`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`
`
`Civil Action No.
`1:18-cv-12029-ADB
`
`
`
`
`
`
`
`FILED UNDER SEAL
`LEAVE TO FILE GRANTED
`05/06/2022 (ECF NO. 340)
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
`
`Plaintiffs,
`
`
`v.
`
`ELI LILLY AND COMPANY,
`Defendant.
`
`
`
`
`
`
`PLAINTIFFS’ CORRECTED OPPOSITION TO DEFENDANT’S MOTION FOR
`PARTIAL SUMMARY JUDGMENT OF NO WILLFUL INFRINGEMENT
`
`
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 2 of 23
`
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION .............................................................................................................. 1
`STATEMENT OF FACTS ................................................................................................. 2
`A. Lilly’s knowledge of Teva’s patents and infringement allegations before Lilly
`launched Emgality®. ........................................................................................................... 2
`B. Lilly’s commercial launch of Emgality® ...................................................................... 3
`C.
` ................................ 4
`LEGAL STANDARDS ...................................................................................................... 4
`ARGUMENT ...................................................................................................................... 5
`A. Substantial evidence demonstrates that Lilly willfully infringed Teva’s patents. ........ 5
`B. Lilly failed to meet its burden to show that it is entitled to judgement as a matter of
`law that it did not willfully infringe the Asserted Patents. ................................................. 8
`1.
`There is no heightened burden to prove willfulness in this case. ............... 9
`2.
`Genuine disputes of material fact permeate Lilly’s subjective beliefs. .... 10
`a. Lilly lacks admissible evidence it can present to the jury concerning
`
` ..................... 10
`b. Lilly cannot establish it is entitled to summary judgment because the
`inferences it asks the Court to draw are not the most favorable to Teva. . 13
`C. The Court should not determine enhanced damages now. ......................................... 15
`CONCLUSION ................................................................................................................. 15
`
`
`
`I.
`II.
`
`III.
`IV.
`
`V.
`
`
`
`i
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 3 of 23
`
`TABLE OF AUTHORITIES
`
`
`
`
`
`Page(s)
`
`Cases
`
`Arctic Cat Inc. v. Bombardier Recreational Prod. Inc.,
`876 F.3d 1350 (Fed. Cir. 2017)........................................................................................5, 8, 14
`
`Asia Vital Components Co. v. Asetek Danmark A/S,
`377 F. Supp. 3d 990 (N.D. Cal. 2019) .....................................................................................13
`
`In re Bartel,
`2008 WL 5396482 (Bankr. D. Mass. Dec. 23, 2008) ................................................................4
`
`Biedermann Techs. GmbH & Co. KG v. K2M, Inc.,
`528 F. Supp. 3d 407 (E.D. Va. 2021) ........................................................................................9
`
`Bio-Rad Lab’ys, Inc. v. 10X Genomics, Inc.,
`2020 WL 2079422 (D. Mass. Apr. 30, 2020) ......................................................................5, 15
`
`Bioverativ Inc. v. CSL Behring LLC,
`2020 WL 1332921 (D. Del. Mar. 23, 2020) ..............................................................................9
`
`Eko Brands, LLC v. Adrian Rivera Maynez Enters., Inc.,
`946 F.3d 1367 (Fed. Cir. 2020)........................................................................................5, 8, 13
`
`Ferguson Beauregard/Logic Controls, Div. of Dover Res., Inc. v. Mega Sys., LLC,
`350 F.3d 1327 (Fed. Cir. 2003)..................................................................................................5
`
`Fred Hutnak Dev. Corp. v. Plan. Bd. of Uxbridge,
`69 Mass. App. Ct. 1104 (2007) ..................................................................................................4
`
`Halo Elecs., Inc. v. Pulse Electronics, Inc.,
`579 U.S. 93 (2016) .................................................................................................................5, 9
`
`i4i Ltd. P’ship v. Microsoft Corp.,
`598 F.3d 831 (Fed. Cir. 2010)....................................................................................................8
`
`Kolcraft Enters., Inc. v. Chicco USA, Inc.,
