Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 1 of 29 PageID #: 23572
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 18-924-CFC
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`Plaintiffs,
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`Defendant.
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`GENENTECH, INC. and CITY OF HOPE,
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`v.
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`AMGEN, INC.,
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`GENENTECH’S COMBINED OPENING BRIEF IN SUPPORT
`OF ITS EMERGENCY MOTIONS FOR A TEMPORARY
`RESTRAINING ORDER AND A PRELIMINARY INJUNCTION
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`PUBLIC VERSION FILED:
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`July 19, 2019
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 2 of 29 PageID #: 23573
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`TABLE OF CONTENTS
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`TABLE OF AUTHORITIES ..................................................................................................... iii
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`Page
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`INTRODUCTION ......................................................................................................................1
`BACKGROUND ........................................................................................................................2
`A.
`Herceptin ..................................................................................................2
`B.
`Genentech’s Patents..................................................................................3
`C.
`Amgen’s Biosimilar Drug .........................................................................4
`ARGUMENT ..............................................................................................................................5
`THE COURT SHOULD ENTER A PRELIMINARY INJUNCTION. ....................................5
`I.
`A.
`Genentech Is Likely to Succeed on the Merits...........................................5
`1.
`Infringement .................................................................................6
`a.
`Direct infringement ...........................................................6
`b.
`Inducement ........................................................................8
`2.
`Validity .........................................................................................9
`B. Amgen’s Infringement Will Irreparably Harm Genentech. ...................... 10
`Genentech will suffer irreparable harm........................................ 10
`1.
`a.
`Price erosion .................................................................... 10
`b.
`Lost market share ............................................................ 12
`c.
`Effect on other products................................................... 13
`d.
`Reputational harm ........................................................... 15
`2.
`infringement. .............................................................................. 16
`The Balance of Hardships Favors Genentech. ......................................... 17
`Granting A Preliminary Injunction Serves The Public Interest. ............... 18
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`Genentech’s irreparable harm is connected to Amgen’s
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`C.
`D.
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`i
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 3 of 29 PageID #: 23574
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`THE COURT SHOULD ENTER A TEMPORARY RESTRAINING ORDER. ...................... 19
`II.
`CONCLUSION ......................................................................................................................... 20
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`ii
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 4 of 29 PageID #: 23575
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`
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`Cases
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`TABLE OF AUTHORITIES
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`Page(s)
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`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2008) ...................................................................................... 10, 13
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`Abraxis Bioscience, Inc. v. Navinta, LLC,
`640 F. Supp. 2d 553 (D.N.J. 2009) ........................................................................................ 6
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`ACCO Brands, Inc. v. ABA Locks Mfrs. Co.,
`501 F.3d 1307 (Fed. Cir. 2007) .............................................................................................. 5
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`Acumed LLC v. Stryker Corp.,
`551 F.3d 1323 (Fed. Cir. 2008) ............................................................................................ 17
`
`Apple Inc. v. Samsung Elecs. Co.,
`695 F.3d 1370 (Fed. Cir. 2012) (Apple I) ............................................................................. 10
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`Apple Inc. v. Samsung Elecs. Co.,
`809 F.3d 633 (Fed. Cir. 2015) (Apple II).................................................................. 10, 16, 17
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`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010) .......................................................................................... 8, 9
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`BioTechnology Gen. Corp. v. Genentech, Inc.,
`80 F.3d 1553 (Fed. Cir. 1996).............................................................................................. 15
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`Celsis in Vitro, Inc. v. Cellzdirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012)........................................................................................ 11, 18
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`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`2011 WL 1980610 (D. Del. May 20, 2011) ................................................................... 19, 20
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`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`717 F.3d 1336 (Fed Cir. 2013) ............................................................................................. 16
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`Eli Lilly & Co. v. Teva Parenteral Meds., Inc.,
`845 F.3d 1357 (Fed. Cir. 2017) .............................................................................................. 8
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`Hoffman-La Roche, Inc. v. Cobalt Pharms., Inc.,
`2010 WL 4687839 (D.N.J. Nov. 10, 2010) .......................................................................... 12
