Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 1 of 11
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
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`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
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`
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`Civil Action No.
`1:18-cv-12029-ADB
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`Defendant.
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`TEVA’S OPPOSITION TO LILLY’S MOTION IN LIMINE NO. 6 TO PRECLUDE
`PLAINTIFFS FROM PRESENTING ARGUMENTS AND EVIDENCE REGARDING
`THE PREVALENCE OF MIGRAINE ENCOUNTERED IN CLINICAL PRACTICE
`AND WHETHER MIGRAINE IS REPRESENTATIVE OF THE HEADACHES THAT A
`POSA WOULD ENCOUNTER IN CLINICAL PRACTICE
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 2 of 11
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`TABLE OF CONTENTS
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`INTRODUCTION .............................................................................................................. 1
`ARGUMENT ...................................................................................................................... 1
`A POSA’s Understanding of the Prevalence and Representativeness of Migraine
`A.
`and Other CGRP-Related Headaches is Relevant to the 112 Inquiry ..................... 1
`Teva’s Experts Applied the Correct Level of Skill ................................................. 4
`Lilly has Failed to Identify Unfair Prejudice Substantially Outweighing the
`Probative Value of Teva’s Evidence ....................................................................... 5
`CONCLUSION ................................................................................................................... 6
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`B.
`C.
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`I.
`II.
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`III.
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`i
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 3 of 11
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
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`Ajinomoto Co. v. Archer-Daniels-Midland Co.,
`228 F.3d 1338 (Fed. Cir. 2000)..................................................................................................5
`
`Amgen Inc. v. Sanofi, Aventisub LLC.,
`987 F.3d 1080 (Fed. Cir. 2021)..................................................................................................3
`
`Atlas Powder Co. v. E.I. du Pont De Nemours & Co.,
`750 F.2d 1569 (Fed. Cir. 1984)..................................................................................................3
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`Enzo Biochem, Inc. v. Gen-Probe, Inc.,
`2002 WL 32063710 (Fed. Cir. July 15, 2002) ...........................................................................3
`
`Idenix Pharmaceuticals LLC v. Gilead Sciences Inc.,
`941 F.3d 1149 (Fed. Cir. 2019)..................................................................................................4
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`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336(Fed. Cir. 2005)...................................................................................................5
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`Statutes
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`35 U.S.C. § 112 ....................................................................................................................1, 2, 3, 4
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`ii
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 4 of 11
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`I.
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`INTRODUCTION
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`The Court should deny Lilly’s Motion in Limine No. 6 (ECF No. 479, “Mot.”) because
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`granting it would require the Court to resolve competing expert testimony about how a person of
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`ordinary skill in the art (“POSA”) would understand the scope of the term “headache.” That would
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`be improper. The relevance of the evidence in dispute is unquestionable, and Lilly has not and
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`cannot articulate any unfair prejudice. While Lilly argues that a POSA would understand the scope
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`of “headaches” referred to in the asserted claims to be dictated by a 2004 publication by the
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`International Classification of Headache Disorders (“ICHD”), Teva’s experts, Drs. Blumenfeld
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`and Hill, disagree because the person of ordinary skill in the art is someone who, among other
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`things, “treat[s] patients with a CGRP-related disease, such as migraine headaches.” ECF No. 368,
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`Ex. O ¶ 73. Teva’s experts explain that the proper perspective for determining the scope of
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`“headaches” is that of practicing physicians who actually treat headache patients in clinical
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`practice. This dispute between the experts is one that should be resolved by the jury.
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`The particular evidence Lilly attempts to exclude—including two academic articles, Lipton
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`2001 and Tepper 2004—is probative of factual disputes underlying the § 112 written description
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`and enablement inquiries and is directly responsive to Lilly’s own arguments about how a POSA
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`would understand the scope of headaches covered by the asserted claims. Moreover, Lilly has
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`failed to identify how such information would be unfairly prejudicial. The Court should therefore
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`deny Lilly’s Motion to exclude under Rules 401, 402, and 403.
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`II.
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`ARGUMENT
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`A.
