Petitioners Brief — Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Amarin Pharma, Inc., et al.
Supreme Court briefFeb 18, 2026
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No. 24-889
In the Supreme Court of the United States
__________
HIKMA PHARMACEUTICALS USA INC. AND
HIKMA PHARMACEUTICALS PLC, PETITIONERS
v.
AMARIN PHARMA, INC., ET AL.
__________
ON WRIT OF CERTIORARI TO THE UNITED STATES
COURT OF APPEALS FOR THE FEDERAL CIRCUIT
__________
BRIEF FOR PETITIONERS
__________
EIMERIC REIG-PLESSIS
Winston & Strawn LLP
101 California Street
San Francisco, CA 94111
(415) 591-1000
ALISON M. KING
Winston & Strawn LLP
35 W. Wacker Drive
Chicago, IL 60601
(312) 558-5600
CHARLES B. KLEIN
Counsel of Record
MICHAEL B. KIMBERLY
CLAIRE A. FUNDAKOWSKI
Winston & Strawn LLP
1901 L Street NW
Washington, DC 20036
(202) 282-5000
cklein@winston.com
SAMUEL S. PARK
EDWARD J. PARDON
Hikma Pharmaceuticals
200 Connell Drive
Berkeley Heights,
NJ 07922
Counsel for Petitioners
QUESTIONS PRESENTED
Congress passed the Hatch-Waxman Act “[t]o facilitate the approval of generic drugs as soon as patents
allow.” Caraco Pharm. Labs., Ltd. v. Novo Nordisk
A/S, 566 U.S. 399, 405 (2012). Recognizing that many
drugs are approved for both patented and unpatented
uses, Congress sought to ensure “that one patented
use will not foreclose marketing a generic drug for
other unpatented ones.” Id. at 415. The statutory
mechanism is a “skinny label”: Generic drugmakers
“carve out” patented uses from their labels, leaving
only instructions to use generic drugs for their unpatented uses. See 21 U.S.C. § 355(j)(2)(A)(viii).
Congress designed this carve-out mechanism to encourage competition and to protect generic drugmakers from allegations that marketing a generic drug for
an unpatented use “actively induces infringement.” 35
U.S.C. § 271(b). After all, active inducement requires
“clear expression or other affirmative steps taken to
foster infringement”—there is no “liability when a defendant merely sells a commercial product suitable for
some lawful use.” Metro-Goldwyn-Mayer Studios Inc.
v. Grokster, Ltd., 545 U.S. 913, 936–937 & n.11 (2005).
The questions presented are:
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
PARTIES TO THE PROCEEDING
Petitioners (defendants-appellees below) are Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (collectively, “Hikma”).
Respondents (plaintiffs-appellants below) are Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland
Limited, and Mochida Pharmaceutical Co., Ltd. (collectively, “Amarin”).
RULE 29.6 STATEMENT
Hikma Pharmaceuticals USA Inc. is an indirect,
wholly owned subsidiary of Hikma Pharmaceuticals
PLC, which is a publicly held corporation.
Hikma Pharmaceuticals PLC does not have a parent corporation, and no publicly held corporation owns
10% or more of its stock.
RELATED PROCEEDINGS
U.S. District Court for the District of Delaware:
Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 20-cv-1630 (Oct. 13, 2022).
U.S. Court of Appeals for the Federal Circuit:
Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 2023-1169 (June 25, 2024).
iii
TABLE OF CONTENTS
Page
QUESTIONS PRESENTED ....................................... i
PARTIES TO THE PROCEEDING .......................... ii
RULE 29.6 STATEMENT ......................................... ii
RELATED PROCEEDINGS...................................... ii
TABLE OF AUTHORITIES ...................................... v
INTRODUCTION ...................................................... 1
OPINIONS BELOW .................................................. 4
JURISDICTION......................................................... 4
STATUTORY PROVISIONS INVOLVED ................ 4
STATEMENT............................................................. 4
A. Background ..................................................... 4
1. The Hatch-Waxman Act ............................ 4
2. Amarin’s icosapent ethyl drug product
branded as Vascepa ................................... 8
3. Hikma’s ANDA for a generic version of
Vascepa ...................................................... 9
B. Procedural background ................................. 10
1. The operative complaint .......................... 10
2. The district court’s decision..................... 18
3. The court of appeals’ decision ................. 19
SUMMARY OF THE ARGUMENT ........................ 21
ARGUMENT ............................................................ 23
I. Indirect liability for inducement under § 271(b)
requires active inducement. ............................... 23
iv
II. Amarin’s complaint fails to state a plausible
claim for active inducement. .............................. 29
A. Rule 12(b)(6) requires dismissing a complaint
that does not contain sufficient factual
allegations to state a plausible claim. .......... 30
B. Hikma’s skinny label encourages only
noninfringing use, and its other statements
do not “actively induce[]” specific conduct. .. 32
C. Hikma’s accused statements, alone or
together, do not encourage action sufficient
for “infringement of a patent.” ...................... 35
D. The Federal Circuit’s decision, if allowed to
stand, would impose liability for mere passive
inducement. ................................................... 38
III. Allowing a complaint like Amarin’s to proceed
would effectively nullify section viii. ................. 41
CONCLUSION ........................................................ 46
v
TABLE OF AUTHORITIES
Page(s)
CASES
ALA, Inc. v. CCAIR, Inc.,
29 F.3d 855 (3d Cir. 1994) .............................. 32, 34
Amarin Pharma, Inc. v. Hikma Pharm.
USA, 449 F. Supp. 3d 967
(D. Nev. 2020), aff’d,
819 F. App’x 932 (Fed. Cir. 2020) .......................... 9
Ashcroft v. Iqbal,
556 U.S. 662 (2009) ................ 18, 21, 30, 31, 32, 34
AstraZeneca Pharms. LP v. Apotex
Corp.,
669 F.3d 1370 (Fed. Cir. 2012)............... 2, 4, 43, 44
Bell Atl. Corp. v. Twombly,
550 U.S. 544 (2007) .......... 18, 21, 23, 30, 31, 32, 45
Blonder-Tongue Labs., Inc. v. Univ. of
Ill. Found.,
402 U.S. 313 (1971) .............................................. 44
Caraco Pharm. Labs., Ltd. v. Novo
Nordisk A/S,
566 U.S. 399 (2012) .... 1, 2, 4, 5, 6, 7, 10, 42, 44, 45
Commil USA, LLC v. Cisco Sys., Inc.,
575 U.S. 632 (2015) .............................................. 25
F.T.C. v. Actavis, Inc.,
570 U.S. 136 (2013) .............................................. 44
vi
GlaxoSmithKline LLC v. Teva Pharms.
USA, Inc.,
7 F.4th 1320 (Fed. Cir. 2021) ............. 19, 42, 44, 46
GlaxoSmithKline LLC v. Teva Pharms.
USA, Inc.,
25 F.4th 949 (Fed. Cir. 2022) ............................... 44
Glob.-Tech Appliances, Inc. v. SEB S.A.,
563 U.S. 754 (2011) .................................. 24, 25, 26
Halo Elecs., Inc. v. Pulse Elecs., Inc.,
579 U.S. 93 (2016) ................................................ 11
HZNP Medicines LLC v. Actavis Labs.
UT, Inc.,
940 F.3d 680 (Fed. Cir. 2019 ................................ 28
Inwood Labs., Inc. v. Ives Labs., Inc.,
456 U.S. 844 (1982) .................................... 7, 36, 37
Limelight Networks, Inc. v. Akamai
Techs., Inc.,
572 U.S. 915 (2014) ............................ 26, 27, 29, 41
Metro-Goldwyn-Mayer Studios Inc. v.
Grokster, Ltd.,
545 U.S. 913 (2005) .......... 24, 25, 26, 27, 28, 35, 41
PLIVA, Inc. v. Mensing,
564 U.S. 604 (2011) .............................................. 13
Smith & Wesson Brands v. Estados
Unidos Mexicanos,
605 U.S. 280 (2025) ...................... 24, 25, 27, 29, 31
vii
Takeda Pharms. U.S.A., Inc. v. W.-Ward
Pharm. Corp.,
785 F.3d 625 (Fed. Cir. 2015)............. 18, 28, 43, 44
Tellabs, Inc. v. Makor Issues & Rights,
Ltd.,
551 U.S. 308 (2007) .............................................. 31
Twitter, Inc. v. Taamneh,
598 U.S. 471 (2023) ........................................ 18, 31
STATUTES
21 U.S.C.
§ 353d(a)(3) ....................................................... 4, 42
§ 355(b)(1) ............................................................... 4
§ 355(d) ................................................................... 4
§ 355(j)(2)(A)(ii)....................................................... 5
§ 355(j)(2)(A)(iv) ...................................................... 5
§ 355(j)(2)(A)(v) ................................................. 5, 12
§ 355(j)(2)(A)(vii)(IV) .............................................. 6
§ 355(j)(2)(A)(viii) ......................................... 1, 6, 10
§ 355(j)(4)(F) ..................................................... 5, 42
§ 355(j)(5)(B)(iii) ................................................. 6, 7
28 U.S.C.
§ 1254(1).................................................................. 4
§ 1331 ...................................................................... 4
§ 1338(a).................................................................. 4
35 U.S.C.
§ 271(a).................................................................. 24
§ 271(b)....................1, 2, 3, 6, 10, 21, 22, 23, 24, 25,
26, 28, 29, 32, 35, 37, 38, 39, 42, 46
§ 271(e)(2)(A) .......................................................... 6
§ 284 ...................................................................... 11
viii
OTHER AUTHORITIES
21 C.F.R. § 314.94(a)(7)(i)...................................... 5, 42
42 C.F.R. § 423.132(a) ............................................... 42
Fed. R. Civ. P.
