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,

AMARIN PHARMA, INC., ET AL.,

Respondents.

ON WRIT OF CERTIORARI TO THE U.S. COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF OF ABBVIE INC. AND BRISTOLMYERS SQUIBB COMPANY AS AMICI CURIAE

IN SUPPORT OF RESPONDENTS

JONATHAN S. MASSEY

Counsel of Record

KYLIE CHISEUL KIM

MASSEY & GAIL LLP

1000 Maine Ave. SW

Suite 450

Washington, D.C. 20024

Tel: (202) 652-4511

jmassey@masseygail.com

March 27, 2026

QUESTIONS PRESENTED

1. When a generic drug label fully carves out a

patented use, are allegations that the generic

drugmaker calls its product a “generic version” and

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

sales) enough to plead induced infringement of the

patented use?

2. Does a complaint state a claim for induced

infringement of a patented method if it does not allege

any instruction or other statement by the defendant

that encourages, or even mentions, the patented use?

TABLE OF CONTENTS

QUESTIONS PRESENTED ....................................... i

TABLE OF AUTHORITIES ..................................... iii

INTEREST OF AMICI CURIAE ............................... 1

SUMMARY OF ARGUMENT.................................... 1

ARGUMENT .............................................................. 7

GENERIC DRUGMAKERS WITH SKINNY

LABELS SHOULD NOT KNOWINGLY

SUPPORT AND PROFIT FROM

PERVASIVE END-USER INFRINGEMENT

....................................................................... 7

II.