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`Impax Labs. Inc. v. Aventis Pharms, Inc.,
`235 F. Supp. 2d 390 (D. Del. 2002) ..................................................................................... 17
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`iii
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 5 of 29 PageID #: 23576
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`Kos Pharms., Inc. v. Andrx Corp.,
`369 F.3d 700 (3d Cir. 2004) ................................................................................................ 17
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`Metalcraft of Mayville, Inc. v. The Toro Co.,
`848 F.3d 1358 (Fed. Cir. 2017) ............................................................................................ 18
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`Momenta Pharms., Inc. v. Amphastar Pharms.,
`882 F. Supp. 2d 184 (D. Mass. 2011)................................................................................... 12
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`Oxford Immunotec Ltd. v. Qiagen, Inc.,
`271 F. Supp. 3d 358 (D. Mass. 2017)..................................................................................... 9
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`PPG Indus., Inc. v. Guardian Indus. Corp.,
`75 F.3d 1558 (Fed. Cir. 1996)................................................................................................ 9
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`Pappan Enters, Inc. v. Hardee’s Food Sys., Inc.,
`143 F.3d 800 (3d Cir. 1998) ................................................................................................ 18
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`Pfizer, Inc. v. Teva Pharms., USA, Inc.,
`429 F.3d 1364 (Fed. Cir. 2005) ............................................................................................ 17
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`Pozen Inc. v. Par Pharm., Inc.,
`800 F. Supp. 2d 789 (E.D. Tex. 2011) ................................................................................. 15
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`Purdue Pharma L.P. v. Boehringer Ingelheim GMBH,
`237 F.3d 1359 (Fed. Cir. 2001) ........................................................................................ 9, 13
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`Robert Bosch LLC v. Pylon Mfg. Corp.,
`659 F.3d 1142 (Fed. Cir. 2011) ............................................................................................ 17
`
`Sanofi v. Glenmark Pharms. Inc., USA,
`204 F. Supp. 3d 665 (D. Del. 2016) ....................................................................................... 5
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`Sanofi v. Watson Labs, Inc.,
`875 F.3d 636, 644 (Fed. Cir. 2017) .................................................................................... 5, 8
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`Sanofi-Synthelabo v. Apotex,
`470 F.3d 1368 (Fed. Cir. 2006) ................................................................................ 11, 12, 18
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`Syntex (USA) LLC v. Apotex Inc.,
`No. C 01-02214 MJJ, 2006 WL 1390435 (N.D. Cal. May 18, 2006) .................................... 19
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`Tinnus Enterprises, LLC v. Telebrands Corp.,
`846 F.3d 1190 (Fed. Cir. 2017) .............................................................................................. 5
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`Tootsie Roll Indus., Inc. v. Sathers, Inc.,
`666 F. Supp. 655 (D. Del. 1987) .......................................................................................... 19
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`iv
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 6 of 29 PageID #: 23577
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`Transcontinental Gas Pipe Line Co. v. Permanent Easements,
`907 F.3d 725 (3d Cir. 2018) .................................................................................................. 5
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`Trebro Mfg., Inc. v. Firefly Equipment, LLC,
`748 F.3d 1159 (Fed. Cir. 2014) .............................................................................................. 5
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`Vanda Pharm. Inc. v. Roxane Labs., Inc.,
`203 F. Supp. 3d 412 (D. Del. 2016) ..................................................................................... 15
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`Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd.,
`887 F.3d 1117 (Fed. Cir. 2018) .............................................................................................. 8
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`Statutes
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`35 U.S.C. § 271(b) ...................................................................................................................... 5
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`Other Authorities
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`4 Robert A. Matthews, Jr., Annotated Patent Digest § 32:44 (June 2019 update) ....................... 13
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`v
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 7 of 29 PageID #: 23578
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`INTRODUCTION
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`Amgen’s trastuzumab biosimilar, Kanjinti, was approved by the FDA on June 13, 2019.
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` Genentech brings this motion for a temporary restraining order (“TRO”) and a
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`preliminary injunction to preserve the status quo pending an adjudication on the merits.
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` And the public interest favors encouraging investment in innovation through the
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`enforcement of patent rights—particularly where, as here, patients already have access to
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`Herceptin regardless of ability to pay. Amgen cannot dispute any of this. Indeed, Amgen has
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`1
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 8 of 29 PageID #: 23579
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`argued in other cases that the equities favor injunctive relief in exactly these circumstances.
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` On June 20, 2019, the Court ordered Amgen to provide discovery concerning Amgen’s
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`own assessments of the validity of Genentech’s patents addressed in this motion.
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`BACKGROUND
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`A.
