Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 1 of 29 PageID #: 25870
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC. and CITY OF HOPE,
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`Plaintiffs,
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`v.
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`AMGEN, INC.,
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`Defendant.
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`C.A. No. 18-924-CFC
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`GENENTECH’S OPENING BRIEF IN SUPPORT OF ITS FED. R. CIV. P.
`62(d) MOTION FOR AN INJUNCTION PENDING APPEAL, OR, IN THE
`ALTERNATIVE, A 14-DAY INJUNCTION TO ENABLE GENENTECH TO
`PURSUE AN EXPEDITED MOTION FOR AN INJUNCTION PENDING
`APPEAL BEFORE THE FEDERAL CIRCUIT PURSUANT TO FED. R. APP. P. 8
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`PUBLIC VERSION FILED:
`JULY 29, 2019
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 2 of 29 PageID #: 25871
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`TABLE OF CONTENTS
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`Page
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`TABLE OF AUTHORITIES ...................................................................................................... ii
`INTRODUCTION ...................................................................................................................... 1
`LEGAL STANDARD ................................................................................................................. 4
`ARGUMENT .............................................................................................................................. 6
`A.
`Unless Enjoined, Amgen’s Infringement Will Irreparably Harm Genentech. .................... 6
`1.
`The Court Finding of Delay Would Require Premature and Unnecessary
`Filings. ................................................................................................................. 6
`The Evidence Presented Supports Genentech’s Irreparable Harm. ...................... 10
`2.
`The Remaining Factors Support Granting Genentech’s Rule 62(d) Motion .................... 12
`1.
`Genentech Has Made a Strong Showing That It Is Likely to Succeed on
`the Merits. .......................................................................................................... 12
`The Balance of Hardships Favors Genentech...................................................... 13
`2.
`Granting An Injunction Pending Appeal Serves The Public Interest. .................. 13
`3.
`CONCLUSION ......................................................................................................................... 15
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`B.
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`i
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 3 of 29 PageID #: 25872
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`
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`Federal Cases
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`TABLE OF AUTHORITIES
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`Page(s)
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`Abbott Labs. v. Sandoz, Inc.,
`500 F. Supp. 2d 807 (N.D. Ill. 2007),..................................................................................... 9
`
`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2008) ........................................................................................ 9, 10
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`Amgen, Inc. v. Sandoz, Inc.,
`No. 2015-1499, D.I. 105 (Fed. Cir. May 5, 2015) .................................................................. 4
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`Amgen Inc. v. Sandoz Inc.,
`No. 3:14-cv-04741-RS (N.D. Cal. Apr. 15, 2015) .................................................................. 4
`
`Apple Inc. v. Samsung Elecs. Co.,
`695 F.3d 1370 (Fed. Cir. 2012) (Apple I) ............................................................................... 6
`
`Apple Inc. v. Samsung Elecs. Co.,
`735 F.3d 1352 (Fed. Cir. 2013) (Apple II) .......................................................................... 3, 9
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`Apple Inc. v. Samsung Elecs. Co.,
`809 F.3d 633 (Fed. Cir. 2015).............................................................................................. 11
`
`Astrazeneca LP v. Breath Ltd.,
`Nos. 2013–1312, 2013–1352, 2013 WL 9853383 (Fed. Cir. May 24, 2013)........................... 5
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`BioTechnology Gen. Corp. v. Genentech, Inc.,
`80 F.3d 1553 (Fed. Cir. 1996).............................................................................................. 11
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`Butamax Adv. Biofuels LLC v. Gevo, Inc.,
`2012 WL 2675232 (D. Del. July 6, 2012) .............................................................................. 5
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`Celsis in Vitro, Inc. v. Cellzdirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012)........................................................................................ 11, 13
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`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`2011 WL 1980610 (D. Del. May 20, 2011) ........................................................................... 5
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`717 F.3d 1336 (Fed Cir. 2013) ............................................................................................. 11
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`High Tech Medical Instrumentation, Inc. v. New Image Industries, Inc.,
`49 F.3d 1551 (Fed. Cir. 1995).............................................................................................. 10
`
`ii
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 4 of 29 PageID #: 25873
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`Impax Labs., Inc. v. Aventis Pharm. Inc.,
`235 F. Supp. 2d 390 (D. Del. 2002) ..................................................................................... 13
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`Kos Pharms., Inc. v. Andrx Corp.,
`369 F.3d 700 (3d Cir. 2004) ................................................................................................ 13
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`Noven Pharm., Inc. v. Mylan Techs. Inc.,
`2018 WL 4007848 (D. Del. Aug. 22, 2018) ........................................................................... 5
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`PPG Indus., Inc. v. Guardian Indus. Corp.,
`75 F.3d 1558 (Fed. Cir. 1996).............................................................................................. 12
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`Pfizer, Inc. v. Teva Pharm., USA, Inc.,
`429 F.3d 1364 (Fed. Cir. 2005) .............................................................................................. 8
