort liability. The Federal Circuit’s freewheeling inferential theory is directly at odds with the common law tradition.
Patent law is not exceptional, and certiorari is warranted
to bring it back into line with general legal principles.
And leaving Federal Circuit’s theory of equivalencestatement liability unchecked would conflict with the basic purposes of the patent system. New uses of a product
3
can be discovered at any time, even decades or centuries
after the original product. So a savvy manufacturer
could repeatedly obtain new-use patents every twentyyear patent term, thereby precluding competitors from
communicating product equivalence forever. That result would contravene the most fundamental tenet that
patent rights are granted only for limited times.
III. This unfounded expansion of patent inducement
liability is not just jurisprudentially unreasonable, but
also economically and societally dangerous. Statements
of equivalence are not limited to the pharmaceutical industry, but abound in industries as diverse as information
technology, manufacturing, construction, and groceries.
The reach of this decision is potentially tremendous.
Across that broad economic spectrum of industries,
multiple harms could arise out of uncertainty about
patent inducement. Free markets depend on open entry of substitutable, equivalent products, meaning that
the decision will be a powerful tool to stifle competition.
Administrative processes also depend on statements of
equivalence to determine regulatory approval, so the decision will result in government waste and inefficiency.
And potential legal liability for statements of equivalence
denies consumers access to important information, potentially creating consumer confusion. These harms are the
unnecessary result of an erroneous expansion of patent
inducement law, so this Court’s correction of that error
would be broadly beneficial.
ARGUMENT
I.
THE FEDERAL CIRCUIT’S DECISION CREATES
A CLOUD OF LIABILITY OVER PRODUCT
EQUIVALENCE STATEMENTS
Under the Federal Circuit’s decision, public statements about a product’s equivalence to another might
sustain a plausible claim of patent inducement liability,
with virtually no guidance as to which statements qualify.
Here, Hikma is a generic manufacturer of the drug icosapent ethyl, a compound derived from cod liver oil that
has been known to have cardiovascular and cholesterolreducing benefits since at least the 1980s.2 The compound is unpatentable now, so Amarin’s patents are instead directed to using icosapent ethyl to treat specific
cardiovascular risks. (Pet. App. 4a–5a.) Hikma’s generic
product is only approved for a different use, and Hikma
never mentioned the patented indication on any of its
marketing or labeling materials. (Id. at 5a–7a.) Amarin
relied on three facts to support its inducement claim:
Hikma’s drug safety label (which the Federal Circuit conceded was insufficient, at 17a), Hikma’s recitation of facts
about Amarin’s aggregate sales, and most importantly,
Hikma’s press releases calling its product a “generic version” of Amarin’s. (Id. at 6a–7a.)
Typically, these facts would fail to state a claim of
inducement. Longstanding precedents require “active
steps taken to encourage direct infringement” before in-
2
See, e.g., T.A.B. Sanders et al., Effect on Blood Lipids and
Haemostasis of a Supplement of Cod-Liver Oil, Rich in Eicosapentaenoic and Docosahexaenoic Acids, in Healthy Young Men, 61
CLINICAL SCI. 317 (1981).
4
5
ducement will be found.3 Neither Hikma’s assertion of
equivalence nor its recitation of factual sales data made
any mention of the specific patented indication. Without
specific instructions on what a direct infringer should do,
it is difficult to see how these general, passive facts actively induce anything.
To reach its counterintuitive result, the Federal Circuit made two inferential leaps. First, it allowed (at
19a) the possibility that a physician reading the press releases, reciting generic equivalence and Amarin’s aggregate sales data, could interpret them “as an instruction or
encouragement to prescribe that drug for any of the approved uses of icosapent ethyl.” But even this inference
was not enough, because a doctor reading these statements would still not know of the infringing indication as
a possible use at all—nothing in the statement of equivalence or sales data identified that indication. Thus, the
decision required a second inference, that a doctor would
independently research Amarin’s product to find the particular patent-infringing use, and then would actually undertake that use.
Which statements of equivalence or marketing materials can trigger these inferential leaps leading to potential inducement liability, the Federal Circuit does not
say. Its decision (at 21a) draws a distinction between the
phrases “generic version” and “AB-rated,” even though
AB-rated is a regulatory term indicating product equiva-
3
Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S.
913, 936 (2005) (ellipses omitted) (quoting Oak Indus., Inc. v. Zenith
Elecs. Corp., 697 F. Supp. 988, 992 (N.D. Ill. 1988)); DSU Med. Corp. v.