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`Herceptin
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`This case involves Genentech’s drug Herceptin, which treats HER2-positive breast
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`cancer. Approximately 20-25% of breast cancer patients are HER2-positive, which means that
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`their cancer cells produce an excessive amount of a cellular receptor known as “HER2.” (D.I. 75,
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`2
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 9 of 29 PageID #: 23580
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`¶1.) Before Herceptin, patients with HER2-positive breast cancer had a poor prognosis; patients
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`with advanced disease had a life expectancy of only 18 months. (Id., ¶2.)
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`Herceptin fundamentally changed the treatment of HER2-positive breast cancer. Its
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`active ingredient is the antibody “trastuzumab,” which Genentech scientists engineered to bind to
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`HER2. (D.I. 75, ¶3.) Following its FDA approval, Herceptin was hailed as a revolution—
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`demonstrating for the first time that solid tumors could be treated with a targeted therapy.
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`(Tannenbaum Decl. ¶22.) Since then, Herceptin has extended and, in early breast cancer, saved
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`the lives of hundreds of thousands of patients. (Id. ¶12.) Indeed, due to Genentech’s research,
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`HER2-positive breast cancer has gone from having the worst prognosis to one of the best. (Id.
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`¶¶6-9.) Herceptin is now the standard of care for HER2-positive cancer. (Id. ¶¶9-12.)
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`Genentech has invested billions of dollars and countless hours of research over more than
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`two decades to improve therapeutic options for HER-2 positive patients. (Oliger Decl. ¶7.) This
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`investment of resources was high risk, with failure far more likely than success. Only 1 in 20
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`oncology drugs make it from Phase I trials to FDA approval. (Jena Decl. ¶117.)
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`This research included investing in clinical trials to extend the use of Herceptin from
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`advanced (i.e., metastatic) breast cancer to early breast cancer patients, who could be given the
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`drug in a curative setting following surgery (referred to as “adjuvant” therapy). (Oliger Decl. ¶8.)
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`Genentech researchers also successfully developed new dosing regimens that make Herceptin
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`more convenient for early breast cancer patients by extending the intervals between visits to a
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`clinic from one week to three weeks. (Tannenbaum Decl. ¶25.)
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`B.
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`Genentech’s Patents
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`Amgen infringes claims of U.S. Patent Nos. 6,627,196 (the “’196 patent”), 7,371,379 (the
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`“’379 patent”) and 10,160,811 (the “’811 patent”) (the “Asserted Patents”). The Asserted
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`3
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 10 of 29 PageID #: 23581
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`Patents relate to methods of treating cancer with a specific dosing regimen: intravenous (“IV”)
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`administration of an initial 8 mg/kg dose followed by one or more 6 mg/kg doses separated by
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`three weeks. (Ex. 1, Cl. 11; Ex. 2, Cl. 11; Ex. 3, Cl. 6.) The ’379 patent further recites co-
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`administration with a chemotherapy agent. (Ex. 2, Cl. 6.) The ’811 patent specifically claims
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`treatment of breast cancer. (Ex. 3, Cl. 11.)1
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`Herceptin was initially approved with a weekly dosing regimen. The dosing regimen
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`claimed in asserted claim 11 of the ’196 patent, claim 11 of the ’379 patent, and claim 7 of
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`the ’811 patent (the “Asserted Claims”) reflects the discovery by Genentech scientists that
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`patients could go for three weeks between doses without compromising the effectiveness of the
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`therapy. This was a significant improvement in patient care which allowed patients to receive
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`the same therapeutic benefits of weekly Herceptin while only going to a clinic or hospital once or
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`twice a month. (Tannenbaum Decl. ¶¶25, 32.)
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`C.
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`Amgen’s Biosimilar Drug
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`Amgen intends to launch a biosimilar version of Herceptin called Kanjinti. Kanjinti is
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`approved to treat the same conditions with the same doses as Herceptin, and the Kanjinti label
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`includes the same clinical study data that Genentech provides for Herceptin, including the study
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`that led to approval of the once-every-three-weeks dosing regimen. (Tannenbaum Decl. ¶37.)
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`1
`Genentech reserves the right to litigate all asserted claims of asserted patents at trial but
`has limited this motion to three claims of three patents to streamline the issues for the Court.
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`4
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 11 of 29 PageID #: 23582
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`AMGKAN02978404; Ex. 7, AMGKAN02978529; Ex. 8 at 1.)