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`Polymer Techs v. Bridwell,
`103 F.3d 970 (Fed. Cir. 1996).......................................................................................... 8, 10
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`Purdue Pharma L.P. v. Boehringer Ingelheim GmbH,
`237 F.3d 1359 (Fed. Cir. 2001) ............................................................................................ 11
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`In re Revel AC, Inc.,
`802 F.3d 558 (3d Cir. 2015) .................................................................................................. 5
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`Sandoz Inc. v. Amgen Inc.,
`137 S. Ct. 1664 (2017) .......................................................................................................... 8
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`Standard Havens Prods., Inc. v. Gencor Indus., Inc.,
`897 F.2d 511 (Fed. Cir. 1990)................................................................................................ 5
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`Trading Techs. Int’l, Inc. v. eSpeed, Inc.,
`No. 04 C 5312, 2008 WL 4531371 (N.D. Ill. May 22, 2008), aff’d, 595 F.3d
`1340 (Fed. Cir. 2010) ............................................................................................................ 9
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`Federal Statutes
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`42 U.S.C. § 262(k)(4) ................................................................................................................ 14
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`Rules
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`Fed. R. App. P. 8 ............................................................................................................... 1, 4, 15
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`Fed. R. Civ. P. 62(d) ..................................................................................................... 1, 4, 5, 12
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`iii
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 5 of 29 PageID #: 25874
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`INTRODUCTION
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`Genentech respectfully brings this motion pursuant to Fed. R. Civ. P. 62(d) for an
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`injunction pending appeal, or, in the alternative, a 14-day injunction to enable Genentech to
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`pursue an expedited motion for an injunction pending appeal before the Federal Circuit pursuant
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`to Fed. R. App. P. 8, as it is required to do prior to filing its motion with the Federal Circuit.
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`Fed. R. App. P. 8(a). Genentech asked Amgen to stipulate to this relief, which it has declined to
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`do.
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`On July 10, 2019, Genentech filed an emergency motion in which it asked the Court to
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`temporarily restrain and preliminarily enjoin Amgen from launching its trastuzumab biosimilar
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`Kanjinti. In its supporting papers, Genentech contended that: (1) without an injunction,
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`Genentech would suffer loss of market share, price erosion, and reputational injury resulting
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`directly from Amgen’s infringement that cannot be addressed with money damages;
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`(2) Genentech is likely to prevail on the merits inasmuch as Amgen effectively concedes
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`infringement, and Amgen’s defense hinges on essentially the same invalidity arguments that the
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`Patent Office recently rejected in multiple IPRs; (3) unlike the significant and permanent harm
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`facing Genentech, Amgen will lose no customers or market share if forced to wait until the
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`issues are resolved in the December trial; and (4) patient access would not be affected because
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`Genentech ensures that patients can obtain Herceptin regardless of ability to pay. The Court did
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`not resolve any of those issues adversely to Genentech.
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`Instead, the Court concluded that Genentech had failed to establish irreparable harm in
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`two other respects—both of which establish new criteria that present substantial appellate issues.
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`First, the Court found that any harm alleged by Genentech could not be “irreparable”
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`because Genentech delayed in filing its motions. While the Court’s opinion does not specify
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`when the period of delay started, it suggests that the clock started ticking on Genentech’s
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`1
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 6 of 29 PageID #: 25875
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`irreparable harm allegations as early as when Amgen first served its Notice of Commercial
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`Marking in May 2018. But at that point in time, and up until FDA approval 15 months later,
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`Genentech had no way of knowing (1) what Amgen’s label would say with respect to Kanjinti
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`dosing requirements—a necessary precursor to assess whether Amgen would infringe any of the
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`extended dosing regimen patents at issue here, or (2) whether the FDA would approve such
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`proposed labelling, which could change significantly during FDA review. Indeed, during this
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`period
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`The Court also suggested that Genentech was on notice that Amgen was preparing to
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`launch Kanjinti, but while Amgen produced documents in April that indicated a desire to be
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`“launch ready” in July 2019, Amgen and its counsel repeatedly represented to the Court and
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`Genentech, as recently as June 26, that no decision as to when to launch had been made. (D.I.