10(c) ........................................................... 21, 32, 34
12(b)(6) ........................ 18, 19, 23, 30, 32, 39, 42, 46
54(b) ...................................................................... 19
Abbreviated New Drug Application
(ANDA), FDA,
https://www.fda.gov/drugs/
types-applications/abbreviated-newdrug-application-anda .......................................... 43
Bryan S. Walsh et al., Frequency of First
Generic Drug Approvals With
“Skinny Labels” in the United States,
181 J. AM. MED. ASS’N INTERNAL
MED. 995 (2021) .................................................... 45
Gregory Day & Steven Udick, Patent
Law and the Emigration of
Innovation,
94 WASH. L. REV. 119 (2019) ................................ 45
William Haddad, The Drug Price
Competition and Patent Term
Restoration Act, Generic Drug Laws:
A Decade of Trial—A Prescription for
Progress (Theodore Goldberg et al.
eds., U.S. Dep’t of Health & Human
Servs. 1986) ............................................................ 7
H.R. Rep. No. 98-857 (1984) ........................................ 8
ix
Health & Human Servs., Comprehensive
Plan for Addressing High Drug
Prices (Sept. 2021),
https://aspe.hhs.gov/sites/default/files/2021-09/Drug_Pricing_Plan_9-9-2021.pdf.......................................... 46
S. Sean Tu & Charles Duan,
Pharmaceutical Patent Two-Step:
The Adverse Advent of Amarin v.
Hikma Type Litigation, 12 NYU J.
INTELL. PROP. & ENT. L. 1 (2022) ......................... 45
Therese J. Ziaks et al., Frequency of
First Generic Drugs Approved
Through “Skinny Labeling,”
2021 to 2023, 31 J. MANAG. CARE
SPEC. PHARM. 343 (2025) ...................................... 46
WEBSTER’S NEW INT’L DICTIONARY
(2d ed. 1945) ......................................................... 24
INTRODUCTION
This case is about the affirmative conduct a complaint must allege to state a plausible claim of “actively induce[d] infringement of a patent.” 35 U.S.C.
§ 271(b). The legal standard for active inducement is
especially important for the generic pharmaceutical
industry because branded drugmakers often hold patents on “a particular method of using [a] drug.” Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S.
399, 405 (2012). Generic drugmakers are not held liable for directly infringing such patents because they do
not treat patients, but they risk actively inducing doctors and patients to infringe depending on the instructions in their generic drug labels, which generally
must match the labels for their branded counterparts.
“To facilitate the approval of generic drugs as soon
as patents allow,” ibid., Congress passed the Drug
Price Competition and Patent Term Restoration Act of
1984, commonly known as the Hatch-Waxman Act,
which created regulatory pathways intended to resolve
patent disputes before generic product launch, or to
avoid litigation altogether. One of the Act’s provisions,
known in the pharmaceutical industry as “section viii,”
authorizes so-called skinny labels, which allow generic-drug manufacturers to carve out patented indications from their generic labels, leaving only unpatented indications that do not actively induce infringement. See 21 U.S.C. § 355(j)(2)(A)(viii).
When it passed section viii, Congress was aware of
state laws allowing automatic substitution by pharmacists of generic-drug equivalents for branded counterparts, meaning that doctors and patients inevitably
would use skinny-labeled generics for patented indications. Infra 7–8. Congress nonetheless contemplated
2
that generic manufacturers who choose the section viii
pathway could avoid labeling that actively induces patent infringement. A skinny label that carves out the
patented indication thus ensures “that one patented
use will not foreclose marketing a generic drug for
other unpatented ones.” Caraco, 566 U.S. at 415.
This skinny-label solution works only if it remains
an economically viable option to expedite generic-drug
competition for unpatented uses. Until recently, the
Federal Circuit understood this: The “market realities” of automatic substitution and resulting infringement by doctors and patients cannot suffice to plead
active inducement by generic drugmakers that invoke
the section viii pathway. AstraZeneca Pharms. LP v.
Apotex Corp., 669 F.3d 1370, 1380 (Fed. Cir. 2012). If
merely alleging that a generic drug with a skinny label
will inevitably be substituted for patented uses were
enough to plead active inducement, it “would, in practice, vitiate” section viii and “allow a pioneer drug
manufacturer to maintain de facto indefinite exclusivity over a pharmaceutical compound by obtaining serial patents for approved methods of using the compound,” “contrary to the statutory scheme.” Ibid.
Following the Federal Circuit’s decision in this
case, however, it no longer makes economic sense for
any generic drugmaker to invoke section viii. The
court below interpreted § 271(b) to impose liability for
the most routine and anodyne statements about
skinny-labeled generics. In doing so, the court of appeals effectively read the word “actively” out of
§ 271(b), replacing it with the precise opposite word,
“passively.” Branded drugmakers now may threaten
lost-profit damages for almost anything a generic
drugmaker might say about generic drug products
3
brought to market under section viii—including (as
here) statements to investors, and not even to doctors
or patients. As a result, the Federal Circuit’s holding
risks shutting down the section viii pathway altogether.
The decision below should not stand. It spurns the
statutory text and trammels Congress’ settled purposes in enacting both the 1952 Patent Act and the
1984 Hatch-Waxman Act. Section 271(b) requires that
(1) the defendant “actively induces” a direct infringer
to take specific action, and (2) that action amounts to
“infringement of a patent.” A complaint assuredly
fails to state a claim for actively induced infringement
of a patented method under that straightforward test
if it does not allege any instruction or other statement
by the defendant that encourages, or even mentions,
the patented use. Where, as here, a skinny label fully
carves out all patented uses under section viii, allegations that the generic drugmaker simply calls its product a “generic version” of the branded drug and cites
public information about the drug (for example, sales
figures) are insufficient to state a claim under § 271(b).
Amarin’s contrary positions are inconsistent with
the plain text of the Patent Act and offend the HatchWaxman Act’s well-recognized purposes. Allowing
cases like this one to survive the pleadings stage—
thus subjecting generic drugmakers to the burdensome costs of discovery and in terrorem threats of massive (and potentially trebled) lost-profits damages—
would make the section viii pathway economically
nonsensical, defeating Congress’ intent to promote generic-drug competition. Reversal is in order.
4
OPINIONS BELOW
The decision below (Pet.App.1a–22a) is reported at
104 F.4th 1370 (Fed. Cir. 2024). The order denying
rehearing (Pet.App.39a–41a) is unpublished. The district court’s decision (Pet.App.25a–38a) is reported at
578 F. Supp. 3d 642 (D. Del. 2022).
JURISDICTION
The district court, which dismissed the case with
prejudice, JA64–65, had jurisdiction under 28 U.S.C.
§§ 1331 and 1338(a). The Federal Circuit entered
judgment on June 25, 2024, and denied rehearing on
October 17, 2024. The Chief Justice extended the time
to file a petition for a writ of certiorari until February
14, 2025. Hikma timely filed the petition, which the
Court granted on January 16, 2026. This Court has
jurisdiction under 28 U.S.C. § 1254(1).
STATUTORY PROVISIONS INVOLVED
The relevant statutory provisions are reproduced
in the petition appendix at 42a–43a.
STATEMENT
A. Background
1. The Hatch-Waxman Act
a. A manufacturer seeking FDA approval to market a new drug must submit a new drug application
(NDA) with “scientific data showing that the drug is
safe and effective, and proposed labeling describing
the uses for which the drug may be marketed.” Caraco, 566 U.S. at 404 (citing 21 U.S.C. § 355(b)(1), (d)).
After FDA approves an NDA, other companies can
seek approval for a “‘generic version’ * * * [of a] reference listed drug,” 21 U.S.C. § 353d(a)(3), by filing an
5
abbreviated new drug application (ANDA). Caraco,
566 U.S. at 404–405.1 Instead of recreating “independent evidence of safety and efficacy, the typical ANDA
shows that the generic drug has the same active ingredients as, and is biologically equivalent to, the referenced brand-name drug”—an expedited process “designed to speed the introduction of low-cost generic
drugs to market.” Id. at 405 (citing 21 U.S.C.
§ 355(j)(2)(A)(ii), (iv)); see also 21 U.S.C. § 355(j)(2)
(A)(iv), (j)(4)(F); 21 C.F.R. § 314.94(a)(7)(i). In general,
“labeling proposed for the [generic version] is the same
as the labeling approved for the [reference] listed
drug.” 21 U.S.C. § 355(j)(2)(A)(v).
“Because the FDA cannot authorize a generic drug
that would infringe a patent, the timing of an ANDA’s
approval depends on the scope and duration of the patents covering the brand-name drug,” which “come in
different varieties.” Caraco, 566 U.S. at 405. Some
cover “the drug compound itself.” Ibid. Others cover
only “a particular method of using the drug.” Ibid.
Importantly, “FDA may approve a brand-name
drug for multiple methods of use—either to treat different conditions or to treat the same condition in different ways”—and, oftentimes, “the brand holds patents on only some approved methods of using the
drug.” Id. at 404, 406. “To facilitate the approval of
generic drugs as soon as patents allow,” the brand
must publicly identify any patents that allegedly cover
the drug or its approved methods of use, and FDA lists
those patents in “the Orange Book.” Id. at 405–406.
1 All emphases are added unless stated otherwise.
6
b. An ANDA filer (i.e., generic-drug manufacturer)
seeking to market a generic version of a reference
listed drug with one or more unexpired patents in the
Orange Book has two options as to each patent.
The first option is to file a “paragraph IV certification” that the listed patent is invalid or not infringed
by the proposed generic drug. Id. at 407 (citing 21
U.S.C. § 355(j)(2)(A)(vii)(IV)). “Filing a paragraph IV
certification means provoking litigation” because it
“gives the brand an immediate right to sue.” Ibid. (citing 35 U.S.C. § 271(e)(2)(A)). “Assuming the brand
does so, the FDA generally may not approve the ANDA
until 30 months pass or the court finds the patent invalid or not infringed,” which may “keep the generic
drug off the market for a lengthy period.” Id. at 407–
408 (citing 21 U.S.C. § 355(j)(5)(B)(iii)).
The second option applies to Orange-Book patents
that cover fewer than all FDA-approved methods of using a drug. To avoid the burdens and delays of patent
litigation, the ANDA filer may submit a section viii
statement, which “asserts that the generic manufacturer will market the drug for one or more methods of
use not covered by the brand’s patents.” Id. at 406 (citing 21 U.S.C. § 355(j)(2)(A)(viii)). Under section viii, an
ANDA filer can use a skinny label “that ‘carves out’
from the brand’s approved label the still-patented
methods of use.” Ibid. Section viii thus represents an
“exception to the usual rule that a generic drug must
bear the same label as the brand-name product.” Ibid.
