Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 1 of 21
`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 1 of 21
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF MASSACHUSETTS
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`Case No. 1:18-cv-12029-ADB
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`
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`Leave to File Granted on
`Feb. 22, 2022 (ECF No. 272)
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`Leave to File Under Seal Granted on
`Mar. 28, 2022 (ECF No. 285)
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`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBHand
`TEVA PHARMACEUTICALSUSA,INC.,
`
`Plaintiffs,
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`V.
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`ELI LILLY AND COMPANY,
`
`Defendant.
`
`DEFENDANT ELI LILLY AND COMPANY’S MEMORANDUMIN SUPPORT OFITS
`MOTION FOR PARTIAL SUMMARY JUDGMENT OF
`
`NO WILLFUL INFRINGEMENT
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`

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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 2 of 21
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`TABLE OF CONTENTS
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`I.
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`II.
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`INTRODUCTION .............................................................................................................. 1
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`STATEMENT OF FACTS ................................................................................................. 3
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`A.
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`B.
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`C.
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`Lilly’s Lengthy Development of the First and Only Biologic Available for
`Both Treatment of Migraine and Episodic Cluster Headache ................................ 3
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`Allegations Related to Willfulness in Teva’s Complaint ....................................... 5
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`Lilly’s Continuous Good-Faith Belief that No Valid or Enforceable Claim
`of the Patents-in-Suit Was Infringed....................................................................... 6
`
`III.
`
`LEGAL STANDARDS ...................................................................................................... 7
`
`A.
`
`B.
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`Summary Judgment ................................................................................................ 7
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`Willful Infringement ............................................................................................... 8
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`IV.
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`NO REASONABLE JUROR COULD FIND WILLFUL INFRINGEMENT ON THE
`EVIDENCE OF RECORD ................................................................................................. 9
`
`A.
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`B.
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`C.
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`Lilly’s Post-Suit Activities Do Not Create a Genuine Dispute of Material
`Fact on Willfulness ................................................................................................. 9
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`At the Time of Alleged Infringement, Lilly Subjectively Believed that No
`Valid or Enforceable Patent Was Infringed .......................................................... 11
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`The Court Need Not Allow Post-Suit Willfulness to Reach the Jury When
`There Is No Evidence Supporting Enhanced Damages ........................................ 13
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`V.
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`CONCLUSION ................................................................................................................. 15
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`i
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 3 of 21
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`TABLE OF AUTHORITIES
`
`
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`Page(s)
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`Cases
`
`Aoki v. Gilbert,
`No. 211CV02797TLNCKD, 2020 WL 6741693 (E.D. Cal. Nov. 17, 2020) ..........................14
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc)............................................................................2, 12
`
`Bayer Healthcare LLC v. Baxalta, Inc.,
`989 F.3d 964 (Fed. Cir. 2021)........................................................................................9, 10, 11
`
`Biedermann Techs., GmbH & Co. KG v. K2M, Inc.,
`528 F. Supp. 3d 407 (E.D. Va. 2021) .............................................................................. passim
`
`bioMérieux, S.A. v. Hologic, Inc.,
`No. 18-21-LPS, 2020 WL 759546 (D. Del. Feb. 7, 2020)...................................................8, 14
`
`Bioverativ Inc. v. CSL Behring LLC,
`No. 17-914-RGA, 2020 WL 1332921 (D. Del. Mar. 23, 2020) ................................................9
`
`Carmona v. Toledo,
`215 F.3d 124 (1st Cir. 2000) ......................................................................................................7
`
`Celotex Corp. v. Catrett,
`477 U.S. 317 (1986) ...............................................................................................................7, 8
