Case 1:20-cv-01630-RGA-JLH Document 123 Filed 06/10/22 Page 1 of 18 PageID #: 1871
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`AMARIN PHARMA, INC., AMARIN
`PHARMACEUTICALS IRELAND
`LIMITED, MOCHIDA
`PHARMACEUTICAL CO., LTD.,
`
`
`Plaintiffs,
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`
`
`C.A. No. 20-1630-RGA-JLH
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTICT OF DELAWARE
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`BRIEF IN SUPPORT OF HIKMA’S MOTION FOR
`ENTRY OF FINAL AND APPEALABLE JUDGMENT UNDER
`FEDERAL RULE OF CIVIL PROCEDURE 54(b)
`
`
`HEYMAN ENERIO
`GATTUSO & HIRZEL LLP
`Dominick T. Gattuso (#3630)
`300 Delaware Avenue, Suite 200
`Wilmington, DE 19801
`(302) 472-7300
`dgattuso@hegh.law
`
`Attorneys for Defendants Hikma
`Pharmaceuticals USA Inc. and
`Hikma Pharmaceuticals PLC
`
`
`HIKMA PHARMACEUTICALS USA
`INC., HIKMA PHARMACEUTICALS
`PLC, AND HEALTH NET, LLC
`
`
`Defendants.
`
`v.
`
`
`
`
`
`
`OF COUNSEL:
`
`Charles B. Klein
`Claire A. Fundakowski
`WINSTON & STRAWN LLP
`1901 L Street, NW
`Washington, DC 20036
`(202) 282-5000
`
`Eimeric Reig-Plessis
`WINSTON & STRAWN LLP
`101 California Street
`San Francisco, CA 94111
`(415) 591-6808
`
`Alison M. King
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`(312) 558-5600
`
`
`
`
`
`

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`Case 1:20-cv-01630-RGA-JLH Document 123 Filed 06/10/22 Page 2 of 18 PageID #: 1872
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`TABLE OF CONTENTS
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`Page
`
`I.
`
`II.
`
`III.
`
`IV.
`
`INTRODUCTION ...............................................................................................................1
`
`BACKGROUND .................................................................................................................2
`
`A.
`
`B.
`
`C.
`
`Amarin originally filed its claims against Hikma alone and added factually
`distinct claims against Health Net after Hikma moved to dismiss. .........................2
`
`The Court dismissed all claims against Hikma but did not dismiss Amarin’s
`separate infringement claims against Health Net.....................................................3
`
`Hikma has consistently sought entry of a final and appealable judgment to
`obtain patent certainty, which the other parties have not opposed. .........................4
`
`LEGAL STANDARD ..........................................................................................................5
`
`ARGUMENT .......................................................................................................................7
`
`A.
`
`B.
`
`The dismissal of Amarin’s claims against Hikma is a final judgment. ...................7
`
`There is no just reason for delaying entry of an appealable judgment. ...................8
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`There is no meaningful overlap between the adjudicated claims
`against Hikma and the unadjudicated claims against Health Net. ...............8
`
`Any possibility that the need for review might be mooted by future
`developments does not warrant delay. .......................................................10
`
`There is no foreseeable possibility that the Federal Circuit will need
`to consider the same issue a second time. ..................................................12
`
`There is no counterclaim that could result in any set-off. ..........................13
`
`No miscellaneous factors weigh against immediate review. .....................13
`
`V.