`2018 WL 3329706 (N.D. Ill. July 6, 2018) ..........................................................................7, 13
`
`Mentor Graphics Corp. v. EVE-USA, Inc.,
`851 F.3d 1275 (Fed. Cir. 2017)..................................................................................................9
`
`Miller v. Young Men’s Christian Ass’n of Cent. Mass.,
`2016 WL 5886543 (Mass. Super. Aug. 29, 2016) .....................................................................4
`
`ii
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 4 of 23
`
`
`
`Mondis Tech. Ltd v. LG Elecs., Inc.,
`407 F. Supp. 3d 482 (D.N.J. 2019) ......................................................................................5, 15
`
`Packet Intel. LLC v. NetScout Sys., Inc.,
`2019 WL 2375218 (E.D. Tex. June 5, 2019), aff’d in relevant part, 965 F.3d
`1299 (Fed. Cir. 2020) ...............................................................................................................10
`
`Packet Intel. LLC v. NetScout Sys., Inc.,
`965 F.3d 1299 (Fed. Cir. 2020)..................................................................................................7
`
`RTC Indus., Inc. v. Fasteners for Retail, Inc.,
`2020 WL 1148813 (N.D. Ill. Mar. 9, 2020) .............................................................................12
`
`Scalli v. Citizens Fin. Grp., Inc.,
`2006 WL 1581625 (D. Mass. Feb. 28, 2006) ..........................................................................11
`
`Simplivity Corp. v. Springpath, Inc.,
`2016 WL 5388951 (D. Mass. July 15, 2016) .............................................................................9
`
`SiOnyx, LLC v. Hamamatsu Photonics K.K.,
`330 F. Supp. 3d 574 (D. Mass. 2018) ........................................................................................5
`
`Spectralytics, Inc. v. Cordis Corp.,
`2009 WL 3851314 (D. Minn. Jan. 13, 2009) ...........................................................................12
`
`Sunoco Partners Mktg. & Terminals L.P. v. U.S. Venture, Inc.,
`No. 2020-1640, 2022 WL 1275697 (Fed. Cir. Apr. 29, 2022) ................................................15
`
`Ultratec Inc. v. Sorenson Commc’ns Inc.,
`2014 WL 4976596 (W.D. Wis. Oct. 3, 2014) ..........................................................................11
`
`In re Varrasso,
`37 F.3d 760 (1st Cir. 1994) ........................................................................................................4
`
`Wrinkl, Inc. v. Facebook, Inc.,
`2021 WL 4477022 (D. Del. Sept. 30, 2021) ..............................................................................9
`
`YKK Corp. v. Velcro USA Inc.,
`2017 WL 11637524 (M.D. Ga. Nov. 16, 2017) .......................................................................12
`
`Other Authorities
`
`Fed. R. Civ. P. 56(a) ........................................................................................................................4
`
`Fed. R. Evid. 801(c)(1) ..................................................................................................................11
`
`Fed. R. Evid. 804(a)(1)(5)..............................................................................................................11
`
`L.R. 16.6(f) ....................................................................................................................................12
`
`iii
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 5 of 23
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 5 of 23
`
`
`
`L.R. 56.1 ........................................................................................................................................11
`LAR. S61 eee ceecesccseesceseeeseessecsseceeeeacesecesecssecseececcacesseesesssecssecsaseaeeseeeeeasaesseecsascaeeceeeseaeeeseessaeeaeeenes 11
`
`
`
`iv
`Iv
`
`
`
`
`
`
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 6 of 23
`
`TABLE OF ABBREVIATIONS
`
`
`
`Description
`Abbreviation
`’045 patent
`U.S. Patent No. 8,586,045 (Ex. E)
`Bold and italicized Emphasis added unless indicated otherwise
`CGRP
`calcitonin gene-related peptide
`IPR
`inter partes review
`Lilly
`Eli Lilly and Company
`Asserted Patents
`U.S. Patent No. 8,586,045 (Ex. E), U.S. Patent No. 9,884,907 (Ex. AL),
`and U.S. Patent No. 9,884,908 (Ex. AO)
`Person of ordinary skill in the art
`L.R. 56.1 Statement of Material Facts in Support of Defendant Eli Lilly
`and Company’s Motion for Partial Summary Judgment of No Willful
`Infringement (ECF No. 307)
`Teva Pharmaceuticals International GmbH and Teva Pharmaceuticals
`USA, Inc.
