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

Supreme Court briefMar 9, 2026

Ask Donna

What actually matters in this document.

Text

No. 24-889

IN THE

Supreme Court of the United States

HIKMA PHARMACEUTICALS USA INC. AND

HIKMA PHARMACEUTICALS PLC,

Petitioners,

AMARIN PHARMA, INC., ET AL.,

Respondents.

On Writ of Certiorari

to the United States Court of Appeals

for the Federal Circuit

BRIEF OF AMICI CURIAE

PATENT LAW PROFESSORS

PAUL R. GUGLIUZZA AND JACOB S. SHERKOW

IN SUPPORT OF NEITHER PARTY

PHILLIP R. MALONE

Counsel of Record

NINA K. SREJOVIC

JUELSGAARD INTELLECTUAL

PROPERTY AND

INNOVATION CLINIC

MILLS LEGAL CLINIC AT

STANFORD LAW SCHOOL

559 Nathan Abbott Way

Stanford, CA 94305

(650) 725-6369

pmalone@stanford.edu

Counsel for Amici Curiae

TABLE OF CONTENTS

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

INTRODUCTION AND SUMMARY OF ARGUMENT

...................................................................................... 2

ARGUMENT ................................................................ 3

Inducing Infringement Under § 271(b) Requires Encouraging, Recommending, or Promoting Infringement. ............................................ 3

II. Hatch-Waxman Does Not Alter the Requirements for Induced Infringement Liability Under § 271(b). ........................................................... 6

III. The Federal Circuit’s Labeling-Based Theory

of Inducement Improperly Expands § 271(b)

Beyond Its Statutory Limits ................................. 8

The Federal Circuit’s decision continues

the trend of imposing inducement liability for regulated statements by generic

drug companies. ............................................ 9

Labeling reflects regulatory compliance

rather than affirmative encouragement. ............. …………………………………11

Labeling cannot be inducement without

evidence of causation. ................................. 13

IV. This Court Should Reaffirm Existing Inducement Law ............................................................. 15

“Skinny labels” and other labeling should

not, alone, create liability for inducement. ............................................................ 15

The plain text of § 271(b) requires a

causal connection between communication and infringement ................................. 17

CONCLUSION ........................................................... 19

TABLE OF AUTHORITIES

Page(s)

Cases

Allergan v. Alcon Labs., Inc.,

324 F.3d. 1322 (Fed. Cir. 2003).............................. 7

Amarin Pharma, Inc. v. Hikma Pharms.

USA Inc.,

104 F.4th 1370 (Fed. Cir. 2024) ............................. 9

Aro Mfg. Co. v. Convertible Top

Replacement Co. (Aro II),

377 U.S. 476 (1964) ............................................ 4, 6

Caraco Pharmaceutical Laboratories,

Ltd. v. Novo Nordisk A/S,

566 U.S. 399 (2012) ......................................... 8, 16

Commil USA, LLC v. Cisco Systems,

Inc.,

575 U.S. 632 (2015) ............................................ 6, 8

Corcept Therapeutics, Inc. v. Teva

Pharms. USA, Inc., 709 F. Supp. 3d

138 (D.N.J. 2023), aff’d,

2026 WL 468866 (Fed. Cir. Feb. 19,

2026) ...................................................................... 16

Corcept Therapeutics, Inc. v. Teva

Pharms. USA, Inc., No. 2024-1346,

2026 WL 468866 (Fed. Cir. Feb. 19,

2026) ..................................................................... 18

DSU Med. Corp. v. JMS Co.,

471 F.3d 1293 (Fed. Cir. 2006)............................... 5

Eli Lilly & Co. v. Medtronic, Inc.,

496 U.S. 661 (1990) ................................................ 7

Gershwin Pub. Corp. v. Columbia Artists

Mgmt., Inc.,

443 F. 2d 1159 (2d Cir. 1971) ................................. 4

GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc. (GSK),

7 F.4th 1320 (Fed. Cir. 2021) ... 2, 9, 10, 12, 14, 16,

GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc.,

25 F.4th 949 (Fed. Cir. 2022) ............................... 10

Global-Tech Appliances, Inc. v. SEB

S.A.,

563 U.S. 754 (2011) .......................... 3, 4, 5, 6, 8, 17

Henry v. A. B. Dick Co.,

224 U.S. 1 (1912) .................................................... 6

Inwood Labs., Inc. v. Ives Labs., Inc.,

456 U.S. 844 (1982) ................................................ 5

Merck KGaA v. Integra Lifesciences I,

Ltd.,

545 U.S. 193 (2005) ................................................ 8

Metro-Goldwyn-Mayer Studios Inc. v.

