Case 1:20-cv-01630-RGA-JLH Document 12 Filed 01/04/21 Page 1 of 25 PageID #: 334
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 20-1630-RGA
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`AMARIN PHARMA, INC., AMARIN
`PHARMACEUTICALS IRELAND
`LIMITED, MOCHIDA
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`PHARMACEUTICAL CO., LTD.,
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`Plaintiffs,
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`v.
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`HIKMA PHARMACEUTICALS USA
`INC., HIKMA PHARMACEUTICALS
`PLC,
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`Defendants.
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`DEFENDANTS’ OPENING BRIEF IN
`SUPPORT OF MOTION TO DISMISS
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`
`
`HEYMAN ENERIO
`GATTUSO & HIRZEL LLP
`Dominick T. Gattuso (#3630)
`300 Delaware Avenue, Suite 200
`Wilmington, DE 19801
`(302) 472-7300
`dgattuso@hegh.law
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`Attorneys for Defendants Hikma
`Pharmaceuticals USA Inc. and Hikma
`Pharmaceuticals PLC
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`
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`OF COUNSEL:
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`Charles B. Klein
`Claire A. Fundakowski
`WINSTON & STRAWN LLP
`1901 L Street, N.W.
`Washington, DC 20036
`(202) 282-5000
`
`Eimeric Reig-Plessis
`WINSTON & STRAWN LLP
`101 California Street
`San Francisco, CA 94111
`(415) 591-6808
`
`Alison Heydorn
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, Illinois 60601
`(312) 558-5600
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`
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`

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`Case 1:20-cv-01630-RGA-JLH Document 12 Filed 01/04/21 Page 2 of 25 PageID #: 335
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`TABLE OF CONTENTS
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`Page
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`NATURE AND STAGE OF THE PROCEEDINGS ..................................................................... 1
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`SUMMARY OF ARGUMENT ...................................................................................................... 1
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`CONCISE STATEMENT OF FACTS ........................................................................................... 5
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`LEGAL STANDARD ................................................................................................................... 11
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`ARGUMENT ................................................................................................................................ 11
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`I.
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`Induced infringement requires not only knowledge of direct infringement, but also
`“active steps” that “specifically encourage” infringement. .............................................. 12
`II. Amarin has not alleged sufficient “active steps” by Hikma to encourage
`infringement. ..................................................................................................................... 13
`A. Alleged knowledge of direct infringement is insufficient to support an
`inducement claim. ....................................................................................................... 13
`B. Failing to discourage infringement does not support an inducement claim. .............. 14
`C. Vague label language combined with speculation is insufficient to satisfy the
`“active steps” pleading requirement for an inducement claim. .................................. 15
`D. Amarin’s complaint viewed as a whole fails to state an inducement claim. .............. 18
`III. Amarin cannot rely on the recent GSK case to survive this motion to dismiss. ............... 18
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`CONCLUSION ............................................................................................................................. 21
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`i
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`Case 1:20-cv-01630-RGA-JLH Document 12 Filed 01/04/21 Page 3 of 25 PageID #: 336
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`TABLE OF AUTHORITIES
`
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`Page(s)
`
`Cases
`
`ALA, Inc. v. CCAIR, Inc.,
`29 F.3d 855 (3d Cir. 1994).......................................................................................................16
`
`Allergan, Inc. v. Alcon Labs., Inc.,
`324 F.3d 1322 (Fed. Cir. 2003)................................................................................................11
`
`Allergan, Inc. v. Sandoz Inc.,
`2011 WL 3794364 (E.D. Tex. Aug. 25, 2011) ........................................................................11
`
`Amarin Pharma, Inc. v. Hikma Pharms. USA,
`449 F. Supp. 3d 967 (D. Nev. 2020), aff’d, 819 F. App’x 932 (Fed. Cir. 2020),
`reh’g denied, 2020-1723, D.I. 90 (Fed. Cir. Nov. 4, 2020) ...............................................1, 3, 5
`
`AstraZeneca Pharm. LP v. Apotex Corp.,
`669 F.3d 1370 (Fed. Cir. 2012)........................................................................................ passim
`
`Bayer Schering Pharma AG v. Lupin, Ltd.,
`676 F.3d 1316 (Fed. Cir. 2012)..........................................................................................11, 19
`
`Bell Atl. Corp. v. Twombly,
`550 U.S. 544 (2007) .................................................................................................................11
`
`Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,
