Amicus Curiae Brief — Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Amarin Pharma, Inc., et al.

Supreme Court briefMar 27, 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.,

Respondents.

On Writ of Certiorari to the United States

Court of Appeals for the Federal Circuit

══════════════════════════════════

BRIEF OF AMICUS CURIAE AMERICAN

INTELLECTUAL PROPERTY LAW ASSOCIATION

IN SUPPORT OF AFFIRMANCE

══════════════════════════════════

Salvatore Anastasi

Barbara A. Fiacco

President

Counsel of Record

AMERICAN INTELLECTUAL

Urszula Nowak

PROPERTY LAW ASSOCIATION Spenser C. Angel

1400 Crystal Drive,

FOLEY HOAG LLP

Suite 600

155 Seaport Blvd.

Arlington, VA 22202

Boston, MA 02210

(703) 415-0780

(617) 832-1000

bfiacco@foleyhoag.com

Counsel for Amicus Curiae

American Intellectual Property Law Association

TABLE OF CONTENTS

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

SUMMARY OF ARGUMENT .....................................2

ARGUMENT ...............................................................4

With the enactment of § 271(b),

Congress codified liability for those who

induce others to infringe a patent....................4

II.

The § 271(b) inducement inquiry

requires a totality-of-circumstances

analysis. ............................................................7

A wide range of conduct

can satisfy the

“affirmative steps”

element of inducement. ...............7

The “affirmative steps”

inquiry considers all facts

and circumstances. ......................9

III.

The Hatch-Waxman Act does not

exempt “skinny label” entrants from

liability for induced infringement. .................13

IV.

The Court should neither change the

pleading standard nor adopt a

categorical exemption from § 271(b) for

section viii entrants. .......................................16

The Iqbal/Twombly

pleading standard

provides appropriate

flexibility for evaluating

an inducement claim. ................16

The Federal Circuit

correctly applied the

pleading standard to

Amarin’s inducement

claim. .........................................21

The Federal Circuit’s

decision does not

“effectively nullify” the

section viii regulatory

pathway established by

Congress. ...................................23

Any categorical decision

to exempt section viii

entrants from induced

infringement liability is

for Congress, not the

Court. .........................................25

CONCLUSION ..........................................................26

iii

TABLE OF AUTHORITIES

Cases

Page(s)

ArthroCare Corp. v. Smith & Nephew, Inc.,

406 F.3d 1365 (Fed. Cir. 2005) .............................. 9

Ashcroft v. Iqbal,

556 U.S. 662 (2009) ........................... 2-4, 16-18, 20

Astornet Techs. Inc. v. BAE Sys., Inc.,

802 F.3d 1271 (Fed. Cir. 2015) .............................. 7

Bell Atl. Corp. v. Twombly,

550 U.S. 544 (2007) ......................2-4, 16-18, 20, 23

In re Bill of Lading,

681 F.3d 1323 (Fed. Cir. 2012) ............................ 18

Caraco Pharm. Labs., Ltd. v. Novo Nordisk

A/S,

566 U.S. 399 (2012) ........................................ 14, 15

Carbice Corp. of Am. v. Am. Patents Dev.

Corp.,

283 U.S. 27 (1931) .................................................. 6

Cleveland Clinic Foundation v. True Health

Diagnostics LLC,

859 F.3d 1352 (Fed. Cir. 2017) ................ 19, 22, 23

Ericsson, Inc. v. D-Link Sys., Inc.,

773 F.3d 1201 (Fed. Cir. 2014) .............................. 9

Global-Tech Appliances, Inc. v. SEB S.A.,

563 U.S. 754 (2011) ................................................ 7

Globus Med., Inc. v. Alphatec Spine, Inc.,

No. 25-cv-1522, 2025 U.S. Dist. LEXIS

253834 (S.D. Cal. Dec. 3, 2025) ........................... 19

Jazz Pharms., Inc. v. Avadel CNS Pharms.,

LLC,

136 F.4th 1075 (Fed. Cir. 2025)..................... 14, 15

Lifetime Indus., Inc. v. Trim-Lok, Inc.,

869 F.3d 1372 (Fed. Cir. 2017) ............................ 18

Liquid Dynamics Corp. v. Vaughan Co.,

Inc.,

449 F.3d 1209 (Fed. Cir. 2006) .............................. 9

Mercoid Corp. v. Mid-Continent Investment

Co.,

320 U.S. 661 (1944) ................................................ 6

Mercoid Corp. v. Minneapolis-Honeywell

Regulator Co.,

320 U.S. 680 (1944) ................................................ 6

Metabolite Labs., Inc. v. Lab. Corp. of Am.

Holdings,

370 F.3d 1354 (Fed. Cir. 2004) .............................. 8

Metro-Goldwyn-Mayer Studios Inc. v.

Grokster, Ltd.,

545 U.S. 913 (2005) .............................. 8, 11, 12, 17

Morton Salt Co. v. G. S. Suppiger Co.,

314 U.S. 488 (1942) ................................................ 6

Nalco Co. v. Chem-Mod, LLC,

883 F.3d 1337 (Fed. Cir. 2018) ............................ 18

Power Integrations, Inc. v. Fairchild

Semiconductor Int’l, Inc.,

843 F.3d 1315 (Fed. Cir. 2016) ............ 7, 10, 11, 17

Takeda Pharms. U.S.A., Inc. v. W.-Ward

Pharm. Corp.,

785 F.3d 625 (Fed. Cir. 2015) .............................. 24

Thomson-Houston Elec. Co. v. Kelsey Elec.