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`266, at 1.) Amgen asserts that it made its launch decision on
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` and decided to launch
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`immediately thereafter, causing Genentech to scramble to protect its rights via a preliminary
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`injunction motion.
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`Genentech is unaware of any case in which a court has found that a party in Genentech’s
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`position is required to move for a preliminary injunction before there is clarity as to whether a
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`biosimilar product will be launched or, if it is launched, what form it will take. At a minimum,
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`2
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 7 of 29 PageID #: 25876
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`the Court’s holding has far-reaching implications, and the appellate court should have an
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`opportunity to consider those issues before Amgen inflicts what Amgen itself has argued
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`elsewhere constitutes irreparable harm.
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`Second, based on licenses that Genentech had executed with Mylan, Celltrion, Samsung,
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`and Pfizer, the Court found that Genentech had placed a monetary value on Amgen’s
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`infringement, thus conceding that any harm is not irreparable. But those agreements all arose out
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`of settlements (of either litigation or IPRs),
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` is why the Federal Circuit and other courts have found that settlement agreements
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`like these cannot be used to undermine a claim of irreparable harm. See, e.g., Apple Inc. v.
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`Samsung Elecs. Co., 735 F.3d 1352, 1370 (Fed. Cir. 2013) (Apple II). The Court’s conclusion
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`that Genentech forfeited its right to obtain an injunction would mean, as a practical matter, that
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`innovators cannot settle biosimilar cases without losing their right to exclude, making settlement
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`effectively impossible. That, too, has far-reaching implications and is an issue worthy of
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`appellate review.
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`Genentech has filed its Notice of Appeal to the Federal Circuit, and as this Court
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`recognized, the stakes are high. (See July 10 Hr’g Tr. at 9:20-23.) Thus, to allow for meaningful
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`review of the Court’s decision, Genentech respectfully requests an Order that maintains the
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`3
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 8 of 29 PageID #: 25877
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`status quo by enjoining Amgen from launching Kanjinti until the Federal Circuit appeal
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`concludes.1 This is the same relief that Amgen itself sought and obtained from the Federal
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`Circuit on an emergency basis (after the district court had denied it), when Amgen was seeking
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`to bar the launch of a competing drug (from Sandoz). (See Ex. 2452 (Amgen, Inc. v. Sandoz, Inc.,
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`No. 2015-1499, D.I. 105 (Fed. Cir. May 5, 2015); Ex. 246 (Order Denying Motion for Injunction
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`Pending Appeal, Amgen Inc. v. Sandoz Inc., No. 3:14-cv-04741-RS (N.D. Cal. Apr. 15, 2015)).)
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`Alternatively, at the very least, Genentech requests a more limited 14-day injunction prohibiting
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`Amgen from launching Kanjinti—to allow Genentech to pursue an expedited Fed. R. App. P. 8
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`motion for an injunction pending appeal from the Federal Circuit, as Judge Stark recently did in
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`analogous circumstances.
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`LEGAL STANDARD
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`“While an appeal is pending from an interlocutory order … that … refuses [or]
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`dissolves … an injunction, the court may … restore[] or grant an injunction on terms for bond or
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`other terms that secure the opposing party’s rights.” Fed. R. Civ. P. 62(d).3 To show that it is
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`entitled to an injunction pending appeal under that standard, Genentech must establish “(1) a
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`strong showing that it is likely to succeed on the merits in its appeal; (2) that absent an injunction
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`it will be irreparably harmed; (3) that an injunction will not substantially injure [Amgen]; and
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`1Given the ongoing irreparable harm to Genentech as set forth herein, Genentech respectfully
`requests expedited consideration of this Motion.
`2Genentech refers to the exhibits previously submitted in the parties’ briefing on Genentech’s
`emergency motion for TRO and preliminary injunction, and consecutively numbers additional
`exhibits submitted in support of this Rule 62(d) motion.
