IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs,
`
`V.
`
`AMGEN INC .,
`
`Defendant and Counterclaim
`
`Plaintiff.
`
`
`
`Case No. 1:18—cv—00924—CFC
`
`PUBLIC VERSION
`
`AMGEN’S CONIBINED OPPOSITION TO GENENTECH’S EMERGENCY MOTIONS
`
`FOR A TENIPORARY RESTRAINING ORDER AND A PRELINIINARY INJUNCTION
`
`Neal Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`SMITH, KATZENSTEIN & JENKINS LLP
`
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`P 302-652-8400
`
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`
`Attornevsfor Defendant Amgen Inc.
`
`Of Counsel:
`
`Michelle Rhyu
`Susan Krumplitsch
`Daniel Knauss
`
`COOLEY, LLP
`3175 Hanover Street
`Palo Alto, CA 94304—1130
`P 650-843—5287
`rhyums@cooley.com
`skrumplitsch@cooley.com
`dknauss@cooley.com
`
`Eamonn Gardner
`
`COOLEY, LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`P 858-550—6086
`
`egardner@cooley.com
`
`Orion Armon
`
`COOLEY, LLP
`380 Interlocken Crescent
`
`Suite 900
`
`Broomfield, CO 80021-8023
`P 720-566-4119
`
`oannon@cooley.com
`
`

`

`Nancy Gettel
`Brian Kao
`
`Lois M. Kwasigroch
`AMGEN, INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`P 805-447-1000
`
`ngettel@amgen.com
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ......................................................................................................................... 1
`
`LEGAL STANDARD .................................................................................................................... 2
`
`BACKGROUND ........................................................................................................................... 3
`
`A.
`
`B.
`
`C.
`
`D.
`
`THE PATENTS ..................................................................................................... 3
`
`THE INTER PARTES REVIEW (IPR) PROCEEDINGS AT THE US. PATENT
`OFFICE .................................................................................................................. 5
`
`GENENTECH’S KNOWLEDGE OF AMGEN’S LAUNCH PLANS ................. 6
`
`GENENTECH’S LICENSES ................................................................................ 8
`
`ARGUIVIENT ................................................................................................................................. 8
`
`I.
`
`INJUNCTTVE RELIEF IS UNWARRANTED IN LIGHT OF GENENTECH’S
`
`INTENTIONAL DELAY 1N SEEKING RELIEF ............................................................ 8
`
`II.
`
`GENENTECH WILL NOT EXPERIENCE IRREPARABLE HARM ........................... 10
`
`A.
`
`B.
`
`C.
`
`B.
`
`Genentech’s delay in seeking a TRO and PI belies its assertion that it will
`be irreparably injured absent such relief.............................................................. 10
`Genentech’s willingness to grant- licenses to the asserted
`patents shows that harm (if any) from sales of Kanjinti is calculable and
`not irreparable ...................................................................................................... 10
`
`Genentech employee admissions confirm that it will not experience
`irreparable harm from Amgen’s commercial marketing of Kanjinti ................... 11
`
`
`Drum the eriod between now and trial, Genentech estimates-
`h ................................................................. l3
`
`III.
`
`GENENTECH HAS NOT SHOWN A LIKELIHOOD THAT IT WILL
`
`SUCCEED ON THE MERITS ........................................................................................ 14
`
`A.
`
`B.
`
`Amgen does not infringe any valid claims .......................................................... 14
`
`The Dosing Patents are invalid as obvious .......................................................... 14
`
`l.
`
`Amgen does not rely on the same prior art as the previous IPRs ............ 15
`
`

`

`TABLE OF CONTENTS
`(continued)
`
`Page
`
`2.
`
`3.
`
`The PTAB’s decision turned on Petitioners’ failure to establish a
`reasonable expectation of success of the obvious combination ............... 16
`Amgen’s evidence demonstrates reasonable expectation of success
`of the obvious claim steps ........................................................................ 16
`
`THE BALANCE OF HARDSHIPS FAVORS DENYING GENENTECH’S
`MOTIONS ....................................................................................................................... 19
`
`DENYING GENENTECH’S MOTIONS WOULD PROMOTE THE PUBLIC
`INTEREST ....................................................................................................................... 20
`
`
`
`IV.
`
`V.
`
`VI.
`
`CONCLUSION ................................................................................................................ 20
`
`
`
`-ii-
`
`
`
`

