Case 1:18-cv-00924-CFC-SRF Document 506 Filed 02/11/20 Page 1 of 62 PageID #:
`34062
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC.,
`
`Plaintiffs,
`
`Case No. 18-924-CFC
`
`v.
`
`AMGEN, INC.
`
`Defendant.
`
`JOINT MEMORANDUM IN SUPPORT OF
`THE PARTIES’ PROPOSED JURY INSTRUCTIONS
`
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`TABLE OF CONTENTS
`Proposed Instruction 2: The Parties and Their Contentions ....................... 1
`I.
`Proposed Instruction 3: Burdens of Proof .................................................. 3
`II.
`Proposed Instruction 4.2: Independent and Dependent Claims ................. 3
`III.
`Proposed Instruction 5.1: Infringement Generally .................................... 4
`IV.
`Proposed Instruction 5.2: Direct Infringement .......................................... 5
`V.
`Proposed Instruction 5.3: Induced Infringement ........................................ 6
`VI.
`Proposed Instruction 5.4: Infringement By Filing Biologics License
`VII.
`Application ...............................................................................................................14
`VIII.
`Proposed Instruction 5.5: Determining Whether Third Parties Had an
`Implied License to Practice the Dosing Patents.......................................................15
`IX.
`Proposed Instruction 6.1: Invalidity Generally ........................................18
`X.
`Proposed Instruction 6.2: Presumption of Validity ..................................19
`XI.
`Proposed Instruction 6.3: Person of Ordinary Skill in the Art .................20
`XII.
`Proposed Instruction 6.4: The Written Description Requirement ............21
`XIII.
`Proposed Instruction 6.5: The Enablement Requirement ........................23
`XIV.
`Proposed Instruction 6.6: Indefiniteness ..................................................23
`XV.
`Proposed Instruction 6.7: Prior Art and Public Use .................................23
`XVI.
`Proposed Instruction 6.8: Anticipation .....................................................25
`XVII.
`Proposed Instruction 6.9: Obviousness ....................................................26
`XVIII.
`Proposed Instruction 6.10-6.11: Derivation and Incorrect Inventorship .29
`XIX.
`Proposed Instruction 6.12: Inequitable Conduct ......................................33
`XX.
`Proposed Instruction 7.1: Damages – Generally ......................................33
`XXI.
`Proposed Instruction 7.2: Kinds of Damages That May Be Recovered ..34
`XXII.
`Proposed Instruction 7.3: Attribution/Apportionment & Proposed
`Instruction 7.16: Reasonable Royalty – Attribution/Apportionment ......................36
`XXIII.
`Proposed Instruction 7.4: Lost Profits – “But-For” Test ..........................42
`XXIV. Proposed Instruction 7.5: Lost Profits – Factors ......................................43
`XXV.
`Proposed Instruction 7.7: Lost Profits – Acceptable Non-Infringing
`Substitutes ................................................................................................................44
`XXVI. Proposed Instruction 7.8: Lost Profits – Market Share ............................45
`XXVII. Proposed Instruction 7.10: Lost Profits – Amount of Profit ....................47
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`XXVIII. Proposed Instruction 7.11: Price Erosion .................................................49
`XXIX. Proposed Instruction 7.21: Damages – Doubts Resolved Against
`Infringer 50
`XXX.
`Proposed Instruction 8: Willful Infringement ..........................................50
`XXXI. Preliminary Instructions ...........................................................................53
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`CASES
`Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., 903 F.3d
`1310 (Fed. Cir. 2018) .................................................................................... 27, 28
`
`Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. 2019) .................................. 4, 5
`
`Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010)................... 22
`
`Aro Mfg. Co. v. Convertible Top Replacement Co., 377 US 476 (1964) ................ 47
`
`Arthrocare Corp. v. Smith & Nephew, Inc., 406 F.3d 1365 (Fed. Cir.
`2005) ................................................................................................................... 10
`
`Aspex Eyewear Inc. v. Clariti Eyewear, Inc., 605 F.3d 1305 (Fed. Cir.