`WO 2007/054809
`European Patent No. 1957106 B1
`
`POSA
`SOF
`
`Teva
`
`’809 patent
`’106 patent
`
`v
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 7 of 23
`
`
`
`I.
`
`INTRODUCTION
`
`Lilly’s motion for summary judgment of no willful infringement fails to identify
`
`undisputed material facts sufficient to establish that it did not willfully infringe the Asserted
`
`Patents as a matter of law. Lilly asks the Court to draw inferences in Lilly’s favor based on
`
`evidence that is irrelevant, circumstantial, or inadmissible to find that Lilly could not have
`
`deliberately or intentionally infringed Teva’s patents. Even if reasonable, the Court should not
`
`draw inferences in Lilly’s favor at summary judgment. When weighed in Teva’s favor, the
`
`evidence reveals numerous genuine disputes of material fact regarding Lilly’s willful infringement
`
`of the Asserted Patents. Lilly’s motion should therefore be denied.
`
`Lilly
`
` sold the accused product, Emgality®, with
`
`actual knowledge of Teva’s allegation that Lilly’s marketing and sale of Emgality® would infringe
`
`the Asserted Patents. Indeed, Teva sought to prevent the launch of Emgality® in two previous
`
`lawsuits. Lilly cannot dispute this, so it instead argues that
`
`
`
`
`
`
`
`
`
` Now, Lilly points to circumstantial, irrelevant, or inadmissible evidence to argue that any
`
`reasonable jury must accept Lilly’s alleged subjective beliefs at face value.
`
`
`
`
`
`
`
`
`
` Moreover,
`
`a jury could—and in fact should—draw the opposite inference from the totality of the evidence,
`
`namely, that Lilly’s shifting and aggressive litigation strategies do not reflect a
`
`
`
`. This inference is particularly reasonable in light of
`
`1
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 8 of 23
`
`
`
`
`
`
`
`
`
`.
`
`Finally, Lilly argues that the Court must decide whether the evidence supports enhanced
`
`damages before allowing the jury to consider willfulness. But enhanced damages is a question for
`
`another day and not relevant to the issue of willfulness. Lilly’s Motion should be denied.
`
`II.
`
`STATEMENT OF FACTS
`
`A. Lilly’s knowledge of Teva’s patents and infringement allegations before Lilly
`launched Emgality®.
`
`Lilly knew about Teva’s patents years before it launched the accused product, Emgality®.
`
`Teva’s predecessor filed the application that led to the Asserted Patents in 2005. See U.S.
`
`Provisional Patent Application 60/736,623 (Filed Nov. 14, 2005). The Asserted Patents claim
`
`methods of treating migraine using anti-CGRP antagonist antibodies. SOF ¶ 21.
`
`
`
`
`
`
`
`
`
` Starting in 2011, Lilly filed patent applications claiming
`
`methods of using anti-CGRP antagonist antibodies for the treatment of migraine. RMF ¶ P5. In
`
`one such application, Lilly referenced a Teva 2006 patent that is in the same family and shares the
`
`same specification as the Asserted Patents and Lilly described its invention as a treatment
`
`“alternative” to the invention disclosed in Teva’s patent. RMF ¶¶ P2–3, P5 (citing ’809 patent).
`
`In 2017 and early 2018, Teva sued Lilly for infringement of the Asserted Patents, seeking
`
`injunctive relief to prevent Lilly’s launch of Emgality®. RMF ¶ P6. Teva asserted that once Lilly
`
`obtained FDA approval and launched Emgality®, it would infringe the Asserted Patents. RMF
`
`2
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 9 of 23
`
`
`
`¶¶ P6–7. Both suits were dismissed after Lilly convinced this Court that FDA approval, which
`
`was a prerequisite for Emgality®’s launch, “[was] too uncertain” to award declaratory relief.
`
`Ex. BF at 15. Teva’s first lawsuits were dismissed on September 27, 2018—the same day Lilly
`
`received FDA approval to sell Emgality® and the same day that Teva filed this lawsuit. RMF ¶ P8.