`3Rule 62 was amended in 2018 such that the text previously found in subsection (c) is now
`found, with minor changes, in subsection (d). See Committee Notes on Rules—2018
`Amendment (“The provisions for staying an injunction, receivership, or order for a patent
`accounting are reorganized by consolidating them in new subdivisions (c) and (d). There is no
`change in meaning.”).
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`4
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 9 of 29 PageID #: 25878
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`(4) that an injunction will not harm the interests of the public.” Noven Pharm., Inc. v. Mylan
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`Techs. Inc., 2018 WL 4007848, at *1 (D. Del. Aug. 22, 2018) (citing Hilton v. Braunskill, 481
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`U.S. 770, 776 (1987)); see In re Revel AC, Inc., 802 F.3d 558, 567-571 (3d Cir. 2015) (similar);
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`Astrazeneca LP v. Breath Ltd., Nos. 2013–1312, 2013–1352, 2013 WL 9853383, at *1 (Fed. Cir.
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`May 24, 2013) (similar).
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`Those four factors “need not be given equal weight.” Butamax Adv. Biofuels LLC v.
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`Gevo, Inc., 2012 WL 2675232, at *1 (D. Del. July 6, 2012); Standard Havens Prods., Inc. v.
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`Gencor Indus., Inc., 897 F.2d 511, 512 (Fed. Cir. 1990). Rather, the injunction analysis is
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`flexible, and the Court should “assess[] the movant’s chances for success on appeal and weigh[]
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`the equities as they affect the parties and the public.” Butamax, 2012 WL 2675232, at *1
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`(quoting E.I. DuPont de Nemours & Co. v. Phillips Petroleum Co., 835 F.2d 277, 278 (Fed. Cir.
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`1987)). Indeed, courts have granted Rule 62(d) motions in similar circumstances to maintain the
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`status quo and allow meaningful review on appeal. See Noven Pharm., Inc., 2018 WL 4007848
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`(D. Del. Aug. 22, 2018) (after denial of preliminary injunction, imposing eight-day injunction
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`under a set of reasonable terms to preserve the status quo and ease the burden placed on the
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`Federal Circuit by the expeditious proceedings); Butamax Advanced Biofuels LLC, 2012 WL
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`2675232 (granting injunction pending expedited appeal and ordering parties to submit
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`supplemental papers, where harm to plaintiff of defendant’s market entry would be greater than
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`harm to defendant of temporary exclusion from that market); In re Cyclobenzaprine
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`Hydrochloride Extended-Release Capsule Patent Litig., 2011 WL 1980610, at *4 (D. Del. May
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`20, 2011) (enjoining the defendants from marketing a generic drug pending the plaintiff’s appeal
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`of the district court’s invalidity finding).
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`5
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 10 of 29 PageID #: 25879
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`ARGUMENT
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`As detailed below, each of the Rule 62(d) factors weighs in favor of entering an
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`injunction here for the duration of the appeal—given that (1) unless Amgen is enjoined,
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`Genentech will suffer irreparable market and reputational injury; (2) Genentech is likely to
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`succeed on its undisputed infringement claim and Amgen’s already-rejected invalidity defense;
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`(3) unlike the extensive harm facing Genentech without an injunction, Amgen will lose no
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`customers or market share if forced to wait until the Federal Circuit appeal resolves; and (4) the
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`public interest favors protecting Genentech’s significant investments and related patents, and if
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`the status quo is maintained, patients will still have the same access to HER2 treatment.
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`A.
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`Unless Enjoined, Amgen’s Infringement Will Irreparably Harm Genentech.
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`In its preliminary injunction briefing, Genentech established a likelihood “that absent an
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`injunction, it will suffer irreparable harm,” and “that a sufficiently strong causal nexus relates the
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`alleged harm to the alleged infringement.” Apple Inc. v. Samsung Elecs. Co., 695 F.3d 1370,
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`1374 (Fed. Cir. 2012) (Apple I).
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`The Court found that essentially undisputed injuries of price erosion, loss of market
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`share, and reputation need not be considered because Genentech delayed seeking injunctive
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`relief and licensed other Herceptin biosimilars,
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`. Genentech respectfully submits that
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`the Federal Circuit should review this finding given its far-reaching implications.
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`1.
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`The Court’s Determination of Delay Would Require Premature and
`Unnecessary Filings.