THIS IS A CLASSIC CASE OF INDUCED

INFRINGEMENT. ........................................ 9

Selling Goods With Knowledge Of

Pervasive And Systemic Infringement

By End Users, While Taking No Steps

To Mitigate or Prevent It, Creates A

Plausible Claim For Induced

Infringement. ...................................... 10

The Comparison To Aiding And

Abetting Liability Supports Inducement

Liability. .............................................. 15

CONCLUSION ......................................................... 22

TABLE OF AUTHORITIES

CASES

A&M Records, Inc. v. Napster, Inc.,

239 F.3d 1004 (9th Cir. 2001) ................. 13, 14

Armstrong v. McAlpin,

699 F.2d 79 (2d Cir. 1983) ............................. 20

Aro Mfg. Co. v. Convertible Top Replacement Co.,

377 U.S. 476 (1964) ....................................... 17

Bowker v. Dows,

3 F. Cas. 1070 (C.C.D. Mass. 1878)

(No. 1,734) ...................................................... 18

Camp v. Dema,

948 F.2d 455 (8th Cir 1991) .......................... 20

Capitol Records, Inc. v. MP3tunes,

821 F. Supp.2d 627 (S.D.N.Y. 2011) ............. 14

Caraco Pharm. Lab’ys, Ltd. v. Novo Nordisk A/S,

566 U.S. 399 (2012) ......................................... 8

Casey v. U.S. Bank N.A.,

127 Cal. App. 4th 1138 (2005)....................... 20

Chas. H. Lilly Co. v. I.F. Laucks, Inc.,

68 F.2d 175 (9th Cir. 1933) ........................... 18

Costar Group, Inc. v. Loopnet, Inc.,

164 F. Supp.2d 688 (D. Md. 2001),

aff’d, 373 F.3d 544

(4th Cir. 2004)................................................ 14

iii

Cox Communications, Inc. v. Sony Music

Entertainment, No. 24-171,

607 U.S. __, slip op. (Mar. 25, 2026) ......... 4, 15

Dawson Chem. Co. v. Rohm & Haas Co.,

448 U.S. 176 (1980) ....................................... 17

Direct Sales Co. v. United States,

319 U.S. 703 (1943) ....................................... 21

Disney Enters., Inc. v. Hotfile Corp.,

798 F. Supp.2d 1303 (S.D. Fla. 2011) ........... 14

Fromberg, Inc. v. Thornhill,

315 F.2d 407 (5th Cir. 1963) ......................... 15

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

563 U.S. 754 (2011) ...... 2, 11, 12, 13, 14, 16, 17

Greer v. Moon,

83 F.4th 1283 (10th Cir. 2023) ...................... 14

Harper v. Shoppell,

28 F. 613 (C.C.S.D.N.Y. 1886)....................... 19

Henry v. A. B. Dick Co.,

224 U.S. 1 (1912), overruled as superseded by

statute,

Motion Picture Patents Co. v. Universal Film

Mfg. Co.,

243 U.S. 502 (1917) ....................................... 19

In re Terrorist Attacks on Sept. 11, 2001,

714 F.3d 118 (2d Cir. 2013) ........................... 20

Keel v. Hainline,

331 P.2d 397 (Okla. 1958) ............................. 20

Louis Vuitton Malletier, S.A. v. Akanoc Sols., Inc.,

591 F. Supp.2d 1098 (N.D. Cal. 2008) .......... 14

Mendelsohn v. Cap. Underwriters, Inc.,

490 F. Supp. 1069 (N.D. Cal. 1979) .............. 20

Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.,

545 U.S. 913 (2005) ... 3, 5, 6, 11, 12, 13, 14, 16,

Monsen v. Consolidated Dressed Beef Co., Inc.,

579 F.2d 793 (3d Cir. 1978) ........................... 22

Rosemond v. United States,

572 U.S. 65 (2014) ......................................... 20

Smith & Wesson Brands, Inc. v. Estados Unidos

Mexicanos,

605 U.S. 280 (2025) ................................. 22, 23

Sony Corp. of America v. Universal City Studios,

Inc.,

464 U.S. 417 (1984) ....................................... 15

Tegal Corp. v. Tokyo Electron Co., Ltd.,

248 F.3d 1376 (Fed. Cir. 2001)...................... 15

Thomson-Houston Elec. Co. v. Ohio Brass Co.,

80 F. 712 (6th Cir. 1897) ............................... 18

Twitter v. Taamneh,

598 U.S. 471 (2023) ........................... 21, 22, 23

United States v. Thompson,

539 F. App’x 778 (9th Cir. 2013) ................... 19

Woodward v. Metro Bank of Dallas,

522 F.2d 84 (5th Cir. 1975) ........................... 22

STATUTES

17 U.S.C. § 512(i)(1)(A) .............................................. 5

35 U.S.C. § 271(b)....................................... 2, 7, 17, 19

FOREIGN JURISDICTION

Warner-Lambert Company LLC (Respondent) v

Generics (UK) Ltd t/a Mylan and another

(Appellants)

[2018] UKSC 56, on appeal from [2016]

EWCA Civ 1006. ............................................ 10

OTHER AUTHORITIES

4 Melville B. Nimmer & David Nimmer,

NIMMER ON COPYRIGHT § 13E.03[B][2][b][iii]

[Napster] (Oct. 2025) ..................................... 14

Lemley, Inducing Patent Infringement,

39 U.C. Davis L. Rev. 225 (2005) .................. 17

Restatement (Third) of Torts: Liab. for Econ.

Harm § 28 ...................................................... 20

S. Rep. No. 82-1979 (1952), as reprinted in

1952 U.S.C.C.A.N. 2394 .......................... 17, 18

INTEREST OF AMICI CURIAE

Amici curiae AbbVie Inc. and Bristol-Myers

Squibb Company are innovator biopharmaceutical

companies that spend billions of dollars researching

and developing cutting-edge therapies for patients

with unmet medical needs. 1 These therapies have

led to treatments for myriad life-threatening

conditions, including various types of cancer and

autoimmune diseases. Amici rely on patents to

protect their groundbreaking inventions, to ensure

that they receive a reasonable return on their

enormous investments in biopharmaceutical research

and development, and to fund the next generation of

research and development of innovative treatments.

SUMMARY OF ARGUMENT

This case asks a narrow question: whether a

manufacturer should be held liable for induced patent

infringement when it continues to supply and profit

from end users’ pervasive and systematic infringing

uses, while knowing that its profit is predominantly

generated from such infringing uses, but taking no

steps to try to mitigate or prevent such infringement.

Specifically, Amarin alleges that Hikma continued

selling and profiting from its generic product despite

knowing that there are only two practical uses for its

product and the overwhelming majority—75%—of

uses have been and will be infringing. Hikma took no

meaningful steps to mitigate or prevent the pervasive

1 No counsel for either party authored this brief in whole or

in part, nor did any party or other person or entity other than

amicus curiae or its counsel make a monetary contribution to the

brief’s preparation or submission.

and systemic infringement by end users, such as

instructing major wholesalers or pharmacies that

they should not sell or use the generic product for the

patented indication, or telling major insurers not to

reimburse for the generic product used for the

patented indication. These allegations are sufficient

to state a plausible claim for active inducement at the

pleading stage under 35 U.S.C. § 271(b). Although

not needed for a plausible pleading under the

circumstances of this case, additional assertions

regarding Hikma’s website, investor statements, or

press releases further support a plausible desire by

Hikma to induce the infringing uses, especially

because it is at least plausible that downstream

buyers such as wholesalers and pharmacies, as well

as end users such as doctors and consumers, consider

the terms “generic” or “AB rated” to mean that

Hikma’s product can be used for all indications. This

plausible interpretation by ordinary end users is

supported by Hikma’s opening brief, which recognizes

that “doctors and patients inevitably would use

skinny-labeled generics for patented indications.”

Pet. Br. 1.