`

`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001)..................................................................................................3
`
`Anjelino v. New York Times Co.,
`200 F.3d 73 (3d Cir. 1999).......................................................................................................10
`
`Apple Inc. v. Samsung Elecs. Co. Ltd.,
`735 F.3d 1352 (Fed. Cir. 2013)................................................................................................20
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010)..................................................................................................3
`
`Baxalta Inc. v. Genentech, Inc.,
`No. 17-509-TBD, 2018 WL 3742610 (D. Del. Aug. 7, 2018).................................................12
`
`BMEF San Diego, L.L.C. v. Gray E. Vill. San Diego L.L.C.,
`No. No. 9963–VCN, 2014 WL 4923722 (Del. Ch. Sept. 30, 2014) ..........................................8
`
`Cordance Corp. v. Amazon.com, Inc.,
`No. 06–491–MPT, 2010 WL 3155505 (D. Del. July 23, 2010) ..............................................11
`
`Cordis Corp. v. Boston Sci. Corp.,
`No. Civ.A. 03–027–SLR, 2003 WL 22843072 (D. Del. Nov. 21, 2003), aff’d,
`99 F. App’x 928 (Fed. Cir. 2004) ......................................................................................10, 13
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`No. 09–MD–2118–SLR, 2011 WL 1980610 (D. Del. May 20, 2011) ......................................2
`
`eBay Inc. v. MercExchange, L.L.C.,
`547 U.S. 388 (2006) ...................................................................................................................2
`
`In re Gen. Motors (Hughes) S’holders Litig.,
`No. 20269-NC, 2003 WL 26474920 (Del. Ch. Oct. 2, 2003) ..................................................10
`
`Graceway Pharm., LLC v. Perrigo Co.,
`722 F. Supp. 2d 566 (D.N.J. 2010) ......................................................................................9, 20
`
`Immunomedics, Inc. v. Venbio Select Advisor LLC,
`No. 17-176-LPS, 2017 WL 822800 (D. Del. Mar. 2, 2017) ............................................3, 8, 10
`
`Intirtoll, Ltd. v. Texar Corp.,
`369 F.3d 1289 (Fed. Cir. 2004)..................................................................................................9
`
`iii
`
`

`

`
`
`King Pharm., Inc. v. Sandoz, Inc.,
`No. 3-08-cv-05974, 2010 WL 1957640 (D.N.J. May 17, 2010) .............................................11
`
`Kos Pharm., Inc. v. Andrx Corp.,
`369 F.3d 700 (3d Cir. 2004).......................................................................................................2
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .................................................................................................................14
`
`Nutrition 21 v. United States,
`930 F.2d 867 (Fed. Cir. 1991)....................................................................................................3
`
`Sandoz Inc. v. Amgen Inc.,
`137 S. Ct. 1664 (2017) ...............................................................................................................8
`
`Winter v. Nat. Res. Def. Council, Inc.,
`555 U.S. 7 (2008) .......................................................................................................................3
`
`Statutes
`
`35 U.S.C. § 103(a) .........................................................................................................................14
`
`42 U.S.C. § 262(l)(8)(B) ..................................................................................................................8
`
`
`
`
`
`iv
`
`
`
`

