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 REGENERON

PHARMACEUTICALS, INC. AS AMICUS

CURIAE IN SUPPORT OF RESPONDENTS

____________________________

Larry A. Coury

Petra Scamborova

REGENERON

PHARMACEUTICALS, INC.

777 Old Saw Mill River Rd.

Tarrytown, NY 10591

Irena Royzman

Katherine E. Munyan

ORRICK, HERRINGTON &

SUTCLIFFE LLP

51 West 52nd Street

New York, NY 10019

Farheena Y. Rasheed

Counsel of Record

Kamilyn Y. Choi

ORRICK, HERRINGTON &

SUTCLIFFE LLP

2100 Pennsylvania

Avenue, NW

Washington, DC 20037

(202) 339-8400

frasheed@orrick.com

Clement Seth Roberts

ORRICK, HERRINGTON &

SUTCLIFFE LLP

305 Howard Street

San Francisco, CA 94105

Counsel for Amicus Curiae

i

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES ..................................... ii

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

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

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

I.

Twombly And Iqbal Supply A Neutral,

Workable Pleading Standard. ............................ 3

II. Petitioners’ Arguments Would Undermine

Twombly And Iqbal By Creating

Heightened Pleading Rules For Certain

Induced-Infringement Claims. ........................... 6

III. Adopting Special Pleading Rules Would

Be Inconsistent With Patent Protections. ......... 8

CONCLUSION ........................................................ 10

ii

TABLE OF AUTHORITIES

Page(s)

Cases

Ashcroft v. Iqbal,

556 U.S. 662 (2009)............................................4, 5

Bell Atlantic Corp. v. Twombly,

550 U.S. 544 (2007)............................................3, 4

Berk v. Choy,

607 U.S. __, 2026 WL 135974 (Jan. 20, 2026) ......8

Eolas Techs. Inc. v. Microsoft Corp.,

399 F.3d 1325 (Fed. Cir. 2005) ..............................8

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

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

Limelight Networks, Inc. v. Akamai

Techs., Inc.,

572 U.S. 915 (2014)................................................6

MGM Studios Inc. v. Grokster, Ltd.,

545 U.S. 913 (2005)................................................6

Swierkiewicz v. Sorema N.A.,

534 U.S. 506 (2002)................................................7

Statutes & Rules

35 U.S.C. § 271(b)........................................................6

Fed. R. Civ. P. 8(a) ......................................................4

Fed. R. Civ. P. 9(b) ......................................................7

Fed. R. Civ. P. 12(b)(6) ................................................3

iii

Other Authorities

Mark D. Janis, Comment, Equilibrium

in a Technology-Specific Patent System, 54 Case W. L. Rev. 743 (2004),

https://perma.cc/UL33-TDN9 ................................9

5 Wright & Miller’s Federal Practice &

Procedure § 1221 (4th ed.) .....................................4

1

INTEREST OF AMICUS CURIAE 1

Regeneron Pharmaceuticals, Inc. is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people

with serious diseases. It regularly seeks and receives

patent protection for its scientific advancements. Regeneron regularly acts as plaintiff and defendant in

patent cases. It has a strong interest in having clear,

predictable, and uniform pleading standards. 2

Regeneron believes (i) that the pleading standards of Twombly and Iqbal work well for patent cases,

and (ii) that the Court should not change those clear

and uniform rules to create industry-or-technologyspecific pleading rules.

SUMMARY OF ARGUMENT

As the law currently stands, a plaintiff can satisfy

the pleading standard for induced infringement by

pleading facts that plausibly show that all of the elements of induced infringement are satisfied.

In evaluating whether a plaintiff has met that

burden, a court will look at all the alleged facts. No

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

part. No party, counsel for a party, or any person other than amicus and its counsel made a monetary contribution intended to

fund the preparation or submission of this brief.

2 Regeneron takes no position on respondents’ pleading. Regeneron’s view is that the Federal Circuit applied the law correctly and that the Court should not impose any technologyspecific pleading rules and that courts should instead consider

all factual allegations in evaluating a motion to dismiss.