`
`Cochran v. Quest Software, Inc.,
`328 F.3d 1 (1st Cir. 2003) ..........................................................................................................8
`
`CTB, Inc. v. Hog Slat, Inc.,
`954 F.3d 647 (4th Cir. 2020) ...................................................................................................11
`
`Eko Brands, LLC v Adrian Rivera Maynez Enters., Inc.,
`946 F.3d 1367 (Fed. Cir. 2020)..............................................................................................8, 9
`
`Evolved Wireless, LLC v. Apple Inc.,
`No. CV-15-542-JFB-SRF, 2019 WL 8128550 (D. Del. Feb. 19, 2019) ..................................10
`
`Griggs-Ryan v. Smith,
`904 F.2d 112 (1st Cir. 1990) ......................................................................................................8
`
`Halo Elecs., Inc. v. Pulse Elecs., Inc.,
`579 U.S. 93 (2016) ........................................................................................................... passim
`
`ii
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 4 of 21
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`Hannon v. Beard,
`645 F.3d 45 (1st Cir. 2011) ........................................................................................................8
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`Juno Therapeutics, Inc. v. Kite Pharma, Inc.,
`No. 2:17-cv-07639, 2020 WL 2844410 (C.D. Cal. Apr. 2, 2020) .......................................9, 11
`
`Medina-Munoz v. R.J. Reynolds Tobacco Co.,
`896 F.2d 5 (1st Cir. 1990) ..........................................................................................................8
`
`Ocasio-Hernandez v. Fortuño-Burset,
`777 F.3d 1 (1st Cir. 2015) ..........................................................................................................7
`
`Probatter Sports, LLC v. Sports Tutor, Inc.,
`No. 05-cv-1975-VLB, 2022 WL 503982 (D. Conn. Feb. 18, 2022) .......................................14
`
`Regents of the Univ. of Cal. v. Eli Lilly & Co.,
`119 F.3d 1559 (Fed. Cir. 1997)............................................................................................2, 12
`
`Simplivity Corp. v. Springpath, Inc.,
`No. CV 4:15-13345-TSH, 2016 WL 5388951 (D. Mass. July 15, 2016) ................................14
`
`SiOnyx, LLC v. Hamamatsu Photonics K.K.,
`330 F. Supp. 3d 574 (D. Mass. 2018) ..........................................................................10, 13, 14
`
`SRI Int’l, Inc. v. Cisco Sys., Inc.,
`14 F.4th 1323 (Fed. Cir. 2021) ..................................................................................................9
`
`Wrinkl, Inc. v. Facebook, Inc.,
`No. 20-cv-1345-RGA, 2021 WL 4477022 (D. Del. Sept. 30, 2021) ...............................2, 9, 11
`
`Statutes
`
`35 U.S.C. § 112 ..............................................................................................................................12
`
`35 U.S.C. § 284 ..........................................................................................................................8, 13
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`Rules
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`Fed. R. Civ. P. 56(a) ........................................................................................................................7
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`iii
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 5 of 21
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`I.
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`INTRODUCTION
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`Teva’s patent infringement assertions against Lilly’s Emgality® (galcanezumab) antibody
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`therapy for treatment of migraine and episodic cluster headache have evolved over the last four
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`and a half years. After two false start complaints that this Court dismissed for lack of subject matter
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`jurisdiction, and after six of the nine patents initially asserted in Teva’s operative complaint were
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`invalidated by the Patent Trial and Appeal Board (“PTAB”), only three method of treatment
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`patents remain in this case (the “patents-in-suit”). But what has not evolved over the years are
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`Teva’s allegations of willful infringement. Consisting of the same language and form as the day
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`they were filed, Teva’s willfulness claims constitute little more than boilerplate legal conclusions
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`even after fact and expert discovery have closed. The Federal Circuit has clarified twice since this
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`litigation began that a proper willfulness inquiry revolves around the infringer’s subjective beliefs
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`and specific intent to infringe a valid patent. Even as the law of willfulness itself has evolved, Teva
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`has never amended or supplemented its pleadings to keep up with the law and to carry its burden
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`of proof.
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`A review of the facts of record in this case shows that there are no genuine factual disputes
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`for a jury to resolve regarding willfulness. Teva has not alleged “pre-suit” willful infringement.