Ry. Specialty Co.,

75 F. 1005 (2d Cir. 1896) ....................................... 8

Wallace v. Holmes,

29 F. Cas. 74 (C.C.D. Conn. 1871) ......................... 5

Westinghouse Elec. & Mfg. Co. v. Precise

Mfg. Corp.,

11 F.2d 209 (2d Cir. 1926) ................................. 5, 8

Statutes

21 U.S.C. § 355(b)(1)(A)(viii) ..................................... 14

§ 355(j) ....................................................... 14

§ 355(j)(2)(A)(vii)(IV) ........................... 14, 21

§ 355(j)(2)(A)(viii) .. 2-4, 15, 16, 20, 21, 23-25

35 U.S.C. § 271 ............................................................ 8

§ 271(b) ............... 2-4, 7, 8, 11, 16, 20, 23, 24

§ 271(c) ..................................................... 4, 7

§ 271(e)(1) .................................................. 23

§ 271(e)(2)(A) ....................................... 14, 15

§ 271(f)(1) ..................................................... 9

Drug Price Competition and Patent Term

Restoration Act of 1984 (“HatchWaxman Act”), Pub. L. No. 98-417,

98 Stat. 1585 ............................... 2, 4, 13-16, 20, 24

Federal Food, Drug, and Cosmetic Act

(“FDCA”), 21 U.S.C. § 301 et seq., ...................... 13

Legislative Materials

H. R. Rep. No. 82-1923 (1952)..................................... 7

Skinny Labels, Big Savings Act, H.R. 6485,

119th Cong. (2025). .............................................. 25

Skinny Labels, Big Savings Act, S. 43,

119th Cong. (2025). .............................................. 25

Other Authorities

21 C.F.R. § 314.53(c)(2)(ii)(P)(3) ......................... 14, 15

68 Fed. Reg. 36,676 (June 18, 2003) ......................... 15

Charles W. Adams, A Brief History of

Indirect Liability for Patent

Infringement, 22 Santa Clara High

Tech. L.J. 369 (2005) ...................................... 5, 6, 8

vii

Mark A. Lemley, Inducing Patent

Infringement, 39 U.C. Davis L. Rev. 225

(2005) .......................................................... 5, 12, 13

Giles S. Rich, Infringement under Section

271 of the Patent Act of 1952, 35 J. Pat.

Off. Soc’y 476 (1953) .......................................... 5, 6

INTEREST OF AMICUS CURIAE

The American Intellectual Property Law

Association (“AIPLA”) is a national bar association

representing the interests of approximately 6,500

members engaged in private and corporate practice,

government service, and academia. AIPLA’s members

represent a diverse spectrum of individuals,

companies, and institutions involved directly or

indirectly in the practice of patent, trade secret,

trademark, and copyright law, as well as other fields

of law relating to intellectual property. Our members

represent both owners and users of intellectual

property.1

AIPLA’s mission includes providing courts with

objective analyses to promote an intellectual property

system that stimulates and rewards invention,

creativity, and investment while accommodating the

public’s interest in healthy competition, reasonable

costs, and basic fairness. AIPLA has no stake in either

of the parties to this litigation or in the result of this

case. AIPLA’s only interest is in seeking correct and

consistent interpretation of the law as it relates to

intellectual property issues.

1 Pursuant

to this Court’s Rule 37.6, no counsel for a party

authored this brief in whole or in part, and no such counsel or

party made a monetary contribution intended to fund the

preparation or submission of the brief. No person or entity other

than the amicus curiae, its members, or its counsel, made a

monetary contribution intended to fund its preparation or

submission.

SUMMARY OF ARGUMENT

This case presents the question of what a patentee

must plead to state a claim for induced infringement

by a generic manufacturer with a skinny label. Under

this Court’s decisions in Iqbal and Twombly, a

complaint must plead facts that allow the court to

draw the reasonable inference that the defendant is

liable for the alleged inducement.

35 U.S.C. § 271(b) conditions liability on “actively”

inducing infringement by another, meaning that

inducement requires the taking of affirmative steps to

promote infringement of a patent. A wide range of

conduct can satisfy this requirement, including

advertising an infringing use and providing

instructions for infringement, as well as distributing

promotional materials and publishing technical

literature that encourage direct infringement. The

inquiry into whether particular conduct constitutes

an active step (or steps) to encourage infringement is

necessarily context-specific and fact-intensive. It

further requires courts to evaluate the totality of a

defendant’s conduct rather than examining each act

in isolation. Acts that might appear insignificant or

benign individually may, when considered together,

demonstrate a coordinated effort to encourage

infringement.

Congress enacted § 271(b) to ensure robust

protection for patent holders against indirect

infringers who facilitated and profited from the

infringement of their patents. Section 271(b) provides

protection against induced infringement regardless of

technology field. And while the Hatch-Waxman Act

created the section viii pathway permitting generic

manufacturers to omit patented methods of use from

their labels, it did not create an exemption to § 271(b)

for “skinny label” manufacturers that would exempt

them from liability for induced infringement or

otherwise disturb that doctrine. FDA’s approval of a

skinny label is not a determination of noninfringement. Section 271(b) remains fully applicable

to the section viii entrant who risks liability if it

engages in conduct encouraging use beyond its

approved label where such use is covered by another’s

patent.

