Amicus Curiae Brief — Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Amarin Pharma, Inc., et al.
Supreme Court briefFeb 25, 2026
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No. 24-889
In the Supreme Court of the United States
\
HIKMA PHARMACEUTICALS USA INC., ET AL.,
PETITIONERS
v.
AMARIN PHARMA, INC., ET AL.
ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
BRIEF FOR THE UNITED STATES
AS AMICUS CURIAE SUPPORTING PETITIONERS
D. JOHN SAUER
Solicitor General
Counsel of Record
BRETT A. SHUMATE
Assistant Attorney General
MALCOLM L. STEWART
Deputy Solicitor General
MAX E. SCHULMAN
Assistant to the
Solicitor General
DANIEL TENNY
GABRIEL I. SCHONFELD
Attorneys
Department of Justice
Washington, D.C. 20530-0001
SupremeCtBriefs@usdoj.gov
(202) 514-2217
QUESTION PRESENTED
The Hatch-Waxman Amendments to the Federal
Food, Drug, and Cosmetic Act authorize the Food and
Drug Administration (FDA) to approve generic drugs
that have the same active ingredients as, and are therapeutically equivalent to, existing brand-name drugs.
Brand-name drugs are frequently protected by patents,
which may cover the drug itself and/or a particular
method of using the drug.
Congress has created a mechanism to promote and
expedite competition from otherwise-approvable generics
in circumstances where some but not all approved methods of using a particular drug are patent-protected. A
generic drugmaker may seek FDA approval for a nonpatented use and sell its generic drug under “skinny”
labeling that “carves out” patented uses but otherwise
duplicates the brand’s labeling.
Petitioners followed that approach here, carving out
the patented use of respondents’ drug from the labeling of
their generic drug. Petitioners accurately described their
drug as the generic version of respondents’ and noted
that respondents’ drug is approved for additional uses.
Petitioners also provided their investors with truthful
information about the total sales of respondents’ drug,
including sales traceable to both the patented and nonpatented uses. The question presented is as follows:
Whether respondents’ complaint plausibly alleged
that petitioners had actively induced infringement of respondents’ patents claiming the carved-out uses.
(I)
TABLE OF CONTENTS
Page
Interest of the United States ........................................................ 1
Introduction ..................................................................................... 2
Statement:
A. Legal background ............................................................... 3
B. Facts ................................................................................... 10
C. Proceedings below ............................................................ 11
Summary of argument ................................................................. 14
Argument:
Amarin’s complaint does not plausibly allege that
Hikma actively induced infringement ................................... 18
A. Amarin’s allegations do not make out a plausible
claim of active inducement to infringe ........................... 20
B. The statements on which the Federal Circuit relied
provide no basis for liability ............................................ 25
C. The Federal Circuit’s decision undermines the
broader Hatch-Waxman scheme .................................... 30
Conclusion ...................................................................................... 34
TABLE OF AUTHORITIES
Cases:
Page
Ashcroft v. Iqbal, 556 U.S. 662 (2009) ....................... 20, 24, 29
Bell Atlantic Corp. v. Twombly,
550 U.S. 544 (2007) ............................................................... 24
Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,
566 U.S. 399 (2012) ........................... 2, 4-6, 18, 21, 26, 30, 32
DSU Med. Corp. v. JMS Co.,
471 F.3d 1293 (Fed. Cir. 2006) ............................................ 25
Eli Lilly & Co. v. Medtronic, Inc.,
496 U.S. 661 (1990) ............................................................... 18
GlaxoSmithKline LLC v. Teva Pharms. USA,
Inc., 7 F.4th 1320 (Fed. Cir. 2021), cert. denied,
143 S. Ct. 2483 (2023) ........................................................... 33
(III)
IV
Cases—Continued:
Page
Global-Tech Appliances, Inc. v. SEB S.A.,
563 U.S. 754 (2011) ......................................................... 14, 21
Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.,
545 U.S. 913 (2005) ................................. 15, 21-23, 25, 29, 30
Statutes and regulations:
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments),
Pub. L. No. 98-417, 98 Stat. 1585.......................................... 4
Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 301 et seq. ............................................................... 3
21 U.S.C. 321(k) ................................................................... 4
21 U.S.C. 321(m) ................................................................. 4
21 U.S.C. 355(a) ................................................................... 3
21 U.S.C. 355(b) (2018 & Supp. III 2021) ........................ 3
21 U.S.C. 355(b)(1)(A)(i) (Supp. III 2021) ........................ 3
21 U.S.C. 355(b)(1)(A)(vi) (Supp. III 2021) ...................... 3
21 U.S.C. 355(b)(1)(A)(viii) (Supp. III 2021) ................... 5
21 U.S.C. 355(c)(2) (Supp. III 2021) ................................. 5
21 U.S.C. 355( j)(2)(A)(ii) .................................................... 4
21 U.S.C. 355( j)(2)(A)(iv) ................................................... 4
21 U.S.C. 355( j)(2)(A)(v) .............................................. 4, 26
21 U.S.C. 355( j)(2)(A)(vii)(III) .......................................... 5
21 U.S.C. 355( j)(2)(A)(vii)(IV) ........................................... 5
21 U.S.C. 355( j)(2)(A)(viii) ....................................... 2, 6, 26
21 U.S.C. 355( j)(5)(B)(iii) ................................................... 6
21 U.S.C. 355( j)(5)(C) ......................................................... 6
35 U.S.C. 271(a) ................................................................... 2, 19
35 U.S.C. 271(b) .......................................2, 3, 11, 14, 19, 21, 23
35 U.S.C. 271(e)(2)(A) ............................................................... 5
35 U.S.C. 271(e)(5) ..................................................................... 5
V
Statutes and regulations—Continued:
Page
Ala. Code § 34-23-8(a)(1) (Lexis 2019) .................................... 7
Alaska Stat. § 08.80.295(a) (Lexis 2024) ................................. 7
Ariz. Rev. Stat. (West 2025):
§ 32-1963.01(A) .................................................................... 7
§ 32-1968(C) ......................................................................... 9
Ark. Code § 17-92-503(a)(1)(A) (Lexis 2024).......................... 7
Cal. Bus. & Prof. Code (West 2019):
§ 4040(a)(1) ........................................................................... 9
§ 4073(a) ................................................................................ 7
Colo. Rev. Stat. (Lexis 2024):
§ 12-280-125(1)(a) ................................................................ 7
§ 12-280-103(31)(a) .............................................................. 9
Conn. Gen. Stat. § 20-619(b) (West 2024) ............................... 7
D.C. Code § 48-803.02(a)(1) (Lexis Supp. 2025) .................... 8
24 Del. Code § 2549(a) (Lexis 2017), repealed by
85 Del. Laws c. 49 (June 30, 2025) (reenacting
provisions of 24 Del. Code § 2549 at 24 Del. Code
§ 2550 effective June 20, 2026) .............................................. 7
Fla. Stat. § 465.025(2) (West 2022) .......................................... 8
Ga. Code Ann. § 26-4-81(a) (Lexis 2023) ................................ 8
Haw. Rev. Stat. § 328-92(a) (Lexis 2022) ............................... 8
Idaho Code (Lexis 2025) § 54-1733B(1) (Lexis 2025) ........... 8
225 Ill. Comp. Stat. Ann. (West Supp. 2025):
§ 85/3(e)................................................................................. 9
§ 85/25 ................................................................................... 8
Ind. Code (Lexis 2023):
§ 16-42-22-5 .......................................................................... 8
§ 16-42-22-6 .......................................................................... 8
§ 16-42-22-8 .......................................................................... 8
VI
Statutes and regulations—Continued:
Page
Iowa Code (West 2021):
§ 155A.2B.............................................................................. 8
§ 155A.8(2) ............................................................................ 8
Kan. Stat. Ann. § 65-1637(g)(1) (2018) .................................... 8
Ky. Rev. Stat. Ann. § 217.822(1) (Lexis 2022) ....................... 8
La. Rev. Stat. § 37:1241(A)(17) (West 2023) .......................... 8
Mass. Gen. Laws ch. 112, § 12D (Lexis 2018) ........................ 8
Md. Code Ann., Health Occ. § 12-504(d)(1)
(Lexis 2023) ............................................................................. 8
Me. Stat. tit. 32, § 13781 (West Supp. 2025)........................... 8