`2010) ................................................................................................................... 54
`
`AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010) ........................... 13
`
`Augustine Med., Inc. v. Progressive Dynamics, Inc., 194 F.3d 1367
`(Fed. Cir. 1999) ................................................................................................... 17
`
`Bayer AG. v. Biovail Corp., 279 F.3d 1340 (Fed. Cir. 2002) .................................... 4
`
`Carborundum Co. v. Molten Metal Equip. Innovations, Inc., 72 F.3d
`872 (Fed. Cir. 1995) ................................................................................ 16, 17, 18
`
`Celltrion v. Genentech, IPR2017-01373 .................................................................. 42
`
`Chiron Corp. v. Genentech, Inc., 363 F.3d 1247 (Fed. Cir. 2004) .................... 19, 20
`
`Cumberland Pharms. Inc. v. Mylan Institutional LLC, 846 F.3d 1213
`(Fed. Cir. 2017) ................................................................................................... 30
`
`Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387
`(Fed. Cir. 1988) ................................................................................................... 28
`
`DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) .............................. 8, 9
`
`Dynacore Holding v. U.S. Philips, 363 F.3d 1263 (Fed. Cir. 2004) ................. 10, 11
`
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`
`Eko Brands, LLC v. Adrian Rivera Maynez Enterprises, Inc., 946 F.3d
`1367 (Fed. Cir. 2020) .......................................................................................... 52
`
`Eko Brands v. Adrian Rivera Maynez Enterprises, No. 2018-2215,
`2020 WL 130439 (Fed. Cir. Jan. 13, 2020) ........................................................ 53
`
`Erfindergemeinschaft UroPep GbR v. Eli Lilly and Company, No.
`2:15-CV-1202, 2017 WL 959592 (E.D.Tex. Mar. 13, 2017) ............................. 20
`
`Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201 (Fed. Cir. 2014) .................... 9, 40
`
`Ex parte Andresen, 212 USPQ 100 (Bd. App. 1981) .............................................. 30
`
`Exergen v. Wal-Mart Stores, 575 F.3d 1312 (Fed. Cir. 2009) .................................. 8
`
`F’Real Foods, LLC v. Hamilton Beach Brands, Inc., No. 1:16-cv-
`00041-CFC .......................................................................................................... 21
`
`Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731 (Fed. Cir. 2013) .................... 29
`
`Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573 (Fed.
`Cir. 1997) ............................................................................................................ 30
`
`Garretson v. Clark, 111 U.S. 120 (1884) ................................................................ 39
`
`Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997) ............................. 4
`
`GlaxoSmithKline LLC v. Glenmark Pharms. Inc., 2017 WL 8948975
`(D. Del. May 30, 2017) ....................................................................................... 47
`
`GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 313 F.Supp.3d 582
`(D. Del. 2018) ............................................................................................... 10, 11
`
`Grain Processing Corp. v. Am. Maize-Prod. Co., 185 F.3d 1341 (Fed.
`Cir. 1999) ............................................................................................................ 45
`
`Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923 (2016) ............................... 52
`
`Hauser, Inc. v. Hawk Measurement Sys. Pty., Ltd., 122 F.3d 1040
`(Fed. Cir. 1997) ................................................................................................... 21
`
`HZNP Medicines LLC v. Actavis Labs. UT, Inc., 940 F.3d 680 (Fed.
`Cir. 2019) ...................................................................................................... 13, 14
`
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`In re Depomed Patent Litig., No. 13-4507, 2016 WL 7163647 (D.N.J.
`Sept. 30, 2016) .................................................................................................... 14
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) .......................................... 21, 26
`
`LaserDynamics, Inc. v. Quanta Comput., 694 F.3d 51 (Fed. Cir. 2012)................. 39
`
`LifeScan, Inc. v. Home Diagnostics, Inc., 103 F. Supp. 2d 345 (D. Del.
`2000) ................................................................................................................... 19
`
`Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d 1301 (Fed. Cir. 2009) ...................... 9
`
`Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275 (Fed. Cir.
`2017) .................................................................................... 37, 38, 39, 40, 41, 44
`
`Mentor Graphics v. EVE, 870 F.3d 1298 (Fed. Cir. 2017) ...................................... 40
`
`Mentor H/S, Inc. v. Med. Device Alliance, Inc., 244 F. 3d 1365 (Fed.