By omitting instructions that might otherwise encourage patented uses, the generic drugmaker avoids
a potential claim that its label “actively induces infringement” under § 271(b). Thus, an ANDA filed with
a section viii statement and no paragraph IV
7
certification does not provoke Hatch-Waxman litigation or otherwise justify a 30-month stay of FDA approval. See 21 U.S.C. § 355(j)(5)(B)(iii). This process
ensures that skinny-labeled generic drugs “can quickly
come to market” inasmuch as “one patented use will
not foreclose marketing a generic drug for other unpatented ones.” Caraco, 566 U.S. at 415.
c. Congress adopted section viii and its skinny-label approach against the backdrop of state generic substitution laws, which “allow[] pharmacists to substitute generic drugs for brand name drugs under certain
conditions.” Inwood Labs., Inc. v. Ives Labs., Inc., 456
U.S. 844, 847 & n.4 (1982). When Congress enacted
the Hatch-Waxman Act in 1984, “all states had repealed their anti-substitution statutes in favor of drug
product substitution.” William Haddad, The Drug
Price Competition and Patent Term Restoration Act,
Generic Drug Laws: A Decade of Trial—A Prescription
for Progress, 509, 510 (Theodore Goldberg et al. eds.,
U.S. Dep’t of Health & Human Servs. 1986); see also
U.S.Cert.Br. 5–6 & nn.2–3 (collecting statutes).
At the time of section viii’s adoption, it was thus
widely understood that doctors and patients necessarily would infringe method-of-treatment patents despite the use of skinny labels. As former Congressman
Henry A. Waxman explained in a later-filed brief to
the Federal Circuit, “Congress was aware that the approval of a generic drug as therapeutically equivalent
to the brand drug means that it may be safely substituted for all uses, including those that are carved out
of the labeling”; yet, Congress “intended that, without
more, a generic would not be liable for infringement if
a physician prescribes generic drugs for patented offlabel uses.” GlaxoSmithKline LLC v. Teva Pharms.
8
USA, Inc., No. 18-1976 (Fed. Cir. Oct. 27, 2021), Amici
Curiae Br. in Support of Pet. for Reh’g En Banc, Dkt.
226, at 5 (citation omitted).
Congress adopted section viii nevertheless. In section viii, Congress allowed generic drugs to reach the
market—with no prior notice to brands—using a
skinny label, to ensure doctors and patients had access
to unpatented drugs for unpatented indications, even
though doctors and patients would inevitably infringe
by also practicing carved-out, patented indications. The House Report explained that, under section
viii, “if [a] listed drug has been approved for hypertension and angina pectoris, and if the indication for hypertension is protected by patent, then [an] applicant
could seek approval for only the angina pectoris indication.” H.R. Rep. No. 98-857, at 21 (1984).
2. Amarin’s icosapent ethyl drug product
branded as Vascepa
In 2012, FDA approved Amarin’s NDA to market
Vascepa, which contains the active ingredient icosapent ethyl. BIO.App.6a, ¶¶ 28, 30. The approval followed the completion of a study demonstrating that
icosapent ethyl reduces triglycerides in patients with
severe hypertriglyceridemia, a condition characterized
by very high levels of triglycerides (fats) in the blood.
BIO.App.6a, ¶ 30. Vascepa was thus initially approved and indicated solely for use to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Ibid.; BIO.App.13a–14a, ¶ 56. This is the “SH
indication.” As Amarin acknowledges, “the primary
concern for patients with severe hypertriglyceridemia”
is pancreatitis, which is general inflammation of the
pancreas. BIO.6.
9
In late 2019, FDA approved a second Vascepa indication for use “as an adjunct to maximally tolerated
statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable
angina requiring hospitalization in adult patients with
elevated triglyceride (TG) levels” and certain risk factors for cardiovascular disease. BIO.App.8a, ¶ 34;
BIO.App.13a–14a, ¶ 56. This is the “CV indication.”
The parties agree the SH and CV indications are
distinct. For one, Amarin acknowledges the SH indication is now “off-patent.” BIO.22. As Amarin also
acknowledges, “FDA was not convinced” that clinical
data demonstrating icosapent ethyl reduces triglycerides “proved a reduction in cardiovascular risk.”
BIO.6; see also BIO.App.7a, ¶ 32 (explaining FDA determined “lowered triglyceride levels * * * did not
show an actual reduction in cardiovascular risk”).
3. Hikma’s ANDA for a generic version of
Vascepa
In 2016, Hikma filed an ANDA seeking approval
for a generic icosapent ethyl product. That ANDA included paragraph IV certifications challenging Amarin’s then-existing patents tied to Vascepa’s sole FDAapproved indication at the time—the SH indication.
Pet.App.4a, n.4. Amarin sued Hikma on those patents. Hikma prevailed, invalidating all asserted SH
patents as obvious. Ibid.; see also Amarin Pharma,
Inc. v. Hikma Pharm. USA, 449 F. Supp. 3d 967 (D.
Nev. 2020), aff’d, 819 F. App’x 932 (Fed. Cir. 2020).
FDA approved the CV indication in 2019, shortly
before trial on the patents for the SH indication.
BIO.App.8a, ¶ 34. Per FDA regulations, Amarin listed
patents associated with the CV indication in the
10
Orange Book. BIO.App.19a–20a, ¶¶ 70–78. Hikma’s
ANDA thus had to address the CV indication before
FDA could approve that ANDA.
Hikma opted not to file paragraph IV certifications
challenging Amarin’s CV-indication patents. Instead,
Hikma filed a section viii statement “seeking FDA approval only for uses not covered by Amarin’s newly
listed CV indication patents.” Pet.App.4a. Hikma
thus sought FDA “approval of a ‘skinny label’ for its
generic product that would include only the SH indication and not the CV indication.” Pet.App.4a–5a.
Hikma’s section viii statement and proposal to
carve out the CV indication were consistent with the
use codes Amarin provided FDA for each of its Orange
Book-listed, CV-indication patents. See Caraco, 566
U.S. at 407 (“whether section viii is available to a generic manufacturer depends on how the brand describes its patent”); BIO.App.26a, ¶ 97 (FDA’s “role
with respect to patents [i]s ‘ministerial’”). FDA approved Hikma’s skinny-label generic product in May
2020. BIO.App.27a, ¶ 105.
In November 2020, shortly after the Federal Circuit summarily affirmed the invalidity judgment for
the SH-indication patents, Hikma launched its generic
icosapent product with the CV indication carved out of
its label. Pet.App.7a. Hikma’s label has remained materially the same ever since. See BIO.App.27a, ¶ 106.
B. Procedural background
1. The operative complaint
Within a month of Hikma’s product launch, Amarin
sued again, this time asserting claims for actively induced infringement of patents that allegedly cover the
CV indication under § 271(b). See BIO.App.1a–62a.
11
Amarin seeks “damages, including lost profits.”
BIO.App.47a, ¶ 170; BIO.App.51a, ¶ 186. Amarin also
seeks a finding that Hikma’s alleged infringement was
willful, BIO.App.59a, which allows courts to “increase
the damages up to three times the amount found or
assessed,” 35 U.S.C. § 284. See Halo Elecs., Inc. v.
Pulse Elecs., Inc., 579 U.S. 93, 103–104 (2016).
Amarin currently asserts two patents allegedly related to the CV indication.2 The first, the ’537 patent,
claims a specific method of treatment, including using
icosapent ethyl with a second agent (a recited statin)
for “reducing occurrence of a cardiovascular event” in
certain patients. Pet.App.8a; BIO.App.10a–11a, ¶ 45;
JA76. The second, the ’861 patent, claims a different
method of treatment for a different patient population
that requires using icosapent ethyl for “reducing risk
of cardiovascular death in a subject with established
cardiovascular disease.” Pet.App.9a; BIO.App.12a–
13a, ¶ 53; JA180. Vascepa is not indicated to reduce
the risk of cardiovascular death. See BIO.App.13a–
14a, ¶ 56 (CV indication covers Vascepa’s use “as an
adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary
revascularization, and unstable angina requiring hospitalization,” with no mention of cardiovascular
death).
Amarin’s induced-infringement allegations, summarized below, rely on a combination of Hikma communications contained in its FDA-approved skinny label, in pre-launch press releases to investors announcing litigation victories, and on its website. Amarin
2 The parties stipulated to dismissal of Amarin’s claim as to
a third asserted patent. Pet.App.3a–4a n.3.
12
alleges that doctors and patients may infer from the
combination of these communications that they may
use Hikma’s product for both Vascepa indications.
a. Amarin does not allege—and no lower court has
found—that Hikma’s label, standing alone, induces infringement. See Pet.App.17a, 21a. Amarin’s complaint instead relies on four features of the label, in
combination with Hikma’s other public statements.
It relies, first, on the absence of a “CV Limitation of
Use” that was in the original Vascepa label, before
FDA approved the CV indication. See BIO.App.27a–
29a, ¶¶ 107–108. That limitation stated that “[t]he effect of VASCEPA on cardiovascular mortality and
morbidity in patients with severe hypertriglyceridemia has not been determined.” BIO.App.14a–16a,
¶ 60. Amarin alleges “Hikma intentionally amended
the proposed labeling for its icosapent ethyl capsules
to remove the CV Limitation of Use.” BIO.App.28a–
29a, ¶ 108. The complaint asserts that the absence of
this language in Hikma’s label leads “healthcare providers and patients [to] believe that Hikma’s generic
icosapent ethyl capsules could be and should be used
* * * to reduce the risk of CV events.” Ibid.
At the same time, Amarin acknowledges that
Hikma never distributed its product with the CV Limitation of Use, against which the absence of the limitation might be compared. Hikma only “removed” the
CV Limitation of Use from a draft label submitted to
FDA that was never public. See BIO.App.27a–29a,
¶¶ 104–108; Pet.App.31a n.1. And Hikma removed the
limitation only because the generic product label must
be the “same” as the branded drug’s label, 21 U.S.C.
§ 355(j)(2)(A)(v), and Vascepa’s label no longer has
that CV Limitation of Use. While section viii allows
13
generic labeling to omit information on patented methods, thus making the label “skinny,” it does not provide
a mechanism for generics to add disclaimer language;
Amarin does not allege otherwise. See generally
PLIVA, Inc. v. Mensing, 564 U.S. 604, 614–615 (2011)
(explaining how generic drug labels generally must be
the same as branded drug labels).