Mich. Comp. Laws Ann. § 333.17755(1) (West 2018) ............ 8
Minn. Stat. § 151.21(3) (West 2025) ........................................ 8
Miss. Code § 73-21-117(1) (West Supp. 2024) ........................ 8
Mo. Ann. Stat. § 338.056(1) (West 2021) ................................. 8
Mont. Code Ann. § 37-7-505(1) (West 2023) .......................... 8
N.C. Gen. Stat. § 90-85.28(a) (Lexis 2023) ............................. 8
N.D. Cent. Code § 19-02.1-14.1(3) (Lexis 2015)..................... 8
Neb. Rev. Stat. Ann. (Lexis 2024):
§ 38-2818.03 .......................................................................... 8
§ 38-28111(1) ........................................................................ 8
Nev. Stat. (Lexis 2022):
§ 639.2352 ............................................................................. 9
§ 639.2583(1)(a) .................................................................... 8
N.H. Rev. Stat. Ann. § 146-B:2(I) (Lexis 2025) ..................... 8
N.J. Stat. Ann. § 24:6E-7 (West 2022) .................................... 8
N.M. Stat. Ann. § 26-3-3(B) (2023) .......................................... 8
N.Y. Educ. Law (West 2024):
§ 6810(6)(a) ........................................................................... 8
§ 6816-a(1)(a)........................................................................ 8
§ 6816-a(1) ............................................................................ 8
Ohio Rev. Code § 4729.38(B) (Lexis 2025) ............................. 8
VII
Statutes and regulations—Continued:
Page
Okla. Stat. tit. 59 (West Supp. 2025):
§ 353.20.1(B) ......................................................................... 9
§ 353.24(B)(4) ....................................................................... 8
Or. Rev. Stat. § 689.515(2) (2023) ............................................ 8
35 Pa. Cons. Stat. (West 2025):
§ 960.3(a)............................................................................... 8
§ 960.3(b) .............................................................................. 8
R.I. Gen. Laws § 5-19.1-19 (Lexis 2019) ................................. 8
S.C. Code Ann. § 39-24-30(a) (West 2011) .............................. 8
S.D. Codified Laws § 36-11-46.1 (West 2015) .........................8
Tenn. Code Ann. § 53-10-205(a) (Lexis 2022) ..........................8
Tex. Occ. Code (West 2018):
§ 562.008(a)........................................................................... 8
§ 562.008(b) .......................................................................... 7
§ 562.009 ............................................................................... 8
Utah Code Ann. § 58-17b-605(2)(a) (Lexis 2025) .................. 8
Va. Code Ann. § 54.1-3408.03(A) (Lexis Supp. 2025) ............ 8
Vt. Stat. Ann. tit. 18, § 4605(a)(1) (2025) ....................................8
Wash. Rev. Code § 69.41.130 (West 2015) .................................8
W. Va. Code § 30-5-12b(b) ........................................................ 8
Wis. Stat. Ann. (West Supp. 2024):
§ 450.11(4m) ......................................................................... 9
§ 450.13(1s) ........................................................................... 8
Wyo. Stat. Ann. § 33-24-148 (Lexis 2025) ............................... 8
21 C.F.R.:
Section 201.57(c) .................................................................. 3
Section 314.94(a)(8)(iv) ................................................. 6, 26
Section 314.94(a)(12)(iii)(A) ............................................... 6
Section 314.127(a)(7) ......................................................... 26
VIII
Regulations—Continued:
Page
22 Tex. Admin. Code § 291.34(b)(7)(A)(vii) ............................ 9
W. Va. Code R. § 15-1-18.1.4.d (2025) ..................................... 9
Miscellaneous:
Ryan Conrad et al., FDA, Estimating Cost
Savings from New Generic Drug Approvals in
2018, 2019, and 2020 (2022) ........................................... 30, 31
FDA:
Orange Book Preface (Jan. 15, 2026),
https://www.fda.gov/drugs/developmentapproval-process-drugs/orange-book-preface .......... 7
Orange Book: Product Details for ANDA 209457,
https://www.accessdata.fda.gov/scripts/cder/
ob/results_product.cfm?Appl_Type=A&Appl
_No=209457#39458 ................................................... 11
Understanding Unapproved Use of Approved
Drugs “Off Label” (Feb. 5, 2018),
https://www.fda.gov/patients/learn-aboutexpanded-access-and-other-treatmentoptions/understanding-unapproved-useapproved-drugs-label .................................................... 9
Alejandra Salazar et al., How Often Do
Prescribers Include Indications in Drug
Orders? Analysis of 4 Million Outpatient
Prescriptions, 76 Am. J. Health-System Pharm.
970 (2019) ................................................................................. 9
Aylin Sertkaya et al., Costs of Drug Development
and Research and Development Intensity in the
US, 2000-2018, JAMA Network Open (June 28,
2024), https://perma.cc/J7WY-N9JH ................................... 4
Bryan S. Walsh et al., Frequency of First Generic
Drug Approvals With ‘Skinny Labels’ in the
United States, 181 JAMA Internal Med. 995
(July 2021) ............................................................................. 31
In the Supreme Court of the United States
No. 24-889
HIKMA PHARMACEUTICALS USA INC., ET AL.,
PETITIONERS
v.
AMARIN PHARMA, INC., ET AL.
ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
BRIEF FOR THE UNITED STATES
AS AMICUS CURIAE SUPPORTING PETITIONERS
INTEREST OF THE UNITED STATES
This case concerns whether respondents have adequately alleged that the manufacturer of a generic drug
unlawfully induced medical professionals to infringe
method-of-use patents held by a brand-name drug manufacturer. The United States has substantial interests in
encouraging manufacturers to bring lower-cost generic
drugs quickly to market, and in lowering prescriptiondrug prices paid by federal programs such as Medicare,
Medicaid, and the Veterans Health Administration. At
the same time, the United States has a substantial interest in the patent protections available to drugmakers
that identify new therapeutic uses for established products. At the invitation of the Court, the United States
filed a brief as amicus curiae at the petition stage of this
case.
(1)
2
INTRODUCTION
The Hatch-Waxman Amendments to the Federal
Food, Drug, and Cosmetic Act reflect Congress’s careful balance of competing policy objectives. On the one
hand, Congress sought to “speed the introduction of lowcost generic drugs to market.” Caraco Pharm. Labs.,
Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012). In
circumstances where some uses of a particular drug are
patented but others are not, the “section viii” mechanism allows “a generic company to identify [the unpatented] uses, so that a product with a label matching
them can quickly come to market.” Id. at 415; see 21
U.S.C. 355( j)(2)(A)(viii). On the other hand, Congress
sought to safeguard patent rights by (1) requiring generic manufacturers to use labeling “that ‘carves out’
from the brand’s approved label the still-patented
methods of use,” Caraco, 566 U.S. at 406; and (2) leaving
in place, and fully applicable to manufacturers of generic drugs, the preexisting statutory bars on both direct infringement of patents, see 35 U.S.C. 271(a), and
active inducement of patent infringement, see 35 U.S.C.
271(b). While Congress presumably expected that some
off-label uses of approved generic drugs would occur,
Congress evidently viewed that prospect as an acceptable cost of expedited competition with respect to the
lawful unpatented uses—so long as generic manufacturers do not actively encourage infringing uses.
The court of appeals in this case departed from that
congressional balance by holding that respondents had
adequately alleged active inducement of infringing conduct. None of petitioners’ allegedly culpable statements
expressly urged or encouraged third parties to infringe
respondents’ patents. Some of those statements—e.g.,
petitioners’ references to their own drug as a “generic
3
version” of respondents’, and petitioners’ use of “carved
out” labeling approved by the Food and Drug Administration (FDA)—are integral to the Hatch-Waxman scheme.
And none of the statements that petitioners are alleged to
have made about their generic drug had any meaningful
likelihood of causing infringing off-label uses, particularly given the critical role of state generic-substitution
laws in governing the prescribing and dispensing practices of healthcare providers.
Because respondents’ complaint does not plausibly
allege active inducement of patent infringement, the
court of appeals erred in allowing this suit to proceed.
That erroneous decision may significantly deter generic
manufacturers from using the section viii mechanism in
the manner that Congress intended. Because the Federal Circuit erred in concluding that respondents have
stated a claim of active inducement under 35 U.S.C.
271(b), this Court should reverse the court of appeals’
judgment.