`
`CONCLUSION ..................................................................................................................14
`
`i
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`

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`Case 1:20-cv-01630-RGA-JLH Document 123 Filed 06/10/22 Page 3 of 18 PageID #: 1873
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`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Allis-Chalmers Corp. v. Philadelphia Elec. Co.,
`521 F.2d 360 (3d Cir. 1975).......................................................................................................6
`
`Berckeley Inv. Grp., Ltd. v. Colkitt,
`455 F.3d 195 (3d Cir. 2006)............................................................................................. passim
`
`Bogosian v. Gulf Oil Corp.,
`561 F.2d 434 (3d Cir. 1977)...............................................................................................11, 12
`
`Commissariat à l'Énergie Atomique v. Chi Mei Optoelectronics Corp.,
`293 F. Supp. 2d 430, 434-35 (D. Del. 2003),
`vacated on other grounds, 395 F.3d 1315 (Fed. Cir. 2005)...............................................10, 11
`
`Curtiss-Wright Corp. v. Gen. Elec. Co.,
`446 U.S. 1 (1980) ...............................................................................................................5, 6, 7
`
`ImageCube LLC v. The Boeing Co.,
`No. 04-7587, 2010 WL 331723 (N.D. Ill. Jan. 22, 2010) ........................................................10
`
`Intell. Ventures I LLC v. Cap. One Fin. Corp.,
`850 F.3d 1332 (Fed. Cir. 2017)..................................................................................................6
`
`Interdigital Commc’ns, Inc. v. ZTE Corp.,
`No. 13-009-RGA, 2016 WL 3226011 (D. Del. June 7, 2016) ...................................................7
`
`Keurig, Inc. v. Sturm Foods, Inc.,
`No. 10-841-SLR, 2012 WL 12896333 (D. Del. Nov. 2, 2012),
`aff’d, 732 F.3d 1370 (Fed. Cir. 2013) ........................................................................................7
`
`Loral Fairchild Corp. v. Victor Co. of Japan,
`931 F. Supp. 1044 (E.D.N.Y. 1996) ........................................................................................10
`
`Medifast, Inc. v. Minkow,
`No. 10-0382-CAB (BGS), 2012 WL 13175888 (S.D. Cal. Apr. 13, 2012).............................13
`
`Polar Electro Oy v. Amer Sports Winter & Outdoor,
`No. 11-1100-GMS, 2015 WL 13842059 (D. Del. July 17, 2015) ...........................................10
`
`Storage Tech. Corp. v. Cisco Sys., Inc.,
`329 F.3d 823 (Fed. Cir. 2003)....................................................................................................6
`
`Teva Pharms. USA, Inc. v. Novartis Pharms. Corp.,
`482 F.3d 1330 (Fed. Cir. 2007)..................................................................................................1
`
`ii
`
`

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`Case 1:20-cv-01630-RGA-JLH Document 123 Filed 06/10/22 Page 4 of 18 PageID #: 1874
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`
`
`TABLE OF AUTHORITIES—continued
`
`
`Woodard v. Sage Prods., Inc.,
`818 F.2d 841 (Fed. Cir. 1987)....................................................................................................6
`
`Page(s)
`
`Other Authorities
`
`Dan Bagatell, “Fed. Circ. Patent Decisions In 2021: An Empirical Review,”
`Law360 (Jan. 6, 2022), available at
`https://www.law360.com/articles/1452355 ............................................................................11
`
`Fed. R. Civ. P. 54(b) ................................................................................................................1, 2, 5
`
`
`iii
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`

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`I.
`
`INTRODUCTION
`
`Hikma respectfully moves for entry of a final and appealable judgment under Federal Rule
`
`of Civil Procedure 54(b). The Court has already dismissed all claims against Hikma (D.I. 97, 98),
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`and the only reason the Court’s decision is not immediately appealable is that Amarin’s separate
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`claims against another defendant, Health Net, remain pending. Amarin added the claims against
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`Health Net in its first amended complaint (D.I. 17, Counts IV–VI), and those claims are distinct
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`from the now-dismissed claims against Hikma (id., Counts I–III), which Amarin initially brought
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`in its original complaint against Hikma alone (D.I. 1).
`
`Where, as here, “more than one claim” or “multiple parties are involved, the court may
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`direct entry of a final judgment as to one or more, but fewer than all, claims or parties only if the
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`court expressly determines that there is no just reason for delay.” Fed. R. Civ. P. 54(b). As shown
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`below, there is “no just reason” to delay entry of final judgment on Amarin’s claims against Hikma,
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`which will allow Hikma to achieve patent certainty that would otherwise be delayed for well over
`
`a year by the pending litigation against Health Net.