Grokster, Ltd.,

545 U.S. 913 (2005) ........................................ 3, 4, 5

PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011) .............................................. 12

Sanofi v. Watson Laboratories Inc.,

875 F.3d 636 (Fed. Cir. 2017)............................... 13

Sony Corp. v. Universal City Studios,

Inc.,

464 U.S. 417 (1984)............................................. 4, 5

Takeda Pharms. U.S.A., Inc. v. WestWard Pharm. Corp.,

785 F.3d 625 (Fed. Cir. 2015)............................. 5, 8

United Therapeutics Corporation v.

Liquidia Technologies,

74 F.4th 1360 (Fed. Cir. 2023) ......................... 2, 11

Vanda Pharmaceuticals v. West-Ward

Pharmaceuticals International Ltd.,

887 F.3d 1117 (Fed. Cir. 2018)......................... 2, 10

Warner-Lambert Co. v. Apotex Corp.,

316 F.3d 1348 (Fed. Cir. 2003)............................... 6

Water-Technologies Corp. v. Calco, Ltd.,

850 F.2d 660 (Fed. Cir. 1988)................................. 5

William R. Warner & Co. v. Eli Lilly &

Co.,

265 U.S. 526 (1924)................................................. 5

Statutes

Drug Price Competition and Patent

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

98 Stat. 1585 ........................................................... 6

21 U.S.C.

§ 355(j) ..................................................................... 6

§ 355(j)(2)(A)(v) ..................................................... 11

§ 355(j)(2)(A)(viii) .................................................. 12

35 U.S.C.

§ 271(b) ......................................................... 3, 7, 17

§ 271(c) ................................................................ 3, 5

§ 271(e) ................................................................ 6, 7

§ 271(e)(1) ................................................................ 8

§ 271(e)(2) ................................................................ 7

Other Authorities

Am. Med. Ass’n, Prescription Product

Labeling H-115.994 (2025),

https://policysearch.amaassn.org/policyfinder/detail/H115.994?uri=%2FAMADoc%2FHOD.

xml-0-141.xml ....................................................... 14

David A. Simon, Off-Label Inducement,

111 Iowa L. Rev. (forthcoming 2026),

https://dx.doi.org/10.2139/ssrn.55333

01 ........................................................................... 14

H.R. Rep. No. 82-1923 (1952) ...................................... 4

H.R. Rep. No. 98-857, pt. 1 (1984)............................... 7

Jacob S. Sherkow & Paul R. Gugliuzza,

Infringement by Drug Label, 78 Stan.

L. Rev. 131 (2026) ... 1, 2, 3, 9, 11, 12, 14, 16, 17, 18

Mark A. Lemley, Inducing Patent

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

225 (2005) ............................................................ 4, 5

Paul R. Gugliuzza & Jacob S. Sherkow,

Corcept v. Teva Oral Argument:

Infringement by Drug Label, Again,

Patently-O (July 8, 2025),

https://patentlyo.com/patent/2025/07/

corcept-argument-infringement.html .................. 17

Paul R. Gugliuzza & Jacob S. Sherkow,

Drug Labels as Evidence of Patent

Infringement — A Troubling Legal

Trend, 394 NEJM 630 (2026) .......................... 1, 11

U.S. Food & Drug Admin., Use of

Approved Drugs for Unlabeled Indications, 12 FDA Drug Bull. 4 (Apr.

1982) ...................................................................... 14

INTEREST OF AMICI CURIAE

Paul R. Gugliuzza is the Thomas W. Gregory Professor of Law at the University of Texas at Austin

School of Law. Jacob S. Sherkow is the Richard W. and

Marie L. Corman Professor of Law at the University of

Illinois College of Law.1 Amici teach and research patent law, including patent litigation under the HatchWaxman Act. Their scholarship includes two recent

articles examining the intersection of drug labels, the

Hatch-Waxman Act, and induced patent infringement.

See Jacob S. Sherkow & Paul R. Gugliuzza, Infringement by Drug Label, 78 Stan. L. Rev. 131 (2026); Paul

R. Gugliuzza & Jacob S. Sherkow, Drug Labels as Evidence of Patent Infringement — A Troubling Legal

Trend, 394 NEJM 630 (2026) [hereinafter Gugliuzza

& Sherkow, Trend].