`Cir. 2001) ............................................................................................................ 10
`
`Metro-Goldwyn-Mayer Studios, Inc. v. Grokster, Ltd., 545 U.S. 913
`(2005) .................................................................................................................. 13
`
`Microsoft v. i4i, 564 U.S. 91 (2011) ............................................................ 19, 25, 26
`
`Mirror Worlds, LLC v. Apple Inc., 692 F.3d 1351 (Fed. Cir. 2012) ......................... 7
`
`Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261 (Fed. Cir.
`1986) ................................................................................................................... 10
`
`Pannu v. Iolab Corp., 155 F.3d 1344 (Fed Cir. 1998) ...................................... 30, 31
`
`Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) .................................... 27
`
`Polara Engineering Inc. v. Campbell Co., 894 F.3d 1339 (Fed. Cir.
`2018) ................................................................................................................... 53
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 843
`F.3d 1315 (Fed. Cir. 2016) ............................................................................. 9, 11
`
`Ricoh Co. v. Quanta Comput. Inc., 550 F.3d 1325 (Fed. Cir. 2008) ....................... 13
`
`Sanofi-Aventis v. Genentech, IPR2015-01624 ......................................................... 42
`
`Sepracor Inc. v. Dey L.P., 2010 WL 2802611 (D. Del. July 15, 2010) .................... 4
`v
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`Shire LLC v. Amneal Pharms., LLC, 2014 WL 2861430 (D.N.J. Jun.
`23, 2014) ....................................................................................................... 13, 14
`
`SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312 (Fed. Cir.
`2006) ..................................................................................................................... 3
`
`SRI Int'l, Inc. v. Advanced Tech. Labs., Inc., 127 F.3d 1462 (Fed. Cir.
`1997) ................................................................................................................... 54
`
`Trovan, Ltd. v. Sokymat SA, Irori, 299 F.3d 1292 (Fed. Cir. 2002) .................. 31, 33
`
`TruePosition Inc. v. Andrew Corp., 568 F. Supp. 2d 500 (D. Del.
`2008) ................................................................................................................... 17
`
`WesternGeco L.L.C. v. ION Geophysical Corp., 913 F.3d 1067 (Fed.
`Cir. 2019) .......................................................................................... 38, 39, 40, 41
`
`STATUTES, RULES, AND REGULATIONS
`
`35 U.S.C. § 102 .................................................................................................. 24, 31
`
`35 U.S.C. §256 ......................................................................................................... 33
`
`35 U.S.C. § 271(e) ..................................................................................................... 4
`
`FRCP 8(c)................................................................................................................. 17
`
`Other Authorities
`
`Manual of Patent Examining Procedure ............................................................ 30, 31
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`In accordance with the parties’ agreement and as approved by the Court
`
`(D.I. 502), Plaintiff Genentech, Inc. and Defendant Amgen, Inc. hereby submit this
`
`memorandum in support of the parties’ competing proposed jury instructions (D.I.
`
`498, 499).
`
`I.
`
`Proposed Instruction 2: The Parties and Their Contentions
`
`I will now review for you the parties to this action, and the positions that you will
`have to consider in reaching your verdict. I will then provide you with detailed
`instructions on what each side must prove to win on each of its contentions.
`
`To refresh your recollection, the parties are Genentech, Inc., the Plaintiff, and
`Amgen Inc., the Defendant. Genentech is asserting four U.S. patents in this case:
`(1) U.S. Patent No. 6,627,196 (“the ’196 Patent”); (2) U.S. Patent No. 7,371,379
`(“the ’379 Patent”); (3) U.S. Patent No. 10,160,811 (“the ’811 Patent”) and (4)
`U.S. Patent No. 8,574,869 (“the ’869 Patent”). I will refer to the ’196, ’379, and
`’811 patents collectively as the “Dosing Patents.” I will refer to the ’869 Patent as
`the Kao Manufacturing Patent. I will refer to all four patents collectively as the
`Patents-in-Suit.
`
`Amgen filed a Biologics License Application (“BLA”) for a biosimilar of
`Herceptin, a drug used to treat cancer. Herceptin was first marketed by Genentech
`in 1998, and its active ingredient is trastuzumab. Amgen began selling its FDA-
`approved trastuzumab biosimilar product, called Kanjinti, in the U.S by July 18,
`2019. ABP 980 is the active ingredient found in Kanjinti.
`
`I will now overview the positions each side has taken. Genentech alleges that
`Amgen infringed, is currently infringing, and will continue to infringe:
`
`1.