`566 U.S. 399 (2012) ...................................................................................................................2
`
`DSU Med. Corp. v. JMS Co., Ltd.,
`471 F.3d 1293 (Fed. Cir. 2006)..........................................................................................10, 12
`
`Eli Lilly & Co. v. Teva Parenteral Meds., Inc.,
`845 F.3d 1357 (Fed. Cir. 2017)................................................................................................17
`
`GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.,
`976 F.3d 1347 (Fed. Cir. 2020)................................................................................5, 18, 19, 20
`
`Grunenthal GMBH v. Alkem Labs., Ltd.,
`919 F.3d 1333 (Fed. Cir. 2019)........................................................................................ passim
`
`HZNP Medicines LLC v. Actavis Labs.,
`940 F.3d 680 (Fed. Cir. 2019).......................................................................................... passim
`
`ICN Pharm., Inc. v. Geneva Pharm. Tech. Corp.,
`272 F. Supp. 2d 1028 (C.D. Cal. 2003) ...................................................................................11
`
`ii
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`

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`
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`Jang v. Boston Sci. Scimed, Inc.,
`729 F.3d 357 (3d Cir. 2013).....................................................................................................11
`
`Johnston v. IVAC Corp.,
`885 F.2d 1574 (Fed. Cir. 1989)................................................................................................19
`
`Morrow v. Balaski,
`719 F.3d 160 (3d Cir. 2013).....................................................................................................11
`
`Phillips v. Cnty. of Allegheny,
`515 F.3d 224 (3d Cir. 2008).....................................................................................................11
`
`Shire LLC v. Amneal Pharms., LLC,
`2014 WL 2861430 (D.N.J. June 23, 2014), aff’d in part, rev’d in part on other
`grounds, 802 F.3d 1301 (Fed. Cir. 2015) ................................................................................11
`
`Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp.,
`188 F. Supp. 3d 367 (D. Del. 2016), vacated on other grounds, 2016 WL
`7230504 (D. Del. Dec. 14, 2016) ...................................................................................4, 12, 18
`
`Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp.,
`2018 WL 6521922 (D. Del. Dec. 12, 2018) ...............................................................................4
`
`Takeda Pharm. U.S.A., Inc. v. West-Ward Pharm. Corp.,
`785 F.3d 625 (Fed. Cir. 2015).......................................................................................... passim
`
`Teva Pharm. USA, Inc. v. Novartis Pharm. Corp.,
`482 F.3d 1330 (Fed. Cir. 2007)................................................................................................19
`
`United Therapeutics Corp. v. Sandoz, Inc.,
`2014 WL 4259153 (D.N.J. Aug. 29, 2014) .............................................................................16
`
`Warner-Lambert Co. v. Apotex Corp.,
`316 F.3d 1348 (Fed. Cir. 2003)........................................................................................ passim
`
`Statutes
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`21 U.S.C. § 355(j)(2)(A)(v) .................................................................................................9, 10, 11
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`21 U.S.C. § 355(j)(2)(A)(viii) ..........................................................................................................2
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`35 U.S.C. § 271(b) ...............................................................................................................2, 11, 13
`
`Other Authorities
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`Fed. R. Civ. P. 12(b)(6)........................................................................................................1, 11, 18
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`Fed. R. Evid. 407 ...........................................................................................................................10
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`iii
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`NATURE AND STAGE OF THE PROCEEDINGS
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`Defendants, Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (together,
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`“Hikma”) are pharmaceutical companies committed to providing patients with high-quality
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`essential medicines. Hikma manufactures oral, nasal, and sterile-injectable medicines across a
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`diversified portfolio, including many of the medicines most needed to treat seriously ill COVID-
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`19 patients. Over the past 10 years, Hikma has invested hundreds of millions of dollars in building
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`and expanding its US and global manufacturing capabilities and seeks to bring more affordable
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`generic medicines to market.
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`Plaintiffs (collectively, “Amarin”) filed this case alleging that Hikma’s launch of a generic
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`version of Amarin’s Vascepa actively induces infringement of U.S. Patent Nos. 9,700,537 (“the
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`’537 patent”), 8,642,077 (“the ’077 patent”), and 10,568,861 (“the ’861 patent”) (collectively,
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`“patents-in-suit”). Hikma moves to dismiss under Rule 12(b)(6).