JMS Co., Ltd., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc).
6
lence.4 The generalized sales data that the Federal Circuit deems incriminating for inducement is not far off
of ordinary comparative advertising—“just like the leading brand.” The undefined, potentially unbounded scope
of the Federal Circuit’s inducement-by-inference theory
thus puts at risk a wide range of commonplace marketing
statements.
II.
LIABILITY BASED ON PRODUCT EQUIVALENCE
STATEMENTS IS CONTRARY TO LAW AND
POLICY
A cloud of liability over public communications about
product equivalence is the erroneous consequence of an
inducement doctrine contrary to basic principles of law.
Certiorari is warranted to correct this error.
A.
THE FEDERAL CIRCUIT’S DECISION RENDERS
PATENT DOCTRINE INCONSISTENT WITH ITS
COMMON LAW BASIS
Inducement of patent infringement is not a sui generis
cause of action, but rather derives from a long tradition
of common law, in particular tort and criminal liability.5
Historically, courts recognized the action for “contributory infringement” of a patent by derivation from aiding
4
See FOOD & DRUG ADMIN., APPROVED DRUG PRODUCTS
WITH THERAPEUTIC EQUIVALENCE EVALUATIONS xiii—xiv (45th
ed. 2025).
5
See, e.g., Nat’l Presto Indus., Inc. v. W. Bend Co., 76 F.3d 1185,
1194 (Fed. Cir. 1996) (citing Sims v. W. Steel Co., 551 F.2d 811, 817
(10th Cir. 1977)); Charles E. Miller, Some Views on the Law of Patent
Infringement By Inducement, 53 J. PAT. OFF. SOC’Y 86, 89–94 (1971);
Charles W. Adams, A Brief History of Indirect Liability for Patent
Infringement, 22 SANTA CLARA COMPUT. & HIGH TECH. L.J. 369,
371–84 (2006).
7
and abetting liability.6 Case law consistently adopted a
requirement of “culpable conduct” for inducement liability, borrowing another common-law phrase.7 When in
1952 Congress recodified the Patent Act, it divided the
common law doctrine into two parts: 35 U.S.C. § 271(c)
for sale of a component with no substantial noninfringing
uses, and § 271(b) for other acts of active inducement of infringement.8 Nevertheless, Congress recognized the continued connection between both forms of indirect patent
liability and their common law origins, characterizing the
new § 271(b) as providing liability for “one who actively
induces infringement as by aiding and abetting.”9
Since that codification, decisions of this Court and others have continued to place patent inducement within
that common law tradition. Global-Tech Appliances,
Inc. v. SEB SA applied the criminal-law willful blindness
doctrine to inducement, seeing “no reason why the doctrine should not apply” to patent law when it applied “to a
wide range of criminal statutes.”10 Commil USA, LLC v.
Cisco Systems, Inc. relied on principles of tortious interference and trespass to determine the scope of patent in6
See, e.g., Wallace v. Holmes, 29 F. Cas. 74 (C.C.D. Conn. 1871);
Tubular Rivet & Stud Co. v. O’Brien, 93 F. 200, 202–03 (C.C.D. Mass.
1989).
7
E.g., DSU Med., 471 F.3d at 1306 (citing Grokster, 545 U.S. at
937); cf. Borden v. United States, 141 S. Ct. 1817, 1823 (2021) (defining
“culpability” under criminal law).
8
See generally Glob.-Tech Appliances, Inc. v. SEB SA, 563 U.S.
754, 761–63 (2011) (reciting history of statute).
9
REVISION OF TITLE 35, UNITED STATES CODE, H.R. REP. NO. 821923, at 28 (1952); see Hewlett-Packard Co. v. Bausch & Lomb Inc.,
909 F.2d 1464, 1469 (Fed. Cir. 1990) (“[N]o substantive change . . . was
intended by the enactment of § 271.”).
10
563 U.S. at 766–67.
8
ducement.11 And Metro-Goldwyn-Mayer Studios Inc. v.
Grokster, Ltd., a copyright case that would adopt patent
law’s inducement doctrine, characterized that doctrine as
one with “common law” origins in “purposeful, culpable
expression and conduct.”12
Expansion of patent inducement potentially to cover
mere statements of equivalence defies these common law
principles of culpable aiding and abetting. Aiding and
abetting under tort law holds liable only one who “gives
substantial assistance or encouragement” to a tortfeasor;
it is not enough merely to make passive, general statements not directly encouraging the direct tortfeasor.13
Indeed, this Court only recently explained the “need to
cabin aiding-and-abetting liability to cases of truly culpable conduct,” or else “ordinary merchants could become
liable for any misuse of their goods and services.”14 Similarly, criminal conspiracy liability based on sales of legal
goods used in crimes has long been limited to situations
where the seller had an active role beyond mere sale of
those goods.15
11
See 575 U.S. 632, 646 (2015).
