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

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 INTELLECTUAL PROPERTY

OWNERS ASSOCIATION AS AMICUS CURIAE

IN SUPPORT OF NEITHER PARTY

________________________

JOHN J. CHEEK

President

LAURA SHERIDAN

Chair, Amicus Brief Committee

SAMANTHA J. AGUAYO

Deputy Executive Director

and Chief Policy Counsel

INTELLECTUAL PROPERTY

OWNERS ASSOCIATION

1501 M St. N.W., Suite 1150

Washington, D.C. 20005

PAUL H. BERGHOFF

Counsel of Record

TAYLOR WEILNAU

MCDONNELL BOEHNEN

HULBERT & BERGHOFF LLP

300 South Wacker Drive

Chicago, IL 60606

(312) 913–0001

Berghoff@mbhb.com

Counsel for Amicus Curiae,

Intellectual Property Owners Association

i

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?

ii

TABLE OF CONTENTS

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

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

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

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

ARGUMENT ............................................................... 5

I.

The Federal Circuit Applied the Correct

Pleading Standard ................................................ 5

II. There is No Statutory Basis for Special

Pleading Standards For Section VIII Carveouts

Against Induced Infringement Claims ................ 7

III. This Court Has Consistently Cautioned

Against Applying Special, Rigid Standards

in Patent Cases ..................................................... 9

IV. The Plausibility Pleading Standard Preserves

the Statutory Balance Between Generic

Competition and Innovation............................... 11

CONCLUSION .......................................................... 13

APPENDIX — MEMBERS OF THE BOARD OF

DIRECTORS INTELLECTUAL PROPERTY

OWNERS ASSOCIATION.................................. 1a

iii

TABLE OF AUTHORITIES

PAGE(S)

CASES

Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.,

104 F.4th 1370, 1379-1381 (Fed. Cir. 2024). ..........6

Ashcroft v. Iqbal,

556 U.S. 662, 678 (2009) ............................ 2, 6, 7, 13

Bell Atl. Corp. v. Twombly,

550 U.S. 544, 556-557 (2007) .................... 2, 6, 7, 13

Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,

566 U.S. 399, 406-407 (2012) ..................................8

eBay Inc. v. MercExchange, L.L.C.,

547 U.S. 388, 391-392 (2006) ..................................9

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki

Co., 535 U.S. 722, 122 S. Ct. 1831 (2002) ............. 10

FTC v. Actavis, Inc.,

570 U.S. 136, 158-160 (2013). ............................... 10

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

563 U.S. 754, 766 (2011)..........................................7

KSR Int'l Co. v. Teleflex Inc.,

550 U.S. 398, 415 (2007) ..........................................9

Limelight Networks, Inc. v. Akamai Techs., Inc.,

572 U.S. 915, 921-923 (2014) ..................................7

STATUTES

21 U.S.C. § 355(j)(2)(A)(viii) ................................ 2, 7, 8

35 U.S.C. § 271 ........................................................ 7, 8

35 U.S.C. § 271(b) ................................................ 2, 3, 7

35 U.S.C. § 271(c) ........................................................7

iv

RULES

Fed. R. Civ. P. 8(a) and 12(b)(6)..................................3

1

INTEREST OF AMICUS CURIAE

Amicus curiae Intellectual Property Owners

Association (IPO)1 represents many of the most

innovative companies in the United States. IPO’s

nearly 200 corporate members develop, manufacture,

and sell technology-based products in a wide range of

industries. IPO is committed to serving the interests

of all intellectual property owners in all industries

and all fields of technology.2

IPO’s corporate members invest tens of billions of

dollars annually on research and development, as well

as employ hundreds of thousands of scientists,

engineers, and skilled professionals in the United

States to develop, produce, and market innovative

new products and services.

To protect their

inventions, IPO’s members collectively hold tens of

thousands of U.S. patents and account for a

substantial portion of the patent applications filed

every year at the United States Patent and

Trademark Office. Based on their ownership of

patents and their prominent positions in

marketplaces involving technology, IPO’s members

appear frequently as parties in federal patent

infringement litigation, both as plaintiffs protecting

their intellectual property and defendants facing

assertions of infringement.