Amarin relies, second, on a warning in the patient
information leaflet under the heading: “What are the
possible side effects of icosapent ethyl?” BIO.App.36a,
¶ 131; JA124–125. One of the “possible side effects”
identified is “[h]eart rhythm problems which can be serious and cause hospitalization * * * especially in people who have heart (cardiovascular) disease or diabetes
with a risk factor for heart (cardiovascular) disease.”
Ibid. This warning to patients with “cardiovascular[]
disease” about “serious” side effects is the only instance in which the label uses the term “cardiovascular.” Amarin asserts that this warning against using
Hikma’s product in patients with CV risk “encourages,
promotes, and instructs treating patients” with “established cardiovascular disease.” BIO.App.36a, ¶ 131.
Amarin relies, third, on language in Hikma’s patient information leaflet concerning “[g]eneral information” about icosapent ethyl, stating that “[m]edicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet.”
BIO.App.36a–37a, ¶ 132; JA125.
Amarin relies, fourth, on other elements of Hikma’s
label, including baseline characteristics of patients in
a clinical study and some statin usage. See, e.g.,
BIO.App.35a–36a, ¶ 130; BIO.App.37a–38a, ¶ 134
(citing JA122). The only clinical study described in
Hikma’s label, however, is the clinical study for
14
“Severe Hypertriglyceridemia.” JA122. Cf. JA85 (current Vascepa label that describes an additional clinical
study for “Prevention of Cardiovascular Events” in
“statin-treated adult patients,” which does not appear
in Hikma’s label).
b. The operative complaint alleges that the combination of Hikma’s label with other public statements
induces infringement. These other statements include
Hikma’s pre-launch press releases from March and
September 2020. See BIO.App.30a–31a, ¶¶ 112 (citing
JA39–41), 118 (citing JA42–44).
The March 2020 press release addresses Hikma’s
trial victory in the earlier litigation regarding Amarin’s SH-indication patents and is titled: “Hikma confirms favourable ruling in generic Vascepa® patent
suit.” JA39. Below are the relevant statements, with
the allegedly inducing statements italicized:
Hikma * * * today confirms that the United
States District Court for the District of Nevada has ruled that Hikma’s generic version of
Amarin Corporation’s Vascepa® (icosapent
ethyl) 1 gm capsules does not infringe six
United States Patents, as asserted by Amarin, because the asserted claims of these patents were held to be invalid.
Hikma is working closely with the U.S. Food
and Drug Administration (FDA) to gain approval for its Abbreviated New Drug Application (ANDA) for its generic version of
Vascepa®. * * *
Vascepa® is a prescription medicine that is
indicated, in part, as an adjunct to diet to
15
reduce triglyceride levels in adult patients
with severe (≥500 mg/dL) hypertriglyceridemia.
According to IQVIA, US sales of Vascepa®
were approximately $919 million in the 12
months ending February 2020.
JA39–40. This pre-launch press release includes no
labeling information for Hikma’s anticipated product,
mentions only Vascepa’s unpatented SH indication,
and is directed to investors. It includes Hikma’s stock
information and invites enquiries to the following
email address: uk-investors@hikma.uk.com. JA40.
The September 2020 press release, which also predates Hikma’s product launch, is similarly titled:
“Hikma receives favourable court ruling for its generic
Vascepa®.” JA42. Below are the relevant statements,
with the allegedly inducing statements italicized:
Hikma * * * announces that the US Court of
Appeals for the Federal Circuit today upheld
a ruling by the US District Court for the District of Nevada finding that Hikma’s generic
version of Vascepa® (icosapent ethyl) 1gm
does not infringe any valid claim of six key
Amarin-owned patents. Hikma received FDA
approval for the product in May 2020 and is
working towards a launch.
Vascepa® is a prescription medicine that is
indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with
severe (≥500 mg/dL) hypertriglyceridemia.
According to IQVIA, US sales of Vascepa®
were approximately $1.1 billion in the 12
months ending July 2020.
16
JA42–43.
Like the March 2020 press release, the only Vascepa
indication mentioned in the September 2020 press release is Vascepa’s unpatented SH indication. Ibid.
Neither press release uses the term “cardiovascular,”
discusses statin use, or contains any use instructions
for Hikma’s anticipated generic product.
Amarin alleges that these press releases induce infringement because they “do[] not state that Hikma’s
‘generic version’ of VASCEPA® should not be used for
the CV Indication” and report annual “sales for all
uses of Vascepa®, including the CV Indication.”
BIO.App.30a–31a, ¶¶ 113–114; BIO.App.32a, ¶¶ 120–
121. The operative complaint asserts, without further
elaboration, that each pre-launch press release “communicates to and instructs healthcare providers and
patients that Hikma’s ‘generic version’ of VASCEPA®
should be used for all the same indications as
VASCEPA®, including to reduce the risk of CV
events.” BIO.App.31a, ¶ 115; BIO.App.32a, ¶ 122.
The press releases themselves, however, are attached
as exhibits to Amarin’s complaint. JA39–44.
Amarin also attached Hikma’s November 2020
press release announcing its generic-product launch.
See JA45–50. That press release, copied below in relevant part, includes labeling information for Hikma’s
generic icosapent product, says the product is indicated for the SH Indication, and states that the product is “not approved for any other indication for the
reference listed drug VASCEPA®”:
Hikma’s FDA-approved Icosapent Ethyl Capsule product is indicated for the following indication: as an adjunct to diet to reduce
17
triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Hikma’s product is not approved for any other
indication for the reference listed drug
VASCEPA®.
JA45–46.
The complaint acknowledges that Hikma removed
the March and September 2020 press releases from
the “Newsroom” webpage on its website in mid-October 2020, before launching its generic product in November 2020. BIO.App.31a, ¶ 117; BIO.App.32a–33a,
¶ 124. Thus, only Hikma’s November 2020 press release, which Amarin does not allege induces infringement, remained on Hikma’s “Newsroom” webpage
when its generic product became available to doctors
and patients.
c. Amarin alleges finally that a Hikma webpage
described Hikma’s generic product as therapeutically
equivalent (i.e., AB rated) to VASCEPA® for treating
“hypertriglyceridemia.” See BIO.App.26a, ¶ 98;
BIO.App.30a, ¶ 111; JA195. This webpage, which does
not mention Vascepa or statins, includes a disclaimer
similar to the one in Hikma’s November 2020 press release: “Hikma’s generic version is indicated for fewer
than all approved indications of the Reference Listed
Drug.” JA195; Pet.App.7a.
Amarin alleges, in substance, that “hypertriglyceridemia” is a broader concept than “severe hypertriglyceridemia.” BIO.App.33a–34a, ¶ 126. But the complaint does not allege that merely treating “hypertriglyceridemia” reduces the risk of a cardiovascular
event or cardiovascular death as required by the asserted patent claims.
See BIO.App.7a, ¶ 32
18
(acknowledging other drugs “lowered triglyceride levels in this patient population but did not show an actual reduction in cardiovascular risk”).
2. The district court’s decision
The district court granted Hikma’s motion to dismiss for failure to state a claim under Federal Rule of
Civil Procedure 12(b)(6). Pet.App.11a, 25a–35a.
The court began by accepting any non-conclusory,
factual allegations as true under this Court’s pleading
standard in Bell Atlantic Corp. v. Twombly, 550 U.S.
544, 555–556 (2007), and Ashcroft v. Iqbal, 556 U.S.
662, 678 (2009). Pet.App.27a. It then addressed Amarin’s factual allegations summarized above.
First, the court found that Hikma’s “label does not
instruct CV risk reduction,” as required by Amarin’s
patents. Pet.App.32a. As the court explained, the
“warning as to side effects * * * * is hardly instruction
or encouragement.” Pet.App.31a.
The court then found “that the lack of a CV limitation on Hikma’s label does not plausibly teach CV risk
reduction.” Pet.App.32a. It cited Federal Circuit precedent “reject[ing] the argument that generic labels
must contain a ‘clear statement’ discouraging use of
the patented indication.”
Ibid. (quoting Takeda
Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785
F.3d 625, 632 n.4 (Fed. Cir. 2015)); see also Twitter,
Inc. v. Taamneh, 598 U.S. 471, 489 (2023) (reinstating
dismissal of complaint—“our legal system generally
does not impose liability for mere omissions, inactions,
or nonfeasance”).
Turning to the press releases, the court found that
statements referring to Hikma’s “icosapent ethyl as
the ‘generic equivalent’ of Vascepa do[ ] not expose
19
Hikma to liability” because they too fail to instruct CVrisk reduction. Pet.App.33a. The court found that, at
most, statements about Vascepa’s sales “might be relevant to intent,” but “[i]ntent alone is not enough; Amarin must plead an inducing act.” Ibid.
Finally, applying the Rule 12(b)(6) standard, the
court accepted Amarin’s theory that the reference to
“Hypertriglyceridemia” on Hikma’s website is broader
than SH and overlaps with the patient population for
the CV indication. Pet.App.32a–33a. But the court
found this alleged overlap “does not rise to the level of
encouraging, recommending, or promoting taking
Hikma’s generic for the reduction of CV risk.”
Pet.App.33a. The court explained that, both in
Hikma’s press releases and website, “Hikma has not
pointed to Vascepa’s patented uses in describing
[Hikma’s product] as Vascepa’s generic equivalent.”
Pet.App.35a; see also Pet.App.34a (quoting GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th
1320, 1335 n.7 (Fed. Cir. 2021) (“GSK”) (“We do not
hold that an AB rating in a true section viii carve-out
(one in which a label was produced that had no infringing indications) would be evidence of inducement.”).
The court thus granted Hikma’s motion to dismiss.
Pet.App.23a–24a. Amarin failed to seek timely leave
to amend its complaint further, so the final judgment
under Rule 54(b) dismissed Amarin’s operative complaint “WITH PREJUDICE.” JA64.
3. The court of appeals’ decision
The Federal Circuit reversed. It agreed that
Hikma’s label, standing alone, “does not, as a matter
of law, recommend, encourage, or promote an infringing use.” Pet.App.17a (cleaned up). As the decision
20
notes, “even Amarin seems to agree that the label
alone does not instruct infringement.” Pet.App.21a.