`

`
`
`Amgen submits this Combined Opposition to Genentech’s Combined Opening Brief in
`
`Support of its Emergency Motions for a Temporary Restraining Order and a Preliminary
`
`Injunction. Dkt. No. 275. Amgen seeks outright denial of both motions because Genentech failed
`
`to establish that it will be irreparably harmed by
`
` sales by Amgen before other
`
`licensed biosimilar competitors enter the market. Genentech also failed to establish a likelihood
`
`of success on the merits because the asserted patents were obvious. They essentially claim giving
`
`3 times the known weekly dose every 3 weeks—a schedule that matches up with the known 3-
`
`weekly schedule for chemotherapy. The patents contain no experiments testing this dosing
`
`regimen. If the Court does not deny both motions, Amgen respectfully requests permission to
`
`submit a supplemental response to the preliminary injunction motion supported by expert
`
`declarations.
`
`INTRODUCTION
`
`Genentech’s internal “Loss of Exclusivity” date for Herceptin was
`
`, and the
`
`company has
`
`. Declaration of Alissa M. Wood in
`
`
`
`Support of Amgen’s Combined Opposition (“Wood Decl.”) Ex. 1 at 194:23-195:25. It is no
`
`coincidence that Genentech’s LOE date for Herceptin
`
`
`
`. Genentech’s willingness to grant
`
` patent
`
`licenses to Mylan, Celltrion, Pfizer (and presumably Samsung)—
`
`
`
`—shows that Genentech seeks to leverage its patents for a competitive gain
`
`far beyond what is warranted by the value of the patents.
`
`
`
`Mylan will begin selling its trastuzumab biosimilar with Genentech’s consent, causing the same
`
`market impacts as Kanjinti.
`
`
`
`1
`
`

`

`
`
`Genentech cannot establish irreparable harm in light of the licensing agreements described
`
`above and its delay in bringing this motion. Genentech’s arguments also contradict testimony by
`
`its designated corporate witness on irreparable harm, Melissa Abreu, and Warner Biddle,
`
`Genentech’s Vice President and Franchise Head, BioOncology Breast & Skin Cancer.
`
`
`
`
`
`
`
`
`
`Genentech is also not likely to succeed on the merits. Genentech’s own description of the
`
`“Dosing Patents” is that they merely made Herceptin therapy “more convenient” by extending the
`
`dosing interval from weekly to every three weeks. This alternative dosing regimen was proposed
`
`long before these patents were filed and the evidence discussed below raises a substantial question
`
`as to their validity.
`
`For each of the foregoing reasons, explained in greater detail below, Amgen respectfully
`
`requests that the Court deny both of Genentech’s motions outright.
`
`LEGAL STANDARD
`
`A request for a TRO is governed by the same general standards that govern the issuance of
`
`a preliminary injunction. In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent
`
`Litig., No. 09–MD–2118–SLR, 2011 WL 1980610, at *1 (D. Del. May 20, 2011). “The decision
`
`to grant or deny ... injunctive relief is an act of equitable discretion by the district court.” eBay
`
`Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006). The grant of such relief is an
`
`“extraordinary remedy” that should be granted only in “limited circumstances.” See Kos Pharm.,
`
`Inc. v. Andrx Corp., 369 F.3d 700, 708 (3d Cir. 2004) (citation omitted).
`
`To be entitled to injunctive relief, a movant must establish: (1) a reasonable likelihood of
`
`success on the merits; (2) irreparable harm if an injunction is not granted; (3) a balance of hardships
`
`
`
`2
`
`
`
`

`

`
`
`tipping in its favor; and (4) the injunction’s favorable impact on the public interest. See Winter v.
`
`Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008). Particular emphasis is placed on the first two
`
`factors. “[A] movant cannot be granted a preliminary injunction unless it establishes both of the
`
`first two factors, i.e., likelihood of success on the merits and irreparable harm.” Amazon.com, Inc.
`
`v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001). Where the request is for
`
`emergency equitable relief, the movant must seek relief with alacrity and the Court’s review of the
`
`elements necessary to establish entitlement to an injunction is viewed through the lens of the
`
`promptness with which the relief is sought. Immunomedics, Inc. v. Venbio Select Advisor LLC,
`
`No. 17-176-LPS, 2017 WL 822800 at *1, 3 (D. Del. Mar. 2, 2017).
`
`“[B]ecause of the extraordinary nature of the relief, the patentee carries the burden of
`
`showing likelihood of success on the merits with respect to the patent’s validity, enforceability,
`
`and infringement.” Nutrition 21 v. United States, 930 F.2d 867, 869 (Fed. Cir. 1991). Accordingly,
`
`to obtain a TRO, Genentech must show, in light of the burdens of proof applicable at trial, that it
`
`“will likely prove infringement of one or more claims of the patents-in-suit, and that at least one
`
`of those same allegedly infringed claims will also likely withstand the validity challenges
`
`presented by the accused infringer.” Amazon.com, Inc., 239 F.3d at 1351. If “the alleged infringer
`
`asserts an infringement or invalidity defense that the patentee has not shown lacks substantial
`
`merit,” the Court should not issue a TRO or preliminary injunction. AstraZeneca LP v. Apotex,
`
`Inc., 633 F.3d 1042, 1050 (Fed. Cir. 2010).
`
`BACKGROUND
`
`
`
`A.
`
`THE PATENTS
`
`Genentech’s motions seek relief based on claims from three “Dosing Patents” (the ’196,
`
`’379, and ’811 patents). These patents originate from a common application and claim methods
`
`of treatment for providing Herceptin at an initial dose of 8 mg/kg (milligrams per kilogram patient
`
`
`
`3
`
`
`
`