2

facts are excluded from the analysis, and no specific

facts or words need be recited.

The position urged by petitioners would change

this status quo. Under the petitioners’ approach, some

facts (e.g., “general” marketing statements) would not

be considered in determining whether a defendant either intended to cause or actually did cause infringement. More specifically, statements outside the

product label would be excluded from the analysis,

along with any alleged facts about the context—i.e.

how the defendant’s marketing statements were understood by the people to whom they were directed.

At the same time, petitioners’ position would require a plaintiff to plead certain “magic words”—

namely it would require a plaintiff to allege that the

defendant expressly called for a specific, patented use

of its product.

Regeneron urges the Court to refrain from either

(i) excluding certain kinds of factual allegations from

the analysis or (ii) requiring a plaintiff to plead that a

defendant has expressly mentioned the patented use.

Instead, the Court should use this case to reaffirm the

basic standard of Twombly and Iqbal—that the only

question at the motion to dismiss stage is whether the

totality of the facts alleged give rise to a plausible

showing that the elements of the asserted claim are

met.

This framework is important. Among other

things, it provides a clear, neutral standard and the

flexibility that lower courts need to adequately address both technological evolution and the messy fact

3

patterns that arise in the real world. Moving away

from this standard and towards a rule-based system

with specialized requirements and exceptions for certain technologies would undermine the neutrality and

the flexibility of the current system.

It would also encourage gamesmanship. Imagine,

for example, if the Court were to adopt petitioners’ position that a defendant cannot be sued for inducing

infringement based on marketing statements. As the

Court knows, inducement requires a defendant to

both (i) actually cause a third party to infringe and (ii)

intend to cause that third party to infringe. Should it

really be the case that a defendant that both intends

to and succeeds in causing infringement gets a pass

because the mechanism through which it acted was a

marketing statement? Petitioners apparently think

so. Regeneron does not.

ARGUMENT

I.

Twombly And Iqbal Supply A Neutral,

Workable Pleading Standard.

This Court’s decisions in Twombly and Iqbal together enunciate the standard for evaluating a motion to dismiss in civil litigation, regardless of the

area of law or claims asserted. In Twombly, the Court

established the “plausibility standard” governing motions to dismiss under Federal Rule of Civil Procedure

12(b)(6). Bell Atlantic Corp. v. Twombly, 550 U.S. 544,

560 (2007). Applying that standard, a court assesses

whether a complaint survives a motion to dismiss by

reviewing whether “all the allegations in the complaint,” if taken as true, are sufficient “to raise a right

4

to relief above the speculative level,” i.e., to establish

“plausible grounds” for relief, excluding only bare “‘legal conclusion[s] couched as … factual allegation[s].’”

Id. at 555-56 (emphasis added). This standard reflects

Federal Rule of Civil Procedure 8(a)’s requirement

that a complaint include “‘a short and plain statement

of the claim showing that the pleader is entitled to relief.’” Id. at 555.

In Iqbal, the Court emphasized that Twombly

provided “the pleading standard for ‘all civil actions.’”

Ashcroft v. Iqbal, 556 U.S. 662, 684 (2009). In other

words, aside from a few special pleading provisions

specifically enumerated in the Federal Rules, see infra 7-8, the Twombly/Iqbal standard “controls in

every case, regardless of its size, complexity, or the

number of parties that may be involved.” 5 Wright &

Miller’s Federal Practice & Procedure § 1221 (4th ed.)

Twombly, Iqbal, and the Federal Rules of Civil

Procedure provide a uniform civil-pleading standard

for good reason. This approach supplies a flexible

standard that keeps the Federal Court system open

without constant Congressional intervention. Put differently, both the kinds of problems and the fact patterns that the Federal Courts must address change

over time. Nothing in the pleading standard permits

a court to ignore the factual allegations in determining whether a plaintiff has established “plausible

grounds” for relief. Twombly, 550 U.S. at 556. To the

contrary, Iqbal, just like Twombly, makes clear that a

court may only disregard improper legal conclusions.

556 U.S. at 678. “When there are well-pleaded factual

allegations, a court should assume their veracity and

5

then determine whether they plausibly give rise to an

entitlement to relief.” Id. at 679.