`
`Lilly began selling Emgality® a few weeks later. RMF ¶ P13.
`
`Teva and Lilly also litigated Teva’s European patents beginning in 2014. RMF ¶ P9.
`
`
`
`
`
`
`
`B. Lilly’s commercial launch of Emgality®
`Lilly has continuously made and sold Emgality® from its launch in
`
`RMF ¶ P13.
`
`
`
`
`
`
`
`3
`
`
`
`
`
`
`
`
`
`
`
` to present.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 10 of 23
`
`C.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`III. LEGAL STANDARDS
`
`Summary judgment may be granted only if, after drawing all reasonable inferences in favor
`
`of the non-moving party, “there is no genuine dispute as to any material fact and the movant is
`
`entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). A defendant moving for summary
`
`judgment “may satisfy its [] burden by either presenting ‘affirmative evidence negating an essential
`
`element’ of the [plaintiff]’s case or ‘by demonstrating that proof of that element is unlikely to be
`
`forthcoming at trial.’” Miller v. Young Men’s Christian Ass’n of Cent. Mass., 2016 WL 5886543,
`
`at *2 (Mass. Super. Aug. 29, 2016) (citation omitted). “Bare assertions of belief are inadequate
`
`information for summary judgment purposes.” Fred Hutnak Dev. Corp. v. Plan. Bd. of Uxbridge,
`
`69 Mass. App. Ct. 1104, at *3 (2007). When a party tries to establish scienter at summary
`
`judgment by inference “‘all reasonable inferences from the facts must be drawn in the manner
`
`most favorable to the nonmovant.’” In re Bartel, 2008 WL 5396482, at *2 (Bankr. D. Mass. Dec.
`
`4
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 11 of 23
`
`
`
`23, 2008) (quoting In re Varrasso, 37 F.3d 760, 763 (1st Cir. 1994)). “Summary judgment is
`
`inappropriate if inferences are necessary for the judgment and those inferences are not mandated
`
`by the record.” Varrasso, 37 F.3d at 763.
`
`Whether an alleged infringer’s conduct demonstrates that it willfully, “deliberate[ly,] or
`
`intentional[ly]” infringed is a question of fact for the jury to determine. Eko Brands, LLC v. Adrian
`
`Rivera Maynez Enters., Inc., 946 F.3d 1367, 1378–79 (Fed. Cir. 2020). The law of willful
`
`infringement in patent cases changed in 2016 with the Supreme Court’s decision in Halo Elecs.,
`
`Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016). Following Halo, proof by a preponderance of
`
`the evidence “that the defendant acted despite a risk of infringement that was ‘either known or so
`
`obvious that it should have been known to the accused infringer,’—can support” a finding of
`
`willfulness and enhanced damages. Arctic Cat Inc. v. Bombardier Recreational Prod. Inc., 876
`
`F.3d 1350, 1371 (Fed. Cir. 2017) (quoting Halo, 579 U.S. at 100). “The concept of ‘willfulness’
`
`requires a jury to find no more than deliberate or intentional infringement.” Eko Brands, 946 F.3d
`
`at 1378. Courts look to the totality of the circumstances in evaluating whether infringement was
`
`willful. Bio-Rad Lab’ys, Inc. v. 10X Genomics, Inc., 2020 WL 2079422, at *4 (D. Mass. Apr. 30,
`
`2020). The subjective state of mind of the alleged infringer can—and is often—proven with
`
`circumstantial evidence. SiOnyx, LLC v. Hamamatsu Photonics K.K., 330 F. Supp. 3d 574, 610
`
`(D. Mass. 2018). Courts generally allow a jury to determine willfulness before the Court decides
`
`the issue of enhance damages. Eko Brands, 946 F.3d at 1378; Mondis Tech. Ltd v. LG Elecs., Inc.,
`
`407 F. Supp. 3d 482, 501–02 (D.N.J. 2019).
`
`IV. ARGUMENT
`
`A. Substantial evidence demonstrates that Lilly willfully infringed Teva’s patents.