`

`
`
`weight), followed by multiple 6 mg/kg doses set at least three weeks apart. In short, they recite an
`
`“8/6 – three weekly” dosing regimen.
`
`The only difference between the asserted claims and the prior art was to increase the dose
`
`amounts and to give them less frequently. When Herceptin was originally approved by the FDA
`
`in September 1998, the label recited a 4/2 – weekly regimen (an initial dose of 4 mg/kg followed
`
`by weekly 2mg/kg doses). But by the priority date of the Dosing Patents (August 1999), detailed
`
`pharmacokinetic (PK), efficacy, and safety data from several Herceptin clinical trials had been
`
`published: The 1998 Herceptin Label summarized available efficacy, safety, and PK data which
`
`enabled a person of skill in the art (POSA) to evaluate higher doses at longer intervals using routine
`
`PK estimation techniques. (Wood Decl. Ex. 40.) Slamon 1998 reported the results of the phase
`
`III trial proving that trastuzumab was safe, efficacious, and “markedly increased chemotherapy’s
`
`anticancer activity.” (Wood Decl. Ex. 2.) Watanabe 1998 disclosed the safety of the 8 mg/kg dose
`
`and taught separation of the first and second doses by three weeks. (Wood Decl. Ex. 3.) Baselga
`
`1996 and Pegram 1998 taught half-life, target serum concentration, and further PK results detailing
`
`the behavior of Herceptin, all useful to a POSA in reducing any uncertainty associated with longer
`
`dosing intervals. (See Wood Decl. Exs. 4 and 5.)
`
`By August 1999, breast cancer oncologists and other skilled artisans appreciated that
`
`Herceptin could and should be dosed less frequently. (See, e.g., Wood Decl. Ex. 6 at 96:1-15;
`
`97:16-98:20, 110:9-111:17, 98:21-99:19 (It was known by the late 1990s that less frequent dosing
`
`would be more convenient for patients especially those receiving standard chemotherapy every
`
`three weeks, and the drug’s PK profile suggested the approach would be efficacious).) Based on
`
`the known synergy of Herceptin and chemotherapy, a clear motivation existed to extend the
`
`Herceptin dosing schedule to match that of standard chemotherapies at the time: once every three
`
`
`
`4
`
`
`
`

`

`
`
`weeks. (See Passamaneck Decl. Ex. 14 at 16-22; Wood Decl. Ex. 7; Ex. 8 (at 961-65, Tables 54.9,
`
`54.10, 54.12); Ex. 2.) Less frequent dosing synchronized with chemotherapy would benefit
`
`patients by improving comfort, convenience, and quality of life. (See id.;
`
`
`
`
`
`
`
`
`
`B.
`
`THE INTER PARTES REVIEW (IPR) PROCEEDINGS AT THE U.S. PATENT OFFICE
`
`Genentech relies heavily on the Patent Office’s Patent Trial and Appeals Board (“PTAB”)
`
`denial of IPRs challenging the ’196 and ’379 patents. In its analysis, however, the PTAB
`
`concluded that a POSA would have been motivated to test the 8/6 – three weekly dosing regimen
`
`claimed by the patents. (See Wood Decl. Ex. 10 at 16-22; see also Passamaneck Decl. Ex. 23 at
`
`16-22.) The PTAB’s analysis shows that the patents barely escaped invalidity, with many of the
`
`predicate facts in the obviousness determination going against them. For example, in the
`
`Hospira/Pfizer IPR challenge, the Patent Office ruled that the Petitioners successfully showed that
`
`(1) all elements of the challenged claims were disclosed by the prior art except shifting the prior
`
`art doses to higher amounts on longer schedules (e.g. every three weeks versus weekly) and (2)
`
`that a clear motivation existed in the field for a POSA to optimize the dosing interval for Herceptin
`
`in the same way claimed in the Dosing Patents. (See Wood Decl. Ex. 10 at 9-22; see also
`
`Passamaneck Decl. Ex. 23 at 9-22.) Genentech ultimately prevailed only because the PTAB found
`
`that the Petitioners failed to demonstrate that a POSA would have had a reasonable expectation of
`
`success that the claimed dosing regimens would be efficacious. (See Wood Decl. Ex. 10 at 22-34;
`
`see also Passamaneck Decl. Ex. 23 at 22-34.) In this action, Amgen has adduced and will present
`
`at trial evidence that was not before the PTAB, demonstrating that a POSA would have had a
`
`reasonable expectation of success that the claimed dosing regimens would be efficacious. See
`
`infra, pp. 16-19.
`
`
`
`5
`
`
`
`