In this case the Federal Circuit did look at all the

facts and analyzed whether (taken together) they

stated a plausible claim—exactly as Twombly and Iqbal require. See, e.g., Pet. App. 13a-15a, 18a-19a, 21a22a.

For example, the court observed that the patent

owner’s claims did not “rest solely on allegations that

the generic manufacturer’s proposed label is ‘not

skinny enough,’ such that the label alone induces infringement.” Pet. App. 13a; see also Pet. App. 17a. Rather, because the “alleged infringement” here was

“based on the generic manufacturer’s skinny label as

well as its public statements and marketing of its already-approved generic product,” Pet. App. 13a, the

court assessed the respondents’ factual allegations regarding “Hikma’s public statements and marketing

materials,” Pet. App. 17a-18a. In doing so, the court

deemed it “at least plausible that a physician could

read” some of these public statements as encouraging

doctors to prescribe Hikma’s product for all approved

uses, including off-label, patent-protected uses. Pet.

App. 18a-19a.

In sum, consistent with the Twombly/Iqbal

standard, the Federal Circuit emphasized that its

conclusion was based on its assessment of the totality

of the factual allegations in the complaint. See Pet.

App. 17a-18a. The Federal Circuit therefore used the

correct standard. See Pet. App. 14a (reciting Twombly

plausibility standard).

6

II. Petitioners’ Arguments Would Undermine

Twombly And Iqbal By Creating Heightened

Pleading Rules For Certain InducedInfringement Claims.

Section 271(b) of the Patent Act provides that

“[w]hoever actively induces infringement of a patent

shall be liable as an infringer.” 35 U.S.C. § 271(b). To

state a claim for induced infringement, a plaintiff

must allege that (i) direct infringement occurred, and

(ii) the defendant both intended to and did something

to induce that infringement. See Limelight Networks,

Inc. v. Akamai Techs., Inc., 572 U.S. 915, 922 (2014);

MGM Studios Inc. v. Grokster, Ltd., 545 U.S. 913,

936-37 (2005). Thus, under Twombly and Iqbal, a

plaintiff must allege facts which, taken together, create a plausible showing that someone infringed, and

that the defendant actively encouraged that infringement.

In this case, the plaintiff made that showing by

relying (in part) on statements the defendant allegedly made in its marketing materials. While none of

these statements explicitly mentioned the patented

use, the complaint alleged that they were both intended to encourage and did in fact encourage doctors

to prescribe the defendant’s drug for the patented

methods of treatment. See, e.g., BIO App. 29a-34a,

37a-38a. And the Federal Circuit agreed that, in context, it was plausible that they did.

According to petitioners, however, the Court

should not accept this perfectly ordinary line of inference. Instead, petitioners apparently believe there

should be special rules that require a plaintiff to

7

allege that the defendant explicitly “mention[ed]” the

patented indications or provided “instructions” for

someone to practice them. Petrs’ Br. 22.

It is a matter of common sense and ordinary communication that exhorting someone to do something

general can, in context, encourage them to do something specific. For instance, if a company that sells

nails says that its product can be used in place of

screws, it is plausible that the company both intends

to encourage and actively did encourage carpenters to

use its nails to secure boards to a deck, even if it did

not call out that specific use. The Court’s caselaw on

induced infringement accordingly has long recognized

that broad messaging may, in context, impermissibly

channel users towards specific infringing uses. See,

e.g., Glob.-Tech Appliances, Inc. v. SEB S.A., 563 U.S.

754, 758-59 (2011). There is no reason to create a technology-specific exception to that principle.

To be sure, there are “limited exceptions” where

the Federal Rules of Civil Procedure call for a heightened pleading standard. Swierkiewicz v. Sorema N.A.,

534 U.S. 506, 513 (2002). For instance, Federal Rule

of Civil Procedure 9(b) creates a heightened pleading

standard for fraud claims, requiring greater “particularity” in alleging the “circumstances constituting

fraud.”