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`Indeed, the facts demonstrate that
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` before
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`the earliest patent-in-suit here was filed (July 11, 2011), and Lilly began clinical trials before Teva.
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`Teva’s patents had no impact whatsoever on Lilly’s independent research and development of an
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`anti-CGRP antibody for preventive treatment of migraine and episodic cluster headache. At most,
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`the existence of the single full-length humanized antibody disclosed in the patents-in-suit
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`(“Antibody G1”) served to confirm how significantly different Lilly’s antibody was from
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`Antibody G1. As for “post-suit” willfulness, which many courts have concluded does not exist as
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`a legal doctrine (see infra §IV.A), Lilly is merely selling an accused product, Emgality®,
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 6 of 21
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`Moreover, one of Lilly’s central legal defenses against the three remaining patents-in-suit—that
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`they violate the written description requirement to functionally claim use of a vast array of
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`molecules with unknown structure that did not exist and could not be described at the time the
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`patent application was filed, and only later were found to possess a desired therapeutic utility—is
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`one that Lilly has consistently pursued in litigation. See, e.g., Regents of the Univ. of Cal. v. Eli
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`Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997); Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336
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`(Fed. Cir. 2010) (en banc). It is beyond genuine dispute that at all times relevant to the willfulness
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`inquiry in this case, Lilly subjectively believed that Teva’s claims were invalid.
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`As one district court has recently framed the issue, “[w]illfulness is based on a defendant’s
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`bad state of mind,” and that state of mind is “worse than the bad state of mind required to prove
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`indirect infringement.” Wrinkl, Inc. v. Facebook, Inc., No. 20-cv-1345-RGA, 2021 WL 4477022,
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`at *7 (D. Del. Sept. 30, 2021). Yet Teva has developed no evidence relevant to a purportedly “bad”
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`state of mind at the time of first infringement. Teva has done nothing more than allege that Lilly
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`indirectly infringed the patents-in-suit, with knowledge of those patents. But as a litany of district
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`courts have held since the Supreme Court’s decision in Halo Electronics, Inc. v. Pulse Electronics,
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`Inc., 579 U.S. 93 (2016), evidence of knowledge and evidence of infringement, even in
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`combination, do not support a claim of willful infringement as a matter of law. Preliminary
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`conclusory assertions like Teva’s can reach a jury if they are developed further in the course of
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`discovery, but Teva has done nothing of the sort here. On this sparse a record, willfulness can be
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`addressed—and disposed of—at the summary judgment stage.
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`2
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 7 of 21
`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 7 of 21
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`II.
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`STATEMENT OF FACTS
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`A.
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`Lilly’s Lengthy Developmentof the First and Only Biologic Available
`for Both Treatment of Migraine and Episodic Cluster Headache
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`p SOF 19-20, 33-37, 58-59.! Instead, Lilly independently began its development program that
`led to Emgality®f|long before Teva’s patent applications published, its patents-in-suit
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`issued, or its Ajovy® product existed. SOF 21-27, 52-57.
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`nonclinical and clinical testing of galeanezumab. SOF 48-51. In contrast, the named inventors of
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`From there, Lilly went on to conduct extensive
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`the patents-in-suit
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`SOF 42-47.
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`1 “SOF...” refers to numbered statements of fact found in the Statement of Material Facts in
`Support of Defendant Eli Lilly and Company’s Motion for Partial Summary Judgment of No
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`Willful Infringement, filed concurrently with this memorandum.
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`3
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 8 of 21
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`Lilly’s Emgality® (galcanezumab) was the first anti-CGRP antagonist antibody proven in
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`the clinic to treat migraine. SOF 48-51, 60-64. The period for the pivotal Phase II clinical study
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`assessing the efficacy and safety of Emgality® in the prevention of migraine ended before Teva
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`even started its Phase II clinical study of Ajovy® for migraine and before the patents-in-suit had
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`issued. SOF 49-57. Indeed, it was Lilly’s Phase II clinical study that satisfied Teva’s concerns as
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`to whether Antibody G1 (fremanezumab or Ajovy®) would work to treat migraine before Teva
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`purchased it. SOF 60-63.