Nevertheless, the Federal Circuit found “it at least
plausible that a physician could read Hikma’s press releases—touting sales figures attributable largely to an
infringing use, and calling Hikma’s product the ‘generic version’ of a drug that is indicated ‘in part’ for the
SH indication—as an instruction or encouragement to
prescribe that drug for any of the approved uses of
icosapent ethyl, particularly where the label suggests
that the drug may be effective for an overlapping patient population.” Pet.App.19a (emphasis in original).
The Federal Circuit also relied on the word “Hypertriglyceridemia” on Hikma’s website to find plausible
induced infringement of Amarin’s asserted CV patents, despite the website’s “express disclaimer that
Hikma’s product is FDA-approved for fewer than all
uses of Vascepa.” Pet.App.19a–20a n.6. But see JA195
(the actual disclaimer does not mention “Vascepa” but
refers to “the Reference Listed Drug”).
The Federal Circuit did not identify any alleged
statement by Hikma that mentions, much less encourages, administering icosapent ethyl for “reducing risk
of cardiovascular death” or “reducing occurrence of a
cardiovascular event” when taken with a statin, as
Amarin’s patents require. Pet.App.8a–9a. Nor did the
Federal Circuit point to any alleged statement by
Hikma instructing doctors and patients that they
should use its generic product as they use Vascepa for
its CV indication (no such statement exists). Yet the
Federal Circuit held that it could not dismiss Amarin’s
complaint without “the benefit of discovery” and that
induced infringement is “not proper for resolution on a
motion to dismiss.” Pet.App.14a, 18a–19a.
21
SUMMARY OF THE ARGUMENT
I. Congress limited liability for induced patent infringement to one who “actively induces infringement
of a patent.” 35 U.S.C. § 271(b). The plain language
requires (1) an “active[]” step that “induce[d]” (i.e., encouraged) a direct infringer to take specific action; and
(2) that induced action must suffice for “infringement
of a patent,” including each limitation of a patent
claim. Absent both requirements, there is no active
inducement under the statute, and mere inferences or
assumptions about how third parties might react to
vague communications that lack any instruction or encouragement to infringe cannot trigger liability.
II.A. These requirements apply with equal force on
a motion to dismiss. Applying this Court’s pleading
standard under Iqbal and Twombly, “[t]hreadbare recitals of the elements of a cause of action, supported by
mere conclusory statements, do not suffice.” Iqbal, 556
U.S. at 678. Thus, a plaintiff cannot avoid a motion to
dismiss merely by asserting that a defendant’s statements actively induce infringement. Rather, the complaint must allege “enough facts to state a claim to relief that is plausible on its face,” Twombly, 550 U.S. at
570, without contradicting or misstating documents
attached to the complaint that are “a part of the pleading for all purposes,” Fed. R. Civ. P. 10(c).
B. Amarin’s complaint fails to state a plausible
claim for actively induced infringement. The only accused Hikma communication that encourages any specific action by doctors and patients is Hikma’s skinny
label, yet it is undisputed that the label alone does not
induce infringement. Pet.App.17a, 21a. The only action it induces is unpatented: Amarin does not allege
that the asserted patents cover the label’s sole
22
indication to treat SH. See BIO.22; BIO.App.21a,
¶ 82. Hikma’s pre-launch press releases and website
are even further afield. Their accurate statements describing Hikma’s anticipated product as a “generic version” or “generic equivalent” that falls within the
“therapeutic category” of “[h]ypertriglyceridemia” do
not encourage specific action by anyone, let alone by
doctors or patients. The complaint fails to state a
claim for this reason alone.
C. An independent reason for dismissal is that any
allegedly induced conduct is insufficient for “infringement of a patent,” as § 271(b) requires. Hikma’s accused statements never mention Vascepa’s allegedly
patented CV indication, which requires co-administering icosapent ethyl with a statin—a second agent that
Hikma does not distribute and its press releases and
website never mention. Nor do Hikma’s accused statements say anything about reducing the risk of CV
events or CV death, as the patent claims require. Because there is no plausible allegation that Hikma’s
statements actively induce specific conduct that satisfies all claim steps for any asserted claim, Amarin fails
to plead actively induced infringement.
D. Instead of pleading actively induced infringement, as the statute requires, Amarin’s theory at best
is a theory of passive inducement, which is not actionable. Amarin relies not on the actual content of
Hikma’s statements, but on alleged inferences and assumptions a third party might draw upon receiving
them. Thus, Amarin and the Federal Circuit purport
to “read” instructions that Hikma never made into
anodyne statements of generic equivalence—effectively misattributing a physician’s intervening reliance on their own knowledge and independent
23
judgment to Hikma. See Pet.App.19a. This passiveinducement theory is untethered from the Patent Act
and, if accepted, would render § 271(b) and Rule
12(b)(6) meaningless: Patentees could always allege
that third parties will interpret statements as instructions to infringe—even when those statements facially
lack instructions at all. This Court should reject Amarin’s passive-inducement theory and reverse.
III. Proper enforcement of the Rule 12(b)(6) pleading requirements is necessary to reconcile § 271(b) and
Hatch-Waxman’s section viii. As this Court recognized
in Twombly: “It is no answer to say that a claim just
shy of a plausible entitlement to relief can, if groundless, be weeded out early in the discovery process
through ‘careful case management.’” 550 U.S. at 559.
Allowing cases like this one to survive the pleadings
stage would eviscerate section viii, which was designed
to expedite generic-drug competition without litigation. Absent reversal, the Federal Circuit’s passiveinducement theory will swallow section viii’s carve-out
provision, smothering generic competition and raising
drug prices—all contrary to congressional intent.
Because Amarin’s operative complaint fails to state
a plausible claim for relief, the Federal Circuit’s decision should be reversed, and the district court’s dismissal with prejudice should be reinstated.
ARGUMENT
I. Indirect liability for inducement
§ 271(b) requires active inducement.
under
A. The Patent Act imposes direct-infringement liability when a party “without authority makes, uses,
offers to sell, or sells any patented invention, within
the United States or imports into the United States
24
any patented invention during the term of the patent
therefor.” 35 U.S.C. § 271(a). Although direct patent
infringement is a strict-liability tort, Congress raised
the bar when imposing indirect liability for inducing
another’s infringement: “Whoever actively induces infringement of a patent shall be liable as an infringer.”
Id. § 271(b).3 Thus, the statute imposes no liability absent allegations that the defendant:
(1) “actively induce[d]” a direct infringer to
take specific action, and
(2) that “induce[d]” action suffices for “infringement of a patent.” Ibid.
First, “actively induces” is unambiguous: “The term
‘induce’ means ‘[t]o lead on; to influence; to prevail on;
to move by persuasion or influence,’” whereas “‘actively’ suggests that the inducement must involve the
taking of affirmative steps to bring about the desired
result.” Glob.-Tech Appliances, Inc. v. SEB S.A., 563
U.S. 754, 760 (2011) (alteration in original) (quoting
WEBSTER’S NEW INT’L DICTIONARY 1269, 27 (2d ed.
1945)). Active inducement thus requires “clear expression or other affirmative steps taken to foster infringement.” Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936–937 (2005). Both GlobalTech and Grokster recognized that active inducement
derives in part from aiding-and-abetting liability,
which requires deliberate action to promote another’s
misconduct. Cf. Smith & Wesson Brands v. Estados
Unidos Mexicanos, 605 U.S. 280, 291 (2025) (reinstating dismissal—“Federal aiding-and-abetting law
3 The statute also requires specific intent, knowledge that
the induced acts constitute infringement, and direct infringement. See Global-Tech, 563 U.S. at 766.
25
reflects a centuries-old view of culpability: that a person may be responsible for a crime he has not personally carried out if he deliberately helps another to complete its commission.”) (cleaned up); id. at 292 (“[A]n
ordinary merchant does not become liable for all criminal misuses of his goods, even if he knows * * * misuse
will occur,” but “only if, beyond providing the good on
the open market, he takes steps to ‘promote’ the resulting crime and ‘make it his own.’”) (cleaned up).
Second, the statute requires the induced conduct to
suffice for “infringement of a patent.” In both patent
and copyright cases, this Court has required “active
steps taken to encourage direct infringement, such as
advertising an infringing use or instructing how to engage in an infringing use”—i.e., “clear expression or
other affirmative steps taken to foster infringement.”
Grokster, 545 U.S. at 936–937 (cleaned up); see also id.
at 935 (requiring “statements or actions directed to
promoting infringement”); Glob.-Tech, 563 U.S. at 766
(“[I]nduced infringement under § 271(b) requires
knowledge that the induced acts constitute patent infringement.”). Thus, “it is necessary for the plaintiff”
both to allege and to show, among other things, that
“the induced acts were infringing.” Commil USA, LLC
v. Cisco Sys., Inc., 575 U.S. 632, 637 (2015).
Only “a showing that infringement was encouraged
overcomes the law’s reluctance to find liability when a
defendant merely sells a commercial product suitable
for some lawful use.” Grokster, 545 U.S. at 936.
“[M]ere knowledge of infringing potential or of actual
infringing uses would not be enough [ ] to subject a distributor to liability.” Id. at 937. Nor does active inducement result from “failure to take affirmative steps
to prevent infringement,” if the defendant merely
26
distributed a product that “otherwise was capable of
substantial noninfringing uses.” Id. at 939 n.12; see
also id. at 940 n.13 (“Inducement liability” applies
“where evidence shows that the distributor intended
and encouraged the product to be used to infringe.”).
“The inducement rule, instead, premises liability
on purposeful, culpable expression and conduct, and
thus does nothing to compromise legitimate commerce
or discourage innovation having a lawful promise.” Id.
at 937. The law requires “evidence [that] goes beyond
a product’s characteristics or the knowledge that it
may be put to infringing uses, and shows statements
or actions directed to promoting infringement.” Id. at
935. In short, “the inducer must persuade another to
engage in conduct that the inducer knows is infringement.” Glob.-Tech, 563 U.S. at 761.
B. Importantly, “[a] method patent claims a number of steps; under this Court’s case law, the patent is
not infringed unless all the steps are carried out.”
Limelight Networks, Inc. v. Akamai Techs., Inc., 572
U.S. 915, 921 (2014). “This principle follows ineluctably from what a patent is: the conferral of rights in a
particular claimed set of elements,” each of which “is
deemed material to defining the scope of the patented
invention.” Ibid. (quotation omitted). “[A] patentee’s
rights extend only to the claimed combination of elements, and no further.” Ibid.