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`Under the current case schedule, the trial between Amarin and Health Net will not take
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`place until October 30, 2023. D.I. 50 at 14–15, ¶ 20. Even after a verdict, a final judgment on all
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`claims will not be entered until the Court rules on post-trial motions. In the meantime, while
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`Hikma is confident that the decision granting its motion to dismiss is correct, Hikma bears the
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`uncertainty and risk that this decision could one day be reversed—potentially exposing Hikma to
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`damages claims for ongoing sales of its accused generic drug product. That uncertainty frustrates
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`the policy goals of “prompt resolution” and “patent certainty” in pharmaceutical patent disputes,
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`which benefit litigants and consumers alike. See, e.g., Teva Pharms. USA, Inc. v. Novartis Pharms.
`
`Corp., 482 F.3d 1330, 1342 (Fed. Cir. 2007) (discussing legislative history of Hatch-Waxman
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`amendments “to obtain patent certainty”).
`
`1
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`

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`No party opposes this motion.1 Shortly after the Court granted Hikma’s motion to dismiss,
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`all parties jointly stipulated to sever Amarin’s claims against Hikma from the pending claims
`
`against Health Net. D.I. 106. That stipulation, however, did not address the Rule 54(b) standard
`
`requiring that “there is no just reason for delay” (Fed. R. Civ. P. 54(b)), and the Court denied the
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`stipulation (D.I. 107). Thus, Hikma now files this unopposed motion to address the Rule 54(b)
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`standard and provide the Court with a reasoned basis for entering a final and appealable judgment
`
`on Amarin’s dismissed claims.
`
`II.
`
`BACKGROUND
`
`A.
`
`Amarin originally filed its claims against Hikma alone and added factually
`distinct claims against Health Net after Hikma moved to dismiss.
`
`Amarin originally filed this patent infringement case in November 2020 solely against
`
`Hikma, which markets a generic version of Amarin’s drug product, Vascepa. See D.I. 1. Amarin’s
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`complaint alleged that Hikma induces infringement of the asserted patents, which claim methods
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`of reducing cardiovascular risk, based on the label for Hikma’s generic product and statements in
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`Hikma’s press releases and website. See id. ¶¶ 90–143.
`
`In January 2021, Hikma moved to dismiss the complaint for failure to state a claim under
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`Federal Rule of Civil Procedure 12(b)(6). D.I. 11, 12. Instead of opposing Hikma’s original
`
`motion to dismiss, Amarin amended its complaint. D.I. 17. But Amarin did not add or change
`
`any claims against Hikma. See D.I. 17-1 (redlined complaint). Apart from one additional
`
`background paragraph (id. ¶ 129), Amarin repeated the same claims and allegations against Hikma
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`that were in its original complaint, while adding new claims and allegations against an unrelated
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`defendant, Health Net (see id. ¶¶ 136–62, Counts IV–VI).
`
`
`1 As set forth in Hikma’s accompanying Statement Pursuant to Local Rule 7.1.1, Hikma conferred
`with Amarin and Health Net before filing this motion. Amarin does not oppose Hikma filing a
`Rule 54(b) motion, and Health Net takes no position on the proposed motion.
`
`2
`
`

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`
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`Health Net is an insurer, not a drug manufacturer. D.I. 17 ¶ 137. Amarin’s theory for why
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`Health Net induces infringement does not involve Hikma’s generic drug label or any of Hikma’s
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`public statements. See id. ¶¶ 136–62. Instead, Amarin’s theory against Health Net is based on a
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`separate set of allegations about the insurance industry. See id. Specifically, Amarin alleges that
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`formularies used by Health Net include both Amarin’s Vascepa and Hikma’s generic version of
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`Vascepa as drug products for which Health Net provides insurance coverage. Id. ¶¶ 139–41.