`

`
`
`
`
`C.
`
`GENENTECH’S KNOWLEDGE OF AMGEN’S LAUNCH PLANS
`
`Genentech has known of Amgen’s intent to market Kanjinti since Amgen served its 180-
`
`day Notice of Commercial Marketing (“NCM”) on May 15, 2018. More recently, Genentech
`
`received information about Amgen’s launch plans through discovery. In February 2019, Amgen
`
`produced documents showing that it filed a resubmission to the FDA in December 2018. Given
`
`the known six month regulatory timeline for FDA to consider the resubmission (see Wood Decl.
`
`Ex. 11 at 4), Genentech was apprised that Amgen would receive a response by the end of June
`
`2019. In April, Amgen produced documents with its launch plan redactions removed, explicitly
`
`noting its anticipated launch in July 2019. (Wood Decl. Ex. 12 at 8.) Other Amgen documents
`
`referred to the timing of Amgen’s go/no go decision.
`
`
`
`
`
`
`
`
`
`
`
`
`
` Despite its
`
`knowledge of Amgen’s plans, Genentech made no attempt to obtain injunctive relief. The Court
`
`held a discovery hearing on May 16, 2019. At that hearing, Genentech blocked discovery of its
`
`license agreements by persuading the Court that injunctive relief was not presently at issue in this
`
`case. (Wood Decl. Ex. 19 at 26:1-4 (The Court: “Mr. Berl, are you seeking injunctive relief? Mr.
`
`Berl: We have a request for a permanent injunction at the trial. We’re not presently seeking
`
`injunctive relief.”).) When Amgen explained that it needed discovery about Genentech’s licenses
`
`to defend against any future request for injunctive relief, the Court accepted Genentech’s
`
`representation but emphasized that Genentech was proceeding at its own risk: “Doesn’t the risk of
`
`that all fall on the plaintiff? . . . . Maybe I will say, well, look, you know what. You had your day.
`
`
`
`6
`
`
`
`

`

`
`
`You agreed we should put this issue of settlement agreement disclosure, you should put that off
`
`until an injunction arose, and so you don’t get a TRO, you don’t get an injunction proposed
`
`preliminarily until it’s adjudicated. That would fall on them, wouldn’t it?” (Wood Decl. Ex. 19 at
`
`49:9-23.) In spite of the Court’s warnings, Genentech maintained its position that injunctive relief
`
`was not at issue. The Court denied Amgen’s motions to compel based on Genentech’s
`
`representations. Dkt. No. 231.
`
`Kanjinti was approved by the FDA on June 13. The next week, on June 18, the Court held
`
`another discovery hearing. Genentech still did not raise the issue of a TRO or PI.
`
`
`
`
`
`
`
`
`
`
`
`Genentech’s business has long been aware of Amgen’s launch plans and has prepared for
`
`biosimilar market entry in
`
`.
`
`Ex. 20.)
`
`Ex. 21; Ex. 22 at 55:17-23.)
`
`
`
` (Wood Decl.
`
`
`
`
`
` (See Wood Decl.
`
`
`
`
`
`history of Genentech’s corporate preparations for biosimilars based on reported launch plans, it is
`
` (Wood Decl. Ex. 23 at 62:7-63:13.) In light of the lengthy
`
`
`
`7
`
`
`
`