`
`2.
`
`3.
`
`4.
`
`claims 11 and 22 of the ’196 Dosing Patent;
`
`claims 11 and 21 of the ’379 Dosing Patent;
`
`claims 6 and 7 of the ’811 Dosing Patent; and
`
`claims 5 and 8 of the Kao Manufacturing Patent.
`
`I will refer to these claims collectively as the Asserted Patent Claims.
`Additionally, Genentech contends Amgen’s infringement of the Asserted Claims is
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`willful. Genentech seeks damages adequate to compensate for Amgen’s
`infringement.
`
`GENENTECH’S PROPOSAL: Amgen denies that it infringes any of the Asserted
`Patent Claims. Amgen further asserts that each of the Asserted Patent Claims is
`invalid. Amgen also denies that it has willfully infringed the Asserted Claims.
`
`AMGEN’S PROPOSAL: Amgen denies Genentech’s infringement allegations as
`to all Asserted Patent Claims. Amgen further asserts that each of the Asserted
`Patent Claims is invalid because the inventions claimed were not new and were
`obvious at the time Genentech claims to have invented them. Amgen also
`contends that the Asserted Claims of the Dosing Patents are invalid for incorrect
`inventorship and/or derivation. Amgen also contends that the Asserted Claims of
`the ’196 Dosing Patent, the ’379 Dosing Patent, and the Kao Manufacturing Patent
`are invalid because the patents do not sufficiently describe and enable the claimed
`inventions and the Asserted Patent Claims themselves are indefinite. Amgen
`further contends the ’869 patent is unenforceable for inequitable conduct.
`
`You will be asked to determine the issues of infringement, invalidity, willful
`infringement, [AMGEN’S PROPOSAL: inequitable conduct,] and damages
`according to instructions I will give you in a moment.
`
`A.
`
`Genentech’s Position
`
`Amgen’s details regarding invalidity are unnecessary, and derivation and
`
`inventorship should be stricken. See D.I. 445; 10/16/2019 Hearing Tr. 195:18-
`
`208:3.
`
`B.
`
`Amgen’s Position
`
`Amgen’s recitation is comparable to that Genentech provided regarding
`
`infringement. Amgen’s defenses are timely (D.I. 456). Proposal on inequitable
`
`conduct withdrawn.
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`II.
`
`Proposed Instruction 3: Burdens of Proof
`
`Put differently, if you were to put each party’s evidence on the opposite sides of a
`scale, the evidence supporting the party with the burden of proof would have to
`make the scales tip [GENENTECH’S PROPOSAL: somewhat on the side]
`[AMGEN’S PROPOSAL: in favor] of that party.
`
`Genentech’s Position
`A.
`Genentech’s explanation is what Amgen proposed in Hospira. C.A. No.
`
`1:15-cv-839-RGA, D.I. 323 at 12; see also AIPLA Model §B (“slightly greater
`
`than 50%”).
`
`III. Proposed Instruction 4.2: Independent and Dependent Claims
`
`An “independent” claim sets forth all of the requirements that must be met in order
`for a process, [GENENTECH’S PROPOSAL: a product made using a process,] of
`the use of a product according to a method to be covered by that claim, and thus
`infringe that claim.
`
`A process, [GENENTECH’S PROPOSAL: a product made using a process] or the
`use of a product according to a method is covered by, and therefore infringes, a
`dependent claim only if it meets all of the requirements of both the dependent
`claim and the claim or claims from which the dependent claim depends.
`
`A.
`
`Genentech’s Position
`
`Genentech’s proposal reflects its Kao patent infringement claim under
`
`§271(g) (product made by patented process).
`
`Amgen’s Position
`B.
`The Asserted Patent Claims do not include product-by-process claims. See
`
`SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006).
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`IV. Proposed Instruction 5.1: Infringement Generally
`
`GENENTECH’S PROPOSAL: Genentech also alleges that Amgen’s filing of its
`BLA is an act of infringement of all the Asserted Patent Claims.
`
`A.