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`In total, Lilly’s clinical program assessed the safety of Emgality® in migraine across ten
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`clinical studies, including four clinical pharmacology studies in healthy subjects; two Phase II
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`studies; and four Phase III studies. SOF 48-49, 64. In other words, the public benefitted from
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`Lilly’s galcanezumab clinical program, even before the patents-in-suit ever issued. Lilly’s
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`Emgality® was ultimately approved by the FDA for the preventive treatment of migraine
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`approximately
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` after development started and within weeks of the approval of Teva’s
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`Ajovy®, with a recommended monthly dose that is much lower—approximately half that for
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`Ajovy®. SOF 21-27, 65-67.
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`Further,
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` SOF 73-75. The FDA grants
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`breakthrough therapy designation to expedite the development and review of drugs for serious or
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`life-threatening conditions that have preliminary clinical evidence demonstrating substantial
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`improvement over existing therapies on one or more clinically significant endpoints. SOF 74-75.
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`B.
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`Allegations Related to Willfulness in Teva’s Complaint
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`Teva filed its Complaint (ECF No. 1) in the above-captioned action on September 27, 2018,
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`the same day as Lilly received FDA approval for Emgality® for the preventive treatment of
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`migraine, asserting infringement of nine patents: U.S. Patent Nos. 8,586,045; 8,597,649;
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`9,266,951; 9,340,614; 9,346,881; 9,884,907; 9,884,908; 9,890,210; and 9,890,211.3 SOF 2, 65.
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`After the remaining patents were held invalid, the parties subsequently filed a stipulation
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`narrowing the asserted patents to the ’045, ’907, and ’908 patents. SOF 1, 10-18. Teva alleged that
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`Lilly induced or contributed to the infringement of each patent and additionally sought a
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`declaratory judgment of infringement of each patent. (ECF No. 1 at 19-38.) Relevant here, Teva’s
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`allegations of willful infringement, which are wholly directed to post-suit conduct, are as follows
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`(SOF 89-91):
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`3 Teva’s two prior suits brought against Lilly in this district were dismissed on grounds that since
`Emgality® had not launched or even been approved by the FDA, “no controversy of sufficient
`immediacy and reality existed at the time that Plaintiffs filed their complaints to support
`declaratory judgment jurisdiction in the present cases.” (E.g., Case No. 1:17-cv-12087 (“First
`Action”), ECF No. 24, ECF No. 42 at 20; Case No. 1:18-cv-10242 (“Second Action”), ECF No.
`14, ECF No. 23 at 20.)
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 10 of 21
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` Eli Lilly is aware of the Patents-in-Suit, but nonetheless is, upon information and belief, in
`the process of launching its own competing biologic product with the active ingredient
`galcanezumab, which will undermine the value of Teva’s substantial investment in the
`Patents-in-Suit. This product is also known as LY2951742 (the “Galcanezumab Product”).
`Like Teva’s patented fremanezumab product, Eli Lilly’s infringing Galcanezumab Product
`is an antibody that targets CGRP. On October 24, 2017, Eli Lilly publicly stated that it had
`submitted its own BLA for the Galcanezumab Product. Ex. 1 at 3. Through its public
`statements and commercial activity, Eli Lilly made clear that it intended to enter the market
`with its Galcanezumab Product as soon as it received FDA approval. (ECF No. 1 at ¶ 5.)
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` On September 27, 2018, Eli Lilly obtained FDA approval to market its Galcanezumab
`Product in the United States under the brand name Emgality™. See Ex. 29. The Eli Lilly
`press release describing the approval states that “Emgality will be available to patients
`shortly after approval.” Id. This demonstrates that the commercial launch of Emgality™ is
`imminent, and upon information and belief, Lilly is offering for sale, selling,
`manufacturing and/or importing, Emgality™ into the United States. (Id. at ¶ 6.)