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`SUMMARY OF ARGUMENT
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`Amarin’s current lawsuit is its latest attempt to stifle legitimate generic competition for its
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`sole product, a branded fish-oil product called Vascepa (icosapent ethyl). Amarin previously
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`filed—and lost—a Hatch-Waxman patent infringement lawsuit to prevent Hikma from bringing
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`its generic icosapent ethyl product to market. In March 2020, the U.S. District Court for the
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`District of Nevada found all patents asserted against Hikma’s generic icosapent ethyl product (with
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`its sole indication to treat severely high triglyceride levels) invalid as obvious, and, in September
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`2020, the Federal Circuit summarily affirmed. Amarin Pharma, Inc. v. Hikma Pharms. USA, 449
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`F. Supp. 3d 967 (D. Nev. 2020), aff’d, 819 F. App’x 932 (Fed. Cir. 2020), reh’g denied, 2020-
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`1723, D.I. 90 (Fed. Cir. Nov. 4, 2020).
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`Hikma subsequently launched its generic product in early November 2020. Amarin then
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`filed this second lawsuit (in a different jurisdiction), alleging that Hikma’s labeling and website,
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`as well as certain superseded press releases, supposedly induce doctors to infringe patents directed
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`to an entirely unrelated, different, and unapproved indication—reducing the risk of certain
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`cardiovascular events such as heart attack and stroke (the “CV Indication”).
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`Amarin’s lawsuit should be dismissed under well-established precedent. In particular,
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`Hikma never sought FDA approval for the methods of use covered by Amarin’s asserted patents,
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`and Hikma’s label does not mention—and never has mentioned—this CV Indication. That is due
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`to what is known as a “carve-out label” under “section viii” of the Hatch-Waxman Amendments.
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`Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 415 (2012); see also 21 U.S.C.
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`§ 355(j)(2)(A)(viii). According to the Supreme Court, section viii “authorize[s] the FDA to
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`approve the marketing of a generic drug for particular unpatented uses; and [it] provides the
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`mechanism for a generic company to identify those uses, so that a product with a label matching
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`them can quickly come to market.” Caraco, 566 U.S. at 415. “The statute thus contemplates that
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`one patented use will not foreclose marketing a generic drug for other unpatented ones.” Id.
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`Amarin apparently reads the statute differently, but its reading has been rejected.
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`Time and again, the Federal Circuit, this Court, and other district courts have held in rulings
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`on pre-trial motions—including at the pleadings stage—that a generic product indicated for fewer
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`than all FDA-approved indications for the reference product does not “actively induce[]”
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`infringement of patents covering a carved-out indication. 35 U.S.C. § 271(b) (emphasis added).
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`This is because there can be no inducement based on a generic product label unless it
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`“encourage[s], recommend[s], or promote[s] infringement.” HZNP Medicines LLC v. Actavis
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`Labs., 940 F.3d 680, 701-02 (Fed. Cir. 2019) (“Horizon”) (citation omitted). “Merely describing
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`the infringing use, or knowing of the possibility of infringement, will not suffice; specific intent
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`and action to induce infringement must be shown.” Id. at 702.
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`2
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`Hikma’s labeling does not mention the CV Indication, much less encourage physicians to
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`practice Amarin’s patents covering that indication. In fact, Amarin never asserted any of the
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`patents-in-suit in its first patent infringement lawsuit in Nevada against Hikma. As the Judge in
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`Amarin’s first lawsuit found, Hikma’s label “do[es] not include the new [CV] indication”:
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`Now that Vascepa has two indications, the law “permits [Defendants] to file
`ANDAs directed to a subset of FDA-approved indications and even provides a
`mechanism for [Defendants] to affirmatively carve out” the new indication from
`their labels. AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370, 1381 (Fed.
`Cir. 2012). Thus, Defendants’ current labels do not include Vascepa’s new
`indication….
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`Amarin, 449 F. Supp. 3d at 974.
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`Now that Hikma recently launched its product, Amarin can rely on information outside of
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`the labeling to prove inducement. But the ultimate question remains the same: “whether the
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`[defendant’s] instructions teach an infringing use of the device such that [the courts] are willing to
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`infer from those instructions an affirmative intent to infringe the patent.” Takeda Pharm. U.S.A.,
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`Inc. v. West-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015) (emphasis in original).