`
`There is ample evidence from which a jury could reasonably infer that Lilly willfully
`
`5
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 12 of 23
`
`
`
`infringed.1 First, it is undisputed that Lilly had full knowledge of Teva’s patents well before it
`
`launched Emgality® in the U.S. in
`
`. RMF ¶¶ P1, P13. Additional evidence
`
`demonstrates Lilly’s knowledge of Teva’s patents dates back to at least2 2011, when Lilly filed a
`
`patent application that referred to Teva’s ’809 patent. In Lilly’s application, it recognized that
`
`“CGRP antibodies for treating migraines and for treating inflammation pain have been
`
`disclosed . . . [including] [the ‘809 patent].” RMF ¶ P5 (describing Lilly’s invention as a treatment
`
`“alternative” to Teva’s invention).
`
`
`
`
`
` Lilly also
`
`knew about Teva’s infringement allegations by that time. RMF ¶ P6 (describing 2017 allegations).
`
`With knowledge of Teva’s patents and infringement allegations, Lilly went ahead with a
`
`full-scale commercial launch of Emgality® in
`
`. SOF ¶ 94. The evidence
`
`demonstrates that
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Lilly’s motion criticizes the sufficiency of Teva’s pleadings (Mot. at 1), but willful infringement
`requires only notice pleading. Ferguson Beauregard/Logic Controls, Div. of Dover Res., Inc. v.
`Mega Sys., LLC, 350 F.3d 1327, 1343 (Fed. Cir. 2003). Lilly never filed any motions under Rule
`12 contesting Teva’s pleadings and it is too late to do so now. Teva provides here and in its RMF
`evidence from which a jury could reasonably conclude that Lilly’s infringement was willful.
`2 A jury could reasonably infer that Lilly was monitoring the relevant art in the space and would
`have been aware of Teva’s patent application when it published in 2007. RMF ¶¶ P2–5.
`
`6
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 13 of 23
`
`
`
`RMF ¶¶ P20–21.
`
`Even worse, despite having knowledge of Teva’s patents and infringement allegations,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Finally, while Lilly cites to its positions in unrelated litigations as evidence that it
`
`subjectively believed the Asserted Patents were invalid (ECF No. 306 (Lilly’s Memo in Support
`
`of Motion for Summary Judgment of No Willful Infringement) (“Mot.”) at 2, 12), the most
`
`probative evidence of Lilly’s subjective beliefs is
`
`
`
`
`
`
`
`
`
`
`
`Drawing all reasonable inferences in the light most favorable to Teva, there should be no
`
`question that the jury needs to resolve the question of willful infringement. Indeed, courts have
`
`upheld findings of willful infringement when
`
` an infringer received actual notice of a
`
`specific charge of infringement, but nonetheless continued its infringing activities without
`
`consulting counsel and investigating the charges. Packet Intel. LLC v. NetScout Sys., Inc., 965
`
`7
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 14 of 23
`
`
`
`F.3d 1299, 1315–16 (Fed. Cir. 2020) (affirming jury verdict of willful infringement where
`
`defendant continued infringing activity after suit was filed); see also Kolcraft Enters., Inc. v.
`
`Chicco USA, Inc., 2018 WL 3329706, at *4–5 (N.D. Ill. July 6, 2018) (denying summary judgment
`
`of no willful infringement where infringer was aware of infringement accusation before suit and
`
`went on to infringe the patents anyway).3 Lilly launched Emgality® with knowledge of Teva’s
`
`infringement allegations,
`
`
`
`
`
`
`
` A jury could reasonably find that Lilly willfully infringed.
`
`B. Lilly failed to meet its burden to show that it is entitled to judgement as a matter of
`law that it did not willfully infringe the Asserted Patents.