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`Based on the placement of Hikma’s generic drug product on Health Net’s formularies, Amarin
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`alleges that “Hikma’s generic version of VASCEPA® has a lower patient copayment than
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`VASCEPA®,” which allegedly “encourages pharmacists to dispense it and patients to use it
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`instead of VASCEPA®.” Id. ¶¶ 145–46.
`
`B.
`
`The Court dismissed all claims against Hikma but did not dismiss Amarin’s
`separate infringement claims against Health Net.
`
`After Amarin filed its first amended complaint, both Hikma and Health Net moved to
`
`dismiss. D.I. 19, 20, 30, 31. Hikma’s motion to dismiss the first amended complaint repeated the
`
`same noninfringement arguments that Hikma had raised in moving to dismiss the original
`
`complaint. Compare D.I. 12 with D.I. 20. Before the Court ruled on either motion, Health Net
`
`filed a motion to sever Amarin’s claims against Health Net from the claims against Hikma. D.I.
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`32, 33. The Court denied the motion to sever without prejudice to renew “at the same time case
`
`dispositive motions are due.” D.I. 65 at 4, ¶ 9. Although it denied the motion, the Court “agree[d]
`
`with Health Net that, if the Court only considers the acts alleged to be inducing, there is little
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`overlap in the allegations against Health Net and Hikma.” Id. at 3, ¶ 5.
`
`In January 2021, the Court granted Hikma’s motion to dismiss the first amended complaint
`
`but denied Health Net’s motion to dismiss. D.I. 97, 98. As to Hikma, the Court held that none of
`
`the statements in Hikma’s generic drug label or Hikma’s other public statements “rise to the level
`
`3
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`

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`
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`of encouraging, recommending, or promoting taking Hikma’s generic for the reduction of
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`[cardiovascular] risk,” as required by Amarin’s asserted patents. D.I. 97 at 8. Thus, the Court held
`
`that “Amarin’s complaint has failed to plead inducement based on Hikma’s label or public
`
`statements.” Id. at 9. By contrast, the Court denied Health Net’s motion to dismiss because of
`
`Amarin’s distinct allegations that Health Net’s “formulary placement induces infringement of
`
`Plaintiffs’ patents by encouraging the use of Hikma’s generic for the [allegedly patented]
`
`indication,” which the Court held raises “factual questions that cannot be resolved on a motion to
`
`dismiss.” Id. at 10, 12.
`
`C.
`
`Hikma has consistently sought entry of a final and appealable judgment to
`obtain patent certainty, which the other parties have not opposed.
`
`In its order granting Hikma’s motion to dismiss, the Court indicated that Amarin “may file
`
`a motion in compliance with the Local Rules seeking leave to amend” its complaint a second time.
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`D.I. 98 n.1. But Amarin never requested such an amendment and informed Defendants that
`
`Amarin “will not be seeking leave to amend its claims against Hikma.” Ex. A at 4. Thus, this case
`
`is effectively over before this Court with respect to Hikma.
`
`In the time since the Court granted Hikma’s motion to dismiss, Hikma has consistently
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`sought entry of a final and appealable judgment. On January 12, 2022 (the week after the Court
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`granted Hikma’s motion to dismiss on January 4), Hikma contacted Amarin to ask whether it
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`would consent to entry of judgment under Rule 54(b). Ex. B. Amarin responded that it preferred
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`to seek severance of the claims against Hikma from the claims against Health Net. Id. In the
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`interest of moving forward, Hikma agreed and kept working with Amarin over the following weeks
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`to finalize papers for severance and entry of final judgment. See Ex. A at 3–5.
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`Eventually, after some disputes between Amarin and Health Net that did not concern
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`Hikma (see id. at 2–3), the parties stipulated to sever Amarin’s dismissed claims against Hikma
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`4
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`

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`
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`(D.I. 106). Because the stipulation sought severance and not a Rule 54(b) judgment, however, it
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`did not address the “no just reason for delay” standard. Fed. R. Civ. P. 54(b). The Court denied
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`the stipulation in an oral order dated March 1, 2022. D.I. 107.