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`Amarin’s complaint fails to allege any instructions by Hikma—in its labeling or
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`otherwise—that actively encourage infringement. In fact, Hikma discourages infringement. Not
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`only does Hikma’s label omit the patented CV indication, its press release announcing the launch
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`(attached to, but not quoted in, the complaint) discourages that carved-out use:
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`Hikma’s FDA-approved Icosapent Ethyl Capsule product is indicated for the
`following indication: as an adjunct to diet to reduce 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®.
`
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`D.I. 1, Ex. N (emphasis added).
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`Amarin nonetheless alleges inducement based on three theories previously rejected by the
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`Federal Circuit. First, according to Amarin, Hikma mentions its product’s “AB” rating on its
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`3
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`website and, thus, allegedly knows that doctors will prescribe, and pharmacies will automatically
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`substitute, its AB-rated generic product for the CV Indication. Id. ¶¶ 93-95, 110-113. But the
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`Federal Circuit rejected this precise argument—that “pharmacists and doctors will … substitute
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`the generic for all indications”—as “unpersuasive” and “contrary to the statutory scheme.”
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`AstraZeneca Pharms. LP v. Apotex Corp., 669 F.3d 1370, 1380 (Fed. Cir. 2012).
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`Second, Amarin alleges that Hikma should have taken even more steps to discourage
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`infringement in its labeling and press releases. D.I. 1, ¶¶ 55-60, 91-92, 96-107. The Federal
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`Circuit (in another case filed against Hikma) rejected this argument—finding that it “turns the legal
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`test on its head” because the patentee “needs to show that Hikma took affirmative steps to induce,
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`not affirmative steps to make sure others avoid infringement.” Takeda, 785 F.3d at 632 n.4.
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`Third, Amarin alleges that Hikma’s labeling includes vague language that does not
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`foreclose using the generic product for non-indicated uses—including statements such as
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`“[m]edicines are sometimes prescribed for purposes other than those listed in a Patient Information
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`leaflet.” D.I. 1, ¶¶ 114-119. The Federal Circuit’s Takeda decision puts this argument to rest.
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`“[V]ague label language cannot be combined with speculation about how physicians may act to
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`find inducement. This would seem to too easily transform that which we have held is ‘legally
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`irrelevant,’—mere knowledge of infringing uses—into induced infringement.” Takeda, 785 F.3d
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`at 632 (quoting Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003)).
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`On remand in Takeda, Judge Robinson dismissed the complaint on similar grounds. Takeda
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`Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp., 188 F. Supp. 3d 367, 377 (D. Del. 2016), vacated
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`on other grounds, 2016 WL 7230504 (D. Del. Dec. 14, 2016); see also Takeda Pharm. U.S.A.,
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`Inc. v. W.-Ward Pharm. Corp., 2018 WL 6521922 (D. Del. Dec. 12, 2018) (granting summary
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`judgment of amended complaint) (Andrews, J.). Amarin’s complaint should suffer the same fate.
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`4
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`Finally, we suspect that Amarin will rely on the Federal Circuit’s recent decision in
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`GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020) (“GSK”). But
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`that split-panel decision did not alter, and could not have altered, the controlling inducement
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`precedent discussed above. GSK is distinguishable and does not apply here. So Amarin’s lawsuit
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`should be seen for what it is—a second attempted bite at the apple in a different forum to disrupt
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`Hikma’s generic launch and to block legitimate generic competition to achieve anticompetitive
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`ends. Its lawsuit has no basis in law and this Court should dismiss the complaint.
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`CONCISE STATEMENT OF FACTS
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`Hikma accepts the allegations (but not the characterizations of documents attached to the
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`complaint) as true for purposes of this motion. Pertinent allegations are summarized below.
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`Vascepa. Vascepa contains the active ingredient icosapent ethyl, which is a purified
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`version of eicosapentaenoic acid (or EPA) found naturally in fish oil. D.I. 1, ¶¶ 21, 24. FDA has
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`approved two methods of treatment for Vascepa. The first—and only indication on Hikma’s
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`labeling—is “as an adjunct to diet solely to reduce triglyceride (TG) levels in adult patients with
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`severe (≥ 500 mg/dL) hypertriglyceridemia” (“SH Indication”). Id. ¶ 26 & Exs. D, K. As
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`background, the primary concern with this patient population is a condition called pancreatitis, not
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`cardiovascular disease. See Amarin, 449 F. Supp. 3d at 973.