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`The Court found that “Genentech has known of Amgen’s intent to market Kanjinti since
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`Amgen served its 180-day Notice of Commercial Marketing on May 15, 2018,” that by February
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`2019 Genentech understood that the FDA would act on Amgen’s resubmission by the end of
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`6
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 11 of 29 PageID #: 25880
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`June 2019, and that Amgen documents produced in April 2019 indicated that Amgen planned to
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`launch in July 2019. (D.I. 299 at 5.) To the extent that the Court implicitly determined that
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`Genentech was required to bring this motion either (1) as soon as Amgen sent the (l)(8) notice of
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`commercial marketing in May of 2018 or (2) sometime prior to Amgen’s receiving FDA
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`approval in late June of 2019, the facts of this case establish that rule’s impracticality. During
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`FDA review,
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` As a result, had Genentech moved for a preliminary injunction on the dosing
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`patents when Amgen filed its (l)(8) notice, Amgen could have defeated that motion simply by
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`showing that its label was subject to change. A blanket rule forcing plaintiffs to file, and the
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`courts to address, motions for preliminary injunction even absent a present need for injunctive
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`relief and even when changes in the biosimilar product would potentially moot the preliminary
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`injunction analysis would waste court and party resources, and is contrary to the requirement of
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`an imminent, irreparable injury necessary to obtain a preliminary injunction.
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`To the extent the Court implicitly determined that Genentech should have filed when it
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`learned that Amgen had been planning a July “launch readiness” date, that too would essentially
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`force originator companies such as Genentech to file prematurely. Amgen itself stressed that it
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`had made no launch decision and thus disputes about a potential launch “may not be ripe” –
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`7
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 12 of 29 PageID #: 25881
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`presumably what Amgen would have said had Genentech moved for a preliminary injunction at
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`that time. (June 18, 2019 Hr’g Tr. 31:4-11 (“So it may not be ripe. It’s all future activity.”); see
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`also id. at 30:3-8 (actual launch might occur “two months,” “six months,” or even “a year”
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`later).) It is undisputed that Amgen made no actual decision to launch
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`.
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`(
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` see June 18, 2019 Hr’g Tr. 29:10-17 (Amgen’s counsel distinguishing
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`between being ready to launch and launching).) Genentech filed its motions
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`.
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`Neither Amgen nor the Court has cited, and Genentech could not find, any cases finding
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`that a party in Genentech’s position is required to seek injunctive relief where the product is in
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`flux and launch is undetermined. Rather, the cases cited by the Court, Pfizer, Inc. v. Teva
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`Pharm., USA, Inc., 429 F.3d 1364 (Fed. Cir. 2005), Polymer Techs v. Bridwell, 103 F.3d 970
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`(Fed. Cir. 1996), are inapplicable because they did not find undue delay, and in any event the
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`defendants had already launched their products. See Pfizer, 429 F.3d at 1371, 1382 (finding that
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`filing suit two months after the launch of the infringer’s generic product, and nearly two years
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`after receiving notice of the defendant’s assertion of noninfringement, did not constitute undue
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`delay on the part of the patent holder); Polymer Techs., 103 F.3d at 976 (declining to rule that
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`party should have filed suit “absent evidence of . . . infringing activities,” which “did not
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`commence until roughly four months before [patent holder] brought this suit”). Moreover, while
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`the Court relies on Amgen Inc. v. Apotex Inc. for the proposition that the BPCIA’s 180-day
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`notice requires an early motion for preliminary injunction, that case was decided before the
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`Supreme Court’s decision in Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017). Pre-Sandoz, the
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`benefit of the 180-day rule espoused by Amgen Inc. v. Apotex Inc. depended on the idea that the
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`180-day notice must issue after FDA approval of the biosimilar. 827 F.3d 1052, 1062 (Fed. Cir.
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`8
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 13 of 29 PageID #: 25882
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`2016) (“[W]e read (8)(A) as allowing the 180-day notice of commercial marketing to be sent as
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`soon as the license issues, even if it is not yet effective, because it is at the time of the license
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`that ‘the product, its therapeutic uses, and its manufacturing processes are fixed.’”). It therefore
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`did not contemplate the situation here, where the scope of potential infringement remained
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`undetermined months after the (l)(8) notice was served.