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`On April 1, 2022, after additional discussions, the parties filed a joint status report in which
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`Amarin and Hikma requested a status conference to obtain guidance on the Court’s preferred
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`method for entering an appealable judgment. D.I. 108.2 The Court denied the request, and no
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`status conference took place. D.I. 109. Hikma now moves, without opposition from any party,
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`for entry of a final and appealable judgment. Hikma submits this brief to demonstrate that the
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`standard for entering judgment under Rule 54(b) is met.
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`III. LEGAL STANDARD
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`In cases involving multiple claims or parties, “the court may direct entry of a final judgment
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`as to one or more, but fewer than all, claims or parties only if the court expressly determines that
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`there is no just reason for delay.” Fed. R. Civ. P. 54(b). The Supreme Court has set forth two
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`“steps to be followed in making determinations under Rule 54(b).” Curtiss-Wright Corp. v. Gen.
`
`Elec. Co., 446 U.S. 1, 7 (1980).
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`First, a court must “determine that it is dealing with a ‘final judgment.’” Id. The underlying
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`order “must be a ‘judgment’ in the sense that it is a decision upon a cognizable claim for relief,
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`and it must be ‘final’ in the sense that it is an ultimate disposition of an individual claim entered
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`in the course of a multiple claims action.” Id. (quotation omitted).
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`Second, “the district court must go on to determine whether there is any just reason for
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`delay.” Id. at 8. This determination is left to the court’s discretion based on “judicial
`
`
`2 The status report also clarified that “Amarin no longer asserts U.S. Patent No. 8,642,077 against
`Hikma and seeks to appeal the Court’s Order dismissing the claims against Hikma only as to U.S.
`Patent Nos. 9,700,537 and 10,568,861.” Id.
`
`5
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`

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`
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`administrative interests as well as the equities involved,” including “such factors as whether the
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`claims under review were separable from the others remaining to be adjudicated and whether the
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`nature of the claims already determined was such that no appellate court would have to decide the
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`same issues more than once even if there were subsequent appeals.” Id. at 8.
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`The Third Circuit has elaborated on this determination and set forth five factors to consider
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`when deciding whether there is “no just reason for delay”:
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`(l) the relationship between the adjudicated and unadjudicated claims;
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`(2) the possibility that the need for review might or might not be mooted by future
`developments in the district court;
`
`(3) the possibility that the reviewing court might be obliged to consider the same
`issue a second time;
`
`(4) the presence or absence of a claim or counterclaim which could result in a set-
`off against the judgment sought to be made final; [and]
`
`(5) miscellaneous factors such as delay, economic and solvency considerations,
`shortening the time of trial, frivolity of competing claims, expense, and the like.
`
`Berckeley Inv. Grp., Ltd. v. Colkitt, 455 F.3d 195, 203 (3d Cir. 2006) (citing Allis-Chalmers Corp.
`
`v. Philadelphia Elec. Co., 521 F.2d 360, 364 (3d Cir. 1975)).
`
`The Federal Circuit has held that its own law applies to determinations under Rule 54(b)
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`as a matter of its appellate jurisdiction. Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 830
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`(Fed. Cir. 2003). But the Federal Circuit has not enumerated its own factors to determine whether
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`there is “no just reason for delay.” Instead, it has turned to regional circuit law as persuasive
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`guidance. See, e.g., Intell. Ventures I LLC v. Cap. One Fin. Corp., 850 F.3d 1332, 1336 (Fed. Cir.
`
`2017) (relying on Fourth Circuit law in appeal from District of Maryland); see also Woodard v.
`
`Sage Prods., Inc., 818 F.2d 841, 844 (Fed. Cir. 1987) (“We may, of course, look for guidance in
`
`6
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`

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`
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`the decisions of the regional circuit to which appeals from the district court would normally lie, as
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`well as those of other courts.”) (citation omitted).