The allegations here present an even stronger

case for inducement than those this Court has

previously found sufficient. In Global-Tech

Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011), for

example, this Court found induced infringement

where the infringer (1) copied a product without

investigating whether the product or its use was

protected by any U.S. patent, (2) failed to disclose its

copying effort to its patent counsel that might have

helped counsel identify relevant patent(s) during

clearance review, and (3) supplied the product to its

U.S. customers. According to Amarin’s allegations,

Hikma did not merely close its eyes to infringement

but had actual knowledge of pervasive and systematic

infringement by end users but continued to supply its

product while taking no steps to address the

infringement. Additionally, it is plausible to infer,

based on the circumstances of this case, that Hikma

sought to make such infringement succeed, because

Hikma marketed its product as “generic” or “AB

rated”, but did not clarify to major wholesalers or

pharmacies that its generic product should not be

dispensed for the patented indication, or advise major

insurers not to reimburse for the product when used

for the patented indication.

Likewise, in Metro-Goldwyn-Mayer Studios Inc. v.

Grokster, Ltd., 545 U.S. 913 (2005), this Court found

contributory copyright infringement by a peer-to-peer

filing sharing platform in which an alleged 90% of

works available on the network were shown to be

copyrighted. In support of its finding of contributory

infringement, this Court cited (1) the defendants’

knowledge that many end users infringed copyrights,

(2) their continuing marketing of their service, (3)

their profiting from end users’ infringing uses, and (4)

their failure to make any effort to mitigate or prevent

infringing uses. Many of these facts emerged only

after discovery. Here, at the pleading stage, Amarin

alleges all of those elements already: (1) Hikma knew

75% of uses of its product infringe; (2) Hikma

continued to market its product as a generic or ABrated, statements that an end user could reasonably

interpret to mean that the product is substitutable for

all indications; (3) Hikma substantially profited from

end users’ infringing uses—namely, 75% of its sales

were attributable to such uses; and (4) Hikma took no

steps to mitigate or prevent infringing uses.

The approach urged here is consistent with this

Court’s recent decision in Cox Communications, Inc.

v. Sony Music Entertainment, No. 24-171, 607 U.S. __,

slip op. (Mar. 25, 2026), which interpreted

contributory copyright liability. The reasons given by

this Court for not applying secondary liability in Cox

are wholly absent here. For example, this Court

emphasized that “Cox repeatedly discouraged

suspending services, and terminating accounts” and

Cox “point[ed] out that its warning and suspension

system ended 98% of identified infringement.” Cox

Communications, Slip op. at 5, 9. By comparison,

Hikma did not take any of the steps cited by this

Court in Cox. In addition, “Cox also contractually

prohibits its subscribers from” infringement. Id. at 4.

Again, Hikma did nothing similar. Moreover, “Cox

simply provided Internet access, which is used for

many purposes other than copyright infringement.”

Id. at 9. In contrast, Hikma’s product has only two

practical uses, and Hikma knowingly sells 75% of its

product for the infringing use. Moreover, the patent

law does not contain any statutory defense akin to the

safe harbor regime under the Digital Millennium

and even if the patent law had such defense, Hikma

would not qualify because it has done nothing to

meaningfully mitigate.

Hikma and its amici are wrong in arguing that

this case threatens the “skinny label” or section viii

carve-out. The section viii carve-out functioned

exactly as intended here, and Hikma’s skinny labeled

product was timely approved. The patentee does not

seek to remove the skinny-labeled generic product

from the market or stop its sale for the approved non4

infringing use. Instead, the patentee simply seeks to

prevent the infringing uses of the patented indication.

This case has little to do with skinny labels or the

section viii carve-out. Rather, this case is simply

about whether the alleged infringer should be

permitted to continue profiting while knowingly

supplying a product that it knows is used in

pervasively and systemically infringing ways, while

taking no steps to try to mitigate or stop those

infringing uses.

By contrast, Hikma advances a categorical rule

that would effectively expand the section viii carveout to foreclose inducement claims whenever a skinny

label is present, regardless of the defendant’s

knowledge of pervasive and systemic infringement

and its decision not to try to mitigate or prevent it.

This position runs directly afoul of Grokster’s

rejection of the suggestion that a producer can never

be held liable so long as its product is capable of

substantial lawful use. 545 U.S. at 934. Hikma’s

position is essentially a version of the argument that

this Court rejected in Grokster: that “there is no

‘liability when a defendant merely sells a commercial

product suitable for some lawful use.’” Pet. Br. 25

(quoting Grokster).

Hikma seeks an unfair rule that would allow it to

retain 75% of its profit through infringing uses

without even attempting to mitigate or prevent them,

and without sharing with the patent holder any of

that 75% profit or otherwise compensating for the

patent holder’s losses. The precedents of this Court,

as well as the patent statutes, have never allowed a

manufacturer to circumvent patent rights by

knowingly profiting from pervasive and systemic

infringement while taking no steps to address it.

Other countries, confronting similar risks, have

required generic manufacturers to take affirmative

steps to ensure that their products are confined to

approved, non-infringing indications.

Hikma’s

unwillingness to take such steps here supports

Amarin’s claim of induced infringement.