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`ARGUMENT
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`I.
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`THE COURT SHOULD ENTER A PRELIMINARY INJUNCTION.
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`In determining whether to grant a preliminary injunction, courts consider four factors:
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`“(1) the likelihood of the patentee’s success on the merits; (2) irreparable harm if the injunction
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`is not granted; (3) the balance of hardships between the parties; and (4) the public interest.”
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`Tinnus Enterprises, LLC v. Telebrands Corp., 846 F.3d 1190, 1202 (Fed. Cir. 2017); accord
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`Transcontinental Gas Pipe Line Co. v. Permanent Easements, 907 F.3d 725, 732 (3d Cir. 2018)
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`(similar). The Federal Circuit generally “review[s] preliminary injunctions using the law of the
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`regional circuit” but will “give[] dominant effect to Federal Circuit precedent insofar as it
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`reflects considerations specific to patent issues.” Tinnus, 846 F.3d at 1202-1203.
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`A.
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`Genentech Is Likely to Succeed on the Merits.
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`To show likelihood of success, “a patentee must prove that success in establishing
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`infringement is ‘more likely than not.’” Trebro Mfg., Inc. v. Firefly Equipment, LLC, 748 F.3d
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`1159, 1166 (Fed. Cir. 2014). To show induced infringement under 35 U.S.C. § 271(b), the
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`“patentee must establish first that there has been direct infringement, and second that the alleged
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`infringer knowingly induced infringement and possessed specific intent to encourage another’s
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`infringement.” ACCO Brands, Inc. v. ABA Locks Mfrs. Co., 501 F.3d 1307, 1312 (Fed. Cir.
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`2007). In “cases alleging that a proposed drug label will induce infringement by physicians,
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`[t]he pertinent question is whether the proposed label instructs users to perform the patented
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`method.” Sanofi v. Glenmark Pharms. Inc., USA, 204 F. Supp. 3d 665, 673 (D. Del. 2016), aff’d,
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`Sanofi v. Watson Labs, Inc. 875 F.3d 636 (Fed. Cir. 2017). “Statements in a package insert that
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`encourage infringing use of a drug product are alone sufficient to establish intent to encourage
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`direct infringement.” Abraxis Bioscience, Inc. v. Navinta, LLC, 640 F. Supp. 2d 553, 570 (D.N.J.
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 12 of 29 PageID #: 23583
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`2009), rev’d & vacated on other grounds, 625 F.3d 1359 (Fed. Cir. 2010).
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`1.
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`Infringement
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`Amgen will infringe at least claim 11 of the ’196 patent, claim 11 of the ’379 patent, and
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`claim 7 of the ’811 patent.
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`a.
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`Direct infringement
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`As Genentech’s declarant Dr. Susan Tannenbaum confirms, physicians who prescribe
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`Kanjinti according to the approved label for Kanjinti would directly infringe the Asserted Claims.
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`(Tannenbaum Decl. ¶¶41-58; Appx. A.)
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`Claim 11 of the ’196 patent recites “[a] method for the treatment of a human patient
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`diagnosed with cancer characterized by overexpression of ErbB22 receptor.” The Kanjinti label
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`instructs this method because Kanjinti is for the treatment of “HER2 overexpressing” breast and
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`metastatic gastric cancer. (Ex. 4, AMGKAN02982377; Tannenbaum Decl. ¶¶44-47; Appx A.)
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`Claim 11 of the ’196 patent further recites:
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`comprising administering an effective amount of an anti-ErbB2 antibody to
`the human patient, the method comprising:
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`administering to the patient an initial dose of approximately 8 mg/kg of the
`anti-ErbB2 antibody; and
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`administering to the patient a plurality of subsequent doses of the antibody in
`an amount that is approximately the same or less than the initial dose, and
`wherein at least one subsequent dose is approximately 6 mg/kg, and
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`wherein the subsequent doses are separated in time from each other by at least
`three weeks.
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`The Kanjinti label instructs this method; the approved regimens include an “[i]nitial dose of 8
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`mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30–90 minutes IV infusion every three
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`ErbB2 refers to HER2. (Tannenbaum Decl. ¶19.)
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 13 of 29 PageID #: 23584
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`weeks for 52 weeks.” (Ex. 4, AMGKAN02982377; Tannenbaum Decl. ¶¶47-49, Appx A.)