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`The Court also found that existence of other licenses negates irreparable harm. In settling
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`with other biosimilar applicants, Genentech relied on Federal Circuit authority that “the fact that
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`a patentee has licensed others under its patents does not mean that unlicensed infringement must
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`be permitted while the patents are litigated.” Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1362
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`(Fed. Cir. 2008). Indeed, the Federal Circuit has reversed denials of injunctions based on the
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`district court’s failure to examine the differences between previously licensed parties and the
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`party sought to be enjoined. Apple Inc. v. Samsung Elecs. Co., 735 F.3d 1352, 1370 (Fed. Cir.
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`2013) (“[T]he district court’s focus on Apple’s past licensing practices, without exploring any
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`relevant differences from the current situation, hints at a categorical rule that Apple’s willingness
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`to license its patents precludes the issuance of an injunction,” which is inconsistent with the
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`Supreme Court’s decision in eBay.)
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`. In this situation, the licenses simply do not indicate that any harm from
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`Amgen’s launch is compensable in damages. See Trading Techs. Int’l, Inc. v. eSpeed, Inc., No.
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`04 C 5312, 2008 WL 4531371, at *4 (N.D. Ill. May 22, 2008), aff’d, 595 F.3d 1340 (Fed. Cir.
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`2010) (finding that the inadequate remedy at law factor in a permanent injunction analysis
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`favored plaintiff where its past licenses “were negotiated in exchange for the parties’ agreement
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`9
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`Case 1:18-cv-00924-CFC Document 335 Filed 07/29/19 Page 14 of 29 PageID #: 25883
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`to settle, rather than litigate”); Abbott Labs. v. Sandoz, Inc., 500 F. Supp. 2d 807, 843 (N.D. Ill.
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`2007), aff’d, 544 F.3d 1341 (Fed. Cir. 2008) (settlement agreements allowing two specific
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`generic drugmakers to enter the market the following year did not mean that patent holder gave
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`up its right to exclude generics in the present).
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`The two cases cited by the Court are not applicable. In Polymer Techs, Inc. v. Birdwell,
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`103 F.3d 970, 975 (Fed. Cir. 1996), there were no licenses at issue; that case merely cites the
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`second case the Court relies upon, High Tech Medical Instrumentation, Inc. v. New Image
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`Industries, Inc., 49 F.3d 1551, 1557 (Fed. Cir. 1995), for the proposition that a party’s licensing
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`history can be a factor. High Tech, in turn, took the patentee’s “apparent willingness to grant a
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`[royalty-bearing] license under its patent” to the defendant in that case—not a third party—into
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`account as one of many factors weighing against injunctive relief. Id. High Tech is further
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`distinguishable because the patentee was a non-practicing entity that had not licensed the patent
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`to any third parties – “the lack of commercial activity by the patentee” was a “significant factor”
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`in the analysis. Id. at 1556.
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`Under the Court’s ruling, a patent owner would be barred from obtaining injunctive relief
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`where it has licensed to the other parties, irrespective of whether those parties have products on
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`the market
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` Such a rule would make litigation settlements in the pharmaceutical area
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`essentially impossible, since a patentee could never settle litigation by permitting licensed entry,
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`even at a future date, without effectively allowing immediate entry to anyone else who chooses
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`to launch at risk. That result is contrary to the strong policy in favor of settlement.
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`2.
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`The Evidence Presented Supports Genentech’s Irreparable Harm.
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`Genentech presented unrebutted evidence that it will suffer irreparable harm via price
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`erosion, lost market share, effect on other products, goodwill, and reputation. (D.I. 275 at 10-16;
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`D.I. 292 at 7-9.) See also Abbott Labs., 544 F.3d at 1361-62 (outlining irreparable harm factors);
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`Celsis in Vitro, Inc. v. Cellzdirect, Inc., 664 F.3d 922, 930 (Fed. Cir. 2012) (price erosion
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`constitutes irreparable harm); Purdue Pharma L.P. v. Boehringer Ingelheim GmbH, 237 F.3d
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`1359, 1368 (Fed. Cir. 2001) (discussing loss of market share); BioTechnology Gen. Corp. v.
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`Genentech, Inc., 80 F.3d 1553, 1566 (Fed. Cir. 1996) (affirming irreparable harm based in part
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`on reductions to research and development spending); Douglas Dynamics, LLC v. Buyers Prods.
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`Co., 717 F.3d 1336, 1344-45 (Fed Cir. 2013) (harm to “perception in the marketplace by
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`customers … and distributors” is irreparable).