Moreover, this case has important implications

beyond pharmaceuticals and beyond patent law. It is

one thing to decline to impose a duty on sellers to

ferret out illegal uses of their products when they

place undifferentiated goods into the stream of

commerce without ongoing customer relationships or

knowledge of misuse. It is quite another to immunize

sellers that knowingly continue to supply and profit

from end users’ pervasive and systematic infringing

uses, where the seller knows that its profits are

predominantly generated from such infringing uses,

yet takes no steps to mitigate or prevent that

infringement. Imposing liability here would create a

narrow and administrable rule that is consistent not

just with well-established patent law, but also with

well-established tort law, trademark law, and

In contrast, adopting Hikma’s

approach would trigger deleterious reverberations

throughout all of these areas of law and frustrate the

clear congressional purpose of Section 271(b) of the

Patent Act.

ARGUMENT

GENERIC DRUGMAKERS WITH SKINNY

LABELS SHOULD NOT KNOWINGLY

SUPPORT AND PROFIT FROM

PERVASIVE END-USER

INFRINGEMENT.

Skinny labels, or section viii carve-outs, have

been enormously successful in bringing generic

products to the market more quickly, as

demonstrated by this case, where Hikma’s product

was timely approved under a skinny label and

remains, and will continue to remain, available to

patients for treating the off-patent indication. At the

same time, this Court has instructed that “the FDA

cannot authorize a generic drug that would infringe a

patent” and that “FDA acceptance of the carve-out

label allows the generic company to place its drug on

the market . . . , but only for a subset of approved

uses—i.e., those not covered by the brand’s patents.”

Caraco Pharm. Lab’ys, Ltd. v. Novo Nordisk A/S, 566

U.S. 399, 405, 406 (2012) (emphasis added).

Yet in practice, many skinny-labeled products are

also used for the carved-out infringing indications by

end users such as doctors and patients, who are often

unaware of the applicable patent protections. In fact,

Hikma contends that doctors and patients will

“inevitably infringe [a brand patent] by also

practicing carved-out, patented indications,” in

addition to unpatented indications. Pet. Br. 8. Hikma

maintains that “market realities” mean that “even if

a generic drug is formally approved only for

unpatented uses, pharmacists and doctors will

nonetheless substitute the generic for all indications

once it becomes available.” Pet. Br. 43 (internal

quotation marks and citations omitted).

Hikma could easily have discouraged the

infringement by clarifying to the purchasers or end

users that its product as a generic is approved only for

the non-patented indication, instructing major

wholesalers or pharmacies that they should not sell

or use the product for the patented indication, or

instructing major insurers not to pay for the product

used for the patented indication. These are readily

available measures. With such steps, it is plausible

that the pharmacists, doctors, or patients would stop

or at least reduce infringing uses. But Hikma fully

exploited end users’ confusion and misunderstanding

and made the overwhelming majority of its profit

from end users’ infringing uses.

Generic manufacturers typically have access to

prescription data reflecting real-world usage patterns

and are therefore aware of the extent of infringing

uses of their skinny-labeled products, yet some may

nevertheless continue supplying their products to

unaware purchasers or end users for infringing uses

without taking steps to mitigate those uses. Where a

generic manufacturer knows that the overwhelming

majority (e.g., 75%) of uses is for the patented

indication, its continued distribution of the generic

product, without taking any steps to prevent or

mitigate that infringement, should plausibly support

the inference that the manufacturer sought to bring

about those infringing uses and therefore supports a

plausible claim of induced infringement.

By way of illustration, other countries have taken

steps to address induced infringement by requiring

measures to ensure that generic products are limited

to approved non-infringing uses. In the United

Kingdom’s Lyrica (pregabalin) litigation, 2 for

example, the generic manufacturer (Actavis) wrote to

over 7,500 pharmacists and English clinical

commissioning groups (CCGs) informing them that

authorization for its generic pregabalin was limited to

the off-patent indications. Under court order, NHS

England, a UK governmental agency, issued guidance

to CCGs advising the use of Lyrica (the innovator’s

product) for the on-patent indications. Software

packages used by general practitioners were updated

to provide warnings of the existence of patent rights

when pregabalin is prescribed for pain. The UK Court

of Appeal indicated that, absent such measures,

infringement could be found against generic

manufacturers with skinny label approval.

II.

THIS IS A CLASSIC CASE OF INDUCED

INFRINGEMENT.

The allegations against Hikma readily satisfy the

standard for a plausible claim of induced

infringement. According to the pleadings, Hikma

allegedly knows that approximately 75% of its skinnylabeled product is used for the patented

cardiovascular indication, while only 25% is used for

the approved, non-infringing indication.