STATEMENT
A. Legal Background
1. The Federal Food, Drug, and Cosmetic Act (FDCA),
21 U.S.C. 301 et seq., generally requires FDA approval before a new drug may be sold in the United States. 21
U.S.C. 355(a). One way to obtain such approval is to submit a new drug application (NDA) to FDA. See 21 U.S.C.
355(b) (2018 & Supp. III 2021). An NDA must contain
scientific data and other information showing that the
drug is safe and effective if used according to the labeling
proposed in the application. 21 U.S.C. 355(b)(1)(A)(i) and
4
(vi) (Supp. III 2021); see 21 C.F.R. 201.57(c).1 Establishing safety and efficacy can be expensive, and it can
easily cost hundreds of millions of dollars to develop a
new drug and obtain FDA approval via an NDA. See
Aylin Sertkaya et al., Costs of Drug Development and
Research and Development Intensity in the US, 20002018, at 7, JAMA Network Open (June 28, 2024), https://
perma.cc/J7WY-N9JH.
Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98
Stat. 1585, known as the Hatch-Waxman Amendments,
to facilitate competition by lower-cost “generic version[s]” of “brand-name drug[s]” that FDA has already
found safe and effective, Caraco Pharm. Labs., Ltd. v.
Novo Nordisk A/S, 566 U.S. 399, 404 (2012). Under those
amendments, a would-be generic competitor may file an
abbreviated new drug application (ANDA) that “piggyback[s]” in key respects on an approved NDA. Id. at 405.
“Rather than providing independent evidence of safety
and efficacy, the typical ANDA shows that the generic
drug has the same active ingredients as, and is biologically equivalent to, the brand-name drug.” Ibid. (citing
21 U.S.C. 355( j)(2)(A)(ii) and (iv)). Subject to specified
exceptions, the labeling proposed for the generic drug
must be “the same as the labeling approved” by FDA
for the brand-name drug. 21 U.S.C. 355( j)(2)(A)(v).
Brand-name drugs are often protected by multiple
patents that claim the listed “drug” itself and/or an approved “method of using” it (including an “ ‘indication,’ ”
The FDCA uses the term “label” for material printed on a drug’s
immediate container, and the broader term “labeling” for any printed
material accompanying a drug. See 21 U.S.C. 321(k) and (m). The
courts below sometimes used the term “label” to refer to labeling.
E.g., Pet. App. 4a-5a.
1
5
which “refers generally to what a drug does,” e.g., “treat
diabetes”). Caraco, 566 U.S. at 405-406, 417 n.7. Accordingly, the requirements that generic drugs have the same
active ingredients as and be therapeutically equivalent
to their predecessors have led to frequent disputes over
whether the brand-name manufacturers’ patents are
valid and (if so) whether sale or use of the generic will
infringe them. The Hatch-Waxman Amendments establish mechanisms to quickly identify and resolve
those disputes so that competition can begin “as soon as
patents allow.” Id. at 405.
At the outset, a brand-name manufacturer must submit to FDA information about each patent that allegedly claims its drug or a relevant method of using the
drug. 21 U.S.C. 355(b)(1)(A)(viii) and (c)(2) (Supp. III
2021). FDA then lists information about those patents
in a published compendium known as the Orange Book.
See Caraco, 566 U.S. at 405-406; 21 U.S.C. 355(c)(2)
(Supp. III 2021).
An ANDA applicant, in turn, generally must address
the listed patents for the brand-name drug. If the applicant does not wish to delay marketing its generic
drug until the relevant patents expire, see 21 U.S.C.
355( j)(2)(A)(vii)(III), it has two options.
First, the applicant may certify its belief that the relevant patents are invalid or would not be infringed by
sale of the generic drug. 21 U.S.C. 355( j)(2)(A)(vii)(IV).
Such a “paragraph IV certification” is deemed an act of
patent infringement and may trigger litigation to determine the disputed patents’ validity and scope. Caraco, 566
U.S. at 407; see 35 U.S.C. 271(e)(2)(A) and (5). By then
filing a timely patent-infringement suit, the brand-name
manufacturer can generally obtain a 30-month stay of
approval of the generic drug (unless the patent litiga-
6
tion is resolved in the generic’s favor before then). 21
U.S.C. 355( j)(5)(B)(iii). This option allows the generic
manufacturer to provoke a lawsuit—which the brandname manufacturer has an incentive to bring in order to
obtain the 30-month stay—and thus obtain judicial resolution of the patent dispute before marketing its product,
eliminating the risk of patent-infringement damages.
The generic manufacturer is also entitled, even if the
brand-name manufacturer does not sue, to file its own
suit seeking a declaratory judgment that the patent is invalid or would not be infringed. 21 U.S.C. 355( j)(5)(C).
Second, a generic manufacturer may submit a statement indicating that it seeks FDA approval to market
its drug only for uses that are not claimed by the brandname manufacturer’s listed method-of-use patents. 21
U.S.C. 355( j)(2)(A)(viii). Such a “section viii statement”
is “typically used when the brand’s patent on the drug
compound has expired and the brand holds patents on
only some approved methods of using the drug.” Caraco, 566 U.S. at 406. An ANDA applicant that submits
a section viii statement proposes “labeling for the generic drug that ‘carves out’ from the brand’s approved
label the still-patented methods of use.” Ibid.; see 21
C.F.R. 314.94(a)(8)(iv) and (12)(iii)(A). By marketing a
generic drug only for unpatented uses under a carved-out
or “skinny” label, the generic manufacturer can potentially launch its product without the 30-month wait that
a paragraph IV certification and subsequent lawsuit
typically entail.
A generic manufacturer may also employ a combination of paragraph IV certifications and section viii statements, because the choice is made on a patent-by-patent
(or claim-by-claim) basis. This combination strategy
7
may narrow the scope of patent litigation and speed the
generic’s path to market.
When FDA approves a generic drug, that approval
reflects that the generic drug has been evaluated as
therapeutically equivalent to its brand-name predecessor.
FDA, Orange Book Preface § 1.7 (Jan. 15, 2026), https://
www.fda.gov/drugs/development-approval-process-drugs/
orange-book-preface. Therapeutic-equivalence evaluations are published in the Orange Book, where generic
drugs that FDA considers to be therapeutically equivalent to their brand-name counterparts are assigned a
code beginning with “A,” such as “AB.” Ibid. Such a
rating indicates that the generic contains the same active ingredients as the brand-name drug; that the two
are identical in certain other respects; and that “data
and information [have been] submitted demonstrating
[biological equivalence].” Ibid.
2. Once one or more approved generics have joined a
brand-name drug on the market, the FDCA does not address which product is dispensed for a given prescription.
Rather, every State either allows or requires pharmacists
to fill a prescription for a brand-name drug by dispensing an available therapeutically equivalent generic—for
example, by filling a prescription for “Crestor” with generic rosuvastatin. Thirty-four States and the District
of Columbia generally permit pharmacists to substitute
a therapeutically equivalent generic (at least when substitution will save the patient money). See, e.g., Tex. Occ.
Code § 562.008(b); Ark. Code § 17-92-503(a)(1)(A).2 The
See also Ala. Code § 34-23-8(a)(1); Alaska Stat. § 08.80.295(a);
Ariz. Rev. Stat. § 32-1963.01(A); Cal. Bus. & Prof. Code § 4073(a);
Colo. Rev. Stat. § 12-280-125(1)(a); Conn. Gen. Stat. § 20-619(b); 24
Del. Code § 2549(a), repealed by 85 Del. Laws c. 49 (June 30, 2025)
2
8
remaining 16 States generally mandate such substitution when it will save the patient money. See, e.g., Fla.
Stat. § 465.025(2).3
In both permissive- and mandatory-substitution States,
doctors may prevent generic substitution by expressly
directing that a prescription identifying the brand-name
drug must be dispensed exactly as written. E.g., Tex.
Occ. Code § 562.008(a); N.Y. Educ. Law §§ 6810(6)(a),
6816-a(1)(a). Most States also give patients an opportunity to refuse substitution at the pharmacy. E.g., Tex.
Occ. Code § 562.009; 35 Pa. Cons. Stat. § 960.3(b).
(reenacting provisions of 24 Del. Code § 2549 at 24 Del. Code. § 2550
effective June 30, 2026); D.C. Code § 48-803.02(a)(1); Ga. Code Ann.