Amici have no personal interest in this case. Their

sole interest is in the orderly development of induced

infringement doctrine in a way that is faithful both to

longstanding patent law and to Congress’s policy

choices in the Hatch-Waxman Act.

1 No counsel for a party authored this brief in whole or in part,

and no party or counsel for a party made a monetary contribution

intended to fund its preparation or submission. No person other

than the amici or their counsel made a monetary contribution to

the preparation or submission of this brief. Amici’s affiliations are

provided for identification purposes only; they are participating

in their individual capacity and not on behalf of their institutions.

INTRODUCTION AND SUMMARY OF

ARGUMENT

The decision below is the latest in a line of Federal

Circuit pharmaceutical cases that have turned decades of patent inducement jurisprudence on its head.

Across GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., United Therapeutics Corp. v. Liquidia

Technologies, Inc., Vanda Pharmaceuticals Inc. v.

West-Ward Pharmaceuticals International Ltd., and

now this case, the Federal Circuit has improperly relied on Food and Drug Administration (FDA)regulated drug labeling to expand inducement liability

beyond its proper boundaries.

By allowing inducement to rest on a bare textual

reading of a drug label combined with anodyne public

statements about generic equivalence, the Federal

Circuit has embraced a theory of liability that amici

have called “infringement by label.” Sherkow & Gugliuzza, supra, at 131. Infringement by label departs

from the common and statutory law of inducement and

patent infringement. Instead of asking whether a generic company has intentionally encouraged and

caused infringement, the Federal Circuit has imposed

liability simply because a generic’s label could be read

to “contain” a patented method of use and the generic

holds itself out as, well, a generic.

Applying common law infringement principles,

this Court has long held that patent inducement liability exists only when a party actively encourages,

recommends, or promotes infringement by taking affirmative acts with the intent to cause direct infringement by another. Nothing in the 1952 Patent Act or

the Hatch-Waxman Act changes these core principles.

The Federal Circuit’s recent decisions, by contrast, improperly base inducement liability on FDA-mandated

drug labels and unremarkable statements about generic equivalence.

Generics do not write their drugs’ labels; FDA law

generally requires them to copy that of the reference

brand drug. Even brand drug labels are produced under intense agency scrutiny and constraints of federal

law. Sherkow & Gugliuzza, supra, at 135, 141. And

physicians rarely rely on these labels for prescribing

decisions. The Federal Circuit’s approach to inducement is inconsistent with this Court’s command that

inducement demands “purposeful, culpable expression

and conduct” demonstrated through clear acts taken

to foster infringement. Cf. Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 937 (2005).

In resolving this case, the Court should reaffirm

that inducement requires evidence of voluntary, targeted efforts that influence prescribing behavior—not

a textual exegesis of isolated phrases from mandatory

labels and innocuous statements about “generic equivalence.”

ARGUMENT

Inducing Infringement Under § 271(b) Requires Encouraging, Recommending, or

Promoting Infringement.

Section 271(b) of the 1952 Patent Act imposes liability on those who “actively induce[] infringement of

a patent.” 35 U.S.C. § 271(b). That section, along with

§ 271(c), was “designed to ‘codify in statutory form

principles of contributory infringement’” that had been

“part of our law for about 80 years.” Global-Tech

Appliances, Inc. v. SEB S.A., 563 U.S. 754, 761 (2011)

(quoting Aro Mfg. Co. v. Convertible Top Replacement

Co (Aro II)., 377 U.S. 476, 485–86 n.6 (1964) (quoting

H.R. Rep. No. 82-1923, at 9 (1952))).

As this Court has recognized in the context of copyright infringement, indirect infringement is based on

“doctrines of secondary liability [that] emerged from

common law principles and are well established in the

law.” Grokster, 545 U.S. at 930 (citing Sony Corp. v.

Universal City Studios, Inc., 464 U.S. 417, 486 (1984)

(Blackmun, J., dissenting)). Therefore “[o]ne infringes

contributorily by intentionally inducing or encouraging direct infringement.” Id. (citing Gershwin Pub.

Corp. v. Columbia Artists Mgmt., Inc., 443 F. 2d 1159,

1162 (2d Cir. 1971)).

As with other forms of secondary liability, indirect

patent infringement liability arose to ensure patent

law could efficiently hold culpable actors liable even

when they do not themselves directly practice the invention. See Mark A. Lemley, Inducing Patent Infringement, 39 U.C. Davis L. Rev. 225, 227–28 (2005).