`
`Genentech’s Position
`
`Genentech alleges infringement in multiple, independent ways, including
`
`under §271(e)(2)(C)(1) by filing a BLA. See Bayer AG. v. Biovail Corp., 279 F.3d
`
`1340, 1350 (Fed. Cir. 2002) (“infringement under § 271(e)(2)(A) by submission of
`
`an ANDA is not synonymous with infringement under § 271(a) by a commercial
`
`product”). “Damages” for such claim “may be awarded,” §271(e)(4)(C), and it is
`
`properly tried to a jury. See Sepracor Inc. v. Dey L.P., 2010 WL 2802611, at *3
`
`(D. Del. July 15, 2010).
`
`In Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997), and
`
`Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. 2019), the court entered
`
`judgment on §271(e) claims where evidence beyond the ANDA/BLA
`
`demonstrated non-infringement. Those cases do not suggest that
`
`commercialization supplants §271(e).
`
`B.
`
`Amgen’s Position
`
`“Patentees were given a jurisdictional basis for bringing suit in federal
`
`district court under 35 U.S.C. § 271(e)(2) when, in light of Section(s) 271(e)(1),
`
`the [biosimilar] applicant was not making, using, or selling the patented product,
`
`the traditional statutorily-defined acts of infringement.” Glaxo, Inc. v. Novopharm,
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`Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997). Courts assess this technical act of
`
`infringement by conducting a “hypothetical inquiry”: if FDA approves the drug
`
`application and the “drug were put on the market,” “would [it] infringe the relevant
`
`patent”? Id. at 1569–70.
`
`But now that FDA has approved Kanjinti and is “currently marketed, it is
`
`unnecessary to determine ‘what is likely to be sold,’ as is required for a technical
`
`act of infringement.” Amgen Inc. v. Sandoz Inc., 923 F.3d 1023, 1030-31 (Fed.
`
`Cir. 2019), reh'g granted, opinion modified, 776 F.App’x 707 (Fed. Cir. 2019).
`
`Instead, “infringement turns on … conventional principles of patent infringement.”
`
`Id. at 1031.
`
`Genentech’s proposal is unnecessary, inefficient, and would confuse the
`
`jury.
`
`V.
`
`Proposed Instruction 5.2: Direct Infringement
`
`A.
`
`Disputed Proposal 1
`
`GENENTECH’S PROPOSAL: Someone can directly infringe a patent without
`knowledge of the patent or without the knowledge that their actions are infringing
`the patent. They also may directly infringe a patent even though they believe in
`good faith that what they are doing does not infringe a patent or if they believe in
`good faith that the patent is invalid.
`
`AMGEN’S PROPOSAL: Amgen’s knowledge of the Kao Manufacturing Patent
`and Amgen’s intent are irrelevant to your determination of infringement of the Kao
`Manufacturing Patent.
`
`1.
`
`Genentech’s Position
`
`Genentech clarifies that intent is irrelevant to direct infringement.
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`B.
`
`Disputed Proposal 2
`
`AMGEN’S PROPOSAL: Genentech does not accuse Amgen of direct
`infringement of the Dosing Patents, but Genentech does accuse Amgen of induced
`infringement of the Dosing Patents. In order to prove that Amgen induced
`infringement of the Dosing Patents, Genentech must prove an act of direct
`infringement of the Dosing Patents by a third party. To prove direct infringement
`of the Dosing Patents by a third party, Genentech must prove by a preponderance
`of the evidence that a direct infringer has used Kanjinti in performing every step of
`an Asserted Claim of the Dosing Patents.
`
`1.
`
`Genentech’s Position
`
`Amgen confusingly recites only part of Genentech’s inducement claim
`
`(recited in Instruction 5.3). Per below, Amgen erroneously suggests a Dosing
`
`Patent infringer must use Kanjinti exclusively.
`
`2.
`
`Amgen’s Position
`
`In order to prove that Amgen induced infringement of the Dosing Patents,
`
`Genentech must first prove direct infringement. Therefore, the jury must be
`
`instructed on what findings it must make for direct infringement of the Dosing
`
`Patents.
`
`VI. Proposed Instruction 5.3: Induced Infringement
`
`A.
`
`Disputed Proposal 1
`
`GENENTECH’S PROPOSAL: To find that Amgen induced infringement, it is not
`necessary to show that Amgen directly infringed the claims itself.
`
`AMGEN’S PROPOSAL: To find that Amgen induced infringement, it is necessary
`to show that someone directly infringes the claim itself.