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`Thus, this Court and others in this District have applied the Third Circuit’s five-factor test
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`in Berckeley to determine whether there is no just reason for delay in patent cases. See Interdigital
`
`Commc’ns, Inc. v. ZTE Corp., No. 13-009-RGA, 2016 WL 3226011, at *1–3 (D. Del. June 7,
`
`2016); Keurig, Inc. v. Sturm Foods, Inc., No. 10-841-SLR, 2012 WL 12896333, at *1 (D. Del.
`
`Nov. 2, 2012), aff’d, 732 F.3d 1370 (Fed. Cir. 2013).
`
`IV. ARGUMENT
`
`The Court should certify its dismissal of Amarin’s claims against Hikma as a final and
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`appealable judgment under Rule 54(b) because (a) the dismissal is a final judgment with respect
`
`to those claims; and (b) there is no just reason to delay any appeal.
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`A.
`
`The dismissal of Amarin’s claims against Hikma is a final judgment.
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`The Court’s order dismissing Amarin’s claims against Hikma meets Rule 54(b)’s first
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`requirement because it is a “final judgment.” Curtiss-Wright, 446 U.S. at 7. The Court ordered
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`that “[t]he first amended complaint (D.I. 17) as to the Hikma Defendants is DISMISSED without
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`prejudice.” D.I. 98. The Court’s order is “a ‘judgment’ in the sense that it is a decision upon a
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`cognizable claim for relief” (Curtiss-Wright, 446 U.S. at 7)—i.e., Amarin’s patent claims against
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`Hikma. The order is also “‘final’ in the sense that it is an ultimate disposition of an individual
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`claim entered in the course of a multiple claims action.” Id.
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`Although the Court indicated that Amarin “may file a motion in compliance with the Local
`
`Rules seeking leave to amend” (D.I. 98 n.1), Amarin elected not to file such a motion (Ex. A at 4).
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`Instead, Amarin stipulated (jointly with Hikma and Health Net) to sever its claims against Hikma
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`for purposes of seeking an immediate appeal. D.I. 106 at 2. Thus, because the Court dismissed
`
`7
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`

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`
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`all claims against Hikma and Amarin is not seeking to amend those claims, the Court’s order is a
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`final judgment for purposes of Rule 54(b).
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`B.
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`There is no just reason for delaying entry of an appealable judgment.
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`The Court should direct entry of a final and appealable judgment based on its order
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`dismissing Amarin’s claims against Hikma because there is no just reason for delay. As shown
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`below, the Third Circuit’s Berckeley factors weigh in favor of this determination.
`
`1.
`
`There is no meaningful overlap between the adjudicated claims against
`Hikma and the unadjudicated claims against Health Net.
`
`The first factor is “the relationship between the adjudicated and unadjudicated claims.”
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`Berckeley, 455 F.3d at 203. This factor favors entering judgment because Amarin’s claims against
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`Hikma are separable and materially different from its claims against Health Net. Indeed, the Court
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`has already found that, with respect to “the acts alleged to be inducing, there is little overlap in the
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`allegations against Health Net and Hikma.” D.I. 65 at 3, ¶ 5.3
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`The lack of overlap between Amarin’s claims against Hikma and Health Net is illustrated
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`by the Court’s decision to grant Hikma’s motion to dismiss but not Health Net’s. The Court
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`recognized that Amarin’s theory against Hikma is that its generic drug “label, along with Hikma’s
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`public statements, induce infringement of Plaintiffs’ patents for the [cardiovascular] indication”
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`that Amarin’s patents allegedly cover. D.I. 97 at 4. This theory turns on whether statements in
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`Hikma’s generic drug label and other public statements “rise to the level of encouraging,
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`recommending, or promoting taking Hikma’s generic for the reduction of CV risk.” Id. at 8. The
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`Court held that Hikma’s statements do not satisfy this standard and, as a result, granted Hikma’s
`
`
`3 Despite finding little overlap in Amarin’s allegations, the Court denied Health Net’s motion to
`sever without prejudice because the joinder statute is “broad enough to encompass situations, like
`this one, where both defendants are alleged to induce the same act of direct infringement of a
`method patent,” regardless of whether the allegations against the defendants overlap. Id. The
`joinder statute is not relevant to Hikma’s request to enter judgment under Rule 54(b).