This principle is critical in inducement cases to
avoid “depriv[ing] § 271(b) of ascertainable standards.” Id. at 922. “If a defendant can be held liable
under § 271(b) for inducing conduct that does not constitute infringement, then how can a court assess
when a patent holder’s rights have been invaded?”
Ibid. A claim for inducement thus lies against only a
27
defendant that actively induces another to perform “all
the steps” of the patented method. Id. at 921. This
legal standard is not disputed. BIO.22 (“Petitioners
also assert that there is no induced infringement of a
method patent unless a third party is induced to perform all the steps. But that is neither disputed nor
contrary to the decision below.”) (citation omitted); see
also U.S.Cert.Br.15 (“Amarin was * * * required to offer particularized allegations establishing a plausible
causal link between [Hikma]’s statements and subsequent infringing uses of its generic drug.”).
C. The statutory standard requiring “actively induce[d] infringement” thus forecloses liability for mere
passive or inferred inducement. This is where the Federal Circuit went astray.
Mere inferences or assumptions on the part of a direct infringer, or speculation as to how the infringer
may respond to the communication, do not state a
claim for actively induced infringement. “[C]ourts
should not create liability for inducement of non-infringing conduct where Congress has elected not to extend that concept.” Limelight, 572 U.S. at 923. Imposing liability for conduct that falls short of actively encouraging “infringement of a patent” would be “trenching on regular commerce” and “ordinary acts incident
to product distribution.” Grokster, 545 U.S. at 937; see
also Smith & Wesson, 605 U.S. at 292 (“[R]outine and
general activity that happens on occasion to assist in a
crime—in essence, ‘incidentally’—is unlikely to count
as aiding and abetting.”).
A communication encouraging only four of five
steps required by a method patent, for example, would
not constitute “actively induce[d] infringement.” A
complaint cannot plead otherwise by alleging that the
28
direct infringer could infer the missing fifth step from
vague statements or omissions falling short of “clear
expression” or from “mere knowledge of infringing potential or of actual infringing uses.” Grokster, 545 U.S.
at 937. Unless the complaint properly pleads a communication that “actively induces” conduct sufficient
for “infringement of a patent,” 35 U.S.C. § 271(b), the
complaint fails to allege the requisite “purposeful, culpable expression and conduct” needed for induced-infringement liability, Grokster, 545 U.S. at 937.
The legal standard under § 271(b) thus imposes no
liability for actively induced patent infringement if the
alleged communication:
is not received by the direct infringer,
is received but does not encourage specific
action (e.g., the communication merely describes a patented method or encourages
only vague action),
encourages specific action that, if taken,
would not satisfy all limitations of a patent
claim, or
does not actually influence the direct infringer’s actions.
See, e.g., Takeda, 785 F.3d at 631 (“merely describing
an infringing mode is not the same as recommending,
encouraging, or promoting an infringing use”); id. at
632 (“vague” language “cannot be combined with speculation about how [others] may act to find inducement”); HZNP Medicines LLC v. Actavis Labs. UT,
Inc., 940 F.3d 680, 702 (Fed. Cir. 2019) (“Merely describing the infringing use, or knowing of the possibility of infringement, will not suffice; specific intent and
action to induce infringement must be shown.”). Cf.
29
Smith & Wesson, 605 U.S. at 292 (“aiding and abetting
is most commonly a rule of secondary liability for specific wrongful acts”) (quotations omitted; emphasis in
original). The types of communications listed above,
without more, do not “actively induce[] infringement of
a patent.” 35 U.S.C. § 271(b).
To be clear, Hikma is not arguing that the statute
requires an inducer to instruct each step of an asserted
method patent explicitly. But the statute requires encouraging conduct that, if followed, would meet each
claim limitation, as there is no induced infringement
of a method patent unless a third party is induced to
perform all the steps. Limelight, 572 U.S. at 921.
Again, Amarin conceded that this standard is not disputed. BIO.22.
II. Amarin’s complaint fails to state a plausible
claim for active inducement.
When a generic drug label fully carves out a patented use, allegations that the generic drugmaker
calls its product a “generic version” and cites public information about the branded drug (e.g., sales) are not
enough to plead induced infringement of the patented
use. These and similar statements, which do not encourage or even mention the patented use, do not state
a plausible claim that a defendant “actively induce[d]”
a direct infringer to take any action, much less action
sufficient for “infringement of a patent.”
To state a claim that Hikma “actively induce[d] infringement of a patent,” 35 U.S.C. § 271(b), Amarin
thus needed—but failed—to plead enough non-conclusory, factual allegations to make it plausible that: (1)
Hikma encouraged specific action; and (2) the encouraged action suffices to satisfy all patent-claim
30
limitations. The district court properly dismissed the
complaint under Rule 12(b)(6), and the Federal Circuit
legally erred when holding otherwise.
A. Rule 12(b)(6) requires dismissing a complaint that does not contain sufficient factual allegations to state a plausible claim.
1. Under Rule 12(b)(6) of the Federal Rules of Civil
Procedure, courts must dismiss a complaint that does
not satisfy this Court’s “two-pronged approach” under
Iqbal and Twombly. Iqbal, 556 U.S. at 679.
First, courts should “begin by identifying pleadings
that, because they are no more than conclusions, are
not entitled to the assumption of truth.” Ibid.
“Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not
suffice.” Id. at 678. In Twombly, for example, the
Court gave no weight to “the plaintiff’s assertion of an
unlawful agreement” or its “allegation of a conspiracy,”
which was merely a “legal conclusion.” Iqbal, 556 U.S.
at 680 (quoting Twombly, 550 U.S. at 555). In Iqbal
too, allegations that government officials discriminated in imposing “harsh conditions of confinement ‘as
a matter of policy’” were “conclusory and not entitled
to be assumed true.” Id. at 680. The Court did “not
reject these bald allegations on the ground that they
are unrealistic or nonsensical,” or otherwise “fanciful,”
but simply due to their “conclusory nature.” Id. at 681.
Second, “[w]hen there are well-pleaded factual allegations, a court should assume their veracity and
then determine whether they plausibly give rise to an
entitlement to relief.” Id. at 679. This is “a contextspecific task that requires the reviewing court to draw
on its judicial experience and common sense.” Ibid.
31
Put simply, plaintiffs must allege “enough facts to
state a claim to relief that is plausible on its face.”
Twombly, 550 U.S. at 570. “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that
the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. “Where a complaint pleads facts
that are merely consistent with a defendant’s liability,
it stops short of the line between possibility and plausibility of entitlement to relief.” Ibid. (cleaned up).
Thus, while “the well-pleaded, nonconclusory factual allegation of parallel behavior” in Twombly “was
consistent with an unlawful agreement, the Court nevertheless concluded that it did not plausibly suggest
an illicit accord because it was not only compatible
with, but indeed was more likely explained by, lawful,
unchoreographed free-market behavior.” Id. at 680.
Similarly, allegations in Iqbal that officials “arrested
and detained thousands of Arab Muslim men” were
“consistent with” discrimination but more likely explained by a “nondiscriminatory intent to detain aliens
who were illegally present in the United States and
who had potential connections to those who committed
terrorist acts.” Id. at 682. The Court has recently applied the same standard to dismiss aiding-and-abetting claims at the pleadings stage. See Twitter, 598
U.S. at 506; Smith & Wesson, 605 U.S. at 296–299.
2. Two important corollaries to the Iqbal-Twombly
framework are relevant.
First, “courts must consider the complaint in its entirety,” including “documents incorporated into the
complaint by reference.” Tellabs, Inc. v. Makor Issues
& Rights, Ltd., 551 U.S. 308, 322 (2007). “A copy of a
written instrument that is an exhibit to a pleading is
32
a part of the pleading for all purposes.” Fed. R. Civ. P.
10(c). Undisputed regional circuit law (Amarin filed in
Delaware) holds that “[w]here there is a disparity between a written instrument annexed to a pleading and
an allegation in the pleading based thereon, the written instrument will control.” ALA, Inc. v. CCAIR, Inc.,
29 F.3d 855, 859 n.8 (3d Cir. 1994).
Second, the “sheer possibility” that discovery might
uncover wrongdoing is not enough; the complaint itself
must allege sufficient “factual content that allows the
court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556
U.S. at 678. “It is no answer to say that a claim just
shy of a plausible entitlement to relief can, if groundless, be weeded out early in the discovery process
through ‘careful case management.’” Twombly, 550
U.S. at 559. As explained below in section III, enforcing Rule 12(b)(6) to dismiss deficient inducement
claims is necessary to reconcile § 271(b) and HatchWaxman’s section viii.
B. Hikma’s skinny label encourages only noninfringing use, and its other statements do
not “actively induce[]” specific conduct.
Applying the Iqbal-Twombly pleading standard,
Amarin’s operative complaint fails to state a plausible
claim that Hikma actively induced infringement. Dismissal is required because Hikma’s skinny label encourages only noninfringing use, and its other statements do not “actively induce” specific conduct.
1. Hikma’s label is the only accused communication that instructs doctors and patients on how to use
Hikma’s generic icosapent product; yet, it admittedly
does not suffice to induce infringement. Pet.App.17a,
33
21a. Hikma’s FDA-approved skinny label undisputedly carves out the allegedly patented CV indication
and, instead, is indicated for only the non-infringing
SH indication. Pet.App.5a, 28a. As Amarin’s complaint admits, “[t]he Hikma Defendants’ generic version of VASCEPA® was FDA approved for only the Severe Hypertriglyceridemia Indication, and not for the
CV Indication.” BIO.App.21a, ¶ 82.
The Federal Circuit thus “agree[d] with the district
court (and Hikma) that the label does not, as a matter
of law, recommend, encourage, or promote an infringing use,” Pet.App.17a (cleaned up), and “even Amarin
seems to agree that the label alone does not instruct
infringement,” Pet.App.21a. There is no serious dispute Hikma’s label is “skinny enough.” Pet.App.13a.
The only time the label uses the term “cardiovascular” is in a warning against using Hikma’s product “in
people who have heart (cardiovascular) disease” because it could cause “serious” side effects requiring
“hospitalization.” JA124–125. As the district court
aptly put it: “This is hardly instruction or encouragement.” Pet.App.31a; see also U.S.Cert.Br.15 (“Treating a generic manufacturer’s approved skinny label as
evidence of culpable inducement would be at odds with
section viii’s basic design.”).