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`Genentech’s Position
`1.
`Genentech’s proposal follows Orexo and properly explains that Amgen may
`
`be liable without performing the claimed methods.
`
`Amgen’s Position
`2.
`See Section VI.B.2.
`
`B.
`
`Disputed Proposal 2
`
`GENENTECH’S PROPOSAL: 1. A third party, such as a doctor or others
`working at the direction or under the control of a doctor, directly infringes that
`claim by performing each step of the claim; … In order to show a third party has
`directly infringed, Genentech must only prove that the third party performed all
`steps of the claimed method; it need not prove that all steps were performed with
`Kanjinti.
`
` A third party, such as a doctor or others working
`AMGEN’S PROPOSAL: 1.
`at the direction or under the control of a doctor, directly infringes that claim by
`performing each and every step of the claim using Kanjinti;
`
`1.
`
`Genentech’s Position
`
`Amgen encourages doctors to switch patients from Herceptin to Kanjinti
`
`because each switched patient results in a sale to Amgen. Amgen’s attempt to
`
`insulate itself from liability is legally baseless.
`
`First, Amgen is wrong to argue that all steps of the asserted methods of
`
`administering trastuzumab must be performed with Kanjinti. The law merely
`
`requires that the direct infringer perform all method steps, not that it use a
`
`particular trastuzumab product. Mirror Worlds, LLC v. Apple Inc., 692 F.3d 1351,
`
`1358 (Fed. Cir. 2012).
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`Second, encouragement is all that is necessary to support Amgen’s intent,
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`and infringement can be shown by circumstantial evidence. Causation as Amgen
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`proposes it is inappropriate. See §VI.C.1.
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`Third, Amgen’s suggestion that “[t]he only trastuzumab product whose use
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`Amgen encourages is Kanjinti” does not mean Amgen is liable only when Kanjinti
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`is used exclusively. Doctors who initially prescribe Herceptin and switch to
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`Kanjinti complete the claimed method steps at Amgen’s encouragement, which is
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`sufficient for inducement. DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1304 (Fed.
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`Cir. 2006) (en banc) (inducement requires “that the alleged infringer’s actions
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`induced infringing acts”).
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`2.
`
`Amgen’s Position
`
`To be liable for induced infringement, Amgen must have intended to and
`
`actually have caused a third party to directly infringe, which requires that third
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`party to perform each and every step of a Dosing Patent claim. See Exergen v.
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`Wal-Mart Stores, 575 F.3d 1312, 1320 (Fed. Cir. 2009). The only trastuzumab
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`product whose use Amgen encourages and promotes is Kanjinti. Thus, Amgen
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`must have specifically intended and caused a third party to carry out each and
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`every requirement of a Dosing Patent claim using Kanjinti.
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`C.
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`Disputed Proposal 3
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`AMGEN’S PROPOSAL: Amgen’s alleged inducement, as opposed to other
`factors, actually caused the third party to perform each and every step of an
`Asserted Claim of a Dosing Patent.
`
`1.
`
`Genentech’s Position
`
`Amgen inserts a notion of “causation” that is contrary to Federal Circuit
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`precedent. A jury may find inducement where defendant has promoted
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`infringement and without disproving other factors. “[I]f an entity offers a product
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`with the object of promoting its use to infringe, as shown by clear expression or
`
`other affirmative steps taken to foster infringement, it is then liable for the
`
`resulting acts of infringement by third parties.” DSU, 471 F.3d at 1305-06. The
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`Federal Circuit has “affirmed induced infringement verdicts based on
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`circumstantial evidence of inducement (e.g., advertisements, user manuals)
`
`directed to a class of direct infringers (e.g., customers, end users) without
`
`requiring hard proof that any individual third-party direct infringer was actually
`
`persuaded to infringe by that material.” Power Integrations, Inc. v. Fairchild
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`Semiconductor Int’l, Inc., 843 F.3d 1315, 1335 (Fed. Cir. 2016) (emphasis added).
`
`Genentech need only show that Amgen promoted infringing uses in materials
`
`communicated to customers. See, e.g., id. at 1332–35 (“affirmative acts to induce
`
`third parties to import its products” sufficient to infer defendant “had induced its
`
`customers” to “infringe as a class”); Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d
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`1201, 1220, 1222 (Fed. Cir. 2014) (advertisements); Lucent Techs., Inc. v.