There is no basis for this Court to read special

protections into inducement law for section viii

entrants as Hikma proposes. Section 271(b) is not only

industry-agnostic, but also flexible. Adopting a

categorical rule that excludes certain public

statements made on a generic drug company’s

website, such as in press releases, from qualifying as

evidence of inducement would fracture the uniformity

of inducement law, create a technology-specific safe

harbor that Congress has not authorized, and invite

other industries to seek similar exemptions from

liability under § 271(b).

The Federal Circuit correctly declined to adopt a

categorical rule excluding certain types of evidence

from the inducement inquiry at the pleading stage.2

2 AIPLA takes no position on the ultimate question of liability in

this case. AIPLA’s interest is solely in urging this Court to apply

the Iqbal/Twombly pleading standard and inducement law

uniformly, evaluating the allegations under the established

totality-of-circumstances framework without creating industryspecific categorical exclusions.

The court applied the Iqbal/Twombly standard to

evaluate the sufficiency of Amarin’s amended

complaint. It accepted the well-pleaded facts as true,

drew all reasonable inferences in favor of Amarin, and

found that Amarin plausibly pled that Hikma’s label

and public statements, taken together, actively

induced healthcare providers’ direct infringement.

Contrary to the arguments of Hikma and its amici,

this Court’s affirmance will not “effectively nullify”

the section viii pathway for generic approval. Section

viii applicants are free to market their products in a

manner consistent with (but not broader than) their

approved use, as Congress contemplated in the HatchWaxman Act. Whether more incentives are needed to

increase the viability of section viii “skinny labels”—

either now or in the future—is a policy decision for

Congress, not the courts.

ARGUMENT

With the enactment of § 271(b), Congress

codified liability for those who induce others to

infringe a patent.

Congress codified the doctrine of indirect

infringement in the Patent Act of 1952, recognizing

two forms of liability. Section 271(b) addresses

inducement; it provides that “[w]hoever actively

induces infringement of a patent shall be liable as an

infringer.” Section 271(c) prohibits contributory

infringement—that is, the sale of components of a

patented product that constitute a material part of the

invention and are known to be especially made for use

in the infringement. 35 U.S.C. § 271(c).

Although the statutory provisions for indirect

infringement were not enacted until 1952, the

underlying doctrine originates from the common law

of torts which has “long punished not only tortfeasors

but also those who aid and abet the commission of a

tort”.

Mark

Lemley, Inducing

Patent

Infringement, 39 U.C. Davis L. Rev. 225, 227 (2005).

The earliest patent cases addressing conduct now

recognized as inducement treated such conduct not as

a separate offense, but as evidence supporting the

then-requisite intent element for contributory

infringement. Id. Where a defendant sold a component

that had no use outside the patented invention, courts

readily inferred intent to cause infringement. See

Wallace v. Holmes, 29 F. Cas. 74, 79-80 (C.C.D. Conn.

1871); see also Giles S. Rich, Infringement Under

Section 271 of the Patent Act of 1952, 35 J. Pat. Off.

Soc’y 476, 482 (1953); Charles W. Adams, A Brief

History of Indirect Liability for Patent Infringement,

22 Santa Clara High Tech. L.J. 369, 371-72 (2005).

The analysis was more complex when a defendant sold

a product capable of both infringing and noninfringing uses. See Lemley, supra, at 227. In such

circumstances, courts sought evidence of intent to

promote infringement, for example, by advertising the

product for use in a patented combination or teaching

the direct infringer how to infringe. See, e.g.,

Westinghouse Elec. & Mfg. Co. v. Precise Mfg.

Corp., 11 F.2d 209, 210-12 (2d Cir. 1926); Adams,

supra, at 375.

By the mid-twentieth century, some patentees had

exploited that contributory infringement doctrine to

extend their patent monopolies beyond the scope of

their inventions through tying arrangements that

required purchasers of patented products to also buy

unpatented goods.3 By 1944, this Court’s Mercoid

decisions dramatically expanded the patent misuse

doctrine, holding that any attempt to control the

market for unpatented goods constituted misuse—

even if those goods had no use outside the patented

invention.

Mercoid Corp.

Mid-Continent

Investment Co., 320 U.S. 661 (1944); Mercoid Corp. v.

Minneapolis-Honeywell Regulator Co., 320 U.S. 680

(1944); see also Adams, supra, at 382-84. The Court

acknowledged that its ruling would “limit

substantially

the

doctrine

contributory

infringement,” but declined to specify “[w]hat

residuum may be left.” Mercoid, 320 U.S. at 669. This

cryptic pronouncement led to confusion for

practitioners and the lower courts.

Congress recognized that the judicial expansion of

the patent misuse doctrine had swung the pendulum

too far away from protecting legitimate patent rights,

effectively eviscerating liability for indirect

infringement and leaving patentees without

meaningful recourse against parties who facilitated

and profited from the infringement of their patents.

See Rich, supra, at 485-89. Concerned that this near

3 If a purchaser bought unpatented goods from a competitor, the

purchaser’s use of the patented device became unauthorized,

which in turn exposed the competing supplier to liability for

contributory infringement. Adams, supra, at 376-84. In response,

this Court developed the defense of patent misuse to bar

patentees from leveraging their patents to monopolize

unpatented materials. See Carbice Corp. of Am. v. Am. Patents

Dev. Corp., 283 U.S. 27 (1931); Morton Salt Co. v. G. S. Suppiger

Co., 314 U.S. 488 (1942).

elimination of contributory infringement liability had

critically weakened patent rights, Congress acted to

restore the balance by “codify[ing] . . . principles of

contributory infringement” that had developed over

the preceding eight decades through its enactment of

§ 271(b) and (c). See H. R. Rep. No. 82-1923, at 9

(1952).