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

and no person or entity other than amicus curiae made a

monetary contribution to the preparation or submission of this

brief.

2 IPO procedures require approval of positions in briefs by a twothirds majority of directors present and voting. The list of

directors is attached to this brief.

2

This case presents a question of substantial

practical importance to IPO: namely, what standard

should be applied in assessing whether a complaint

sufficiently pleads a claim for active inducement of

patent infringement. IPO submits that all claims of

patent infringement, regardless of the particular

technology involved, should be assessed based on the

totality of well-pled facts alleged in the complaint.

IPO contends that this standard agrees with this

Court’s guidance in Ashcroft v. Iqbal, 556 U.S. 662,

678 (2009) and Bell Atl. Corp. v. Twombly, 550 U.S.

544, 556-557 (2007), and provides a fair balance

between the interests of plaintiff patent owners and

defendants accused of infringement.

SUMMARY OF THE ARGUMENT

IPO submits that the requirements for adequately

pleading a claim for active inducement of

infringement under 35 U.S.C. § 271(b) should be no

different than the standards established by this Court

in Iqbal and Twombly, which apply to all types of

federal claims. See Iqbal, 556 U.S. at 684. No special,

bright-line pleading rules should be implemented for

cases involving U.S. Food and Drug Administration

(“FDA”) approved drugs or 21 U.S.C. §

355(j)(2)(A)(viii) (“Section viii”) carveouts (“skinny

labels”) or, indeed, for any other specific technology.

IPO submits that the U.S. Court of Appeals for the

Federal Circuit applied this Court’s pleading

standards under Iqbal and Twombly to the particular

fact pattern of this case. This approach is the legally

appropriate framework for assessing the sufficiency of

3

a complaint

infringement.3

alleging

active

inducement

of

Specifically, IPO contends that lower courts

should review all well-pled facts in determining

whether a claim for active induced infringement of a

granted U.S. patent has been sufficiently pled under

35 U.S.C. § 271(b). In the context of a pharmaceutical

patent, this would include all statements and

information included in the FDA-approved drug label,

as well as all statements made by the accused

infringer in connection with the marketing of the

alleged infringing drug product. Such an evaluation

of the totality of the circumstances will turn on the

particular facts plausibly pled in the complaint, as

IPO contends it should.

In response to the first question presented in this

case, IPO submits that the overall context of all wellpled factual allegations in a complaint should be

taken into account in determining whether a

complaint should be dismissed pursuant to Federal

Rules of Civil Procedure 8(a) and 12(b)(6). Referring

to the facts at issue in this case, a statement by Hikma

that its drug is a "generic version" of Amarin’s drug,

Vascepa®, standing entirely alone, may not be

sufficient to state a claim for inducement. But if, for

example, that statement were to follow another

statement that Vascepa® has been approved for both

the infringing cardiovascular (CV) use and the

noninfringing severe hypertriglyceridemia (SH) use,

the import of Hikma’s statement that its drug is a

“generic version” of Vascepa® changes and may now

3 IPO takes no position concerning any of the other issues, either

factual or legal, presented by this matter.

4

encourage use of Hikma’s drug for both noninfringing

and infringing uses. The crucial point here is that

context matters. Analyzing statements in isolation

rather than in the total context of well-pled facts can

lead to incorrect conclusions.

In its first Question Presented, Petitioner appears

to be advocating for several “”bright-line” rules, i.e.,

that statements by a generic drugmaker calling its

product a “generic version” and statements citing

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

sales), cannot, as a matter of law, constitute evidence

of active inducement of patent infringement. IPO

submits that the imposition of any special, bright-line

pleading rules is inconsistent with this Court’s

precedent and does not find support in either the

Federal Food, Drug, and Cosmetic Act (“FFDCA”) or

the Patent Act of 1952. The practical effect of these

bright-line tests advocated for by Petitioner would

permit generic drugmakers to game the carefully

balanced system set up by Congress, allowing generic

drugmakers to receive FDA approval based on a

Section viii carveout while, at the same time,

promoting potentially infringing, off-label uses.