545 U.S. at 936–37.
13
RESTATEMENT (SECOND) OF TORTS § 876(b) (AM. L. INST. 1978);
see, e.g., Sindell v. Abbott Lab’ys, 26 Cal. 3d 588, 605 (Cal. 1980) (drug
manufacturers’ “parallel or imitative conduct” in marketing cannot
give rise to indirect tort liability; alternative “would render virtually
any manufacturer liable for the defective products of an entire industry”); Juhl v. Airington, 936 S.W.2d 640, 645 (Tex. 1996) (rejecting
aiding-and-abetting tort liability where defendants’ passive actions,
which “could have acted as moral support” to the direct tortfeasor,
did not “give any verbal encouragement”).
14
See Twitter, Inc. v. Taamneh, 143 S. Ct. 1206, 1221 (2023) (citing RESTATEMENT (SECOND) OF TORTS § 876, cmt. d (AM. L. INST.
1978)).
15
See Dylan Niederland, The Software Inducement Paradox, AM.
U. L. REV. (forthcoming Feb. 22, 2025) (manuscript at 16), available
12
9
The Federal Circuit’s overbroad theory of patent inducement liability is thus exceptional when compared
to basic, longstanding principles of culpability under the
common law. In that sense, this case is much like numerous recent others, in which this Court has disapproved of
a patent-specific Federal Circuit rule contrary to the law
as a whole.16 The present decision is as much an outlier
as the others, and requires realignment.
B.
PATENT LIABILITY COULD NOW THEORETICALLY RUN FOREVER, CONTRARY TO THE
LIMITED PATENT TERM
The grand bargain of the U.S. patent system, enshrined in the Constitution, permits patents to last only
for “limited times.” Yet patent inducement liability based
on equivalence statements could control competitors’ behavior forever, dismantling the patent bargain and the
online. Perhaps the closest case in opposition is Grokster, in which
inducement of copyright infringement was premised on a filesharing
service’s advertisements that it was “offering the same file-sharing
ability as” another infringing service. See 545 U.S. at 938. While
this could be seen as a statement of equivalence, this Court was clear
that far more was involved: “other unequivocal indications of unlawful purpose” made inducement “unmistakable.” Id. at 938–840. Most
importantly, the target of equivalence in Grokster was understood
to be overwhelmingly a tool for infringement. See id. at 924. Here,
by contrast, both the brand-name drug and the generic advertised
as equivalent have the same substantial noninfringing uses, namely
treatment of unpatented indications. Locations of authorities available online are shown in the Table of Authorities.
16
See, e.g., Halo Elecs., Inc. v. Pulse Elecs., Inc., 579 U.S. 93
(2016); Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., 572 U.S.
559 (2014); eBay Inc. v. MercExchange, LLC, 547 U.S. 388 (2006).
See generally Tejas N. Narechania, Certiorari, Universality, and
a Patent Puzzle, 116 MICH. L. REV. 1345, 1349 (2018) (noting this
Court’s “general trend for disciplining ‘patent exceptionalism’”).
10
underlying innovation incentives that the patent system
is supposed to serve.
There is no time limit on obtaining new-use patents,
on a drug or any other product.17 An invention is
patentable consistent with the requirements of the
Patent Act, most significantly that it be new and nonobvious.18 It is long settled that “earlier disclosure of a genus
does not necessarily prevent patenting a species member of the genus” unless the genus and species are sufficiently related so as to render the latter obvious.19 Thus,
the prior use of a drug for a broad indication will generally not invalidate a later patent on using the drug on a
more specific indication.20 A simple way of finding potentially patentable new uses, then, is to subdivide an existing use into ever smaller subcategories, obtaining newuse patents seriatim for each of them.
This subgroup-division strategy is the source of the
patents in this case.21 As noted earlier, the icosapent
ethyl drug at issue here is a fish oil derivative known since
at least the 1980s.22 Amarin’s first wave of patents was
17
See S. Sean Tu & Aaron S. Kesselheim, Preserving Timely
Generic Drug Competition with Legislation on “Skinny Labeling,”
115 CLINICAL PHARMACOLOGY & THERAPEUTICS 22 (2024).
18
See 35 U.S.C. § 102; § 103.