II.

The § 271(b) inducement inquiry requires a

totality-of-circumstances analysis.

A wide range of conduct can satisfy the

“affirmative steps” element of inducement.

Section 271(b) expressly requires that a defendant

“actively” induce infringement in order to be liable for

another’s direct infringement of a patent. This Court

has observed that the addition of the adverb “actively”

to the text of § 271(b) “suggests that [] 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). The Federal

Circuit has long taken a consistent approach: “[t]o

prove inducement of infringement, the patentee must

[]show that the accused inducer took an affirmative

act to encourage infringement with the knowledge

that the induced acts constitute patent infringement.”

Power Integrations, Inc. v. Fairchild Semiconductor

Int’l, Inc., 843 F.3d 1315, 1332 (Fed. Cir. 2016)

(quoting Astornet Techs. Inc. v. BAE Sys., Inc., 802

F.3d 1271, 1279 (Fed. Cir. 2015)).

The affirmative steps requirement ensures that

inducement liability attaches only to those who take

deliberate action to encourage infringement.

Advertising an infringing use or providing

instructions for infringement are classic examples of

conduct long recognized as probative of the

affirmative encouragement required for inducement.

See, e.g., Westinghouse, 11 F.2d at 210; ThomsonHouston Elec. Co. v. Kelsey Elec. Ry. Specialty Co., 75

F. 1005, 1007–08 (2d Cir. 1896). This Court’s 2005

decision in Grokster recognized that principle in the

infringing use or instructing how to engage in an

infringing use” as “[e]vidence of active steps taken to

encourage direct infringement.” Metro-GoldwynMayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913,

936 (2005).

While traditional advertising and instructions are

illustrative of the conduct that can satisfy the

affirmative steps requirement, they are not the only

conduct that can do so. As Judge Giles S. Rich wisely

foresaw at the time of § 271(b)’s enactment, “[a]n

infinite variety of promotional activities calculated to

result in infringement to a greater or less degree, can

be envisaged.” Rich, supra, at 497.4 Courts applying

the inducement doctrine have accordingly found a

wide range of conduct probative of affirmative

encouragement.

For example, in Metabolite Labs., Inc. v. Lab.

Corp. of Am. Holdings, 370 F.3d 1354, 1365 (Fed. Cir.

2004), the Federal Circuit upheld an inducement

verdict where the defendant published educational

4 Judge Rich played an important role on the committee

of the

Patent Law Association of New York that initially drafted the

bill that became 35 U.S.C. § 271. Adams, supra, at 384.

articles and a directory of the laboratory tests it

offered to the physicians who ordered such tests,

which together specifically promoted the infringing

use of the patented method by instructing physicians

on how to interpret the test results. In ArthroCare

Corp. v. Smith & Nephew, Inc., 406 F.3d 1365, 1377

(Fed. Cir. 2005), the court affirmed inducement based

on sales literature and instruction manuals that

directed surgeons to use the accused surgical probes

in the precise manner covered by the patented

method.

As yet another example, in Ericsson, Inc. v. D-Link

Sys., Inc., 773 F.3d 1201, 1220, 1222 (Fed. Cir. 2014),

the court affirmed the jury’s finding of induced

infringement where the defendants advertised their

products’ compliance with a WiFi standard that

practiced the patented methods, thereby encouraging

customers to use the products in an infringing

manner. And in Liquid Dynamics Corp. v. Vaughan

Co., Inc., 449 F.3d 1209, 1223 (Fed. Cir. 2006), the

court affirmed the jury’s finding of induced

infringement under 35 U.S.C. § 271(f)(1). The court

held that there was circumstantial evidence of

inducement where the defendant distributed an

engineering manual to its customers that was replete

with examples of tank installations similar to the

patented design, supporting the inference that the

defendant intended its buyers to install systems that

practice the patented invention outside the U.S.

The “affirmative steps” inquiry considers all

facts and circumstances.

Whether a given act promotes an infringing use

cannot be resolved in the abstract. The inquiry is

inherently fact-bound, requiring careful examination

of the context surrounding the alleged inducing

conduct. Courts must therefore evaluate each case on

its own facts, assessing the nature, content, and likely

effect of the defendant’s affirmative actions and

communications in light of the surrounding

circumstances.

The Federal Circuit has consistently held that

inducement must be evaluated based on the totality of

a defendant’s conduct, not by examining each act in

isolation, including in the oft-cited Power

Integrations, 843 F.3d 1315. In that case, Power

Integrations accused Fairchild of inducing third

parties to import controller chips into the United

States that practiced Power Integrations’ patents. In

evaluating whether substantial evidence could

support an inducement verdict, the court considered

multiple affirmative acts by Fairchild: (1) designing

its controller chips to meet U.S. energy standards; (2)

competing for business it knew was directed to the

U.S.; (3) providing demonstration boards containing

the infringing controller chips to customers in the

U.S.; (4) maintaining a website that enabled

customers to locate a U.S.-based distributor that sold

Fairchild’s infringing controller chips; (5) maintaining

a technical support center in the U.S. that provided

support for the infringing chips to customers in the

U.S.; and (6) having standard terms and conditions

that indemnified customers against claims for

infringement of U.S. patents. Id. at 1333-34.