`
`8
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`
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`motion to dismiss because “Amarin’s complaint has failed to plead inducement based on Hikma’s
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`label or public statements.” Id. at 9.
`
`By contrast, Amarin’s theory against Health Net has nothing to do with Hikma’s generic
`
`drug label or public statements. Instead, as the Court explained, Amarin alleges that “Health Net’s
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`formulary placement induces infringement of Plaintiffs’ patents by encouraging the use of
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`Hikma’s generic for the [allegedly patented] indication” because its “formulary lists Hikma’s
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`generic in a lower tier than Amarin’s Vascepa, resulting in lower copays when a patient opts for
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`Hikma’s generic.” Id. at 10. According to Amarin, “this formulary placement leads to substitution
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`on ‘all VASCEPA prescriptions,’” including for the allegedly patented uses. Id. Unlike Amarin’s
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`theory against Hikma, the Court held that this theory raises distinct “factual questions that cannot
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`be resolved on a motion to dismiss.” Id. at 12.
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`Given these materially different theories of infringement, there is no meaningful overlap
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`between Amarin’s claims against Hikma and Amarin’s claims against Health Net that would
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`warrant any delay. Simply put, any appeal of the Court’s decision to dismiss Amarin’s claims
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`against Hikma will not involve any allegations about Health Net’s formulary placement, and the
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`ongoing litigation between Amarin and Health Net will not involve any allegations about Hikma’s
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`generic drug label or public statements. Tellingly, with no remaining disputes about whether
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`Hikma’s label induces infringement, Amarin and Health Net stipulated to vacate all further claim
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`construction briefing and forego any Markman hearing. D.I. 105.
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`There is also no question that Amarin’s claims against Hikma are separable from its claims
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`against Health Net. In its original complaint, Amarin brought the same claims against Hikma
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`separately and without naming Health Net. D.I. 1. If Amarin had not amended its complaint to
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`add new and different allegations against Health Net, the Court’s order granting Hikma’s motion
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`to dismiss would already be an appealable judgment.
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`Courts in this District and others have entered Rule 54(b) judgments in analogous
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`circumstances, where the same patents are asserted against multiple defendants and one of them
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`prevails early in the case on an issue that does not apply to the other defendants. See, e.g., Polar
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`Electro Oy v. Amer Sports Winter & Outdoor, No. 11-1100-GMS, 2015 WL 13842059, at *1 n.1
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`(D. Del. July 17, 2015) (entering Rule 54(b) judgment after dismissing one defendant for lack of
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`personal jurisdiction); ImageCube LLC v. The Boeing Co., No. 04-7587, 2010 WL 331723, at *4
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`(N.D. Ill. Jan. 22, 2010) (entering Rule 54(b) judgment after summary judgment where, “barring
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`a reversal on appeal, the case is over as to [one defendant]”); Commissariat à l’Énergie Atomique
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`v. Chi Mei Optoelectronics Corp., 293 F. Supp. 2d 430, 434–35 (D. Del. 2003), vacated on other
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`grounds, 395 F.3d 1315 (Fed. Cir. 2005) (entering Rule 54(b) judgment after dismissing one
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`defendant for lack of personal jurisdiction “because it was the ultimate disposition of an individual
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`claim entered in the course of a multiple claims action”) (quotation omitted); Loral Fairchild Corp.
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`v. Victor Co. of Japan, 931 F. Supp. 1044, 1046 (E.D.N.Y. 1996) (Rader, C.J., by designation)
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`(entering Rule 54(b) judgment in case asserting two patents against multiple defendants where the
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`court “finally resolved all liability issues [as to one defendant] but with pending claims against the
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`other defendants”).