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`Claim 11 of the ’379 patent is similar to claim 11 of the ’196 patent and additionally
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`recites “further comprising administering an effective amount of a chemotherapeutic agent to the
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`patient.” The Kanjinti label instructs this method because it is indicated for use “as a single
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`agent following multi-modality anthracycline based therapy [i.e., chemotherapy].” (Ex. 4,
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`AMGKAN02982380; Tannenbaum Decl. ¶¶50-51, Appx A.)
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`Claim 7 of the ’811 patent recites “[a] method for the treatment of a human patient
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`diagnosed with breast cancer.” As discussed above, the Kanjinti label instructs “treatment of
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`HER2 overexpressing breast cancer.” Claim 7 of the ’811 patent further recites:
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`administering intravenously to the patient an initial dose of 8 mg/kg of anti-
`ErbB2 huMAb 4D5-8 antibody
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`and administering intravenously to the patient a plurality of subsequent 6
`mg/kg doses of the antibody,
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`wherein the initial dose is separated in time from the first subsequent dose by
`three weeks,
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`and the subsequent doses are separated from each other in time by three weeks.
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`As discussed for ’196 patent claim 11, the Kanjinti label instructs this dosing method for treating
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`adjuvant breast cancer, including “IV infusion.” (Ex. 4, AMGKAN02982377.)
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`Lastly, claim 7 of the ’811 recites a method of treatment of a patient “diagnosed with
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`breast cancer” that is characterized by a specific method: “2+ or 3+ overexpression of ErbB2
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`receptor as determined by immunohistochemistry or fluorescence in situ hybridization (FISH).”
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`The Kanjinti label instructs the use of immunohistochemistry or FISH assays to identify patients
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`for treatment, and illustrates the use of those assays in accordance with claim 7 in the
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`descriptions of the clinical studies included in the Kanjinti label. (Tannenbaum Decl. ¶¶53-57;
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`see Ex. 4, AMGKAN02982377; Ex. 3, Cl. 7.)
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`7
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 14 of 29 PageID #: 23585
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`b.
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`Inducement
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`Amgen has knowledge of the ’196, ’379, and ’811 patents, including based on the
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`Complaint in this action and Genentech’s notice to Amgen of the patents pursuant to 42 U.S.C. §
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`262(l)(3)(A). (Ex. 15A at 3; Ex. 15B at 1.)
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` See,
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`e.g., Sanofi, 875 F.3d at 644-46; AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir.
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`2010); Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357 (Fed. Cir. 2017) (affirming
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`finding of induced infringement where label instructed claimed use); Vanda Pharms. Inc. v.
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`West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) (same).
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`8
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 15 of 29 PageID #: 23586
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`AMGKAN02833283; Ex. 6, 232:9-24; 234:5-24; 239:10-240:10.) See AstraZeneca, 633 F.3d at
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`1059 (intent to induce infringement where defendant “was aware of and certainly concerned
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`about potential infringement problem by its label, but nevertheless decided to proceed with the
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`label”) (citation and quotation marks omitted).
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`2.
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`Validity
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`At the preliminary injunction stage, “the very existence of the patent satisfies [the
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`patentee’s] burden on validity.” Purdue Pharma L.P. v. Boehringer Ingelheim GMBH, 237 F.3d
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`1359, 1365 (Fed. Cir. 2001). To prevail on this issue, the burden is on the infringer to show
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`“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). Amgen bears the burden of proof to show invalidity, and Genentech will
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`respond to any such argument in reply.
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`Notably, the validity of the ’196 and ’379 patents was recently confirmed by the Patent
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`Office after full IPR trials. (See Ex. 21, at 25-26; Ex. 22, at 33-34; Ex. 23, at 15-16; Ex. 24, at
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`24.) The ’811 patent issued after those IPRs and recites the same non-obvious dosing regimen.
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`.) Amgen cannot
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`show it is unlikely that Genentech will succeed on the merits by recycling art and arguments
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`conclusively rejected in the IPRs. See Oxford Immunotec Ltd. v. Qiagen, Inc., 271 F. Supp. 3d
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`358, 366-67 (D. Mass. 2017) (finding patentee likely to succeed on validity where infringer
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`made validity arguments rejected in IPRs). Indeed, the technically trained three judge panel of
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`9
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 16 of 29 PageID #: 23587
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`the Patent Trial and Appeal Board applied a lower burden of proof (preponderance of the
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`evidence) than Amgen will need to meet to show invalidity (clear and convincing evidence).3
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`B. Amgen’s Infringement Will Irreparably Harm Genentech.