§ 26-4-81(a); Idaho Code § 54-1733B(1); 225 Ill. Comp. Stat. Ann.
§ 85/25; Ind. Code §§ 16-42-22-5, 16-42-22-6, 16-42-22-8; Kan. Stat.
Ann. § 65-1637(g)(1); La. Rev. Stat. § 37:1241(A)(17); Md. Code Ann.,
Health Occ. § 12-504(d)(1); Mich. Comp. Laws Ann. § 333.17755(1);
Miss. Code § 73-21-117(1); Mo. Ann. Stat. § 338.056(1); Mont. Code
Ann. § 37-7-505(1); Neb. Rev. Stat. Ann. §§ 38-2818.03, 38-28111(1);
N.H. Rev. Stat. Ann. § 146-B:2(I); N.M. Stat. Ann. § 26-3-3(B); N.C.
Gen. Stat. § 90-85.28(a); N.D. Cent. Code § 19-02.1-14.1(3); Ohio
Rev. Code § 4729.38(B); Okla. Stat. tit. 59, § 353.24(B)(4); Or. Rev.
Stat. § 689.515(2); S.C. Code Ann. § 39-24-30(a); S.D. Codified Laws
§ 36-11-46.1; Utah Code Ann. § 58-17b-605(2)(a); Va. Code Ann.
§ 54.1-3408.03(A); Wyo. Stat. Ann. § 33-24-148. Iowa law does not
specifically address generic substitution, but it broadly authorizes
licensed pharmacists to dispense prescription drugs consistent with
“the appropriate standard of care.” Iowa Code §§ 155A.2B, 155A.8(2).
All citations to state statutes are dated 2026 unless otherwise specified.
3
See also Haw. Rev. Stat. § 328-92(a); Ky. Rev. Stat. Ann.
§ 217.822(1); Me. Stat. tit. 32, § 13781; Mass. Gen. Laws ch. 112,
§ 12D; Minn. Stat. § 151.21(3); Nev. Stat. § 639.2583(1)(a); N.J. Stat.
Ann. § 24:6E-7; N.Y. Educ. Law § 6816-a(1); 35 Pa. Cons. Stat.
§ 960.3(a); R.I. Gen. Laws § 5-19.1-19; Tenn. Code Ann. § 53-10205(a); Vt. Stat. Ann. tit. 18, § 4605(a)(1); Wash. Rev. Code § 69.41.130;
W. Va. Code § 30-5-12b(b); Wis. Stat. Ann. § 450.13(1s).
9
The FDCA does not prohibit doctors or pharmacists
from prescribing or dispensing a drug “off-label”—i.e.,
for uses other than those for which FDA has determined that the drug is safe and effective if used as instructed on the drug’s labeling. See FDA, Understanding Unapproved Use of Approved Drugs “Off Label”
(Feb. 5, 2018), https://www.fda.gov/patients/learn-aboutexpanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label. And no
State’s law makes substitution depend on whether a generic drug is labeled for the use for which a drug is being prescribed. Indeed, no State even requires that prescriptions for non-controlled substances must contain
the information about a patient’s diagnosis and treatment that would enable pharmacists to make that determination. As relevant here, state laws typically require only that such prescriptions identify the drug being prescribed and provide basic directions for use (e.g.,
“take once daily with food”). See, e.g., Ariz. Rev. Stat.
§ 32-1968(C).4 Accordingly, only a small percentage of
prescriptions include information about the use for
which the drug is prescribed. See Alejandra Salazar et
al., How Often Do Prescribers Include Indications in
Drug Orders? Analysis of 4 Million Outpatient Prescriptions, 76 Am. J. Health-System Pharm. 970, 973
(2019) (finding that “more than 92% of prescriptions in
a large database * * * did not include indications”).
Several States allow doctors to include indication information on
a prescription or require them to include that information if a patient so requests. See Cal. Bus. & Prof. Code § 4040(a)(1); Colo.
Rev. Stat. § 12-280-103(31)(a); 225 Ill. Comp. Stat. Ann. 85/3(e); Nev.
Stat. § 639.2352; Okla. Stat. tit. 59, § 353.20.1(B); 22 Tex. Admin.
Code § 291.34(b)(7)(A)(vii); W. Va. Code R. § 15-1-18.1.4.d; Wis.
Stat. Ann. § 450.11(4m).
4
10
B. Facts
Respondents (collectively, “Amarin”) market icosapent ethyl under the brand name Vascepa. Pet. App.
2a. Vascepa is used to treat patients with two conditions
involving excessive levels of triglycerides, a type of fat
that circulates in the blood. “ ‘Hypertriglyceridemia’ refers to having a blood triglyceride level above the acceptable level of 150 mg/dL,” and “ ‘[s]evere hypertriglyceridemia’ (or SH) refers to having a blood triglyceride level above 500 mg/dL.” Br. in Opp. 4 (emphasis
added; citations omitted).
FDA has approved Vascepa for two indications addressing these two health conditions. Pet. App. 2a-3a.
In 2012, FDA approved Vascepa for treatment of severe
hypertriglyceridemia (the “SH Indication”). Id. at 2a.
Amarin later conducted additional clinical trials, which
showed that Vascepa reduced cardiovascular risk in
certain patients. Id. at 3a. Based on those data, in 2019
the agency approved Vascepa for use to “reduce cardiovascular risk” in “patients having blood triglyceride
levels of at least 150 mg/dL” (the “CV Indication”)—i.e.,
patients with hypertriglyceridemia, not limited to those
with severe hypertriglyceridemia. Ibid. Amarin holds
two listed method-of-use patents that claim use of icosapent ethyl for the CV Indication. Ibid.
In 2016, petitioners (collectively, “Hikma”) submitted an ANDA for generic icosapent ethyl. Pet. App. 4a.
After FDA approved Vascepa for the CV Indication in
2019, Hikma amended its ANDA to include section viii
statements as to Amarin’s method-of-use patents. Hikma
thus “sought the FDA’s approval of a ‘skinny label’ for
its generic product that would include only the SH indication,” not the patented CV Indication. Id. at 4a-5a;
see p. 6, supra. Apart from the carve-out of the CV In-
11
dication, Hikma sought to conform its proposed labeling
to Amarin’s. Pet. App. 5a.
In May 2020 FDA approved Hikma’s ANDA, including its carved-out or “skinny” labeling. Pet. App. 5a.
Unlike Vascepa’s labeling, the labeling for Hikma’s generic drug “does not provide an implied or express instruction to prescribe the drug for the CV indication”
and omits clinical evidence showing effectiveness for
that use. Id. at 16a; compare J.A. 78, 85-88 (Vascepa),
with J.A. 114, 122 (Hikma). FDA has assigned Hikma’s
generic an “AB” rating, indicating that it is therapeutically equivalent to Vascepa when used according to its
labeling. FDA, Orange Book: Product Details for ANDA
209457, https://www.accessdata.fda.gov/scripts/cder/ob/
results_product.cfm?Appl_Type=A&Appl_No=209457
#39458; see pp. 6-7, supra.
C. Proceedings Below
1. Shortly after Hikma began marketing its generic
drug, Amarin filed suit in the District of Delaware, alleging that Hikma had actively induced others to infringe Amarin’s method-of-use patents. Pet. App. 7a8a; see 35 U.S.C. 271(b) (“Whoever actively induces infringement of a patent shall be liable as an infringer.”).
Amarin’s operative complaint does not allege that
Hikma’s carved-out labeling, standing alone, encouraged doctors or pharmacists to prescribe or dispense
the generic drug for the CV Indication. See Pet. App.
17a-18a. Rather, Amarin alleges that the “totality” of
statements in Hikma’s labeling, press releases, and
website encouraged that infringing use. Br. in Opp.
App. 34a (¶ 128); see id. at 34a, 37a (¶¶ 127, 133). The
relevant press releases—which Hikma issued before it
began to market the drug—directed inquiries to
Hikma’s investor- and public-relations teams rather
12
than to its sales and marketing personnel. See J.A. 2, 3940, 42-43. The press releases described Hikma’s product as a generic version of Vascepa, and in some instances they provided information about Vascepa’s total
sales without distinguishing between Vascepa’s two indications. Ibid. The press releases also stated that Vascepa
was approved only “in part” for the SH Indication. J.A.
40, 42. The website identified Hikma’s generic drug’s
rating as “AB” and its “Therapeutic Category” as “Hypertriglyceridemia.” J.A. 195; see p. 10, supra.