19
See, e.g., Eli Lilly & Co. v. Bd. of Regents of the Univ. of Wash.,
334 F.3d 1264, 1270 (Fed. Cir. 2003) (citing Bristol-Myers Squibb Co. v.
Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001)); Abbvie
Inc. v. Mathilda & Terence Kennedy Inst., 764 F.3d 1366, 1379 (Fed.
Cir. 2014).
20
See Prometheus Lab’ys v. Roxane Lab’ys, 805 F.3d 1092, 1098
(Fed. Cir. 2015).
21
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).
22
See supra p. 4.
11
directed not to the drug chemical itself, but rather to a
method of using icosapent ethyl to the small class of patients with especially high triglyceride levels.23 Amarin
subsequently filed a second wave of patent applications,
seeking to cover a different patient population with moderately high triglyceride levels but also with “good cholesterol” (HDL-C) levels below a usual threshold, and further limited to patients who have “not previously had a
cardiovascular event.”24 Later-expiring patents apply to
patients within different ranges of triglyceride levels.25
Once these patents expire, Amarin could further discern
yet more patient subpopulations that respond well to icosapent ethyl, and thereby continue its chain of new-use
patents.26
Under the Federal Circuit’s theory of inducement,
any of these future new-use patents—even those decades
from the original drug patent expiration and covering a
minuscule subpopulation—could open the door to an inducement case against a generic competitor advertising
its product as an equivalent. The bar on the generic’s ability to truthfully advertise about its own product would
not end after the twenty-year patent term, but could potentially last forever. And indeed, a rising number of new23
See Amarin Pharma v. Hikma Pharms. USA, 449 F. Supp. 3d
967, 987 (D. Nev. 2020).
24
U.S. Patent No. 9,700,537 cl. 1 (issued July 11, 2017) (patients
with triglycerides of at least 150mg/dl).
25
See, e.g., 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).
26
Importantly, Amarin could likely do so without the expense of
new clinical trials, instead just mining its existing trial data with statistical analysis to find appropriate patient groups. The cost of “discovering” these new uses would be minimal.
12
use pharmaceutical patents suggests that firms are aware
of and beginning to take advantage of this strategy.27
Beyond flouting the limited-times restriction on
patents, the Federal Circuit’s rule misaligns the incentives for innovation that patents are supposed to provide.
The exclusive rights of a patent are designed to be a
market-based reward, where the more valuable an invention is, the greater market share the patent captures.28
Yet the Federal Circuit’s inducement rule, particularly
in light of the potential injunctive relief available, potentially makes even the narrowest new-use patent equally
effective for interfering with equivalent product purveyors such as generic firms.29 The incentives for patent
holders will be to aggregate tremendous estates of newuse patents of minor value, contributing minimally to the
larger project of innovation, but plenty enough to foreclose competitive and fair markets.
III.
IMPEDIMENTS TO PRODUCT EQUIVALENCE
STATEMENTS WOULD CAUSE MULTIPLE
SOCIETAL HARMS
Uncertainty over the permissibility of equivalence
statements, resulting from an erroneous expansion of
patent inducement liability, invites multiple harms to
competition, good government, and consumer welfare.
Those harms are perhaps most acute in the pharmaceutical industry due to the importance of generic drugs. But
27
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).
28
See, e.g., Daniel J. Hemel & Lisa Larrimore Ouellette, Innovation Policy Pluralism, 128 YALE L.J. 544, 553 (2019).
29
See Charles Duan, Mandatory Infringement, 75 FLA. L. REV.
219, 256–57 (2023).
13
they also extend to many other markets. The ramifications of this error in patent law thus potentially ripple far
throughout the economy.
A.
NUMEROUS INDUSTRIES BEYOND PHARMACEUTICALS DEPEND ON EQUIVALENCE
STATEMENTS
Opening the door to patent inducement liability based
on mere statements of product equivalence affects not
just pharmaceutical products like those in the present
case, but a wide variety of products and industries. This
is because statements of product equivalence, in one form
or another, are found in many places.
Consider, for example, computer and information
technology. Compatibility, and statements advertising
compatibility, abound here.30 Laptops and mobile phones
tout compatibility with the latest 5G cellular standards.
Email systems advertise their compatibility with the
technical standards for email transport. The Supreme
Court’s electronic filing system requires uploaded documents to be compatible with the PDF/A file format, that
format defined in a technical standard.31
Yet computer compatibility claims are arguably a sort
of equivalence statement, insofar as a system asserting
30
See Google LLC v. Oracle Am., Inc., 141 S. Ct. 1183, 1203–04
(2021); Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1208–09
(Fed. Cir. 2014).