But no such rule applies to this case. And heightened pleading rules may be prescribed only by amending the Federal Rules, not by judicial fiat.

Accordingly, the Court has “consistently rejected”

lower court efforts “[t]o protect defendants from th[e]

burden” of discovery by “tr[ying] to require more

8

information for certain kinds of claims” at the pleading stage. See Berk v. Choy, 607 U.S. __, 2026 WL

135974, at *4 (Jan. 20, 2026).

Because the FRCP do not impose a heightened

pleading standard on inducement claims, the inquiry

should be the one this Court articulated in Twombly

and Iqbal—whether the facts, taken together, plausibly allege the required claim elements. The Court

should not adopt a special rule specific to this context

or more generally that categorically disregards certain facts and inferences (e.g., that a general exhortation encourages specific conduct) or that requires a

particular fact to be plead (e.g., that a defendant expressly called out a patented use in its communications).

III. Adopting Special Pleading Rules Would Be

Inconsistent With Patent Protections.

Creating a technology-specific pleading rule

would also be contrary to the technology-neutral

structure of the Patent Act and the United States’ international commitments. Patent law in the United

States has long “accord[ed] the same treatment to all

forms of invention.” Eolas Techs. Inc. v. Microsoft

Corp., 399 F.3d 1325, 1339 (Fed. Cir. 2005). The

Agreement on Trade-Related Aspects of Intellectual

Property Rights (TRIPS) likewise requires signatories

to commit to making “patents … available and patent

rights enjoyable without discrimination as to the

place of invention[] [and] the field of technology.”

TRIPS Agreement, Part II, Section 5 (1994).

9

Commentators have explained that technologyneutral rules allow the patent system to adapt to new

technologies without constant statutory revision and

preserve coherence across fields. See Mark D. Janis,

Comment, Equilibrium in a Technology-Specific Patent System, 54 Case W. L. Rev. 743, 744 (2004),

https://perma.cc/UL33-TDN9. “[A] regime of near-infinite specificity” presents courts with “an insurmountable number of boundaries to police” while

litigants face overwhelming uncertainty. Id. at 746.

A heightened pleading rule crafted for a subset of

induced-infringement cases would undermine that

neutrality. It would cause arguments over whether

other industries warrant similar treatment. And it

would incentivize ancillary litigation about how to

categorize the subject matter in question, with litigants fighting to get into the technology-specific regime that appears most favorable to their position.

See id. at 745.

Most troublingly, petitioners’ rule would also risk

under-protecting entire classes of inventions in fields

where inducement is the only viable theory of enforcement. If a complaint must allege that the accused inducer specifically directed users to practice the

patented method, inducement claims become enforceable only against defendants who are candid enough

to put the infringing instructions in writing. That

turns the current standard into a rule that could be

avoided through gamesmanship.

Indeed, were petitioners’ pleading standard

adopted, a defendant could avoid inducing infringement by couching its instructions in general

10

language, perhaps accompanied by a wink and a

nudge. That would work, because (again, under petitioners’ position) courts would not be allowed to consider the wink or the nudge, as they would no longer

look at the totality of the factual allegations.

CONCLUSION

Regeneron urges the Court to affirm that the ordinary pleading rules apply to induced-infringement

claims and to decline any invitation to adopt technology-specific pleading rules.

Respectfully submitted,

Larry A. Coury

Petra Scamborova

REGENERON

PHARMACEUTICALS, INC.

777 Old Saw Mill River Rd.

Tarrytown, NY 10591

Irena Royzman

Katherine E. Munyan

ORRICK, HERRINGTON &

SUTCLIFFE LLP

51 West 52nd Street

New York, NY 10019

Farheena Y. Rasheed

Counsel of Record

Kamilyn Y. Choi

ORRICK, HERRINGTON &

SUTCLIFFE LLP

2100 Pennsylvania

Avenue, NW

Washington, DC 20037

(202) 339-8400

frasheed@orrick.com

Clement Seth Roberts

ORRICK, HERRINGTON &

SUTCLIFFE LLP

305 Howard Street

San Francisco, CA 94105

Counsel for Amicus Curiae

March 27, 2026