Before enactment of the 1952 Patent Act, indirect infringement consisted of contributory infringement—

the aiding and abetting of direct infringement—with

inducement treated as evidence of the intent required

for such liability. Glob.-Tech, 563 U.S. at 764; Lemley,

supra, at 227. While courts were comfortable assuming intent when the indirect infringer sold products

useful only for infringing acts, they required affirmative acts demonstrating infringement when products

could be used for noninfringing purposes. See Lemley,

supra, at 227.

When indirect infringement was codified in

§ 271(c) and § 271(b), the basic distinction was

between liability for contributory infringement and liability for inducing infringement. While contributory

infringement requires the sale of products “especially

made or especially adapted for use in an infringement,” 35 U.S.C. § 271(c), inducing infringement requires “‘other acts’ that direct, facilitate, or abet infringement.” Lemley, supra, 227 (2005).

The rule of inducement “as developed in the early

cases is no different today.” Grokster, 545 U.S. at 936.

Inducement “must involve the taking of affirmative

steps to bring about the desired result,” Glob.-Tech,

563 U.S. at 760, and requires proof that the defendant

“actively and knowingly aid[ed] and abett[ed] another’s direct infringement.” DSU Med. Corp. v. JMS

Co., 471 F.3d 1293, 1305 (Fed. Cir. 2006) (citing Water

Techs. Corp. v. Calco, Ltd,, 850 F.2d 660, 668 (Fed.

Cir. 1988)). Furthermore, those acts must “encourage,

recommend, or promote infringement.” Takeda

Pharms. USA, Inc. v. West-Ward Pharm. Corp.,

785 F.3d 625, 631 (Fed. Cir. 2015).

Reflecting inducement’s common law origins, this

Court has applied the same principles to patent, copyright, and trademark law. See, e.g., Grokster, 545 U.S.

at 936 (citing Sony, 464 U.S. at 417) (adopting patent

law’s inducement rule as “a sensible one for copyright”); Glob.-Tech, 563 U.S. at 763 (citing Grokster,

545 U.S. at 913); see also Inwood Labs., Inc. v. Ives

Labs., Inc., 456 U.S. 844, 854 (1982) (“[I]f a manufacturer or distributor intentionally induces another to

infringe a trademark . . . [it] is contributorily responsible.”) (citing William R. Warner & Co. v. Eli Lilly &

Co., 265 U.S. 526 (1924)).

Nor does inducement change based on the industry in which the patent arises or the presence of

overlapping regulatory schemes. See Glob.-Tech,

563 U.S. at 762–64 (consumer appliances) (deriving

the inducement knowledge standard from Aro II,

377 U.S. 476 (automobile parts), and Henry v. A. B.

Dick Co., 224 U.S. 1 (1912) (office equipment)); Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632 (2015)

(telecommunications) (reaffirming inducement framework from Glob.-Tech, 563 U.S. 754, and Aro II,

377 U.S. 476).

II. Hatch-Waxman Does Not Alter the Requirements for Induced Infringement

Liability Under § 271(b).

Just as inducement principles are the same across

various forms of intellectual property and among different industries, those principles remain unaltered in

cases involving generic drugs. Decades ago, Congress

enacted the Drug Price Competition and Patent Term

Restoration Act of 1984 (“Hatch-Waxman Act”), Pub.

L. No. 98-417, 98 Stat. 1585, which established a litigation framework that allows generic drugs to enter

the market as soon as patent protection for a brandname drug ends. 35 U.S.C. § 271(e); 21 U.S.C. § 355(j).

In order to achieve that goal, the Act created “an ‘artificial’ act of infringement that creates case-or-controversy jurisdiction” enabling early judicial resolution of

patent disputes between brand name and generic drug

companies. Warner-Lambert Co. v. Apotex Corp.,

316 F.3d 1348, 1365 (Fed. Cir. 2003).

However, “once jurisdiction is established . . . the

substantive determination whether actual infringement or inducement will take place is determined by

traditional patent infringement analysis[.]” Id. This is

confirmed by the Act’s own legislative history: “The

provisions of [the Hatch Waxman Act] relating to the

litigation of disputes involving patent . . . infringement are not intended to modify existing patent law

with respect to the burden of proof and the nature of

the proof to be considered by the courts in determining

whether a patent is . . . infringed.” H.R. Rep. No. 98857, pt. 1, at 27–28 (1984).