`
`The above evidence could lead a jury to reasonably infer that Lilly’s infringement was
`
`“intentional” and “deliberate.” Eko Brands, 946 F.3d at 1378–79. A jury could also reasonably
`
`infer that Lilly launched Emgality® “despite a risk of infringement that was ‘either known or so
`
`obvious that it should have been known to the accused infringer.’” Arctic Cat, 876 F.3d at 1371
`
`(citation omitted). No more is required for the Court to deny Lilly’s Motion. Lilly suggests that
`
`the inquiry here is somehow different because Lilly’s conduct occurred “post suit,” and asserts
`
`that circumstantial evidence—such as its IPR petitions and arguments made in other cases—could
`
`lead a jury to infer that Lilly subjectively believed Teva’s patents to be invalid. Lilly gets the law
`
`wrong, and much of its circumstantial evidence is inadmissible. Even if Lilly could get this
`
`
` an accused infringer
`3 Courts have also upheld findings of willful infringement when
`engaged in aggressive marketing and sales tactics in spite of infringement allegations. See i4i Ltd.
`P’ship v. Microsoft Corp., 598 F.3d 831, 860 (Fed. Cir. 2010) (substantial evidence supported
`jury’s finding of willful infringement where accused infringer openly sought to use the sales of its
`accused product to make the patentee’s product “obsolete”). Courts have granted summary
`judgment of willful infringement when (
`
`and had no other evidence to show that its acts were not willful. Ball Aerosol & Specialty
`Container, Inc. v. Limited Brands, Inc., 553 F. Supp. 2d 939, 953–56 (N.D. Ill. 2008), vacated on
`other grounds, 555 F.3d 984 (Fed. Cir. 2009).
`
`8
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 15 of 23
`
`
`
`evidence before the jury, it creates (at most) a dispute of fact for the jury to resolve.
`
`1.
`
`There is no heightened burden to prove willfulness in this case.
`
`Lilly goes to great lengths to suggest that the requirements for willful infringement are
`
`heightened when allegations are based on “post-suit” conduct and that Teva was required to file
`
`for an injunction. That is not the law. Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275,
`
`1295 (Fed. Cir. 2017) (rejecting argument that patentee “could not assert willful infringement
`
`because it did not seek a preliminary injunction.”); Simplivity Corp. v. Springpath, Inc., 2016 WL
`
`5388951, at *18 (D. Mass. July 15, 2016) (finding that defendant’s escalation of sales and
`
`promotions post-suit knowing “litigation was afoot” was “plausibly reckless and so, under Halo,
`
`[defendant was] subject to the prospect of enhanced damages”). To be sure, there are cases where
`
`the defendant is already selling a product and first learns of the asserted patent when the lawsuit is
`
`filed. The cases cited by Lilly—Wrinkl and Bioverativ—are illustrative. See Wrinkl, Inc. v.
`
`Facebook, Inc., 2021 WL 4477022, at *7 (D. Del. Sept. 30, 2021) (“[W]hen there is no pre-suit
`
`knowledge, it is not sufficient merely to allege the defendant has knowledge since the filing of the
`
`original complaint and has not ceased doing whatever the infringing behavior is alleged to be.”);
`
`Bioverativ Inc. v. CSL Behring LLC, 2020 WL 1332921, at *4 (D. Del. Mar. 23, 2020) (finding
`
`“no colorable willfulness case” when nothing occurred between when the first patent issued and
`
`when the lawsuit was filed).4
`
`This is not one of those cases. Substantial evidence shows that Lilly knew of Teva’s patents
`
`
`4 The Biedermann case is wholly distinguishable from the facts here because there was no evidence
`that the defendant was “‘on notice’ of the patents-in-suit prior to the filing of the instant lawsuit.”
`Biedermann Techs. GmbH & Co. KG v. K2M, Inc., 528 F. Supp. 3d 407, 426 (E.D. Va. 2021). A
`jury would therefore be confined to evaluating the defendant’s post-suit conduct for willfulness.
`Id. The court then determined as a matter of law that the defendant’s post-suit conduct did not
`satisfy the increased “degree of egregiousness” required for willfulness claims based entirely on
`post-suit conduct. Id. at 429–30. Here, Lilly had actual notice of Teva’s patents and allegations.
`
`9
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 16 of 23
`
`
`
`and Teva’s infringement allegations before Lilly launched Emgality®. See pp. 2–3, supra. At the
`
`same time that Teva was trying to stop Lilly’s infringement before it began (RMF ¶ P6), Lilly was
`
`
`
`
`
`
`
`
`
` These facts are more egregious
`
`than the typical willful infringement patent case because Lilly started infringing in earnest after
`
`Teva filed suit. Cf., Packet Intel. LLC v. NetScout Sys., Inc., 2019 WL 2375218, *8–9 (E.D. Tex.