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`And as discussed in Genentech’s papers, Amgen is a unique biosimilar—Amgen
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`manufactures both its own innovative biologic products as well as biosimilars such that Amgen
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`can leverage its reputation and relationships with customers to vigorously compete with
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`Genentech. Amgen will also be the only Herceptin biosimilar on the market,
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`. Indeed, Amgen did not contest
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`that its unauthorized launch will cause Genentech to suffer price erosion and lost market share,
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`or that these injuries are irreparable. That lack of protest is not surprising given that, when
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`Amgen has sought to protect its own patent rights via injunctive relief, it has consistently taken
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`the position that these same types of harms are irreparable and support the entry of an injunction.
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`(Ex. 28, at 14-15; Ex. 30, 12-13; Ex. 76, at 19.)
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`Nor can Amgen dispute that the resulting harm to Genentech would be directly
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`attributable to Amgen’s conceded infringement of the three-week-interval claims. Apple Inc. v.
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`Samsung Elecs. Co., 809 F.3d 633, 641 & n.1 (Fed. Cir. 2015) (explaining there must be “‘some
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`connection’ between the harm alleged and the infringing acts”).
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`. See id. at 643 (market demand for infringing features and infringer’s belief that
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`infringing features were driver of sales “establishes a causal nexus”).
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`In sum, the clear and substantial harm that Genentech would face without an injunction is
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`the very definition of irreparable harm—once Amgen launches, there is no way to make
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`Genentech whole, and damages and/or an injunction after trial will not return Genentech to its
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`pre-Kanjinti-launch position. (Jena Decl. ¶¶99-101.) And the harm to Genentech will be even
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`more difficult to quantify if other biosimilars launch later this year. (Id. ¶¶70-72.)
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`B.
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`The Remaining Factors Support Granting Genentech’s Rule 62(d) Motion
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`Except for a footnote addressing the public interest, the Court did not engage the
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`remaining factors for injunctive relief. Like irreparable harm, these factors all support granting
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`Genentech’s motion.
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`1.
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`Genentech Has Made a Strong Showing That It Is Likely to Succeed
`on the Merits.
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`The Court did not address this factor in its analysis, but Genentech is likely to succeed on
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`the merits of its appeal. In the parties’ earlier injunction briefing, Amgen conceded infringement
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`of the dosing patents, did not put forward any expert testimony, and instead retread invalidity
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`arguments that the Patent Office already rejected in the recent IPR proceedings. Based on this
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`record, and for all the reasons addressed in Genentech’s briefing on the injunction, Amgen failed
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`to show “evidence of invalidity that is sufficiently persuasive [that] it is likely to overcome the
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`presumption of patent validity.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1566
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`(Fed. Cir. 1996).
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`2.
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`The Balance of Hardships Favors Genentech.
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`The Court did not address this factor either, but it favors Genentech because granting
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`injunctive relief will achieve the “goal[] of the preliminary injunction analysis [of] maintain[ing]
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`the status quo, defined as the last peaceable, noncontested status of the parties.” Kos Pharms.,
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`Inc. v. Andrx Corp., 369 F.3d 700, 729 (3d Cir. 2004). In contrast to the real-world, significant
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`harms detailed above that Genentech will suffer by Amgen’s unauthorized launch, Amgen will
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`suffer no prejudice from an injunction during the appeal. Because Amgen’s product is not yet on
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`the market, an injunction pending appeal would impose “minimal hardship since doing so will
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`leave [it] in the same position as it was in before the injunction was granted.” Impax Labs., Inc.
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`v. Aventis Pharm. Inc., 235 F. Supp. 2d 390, 396 (D. Del. 2002).And because no other
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`trastuzumab biosimilars have launched
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`will not lose any ground to other competitors in the marketplace.
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`, Amgen
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`The risk of harm to Amgen is even further lessened by the fact that Genentech is seeking
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`to have this issue resolved as expeditiously as possible, and is prepared to move as quickly as the
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`Federal Circuit will allow.
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`3.
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`Granting An Injunction Pending Appeal Serves The Public Interest.
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`The public interest is best served by “the enforcement of [Genentech’s] patent rights.”
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`Celsis In Vitro, 664 F.3d at 931-32. There is no question that Genentech can continue to supply
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`the market with Herceptin so that no patient will be deprived of therapy.
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`Further, removing Kanjinti from the market after launch would be difficult for doctors
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`and patients as well as the parties to this case. In generic drug cases under the Hatch-Waxman
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