As to the second Question Presented, IPO sees it

as a tautology. If the totality of well-pled facts in the

Complaint does not “encourage” the patented use,

then, by definition, there is no inducement. IPO

agrees with that proposition, but it merely begs the

question. As an example from the facts in this case,

Amarin’s Complaint quotes statements by Hikma

that its drug treats “hypertriglyceridemia,” which is

alleged to be broad enough to cover both infringing

and noninfringing uses. Accepted as true, as is

5

required at the pleadings stage, this is an example of

a well-pled fact that should be considered as part of

the totality of circumstances in assessing Hikma’s

motion to dismiss, even in the absence of any explicit

mention of the patented CV indication.

ARGUMENT

I.

THE FEDERAL CIRCUIT APPLIED

CORRECT PLEADING STANDARD.

THE

The District Court granted Hikma’s motion to

dismiss the Complaint for failing to state a cause of

action for active inducement. In an opinion authored

by Judge Lourie and joined by Chief Judge Moore and

Judge Albright (sitting by designation from the

Western District of Texas), the Federal Circuit panel

reversed the District Court’s dismissal, holding that

Amarin’s Complaint sufficiently alleges active

inducement of the CV treatment claims such that the

case can proceed to discovery.

We therefore focus narrowly on the question

whether Amarin’s complaint plausibly pleads

that Hikma ‘actively’ induced healthcare

providers’ direct infringement, i.e., that

Hikma ‘encourage[d], recommend[ed], or

promote[d] infringement.’ . . . Accepting all

well pleaded facts as true and drawing all

reasonable inferences in Amarin’s favor, we

conclude that it does.

....

Though the merits of Amarin’s allegations

have not yet been tested or proven, we cannot

say at this stage that those allegations are not

at least plausible.

6

Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.,

104 F.4th 1370, 1379-1381 (Fed. Cir. 2024).

The analytical framework used by the Federal

Circuit comports with the requirements of Iqbal and

Twombly by identifying the narrow question of

whether the complaint plausibly pleaded that Hikma

actively induced infringement. Under this standard,

the Complaint does not need to prove the case at the

outset but rather need only plead “enough facts to

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

Twombly 550 U.S. at 570. This threshold standard is

the benchmark “in all civil actions and proceedings in

United States district courts,” including those for

patent infringement. Iqbal, 556 U.S. at 684.

Under Iqbal and Twombly, pleading sufficiency is

a “context-specific task that requires the reviewing

court to draw on its judicial experience and common

sense.” Id. at 679. The line between legal competition

and inducement of infringement is often a fine one in

the realm of Section viii carveout drug products and

induced

infringement.

The

Federal

Circuit

appropriately drew upon its comprehensive

experience and expertise in this realm to determine

the plausibility of the pleaded facts, not their

probability. Uniformity in federal pleadings is the

rule, not the exception. Neither Congress nor this

Court has established a heightened bar for induced

infringement claims involving “skinny labels.” Thus,

the plausibility standard under Iqbal and Twombly

should apply.

7

II.

THERE IS NO STATUTORY BASIS FOR SPECIAL

PLEADING STANDARDS FOR SECTION VIII

CARVEOUTS

AGAINST

INDUCED

INFRINGEMENT CLAIMS.

There is no statutory or precedential basis for

creating a special pleading standard for Section viii

carveouts, or any other specific technology.4 Thus,

IPO contends that the requirements for adequately

pleading a claim for active inducement of

infringement under § 271(b) should be no different

than the standards set by the Supreme Court in Iqbal

and Twombly.