`
`June 5, 2019), aff’d in relevant part, 965 F.3d 1299, 1315–16 (Fed. Cir. 2020) (affirming
`
`willfulness verdict where infringer continued infringing after being sued).
`
`2.
`
`Genuine disputes of material fact permeate Lilly’s subjective beliefs.
`
`Lilly rests on the claim that
`
`
`
` Lacking direct
`
`evidence, Lilly cites circumstantial evidence to bolster its purported good faith: (1) Lilly’s IPR
`
`petitions; (2) Lilly’s invalidity defenses in unrelated patent litigations; (3) Lilly’s non-infringement
`
`defenses in this case; and (4) Lilly’s invalidity and unenforceability defenses in this case. Id.
`
`Lilly’s argument fails. First,
`
` Second, Lilly fails to explain how
`
`
`
`most of its circumstantial evidence is admissible. (It is not.) Third, even if the evidence were
`
`admissible, the Court cannot grant Lilly summary judgment based on competing inferences
`
`because Teva gets the benefit of all reasonable inferences at summary judgment.
`
`a.
`
`Lilly lacks admissible evidence it can present to the jury concerning its
`
`
`Lilly relies heavily on its assertion that
`
`
`
`10
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 17 of 23
`
`
`
`
`
`
`
`, it should be precluded
`
`Of course,
`
`from doing so now.
`
`Lilly has failed to identify any way it could introduce such evidence at trial.
`
`
`
`
`
`
`
` (see Scalli v. Citizens Fin.
`
`Grp., Inc., 2006 WL 1581625, at *17 (D. Mass. Feb. 28, 2006). Lilly neither
`
`
`
`
`
`Lilly’s L.R. 56.1 Statement of Facts further highlights its evidentiary problems.
`
`
`
`11
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 18 of 23
`
`
`
` Those out-of-court documents are classic hearsay, not subject to an exception,7 that Lilly
`
`attempts to use for the truth of the matter asserted in those papers, namely, that Lilly believed
`
`Teva’s patents to be invalid. See Fed. R. Evid. 801(c)(1) (hearsay is “a statement that: (1) the
`
`declarant does not make while testifying at the current trial or hearing”). They are inadmissible.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`7 Lilly cannot reasonably claim that its IPR expert—Dr. Alain Vasserot—was unavailable. See
`Fed. R. Evid. 804(a)(1)(5). Rather, Lilly simply chose to use a different expert in this case.
`8 See, e.g.,
`
`
`
`12
`
`
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 19 of 23
`
`
`
`. See YKK Corp. v. Velcro USA Inc.,
`
`2017 WL 11637524, *2 (M.D. Ga. Nov. 16, 2017) (barring accused infringer from using an
`
`opinion of counsel after asserting attorney-client privilege during the litigation).9 Lilly is not
`
`entitled to summary judgment of no willful infringement based on these unsupported assertions.
`
`b.
`
`Lilly cannot establish it is entitled to summary judgment because the
`inferences it asks the Court to draw are not the most favorable to Teva.
`
`Lilly’s Motion depends on a jury inferring that the defenses Lilly has raised in this lawsuit
`
`and the IPRs reflect its subjective, sincere beliefs. But defenses raised by outside litigation counsel
`
`often do not reflect the actual, subjective belief of the defendant. See Asia Vital Components Co.
`
`v. Asetek Danmark A/S, 377 F. Supp. 3d 990, 1021 (N.D. Cal. 2019) (reasonable non-infringement
`
`defenses do not preclude finding of willfulness “because an infringer’s subjective bad faith alone
`
`may support an award of enhanced damages”); see also Eko Brands, 946 F.3d at 1377 (Fed. Cir.