Yet it

continues to sell—and profit from—the product

without taking any steps to clarify its product or

otherwise mitigate or prevent the infringing use, such

as telling major wholesalers or pharmacies that they

should not sell or use the product for the patented

2 Warner-Lambert Company LLC (Respondent) v Generics

(UK) Ltd t/a Mylan and another (Appellants) [2018] UKSC 56,

on appeal from [2016] EWCA Civ 1006.

indication, or telling major insurers not to pay for the

product used for the patented indication. Those

allegations alone, even without resorting to Hikma’s

website, investor statements, or press releases, are

more than sufficient to establish a plausible claim of

induced infringement at the pleading stage. But

these additional public statements by Hikma further

support a plausible inference that Hikma desires to

continue to exploit unaware end users’ confusion

about the terms “generic” or “AB-rated,” so that

Hikma can continue to profit from end users’

infringement.

Selling Goods With Knowledge Of

Pervasive And Systemic

Infringement By End Users, While

Taking No Steps To Mitigate or

Prevent It, Creates A Plausible

Claim For Induced Infringement.

If the allegations pleaded here are insufficient,

then there would have been no infringement liability

in either Global-Tech or Grokster. In Global-Tech, the

alleged infringer copied the product at issue, did not

attempt to confirm whether any aspect of the product

or its use was covered by any patent, did not know

whether the end users would use its product in an

infringing way, did not tell its patent attorney or end

users about its copying, and did not explicitly promote

or encourage the end users to infringe. This Court

found induced infringement and made clear that

willful blindness was the same as actual knowledge.

Defendants who behave in this manner “are just as

culpable as those who have actual knowledge,”

because those who “blind themselves to direct proof of

critical facts in effect have actual knowledge of those

facts.” 563 U.S. at 766. Here, Hikma copied the

product at issue, did know that one of the only two

practical uses of the product was covered by a patent,

did know that 75% of the end users use the product in

an infringing way, and did inform the public of its

copying.

Amarin and Hikma debate whether Hikma

promoted or encouraged the end users to infringe

through its website, investor statements, press

releases, and label. But Global-Tech makes clear

such allegations are not necessary to state a claim for

induced infringement. After all, the defendant in

Global-Tech did not explicitly promote or encourage

the end users to infringe, either.

Similarly, in Grokster, the defendants knew that

many users (90% of all uses) infringed, marketed

their product as a substitute for another product

widely used to infringe, profited from that

infringement, and took no meaningful steps to curb it.

Grokster flatly rejected any suggestion that a

manufacturer cannot be held liable so long as its

product is capable of substantial lawful use. 545 U.S.

at 934. Instead, the Court noted that each defendant

company “showed itself to be aiming to satisfy a

known source of demand” for the infringement;

second, neither company developed software filtering

tools to minimize their infringement; and third, the

companies profited by the increased infringement of

their users. Id. at 939-40.

The Grokster Court emphasized that the failure to

implement measures to prevent known infringing

uses “underscores [the defendants’] intentional

facilitation” of infringement. Id. at 939. The same

reasoning applies here: Hikma allegedly knew that

roughly 75% of uses infringed and would continue to

infringe, sold its product as a “generic” or substitute

for Amarin’s patented product, and made no effort to

prevent end users’ pervasive and systemic infringing

use. That is more than sufficient to state a claim for

induced infringement at the pleading stage.

Grokster also makes clear that inducement

liability does not require knowledge of specific acts of

infringement—only general awareness that a device

is being used to infringe. See 545 U.S. at 922

(Grokster “d[id] not … know when particular files

[were] copied”); see also Global-Tech, 563 U.S. at 76869 (Grokster’s liability arose from its awareness that

its file-sharing software was being used to infringe).

Likewise, in A&M Records, Inc. v. Napster, Inc.,

239 F.3d 1004, 1022 (9th Cir. 2001), the Ninth Circuit

imposed liability where the peer-to-peer music

sharing service failed to block access to known

infringers or remove infringing material despite

actual knowledge of specific infringing material. The

Ninth Circuit rejected Napster’s argument that its

service was merely a passive conduit, because “[t]he

record supports the district court’s finding that

Napster has actual knowledge that specific infringing

material is available using its system, that it could

block access to the system by suppliers of the

infringing material, and that it failed to remove the

material.” Id. The Napster court thus confirmed that

knowledge of infringement combined with providing

the means to infringe and refusing to remove known

infringing material suffices for contributory copyright

liability. A long line of precedent in the online

environment has firmly established that rule. 3 Here

too, Hikma allegedly had actual knowledge that the

overwhelming majority of end users were infringing,

yet took no steps to mitigate or prevent it. These

allegations more than suffice to plausibly state a

claim of induced infringement, particularly given

Hikma’s full exploitation, without any meaningful

attempt at clarification, of potentially confusing

terms such as “generic” or “AB-rated,” the

interpretation of which may well depend on the

audience.