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` Upon information and belief, Defendant will knowingly and willfully infringe the [patents-
`in-suit]. (Id. (Count I, Count VI, Count VII) at ¶¶ 104, 148, 158; see also id. (Count X,
`Count XV, Count XVI) at ¶¶ 182, 212, 218 (declaratory judgment counts stating the
`same).)
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`Teva seeks enhanced damages based on these willful infringement claims. (Id. at 38,
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`Prayer for Relief.) Teva has never amended its Complaint to allege facts plausibly supporting these
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`naked allegations, nor has it filed a motion for a preliminary injunction. SOF 92-93, 101-103.
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`C.
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`Lilly’s Continuous Good-Faith Belief that No Valid or Enforceable
`Claim of the Patents-in-Suit Was Infringed
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`Lilly did not hesitate in signaling that it believed the patents-in-suit were invalid and
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`unenforceable. Within three days after Teva filed its Complaint, Lilly had filed inter partes review
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`(IPR) petitions challenging the validity of each of the three patents-in-suit with the PTAB. SOF 3,
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`95, 97, 99. The PTAB instituted all three IPRs on April 3, 2019, stating in each case that Lilly had
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`“established a reasonable likelihood of prevailing on its contentions.” (ECF No. 39 at 1.) The
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`PTAB additionally instituted Lilly’s IPR petitions against the other six patents (SOF 4) that had
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`been initially asserted in Teva’s Complaint. (ECF Nos. 35, 37.) Ultimately, on March 31, 2020,
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`the PTAB issued final written decisions in all nine IPRs, finding that the challenged claims in six
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 11 of 21
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`of the nine IPRs (corresponding to compound and composition claims) were invalid as obvious,
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`and finding that the challenged claims in the remaining three IPRs (IPR2018-1710, -1711, and -
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`1712, corresponding to the method claims of the patents-in-suit) were not invalid as obvious. SOF
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`5, 8. Both parties appealed to the Federal Circuit, which affirmed the PTAB’s rulings on August
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`16, 2021. SOF 6, 7, 9.
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`Lilly also answered the Complaint and lodged counterclaims of non-infringement,
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`invalidity, unenforceability, and affirmative defenses against Teva on November 2, 2018. (ECF
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`No. 17.) Lilly has maintained and bolstered these counterclaims and affirmative defenses through
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`fact and expert discovery, which are now closed. (ECF Nos. 245, 248.) Earlier this year, Lilly
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`amended its pleadings to add new counterclaims and affirmative defenses that the patents-in-suit
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`are unenforceable for inequitable conduct and to supplement the bases for its unclean hands
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`defense. (ECF No. 277.) With this amendment, Lilly maintained all previous counterclaims and
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`defenses as to the patents-in-suit.
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`III.
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`LEGAL STANDARDS
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`A.
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`Summary Judgment
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`Summary judgment is appropriate when there is no genuine dispute as to any material fact
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`and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). The moving
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`party bears the initial burden of demonstrating the absence of a genuine issue of material fact.
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`Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). To show there is no dispute of material fact,
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`the movant must “affirmatively produce evidence that negates an essential element of the non-
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`moving party’s claim,” or “demonstrate that the non-moving party will be unable to carry its
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`burden of persuasion at trial” using evidence of record. Ocasio-Hernández v. Fortuño-Burset, 777
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`F.3d 1, 4-5 (1st Cir. 2015) (quoting Carmona v. Toledo, 215 F.3d 124, 132 (1st Cir. 2000)). Upon
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 12 of 21
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`such a showing, the burden shifts to the nonmoving party to set forth facts demonstrating that a
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`genuine issue of disputed fact remains. Celotex, 477 U.S. at 323-24.
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`When reviewing a motion for summary judgment, the court must take all properly
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`supported evidence in the light most favorable to the nonmovant and draw all reasonable
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`inferences in the nonmovant’s favor. Griggs-Ryan v. Smith, 904 F.2d 112, 115 (1st Cir. 1990).