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`The CV Indication, approved in late 2019, is for use “as an adjunct to maximally tolerated
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`statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and
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`unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels
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`(≥ 150 mg/dL)” and certain risk factors for cardiovascular disease. See D.I. 1, Ex. D. The two
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`indications are distinct. For example, “the cardiovascular risk reduction was not associated with
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`attainment of a more normal triglyceride level.” Amarin, 449 F. Supp. 3d at 994.
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`5
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`

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`Patents-in-suit. Amarin asserts induced infringement for three patents covering the CV
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`Indication. All three patents require treating a patient with elevated cholesterol levels or
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`cardiovascular disease (as opposed to very high triglyceride levels per the SH Indication), two of
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`the three patents require co-administration with a statin—and, most importantly, none is directed
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`to treating severe hypertriglyceridemia. See ¶¶ 65-73.
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`The ’537 patent (asserted in Count I) covers specific methods of reducing cardiovascular
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`events in a hypercholesterolemia patient—i.e., a patient with high cholesterol—if the patient has
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`not previously had a cardiovascular event and also takes a particular statin within a specified dose
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`range, according to a specific dosing regimen. Representative claim 1 recites:
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`1. A method of reducing occurrence of a cardiovascular event in a
`hypercholesterolemia patient consisting of identifying a patient having triglycerides
`(TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample
`taken from the patient as a risk factor of a cardiovascular event, wherein the patient
`has not previously had a cardiovascular event, and administering ethyl icosapentate
`in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor
`[i.e., a statin],
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`wherein [the statin] is administered to the patient at least one of before, during and
`after administering the ethyl icosapentate; and
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`wherein the [statin] is selected from the group consisting of pravastatin, lovastatin,
`simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof,
`and
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`wherein daily dose of the [statin] are 5 to 60 mg for pravastatin, 2.5 to 60 mg for
`simvastatin, 10 to 180 mg for fluvastatin sodium, 5 to 120 mg for atorvastatin
`calcium hydrate, 0.5 to 12 mg for pitavastatin calcium, 1.25 to 60 mg for
`rosuvastatin calcium, 5 to 160 mg for lovastatin, and 0.075 to 0.9 mg for
`cerivastatin sodium.
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`D.I. 1, Ex. C.
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`The ’077 patent (asserted in Count II) covers specific methods of reducing triglycerides in
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`a subject with mixed dyslipidemia on statin therapy. Representative claim 1 recites:
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`1. A method of reducing triglycerides in a subject with mixed dyslipidemia on
`statin therapy comprising, administering to the subject a pharmaceutical
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`6
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`
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`composition comprising about 2500 mg to 5000 mg per day of ethyl
`eicosapentaenoate and not more than about 5%, by weight of all fatty acids,
`docosahexaenoic acid or its esters to effect a reduction in fasting triglyceride levels
`in the subject.
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`D.I. 1, Ex. O. Mixed dyslipidemia refers to elevated LDL cholesterol and triglyceride levels. The
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`specification draws a distinction between “mixed dyslipidemia” and “very high triglycerides.” Id.
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`16:7-10; see also id. 21:65-22:7.
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`The ’861 patent (asserted in Count III) covers specific methods of reducing the risk of
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`cardiovascular death in a patient who has cardiovascular disease. Representative claim 1 recites:
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`1. A method of reducing risk of cardiovascular death in a subject with
`established cardiovascular disease, the method comprising administering to said
`subject about 4 g of ethyl icosapentate per day for a period effective to reduce risk
`of cardiovascular death in the subject.
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`D.I. 1, Ex. P.
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`Hikma’s labeling. Hikma carved out the CV Indication from its labeling under section
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`viii. Id. ¶¶ 79, 88-90. Thus, Hikma’s label is indicated solely for the SH Indication and not for
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`any cardiovascular therapy. See id., Ex. K. Nor does Hikma’s label encourage co-administering
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`its product with statins, much less according to a specific statin regimen (e.g., as required by the
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`’537 patent). In fact, Hikma’s label mentions statins only twice—in § 12.3, to report no drug-drug
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`interactions with atorvastatin; and in § 14.2, to note that 25% of patients in the reported clinical
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`trial happened to be taking statins. See id.