Hikma moved to dismiss Amarin’s complaint for failure to state a claim, arguing that Amarin had not plausibly alleged that Hikma took active steps to encourage
infringement of Amarin’s method-of-use patents. Pet.
App. 9a. The district court granted the motion. Id. at
23a-38a. The court determined that Hikma’s description of its product as a generic equivalent of Vascepa
could not plausibly be understood as active inducement
to infringe. Id. at 32a-35a. It also concluded that
Hikma’s “citation of Vascepa’s sales figures” was potentially relevant to “Hikma’s intent to induce” infringement, but that the citation itself was not “an inducing
act.” Id. at 33a. And the court determined that Amarin
had not plausibly alleged active inducement based on
Hikma’s description of its generic drug as being in a “therapeutic category”—“ ‘hypertriglyceridemia’ ”—that includes both infringing and non-infringing uses. Id. at
33a-35a. The court concluded that this broad description did not “specifically encourage[]” infringement. Id.
at 35a (citation omitted).
2. The Federal Circuit reversed. Pet. App. 1a-22a.
The court of appeals concluded that “the totality of the
allegations” in Amarin’s complaint “plausibly states a
claim for induced infringement.” Id. at 21a. The court
13
treated as undisputed for purposes of the appeal that
(1) third parties had used Hikma’s product to reduce
cardiovascular risk, thereby infringing Amarin’s patents; and (2) Hikma knew and intended that such infringement would occur. Id. at 15a. The court therefore
focused on whether Amarin had plausibly alleged “that
Hikma ‘actively’ induced” others’ “direct infringement,
i.e., that Hikma ‘encouraged, recommended, or promoted infringement.’ ” Id. at 15a-16a (brackets and citations omitted).
The court of appeals concluded that, taken together,
Amarin’s allegations about Hikma’s carved-out labeling, public statements, and marketing materials plausibly supported an inference that Hikma had actively induced infringement of Amarin’s method-of-use patents.
Pet. App. 16a-21a. The court deemed it “at least plausible” that a doctor could discern “encouragement to prescribe [Hikma’s] drug for any of [Vascepa’s] approved
uses” from statements in Hikma’s press releases “touting [Vascepa’s] sales figures attributable largely to” the
CV Indication, and “calling Hikma’s product the ‘generic version’ of a drug [Vascepa] that is indicated ‘in
part’ for the SH indication”—“particularly where”
Hikma’s carved-out labeling “suggests that the drug
may be effective for an overlapping patient population”
that encompasses both infringing and non-infringing
uses. Id. at 19a. The court likewise deemed it plausible
that doctors could understand Hikma’s website “marketing its drug in the broad therapeutic category of
‘Hypertriglyceridemia’ ” as “encouraging prescribing
the drug for an off-label use.” Ibid.
The Federal Circuit cautioned that it was not permitting claims of active inducement to go forward based on
a “mere statement that a generic manufacturer’s prod-
14
uct is the ‘generic version’ of a brand-name drug,” or on
the bare fact that a generic manufacturer “not[es]
(without mentioning any infringing uses) that FDA
ha[s] rated a product as therapeutically equivalent to a
brand-name drug.” Pet. App. 21a (citation omitted). To
the extent questions remained as to what message
Hikma’s statements had “communicate[d] to physicians
and the marketplace,” the Federal Circuit left those
questions to be resolved after discovery. Id. at 18a-19a.
3. The Federal Circuit denied Hikma’s petition for
rehearing en banc. Pet. App. 39a-41a.
SUMMARY OF ARGUMENT
Pleading a claim of active inducement to infringe a patent requires, at minimum, factual allegations that plausibly explain how the defendant’s statements or actions—
beyond the bare sale of a product that may be put to
infringing use—actively encouraged and caused direct
infringement by a third party. Amarin’s complaint includes no such allegations.
A. Although the Hatch-Waxman Amendments provide important context for assessing Amarin’s inducement claims, the Amendments do not contain their own
inducement provision. Rather, Amarin seeks to hold
Hikma liable under the generally applicable Patent Act
rule that “[w]hoever actively induces infringement of a
patent shall be liable as an infringer.” 35 U.S.C. 271(b);
see Br. in Opp. App. 45a, 48a, 49a, 51a, 54a, 56a. Amarin’s complaint does not plausibly allege that Hikma actively induced infringement of Amarin’s patents.
Inducement liability under Section 271(b) is premised on “the taking [by the defendant] of affirmative
steps to bring about the desired result.” Global-Tech
Appliances, Inc. v. SEB S.A., 563 U.S. 754, 760 (2011).
Establishing such liability requires “evidence [that] goes
15
beyond a product’s characteristics or the knowledge
that it may be put to infringing uses, and shows statements or actions directed to promoting infringement.”
Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.,
545 U.S. 913, 935 (2005); see ibid. (“The classic case of
* * * unlawful purpose occurs when one induces commission of infringement by another.”). To satisfy that
standard at the pleading stage, Amarin’s complaint at
minimum needed to include factual allegations describing a plausible chain of events by which Hikma’s statements caused healthcare providers to prescribe or dispense Hikma’s generic drug to reduce cardiovascular
risk.
Amarin’s complaint contains no such factual allegations. It relies instead on the conclusory assertion that
any healthcare provider who encounters Hikma’s statements will inevitably infringe Amarin’s patents. That is
not enough to state a plausible claim. Amarin does not
identify any plausible reason to believe that healthcare
providers would have seen most of Hikma’s allegedly
problematic statements. Nor does it plausibly explain
how those statements would have influenced providers’
behavior or played any causal role in infringement of
Amarin’s method-of-use patents. Any inference that
Hikma’s statements would have had that forbidden effect is especially unlikely given the prevalence of state
laws that encourage or mandate generic substitution regardless of the indication for which a particular drug is
prescribed.
B. In concluding that Amarin had adequately alleged
active inducement of infringing uses, the Federal Circuit relied on three categories of statements made by
Hikma. Those statements are insufficient to create a
plausible inference of culpable active inducement.
16
First, Hikma’s skinny labeling cannot properly be
viewed as evidence of culpable encouragement to infringe. Doing so would contravene the basic design of
section viii, under which generic drugs may be approved
and sold for unpatented uses even while valid patents
still claim some of the approved uses of the brand-name
drug. The point of the section viii carve-out mechanism
is to ensure that the generic’s label does not reference,
and thus potentially encourage, still-patented uses of
the relevant drug. The text of a generic’s carved-out
labeling, moreover, is driven by statutory and regulatory requirements rather than by a generic manufacturer’s independent choices. At least absent exceptional circumstances, treating the generic manufacturer’s compliance with those requirements as evidence
of culpable encouragement to infringe would be illogical
and would significantly deter generic manufacturers
from invoking the section viii mechanism that Congress
provided.
Second, the Federal Circuit erred in treating
Hikma’s description of its own product as a “generic
equivalent” or “generic version” of Amarin’s drug
Vascepa, and Hikma’s description of Vascepa as approved “in part” for an unpatented indication, as potentially culpable efforts to encourage infringement of Amarin’s method-of-use patents. These statements accurately communicated that Hikma’s product met the
statutory and regulatory requirements for genericdrug approval as a therapeutic equivalent to Amarin’s
drug, and they described the unpatented indication for
which Amarin’s drug is approved. Like the labeling itself,
that sort of statement is essential to the Hatch-Waxman
scheme: Medical professionals must know which generic
products are therapeutically equivalent to which brand-
17
name drugs in order to determine whether the generics
may be substituted safely and effectively.
Third, Hikma’s other disputed public statements do
not lend plausibility to Amarin’s claim that Hikma took
active steps to induce infringement. The Federal Circuit relied in part on sales figures contained in press releases that predated the launch of Hikma’s generic and
were directed on their face to investors rather than to
medical professionals. Potential Hikma investors do
not make medical decisions, but they would likely want
to know the potential market for Hikma’s generic drug,
which will ultimately include lawful on-label use of
Hikma’s drug for the CV Indication once Amarin’s
method-of-use patents expire. At least in the absence
of specific factual allegations suggesting such a practice, there is no reason to believe that any healthcare
provider would have made prescribing or dispensing decisions based on sales figures cited in outdated press releases. Treating these press releases as attempts to influence the decisions of medical providers therefore
would be implausible, and it would needlessly impede
the intended operation of the Hatch-Waxman scheme.