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`Proof of irreparable harm in a patent case requires two elements. First, the patentee must
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`establish there is a likelihood “that absent an injunction, it will suffer irreparable harm.” Apple
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`Inc. v. Samsung Elecs. Co., 695 F.3d 1370, 1374 (Fed. Cir. 2012) (Apple I). Second, the patentee
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`must also demonstrate “that a sufficiently strong causal nexus relates the alleged harm to the
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`alleged infringement.” Apple I, 695 F.3d at 1374. That is, it must show “some connection”
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`between the irreparable harm suffered and the infringement alleged. Apple Inc. v. Samsung
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`Elecs. Co., 809 F.3d 633, 641 & n.1 (Fed. Cir. 2015) (Apple II).
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`1. Genentech will suffer irreparable harm.
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`The Federal Circuit has explained that patent infringement can irreparably harm a
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`patentee through, at least, price erosion, lost market share, and damage to the patentee’s
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`reputation. See, e.g., Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1361-62 (Fed. Cir. 2008).
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`Amgen’s infringement will cause Genentech to suffer each of those categories of harms if an
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`injunction does not issue.
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`a.
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`Price erosion
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`The Federal Circuit has repeatedly held that price erosion—i.e., the decrease in the
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`3
`The Court ordered Amgen to provide discovery concerning its assessments of the validity
`of these patents (D.I. 259 at 1-2), but Amgen has refused to comply, as discussed in more detail
`below. Genentech reserves the right to supplement this motion after receiving that discovery.
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`amount of money the patentee can charge for its product due to the infringer’s launch—
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`constitutes irreparable harm. E.g., Celsis in Vitro, Inc. v. Cellzdirect, Inc., 664 F.3d 922, 930
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`(Fed. Cir. 2012) (collecting cases). Amgen has consistently agreed, for example, arguing in this
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`District that “[p]rice erosion alone is sufficient to establish irreparable harm.” See Ex. 26,
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`Plaintiffs’ Opening Brief at 6, Amgen Inc. et al. v. Sanofi et al., No. 14-cv-1317-SLR, D.I. 340
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`(D. Del. April 27, 2016) (“Sanofi I Brief”) (emphasis added). And in a separate biosimilar
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`litigation in this District, Amgen conceded that an offer of discounts or rebates by a biosimilar
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`maker in the oncology market “will irreparably harm” the reference product sponsor, there
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`Amgen, by causing price erosion that will have “irreversible effects” on price and the market.
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`See Ex. 28, Opening Brief at 16-17, Amgen Inc. et al. v. Hospira, Inc., No. 1:15-cv-839-RGA,
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`D.I. 230 (D. Del. June 5, 2017) (“Hospira Brief”).
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`Genentech will suffer those same irreparable injuries if Amgen launches Kanjinti.
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`The price erosion caused by an Amgen entry will be irreversible, including because any
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`attempt to raise prices to pre-entry levels will be met with severe backlash and loss of goodwill.
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`(Jena Decl. ¶¶99-100.) Genentech will not be able to recoup loss due to price erosion by future,
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`higher prices or reduced discounts. See Sanofi-Synthelabo v. Apotex, 470 F.3d 1368, 1382 (Fed.
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`Cir. 2006) (irreparable harm due to “irreversible price erosion”); see also Hoffman-La Roche, Inc.
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`v. Cobalt Pharms., Inc., 2010 WL 4687839 at *12 (D.N.J. Nov. 10, 2010) (“phenomenon of
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`price erosion in the pharmaceutical industry is well known”); Momenta Pharms., Inc. v.
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`Case 1:18-cv-00924-CFC Document 308 Filed 07/19/19 Page 18 of 29 PageID #: 23589
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`Amphastar Pharms., 882 F. Supp. 2d 184, 197 (D. Mass. 2011) (“‘Requiring purchasers to pay
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`higher prices after years of paying lower prices to infringers is not a reliable business option.’”).
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`The specific harm to Genentech as a result of price erosion is difficult to quantify.
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`Genentech’s responses to Amgen’s entry will be multi-faceted and complex, and the specific
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`effects of Amgen’s activity will be difficult to unravel from other market conditions. (Jena Decl.