Therefore, whether a claim is made under

35 U.S.C. § 271(b), which codified the common law

standard for inducing patent infringement, or

§ 271(e)(2), under the Hatch-Waxman Act, the inquiry

about inducement is the same. See Allergan v. Alcon

Labs., Inc., 324 F.3d. 1322, 1337 (Fed. Cir. 2003)

(Schall, J., concurring) (noting that a cause of action

exists for “induced infringement under section 271(e)(2)” because otherwise “the owner of a

method of use patent . . . will bring a section 271(b)

induced infringement action, after the ANDA has been

approved[.]”).

When resolving other infringement questions

arising under the Hatch-Waxman Act, this Court has

adhered to ordinary infringement principles rather

than inventing a pharmaceutical-specific doctrine. In

Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990),

the Court described § 271(e)(2)’s submission-based

trigger as a “highly artificial act of infringement,” created solely to permit premarket adjudication. Id. at

678. But the Court did not alter what counts as infringement. To the contrary, it analyzed liability by

reference to the traditional categories in § 271(a) of

making, using, and selling—confirming that HatchWaxman changes when suit may be brought, not what

must be proved. Id. at 670–71, 678.

Likewise, in Merck KGaA v. Integra Lifesciences I,

Ltd., 545 U.S. 193, 201 (2005), the Court, relying on

the Hatch-Waxman Act’s text and structure, treated

§ 271(e)(1) as a safe harbor from liability, not as a redefinition of substantive patent rights. In doing so, the

Court rejected arguments that the safe harbor provision should be narrowly construed. The Court left the

underlying standards of infringement untouched. Id.

at 201–02.

And in Caraco Pharmaceutical Laboratories,

Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 403 (2012)—

a case about a particular provision of the Hatch-Waxman Act regarding “use codes”—this Court, again, did

not alter any substantive requirements of the law of

infringement, treating the Hatch-Waxman Act simply

as procedural scaffolding to facilitate generic entry. Id.

at 404.

None of these decisions—nor any others from this

Court—suggest that the doctrine of patent inducement should be treated differently under the HatchWaxman Act. Inducement liability under § 271(b) thus

continues to require proof that the alleged inducer had

knowledge of the patent, intended that the induced

acts constitute infringement, and engaged in affirmative acts that caused direct infringement. Glob.-Tech,

563 U.S. at 766; Commil, 575 U.S. at 642; Takeda,

785 F.3d at 631.

III. The Federal Circuit’s Labeling-Based

Theory of Inducement Improperly Expands

§ 271(b) Beyond Its Statutory Limits.

Despite widespread acknowledgment that the

Hatch-Waxman Act does not change the standard for

inducement, a line of Federal Circuit cases has made

up a special rule about inducement in generic drug patent cases: “infringement by label.” This theory predicates inducement liability on a generic drug’s label

text alongside common-place statements about “generic equivalence.” Sherkow & Gugliuzza, supra, at

134. That approach is wrong under the common law,

distorts patent inducement doctrine, misunderstands

the FDA’s labeling framework, and thwarts the HatchWaxman Act.

The Federal Circuit’s decision continues the trend of imposing inducement

liability for regulated statements by generic drug companies.

In this case, the Federal Circuit reversed the district court’s holding that Amarin had not adequately

pleaded the facts necessary to find Hikma induced infringement by marketing a generic version of Amarin’s

brand name drug, Vascepa. Amarin Pharma, Inc. v.

Hikma Pharms. USA Inc., 104 F.4th 1370, 1380 (Fed.

Cir. 2024). The Federal Circuit ruled that, notwithstanding Hikma’s use of a skinny label to carve out the

indication claimed in Amarin’s patents, Amarin adequately alleged inducement based on “Hikma’s press

releases, website, and product label evidence.” Id. at

1375. The Federal Circuit ruled that those statements

could plausibly induce physicians to prescribe the

medication for a patented use. Id. at 1380.

The Federal Circuit’s reasoning in this case follows from that court’s earlier decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.

(GSK), 7 F.4th 1320 (Fed. Cir. 2021) in which it ruled

that the generic’s carved-out label “intentionally encouraged” infringement. Id. at 1338. In that case, Teva

launched a generic version of GlaxoSmithKline’s

Coreg with a section viii carve-out omitting the patented congestive heart failure (CHF) indication and

retaining only unpatented indications. Id. at 1323–24.