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`A POSA’s Understanding of the Prevalence and Representativeness of
`Migraine and Other CGRP-Related Headaches is Relevant to the 112 Inquiry
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`A POSA’s understanding of the prevalence and representativeness of migraine and other
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`CGRP-related headaches in a clinical setting is probative of the parties’ dispute regarding Lilly’s
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`1
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 5 of 11
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`§ 112 defenses. In its Motion, Lilly assumes the correctness of its expert’s position that
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`“headache” in the asserted claims refers to specific diagnostic criteria adopted in 2004 by the ICHD
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`and contends that Teva’s contrary evidence is irrelevant or unfairly prejudicial. But Teva’s
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`contrary evidence is relevant and does not pose any undue prejudice or risk of jury confusion.
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`Teva’s experts disagree that the “full scope” of headaches in the asserted claims is
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`determined by the ICHD for several factual reasons. First, Teva’s experts explain that the ICHD
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`was principally used for clinical trials and not widely deployed by treating physicians in ordinary
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`clinical practice. ECF No. 368, Ex. L ¶ 102; ECF No. 368, Ex. V ¶ 410. Second, Teva’s experts
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`explain that a POSA would assess the full scope of headache disorders through the lens of what is
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`treated in a clinical setting, before citing empirical evidence (including Lipton 2001 and Tepper
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`2004) showing that the vast majority of headaches encountered in clinical practice are migraine.
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`ECF No. 368, Ex. L ¶ 103. Third, Teva’s experts explain that the ICHD had been criticized and
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`had limited utility for treating physicians as of 2006. Id. ¶ 104. The studies in Lipton 2001 and
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`Tepper 2004 stand for the more general proposition that, when a patient complains to his or her
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`doctor about headache, that “headache” is a migraine upwards of 90% of the time.1 Lipton 2001,
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`in particular, looked at other common terms used by physicians such as “sick headache,” “sinus
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`headache,” and “tension headache” and then evaluated whether those diagnoses were, in fact,
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`migraines. ECF No. 486, Ex. AA at 639. To the extent Lilly believes Lipton 2001 and Tepper
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`2004 are less probative because those studies were mostly (but not entirely) surveys of primary
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`care physicians, Lilly can explore that on cross examination.
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`1 Lipton 2001 included, but was not limited to diagnosis in “primary care settings.” ECF No. 486,
`Ex. AA at 643. Lipton 2001 was a prevalence study that surveyed 20,000 household and asked,
`among other things, “Have you ever been diagnosed by a physician as suffering from migraine?”
`Id. at 639.
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`2
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 6 of 11
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`Lilly intends to argue that the full scope of the asserted claims are not described or enabled
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`by the asserted patents because the ICHD classifications included rare, outlier headaches that a
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`POSA would not expect to respond to anti-CGRP antibody treatment. But as the evidence Lilly
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`seeks to exclude demonstrates, these outliers do not mean that the “full scope” of headache is not
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`described or enabled. Teva’s experts will show that migraines are representative of headaches
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`treated by POSA, such that the asserted patents satisfy the written description and enablement
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`requirements of § 112. Put another way, the evidence shows that “migraines” are representative
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`of headaches because they account for the vast majority of headaches encountered by POSAs (no
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`matter the label affixed to the headache). The written description requirement requires only that
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`the specification be “representative” of the full scope of the claims. Enzo Biochem, Inc. v. Gen-
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`Probe, Inc., 2002 WL 32063710, at *7 (Fed. Cir. July 15, 2002) (vacating finding of no written
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`description where patentee’s disclosure was “representative of the scope of the genus claims”).
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`Similarly, the enablement requirement does not require the specification to “exhaust a genus.”
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`Amgen Inc. v. Sanofi, Aventisub LLC., 987 F.3d 1080, 1088 (Fed. Cir. 2021) (emphasis original).
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`A claim does not lack an enabling disclosure just because some possible embodiments within the
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`scope of the claimed invention are inoperative. See, e.g., Atlas Powder Co. v. E.I. du Pont De
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`Nemours & Co., 750 F.2d 1569, 1576–77 (Fed. Cir. 1984) (“It is not a function of the claims to
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`specifically exclude . . . possible inoperative substances . . . .” (quotation omitted)). The number
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`of inoperative combinations “becomes significant” for § 112 only when their existence “forces one
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`of ordinary skill in the art to experiment unduly in order to practice the claimed invention.” Id.
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`Lilly’s argument that anti-CGRP antagonist antibodies may not effectively treat every conceivable
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`form of headache is, at most, a disputed issue of fact for the jury. It comes nowhere close to
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`justifying exclusion of Teva’s responsive evidence.