The Power Integrations court explained that

“[w]hile each piece of evidence may not individually be

sufficient to establish [the defendant’s] liability…the

evidence as a whole provided the jury substantial

evidence upon which to find inducement.” Id. at 1334.

This holistic approach recognizes that context

matters—acts that might appear benign in isolation

may, when considered together, demonstrate a

coordinated effort to encourage infringement.

This longstanding approach to inducement under

§ 271(b) is consistent with this Court’s unanimous

2005 decision in Grokster. Although Grokster arose in

the copyright context, this Court expressly grounded

its inducement analysis in patent law. Grokster, 545

U.S. at 936-37. It held that “one who distributes a

device with the object of promoting its use to infringe

affirmative steps taken to foster infringement, is

liable for the resulting acts of infringement by third

parties.” Id. at 919. The conduct that the Court relied

on to support liability in Grokster was informed by the

circumstances surrounding the alleged inducement,

most notably the shutdown of Napster, an earlier

peer-to-peer file sharing service that had facilitated

massive copyright infringement by enabling users to

share copyrighted music files freely over the internet.

The affirmative steps identified in Grokster included

the naming of defendants’ systems as “Swaptor” and

“OpenNap”—wordplays on “Napster” and file

swapping, which the Court found to be evidence of

affirmative encouragement to former Napster users to

infringe on the new systems. Id. at 937-38. The Court

also pointed to Grokster’s distribution of a newsletter

containing links to articles promoting its software’s

ability to access popular copyrighted music, and

defendants’ affirmative responses to user requests for

help locating and playing copyrighted materials. Id. at

924-27, 937-38.

In addition to the advertising and instructing

conduct detailed above, the Court stated that the

record was “replete with other evidence that

[defendants]…acted with a purpose to cause copyright

violations by use of software suitable for illegal use.”

Id. at 938. For example, the Court relied on the fact

that defendant “StreamCast’s internal documents

made constant reference to Napster,” revealing a

deliberate strategy to capture the market of former

Napster users. Id. at 939. The Court also found it

significant that neither defendant attempted to

develop filtering tools or other mechanisms to

diminish infringing activity. Id. And the Court noted

that defendants’ advertising-based revenue model

depended on high-volume infringing use, confirming

that the “commercial sense of their enterprise turns

on high-volume use, which the record shows is

infringing.” Id. at 940. The Court emphasized that

this business-model evidence “alone would not justify

an inference of unlawful intent, but viewed in the

context of the entire record its import is clear.” Id. at

939-40. Thus, the Court’s analysis of liability turned

on a holistic assessment of evidence of intent,

including defendants’ outward-facing affirmative

steps to promote infringement and other evidence of

intent revealed through discovery.5

5 Professor Lemley has posited that rather than creating “a single

category of forbidden acts or a proper level of intent” the

elements should be understood to “interact”: “[t]he more

significant the defendant’s conduct, the less intent should be

This totality-of-circumstances approach makes

eminent sense: an accused inducer may engage in

numerous acts and communications, including over a

period of time. Those acts and communications must

be considered as a whole to determine whether the

accused party was knowingly and actively

encouraging conduct that practices the patented use.

III.

The Hatch-Waxman Act does not exempt

“skinny label” entrants from liability for

induced infringement.

Hikma argues that when a generic drug label fully

carves out a patented use, allegations that the generic

drug maker calls its product a “generic version” and

cites public information about the branded drug (e.g.,

sales) cannot be enough to plead induced infringement

of the patented use as a matter of law. Pet. Br. at 29.

However, in creating the regulatory pathway for

generic drugs, the Drug Price Competition and Patent

Term Restoration Act of 1984, Pub. L. No. 98-417, 98

Stat. 1585 (the “Hatch-Waxman Act”) left unchanged

the law of inducement and the courts’ role in

adjudicating patent rights.

The Hatch-Waxman Act amended both the Federal

Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C.

§ 301 et seq., and the Patent Act to balance

required for liability,” and conversely, “[t]he clearer the

defendant’s intent to facilitate patent infringement, the less

direct his contribution need be.” Lemley, supra, at 242-44. At the

same time, the law correctly maintains minimum thresholds for

each element: the defendant must take some affirmative act, and

must possess some level of intent.

facilitating generic drug entry and ensuring that the

Patent Act continues to incentivize the innovation of

new medicines. It created the Abbreviated New Drug

Application (“ANDA”) pathway for the approval of

generic drugs, through which a “bioequivalent” drug

can rely upon the safety and efficacy data of an

approved drug. See Pub. L. No. 98-417 § 101, codified

at 21 U.S.C. § 355(j). As part of this regulatory

framework, FDA maintains an official register called

the Orange Book that lists approved drugs, the

regulatory exclusivities to which they may be entitled,

and any patents covering those drugs.6

If the Orange Book includes unexpired patents for

the approved drug, a generic manufacturer has two

options. One option is a paragraph IV certification,

where the ANDA applicant certifies that its

marketing of the generic product will not infringe the

listed patent or that the patent is invalid. 21 U.S.C.