Settled precedent also makes clear that there is

no merit to Hikma’s position that inducement liability

cannot attach to supposed “failures to take action”

against infringers. The salient point of Global-Tech

and Grokster (as well as Napster) is that continuing to

supply goods or services after gaining knowledge of

pervasive and systemic infringement, while taking no

See 4 Melville B. Nimmer & David Nimmer, NIMMER ON

examples of online defendants deemed to provide material

contribution to infringing activity; Greer v. Moon, 83 F.4th 1283,

1295 (10th Cir. 2023) (website that hosted infringing third-party

submissions and failed to take them down after requests); Louis

Vuitton Malletier, S.A. v. Akanoc Sols., Inc., 591 F. Supp.2d

1098, 1102 (N.D. Cal. 2008) (website hosting service that

provided service space and IP addresses to direct infringers and

“fail[ed] to take simple measures to limit the known infringing

activity taking place on their systems”); Costar Group, Inc. v.

Loopnet, Inc., 164 F. Supp.2d 688 (D. Md. 2001), aff’d, 373 F.3d

544 (4th Cir. 2004) (website that hosted and presented

aggregated real estate listings); Disney Enters., Inc. v. Hotfile

Corp., 798 F. Supp.2d 1303, 1310 (S.D. Fla. 2011) (website

allowing uploads and downloads of copyrighted films); Capitol

Records, Inc. v. MP3tunes, 821 F. Supp.2d 627 (S.D.N.Y. 2011)

(website giving users individual “lockers” into which they could

download MP3 files from third-party websites)).

steps to mitigate or stop it, is itself an act of

assistance, not an omission.

The courts have

recognized that the term “actively inducing”

encompasses a wide range of conduct. The term “is as

broad as the range of actions by which one in fact

causes, or urges, or encourages, or aids another to

infringe a patent.” Tegal Corp. v. Tokyo Electron Co.,

Ltd., 248 F.3d 1376, 1379 (Fed. Cir. 2001) (quoting

Fromberg, Inc. v. Thornhill, 315 F.2d 407, 411 (5th

Cir. 1963)).

Sony Corp. of America v. Universal City Studios,

Inc., 464 U.S. 417 (1984), is consistent with the

approach urged here. Although this Court found no

infringement in Sony, it was careful to note that the

defendant did not “supply its products to identified

individuals known by it to be engaging in continuing

infringement of respondents’ copyrights.” Id. at 439

n.19. In addition, the Court observed that there were

no obvious steps that Sony could have taken to

prevent or reduce infringement by end users. Id. at

438. The allegations here are different on both points.

Hikma knew that the vast majority of its drug would

be used for an infringing indication. And Hikma had

readily available means to mitigate or prevent that

infringement yet took no steps to employ them.

This Court’s decision in Cox Communications,

Inc. v. Sony Music Entertainment, No. 24-171, 607

U.S. __, slip op. (Mar. 25, 2026), is also consistent with

the approach urged here. While Cox held that an

internet service provider could not be held liable for

contributory copyright infringement for allowing

customers to illegally download copyrighted music,

the decision is inapposite here. In Cox, this Court

stressed key facts that distinguish that case from the

situation here. For example, this Court noted that

“Cox repeatedly discouraged copyright infringement

by sending warnings, suspending services, and

terminating accounts,” and Cox “point[ed] out that its

warning and suspension system ended 98% of

identified infringement.” Slip op. at 5, 9. Hikma did

nothing similar. In addition, “Cox also contractually

prohibits its subscribers from” infringement. Id. at 4.

Again, Hikma did nothing similar. Moreover, “Cox

simply provided Internet access, which is used for

many purposes other than copyright infringement”

and “merely providing a service to the general public

with knowledge that it will be used by some to

infringe copyright.” Id. at 1, 9. In contrast, Hikma’s

product has only two practical uses, and Hikma

knowingly sells 75% of its product for the infringing

use. In short, the reasons given by this Court in Cox

for not imposing secondary liability are wholly absent

here.

The Comparison To Aiding And

Abetting Liability Supports

Inducement Liability.

Both Grokster and Global-Tech expressly

acknowledged the aiding-and-abetting foundations of

induced infringement. Grokster explained the “classic

case of direct evidence of unlawful purpose occurs

when one induces commission of infringement by

another, or ‘entic[es] or persuad[es] another’ to

infringe,” and it recognized “liability for inducement

where one ‘actively and knowingly aid[s] and abet[s]

another’s direct infringement.’” 545 U.S. at 935-36

(citation omitted) (brackets in original). Global-Tech

was equally explicit, characterizing contributory

infringement as “the aiding and abetting of direct

infringement by another party.” 563 U.S. at 764

(quoting Lemley, Inducing Patent Infringement, 39

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

Congress made clear that § 271(b) was intended

codify

aiding-and-abetting

liability

for

infringement. See S. Rep. No. 82-1979, at 8 (1952), as

reprinted in 1952 U.S.C.C.A.N. 2394, 2402

(“Paragraph (b) recites in broad terms that one who

aids and abets an infringement is likewise an

infringer.”); cf. Aro Mfg. Co. v. Convertible Top

Replacement Co., 377 U.S. 476, 485-86 n.6 (1964)

(recognizing that Congress in the 1952 Patent Act

intended to codify pre-1952 contributory infringement

principles). In codifying contributory infringement,

Congress explained that the doctrine exists to enjoin

those who seek to cause infringement “by supplying

someone else with the means and directions for

infringing a patent,” and to prevent such actors from

“appropriating the benefit of the patented invention.”