Even though the purpose of the CHF carve-out was to

avoid having physicians practice an infringing use, the

Federal Circuit concluded that the remaining indications fell “within the definition of congestive heart failure.” Id. at 1330. Combined with Teva’s statements

that its generic product was a “therapeutic equivalent”—a term of art under FDA law—the court concluded that Teva had encouraged substitution for all

the drug’s uses. Id. at 1335.

In dissent, Judge Prost pointed out that Teva complied with the Hatch-Waxman Act by removing the patented use, that unrebutted evidence showed physicians rarely rely on labels, and that it makes little

sense to infer culpable intent from describing a drug

as “equivalent” in a system that requires generics to

be equivalent. Id. at 1360–61. In a subsequent dissent

from the denial of rehearing en banc in that case,

Judge Prost further cautioned that, under the court’s

view of inducement, “no skinny-label generic is safe.”

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.,

25 F.4th 949, 955 (Fed. Cir. 2022) (Prost, J., dissenting).

Notwithstanding Judge Prost’s critique, the

flawed reasoning in GSK has been replicated in other

Federal Circuit decisions. In Vanda Pharmaceuticals v. West-Ward Pharmaceuticals International Ltd.,

887 F.3d 1117, 1130–31 (Fed. Cir. 2018), the Federal

Circuit affirmed an inducement finding based on an

FDA-required warning in a generic’s label, one which

the generic had no authority to alter or modify, and

which was copied directly from the brand’s label. And

in United Therapeutics Corporation v. Liquidia Technologies, 74 F.4th 1360, 1370 (Fed. Cir. 2023), the

court sustained inducement liability because following

the label’s instructions could hypothetically infringe,

even absent evidence that physicians read the label or

that the label influenced any physician’s prescribing

decisions.

Labeling reflects regulatory compliance

rather than affirmative encouragement.

The Federal Circuit’s infringement-by-label case

law, including the decision below, allows inducement

liability to rest on cobbled-together snippets of label

text and anodyne equivalence statements. It also fails

to account for how drug labels are developed and regulated. FDA regulations require every prescription

drug, made by either a brand or generic company, to

include a document describing indications, dosing,

contraindications, clinical trial results, and safety

measures, known as the drug’s package insert. Gugliuzza & Sherkow, Trend, supra, at 630. This insert is

not unilaterally prepared by the drug company or the

FDA. Rather, it is the result of negotiations between

the companies and the federal government. Sherkow

& Gugliuzza, supra, at 135, 140.

Practically, this means that drug companies cannot include in their labeling any information that has

not been approved by the FDA, down to such minutiae

as comma placement. Id. at 141. FDA drug labeling is

not a marketing document, but a legally mandated

regulatory instrument. See 21 U.S.C. § 355(j)(2)(A)(v).

It reflects what a drug company must say, not what it

wishes to promote. Sherkow & Gugliuzza, supra, at

188.

FDA regulations are even more restrictive for generic drug labels which must, absent specific and narrow exceptions, copy the brand drug’s label. As Judge

Prost explained in her GSK dissent, the statutory design of the Hatch-Waxman Act makes it untenable to

infer culpable intent from what the law mandates.

7 F.4th at 1357 (Prost, J., dissenting). Physicians understand that a generic is, by definition, therapeutically equivalent to its brand counterpart, and generics

are required to communicate that equivalence to participate in the regime Congress created. See id. at 1360

(Prost, J., dissenting) (“Given that the Hatch-Waxman

Act’s framework requires ANDA generics to be the

same as a brand drug, and that doctors understand

what being a generic means, [inducement] seems a dubious proposition.”).

This Court has recognized the same reality, explaining that generic companies operate under an ongoing federal “duty of ‘sameness.’” PLIVA, Inc. v.

Mensing, 564 U.S. 604, 616 (2011). Accordingly, the

“sameness” of these labels reflects federal law; something physicians and other market participants readily understand when they encounter a generic equivalent.

“Skinny labels,” which omit patented indications

while retaining unpatented ones, similarly reflect regulatory compliance rather than volitional advocacy to

promote direct infringement. See § 355(j)(2)(A)(viii).

As Judge Prost explained in her GSK dissent, a skinny

label that omits the patented indication demonstrates

that the generic “very much intended not to encourage

infringement.” 7 F.4th at 1350 (Prost, J., dissenting).

Inferring inducement from a label that has “intentionally omitted everything that the brand said covers that

method” is inconsistent with the requirement of purposeful encouragement to establish inducement. Id.