§ 355(j)(2)(A)(vii)(IV). The Hatch-Waxman Act’s

amendments to the Patent Act make the filing of a

paragraph IV certification an act of “artificial”

infringement under § 271(e)(2)(A), establishing a

specific litigation process for the branded

manufacturer to pursue patent infringement claims

prior to the generic’s approval. See Jazz Pharms., Inc.

6 The Orange Book lists the patent number, expiration date, and,

for method-of-use patents, a short description known as a “use

code” for each patent that the unlicensed manufacture, sale, or

use of a listed drug could reasonably infringe. This information

is provided to FDA by branded manufacturers as part of the new

drug approval process. 21 U.S.C. § 355(b)(1)(A)(viii); 21 C.F.R.

§ 314.53(c)(2)(ii)(P)(3); Caraco Pharm. Labs., Ltd. v. Novo

Nordisk A/S, 566 U.S. 399, 405 (2012).

v. Avadel CNS Pharms., LLC, 136 F.4th 1075, 1086

(Fed. Cir. 2025). This procedure reflects “[a]

fundamental assumption” about the Hatch-Waxman

Act: “that the courts are the appropriate mechanism

for the resolution of disputes about the scope and

validity of patents.” 68 Fed. Reg. 36,676, 36,683 (June

18, 2003).

Alternatively, where there are method-of-use

patents listed, the generic manufacturer may make a

section viii statement to certify that it is not seeking

approval for any patented method of use. See 21

U.S.C. § 355(j)(2)(A)(viii); Caraco, 566 U.S. at 406. If

approved, the generic manufacturer may market its

drug “only for a subset of approved uses—i.e., those

not covered by the brand’s patents.” Id. FDA does not

make a determination as to whether the proposed

skinny label infringes the unexpired method-of-use

claims. It considers only whether the contents of that

label overlap with the listed method-of-use patent’s

use code—a short description of the claimed use which

is submitted by the branded manufacturer. 21 C.F.R.

§ 314.53(c)(2)(ii)(P)(3); Caraco, 566 U.S. at 406-407.

FDA “does not independently assess the patent’s

scope or otherwise look behind the description

authored by the brand” because “it lacks ‘both [the]

expertise and [the] authority’ to review patent

claims.” Caraco, 566 U.S. at 406-407 (quoting 68 Fed.

Reg. at 36,683).

In addition to the creation of an artificial act of

infringement to allow for pre-launch patent litigation

in § 271(e)(2)(A), the Hatch-Waxman Act amended

other provisions of the Patent Act. For example, it

created a “safe harbor” exemption from patent

infringement for activities reasonably related to

developing and submitting information to FDA. Pub.

L. No. 98-417 § 202. However, the Hatch-Waxman Act

did not amend the induced infringement provision

codified by the 1952 Patent Act. Section 271(b)

remains fully applicable. Accordingly, a section viii

entrant risks liability for inducing infringement if it

engages in conduct encouraging the use of the

reference-listed drug’s patented methods.

IV.

The Court should neither change the pleading

standard nor adopt a categorical exemption

from § 271(b) for section viii entrants.

Hikma asks this Court to adopt a categorical rule

excluding certain types of statements, such as

references to its product as a “generic version” of the

branded drug and public information about the drug

(including sales information), from qualifying as

evidence of inducement when the accused inducer is a

section viii entrant. See Pet. Br. at 3. This Court

should reject that invitation. A rigid rule that

categorically excludes particular types of evidence of

section viii entrants’ actions would fracture the

uniformity of inducement law and create technologyspecific safe harbors that Congress has not authorized

and that the inducement doctrine does not recognize.

The Iqbal/Twombly pleading standard

provides

appropriate

flexibility

for

evaluating an inducement claim.

This Court and the Federal Circuit have

consistently held that the inducement inquiry is

contextual and fact-intensive, requiring courts to

evaluate the totality of a defendant’s conduct and

other evidence of intent. See Grokster, 545 U.S. at

937-40; Power Integrations, 843 F.3d at 1334.

Accordingly,

the

line

between

actionable

encouragement and lawful commercial activity is

often difficult to draw without a developed factual

record, including the full context within which the

alleged conduct has occurred.

The

conventional

Iqbal/Twombly

pleading

standard provides the appropriate threshold for

making the determination of whether an inducement

claim may proceed past the pleading stage and into

discovery. See Ashcroft v. Iqbal, 556 U.S. 662, 678

(2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570

(2007). A complaint satisfies this standard when it

pleads enough “factual content that allows the court

to draw the reasonable inference that the defendant is

liable for the misconduct alleged” but not when it

offers only “[t]hreadbare recitals of the elements of a

cause of action, supported by mere conclusory

statements.” Iqbal, 556 U.S. at 678 (citing Twombly,

550 U.S. at 555-56). In short, the complaint must

“state a claim to relief that is plausible on its face.”

Twombly, 550 U.S. at 570. Critically, this plausibility

standard must not be conflated with the ultimate

standard for liability. The plausibility inquiry “is not

akin to a ‘probability requirement,’” Iqbal, 556 U.S. at

678 (quoting Twombly, 550 U.S. at 556); rather, “a

well-pleaded complaint may proceed even if it strikes

a savvy judge that actual proof of those facts is

improbable.” Twombly, 550 U.S. at 556. The question

is simply whether the complaint pleads enough facts

to raise a reasonable expectation that discovery will

reveal evidence of the misconduct alleged. Id.