Statutory interpretation supports that lower

courts should evaluate the totality of the

circumstances pled in a complaint when deciding

whether it states a plausible claim for induced

infringement by a Section viii drug product. That a

generic drug applicant has been approved for a skinny

label based on a Section viii carveout should not be the

end of the inquiry. The portion of the FDA statute

creating skinny labels, 21 U.S.C. § 355(j)(2)(a)(viii),

does not include provisions relating to inducement of

patent infringement and indeed never refers to 35

4 In the same way, IPO believes that there is no need to alter the

standards for proving induced or contributory patent

infringement under 35 U.S.C. §§ 271 (b) and (c) as set forth in

the previous decisions of this Court, such as Glob.-Tech

Appliances, Inc. v. SEB S.A., 563 U.S. 754, 766 (2011) (holding

that induced infringement under 35 U.S.C. § 271(b) requires

knowledge that the induced acts constitute patent infringement

and such knowledge can be satisfied by willful blindness) and

Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915,

921-923 (2014) (holding that liability for induced infringement

must be predicated on a finding of direct infringement under 35

U.S.C. § 271).

8

U.S.C. § 271. In similar fashion, the Patent Act of

1952 does not create any special requirements,

pleadings or otherwise, for a claim of active

inducement involving a Section viii carveout.

A generic drug applicant’s approval for a “skinny

label” via a Section viii carveout is a regulatory

milestone, not a legal immunity. When dealing with

Section viii carveout drug products, the FDA does not

itself evaluate induced infringement by the generic

drug product. See, e.g., Caraco Pharm. Labs., Ltd. v.

Novo Nordisk A/S, 566 U.S. 399, 406-407 (2012)

(describing that the FDA will not approve a Section

viii carveout label if it overlaps with the brand’s

patent use code, but the FDA “does not independently

assess the patent’s scope or otherwise look behind the

description authored by the brand.”). It follows that

the reach of 21 U.S.C. § 355(j)(2)(a)(viii) should not

extend beyond FDA approval and should not interfere

with well-settled patent infringement statutes or this

Court’s precedents regarding those statutes.

In implementing Section viii carveout protections,

Congress could have made clear that obtaining a

“skinny label” insulated a generic drug filer from all

claims of inducing patent infringement of the

indications that were carved out. Primarily, Congress

could have added this “safe harbor” language to the

Federal Food, Drug, and Cosmetic Act (FFDCA). It

did not.

Similarly, Congress could have added

language to this effect to the Patent Act of 1952. It

did not.

Finally, if Congress had intended to

implement special rules for pleading induced

infringement claims by a Section viii generic

drugmaker, it would have made those rules explicit in

9

either of the relevant statutes. It did not. Absent that

direction, it is not the role of federal courts to create

such immunity on their own.

III.

THIS COURT HAS CONSISTENTLY CAUTIONED

AGAINST

APPLYING

SPECIAL,

RIGID

STANDARDS IN PATENT CASES.

Petitioner argues for the creation of categorical,

“bright-line” tests for assessing the sufficiency of

pleading inducement in Section viii carveout drug

product cases, i.e., that statements by a generic

drugmaker calling its product a “generic version” and

statements citing public information about the

branded drug (e.g., sales), cannot, as a matter of law,

constitute evidence of active inducement of patent

infringement. IPO submits that such rigid tests are

inappropriate at the pleading stage and run counter

to this Court’s longstanding jurisprudence.

This Court has repeatedly overturned patentspecific, formalistic tests, favoring instead flexible

standards that account for the nuances of each case.

Over the past two decades, this Court has struck down

several patent specific, rigid tests implemented by the

Federal Circuit in the context of infringement,

validity, and remedy. See, e.g., KSR Int'l Co. v.

Teleflex Inc., 550 U.S. 398, 415 (2007) (holding that

the Federal Circuit’s rigid, mandatory application of

the “teaching, suggestion, or motivation” (TSM) test

was improper where obviousness determinations

require a “expansive and flexible approach”); eBay

Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391-392

(2006) (overturning the Federal Circuit’s “general rule

. . . that a permanent injunction will issue once

infringement and validity have been adjudged” and

10

holding that courts must apply the four-factor

equitable test); and Festo Corp. v. Shoketsu Kinzoku

Kogyo Kabushiki Co., 535 U.S. 722, 737-738 (2002)

(holding prosecution history estoppel is not a

“complete bar” to the doctrine of equivalents, but

instead creates a rebuttable presumption of

surrendered equivalents). Additionally, in FTC v.