31
See SUP. CT. OF THE U.S., ELECTRONIC FILING SYSTEM USER
GUIDE B–1 (Nov. 2017), available online; INT’L ORG. FOR STANDARDIZATION, ISO 19005-1, ELECTRONIC DOCUMENT FILE FORMAT FOR
LONG-TERM PRESERVATION—PART 1: USE OF PDF 1.4 (PDF/A-4)
(2005). See generally Charles Duan, Internet of Infringing Things:
The Effect of Computer Interface Copyrights on Technology Standards, 45 RUTGERS COMPUT. & TECH. L.J. 1, 5–7 (2019).
14
compatibility with a certain technology essentially describes itself as equivalent to other similarly compatible systems—an Apple iPhone is “equivalent” to a Samsung phone in that both are compatible with 5G networks. The Federal Circuit’s inducement-by-inference
theory could thus plausibly be adapted to computer devices: (1) a statement of compatibility could be interpreted as an instruction to use a device for any compatible purpose; and (2) consumers would research, discover,
and perform patented uses based on the device’s compatibility.32 Nothing in the Federal Circuit’s decision clearly
rejects this possibility, and given the ubiquity of compatibility statements in the information technology industry,
the mere possibility that this theory of liability could succeed invites tremendous uncertainty and risk.
Beyond computer technology, equivalent consumer
products are abundant and a staple of competition. Multiple manufacturers produce equivalent puffed-rice cereals,
car tires, screws, lightbulbs, batteries, and more.33 These
products, sometimes called house brands or private labels, often advertise as equivalents to other products either expressly on their labels or implicitly through packaging appearance and design.34
Sometimes, product equivalence is driven by compatibility needs—car tires must be equivalent in order to
fit onto a particular make and model of car. In other
cases, though, equivalence is the natural consequence of
32
Cf. supra p. 5. See generally Niederland, supra note 15, at 11–12.
See McNeil Nutritionals, LLC v. Heartland Sweeteners, LLC,
511 F.3d 350, 353–54 (3d Cir. 2007); Eric Goldman, Brand Spillovers,
22 HARV. J.L. & TECH. 381, 390 & n.40 (2009).
34
See Andrew W. Coleman, National Brands, Private Labels and
Unfair Competition, 87 TRADEMARK REP. 79, 81 & n.6 (1997).
33
15
a competitive market. House-brand products are regularly priced lower than their name-brand equivalents, giving consumers choices and driving prices down overall.35
But for in order for consumers to make those informed
choices, competing products identify themselves as equivalent. As one court observed about the ubiquity of house
brands, “any shopper” in a typical retail store “has likely
been exposed to generic or discount house brands before . . . observing the many ‘compare and save’ signs.”36
Patents on methods of using consumer products—
the kinds of patents that could be the subject of inducement litigation under the Federal Circuit’s theory of
inference—are common outside the pharmaceutical sector.37 General Mills does in fact have patents on using
breakfast cereals to make snack bars.38 The existence
of such patents means that questions about the legal consequences of statements of equivalence, arising from the
Federal Circuit decision’s ambiguity, affect a potentially
wide range of consumer products and goods.
B.
EQUIVALENCE STATEMENTS ARE NECESSARY
FOR EFFICIENT FREE-MARKET COMPETITION
In these many industries, product equivalence is the
prerequisite to market efficiency. An ideally efficient
35
See Coleman, supra note 34, at 82–83.
Warner Lambert Co. v. McCrory’s Corp., 718 F. Supp. 389, 399–
400 (D.N.J. 1989).
37
See, e.g., Courtenay C. Brinckerhoff, Yes, You Can Patent Food
Products!, FOLEY & LARDNER LLP (Aug. 22, 2024), available online. Business method patents, as well, are patents on methods of
using computers or other systems. See, e.g., Alice Corp. Pty. Ltd. v.
CLS Bank Int’l, 573 U.S. 208 (2014).
38
See, e.g., U.S. Patent No. 7,431,955 (issued Oct. 7, 2008).