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`This posture “is favorable to the nonmoving party, but it does not give him a free pass to trial.”
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`Hannon v. Beard, 645 F.3d 45, 48 (1st Cir. 2011). Courts may discount “conclusory allegations,
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`improbable inferences, and unsupported speculation” in their analysis of whether a genuine dispute
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`of material fact exists. Cochran v. Quest Software, Inc., 328 F.3d 1, 6 (1st Cir. 2003) (quoting
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`Medina-Munoz v. R.J. Reynolds Tobacco Co., 896 F.2d 5, 8 (1st Cir. 1990)).
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`B.
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`Willful Infringement
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`A district court may enhance damages for patent infringement up to three times the amount
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`found or assessed. 35 U.S.C. § 284. The Federal Circuit has recently split the enhanced damages
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`inquiry into two stages: first, determination of willful infringement, which is a question of fact for
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`juries; and second, evaluation of the enhancement of damages by district courts. Eko Brands, LLC
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`v. Adrian Rivera Maynez Enters., Inc., 946 F.3d 1367, 1378-79 (Fed. Cir. 2020). Both prongs of
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`such inquiry, however, “are appropriately taken up on summary judgment” as to allegations
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`“limited to post-suit willful infringement.” Biedermann Techs. GmbH & Co. KG v. K2M, Inc., 528
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`F. Supp. 3d 407, 431 (E.D. Va. 2021). Otherwise, “a great percentage of patent cases would permit
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`the pursuit of enhanced damages at trial absent a shred of evidence of egregious behavior.” Id.
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`To support a finding of willful infringement, “a patentee must prove, by a preponderance
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`of the evidence, that an accused infringer took actions, with knowledge of the patent, and with the
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`intent of infringing the patent.” bioMérieux, S.A. v. Hologic, Inc., No. 18-21-LPS, 2020 WL
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`759546, at *11 (D. Del. Feb. 7, 2020) (citing Halo, 579 U.S. at 104-10). “Knowledge of the
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 13 of 21
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`asserted patent and evidence of infringement is necessary, but not sufficient, for a finding of
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`willfulness.” Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964, 988 (Fed. Cir. 2021). Instead,
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`a determination of willfulness also requires a finding of “deliberate or intentional”
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`infringement. See SRI Int’l, Inc. v. Cisco Sys., Inc., 14 F.4th 1323, 1330 (Fed. Cir. 2021) (quoting
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`Eko, 946 F.3d at 1378). Willfulness requires “specific intent to infringe at the time of the
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`challenged conduct,” Bayer, 989 F.3d at 987 (citing Halo, 579 U.S. at 105-06), meaning the
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`accused infringer’s beliefs should properly be assessed “at the time of first infringement.” Juno
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`Therapeutics, Inc. v. Kite Pharma, Inc., No. 2:17-cv-07639, 2020 WL 2844410, at *9 (C.D. Cal.
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`Apr. 2, 2020).
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`With respect to enhanced damages, “[a]s the Supreme Court stated in Halo, ‘[t]he sort of
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`conduct warranting enhanced damages has been variously described in our cases as willful,
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`wanton, malicious, bad-faith, deliberate, consciously wrongful, flagrant or—indeed—
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`characteristic of a pirate.’” Bayer, 989 F.3d at 987 (quoting Halo, 579 U.S. at 103-04).
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`IV.
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`NO REASONABLE JUROR COULD FIND WILLFUL INFRINGEMENT
`ON THE EVIDENCE OF RECORD
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`A.