The Federal Circuit also erred in inferring culpability
from a Hikma website that described its generic as a
therapy for “hypertriglyceridemia”—a term that encompasses both infringing and non-infringing uses.
C. The decision below threatens to undermine the
broader Hatch-Waxman scheme. Section viii plays a
key role in that scheme by allowing FDA to approve the
sale of generic drugs even while some uses of the relevant chemical compound remain patented. Section viii
thereby encourages the introduction of low-cost drugs
for American consumers and helps avoid exploitative
and anticompetitive practices by brand-name manufac-
18
turers. The Federal Circuit’s decision creates a significant disincentive for generic manufacturers to use the
section viii mechanism, especially given the threat of
massive patent-infringement damages under Federal
Circuit precedent. This Court should reverse the decision below and restore the proper functioning of the balanced scheme created by the Hatch-Waxman Amendments.
ARGUMENT
AMARIN’S COMPLAINT DOES NOT PLAUSIBLY ALLEGE
THAT HIKMA ACTIVELY INDUCED INFRINGEMENT
The Hatch-Waxman Amendments reflect Congress’s
effort to “speed the introduction of low-cost generic
drugs,” Caraco Pharm. Labs., Ltd. v. Novo Nordisk
A/S, 566 U.S. 399, 405 (2012), while “guard[ing] against
infringement of [brand-name] patents,” Eli Lilly & Co.
v. Medtronic, Inc., 496 U.S. 661, 676-677 (1990). In
striking that balance between competing objectives,
Congress determined that patents covering only some
approved methods of using a drug should “not foreclose
marketing a generic drug for other unpatented ones.”
Caraco, 566 U.S. at 415. The section viii mechanism reflects and reinforces the Hatch-Waxman scheme’s larger
goals by allowing generics labeled only for non-infringing uses to “quickly come to market,” ibid., so that a patent on one method of using a drug does not create a de
facto monopoly on the drug itself.
Congress presumably understood that, if generic manufacturers can market drugs approved for unpatented
methods of use while other uses of those drugs remain
patented, some off-label uses will occur. Congress evidently viewed that prospect as an acceptable cost of expedited competition with respect to lawful unpatented
uses. Congress attempted, however, to prevent generic
19
manufacturers who use section viii from encouraging
infringing uses. By prohibiting labeling that suggests
that a generic drug is approved for still-patented methods of use, section viii itself precludes one obvious way
that generic manufacturers might encourage infringement. More generally, the Patent Act provisions that
govern both direct infringement and active inducement,
see 35 U.S.C. 271(a) and (b), remain fully applicable to
the marketing, sale, and use of generic drugs.
To be sure, allowing generic entry while method-of-use
patents remain in force may entail meaningful costs.
Even when a particular drug is no longer patented, the
prospect of obtaining method-of-use patents may encourage valuable innovation by creating a financial incentive for brand-name manufacturers to identify new
therapeutic benefits of their existing products. Widespread infringement of such method-of-use patents may
reduce that incentive to innovate by reducing the perceived value of those patents.
Section viii makes clear, however, that Congress preferred to accept that risk rather than to delay generic
entry until all method-of-use patents for a given drug
have expired. Under the basic bargain struck in section
viii and in the Hatch-Waxman Amendments more generally, a generic manufacturer may market its product
with skinny labeling so long as it does not actively encourage healthcare professionals to infringe the patents
that still protect the carved-out uses. That approach is
consistent with the rules that generally govern inducement liability in the intellectual-property context, under which vendors may sell goods or services that are
capable of both infringing and non-infringing uses so
long as they do not actively encourage infringement.
20
The decision below subverts Congress’s balance between competing interests by subjecting Hikma to a
substantial threat of infringement liability for statements that (a) are integral to the Hatch-Waxman
scheme, including the section viii mechanism; and/or
(b) have no meaningful likelihood of causing infringing
off-label uses. The content of Hikma’s “skinny label” is
largely dictated by the Hatch-Waxman Amendments,
and Hikma’s description of its drug as the “generic
equivalent” of Vascepa is central to the Hatch-Waxman
scheme. And while the Federal Circuit identified a handful of other statements to investors that accurately described the generic drug and its brand-name counterpart, the complaint in this case did not describe any
plausible sequence of events by which those statements
could have led healthcare professionals to engage in direct infringement.
Section viii cannot function as Congress intended if a
generic manufacturer’s anodyne descriptions of its product create a serious risk of massive patent-infringement
liability. Uncertainty about section viii will deter generic
manufacturers from invoking that mechanism, thereby
threatening the availability of lower-cost generic drugs,
in contravention of the statutory design. This Court
should reverse the judgment of the court of appeals.
A. Amarin’s Allegations Do Not Make Out A Plausible Claim
Of Active Inducement To Infringe
Amarin’s allegations do not support a plausible inference that Hikma actively encouraged infringement of
Amarin’s patents. See generally Ashcroft v. Iqbal, 556
U.S. 662 (2009).
Although the Hatch-Waxman Amendments provide
important context for assessing Amarin’s inducement
claims, those claims arise under the Patent Act’s gener-
21
ally applicable inducement provision, 35 U.S.C. 271(b).
See Br. in Opp. App. 45a, 48a, 49a, 51a, 54a, 56a. That
provision states: “Whoever actively induces infringement
of a patent shall be liable as an infringer.” 35 U.S.C.
271(b). Section 271(b)’s use of “the adverb ‘actively’ suggests that the inducement must involve the taking of affirmative steps to bring about the desired result.”
Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754,
760 (2011). And inducement liability is premised on “culpable expression and conduct.” Metro-Goldwyn-Mayer
Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936-937
(2005) (drawing on patent law to adopt a liability rule
for inducing copyright infringement).
The Hatch-Waxman Amendments (and section viii in
particular) allow generic manufacturers to sell their
products when (a) the drug itself is no longer patented
and (b) some but not all FDA-approved uses of the drug
are still covered by method-of-use patents. See Caraco,
566 U.S. at 406. In allowing the sale of generic drugs that
are capable of both infringing and non-infringing uses,
section viii is consistent with the rules that generally
govern inducement liability in the intellectual-property
context. See Sony Corp. v. Universal City Studios, Inc.,
464 U.S. 417, 441 (1984) (“Unless a commodity has no
use except through practice of the patented method, the
patentee has no right to claim that its distribution constitutes contributory infringement.”) (citation and internal quotation marks omitted). As a general rule, “mere
knowledge of infringing potential or of actual infringing
use[],” or suggestions to purchase a product for broad
categories of uses that are not “necessarily infringing,”
do not suffice to establish inducement liability. Grokster, 545 U.S. at 931, 937. Rather, the law requires “evidence [that] goes beyond a product’s characteristics or
22
the knowledge that it may be put to infringing uses, and
shows statements or actions directed to promoting infringement.” Id. at 935. Examples of such culpable “ ‘active steps’ ” include “advertising an infringing use or instructing how to engage in an infringing use.” Id. at 936
(citation omitted).
Read literally, none of Hikma’s statements can plausibly be viewed as an explicit instruction or exhortation
to use Hikma’s generic drug for the CV indication. To
be sure, doctors and pharmacists are sophisticated actors who possess a base of relevant knowledge that most
laypeople lack. In determining whether a brand-name
manufacturer has alleged active inducement with sufficient plausibility, courts should keep in mind the sophistication of an alleged statement’s intended audience.
In assessing the plausibility of such allegations, however, courts should also consider the likelihood (or unlikelihood) that potential direct infringers will become aware
of, and will be influenced by, particular statements that
are alleged to induce infringement. Here, it appears to be
undisputed that dispensing decisions are usually made
by pharmacists who do not know why a particular drug
is being prescribed (because prescriptions typically do
not specify), and whose choice between a brand-name
drug and its generic equivalent may be compelled or constrained by state law. See pp. 7-9, supra; see also Br. in
Opp. App. 34a-35a (¶ 129) (acknowledging that some
States have policies that “encourage or require” generic
substitution “regardless of whether the generic drug label
includes all the indications in the branded drug labeling”).
And some of Hikma’s statements were directed to potential investors rather than to the healthcare professionals
who are the potential direct infringers here. The ultimate
question is whether Amarin’s allegations, considered in
23
light of undisputed market realities and with all reasonable inferences drawn in Amarin’s favor, make it plausible that Hikma crossed the line between merely “ ‘expect[ing]’ ” infringement and culpably “promoting” infringing uses. Grokster, 545 U.S. at 935 (citation omitted).