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`Amarin’s inducement allegations. In its complaint, Amarin points to no instruction by
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`Hikma to use its generic product for any of the specific methods covered by the patents-in-suit.
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`Instead, Amarin alleges the following three theories that Hikma’s labeling, together with its press
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`releases and website, supposedly encourage those specific methods:
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`1.
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`Amarin’s first theory is that although Hikma’s product is indicated solely for the
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`SH Indication, Hikma knows that doctors will prescribe, and pharmacies will automatically
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`7
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`substitute, its AB-rated generic product for the CV indication as well. D.I. 1, ¶¶ 93-95, 110-113.
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`For example, the complaint alleges: “On information and belief, Hikma is aware and intends that
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`its generic product, which Hikma describes as AB
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`rated
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`to VASCEPA®
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`for
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`‘hypertriglyceridemia,’ will be substituted for all VASCEPA® prescriptions, not just the
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`prescriptions directed to the Severe Hypertriglyceridemia Indication.” Id. ¶ 95. Amarin further
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`alleges that “Hikma developed its product based on market assumptions that included the entirety
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`of VASCEPA®’s sales, not just for sales resulting from treatment pursuant to the Severe
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`Hypertriglyceridemia Indication.” Id. ¶ 93.
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`2.
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`Amarin’s second theory is that Hikma has not taken sufficient steps to discourage
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`infringement. As mentioned and incorporated into Amarin’s complaint, however, Hikma’s
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`November 2020 press release announcing icosapent’s generic launch actually does discourage its
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`use for non-labelled indications, including the patented methods: “Hikma’s product is not
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`approved for any other indication for the reference listed drug VASCEPA®.” Id., Ex. N (emphasis
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`added). According to Amarin, however, Hikma should be held liable for inducement because it
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`has not done enough to discourage the patented methods. See id. ¶¶ 91-92, 96-99, 103-106, 111.
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`For example, Amarin alleges that Hikma’s label induces infringement because it does not
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`include an explicit “limitation of use” as to cardiovascular benefits. See id. ¶¶ 91-92. As the
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`complaint explains, from 2012 until late 2019, when FDA approved the CV Indication, the
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`Vascepa label contained the following limitation of use: “The effect of VASCEPA on
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`cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been
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`determined.” Id. ¶ 56. Hikma’s proposed generic label, like Vascepa’s label, initially included
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`this limitation as well. Id. ¶ 92. After FDA approved Vascepa’s CV Indication, however, Amarin
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`amended the Vascepa labeling to include that new indication and also to delete this limitation of
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`use. Id. ¶¶ 58-61. Hikma, pursuant to FDA regulations, made conforming changes to its label by
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`deleting this limitation of use and revised its generic labeling to omit the CV Indication under
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`section viii. Id. ¶ 88. Because generic products generally need to copy the labeling of the reference
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`drug, Hikma’s revised label also omitted the limitation of use with regard to cardiovascular
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`benefits removed from the Vascepa label. Id. ¶¶ 88-92, 111; see also 21 U.S.C. § 355(j)(2)(A)(v)
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`(typically, generic labeling must be “the same as the labeling approved for the listed drug”).
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`Amarin also alleges that earlier Hikma press releases from March and September 2020
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`(announcing the trial and appellate wins, respectively) recite the SH Indication, but do not
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`expressly “state that Hikma’s ‘generic version’ of VASCEPA® should not be used for the CV
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`Indication or that the effect of icosapent ethyl on cardiovascular mortality and morbidity had not
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`been determined.” D.I. 1, ¶¶ 99, 106. According to Amarin, Hikma’s failure to include such a
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`disclaimer in these earlier press releases somehow constitutes an affirmative instruction “that
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`Hikma’s ‘generic version’ of VASCEPA® should be used for all of the same indications as
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`VASCEPA®, including to reduce the risk of CV events per the CV Indication and as claimed in
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`the” patents-in-suit. Id. ¶¶ 100, 107 (emphasis in original). The actual press releases attached to
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`the complaint, however, do not say this. Compare id. ¶¶ 99, 107 with id., Exs. L, M.