2. Hikma’s pre-launch press releases and website
do not actively lead on, influence, persuade, recommend, encourage, promote, or otherwise instruct doctors and patients to bring about any desired result.
Thus, they cannot support a claim for “active[] induce[ment]” as a matter of law.
The press releases merely announce litigation victories to investors and contain no information on how
34
to use Hikma’s generic product, which was not yet
even on the market. Compare BIO.App.34a, ¶¶ 127–
128 (relying on press releases in March and September
2020), with BIO.App.4a, ¶ 13 (Hikma launched its generic product in November 2020). Hikma did not provide such usage information until its (unaccused) November 2020 press release, which recites the sole indication in Hikma’s labeling (for treating SH) and says:
“Hikma’s product is not approved for any other indication for the referenced listed drug VASCEPA®.” JA45–
46; see also U.S.Cert.Br.16 (“[T]he Federal Circuit
erred in treating Hikma’s description of its own product as a ‘generic equivalent’ or ‘generic version’ of
Vascepa, and Hikma’s description of Vascepa as approved ‘in part’ for the SH Indication, as suggesting
culpable intent to encourage infringement.”) (citing
Pet.App.18a–21a).
To be sure, Amarin’s operative complaint includes
conclusory assertions that Hikma’s pre-launch press
releases “communicate[] to and instruct[] healthcare
providers and patients” to use its generic product for
both Vascepa indications. BIO.App.31a–32a, ¶¶ 115,
122. But those assertions carry no weight under this
Court’s Iqbal-Twombly pleading standard because
they are “conclusory and not entitled to be assumed
true.” Iqbal, 556 U.S. at 681. Moreover, the accused
communications—which do not contain the alleged instructions—are attached as exhibits to Amarin’s complaint and thus are part of the pleadings. See Fed. R.
Civ. P. 10(c). Where, as here, “there is a disparity between a written instrument annexed to a pleading and
an allegation in the pleading based thereon, the written instrument will control.” ALA, 29 F.3d at 859 n.8.
35
The accused statements from Hikma’s website—
i.e., that Hikma’s product falls under the therapeutic
category “[h]ypertriglyceridemia” and is “AB” rated—
also do not encourage specific action directed to doctors
and patients for using Hikma’s product. The only potential instruction on the website is to “[b]rowse our
products.” JA195. The website makes no mention of
Vascepa, SH use, CV use, or statins. And, like the November 2020 press release, it contains “an express disclaimer” (Pet.App.20a n.6): “Hikma’s generic version is
indicated for fewer than all approved indications of the
Reference Listed Drug.”
JA195; see also
U.S.Cert.Br.18 (“the website’s statement does not urge
a ‘necessarily infringing’ use”) (quoting Grokster, 545
U.S. at 931).
An accused statement cannot actively encourage a
patented method-of-use without encouraging use. The
accused press releases and website are legally irrelevant because they do not actively induce potential direct infringers to use Hikma’s product. The Federal
Circuit’s judgment should be reversed on this basis
alone.
C. Hikma’s accused statements, alone or together, do not encourage action sufficient
for “infringement of a patent.”
In addition to these fatal pleading deficiencies, the
accused statements in Hikma’s labeling, pre-launch
press releases, and website—alone or in combination—certainly do not encourage conduct sufficient to
constitute “infringement of a patent.” 35 U.S.C.
§ 271(b).
1. Attempting to allege otherwise, Amarin points
to statements in Hikma’s pre-launch press releases
36
referring to its product as a “generic version” or “generic equivalent” of Vascepa that is “indicated, in
part,” for the unpatented SH indication. BIO.App.30a,
¶¶ 111–112; BIO.App.31a–32a, ¶¶ 118–119. As the
government explains, these are all “anodyne statements with logical explanations.” U.S.Cert.Br.19.
According to Hatch-Waxman and FDA regulations,
Hikma’s product is a “generic version” and a “generic
equivalent” of Vascepa even though it has a skinny label. See supra 4–7. It is “normal industry practice”
that generic drugmakers “truthfully describe generic
[drugs] as ‘equivalent’ or ‘comparable’ to [their
branded counterparts].” Inwood Labs., 456 U.S. at
847–848. Amarin itself publicly referred to “generic
versions of VASCEPA.”4 See JA58 (Amarin letter to
insurance payors: “Amarin is aware that Hikma Pharmaceuticals has launched a generic version of
VASCEPA® (icosapent ethyl) 1-gram capsules.”).
Amarin alleges that these press releases cite
Vascepa’s annual sales, including sales tied to the CV
indication. BIO.App.30a, ¶ 113; BIO.App.32a, ¶ 120.
While such data may be relevant to investors deciding
whether to invest in Hikma, Vascepa sales figures do
not plausibly convey information relevant to doctors or
patients on how Hikma’s product should be used.
Again, these press releases do not encourage any
action, much less action sufficient to infringe the specific methods of treatment claimed by the two asserted
patents. The press releases do not mention CV use or
https://www.amarincorp.com/news-and-media/amarincomments-ruling-vascepar-anda-litigation (Amarin March
30, 2020, press release stating Amarin seeks to “prevent
launch of generic versions of VASCEPA”).
4
37
otherwise encourage using Hikma’s then-forthcoming
product for off-label use, much less a patented
one. The only use mentioned is the unpatented SH use
on Hikma’s label. Statins are not mentioned at all.
2. Amarin unduly relies on Hikma’s website, which
is plainly directed to customers who purchase generic
products—i.e., “wholesalers, hospitals, and retail
pharmacies,” not doctors or patients. See Inwood
Labs., 456 U.S. at 847–848. The website merely informs such customers that Hikma’s product is available for purchase. Amarin does not allege that Hikma
sells its products to doctors or patients (Hikma does
not). Nor does Amarin allege that Hikma’s customers
administer its product to patients (they do not).
Like the press releases, the website does not encourage (and there would be no reason to encourage)
any use of the product, much less encourage action by
doctors or patients to use the product for unlabeled indications with a statin. Describing the “therapeutic
category” does not encourage any patented CV
method, especially given the undisputed disclaimer
that “Hikma’s generic version is indicated for fewer
than all approved indications of the Reference Listed
Drug”—with no mention of Vascepa. JA195. And, to
the extent a reader had questions about how to use
Hikma’s product, there is a link to Hikma’s “Package
Insert,” which is the non-infringing skinny label. Ibid.
Amarin cannot cobble together disparate documents intended for different audiences—i.e., Hikma’s
label, pre-launch press releases, and website—to infer
instructions that the documents never actually make.
Alone or together, the accused communications do not
(1) “actively induce[]” specific action (2) sufficient for
“infringement of a patent.” 35 U.S.C. § 271(b).
38
D. The Federal Circuit’s decision, if allowed
to stand, would impose liability for mere
passive inducement.
1. Ultimately, Amarin’s complaint fails to state a
claim because it relies on alleged instructions or encouragement inferred from vague and innocuous statements describing Hikma’s product instead of “actively
induce[d]” conduct under § 271(b). That is passive—
not active—inducement. The Federal Circuit legally
erred in holding such allegations sufficient:
[W]e find it at least plausible that a physician
could read Hikma’s press releases—touting sales
figures attributable largely to an infringing use,
and calling Hikma’s product the ‘generic version’
of a drug that is indicated ‘in part’ for the SH
indication—as an instruction or encouragement
to prescribe that drug for any of the approved
uses of icosapent ethyl, particularly where the label suggests that the drug may be effective for
an overlapping patient population.
Pet.App.19a. The court doubled down on this passiveinducement theory when referring to Hikma’s website:
Further, it is at least plausible that a physician
may recognize that, by marketing its drug in the
broad therapeutic category of ‘Hypertriglyceridemia’ on its website, Hikma was encouraging prescribing the drug for an off-label use.
Ibid.
The Federal Circuit thus allowed Amarin’s complaint to survive based on inferred instructions that
Hikma never made—as confirmed by the undisputed,
accused communications attached to Amarin’s operative complaint. Even worse, the court of appeals
39
essentially slammed the door on Rule 12(b)(6) challenges in the section viii context, holding that whether
conclusory allegations like those at issue here support
a claim for induced infringement is “not proper for resolution on a motion to dismiss.” Pet.App.14a, 18a–19a.
But Amarin cannot avoid Rule 12(b)(6) by speculating about how a direct infringer “could read” statements accurately describing Hikma’s product that, objectively, do not encourage any action, much less action sufficient to infringe. If this were enough, plaintiffs could allege inducement in any case simply by asserting that third parties would infer instructions that
defendants never made. Neither Congress nor this
Court has ever adopted such a cause of action for induced infringement caused by intervening inferences
and conduct by third parties, and doing so would contradict the plain statutory language imposing inducement liability only on one who “actively induces infringement of a patent.” 35 U.S.C. § 271(b).
2. Instead of alleging any communication that actively induces conduct sufficient to infringe, Amarin’s
complaint requires the reader to suspend logic and assume the following events:
(a) after Hikma launched its product, doctors and
patients ignored Hikma’s press release at the time of
launch expressly disclaiming indications other than
the unpatented SH indication and, instead, searched
for archived copies of Hikma’s pre-launch press releases announcing litigation victories;5
5 The operative complaint alleges that these materials had
been removed from Hikma’s “Newsroom” webpage by the
40
(b) these doctors and patients would have seen references in the pre-launch press releases only to the SH
indication but nonetheless believed that Hikma was
encouraging use of its product for other, unmentioned
indications;
(c) these same doctors and patients would have inferred from vague statements referring to Hikma’s
product as a “generic version” or “generic equivalent”
of Vascepa, Vascepa sales data, and/or the fact that
Hikma’s website refers to its icosapent product as falling under the “[h]ypertriglyceridemia” therapeutic
category, that Hikma was instructing to use its product with a second drug—a statin—for all Vascepa indications (even though Hikma never said any of this or
encouraged using its product with a statin);
(d) these doctors and patients would either know
about the Vascepa CV indication, or look it up;
(e) optionally, these doctors and patients would
then look to Hikma’s FDA-approved skinny label, but
would disregard the indication solely for the unpatented SH indication—instead, these doctors and patients would focus on the warning about administering
Hikma’s product to CV patients and read that warning
as encouraging use of Hikma’s product, off-label, with
a statin, to reduce CV risks or death (even though the
label never says any of this); and then
(f) patients would be induced from the combination
of all these assumptions and inferences from Hikma’s
pre-launch press releases, its website, and portions of
time of Hikma’s product launch, but they allegedly were
still available online at specific URLs. BIO.App.31a, ¶ 117;
BIO.App.32a–33a, ¶ 124.