Applied

induced

infringement,

the

Iqbal/Twombly framework requires facts plausibly

showing that the accused infringer “specifically

intended [another party] to infringe [the patent] and

knew that the [other party]’s acts constituted

infringement.” Lifetime Indus., Inc. v. Trim-Lok, Inc.,

869 F.3d 1372, 1379 (Fed. Cir. 2017) (quoting In re Bill

of Lading, 681 F.3d 1323, 1339 (Fed. Cir. 2012)).

Where concrete allegations support the required

inferences, courts have denied motions to dismiss. For

example, where the plaintiff alleged that the

defendants advertised their products’ ability to

perform functions closely mirroring the steps of the

patented method (and did so after receiving ceaseand-desist letters making them aware of the patent),

the Federal Circuit reversed the dismissal of

inducement claims. In re Bill of Lading, 681 F.3d at

1341. Likewise, in Lifetime Industries, the court

found inducement adequately pled where the plaintiff

alleged that former employees with knowledge of the

patent had joined the defendant shortly before the

allegedly infringing conduct, and the defendant

thereafter directed the installation of an identical

product to perform the patented method. 869 F.3d at

1379–80. And in Nalco Co. v. Chem-Mod, LLC, 883

F.3d 1337, 1355–56 (Fed. Cir. 2018), the court

reversed dismissal of inducement claims where it was

pled that the defendants provided instructions,

support, and technical assistance to downstream

customers with knowledge of the patent and specific

intent to induce practice of the patented method.

The Iqbal/Twombly standard thus permits

plaintiffs who allege specific affirmative acts,

knowledge, and intent to proceed to discovery, where

the factual record may be developed to support the

allegations, while screening out complaints resting on

bare awareness and speculation. For example, where

the patentee alleged that a diagnostic laboratory’s test

reports would lead physicians to administer a lipidlowering treatment covered by the patent, the

complaint was properly dismissed because it alleged

“no facts that suggest any connection between [the

defendant] and doctors that may prescribe lipid

lowering drugs,” and thus the patentee fell “short of

showing ‘specific intent and action’ on behalf of [the

defendant-laboratory] to induce infringement.”

Cleveland Clinic Foundation v. True Health

Diagnostics LLC, 859 F.3d 1352, 1364 (Fed. Cir.

2017). Similarly, the court dismissed induced

infringement claims where the complaint recited that

the defendant published surgical techniques,

conducted training courses, and engaged in marketing

activities—but failed to identify the specific content of

those materials or explain how they encouraged

infringement. Globus Med., Inc. v. Alphatec Spine,

Inc., No. 25-cv-1522, 2025 U.S. Dist. LEXIS 253834,

*9-10 (S.D. Cal. Dec. 3, 2025).

Hikma argues that “Amarin cannot cobble

together disparate documents intended for different

audiences—i.e. Hikma’s label, pre-launch press

releases, and website—to infer instructions that the

documents never actually make.” Pet. Br. at 37. This

reductive approach flies in the face of the totality-ofcircumstances analysis that considers the context of

the alleged affirmative acts including any norms,

practices, and terms of art familiar to alleged direct

infringers. It would also require courts to make factintensive determinations at the pleading stage about

the intent and effect of communications to an alleged

direct infringer.

Nothing in the Patent Act, the Hatch-Waxman

Act, or this Court’s precedent supports the proposition

that plaintiffs alleging inducement in pharmaceutical

cases must surmount a higher hurdle for pleading an

inducement claim under § 271(b) than patent

plaintiffs in any other inducement case. Yet if this

Court were to adopt Hikma’s proposed categorical rule

and hold that press releases, equivalence statements,

or reference to a branded drug’s total sales figures are

categorically irrelevant to a section viii inducement

claim, branded pharmaceutical litigants would face a

more demanding set of pleading standards than

litigants in other technology sectors.

Hikma’s proposed rule about section viii

inducement cases would also invite requests for courts

to create policy-driven exemptions from inducement

liability in other sectors to purportedly advance policy

goals over § 271(b)’s express statutory prohibition.

This could result in a judicially created patchwork of

industry-specific safe harbors that would incentivize

gamesmanship; parties could then carefully craft

their communications to encourage infringing acts

through

exempted

communications,

thereby

exploiting those safe harbors.

The Iqbal/Twombly pleading standard provides

appropriate flexibility for evaluating an inducement

claim. The need for flexibility, rather than categorical

exclusions, is underscored by the reality that the

channels through which companies communicate with

customers, end users, and the public are continually

evolving. Product instructions, specifications, and

labeling are no longer confined to physical packaging;

they are published on company websites, where

potential users routinely consult them. Press releases

and other communications detailing new products

circulate instantly online. A wide range of

promotional content reaches professionals and

consumers through various social media platforms. A

categorical rule that treats only certain types of

statements as relevant would inevitably fail to

account for the diverse and evolving ways in which

companies may signal to potential direct infringers

that a product is suitable for patented uses. The

inducement inquiry must remain flexible enough to

encompass

the

full

spectrum

modern

communications and promotional activity through

which encouragement to infringe may be conveyed.

The Federal Circuit correctly applied the

pleading standard to Amarin’s inducement

claim.