`

`
`
`incredible for Genentech to now argue that the more detailed launch plans Amgen divulged during
`
`discovery were too vague for it to anticipate that Amgen would launch in July 2019.
`
`
`
`D.
`
`GENENTECH’S LICENSES
`
`Genentech granted
`
` patent licenses to the Dosing Patents, among others, to
`
`Mylan, Pfizer, Celltrion, and presumably Samsung. (Wood Decl. Exs. 37-39.) Thus,
`
`
`
` Mylan will begin selling its trastuzumab biosimilar under
`
`its license from Genentech, with an FDA approved label that includes the same indications that
`
`Genentech alleges Amgen will infringe by selling Kanjinti. (Dkt. No. 277, ¶ 45; Wood Decl. Ex.
`
`24.) The other three biosimilars will presumably launch soon thereafter.
`
`ARGUMENT
`
`I.
`
`INJUNCTIVE RELIEF IS UNWARRANTED IN LIGHT OF GENENTECH’S INTENTIONAL
`DELAY IN SEEKING RELIEF1
`
`Genentech should not be granted the extraordinary relief of an injunction when it has sat
`
`on its rights and delayed adjudication of these complex matters. Courts will not permit a party
`
`with knowledge of a potential event to sit on that knowledge and then ask the parties and the Court
`
`to treat the pending event as an “emergency” requiring expedited treatment and extraordinary
`
`relief. See Immunomedics, Inc., 2017 WL 822800 at *1, 3; see also BMEF San Diego, L.L.C. v.
`
`
`1 Genentech’s actions are also contrary to the spirit of the BPCIA. Genentech’s window for filing
`a motion for preliminary injunctive relief opened when Amgen filed its Notice of Commercial
`Marketing (“NCM”) under Section 262(l)(8)(A) on May 15, 2018. The NCM requirement is
`precisely to give the reference product sponsor, here Genentech, the opportunity to seek
`preliminary injunctive relief before commercial marketing of the biosimilar product has
`commenced, rather than as an emergency in the midst of its commercial launch. 42 U.S.C.
`§ 262(l)(8)(B). See also Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1677 (2017) (contrasting
`(l)(8)(A) with (l)(8)(B) and noting that § 262(l)(8)(B) “expressly sets forth just that type of dual
`timing requirement.”). This interpretation is consistent with the legislative history of the BPCIA.
`Wood Decl. Ex. 25 at 9 “[Resolving disputes regarding biosimilars] would take place within a
`short window of time, roughly 6 to 8 months after the biosimilar application has been filed with
`the FDA. It will help ensure that litigation surrounding relevant patents will be resolved
`expeditiously and prior to the launch of the biosimilar product.” (emphasis added).
`
`
`
`8
`
`
`
`