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`Amarin further alleges that Hikma promotes its generic product on its website as “‘AB’
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`rated in the ‘Therapeutic Category: Hypertriglyceridemia.’” Id. ¶¶ 110-11 & Ex. T. As the exhibit
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`attached to the complaint makes clear, Hikma’s website did not mention—much less actively
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`encourage—any of the methods claimed by the patents-in-suit. Id., Ex. T. On the contrary, the
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`website said: “Hikma’s generic version is indicated for fewer than all approved indications of the
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`Reference Listed Drug.” Id.1 Regardless, as Amarin concedes, “FDA has explained that an AB
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`rating reflects a decision that a generic drug is therapeutically equivalent to a branded drug when
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`the generic drug is used as labeled, and it does not reflect a decision of therapeutic equivalence
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`for off-label uses.” Id. ¶ 82 (emphasis added). Yet, Amarin alleges that Hikma’s press releases,
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`together with this mention of the “AB” rating on the website, “instruct, promote, and encourage”
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`infringement even though no patented use appears in Hikma’s labeling, press releases, or on its
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`website. Id. ¶ 112.
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`3.
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`Finally, despite the Nevada court’s finding that “Defendants’ current labels do not
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`include Vascepa’s new [CV] indication,” Amarin points to the following snippets from Hikma’s
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`label that, when viewed collectively, allegedly encourage the non-indicated, patented methods
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`because some patients in the reported study had elevated cholesterol levels:
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`• “Assess lipid levels before initiating therapy.” Id., Ex. K, § 2.1.
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`• “Atorvastatin: In a drug-drug interaction study of 26 healthy adult subjects, icosapent
`ethyl 4 g/day at steady-state did not significantly change the steady-state AUCτ or
`Cmax of atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin when co-
`administered with atorvastatin 80 mg/day at steady state.” Id. § 12.3.
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`• “Twenty-five percent of patients [in the reported clinical study] were on concomitant
`statin therapy.” Id. § 14.2.
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`• “Heart rhythm problems which can be serious and cause hospitalization have happened
`in people who take icosapent ethyl, especially in people who have heart
`(cardiovascular) disease or diabetes with a risk factor for heart (cardiovascular)
`disease, or who have had heart rhythm problems in the past.” Id. at Patient Information
`leaflet (emphases added).
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`1 To address Amarin’s concerns raised in its allegations—even though they do not support an
`inducement claim—Hikma has completely removed the March and September 2020 press releases,
`and omitted the “AB” rating reference, from its website. Federal Rule of Evidence 407 belies
`Amarin’s allegation that this type of action “demonstrates Hikma’s knowledge that these
`documents and statements “encourage[]” infringement. Compare D.I. 1, ¶¶ 102, 109 with Fed. R.
`Evid. 407 (evidence of subsequent remedial measures “is not admissible to prove … culpable
`conduct”), and DSU Med. Corp. v. JMS Co., Ltd., 471 F.3d 1293, 1306 (Fed. Cir. 2006)
`(inducement “requires evidence of culpable conduct”).
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`• “Advise the patient to read the FDA-approved patient labeling before starting icosapent
`ethyl (Patient Information).” Id. § 17.
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`• “Medicines are sometimes prescribed for purposes other than those listed in a Patient
`Information leaflet.” Id. at Patient Information leaflet.
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`LEGAL STANDARD
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`A complaint should be dismissed under Fed. R. Civ. P. 12(b)(6) if it does not allege
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`“enough facts to state a claim to relief that is plausible on its face.” Phillips v. Cnty. of Allegheny,
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`515 F.3d 224, 234 (3d Cir. 2008) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)).
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`While a court must accept as true the allegations in the complaint, a claimant must still plead
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`sufficient facts that, if true, satisfy the elements of the relevant cause of action. Jang v. Boston
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`Sci. Scimed, Inc., 729 F.3d 357, 367 (3d Cir. 2013). The Court is “not compelled to accept
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`unsupported conclusions and unwarranted inferences, or a legal conclusion couched as a factual
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`allegation.” Morrow v. Balaski, 719 F.3d 160, 165 (3d Cir. 2013).
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`ARGUMENT
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`While Congress holds direct infringers strictly liable, inducement liability under the Patent
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`Act a