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`Lilly’s Post-Suit Activities Do Not Create a Genuine Dispute of
`Material Fact on Willfulness
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`Teva’s allegations of willful infringement are based on Lilly’s conduct after the filing of
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`this lawsuit: “Upon information and belief, Defendant will knowingly and willfully infringe the
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`[patents-in-suit].” SOF 89-91. A finding of willful infringement based solely on post-suit conduct
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`is rare and disfavored. See, e.g., Wrinkl, 2021 WL 4477022, at *7 (holding that “[w]illful patent
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`infringement is the rare exception, not the rule” (citing Bayer, 989 F.3d at 987-88)); Bioverativ
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`Inc. v. CSL Behring LLC, No. 17-914-RGA, 2020 WL 1332921, at *4 (D. Del. Mar. 23, 2020)
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`(explaining that without clear evidence of copying, “[i]t makes it difficult for both sides to argue
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`the willfulness issue at trial when willfulness is based on post-filing conduct”).
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 14 of 21
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`Teva cannot carry its burden under the governing case law to prove that Lilly willfully
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`infringed the patents-in-suit based on its post-suit conduct. Whether infringement is willful must
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`be “inferred from all the circumstances by the factfinder.” SiOnyx, LLC v. Hamamatsu Photonics
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`K.K., 330 F. Supp. 3d 574, 608 (D. Mass. 2018). But like any fact-based issue, the Court is
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`empowered to resolve willfulness at the summary judgment stage when no facts are in dispute to
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`support the claim. See Biedermann, 528 F. Supp. 3d at 425 (finding partial summary judgment of
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`no willful infringement “when an alleged infringer demonstrates an absence of evidence on which
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`a reasonable jury could make a finding of willfulness”). The possible inferences the Court can
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`draw on the facts of record, even making those inferences in Teva’s favor, are insufficient as a
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`matter of law.
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`There is no dispute that Lilly was aware of the patents-in-suit prior to the filing of Teva’s
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`operative Complaint.4 But post-Halo, courts have consistently held that mere awareness is not
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`enough to sustain a claim of willfulness as a matter of law. Instead, willfulness requires “specific
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`intent to infringe at the time of the challenged conduct.” Bayer, 989 F.3d at 987 (citing Halo, 579
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`U.S. at 105-06). There is both a timing element and a specific intent element to willfulness. See
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`Evolved Wireless, LLC v. Apple Inc., No. 15-542-JFB-SRF, 2019 WL 8128550, at *3 (D. Del. Feb.
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`19, 2019) (“The question of willful infringement turns on whether, at the time of the infringement,
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`the infringer knew or, it was so obvious that the infringer should have known, that its actions
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`constituted infringement of a valid and enforceable patent.” (emphases added)). Teva cannot
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`4 Lilly agreed to stipulate in September 2021 that “Lilly possessed knowledge of U.S. Patent Nos.
`8,586,045 as of October 24, 2017” (the date Teva filed its First Action) and that “Lilly possessed
`knowledge of U.S. Patent Nos. 9,884,907 and 9,884,908 as of February 6, 2018” (the date Teva
`filed its Second Action), but Teva inexplicably never filed the stipulation with the Court. SOF 104-
`106.
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 15 of 21
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`prove specific intent by Lilly to infringe any valid or enforceable patent-in-suit at the time of first
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` Lilly’s generalized awareness of Teva’s patents-in-suit is insufficient to prove
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`willfulness. If that were the law, “every patent case between two companies in the same industry
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`would, by default, require that a jury decide willfulness based on factually unsupported supposition
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`about what the other ‘must have known.’” Biedermann, 528 F. Supp. 3d at 427 (citing CTB, Inc.
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`v. Hog Slat, Inc., 954 F.3d 647, 658 (4th Cir. 2020)). As one court has stated, “if all that is required
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`is the filing of a complaint and a plausible allegation of infringement, then every case would be a
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`willful infringement case.” Wrinkl, 2021 WL 4477022, at *8.
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`Even if, arguendo, the jury ultimately determines that Lilly induced infringement of the
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`patents-in-suit, the Federal Circuit has specifically found that those facts are insufficient for a
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`patentee to prove willful infringement as a matter of law. See Bayer, 989 F.3d at 988 (granting
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`judgment of no willful infringement as a matter of law when evidence showed only awareness of
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`patent-in-suit and direct infringement of that patent); see also Wrinkl, 2021 WL 4477022, at *7
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`(explaining that “[w]illfulness is based on a defendant’s bad state of mind,” and that state of mind
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`must be “worse than the bad state of mind required to prove indirect infringement”).