To survive a motion to dismiss under these established
pleading standards, Amarin needed to plausibly allege
that Hikma took active steps to induce infringement of
Amarin’s patents. In particular, Amarin needed to
identify some plausible chain of events through which
statements made by Hikma led healthcare providers—
presumably doctors or pharmacists—to prescribe or
dispense Hikma’s drug to reduce patients’ cardiovascular risk. Without (at minimum) particularized allegations making it plausible that these statements actually
“foster[ed]” infringing uses of Hikma’s product, there is
no basis to infer that the statements caused infringement to occur, or that Hikma made them with the “object of promoting” that unlawful result rather than
merely “incident” to “legitimate commerce” in an FDAapproved generic drug. Grokster, 545 U.S. at 936-937.
Amarin’s complaint contains no such allegations. It
relies instead on the conclusory assertion that “a
healthcare provider with knowledge” of Vascepa’s approvals and Hikma’s statements “will inevitably” infringe Amarin’s patents. Br. in Opp. App. 37a (¶ 133).
To state a claim against Hikma under Section 271(b),
however, Amarin must plausibly allege not only that
Hikma’s generic drug has been used to infringe Amarin’s patents, but also that Hikma’s statements encouraged and caused that infringement. Under established
and widespread prescribing and dispensing practices, a
doctor seeking to treat cardiovascular risk could write
24
a prescription for “Vascepa,” which might then be filled
with Hikma’s generic drug by a pharmacist who does
not know the purpose for which the drug will be used.
These market realities may make it inevitable that some
degree of direct infringement will occur. But Amarin’s
complaint identifies no basis for inferring that Hikma’s
allegedly inducing statements will increase the frequency of such infringement, or that Hikma made the
statements for the purpose of producing that result.
Absent factual allegations that plausibly connect
Hikma’s statements to direct infringement by a third
party, the complaint’s conclusory allegations that those
statements “instruct, promote, and encourage” infringement, Br. in Opp. App. 34a (¶ 128), and that healthcare
professionals “will inevitably” infringe as a result, id. at
37a (¶ 133), are “not entitled to be assumed true.” Iqbal,
556 U.S. at 681. These sorts of conclusory allegations
resemble the “bare assertion of conspiracy” held to be
inadequate to plead an antitrust claim in Bell Atlantic
Corp. v. Twombly, 550 U.S. 544, 556 (2007). If anything,
the grounds for inferring a connection between Hikma’s
statements and any infringing conduct are weaker here
than in Twombly. There, this Court explained that
while “parallel conduct” by interdependent businesses
could provide circumstantial evidence of an agreement,
such conduct was “just as much in line with a wide swath
of rational and competitive business strategy unilaterally prompted by common perceptions of the market.”
Id. at 554. Here, the off-label dispensing of generic drugs
that is routine and even required in some States does
not provide even circumstantial evidence of an additional push by Hikma to induce healthcare providers to
engage in infringing activity.
25
Contrary to Amarin’s contention (Supp. Br. 10-11), the
fact that Hikma is not presently contesting its general
knowledge and intent that direct infringement would
occur, see Pet. App. 15a, does not strengthen Amarin’s
allegations of active inducement. As a practical matter,
every generic manufacturer will subjectively want its
product to be used as widely as possible and will know
that generic-substitution laws often lead to infringing
off-label uses. And while Hikma has not disputed that
those circumstances are present here, it has contested
Amarin’s assertion that the statements alleged in the
complaint plausibly suggest “culpable conduct, directed to
encouraging” direct infringement. Pet. C.A. Br. 24 (quoting DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306
(Fed. Cir. 2006) (en banc)) (emphasis omitted); see id.
at 39-40 (explaining that alleged inducer’s knowledge of
direct infringer’s conduct is insufficient to establish inducement liability, and that “Amarin has not plausibly
alleged that Hikma took ‘active steps’ to encourage infringement”) (citation omitted). Hikma’s subjective expectations or “knowledge that it[s drug] may be put to infringing uses” does not control the determination whether
Amarin has plausibly alleged “statements or actions directed to promoting infringement.” Grokster, 545 U.S.
at 935.
B. The Statements On Which The Federal Circuit Relied
Provide No Basis For Liability
In concluding that Amarin had adequately alleged
active inducement of infringing uses, the Federal Circuit relied on three categories of statements made by
Hikma. Read literally, none of those statements encourages any healthcare provider to infringe Amarin’s
method-of-use patents. Both individually and taken to-
26
gether, those statements are insufficient to create a
plausible inference of culpable active inducement.
First, Hikma’s skinny labeling cannot properly be
treated as evidence of culpable encouragement to infringe. Section viii is designed to enable generic versions of a brand-name drug to be marketed where the
drug itself is not patented and only some of its FDAapproved uses are claimed by method-of-use patents.
See 21 U.S.C. 355( j)(2)(A)(viii); pp. 4-7, supra. By authorizing FDA to approve an ANDA in those circumstances, Congress necessarily contemplated and intended that “one patented use will not foreclose marketing a generic drug for other unpatented ones.” Caraco,
566 U.S. at 415.
Treating a generic manufacturer’s approved skinny
labeling as evidence of culpable inducement would be at
odds with section viii’s basic design. The content of
carved-out labeling is driven by statutory and regulatory requirements that allow only narrow exceptions to
the general statutory command that generic labeling
must be the same as the brand’s labeling. See 21 U.S.C.
355( j)(2)(A)(v); 21 C.F.R. 314.94(a)(8)(iv). Before FDA
approves an ANDA, the agency reviews the generic
manufacturer’s proposed skinny labeling to verify
(i) that the labeling omits the uses that the brand-name
manufacturer has described as claimed by its patents,
see Caraco, 566 U.S. at 405-407; (ii) that those omissions
do not “render the proposed [generic] drug product less
safe or effective than the [brand] drug for all remaining,
nonprotected * * * use[s],” see 21 C.F.R. 314.127(a)(7);
and (iii) that the carved-out labeling remains the same
as the brand’s with respect to the remaining methods of
use, see ibid.
27
The point of the skinny-label mechanism is to make
unlawful inducement less likely, by ensuring that the
generic’s label does not reference (and thus potentially
encourage) still-patented uses of the drug. And because
the content of the skinny label is largely dictated by
statute and regulations, use of the label says little about
the generic manufacturer’s culpability. At least absent
exceptional circumstances, treating the generic manufacturer’s compliance with those requirements as evidence of culpable encouragement to infringe therefore
would be illogical and would significantly deter generic
manufacturers from using section viii, thus defeating
the statutory scheme.
Second, and for similar reasons, the Federal Circuit
erred in concluding that Hikma’s description of its own
product as a “generic equivalent” or “generic version” of
Vascepa, and Hikma’s description of Vascepa as approved “in part” for the SH Indication, could plausibly
be viewed as culpable attempts to encourage infringement. See Pet. App. 18a-21a. Those statements did not
mention the patented CV Indication, let alone encourage healthcare professionals to prescribe or dispense
Hikma’s generic drug for that purpose. Rather, they
communicated that Hikma’s product meets the statutory and regulatory requirements (including therapeutic equivalence to Vascepa) for approval under an
ANDA, and they described the unpatented indication
for which Vascepa is approved.
Like the labeling itself, that sort of statement is essential to the Hatch-Waxman scheme, since medical professionals must know which generic products are therapeutically equivalent to which brand-name drugs in order to
determine whether the generics may be substituted safely
and effectively. To the extent such statements reach indi-
28
viduals who make prescribing and dispensing decisions,
they serve Hatch-Waxman’s purpose of encouraging
substitution of cheaper generics for unpatented indications. And to the extent particular statements do not
reach such individuals, those statements cannot induce
infringement of the patented methods of use.
Third and finally, Hikma’s other disputed public
statements—which were not directed to medical
professionals—do not lend plausibility to Amarin’s claim
that Hikma took active steps to induce infringement.
To be sure, unlike the labeling and generic-equivalent
statements discussed above, Hikma’s citation in press
releases of Vascepa’s total sales figures is not necessary
to the operation of the Hatch-Waxman scheme. But that
is largely because those press releases are orthogonal
to the processes by which generic drugs are approved,
labeled, prescribed, and dispensed. They relate instead
to the commercial processes by which generic manufacturers seek to attract the investors needed to develop
and market their drugs. On their face, Hikma’s press
releases were directed to investors rather than to medical professionals, and they were issued before Hikma’s
generic drug was on the market (and in some instances
before FDA had approved the generic).