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`¶¶65-67.) See Sanofi-Synthelabo, 470 F.3d at 1372 (“complex pricing scheme” for prescription
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`drugs means additional entrants have potential to irreversibly erode prices in unpredictable ways);
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`Hoffman-La Roche Inc., 2010 WL 4687839, at *12.
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`The price erosion that Genentech would suffer from Amgen’s launch would be
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`particularly severe because
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`. (Oliger
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`Decl. ¶53; Jena Decl. ¶59.) The harms from Amgen’s entry would continue even if Amgen were
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`later removed from the market because Genentech would be unable to raise prices to pre-entry
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`levels. (Jena Decl. ¶99-101.)
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`. Indeed, once other
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`biosimilars are on the market, isolating the impact of Kanjinti as opposed to other biosimilars on
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`the price of Herceptin will be even more complex. (Id. ¶¶70-72.)
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`b.
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`Lost market share
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`It is well-established that a patentee’s loss of market share can constitute irreparable harm.
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`See, e.g., Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1361-62 (Fed. Cir. 2008); Purdue Pharma
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`L.P. v. Boehringer Ingelheim GmbH, 237 F.3d 1359, 1368 (Fed. Cir. 2001). As Amgen itself
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`has stated in seeking a preliminary injunction in a biosimilar case, “[c]ourts have repeatedly held
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`that the steep loss of market share and revenue…caused by the introduction of a generic drug
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`constitute irreparable harm justifying the entry of injunctive relief.” Ex. 28, at 15; see also Ex.
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`30, Amgen Inc. v. Amneal Pharms. LLC, et al., No. 1:16-cv-853-MSG, D.I. 440 at 12-13 (D. Del.
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`Mar. 26, 2019) (“Amneal Brief”) (“loss of market share…[is an] accepted form[] of irreparable
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`harm”);4 see also 4 Robert A. Matthews, Jr., Annotated Patent Digest § 32:44 (June 2019 update)
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`(collecting cases).
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`Amgen’s launch of Kanjinti undisputedly will reduce Genentech’s market share.
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`will be difficult for Genentech to recapture market share from Amgen.
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`.) It
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`later removed from the market, Genentech is unlikely to recapture its pre-entry market share.
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` And even if Amgen were
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`(Jena Decl. ¶98.)
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` Indeed,
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`, Genentech will continue to be
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`irreparably harmed because the percentage of the loss of market share attributable to Amgen will
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`become even harder to quantify and thus fully compensate. (Id., ¶¶70-72.)
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`c.
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`Effect on other products
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`4
`Amgen’s acknowledgement of these well-accepted types of irreparable harm is equally
`relevant from small-molecule cases (such as Amneal) and biosimilar cases (such as Hospira).
`Indeed, Amgen relied on precedent regarding small-molecule generics in seeking an injunction
`in the Hospira biosimilar case. (See Ex. 28, at 15-16.)
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`The irreparable injuries that Genentech will suffer from Amgen’s infringement are not
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`limited only to Herceptin, but would also extend to other Genentech products.
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` First, Amgen’s biosimilar launch would likely have an incalculable but material
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`negative effect on the market for Genentech’s Perjeta and Kadcyla products. Like Herceptin,
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`Perjeta and Kadcyla are antibodies that treat breast cancer. Perjeta has been approved for use at
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`the same time as Herceptin and is thought to have synergistic effects with Herceptin. (Oliger
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`Decl. ¶¶11, 22.) Kadcyla is used for certain patients who have already been treated with
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`Herceptin and chemotherapy and has also been newly approved as an alternative to Herceptin for
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`some patients. (Oliger Decl. ¶¶11, 24.) Amgen’s launch of Kanjinti is likely to have significant
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`adverse effects on Perjeta and Kadcyla for two reasons.
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`Second, Amgen’s launch would likely result in lost sales and price erosion for two other
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`Genentech biologic drugs, Avastin and Rituxan, which are likely to face threats of biosimilar
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`competition now or in the near future.
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` These harms are difficult to quantify and therefore
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`irreparable. Indeed, Amgen itself has acknowledged that irreparable harm can be shown where
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`launch of an infringing drug will affect the market for a patentee’s other products, arguing that
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`the launch of a biosimilar to one of Amgen’s products would irreparably harm the market for two
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`other Amgen products as well. (Ex. 28, at 14-15.)
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`Third, Genentech is a research-based company, and Amgen’s launch will hinder
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`Genentech’s ability to fund research