Actavis, Inc., this Court rejected a rigid immunity for

pharmaceutical patent settlements. This Court held

that patent-related agreements must be subject to the

same “rule of reason” analysis in antitrust claims,

similar to any other commercial contract. 570 U.S.

136, 158-160 (2013). By refusing to grant an

“exceptional” shield to patent-related transactions,

the Court emphasized that patent law does not

operate in a vacuum, insulated from general legal

principles. See id.

This case is no different. Just as this Court has

found in other patent cases, the sufficiency of a

complaint alleging induced infringement of a Section

viii carveout cannot be immune from general legal

principles. Thus, whether a Complaint states an

actionable claim of induced infringement by a Section

viii drug product should be no different and should be

analyzed based on the totality of the well-pled facts.

In the context of generic drugmakers, determining

whether a claim for active inducement has been

sufficiently pled should include all statements and

information included in the drug label and statements

made by the accused infringer in marketing and

promotional efforts. Such an evaluation of the totality

of the circumstances will turn on the particular facts

plausibly pled in the complaint, as it should.

11

IV.

THE PLAUSIBILITY PLEADING STANDARD

PRESERVES THE STATUTORY BALANCE

BETWEEN GENERIC COMPETITION AND

INNOVATION.

The FFDCA and Patent Act of 1952, as enacted by

Congress, reflect a delicate public policy balance: to

facilitate the entry of generic drugs into the

marketplace for patient access with the need to

encourage continued innovation by branded

drugmakers.

The existing statutory framework

allows a generic drugmaker to carve out patented

indications and receive FDA approval for limited

indications. A heightened, rigid pleading standard for

Section viii carveout drug products would upset this

equilibrium, creating an extra-statutory immunity for

generic manufacturers. A generic drugmaker who

holds a skinny label cannot promote uses of its drug

outside of its skinny label. If the generic drugmaker

abides by this restriction, IPO agrees that there

should be no viable claim for active induced

infringement of the carved out, patented indication.

This balance is upset, however, when the generic

drugmaker promotes its generic drug for indications

beyond its skinny label. It is often monetarily

advantageous for generic drugmakers to blur this line

and promote uses beyond its limited label, including

patented indication(s). Why? Because, as in this

matter, the off-label uses often form a substantial

portion (or the majority) of the sales of its drug. While

such off-label promotion may make sense from a sales

perspective, it should subject the generic drugmaker

to potential infringement liability. IPO contends that

whenever a generic drugmaker crosses the line and

encourages the use of its drug for patented

12

indications, by any means, a valid claim for induced

infringement of the patented indication should be

allowed to proceed through the discovery process. The

plausibility pleading standard serves as the

appropriate gatekeeper in these instances. This

standard ensures that when a plaintiff provides wellpleaded factual allegations of such plausible

promotion, the claim may proceed to discovery to

determine the true extent of any inducement.

There are good policy reasons supporting this

approach with respect to skinny labels. The patent

system is designed to encourage innovation.

Incentivizing new uses for existing drugs should be

encouraged to help maintain a healthy pipeline of new

treatment regimens for patients and physicians.

However, if regulatory carveouts are transformed into

a shield against induced infringement liability,

pharmaceutical innovators will have little incentive to

look for, let alone conduct the necessary clinical trials

to identify new diseases and conditions that can be

safely and efficaciously treated with existing drugs.

This would potentially allow generic drugmakers to

receive FDA approval for an unpatented indication

while simultaneously giving generic drugmakers a

free pass to promote its use for the patented

indication. Of course, to the extent that an approved

FDA label is truly “skinny” and the generic

manufacturer does not otherwise encourage

infringement of a carved-out indication, it remains

clear that an infringement suit against the generic

drugmaker for inducement cannot stand.