Because potential Hikma investors do not make prescribing or dispensing decisions, those statements directed to them cannot plausibly be viewed as attempts
to induce infringement. But potential investors would
likely want to know the potential market for Hikma’s
generic drug. And that potential market will ultimately
include use of Hikma’s drug for the CV Indication, since
generic icosapent ethyl may lawfully be promoted for
that indication—indeed, its labeling must be updated to
include that indication—once Amarin’s method-of-use
29
patents expire. Chilling such investor communications,
by implausibly construing them as actively encouraging
infringement by medical providers, would needlessly
impede the intended operation of the Hatch-Waxman
scheme.
In order for Hikma’s press releases to induce infringement, a prescriber or pharmacist would need to (1) have
read an outdated investor press release, (2) know of the
relative contributions to sales made by each of Vascepa’s
two indications, (3) construe the bare inclusion of total
Vascepa sales in Hikma’s estimate of market size as encouragement to prescribe or dispense Hikma’s drug to
reduce cardiovascular risk, and (4) act to prescribe or dispense Hikma’s drug based upon that encouragement rather than based upon other reasons, such as the constraints imposed by state generic-substitution laws, see
pp. 7-9, supra. At a minimum, further factual allegations
would be needed to plead a plausible causal connection
between the press releases and any ultimate acts of direct infringement. But Amarin’s complaint offered no
subsidiary allegations suggesting that this sequence of
events can plausibly be thought to have occurred. See
Iqbal, 556 U.S. at 679 (holding that a complaint does not
state a claim for relief “where the well-pleaded facts do
not permit the court to infer more than the mere possibility of misconduct”).
Like Hikma’s press releases, the relevant page on
Hikma’s website does not mention cardiovascular risk
at all. The website describes icosapent ethyl as a therapy for “Hypertriglyceridemia,” J.A. 195, but even the
non-infringing SH Indication treats that condition, see
p. 10, supra. Accordingly, the website’s statement does
not urge a “necessarily infringing” use, Grokster, 545
U.S. at 931, but rather amounts at most to marketing a
30
lawful product in terms broad enough to encompass both
infringing and non-infringing uses. Even apart from the
unlikelihood that individuals who prescribe and dispense
drugs would consult the website, the statement does not
raise a plausible inference of culpable inducement to infringe.
The nature of the statements on which the Federal
Circuit relied highlights the unduly lenient standard it
applied in assessing Amarin’s complaint. For example,
the court faulted Hikma for noting that Vascepa was approved only “in part” for the indication for which Hikma’s
drug was approved. Pet. App. 19a. But if Hikma had
omitted that qualifier, it could equally have been faulted
for failing to provide sufficient notice that Hikma’s
product is not labeled for all the same indications as
Vascepa. At every turn, the Federal Circuit relied on
anodyne statements with logical explanations having
nothing to do with active encouragement of infringing
uses, see Grokster, 545 U.S. at 937 (emphasizing that
“ordinary acts incident to product distribution” do not
“support liability in themselves”), without identifying
any factual allegations in the complaint suggesting a
causal link between these statements and any subsequent prescribing or dispensing decisions.
C. The Federal Circuit’s Decision Undermines The Broader
Hatch-Waxman Scheme
1. The section viii mechanism is an integral component of a complex statutory scheme designed to encourage market entry by generic-drug manufacturers “as
soon as patents allow.” Caraco, 566 U.S. at 405. Generic
drugs approved between 2018 and 2020 are estimated to
have saved consumers more than $50 billion in the first
12 months of generic sales. Ryan Conrad et al., FDA,
Estimating Cost Savings from New Generic Drug Ap-
31
provals in 2018, 2019, and 2020, at 3 (2022). In many
instances, FDA approval of the first generic version of
a brand-name drug reduced the price of the drug by
more than 75%. Id. at 4. Such “first generic” approvals
often involve carved-out labeling. See, e.g., Bryan S.
Walsh et al., Frequency of First Generic Drug Approvals With ‘Skinny Labels’ in the United States, 181
JAMA Internal Med. 995, 995-997 (July 2021). According to one recent study, the section viii mechanism has
allowed generic drugs to be approved for sale an average of three years before the relevant method-of-use
patents expired. See id. at 995.
Section viii reflects Congress’s judgment that a patent on one use of a drug should not create a de facto
monopoly on the drug itself. That policy judgment does
not reflect special solicitude for manufacturers of generic drugs. Rather, it is consistent with the general
rule that sales of a product with both infringing and
non-infringing uses will not subject the seller to inducement liability unless the seller actively encourages infringing conduct. See, e.g., Sony, 464 U.S. at 441 (“[I]n
contributory infringement cases arising under the patent laws the Court has always recognized the critical
importance of not allowing the patentee to extend his
monopoly beyond the limits of his specific grant.”).
To be sure, the availability of method-of-use patents
provides an important incentive for continued research
to identify additional therapeutic uses of established
drugs. Direct infringement of method-of-use patents
would be reduced, and those patents would become
more valuable (and accordingly would provide a greater
incentive for such research), if generic equivalents
could not be marketed at all until every method-of-use
patent on the relevant drug has expired or been success-
32
fully challenged. The whole point of section viii, however,
is to reject that all-or-nothing approach, which had previously enabled “anticompetitive practices” by brandname manufacturers “to prevent or delay the marketing
of generic drugs.” Caraco, 566 U.S. at 408. And the HatchWaxman Amendments’ skinny-label mechanism represents an evident congressional determination that, so
long as generic manufacturers do not encourage infringing uses of their drugs, some measure of dispensing for such uses is an acceptable price for expediting
generic competition with respect to non-infringing uses.
To achieve the balance that Congress struck in enacting section viii, generic manufacturers must be able
to take the steps necessary to bring lower-cost generic
drugs to market, such as using carved-out labeling, describing their drugs as the generic version of the corresponding brand-name drugs, and providing basic information to investors. It is equally important to the federal
scheme that generic manufacturers not urge medical
professionals to infringe brand-name manufacturers’
method-of-use patents. But absent any allegation that
Hikma’s statements encouraged the people who make
prescribing and dispensing decisions to use Hikma’s
drug for the CV Indication, the Federal Circuit’s decision does not meaningfully enforce those limits.
2. The Federal Circuit’s decision creates a substantial disincentive to use of the section viii mechanism,
both by increasing the likelihood of ultimate damages
liability and by allowing conclusory allegations to subject generic manufacturers to the burdens of litigation.
That disincentive is exacerbated by the approach the
Federal Circuit has taken to the calculation of damages
when generic manufacturers are found liable for inducing
infringement of method-of-use patents. Federal Circuit
33
precedent suggests that a prevailing brand-name plaintiff in such a case may recover lost profits calculated as
if the brand-name manufacturer would (but for the inducement) have captured “every infringing sale” of the
defendant’s generic drug for the patented use. GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th
1320, 1340-1341 (Fed. Cir. 2021) (per curiam), cert. denied, 143 S. Ct. 2483 (2023). That analysis could be read
to mean that, if Hikma’s statements on its website and
to investors are found to have caused some small number of doctors or pharmacists to engage in infringing
off-label uses of Hikma’s generic drug, Hikma can be
made to pay damages for all infringing uses of its drug,
including uses that the statements played no causal role
in inducing. See id. at 1341 (rejecting argument that
automatic generic substitution by pharmacies would
break chain of causation for damages purposes). To be
sure, Amarin asserts that a later Federal Circuit decision has adopted a more measured approach. See Supp.
Br. 11. But at a minimum, uncertainty as to the calculation of potential damages increases the disincentive
that the decision below creates for generic manufacturers to invoke the section viii mechanism.
34
CONCLUSION
The judgment of the court of appeals should be
reversed.
Respectfully submitted.
D. JOHN SAUER
Solicitor General
BRETT A. SHUMATE
Assistant Attorney General
MALCOLM L. STEWART
Deputy Solicitor General
MAX E. SCHULMAN
Assistant to the
Solicitor General
DANIEL TENNY
GABRIEL I. SCHONFELD
Attorneys
FEBRUARY 2026
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.