`

`
`
`Gray E. Vill. San Diego L.L.C., No. No. 9963–VCN, 2014 WL 4923722, at *1 (Del. Ch. Sept. 30,
`
`2014) (“[w]hether characterized as laches or simply undue delay, imposition of the burdens of
`
`expedited proceedings upon the [d]efendants and the Court cannot be reconciled with [p]laintiffs’
`
`failure to proceed with alacrity.”). “[Injunctive relief] will not be . . . granted in the face of a
`
`movant’s inequitable conduct, including unjustified delay or dilatory conduct.” Graceway
`
`Pharm., LLC v. Perrigo Co., 722 F. Supp. 2d 566, 569 (D.N.J. 2010) (quoting Intirtool, Ltd. v.
`
`Texar Corp., 369 F.3d 1289, 1290 (Fed. Cir. 2004) (emphasis added).
`
`Genentech’s emergency TRO and PI motions should be denied as a result of its unjustified
`
`and prejudicial delay. Genentech has been on notice of Amgen’s intent to market Kanjinti since
`
`May 2018, and had actual notice of Amgen’s planned July launch date since at least February
`
`2019. See supra, pp. 6-8. Rather than seek injunctive relief timely, so that the issues could be
`
`resolved before Amgen’s launch, Genentech told the Court that it was not pursuing a claim for
`
`preliminary injunctive relief during the May 16 hearing, which persuaded the Court to deny most
`
`of the license-related discovery Amgen sought. (Wood Decl. Ex. 19 at 26:3-4.) As the Court
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`recognized when it accepted Genentech’s representation, Genentech was proceeding at risk. (Id.
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`at 49:18-23.) Genentech again withheld from the Court its plan to file an “emergency” motion
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`during the June 18 discovery conference after Kanjinti’s approval by the FDA on June 13.
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`Amgen has been greatly prejudiced as a result of Genentech’s dilatory behavior. Amgen
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`was denied full discovery of Genentech’s license agreements with Mylan, Celltrion and Pfizer,
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`based on Genentech’s representation that injunctive relief was not at-issue. See supra, pp. 6-7.
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`Because Amgen was only provided heavily redacted agreements and no related negotiations
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`documents, it has been hamstrung in its ability to respond to the current motions. Further discovery
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`now is not a viable solution. Time is critical. Genentech is trying to keep Kanjinti off the market
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`9
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`as it runs out the clock
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`. Delaying adjudication of the
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`TRO and PI motions for license discovery would only compound Amgen’s prejudice. The Court
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`should hold Genentech to its words and deeds, which unequivocally established that Genentech
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`would not seek preliminary injunctive relief in this case. Anjelino v. New York Times Co., 200
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`F.3d 73, 100 (3d Cir. 1999) (affirming application of judicial estoppel to hold party to its earlier
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`“tactical” representation that no further discovery was required).
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`II.
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`GENENTECH WILL NOT EXPERIENCE IRREPARABLE HARM
`A.
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`Genentech’s delay in seeking a TRO and PI belies its assertion that it
`will be irreparably injured absent such relief
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`Genentech’s delay is also a factor weighing heavily against Genentech’s claims of
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`irreparable injury. Immunomedics, Inc., 2017 WL 822800 at *1, 3 (considering delay in assessing
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`irreparable injury and denying preliminary injunction). This approach is also well accepted in the
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`Court of Chancery. See, e.g., In re Gen. Motors (Hughes) S’holders Litig., No. 20269-NC, 2003
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`WL 26474920, at *2 (Del. Ch. Oct. 2, 2003) (claim of irreparable injury undercut by movant’s
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`delay.)
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`B.
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` licenses to the asserted
`Genentech’s willingness to grant
`patents shows that harm (if any) from sales of Kanjinti is calculable
`and not irreparable
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`Genentech failed to carry its burden of proving irreparable harm from Amgen’s alleged
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`infringement of the Dosing Patents. Genentech’s generalized allegations of economic and non-
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`economic harm fail to address the reality that it judged its own loss of exclusivity date as
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`
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` and it granted
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` licenses to the Dosing Patents to Mylan, Celltrion, Pfizer (and
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`presumably Samsung) allowing them to begin entering the market
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`. See Cordis
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`Corp. v. Boston Sci. Corp., No. Civ.A. 03–027–SLR, 2003 WL 22843072 at *2 (D. Del. Nov. 21,
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`2003), aff’d, 99 F. App’x 928 (Fed. Cir. 2004) (denying a PI motion, in-part because no irreparable
`
`
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`10