Id.; see also Dawson Chem. Co. v. Rohm & Haas Co.,

448 U.S. 176, 188 (1980) (contributory infringement

“exist[ed] to protect patent rights from subversion by

those who, without directly infringing the patent

themselves, engage in acts designed to facilitate

infringement by others”). Congress further made

clear that liability does not turn on the provision of

“specific” directions to infringe; “implied” directions

may suffice where the defendant knowingly supplies

the means for infringement and facilitates its

commission. Id. Accordingly, Hikma is wrong in

demanding that Amarin must plead specific

directions to infringe.

Pre-1952 courts drew on aiding-and-abetting

principles and applied them to what one court

described as “trespass upon patent property.”

Thomson-Houston Elec. Co. v. Ohio Brass Co., 80 F.

712, 721 (6th Cir. 1897); see also Chas. H. Lilly Co. v.

I.F. Laucks, Inc., 68 F.2d 175, 181 (9th Cir. 1933).

Recognizing that direct infringers were often difficult

to reach, the Sixth Circuit (per then-Judge Taft) in

Thomson-Houston held that “the only effective mode

of preventing infringement” was to proceed against

those who made infringement possible and

“intentionally solicit[ed] and promote[d] such

invasions of the patentee’s rights.” 80 F. at 721 . Even

where the products were capable of non-infringing

uses, contributory infringement could still be

established by showing an intent to assist

infringement through their distribution. Id. at 723.

The court went so far as to impose on the defendant a

duty to ensure that the combinations it was

“intentionally inducing and promoting” were confined

to lawful uses. Id.

Knowledge of downstream infringement has long

been central in patent and other intellectual property

cases. In Bowker v. Dows, 3 F. Cas. 1070 (C.C.D.

Mass. 1878) (No. 1,734), the defendant was liable for

selling a product to purchasers he knew intended to

use it in an infringing combination. Id. at 1071.

Likewise, in Henry v. A. B. Dick Co., 224 U.S. 1 (1912),

overruled as superseded by statute, Motion Picture

Patents Co. v. Universal Film Mfg. Co., 243 U.S. 502,

517–18 (1917), this Court held that when a seller

knows purchasers will use a product to infringe, the

sale may be treated as made with the intent that it be

so used. Id. at 49. The Court added that, under those

circumstances, “[i]t is not open to [defendants] to say

that it might be used in a noninfringing way.” Id.

Early copyright law applied the same principle: a

defendant was held liable for selling a printing plate

he knew would be used for infringement, even though

the plate was capable of lawful uses. Harper v.

Shoppell, 28 F. 613, 615 (C.C.S.D.N.Y. 1886).

Measured against that framework, the pleading

allegations here are more than adequate to state a

claim of induced infringement. Hikma allegedly knew

that the overwhelming majority of its product would

be used for an infringing indication and nonetheless

continued supplying it, while taking no steps to

mitigate or prevent the infringement.

This

constitutes precisely the kind of affirmative

facilitation that pre-1952 caselaw and wellestablished aiding-and-abetting precedent have long

treated as sufficient to create secondary liability.

Section 271(b), rooted in those same principles, does

not demand explicit instructions to infringe; it

reaches those who knowingly and purposefully make

infringement succeed.

Supplying a person with a product or service with

the knowledge they will misuse it creates clear aidingand-abetting liability, even if the good or service is

capable of proper use. For example, a person who

gives a hammer to a friend known to be planning a

burglary is aiding and abetting, even though lending

tools to friends is usually perfectly innocent. See

United States v. Thompson, 539 F. App’x 778, 779

(9th Cir. 2013). Someone who hands erasers to

negligent students engaged in an eraser fight is

aiding and abetting, even though the act of doing so

in other contexts is innocent. See Keel v. Hainline, 331

P.2d 397, 400 (Okla. 1958). And a broker who

processes trades from an investment advisor that the

broker knows to be churning is aiding and abetting

the churning, see Armstrong v. McAlpin, 699 F.2d 79,

91 (2d Cir. 1983); Restatement (Third) of Torts: Liab.

for Econ. Harm § 28 cmt. d illus. 6, even though

providing routine financial services is typically free

from liability to third persons. See In re Terrorist

Attacks on Sept. 11, 2001, 714 F.3d 118, 126 (2d Cir.

2013); Mendelsohn v. Cap. Underwriters, Inc., 490 F.

Supp. 1069, 1083–84 (N.D. Cal. 1979).