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`B.
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`At the Time of Alleged Infringement, Lilly Subjectively Believed that
`No Valid or Enforceable Patent Was Infringed
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`The proper willfulness inquiry is centered around
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` when Lilly’s Emgality®
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`was launched in the United States. SOF 94. See Juno, 2020 WL 2844410, at *9 (“the relevant
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`inquiry for determining whether infringement was willful” is “[d]efendant’s good-faith belief at
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`the time of first infringement”). Here, Lilly and its principals never subjectively believed that the
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 16 of 21
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`Teva patents-in-suit were infringed, valid, and/or enforceable as evidenced by (1) Lilly’s drafting
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`of IPR petitions prior to October 2018 against each of the patents-in-suit, which were filed on or
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`before October 1, 2018, and within 1-3 days of Teva’s Complaint;5 (2) Lilly’s consistent assertions
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`in prior litigations that broad claims like Teva’s encompassing use of vast arrays of molecules that
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`are yet to exist or be described and that may later be shown to have a desired therapeutic property
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`violate at least the written description requirement of 35 U.S.C. § 112, (see generally Ariad and
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`Regents of the Univ. of Cal.; see supra, §I); (3) the above-described great structural and functional
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`differences between the Lilly antibody and Teva’s sequence-specific claims foreclosing any
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`reasonable assertion of their infringement; and (4) Lilly’s filing of counterclaims and affirmative
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`defenses that the patents-in-suit are not infringed, invalid, and unenforceable in this case within a
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`month of Teva’s Complaint.6 (ECF No. 17.)
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`Teva has presented no evidence of a subjective belief by Lilly that it was infringing a valid
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`or enforceable patent through the sales of Emgality®. To the contrary, Lilly immediately filed
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`IPRs against all the asserted patents, and has pleaded nine affirmative defenses and nine
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`counterclaims seeking judgment that the patents-in-suit are not infringed, are invalid, and/or are
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`unenforceable. (See ECF No. 277 at 68-134.) Lilly’s IPR petitions were not merely litigation
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`defenses; there can be no reasonable dispute that these complex petitions totaling hundreds of
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`5 All three IPRs were instituted in 2019, and were not finally resolved until August 2021.
`6 To the extent Teva provides argument regarding Lilly’s subjective beliefs after resolution of the
`IPRs, Lilly maintained its allegations that the patents-in-suit were invalid inter alia for lack of
`written description and enablement—and is moving for summary judgment of invalidity on both
`grounds. As discussed in §II.C, supra, following the close of fact discovery, Lilly also sought leave
`to amend its answer with new counterclaims and affirmative defenses that the patents-in-suit are
`unenforceable for inequitable conduct and to supplement the bases for its unclean hands defense.
`(ECF Nos. 263, 277.) This Court found “that the allegations in the proposed amended answer,
`when construed in Lilly’s favor, support the reasonable inference that [two of the named inventors]
`acted with specific intent and knew the materiality of the withheld information.” (ECF No. 251 at
`25.)
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`Case 1:18-cv-12029-ADB Document 306 Filed 03/28/22 Page 17 of 21
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`pages were in preparation for months prior to their filing with the PTAB. Indeed, the declaration
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`of Dr. Alain Vasserot that accompanied Lilly’s IPR petition for the ’045 patent-in-suit alleging
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`invalidity of both independent claims and various dependent claims was dated September 9, 2018,
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`nearly three weeks before Teva’s Complaint was filed and before Lilly had a product on the market
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`in the United States. SOF 96. Dr. Vasserot signed his declarations accompanying Lilly’s IPR
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`petitions for the ’907 and ’908 patents-in-suit on the same day that Teva’s Complaint was filed.
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`SO