This case is a standard induced infringement case

directed to a product that is being promoted and

marketed. As the Federal Circuit noted, it is not a

paragraph IV litigation triggered by an artificial act

of infringement. Nor is it a section viii case in which

the patent owner’s inducement claim rests solely on

allegations that the proposed label is not “skinny

enough” such that the label alone induces

infringement. App. at 12a-13a. Rather, Amarin’s

inducement claim is based “on the label in

combination with Hikma’s public statements and

marketing materials” including those that describe its

product as the “generic equivalent” of Amarin’s

Vascepa and within the “therapeutic category” of

“hypertriglyceridemia,” a category that includes

patented and non-patented indications. App. 17a-18a

(emphasis added). The Federal Circuit properly

considered the product label as part of its totality-ofcircumstances analysis because the label provides

necessary context for understanding a manufacturer’s

public statements and marketing materials.

While the court noted that, in isolation, the

statements on Hikma’s label may not, as a matter of

law, actively induce infringement, it reasoned that

“many of the allegations depend on what Hikma’s

label and public statements would communicate to

physicians and the marketplace.” Id. at 18a-19a. The

court emphasized that this “is a question of fact—not

law—and is therefore not proper for resolution on a

motion to dismiss.” Id. On such a motion, Amarin’s

allegations regarding what those statements

communicate, and reasonable inferences supported by

those allegations, must be accepted as true. Id. The

Federal Circuit correctly concluded that, when

considered as a whole, Amarin’s allegations “at least

plausibly state a claim for induced infringement.” Id.

at 18a.

This case is readily distinguishable from the

Federal Circuit’s decision in Cleveland Clinic, 859

F.3d 1352. That case involved a method of treatment

claim directed to administering a lipid-lowering agent

to a patient based on elevated levels of

myeloperoxidase (MPO) mass and/or activity. The

Federal Circuit affirmed the grant of a motion to

dismiss where the only alleged affirmative act to

induce physicians to infringe the method claim was

defendant’s provision of MPO mass and/or activity

test results to physicians. It was undisputed that the

accused inducer did not sell or prescribe lipid-lowering

agents to patients, and plaintiff alleged no facts

suggesting any communication or connection between

the accused inducer and physicians other than the

provision of the test results. Id. at 1364.

To be clear, as this Court has stated, plausibility is

not probability. See Twombly, 550 U.S. at 556

(“Asking for plausible grounds…does not impose a

probability requirement at the pleading stage; it

simply calls for enough fact to raise a reasonable

expectation that discovery will reveal evidence of

illegal agreement.”). Amarin may not ultimately

prevail at trial, or even survive summary judgment

based on the record evidence developed in discovery,

but its claim is adequately pled under the law and

should move forward.

The Federal Circuit’s decision does not

“effectively nullify” the section viii

regulatory pathway established by

Congress.

Assertions that the Federal Circuit’s decision will

eviscerate the section viii pathway for generic drug

entry are unfounded. Pet. Br. at 41. Congress’s

creation of the section viii pathway eliminated a

regulatory hurdle for a generic drug product, but that

pathway is not and has never been entirely free from

the risk of inducement liability.

The constraints of § 271(b) remain in place and

apply to section viii entrants. When Congress wants

to do so, it knows how to establish an exemption to

infringement—as the § 271(e)(1) safe harbor provision

in the Hatch-Waxman Act evidences. It did not create

any exemption to the induced infringement doctrine

for section viii entrants.

At the same time, § 271(b) does not impose liability

merely because a manufacturer markets a product

under a skinny label. Section viii entrants who

exercise care in marketing their products in a manner

consistent with their approved indications and who do

not take affirmative steps to encourage patented uses

remain free from inducement liability.

The Federal Circuit’s decision in this case does not

“force” generic drug companies to take affirmative

steps to avoid liability for inducement, but they could

choose to do so. Historically, companies across sectors

seeking to minimize the risk of induced infringement

claims may decide to include statements in their press

releases, instruction manuals, or statements on their

websites that their product is not intended for certain

uses. However, the choice not to do so does not render

them per se liable for inducing infringement of

patented uses of their product. See Takeda Pharms.

U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625,

632 n.4 (Fed. Cir. 2015). Rather, the pleading

standard will continue to protect section viii entrants

against unfounded claims by screening out baseless

complaints while permitting plaintiffs who allege

specific affirmative acts, knowledge, and intent to

proceed to discovery.

Any categorical decision to exempt section

viii entrants from induced infringement

liability is for Congress, not the Court.

While Congress may have understood that offlabel infringing uses would result from skinny label

approvals, see Pet. Br. at 43, it nevertheless made the

policy determination to create the section viii pathway

to enable access to generic drugs for unpatented uses

without delay. But Congress did not authorize section

viii entrants to engage in inducing conduct, nor did it

create a per se exemption from induced infringement

liability for those entrants. Rather, it left in place the

law of inducement codified in the 1952 Patent Act so

that section viii entrants do not encourage off-label

infringing uses that undercut patent rights. The

Court should respect Congress’s policy choice.

If significant adverse impacts on section viii

generic manufacturers materialize from the

application of existing inducement law, it is for

Congress—not this Court—to address those

consequences. Indeed, companion bills proposing

certain exemptions from induced infringement

liability for section viii entrants have already been

introduced. Skinny Labels, Big Savings Act, S. 43 &

H.R. 6485, 119th Cong. (2025). The creation of

exemptions from infringement is fundamentally a

policy choice for Congress.

CONCLUSION

For the foregoing reasons, the decision of the

court of appeals should be affirmed.

Respectfully submitted,

Salvatore Anastasi

President

AMERICAN INTELLECTUAL

PROPERTY LAW

ASSOCIATION

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