The Federal Circuit’s embrace of “infringement by

label” converts 35 U.S.C. § 271(b)’s narrow, intentbased doctrine into a form of strict liability triggered

by paperwork rather than actual persuasion.

Labeling cannot be inducement without evidence of causation.

The Federal Circuit’s recent cases have not fully

articulated how drug labels and equivalence statements affect physician behavior. Instead, the court’s

approach makes all information provided by a generic

potentially inducing, creating a regime of text-based

liability that is untethered from both causation and intent.

An extreme example is Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017), in which a

clinical trial describing the patented use was mentioned in the Indications and Usage section of the

package insert, with the summary statistics of that

trial in the separate Clinical Trials section. The Federal Circuit did not ask whether physicians would

have examined the Indications and Usage section,

turned to the Clinical Trials section, and, based on

that information, prescribe the drug for the patented

use. Instead, the court found it sufficient that the patented method of use was in the label, skipping any

causal analysis. Id. at 645–46.

Focusing on a label’s text, rather than its effect,

rests on the assumption that physicians review and

adhere to every section of a package insert. Sherkow

& Gugliuzza, supra, at 142. However, both empirical

data and clinical experience indicate that physicians

rarely consult labels when making treatment decisions.

Instead, physicians prescribe medications guided

by clinical judgment, peer-reviewed literature, and established professional guidelines—not regulatory disclosures. As noted by Judge Prost in her GSK dissent,

“every expert cardiologist at trial said he didn’t even

read the label to make prescribing decisions.” 7 F.4th

at 1342 (Prost, J., dissenting); see also Sherkow &

Gugliuzza, supra, at 180–82 (describing the prevalence of off-label prescribing); David A. Simon, Off-Label Inducement, 111 Iowa L. Rev. (forthcoming 2026)

(manuscript

7–9),

https://dx.doi.org/10.2139/ssrn.5533301 (same). The

American Medical Association (“AMA”) confirms this

clinical reality, stating that official labeling “should

not be regarded as the sole standard of acceptable or

accepted medical practice,” nor should it serve as a

“substitute for clinical judgment or experience.” Am.

Med. Ass’n, Prescription Product Labeling H-115.994

(2025), https://perma.cc/7QN8-V2N8. Rather, the

AMA clarifies that FDA-approved statements merely

“establish the parameters governing advertising or

promotion.” Id.

The AMA’s statements demonstrate that physicians view the label as a regulatory boundary for drug

companies, not a directive for patient care. The FDA

has also stated that it views the package insert as “informational only” in relation to its role in medical practice and that unlabeled uses may be “appropriate and

rational in certain circumstances.” U.S. Food & Drug

Admin., Use of Approved Drugs for Unlabeled Indications, 12 FDA Drug Bull. 4, 5 (Apr. 1982). If physicians

neither read nor rely on the label, then the label cannot be said to “induce” anything.

IV. This Court Should Reaffirm Existing

Inducement Law.

The Federal Circuit’s recent decisions have created a system in which generic companies that adhere

to FDA requirements may still face liability if any portion of their products’ labeling, such as warnings or descriptions of clinical trials, could be interpreted as referencing a patented method of use. In resolving this

case, the Court should reaffirm that inducement requires active, volitional conduct that encourages, recommends, or promotes infringement and that actually

influences physicians’ prescribing behavior. Moreover,

the Court should make clear that FDA-mandated labeling, coupled with rote statements about generic

equivalence, are not, alone, sufficient to establish inducement.

“Skinny labels” and other labeling

should not, alone, create liability for inducement.

If complying with FDA-mandated labeling requirements can trigger inducement liability, market

entry by generics becomes legally precarious and economically untenable, particularly for drugs with multiple indications. Faced with legal uncertainty, generic

companies may forgo or delay entry, resulting in prolonged high prices and restricted patient access. This

outcome subverts the purpose of the Hatch-Waxman

Act: to encourage the development of new drugs and

lower the costs of generic entry. Sherkow & Gugliuzza,

supra, at 145; see also Caraco, 566 U.S. at 405 (“As we

have previously recognized, this process is designed to

speed the introduction of low-cost generic drugs to

market.”). A “skinny label” carve-out should be strong

evidence that the generic lacks the intent to encourage

infringement—though that inference can of course be

countered with evidence of a generic’s promotional

conduct and other real-world evidence of inducement.

Sherkow & Gugliuzza, supra, at 188.