`9
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`Gateway, Inc., 580 F.3d 1301, 1323 (Fed. Cir. 2009) (user documentation);
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`Arthrocare Corp. v. Smith & Nephew, Inc., 406 F.3d 1365, 1377 (Fed. Cir. 2005)
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`(“sales literature” and “manuals”); Mentor H/S, Inc. v. Med. Device Alliance, Inc.,
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`244 F. 3d 1365, 1379 (Fed. Cir. 2001); Moleculon Research Corp. v. CBS, Inc.,
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`793 F.2d 1261, 1272 (Fed. Cir. 1986) (“instruction sheet[s]” and “solution
`
`book[s]”).
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`Genentech’s proposal is consistent with Power Integrations and Amgen’s is
`
`not. Amgen acknowledges that circumstantial evidence may be used to prove
`
`intent. Consistently, Genentech’s instruction instructs the jury to consider Amgen’s
`
`statements and actions. Amgen, in contrast, suggests a heightened causation
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`requirement, that “other factors” must be excluded and “actually cause” a
`
`particular third party to infringe, which is not required. See Power Integrations,
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`843 F.3d at 1334-35 (rejecting requirement of evidence specifically connecting
`
`inducing acts to acts of direct infringement).
`
`GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 313 F.Supp.3d 582, 591
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`(D. Del. 2018) is contrary to precedent and currently on appeal. Dynacore Holding
`
`v. U.S. Philips, 363 F.3d 1263 (Fed. Cir. 2004) does not support Amgen’s
`
`heightened causation standard; it merely found patentee’s infringement allegations
`
`lacking where the accused product had multiple uses and patentee offered no
`
`evidence the product was used for the infringing use. Id. at 1275-78.
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`Amgen’s Position
`2.
`Contrary to Genentech’s arguments, Power Integrations held that causation
`
`is required. The court found that an instruction that “[direct] infringement need not
`
`have been actually caused by the [alleged inducer]’s actions … left the jury with
`
`the incorrect understanding that a party may be liable for induced infringement
`
`even where it does not successfully communicate with and induce a third-party
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`direct infringer.” Power Integrations, 843 F.3d at 1330-1331. “To prevail under a
`
`theory of indirect infringement, [plaintiff] must first prove that the defendants’
`
`actions led to direct infringement.” See id. at 1332 (quoting Dynacore Holding v.
`
`U.S. Philips, 363 F.3d 1263, 1274 (Fed. Cir. 2004)). That “hard proof” of
`
`causation may not be necessary addresses the unremarkable proposition that the
`
`causation requirement can be proven with circumstantial evidence. Power
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`Integrations, 843 F.3d at 1335; see Dynacore, 363 F.3d at 1274 (“[L]iability for
`
`indirect [induced] infringement must relate to the identified instances of direct
`
`infringement.”); GlaxoSmithKline LLC v. Teva Pharm. USA, 313 F.Supp.3d 582,
`
`591 (D. Del. 2018) (proof that defendant’s “alleged inducement, as opposed to
`
`other factors, actually caused the physicians to directly infringe” is “an essential
`
`element”). See also Section VIII.B.
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`D.
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`Disputed Proposal 4
`
`AMGEN’S PROPOSAL: If you find that Amgen was aware of the Dosing
`Patents, but believed that the acts it encouraged did not infringe those patents,
`Amgen cannot be liable for inducement.
`
`1.
`
`Genentech’s Position
`
`Amgen’s statement of law is irrelevant. Amgen has not argued it believed
`
`others would not directly infringe the Dosing Patents. This would be baseless, as
`
`Amgen’s label instructs all claimed steps. If Amgen newly makes such argument,
`
`it will implicate additional privilege waiver, prejudicing Genentech and requiring
`
`substantial discovery.
`
`E.
`
`Disputed Proposal 5
`
`AMGEN’S PROPOSAL: In order to establish active inducement of infringement,
`it is not sufficient that a third party itself directly infringes the claim. It is also not
`sufficient that Amgen knew of acts of direct infringement. Rather, in order to find
`induced infringement, you must find that Amgen specifically intended and caused
`the third party to carry out each and every requirement of an Asserted Claim of the
`Dosing Patents using Kanji