“Routine” and “normal everyday business

practices” might require “a higher degree of

knowledge” to constitute aiding and abetting than

shady or unusual business practices, but once that

knowledge is achieved, liability will attach to any

further aid. Camp v. Dema, 948 F.2d 455, 459 (8th Cir

1991); see also Casey v. U.S. Bank N.A., 127 Cal. App.

4th 1138, 1145 (2005) (“[C]ommon sense tells us that

even ‘ordinary business transactions’” may be

substantial assistance “if the bank actually knew

those transactions were assisting the customer in

committing a specific tort.”).

As this Court explained in Rosemond v. United

States, 572 U.S. 65, 73 (2014), even “minimal”

assistance suffices to establish aiding and abetting

liability, because “every little bit helps”; the “quantity

of assistance [is] immaterial” so long as the

accomplice does “something” to aid the crime. Id.

(brackets altered). What matters is not the magnitude

of the act but the combination of knowledge and

purposeful facilitation.

In Direct Sales Co. v. United States, 319 U.S. 703

(1943), for example, a mail-order pharmacy was held

liable for conspiracy because it “sold morphine

sulphate to [one doctor] in such quantities, so

frequently and over so long a period”—and after “the

Bureau of Narcotics informed” the pharmacy “it was

being used as a source of supply by convicted

physicians”—that “it must have known” the doctor

was “distributing the drug illegally.” Id. at 705, 707.

That decision shows that secondary liability can be

created by continuing to sell to third parties knowing

that they will use the product unlawfully. Id. at 712

& n.8. Indeed, the Court found relevant the supplier’s

“stake in the venture”—which was “making the

profits which it knew could come only from its

encouragement of [the doctor’s] illicit operations.” Id.

at 713.

This Court’s decision in Twitter v. Taamneh, 598

U.S. 471 (2023), supports the position advocated here.

The Twitter Court recognized that there may be

“situations where the provider of routine services does

so in an unusual way or provides such dangerous

wares that selling those goods to a terrorist group

could constitute aiding and abetting a foreseeable

terror attack.” Id. at 502. This Court also recognized

that “there may be situations” where “a duty exists”

that “would require … communication-providing

services to terminate customers after discovering that

the customers were using the service for illicit ends.”

Id. at 501. The Court further recognized the situation

that a “failure to stop ISIS from using these

platforms” could be “culpable” on a “strong showing of

assistance and scienter.” Id. at 500. But it found that

showing lacking on the allegations before it. See, e.g.,

id. at 505. Here, Amarin has plausibly alleged

knowledge on Hikma’s part of pervasive and systemic

infringement, which Hikma has taken no steps to

prevent or mitigate. Hikma did not even try to clarify

the confusing statements about “generic” or “ABrated” by (for example) further explaining to the

buyers or end users that its AB-rated product has not

been authorized to be used for the patented

indication. Amarin’s allegations more than meet the

standard.

The cases cited by this Court in Twitter provide

additional support for the position urged here. As the

Fifth Circuit explained in a case repeatedly cited by

Twitter, even routine and everyday business practices

can underpin an aiding and-abetting claim—provided

the defendant consciously intended to assist the

underlying wrong via those business practices.

Woodward v. Metro Bank of Dallas, 522 F.2d 84, 97

(5th Cir. 1975) (cited in Twitter, 598 U.S. at 486, 492,

501). And even “inaction . . . may provide a predicate

for liability where the plaintiff demonstrates that the

aider-abettor Consciously intended to assist in the

perpetration of a wrongful act.” Monsen v.

Consolidated Dressed Beef Co., Inc., 579 F.2d 793, 800

(3d Cir. 1978) (cited in Twitter, 598 U.S. at 491).

Nor does Smith & Wesson Brands, Inc. v. Estados

Unidos Mexicanos, 605 U.S. 280 (2025), support

Hikma. There, Mexico failed to allege any specific

criminal acts facilitated by the gun manufacturer

defendants resulting in harm to Mexico. Id. at 294.

Mexico’s complaint alleged only that “some, though

unidentified, dealers” in the defendant’s arms “often

engage in illegal transactions with Mexican

traffickers.” Id. at 296. The Court stated that, “[t]o

survive, the charge must be backed by plausible

allegations of ‘pervasive, systemic, and culpable

assistance.’” Id. at 294.

Here, by contrast, Amarin alleges that Hikma has

the knowledge of pervasive, systemic and culpable

infringement that was lacking in Twitter and Smith

& Wesson, thus establishing a clear nexus between

the underlying infringement by end users and

Hikma’s continuing provision of the means to carry it

out, with no steps taken to prevent or mitigate it.

CONCLUSION

Allowing the judgment below to stand preserves

both the integrity of Section 271(b) and the continued

viability of skinny‑labeled generics. The Federal

Circuit’s judgment should be affirmed.

Respectfully submitted.