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`harm where “Cordis ha[d] licensed major competitors lmder the asserted ’762 patent”); Cordnnce
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`Corp. v. Amazon.com, Inc, No. 06—491—MPT, 2010 WL 3155505, at *4 (D. Del. July 23, 2010)
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`(denying injrmctive relief where Cordance granted licenses to “anyone willing to use its
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`technology”). Given these facts, Genentech had the blu'den ofproving that sales of Kanj inti would
`
`cause it irreparable harm— Genentech offers no evidence showing that
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`alleged harms from Kanjinti sales made now are any different from the impacts of the licensed
`
`sales it has allowed to begin in_.
`
`The fact that Genentech has negotiated to allow licensees to begin entering the market in
`
`— means that potential damages for sales— should be
`
`quantifiable. In a market as heavily tracked and mature as the market for Herceptin, it would be
`
`well within the ability of patent damages experts to quantify at trial the infringement damages (if
`
`anY)—
`
`—. See King Pharm., Inc. v. Sandoz, Inc, No. 3-08-cv-05974, 2010 WL 1957640,
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`at *6 (D.N.J. May 17, 2010) (damages calculable where trial would be in 2 months).
`
`C.
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`Genentech employee admissions confirm that it will not experience
`
`irreparable harm from Amgen’s commercial marketing of Kanjinti
`
`Genentech’s VP. and Franchise Head. BioOncology Breast & Skill Cancer, Warner
`
`Biddle. testified that sales of Kanjinti will not cause Genentech to experience the types of harm
`
`that courts traditionally have formd to be irreparable:
`
`
`
`ll
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`Genentech also will not experience hann to its goodwill or reputation as a result of Kanj inti
`
`sales.
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`Genentech’s assertion of irreparable harm resulting from lost sales of its other products
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`(i.e.. other than Herceptin or its subcutaneous form. Hylecta) are speculative and entitled to no
`
`weight. Barn/m Inc. v. Genenrech, Inc. No. 17-509-TBD. 2018 WL 3742610. at *11 (D. Del.
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`Aug. 7. 2018) (disregarding speculative hanns in ineparable hann analysis).
`
`12
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`E.
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`During the period between now and trial, Genentech estimates
`
`
`Genentech’s internal forecasts do not support its claims that potential lost revenues from
`
`lost sales and price erosion due to Kanjinti would be irreparable.
`
`
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`In this case, where Genentech has surrendered its right to exclude by granting
`
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`
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`licenses to its major competitors, loss of market share and price erosion in the range of
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` of
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`revenues is an economic harm that is compensable by money damages. Cordis Corp., 2003 WL
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`22843072 at *2, aff'd, 99 F. App’x 928 (Fed. Cir. 2004) (denying motion for preliminary injunction
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`in-part because “the evidence shows that the entire drug-eluting stent market in the United States
`
`would comprise only about five percent of Johnson & Johnson’s total sales.”).
`
`
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`13
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`III.
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`GENEN'I‘ECH HAS NOT SHOWN A LIKELrHoon THAT IT WILL SUCCEED ON THE MERITS
`
`A.
`
`Amgen does not infringe any valid claims
`
`For the purposes of this Opposition Brief, Amgen does not dispute that practicing two of
`
`the four indications on the Kanj inti label would fall within the scope of the asserted claims. Amgen
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`vigorously disputes the validity of those claims as discussed below. Genentech has only alleged
`
`infringement of two ofthe four indications on the Kanjinti label, thus there are two recited methods
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`of using Kanjinti (for metastatic breast cancer and the adjuvant indication involving weekly
`
`dosing) that are free of any allegations of infringement.
`
`(Wood Decl. Ex. 28, Ex. A Sections I-
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`111-)
`
`Genentech’s
`
`insinuations
`
`regarding Amgen’s
`
`labeling strategy are irrelevant
`
`to
`
`adjudication of Genentech’s motions. The PTAB’s rulings on the IPR challenges to the ’ 196 and
`
`’379 patents were not the last word on the patents’ validity. Discovery in PTAB proceedings is
`
`extremely limited. In the Dosing Patent IPRs, there were no fact depositions. Discovery developed
`
`in this case substantially calls into question the validity of the Dosing Patents.
`
`B.
`
`The Dosing Patents are invalid as obvious2
`
`Genentech’s assertion that Amgen rests on recycled art and arguments that were rejected
`
`by the PTAB in [PR proceedings brought by other parties is simply wrong. (Op. Br. at 9.) Amgen
`
`relies on new art never considered by the PTAB and has adduced additional evidence and
`
`arguments that raise a substantial question as to the obviousness of the Dosing Patents, including:
`
`.—
`
`2 A claim is unpatentable for obviousness “if the differences between the subject matter sought to
`be patented and the prior art are such that the subject matter as a whole would have been obvious
`at the time the invention was made to a person having ordinary skill in the art to which said subject
`matter pertains.” 35 U.S.C. § 103(a) (pre—AIA); see also KSR Int'l Co. v. Teleflar Inc, 550 US.
`398, 406 (2007).
`
`14
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`o Dosing of monoclonal antibodies