36
16
market, in which the discipline of competition avoids monopolistic profit and deadweight loss, depends on the ability of firms to enter the market freely with perfect substitutes. Where only imperfect substitutes are available,
the equilibrium price to consumers will be higher than a
fully competitive market, because product differentiation
enables suppliers to raise prices without losing all sales.39
And barriers to entry, which raise the cost of new firms
hoping to introduce products, also allow incumbents to
charge higher prices with diminished concern for inviting
competitive new entrants.40
Products can, of course, be equivalent without advertising themselves as such. Nevertheless, a bar on statements of product equivalence introduces economic inefficiency. An inability to market a product as equivalent to
another adds an information cost to the product.41 If the
house-brand puffed rice cereal cannot promote itself as
just as good as the leading brand, then buyers will have
to expend resources to find out, or guess and hope for the
best. And the house-brand cereal’s label would have to
be filled with detailed descriptions of the crunchiness and
taste of the cereal—information that could be much more
compactly expressed with a statement of equivalence. So
a bar on equivalence statements creates barriers to entry
that gives incumbents an inappropriate edge over competitors.
For competition among pharmaceuticals, statements
of equivalence take on even greater importance for
two reasons. First, those statements have legal effect.
39
See, e.g., W. KIP VISCUSI ET AL., ECONOMICS OF REGULATION
AND ANTITRUST 87 (4th ed. 2005).
40
See VISCUSI ET AL., supra note 39, at 165.
41
Cf. Coleman, supra note 34, at 85.
17
State drug substitution laws enable pharmacies to dispense generic equivalents of brand-name drugs where
available—but only if those generic equivalents are asserted to be equivalent.42 Absent such a statement of
equivalence, a generic would only be dispensed if the prescription explicitly called for the generic. Statements of
equivalence of generic drugs are thus not just helpful for
competition, but legally necessary.
Second, competitive pharmaceutical markets are of
such importance that Congress has explicitly sought to
foster such competition. A primary objective of the
Hatch–Waxman Act, enacted in 1984, was to stimulate
entry of generic drugs after expiration of original compound patents, reaping tremendous cost savings to patients resulting from such competition.43 That statute
recognized the potential for new-use patents to inhibit
this valuable generic competition, and created a specific
“skinny labeling” pathway giving the U.S. Food and Drug
Administration (“FDA”) the ability to approve generic,
off-patent drugs despite later-obtained patents on specific uses and indications.44 The skinny labeling pathway
has saved Medicare Part D $15 billion and accelerated
generic drug entry by an average of 2.5 years between
42
See, e.g., Jesse C. Vivian, Generic-Substitution Laws, 33 US
PHARMACIST 30 (2008), available online.
43
Pub. L. No. 98-417, 98 STAT. 1585 (1984); see Caraco Pharm.
Lab’ys, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012); Michael
A. Carrier, Unsettling Drug Patent Settlements: A Framework for
Presumptive Illegality, 108 MICH. L. REV. 37, 42 (2009).
44
See Federal Food, Drug, and Cosmetics Act (FFDCA) § 505(j)(2)
(A)(viii), 21 U.S.C. § 355; Bryan S. Walsh et al., Frequency of First
Generic Drug Approvals with “Skinny Labels” in the United States,
181 JAMA INTERNAL MED. 995, 997 (2021).
18
2015 and 2019,45 with similar benefits for biologic therapeutics.46 A robustly competitive generic drug market
produces these tremendous cost savings, and that market depends on the continued marketing of generics truthfully as generic equivalents.
C.
EQUIVALENCE STATEMENTS REDUCE
REGULATORY COMPLIANCE COSTS AND AVOID
ADMINISTRATIVE WASTE
While equivalence statements are important enough
in unregulated markets, they take on even further importance where products are regulated. Here, statements of
equivalence promote efficiency and fairness in the regulatory process, and preclusion of statements risks government waste and unfairness.
Multiple fields of regulation turn on statements of
product equivalence. Most prominently, as in this case,
generic drugs must assert several levels of equivalence
to another drug in order to win approval before the FDA.
The generic drug itself must be “bioequivalent,” and labeling attached to the generic must be “the same” as
that for its brand-name counterpart.47 Regulations for
pesticides, medical devices, and marine vessels similarly
require statements of equivalence in order to take advantage of expedited regulatory approval pathways.48
45
See Alexander C. Egilman et al., Estimated Medicare Part D
Savings from Generic Drugs with a Skinny Label, 177 ANNALS INTERNAL MED. 833 (2024).
46
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).
47
See FFDCA § 505(j)(2)(A)(iii)–(iv).