41
its product label—instead of relying on the independent judgment of their doctors, or automatic substitution by the pharmacy—to use Hikma’s product off label with a statin for Vascepa’s CV indication.
These allegations are not plausible. See U.S.Cert.
Br.18. To say Amarin’s inducement theory is farfetched would be an understatement. At most, Hikma
accurately referred to its anticipated icosapent product
as a “generic version” or “generic equivalent” of
Vascepa for its SH indication, and this indication falls
within the “hypertriglyceridemia” therapeutic category. These statements do not encourage any doctors
or patients to take any action, much less action sufficient to meet all limitations of an asserted patent
claim.
As discussed, “courts should not create liability for
inducement of non-infringing conduct where Congress
has elected not to extend that concept.” Limelight, 572
U.S. at 923. The Federal Circuit’s decision to recognize
a cause of action based on communications that facially fall short of encouraging patent infringement
improperly proscribes legitimate commercial speech.
Reversal is needed to avoid “trenching on regular commerce” and chilling “ordinary acts incident to product
distribution.” Grokster, 545 U.S. at 937.
III. Allowing a complaint like Amarin’s to proceed would effectively nullify section viii.
The Federal Circuit’s expansion of induced-infringement liability to encompass a theory of passive
inducement is especially egregious in the context of the
Hatch-Waxman Act. No skinny label would be safe
from a post-launch suit if the decision below were affirmed. The Federal Circuit converted what Congress
42
intended to be risk-free generic-product launches to atrisk product launches—creating extreme financial disincentives to invoke the section viii process. The interplay between § 271(b) and Hatch-Waxman’s section
viii requires enforcing Rule 12(b)(6)’s gatekeeping
function to dismiss Amarin’s complaint.
A. The Federal Circuit doubled down on its controversial decision in GSK, 7 F.4th 1320, when it allowed
this case to survive the pleadings—driving a final nail
into the section viii coffin. Under the Federal Circuit’s
logic, a branded drugmaker can plead induced infringement despite a skinny label based on mere speculation that doctors could “read” instructions that induce infringement into statements that merely describe Hikma’s product accurately as a generic version
or equivalent of Vascepa. Pet.App.19a. As the dissent
in GSK recognized: “Essentially all ANDA generics are
the ‘generic version’ or ‘generic equivalent’ of a brand
drug; the law requires them to be.” GSK, 7 F.4th at
1353 (Prost, J., dissenting) (citing 21 U.S.C.
§ 355(j)(2)(A)(iv), (j)(4)(F) (requiring ANDA applicants
to establish “bioequivalence”) and 21 C.F.R.
§ 314.94(a)(7)(i)).
Congress itself refers to generic drugs as the “‘generic version’ * * * [of a] reference listed drug.” 21
U.S.C. § 353d(a)(3). This Court used the same phrase
when interpreting section viii. See Caraco, 566 U.S. at
415 (“Caraco wishes to market a generic version of repaglinide for two (and only two) uses.”). So has the Department of Health and Human Services, which includes FDA. See 42 C.F.R. § 423.132(a) (referring to
the “lowest priced generic version of [a] covered [Medicare] Part D drug”). As FDA explains, the Hatch-Waxman Act allows it “to approve applications to market
43
generic versions of brand-name drugs without repeating costly and duplicative clinical trials to establish
safety and efficacy.” Abbreviated New Drug Application (ANDA), FDA, https://www.fda.gov/drugs/
types-applications/abbreviated-new-drug-applicationanda.
Congress could not have intended for generics to be
held liable for inducing patent infringement, despite a
section viii carve-out, merely for characterizing a product as a “generic version” consistent with Hatch-Waxman’s statutory scheme.
B. It is no answer that Vascepa’s sales figures are
“largely attributable to the off-label CV indication.”
Pet.App.18a. Sales of a branded drug will always include uses that are “off-label” for a skinny-label generic; by definition, the skinny label does not include
all uses of the branded drug. And the informed investor community understands “market realities”—“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.” AstraZeneca, 669 F.3d at 1380. If
that were enough to plead inducement, it “would, in
practice, vitiate” section viii and “allow a pioneer drug
manufacturer to maintain de facto indefinite exclusivity over a pharmaceutical compound by obtaining serial patents for approved methods of using the compound,” “contrary to the statutory scheme.” Ibid.
Enforcing § 271(b)’s “requirement of inducing acts
is particularly important in the Hatch-Waxman Act
context” because the Act “was designed to enable the
sale of drugs for non-patented uses even though this
would result in some off-label infringing uses.”
Takeda, 785 F.3d at 631; see also supra 7–8. Instead
44
of requiring “inducing acts,” however, the decision below finds plausible inducement based on accurately reporting sales figures that allegedly include “off-label
infringing uses.” Takeda, 785 F.3d at 631. Because
patentees can always allege that a skinny-label generic will effectively compete for sales attributable to
off-label uses, the decision below will, “in practice, vitiate” section viii. AstraZeneca, 669 F.3d at 1380.
C. Absurdly, the decision below makes skinny labels riskier than paragraph IV certifications. At least
with a paragraph IV certification, the generic drugmaker is unlikely to pay damages: Any litigation begins before FDA can approve the generic drug, Caraco,
566 U.S. at 407, so it “is usually true of a paragraph IV
litigation” that there is “no claim for damages,” F.T.C.
v. Actavis, Inc., 570 U.S. 136, 152 (2013). In contrast,
the decision below allows brands to assert patents
against skinny-label generics after launch—when the
generic can be on the hook for the brand’s lost profits.
In GSK, for example, a jury awarded more than $234
million in lost profits. 7 F.4th at 1340–1341. As the
dissent foresaw, “generics simply won’t play” with section viii if complying with it can lead to massive damages. GlaxoSmithKline LLC v. Teva Pharms. USA,
Inc., 25 F.4th 949, 955 (Fed. Cir. 2022) (Prost, J., dissenting). “The risk is too great. Generics sell their
products for considerably less than brands, so a jury’s
award of lost profits to the brand can dwarf whatever
profits a generic could make.” Ibid.
Beyond the risk of damages, the cost of litigation
alone will deter generic drugmakers from invoking section viii. This Court has long recognized that “patent
litigation is a very costly process.” Blonder-Tongue
Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 334,
45
338 (1971). Seven years ago, “the average cost to defend an infringement lawsuit in the United States
[wa]s roughly $3.5 million.” Gregory Day & Steven
Udick, Patent Law and the Emigration of Innovation,
94 WASH. L. REV. 119, 125 (2019). Thus, even unsuccessful “lawsuits increase the potential costs for competitors to enter the market or delay the entry of” generic drugs. S. Sean Tu & Charles Duan, Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin
v. Hikma Type Litigation, 12 NYU J. INTELL. PROP. &
ENT. L. 1, 18 (2022). As in Twombly, “the potentially
enormous expense of discovery” often “will push costconscious defendants to settle even anemic cases.” 550
U.S. at 559.
D. By deterring generic companies from using section viii, the decision below will delay generic market
entry and increase drug prices, defeating Congress’ intent “to speed the introduction of low-cost generic
drugs to market.” Caraco, 566 U.S. at 405.
Section viii plays a critical role in achieving these
cost savings. Historically, nearly half of all generics
for drugs with multiple approved uses launched with
skinny labels, providing low-cost alternatives years before patents on carved-out uses expired. Tu & Duan,
supra, 12 NYU J. INTELL. PROP. & ENT. L. at 15; see
also Bryan S. Walsh et al., Frequency of First Generic
Drug Approvals With “Skinny Labels” in the United
States, 181 J. AM. MED. ASS’N INTERNAL MED. 995
(2021). In a five-year period, skinny labels saved Medicare an estimated $1.5 billion. Ibid. The federal government has echoed that skinny labeling is a “critical
practice[ ]” that “may result in decreased costs to patients and to the federal government.” U.S. Dep’t of
46
Health & Human Servs., Comprehensive Plan for Addressing High Drug Prices 21 (Sept. 2021).
As the decision below illustrates, however, “[r]ecent
litigation * * * may discourage the use of carve-outs
and thus delay the approval of some generic drugs.”
Ibid. A recent study confirms that the decisions below
and in GSK have had a chilling effect on section viii
filings. While “approximately half” of all drugs eligible
for labeling carve-outs had a generic launch with
skinny labeling in 2021 and 2022, “[i]n 2023, only onefifth (20%) of susceptible brand-name drugs had [ ]
skinny label generic prescriptions, which may be a signal of a diminished use of the pathway.” Therese J.
Ziaks et al., Frequency of First Generic Drugs Approved Through “Skinny Labeling,” 2021 to 2023, 31 J.
MANAG. CARE SPEC. PHARM. 343, 346 (2025).
As the government predicted, “the lenient pleading
standard applied by the court below may cause fewer
generic manufacturers to invoke the section viii pathway.” U.S.Cert.Br.23. Enforcing Rule 12(b)(6) for deficient claims under § 271(b) can prevent that result
and restore Congress’ intent in enacting section viii.
CONCLUSION
The court of appeals’ judgment should be reversed,
and the district court’s order dismissing Amarin’s
claims with prejudice should be reinstated.
47
Respectfully submitted.
EIMERIC REIG-PLESSIS
Winston & Strawn LLP
101 California Street
San Francisco, CA 94111
(415) 591-1000
ALISON M. KING
Winston & Strawn LLP
35 W. Wacker Drive
Chicago, IL 60601
(312) 558-5600
CHARLES B. KLEIN
Counsel of Record
MICHAEL B. KIMBERLY
CLAIRE A. FUNDAKOWSKI
Winston & Strawn LLP
1901 L Street NW
Washington, DC 20036
(202) 282-5000
cklein@winston.com
SAMUEL S. PARK
EDWARD J. PARDON
Hikma Pharmaceuticals
200 Connell Drive
Berkeley Heights,
NJ 07922
Counsel for Petitioners
FEBRUARY 2026
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