`
`2020). Indeed, a jury could reasonably infer based on Lilly’s behavior that its arguments in the
`
`IPRs and this litigation amount to nothing more than post-hoc litigation strategies. Kolcraft
`
`Enters., Inc. v. Chicco USA, Inc., 2018 WL 3329706, at *4–5 (N.D. Ill. July 6, 2018) (holding that
`
`a jury could also find that an IPR filing was “merely [a] post-hoc litigation strateg[y] to try to avoid
`
`enhanced damages.”). For example, Lilly lost its IPRs for the Asserted Patents but still fiercely
`
`competes with Teva in the CGRP market. And after Lilly was estopped10 from asserting that the
`
`Asserted Patents were obvious, it now argues that they are invalid under § 112 based on factual
`
`
`9 See also Spectralytics, Inc. v. Cordis Corp., 2009 WL 3851314, *4 (D. Minn. Jan. 13, 2009)
`(infringer will not receive a positive inference of good faith from obtaining an opinion of counsel
`where it does not disclose the details); RTC Indus., Inc. v. Fasteners for Retail, Inc., 2020 WL
`1148813, at *5 (N.D. Ill. Mar. 9, 2020) (explaining that infringer cannot use opinion as a sword to
`defend against a charge of willful infringement while using the attorney-client privilege as a shield
`to withhold other communications on the same subject matter).
`10 Lilly tried to re-litigate obviousness in this case despite being statutorily estopped from doing
`so, but eventually dropped that defense. ECF No. 71 (Letter to Court from Blais); ECF No. 160.
`
`13
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 20 of 23
`
`
`
`assertions about the state of the art that are directly contrary to those it made in the IPRs. ECF No.
`
`315 (Teva’s Mot. for Summary Judgment Regarding Judicial Estoppel). A jury could reasonably
`
`conclude that Lilly’s flip-flopping views of the prior art supports an inference of bad faith.
`
`Lilly’s weak inequitable conduct defense does not help Lilly either. Lilly stated that it had
`
`no knowledge of that defense until shortly before it filed a motion to amend the pleadings on
`
`October 4, 2021. ECF No. 176 at 14–15 (stating that Lilly did not have a reason to assert its lead11
`
`inequitable conduct theory until September 2021). Taking Lilly at its word, any alleged belief in
`
`the unenforceability of the patents cannot show a lack of willful infringement because Lilly did
`
`not form that belief until years after the launch of Emgality®.
`
`Lilly’s reliance on its invalidity positions in litigations from decades ago on unrelated
`
`patents is both legally and factually irrelevant to its subjective beliefs in this case. Lilly cites no
`
`case where a court relied on similar evidence to find that an alleged infringer’s conduct was not
`
`willful, and a jury could reasonably conclude that Lilly’s reliance on this reductive, “all-patents-
`
`are-invalid,” justification for launching Emgality® was merely a pretense for choosing the more
`
`profitable approach—launching despite a risk of infringement. See Arctic Cat, 876 F.3d at 1371
`
`(infringer’s “cursory analysis” of the asserted patents supported jury’s willfulness finding). And
`
`if a jury considers Lilly’s conduct in other cases,
`
`
`
`
`
` Finally,
`
`
`
`
`
`
`
`
`11 Lilly’s original answer contained a different inequitable conduct theory that Lilly is no longer
`pursuing. ECF No. 302 (Teva’s Mot. for Summary Judgment of No Inequitable Conduct and
`Unclean Hands) at 3–5. It can therefore be discounted by the Court.
`
`14
`
`
`
`Case 1:18-cv-12029-ADB Document 446 Filed 07/27/22 Page 21 of 23
`
`
`
`
`
` A jury could reasonably conclude from these facts
`
`that Lilly made a calculated decision to launch Emgality despite a high risk of infringement.
`
`
`
` In 2014, Lilly challenged Teva’s ’106 patent, which is in the same family
`
`as the Asserted Patents, and is similarly directed to methods of using “antagonist antibodies
`
`directed against [CGRP].” RMF ¶ P9. Lilly argued that the ’106 patent “provide[s] a very broad
`
`scope of protection” that “encompasses almost all anti-CGRP antagonist antibodies that may have
`
`therapeutic utility,” essentially conceding that Emgality® would infringe those claims. RMF
`
`¶ P10; see Ex. CC ¶ 60 (admitting that