48
See, e.g., Federal Food, Drug, and Cosmetics Act § 513(f)(1)(A)
(ii), 21 U.S.C. § 360c (exempting, from stringent class III regulation,
19
Television broadcasts are required to be compatible with
government-approved technical standards, which is a
form of equivalence as explained above.49
Impediments to equivalence statements are harmful
to these regulated fields in at least two ways. First,
where a regulation requires a statement of equivalence,
a bar on that statement puts regulated entities into
an impossible double bind.50 In SmithKline Beecham
Corp. v. Apotex Corp., for example, the manufacturer of
brand-name nicotine patches sued a generic competitor
seeking to enter the market.51 Patents on the patches
had expired, but the brand firm instead alleged copyright infringement in the text of the generic’s warning
labels—despite the fact that, by regulatory command, the
generic’s labels were required to use identical text.52
Absent the Second Circuit’s determination that the
regulation’s authorizing statute overrode the Copyright
Act, generic firms would have been unable to comply
with both copyright law and the regulatory equivalence
requirement.53 That would have created a de facto
monopoly over nicotine patches, even after those patches
were off patents and open to competition.54 And the lure
medical devices that are “substantially equivalent” to certain preexisting devices); Federal Insecticide, Fungicide, and Rodenticide Act
§ 3(c)(3)(B)(i)(I), 7 U.S.C. § 136a (providing for expedited review of
pesticides “identical or substantially similar in composition and labeling to a currently-registered pesticide”); 46 C.F.R. § 175.540(b) (permitting approval of certain high-speed craft based on equivalence to
international safety standards).
49
See 47 C.F.R. 73.682/d1.
50
See generally Duan, supra note 29.
51
See 403 F.3d 1331, 22–23 (Fed. Cir. 2005).
52
See 403 F.3d at 23–24 (discussing § 505(j)(2)(A)(v)).
53
See 403 F.3d at 27–28.
54
See 403 F.3d at 28; Duan, supra note 29, at 237–38.
20
of post-patent monopolies would almost certainly invite
manipulation of regulations involving regulatory equivalence requirements, leveraging them to stifle rivals.55
Second, even where product equivalence only expedites regulatory processes rather than being mandatory,
those statements avoid wasteful, duplicative costs for
both the government and regulated entities. Proof that
a product is equivalent to an already approved one may
allow administrators to avoid a full regime of compliance
testing, which often is costly.56 For example, approval
of a new drug requires multiple phases of clinical trials,
which run a median of $19 million.57 Bioequivalence studies, by contrast, require simple blood test measurements,
which cost about $250,000, or 1.3% of full clinical trials.58
Government regulators, too, must review submitted testing data, which presumably is simpler and faster when
the only data is evidence of equivalence.
Equivalence statements allow regulators to do their
jobs more efficiently and effectively. Taxpayers save
55
See Duan, supra note 29, at 255–58.
See Francesco Trebbi & Miao Ben Zhang, The Cost of Regulatory Compliance in the United States 12 n.25 (Nat’l Bureau of Econ.
Rsch., Working Paper 30691, Nov. 2022), available online (estimating “aggregate nominal regulatory compliance costs” in the United
States in 2014 to be $103 billion). The authors of the study caution
that they measure “the costs of regulation without addressing the
benefits of regulation.” Id. at 4.
57
See Thomas J Moore et al., Estimated Costs of Pivotal Trials
for Novel Therapeutic Agents Approved by the US Food and Drug
Administration, 2015–2016, 178 JAMA INTERNAL MED. 1451, 1454
(Sept. 24, 2018), available online.
58
See Jack A. Cook & Howard N. Bockbrader, An Industrial Implementation of the Biopharmaceutics Classification System, DISSOLUTION TECHS., May 2002, at 6, available online; AYLIN SERTKAYA
ET AL., E. RSCH. GRP., INC., COST OF GENERIC DRUG DEVELOPMENT AND APPROVAL 12–13 tbl.4 (Dec. 31, 2021), available online.
56
21
when government avoids duplicative activity, and consumers enjoy lower prices when regulatory compliance is
simplified. Prohibitions on equivalence statements would
create unnecessary government waste, and are likely also
invite improper manipulation of the regulatory process.
D. EQUIVALENCE STATEMENTS PROTECT
CONSUMERS FROM CONFUSION
Ultimately, the benefits of equivalence statements
and the harms of barring them fall upon consumers who
buy equivalents, like generic drugs or store brand cereals. Consumers pay for oligopoly pricing resulting from
reduced competition, and they bear the costs of regulatory inefficiency in the form of higher taxes.