Grounding the inducement inquiry in the regulatory and commercial reality of the pharmaceutical

market would also resolve a procedural quandary

plaguing these cases. Namely, the Federal Circuit has

treated the interpretation of mandatory label text as

presenting a question of fact to be decided by a jury

and entitled to deference on review. E.g., GSK, 7 F.4th

at 1330 (“[T]he district court erred by treating this fact

question—whether the post-MI LVD indication [in the

generic label] instructs a physician to prescribe carvedilol for a [patented] use—as though it were a legal one

for it to decide de novo.”). By focusing on a generic company’s actual promotional activity, courts can avoid

resting the factual determination of inducement on

the interpretation of legally mandated label text.

Sherkow & Gugliuzza, supra, at 188.

And when a patent owner cannot point to realworld conduct encouraging an infringing use (independent of the FDA-mandated label) there should be

no plausible claim of inducement as a matter of law.

Disposing of deficient claims early would avoid years

of costly litigation. Cf. Corcept Therapeutics, Inc. v.

Teva Pharms. USA, Inc., 709 F. Supp. 3d 138, 142

(D.N.J. 2023) (“The [c]ourt denied the parties’ cross-

motions for summary judgment, observing that it was

critical to hear ‘expert testimony regarding [the generic] label’s dosing regimens[.]’”), aff’d per curiam,

No. 2024-1346, 2026 WL 468866 (Fed. Cir. Feb. 19,

2026); see also Paul R. Gugliuzza & Jacob S. Sherkow,

Corcept v. Teva Oral Argument: Infringement by Drug

Label,

Again,

Patently-O

(July 8,

2025),

https://perma.cc/4YXX-CRYN (“Teva wasn’t really

able to dispute that the patented method is in its label—albeit in a section discussing safety and warnings—even if no doctor in the real world would ever

practice the patented method.”).

Conversely, in cases where there are plausible allegations and genuine, disputed evidence of inducement beyond the mere wording of a label, both brands

and generics would retain their right to have those factual disputes resolved at trial. A clear distinction between regulatory disclosures that, on their own, cannot establish a claim of inducement, and active affirmative promotion of infringement, which can, would ensure that § 271(b) remains a tool for penalizing culpable conduct rather than a mechanism for imposing (or

threatening to impose) significant litigation costs.

Sherkow & Gugliuzza, supra, at 188–89.

The plain text of § 271(b) requires a

causal connection between communication and infringement.

Section 271(b) targets conduct that persuades

others to infringe; this Court has repeatedly emphasized that inducement requires “affirmative steps.”

Glob.-Tech, 563 U.S. at 760. Rather than relying on labeling or marketing statements about generic equivalence, courts should ask concrete, behavioral

questions: Did physicians read the challenged statements? And were they induced to act in accordance

with them? Those questions cannot be answered by

parsing language in the abstract. It requires evidence

of real-world effect. Brand companies should be required to provide evidence of a demonstrated connection between what the generic communicated and how

physicians actually behaved. Sherkow & Gugliuzza,

supra, at 187.

Inducement turns on actual influence, not on conjecture about what someone might have inferred from

regulatory language. Applied in the pharmaceutical

context, that principle yields a straightforward rule.

Liability must rest on communications or conduct that

shapes prescribing behavior—targeted promotional efforts such as sales calls, marketing materials directed

toward healthcare providers, “Dear Doctor” letters, advertising, or direct communications with healthcare

decisionmakers—not the mere existence of FDAmandated label text or unremarkable statements

about generic equivalence. Sherkow & Gugliuzza, supra, at 188.

A recent nonprecedential Federal Circuit decision

reflects a more appropriate approach to claims of infringement by label. In Corcept, 2026 WL 468866, at

*3, the Federal Circuit made clear that “outside-thelabel evidence” that physicians had not and were not

likely to practice the patented methods could defeat a

claim of inducement, regardless of what the label said.

CONCLUSION

Expanding indirect infringement liability to encompass passive labeling, regulatory compliance, and

unheeded information—as the Federal Circuit has

done in GSK, the decision below, and several other recent opinions—untethers inducement doctrine from

its common-law roots, converting a narrow secondaryliability rule into a sweeping form of strict liability.

However the Court resolves this case, it should reject

the Federal Circuit’s embrace of infringement by label

and reaffirm the settled rule that inducement requires

active encouragement, direction, or promotion of infringing conduct that causes direct infringement.

Respectfully submitted,

Phillip R. Malone

Counsel of Record

Nina K. Srejovic

JUELSGAARD INTELLECTUAL

PROPERTY AND INNOVATION

CLINIC