13

CONCLUSION

The Federal Circuit’s application of the pleading

standards dictated by Iqbal and Twombly does not

threaten the Section viii carveout system, it upholds

its integrity. Without specific Congressional or

precedential direction, IPO respectfully submits that

rigid, bright-line tests are inappropriate for assessing

the sufficiency of pleadings for active inducement of

patent infringement made against all classes of

accused infringers, including generic drugmakers.

Instead, pleadings should be judged based on the

totality of well-pled facts, accepted as true, in

accordance with Iqbal, Twombly, and the Federal

Rules of Civil Procedure.

Respectfully submitted,

JOHN J. CHEEK

PAUL H. BERGHOFF

President

Counsel of Record

LAURA SHERIDAN

TAYLOR WEILNAU

Chair, Amicus Brief Committee MCDONNELL BOEHNEN

SAMANTHA J. AGUAYO

HULBERT & BERGHOFF LLP

Deputy Executive Director 300 South Wacker Drive

and Chief Policy Counsel Chicago, IL 60606

INTELLECTUAL PROPERTY

(312) 913–0001

OWNERS ASSOCIATION

Berghoff@mbhb.com

1501 M St. N.W., Suite 1150

Washington, D.C. 20005

APPENDIX

i

TABLE OF APPENDICES

Page

APPENDIX — MEMBERS OF THE BOARD OF

DIRECTORS INTELLECTUAL PROPERTY

OWNERS ASSOCIATION . . . . . . . . . . . . . . . . . . . . 1a

1a

Appendix

APPENDIX — MEMBERS

OF THE BOARD OF

DIRECTORS INTELLECTUAL PROPERTY

OWNERS ASSOCIATION

David Alban

Xylem

Tonya Combs

Eli Lilly and Co.

Matthew Anderson

Medtronic, Inc.

Jamie Davis

Bayer Intellectual

Property GmbH

Ronald Antush

Nokia of Americas Corp.

Scott Barker

Micron Technology, Inc.

Thomas R. Beall

Corning Incorporated

Tyrome Brown

Dolby Laboratories

John J. Cheek

Tenneco Inc.

Dan Choi

Microsoft Corporation

Brandon Clark

SLB

Robinson Clark

Exxon Mobil Corp.

Ewa Davison

The Boeing Co.

Anthony DiBartolomeo

SAP SE

Cass Dottridge

Cargill, Inc.

Jake Feldman

Kenvue

Yen Florczak

3M Innovative Properties Co.

Louis Foreman

Enventys

Darryl P. Frickey

Dow Chemical Co.

2a

Appendix

Mony Ghose

Danaher Corp.

Christine Lam

NetApp

Robert Giles

Qualcomm Inc.

David Lane

Johnson & Johnson

Laura Ginkel

Merck & Co.

Alexander Long

GE Aerospace

Krish Gupta

Dell Technologies

Ceyda Maisami

HP Inc.

Henry Hadad

Bristol-Myers Squibb Co.

Paul Mussell

Wells Fargo & Company

Aamir Haq

Hewlett Packard

Enterprise

Jeffrey Myers

Apple Inc.

Scott Hayden

Amazon

Michael King

Caterpillar Inc.

Thomas R. Kingsbury

Bridgestone Americas, Inc.

Laurie Kowalsky

Koninklijke Philips N.V.

Sandra Nowak

Solventum

Hugh Pasika

Thermo Fisher Scientific Inc.

Erik Perez

Shell USA, Inc.

Troy Prince

RTX Corporation

3a

Appendix

Kaveh Rashidi-Yazd

Eaton Corporation

Corey Salsberg

Novartis

Matthew Sarboraria

Oracle Corporation

Laura Sheridan

Google Inc.

Jessica Sinnott

DuPont

Thomas Smith

GlaxoSmithKline

Daniel Staudt

Siemens Corp.

Sarah Tully

Roche, Inc.

Mark Vallone

IBM Corp.

Stuart Watt

Amgen, Inc.