And beyond these harms, equivalence statements protect against potentially significant consumer confusion. A
claim that one product is equivalent to another is a simple, compact way of conveying a great deal of information
about the product, as noted above. But where a product expected to equivalent lacks any such claim, the potential implication is that the two products are not the
same. Any lawyer is familiar with the canon of construction that “a material variation in terms suggests a variation in meaning.”59 If the Goodyear Tire company cannot promote its products as equivalent to original Ford
F-150 tires, then truck owners would reasonably ques59
ANTONIN SCALIA & BRYAN A. GARNER, READING LAW: THE
INTERPRETATION OF LEGAL TEXTS 170 (2012); Russello v. United
States, 464 U.S. 16, 23 (1983) (“[I]t is generally presumed that
Congress acts intentionally and purposely in the disparate inclusion
or exclusion.”) (quoting United States v. Wong Kim Bo, 472 F.2d 720,
722 (5th Cir. 1972)).
22
tion whether Goodyear tires would fit their trucks—even
if those tires in reality are equivalent.
Equivalence statements are especially important for
consumers of pharmaceuticals. Many consumers question whether generic equivalents are, in fact, equivalent
to their brand-name counterparts.60 These questions persist despite federal policy designed to boost public confidence in the equivalence of generic drugs, and a regulatory apparatus for proving such equivalence.61 If generic
manufacturers are forced to employ awkward, legalistic
explanations of equivalence to avoid liability under the
Federal Circuit’s uncertain inducement standard, that
would only stoke further unnecessary skepticism, increasing costs in an already strained American healthcare system.
Across a wide range of industries, statements of product equivalence promote efficient competition, streamline
regulatory processes, avoid undue legal gamesmanship,
and avoid consumer confusion. A legal cloud over statements of equivalence, such as that created by the Federal
Circuit’s ambiguous inducement doctrine, risks harming
these interests of national importance.
60
See, e.g., Suzanne S. Dunne & Colum P. Dunne, What Do People Really Think of Generic Medicines? 20, in 13 BMC MED. no. 173
(2015), available online; cf. Aaron S. Kesselheim et al., Variations in
Patients’ Perceptions and Use of Generic Drugs, 31 J. GEN. INTERNAL MED. 609, 611, 613 (2016), available online.
61
See Ed Silverman, FDA Scolds Drugmaker over Promotion
That Touts “Misleading” Comparison with Generics, STAT NEWS
(Mar. 4, 2005), available online; Aaron S. Kesselheim & Jonathan J.
Darrow, Hatch–Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era?, 15 YALE J. HEALTH POL’Y L. & ETHICS
293, 311–12 (2015).
CONCLUSION
For the foregoing reasons, the petition for a writ of
certiorari should be granted.
Respectfully submitted,
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
Counsel for Amici Curiae
March 2025
23
APPENDIX A
LIST OF ACADEMIC SIGNATORIES
The brief presents the views of the individual signers.
Institutions are listed for identification purposes only.
Gerard Anderson
Johns Hopkins School of Medicine
Michael Carrier
Rutgers Law School
Bernard Chao
University of Denver Sturm College of Law
Thomas Cheng
University of Hong Kong, Faculty of Law
Robyn T. Cohen
Boston University Chobanian & Avedisian School of
Medicine
Jonathan J. Darrow
Baylor College of Medicine
Charles Duan
American University Washington College of Law
William Feldman
Harvard Medical School
James Grimmelmann
Cornell Law School
Ravi Gupta
Johns Hopkins University School of Medicine
Bronwyn H. Hall
University of California, Berkeley, Department of
Economics
24
25
Yaniv Heled
Georgia State University College of Law
H.E. Frech, III
University of California, Santa Barbara, Department of Economics
Aaron S. Kesselheim
Harvard Medical School
Mark A. Lemley
Stanford Law School
Yvette Joy Liebesman
Saint Louis University School of Law
Lee Ann Wheelis Lockridge
Louisiana State University Law Center
Jing Luo
University of Pittsburgh School of Medicine
Christopher J. Morten
Columbia Law School
Tyler Ochoa
Santa Clara University School of Law
Thomas Radomski
University of Pittsburgh School of Medicine
Benjamin Rome
Harvard Medical School
Joseph Ross
Yale School of Medicine
Christy Sadreameli
Johns Hopkins University School of Medicine
26
Ameet Sarpatwari
Harvard Medical School
Michael S. Sinha
Saint Louis University School of Law
David Stein
Northeastern Law School
S. Sean Tu
West Virginia University College of Law
Liza Vertinsky
University of Maryland Francis King Carey School
of Law
Olivier J. Wouters
Brown University School of Public Health
Rev. 28bc3ad5
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.