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`Thus, the first Berckeley factor weighs in favor of finding no just reason for delay.
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`2.
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`Any possibility that the need for review might be mooted by future
`developments does not warrant delay.
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`The second factor is “the possibility that the need for review might or might not be mooted
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`by future developments in the district court.” Berckeley, 455 F.3d at 203. This factor is neutral
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`or, at a minimum, does not outweigh the other factors favoring review.
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`The only foreseeable development that could moot an appeal on Amarin’s claims against
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`Hikma is that the asserted patents could be held invalid. Because the case between Amarin and
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`Health Net is still at an early stage, however, that possibility is speculative. The trial between
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`Amarin and Health Net is currently scheduled for October 30, 2023—almost 17 months away.
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`Any jury verdict that Amarin’s patents are invalid would be subject to post-trial motions before
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`entry of judgment, and that judgment itself would be subject to appeal. In the meantime, the
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`Federal Circuit could potentially resolve an appeal on Amarin’s claims against Hikma before the
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`trial against Health Net even begins. Last year, for example, the Federal Circuit disposed of patent
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`cases in an average of 12.7 months from docketing to date of decision.4
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`In any event, potential future developments that could moot an appeal are not dispositive
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`and do not preclude entering judgment under Rule 54(b). In this District, the court in Commissariat
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`à l’Énergie Atomique entered a Rule 54(b) judgment after dismissing one defendant despite
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`arguments that ongoing litigation with the remaining defendants “may render the patents in suit
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`invalid whether or not [the dismissed defendant] is involved.” 293 F. Supp. 2d at 434. Similarly,
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`in Bogosian v. Gulf Oil Corp., the Third Circuit affirmed a district court’s Rule 54(b) certification
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`despite the “possibility that decision on [a] contract theory pending trial could moot the question
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`presented on the appeal from [a] conspiracy-tying theory” that was resolved on summary
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`judgment. 561 F.2d 434, 443 (3d Cir. 1977). The Third Circuit explained that “a decision on th[e]
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`claim [pending trial] might take a number of years to reach, and, in the interim, the defendants
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`would bear the uncertainty arising from the fact that they may be forced to defend a massive
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`antitrust claim years in the future.” Id. In addition, the court noted that “because the summary
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`4 Dan Bagatell, “Fed. Circ. Patent Decisions In 2021: An Empirical Review,” Law360 (Jan. 6,
`2022), available at https://www.law360.com/articles/1452355 .
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`judgment was granted on the basis of the pleadings, [the] need to examine the record at this stage
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`is minimal,” which mitigated any concerns about having multiple judgments that could be
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`separately appealed. Id.
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`This case presents analogous facts. While Amarin’s patents might be found invalid, that
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`issue is unlikely to be resolved for more than a year. Meanwhile, Hikma faces uncertainty over
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`whether Amarin’s claims against it will someday be revived and whether it will need to defend
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`itself in a later trial. Moreover, because the Court dismissed Amarin’s claims against Hikma on
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`the pleadings, there is no substantial record for the Federal Circuit to review.
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`Thus, despite a possibility of mootness due to invalidity, the second Berckeley factor is
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`neutral or does not otherwise weigh against finding no just reason for delay.
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`3.
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`There is no foreseeable possibility that the Federal Circuit will need to
`consider the same issue a second time.
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`The third factor — “the possibility that the reviewing court might be obliged to consider
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`the same issue a second time” — weighs toward finding no just reason for delay. Berckeley, 455
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`F.3d at 203. For the same reasons discussed above for the first factor, the Federal Circuit will not
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`need to consider the same issues twice because Amarin’s claims against Hikma and its claims
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`against Health Net are based on materially different theories.
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`Any appeal of the Court’s order dismissing Amarin’s claims against Hikma would be
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`limited to whether Hikma’s generic drug label and it