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`3
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 7 of 11
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`Lilly’s reliance on Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., a case that did not
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`address exclusion of evidence, is misplaced because Teva’s experts are not construing the meaning
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`of “headache” to be limited to migraine. 941 F.3d 1149, 1162 (Fed. Cir. 2019). Rather, Teva’s
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`experts will testify that persons of skill in the art would understand that (i) “migraines” were called
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`by other names, (ii) migraines were the most prevalent form of headache (no matter how labeled)
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`and (iii) diagnostic criteria for migraine were not universally adopted, such that migraines are
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`sufficiently representative of the full scope of the claim term “headache” for purposes of § 112.
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`Lilly’s merits arguments about the proper scope of the claims are simply competing evidence for
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`the jury to consider, alongside Teva’s responsive evidence, in weighing Lilly’s § 112 defenses.
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`B.
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`Teva’s Experts Applied the Correct Level of Skill
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`Lilly’s argument that Teva’s evidence is irrelevant because Teva’s experts have improperly
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`offered evidence from the perspective of a primary care physician instead of a person of ordinary
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`skill in the art is puzzling. Lilly argues that Drs. Blumenfeld and Hill improperly replaced the
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`agreed-upon level of knowledge attributable to a POSA2 with that of a primary care physician
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`because the meta-analyses conducted in Lipton 2001 and Tepper 2004 cite, inter alia, primary care
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`physicians’ tendency to misdiagnose migraine. Lilly apparently misstates Drs. Blumenfeld’s and
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`Hill’s opinions. They have not offered opinions on the sufficiency of the asserted patents’ shared
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`specification from the perspective of a primary care physician. Rather, they have opined that a
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`properly qualified POSA would have had access to studies such as Lipton 2001 and Tepper 2004
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`and that those sources would have supported a POSA’s understanding that migraine and CGRP-
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`related headaches account for an outsized portion of headaches treated in a clinical setting. Teva’s
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`2 The parties agree that a POSA is, in relevant part, “an M.D. with a residency or specialty in
`neurology, and several years of experience studying CGRP or treating patients with a CGRP-
`related disease, such as migraine headaches.” ECF No. 368, Ex. O ¶ 73.
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`4
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 8 of 11
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`experts thus properly assess the scope of the asserted claims in light of the knowledge that would
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`be available to a person of ordinary skill in the art in 2006. See LizardTech, Inc. v. Earth Res.
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`Mapping, Inc., 424 F.3d 1336, 1345(Fed. Cir. 2005) (“The patent specification is written for a
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`person of skill in the art, and such a person comes to the patent with the knowledge of what has
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`come before.”); Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345 (Fed. Cir.
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`2000) (“Enablement is determined from the viewpoint of skill in the field of the invention at the
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`time the patent application was filed.”). Additionally, the studies conducted by Lipton 2001 and
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`Tepper 2004, even if they mostly (but not entirely) surveyed primary care physicians, directly
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`contradict Lilly’s expert’s testimony that the ICHD classification system was widely adopted in
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`clinical practice. Lilly’s criticisms with how those surveys were conducted goes purely to the
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`weight that the jury should afford that evidence and does not warrant exclusion.
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`C.
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`Lilly has Failed to Identify Unfair Prejudice Substantially Outweighing the
`Probative Value of Teva’s Evidence
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`Lilly’s assertion that evidence regarding the POSA’s understanding of migraine’s
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`prevalence and representativeness in a clinical setting will “invite the jury to apply an improper
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`level of skill in the art and disregard the ‘full scope’ requirement” is unsupported. Mot. at 3.
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`First, with respect to the appropriate level of skill, neither Teva nor its experts have opined
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`on the sufficiency of the asserted patents’ shared specification from the perspective of a primary
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`care physician,3 supra at 4. Lilly provides no other explanation as to how such evidence might
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`confuse the level of skill in the art.
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`3 Teva understands that Lilly’s reference to primary care physicians here, Mot. at 2, is intended to
`indicate only those who do not meet the agreed-upon level of skill of a POSA because they lack
`“a residency or specialty in neurology, and several years of experience studying CGRP or treating
`patients with a CGRP-related disease, such as migraine headaches.” Supra at n.2.
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`5
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 9 of 11
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`Second, Lilly fails to identify which part of the “full scope” requirement it contends is
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`likely to be eroded by evidence suggesting that a POSA would have read the claim term as
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`informed by clinical information. Again, Lilly’s view of the “full scope” of the claims assumes
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`the correctness of its expert’s opinion. The evidence that Lilly seeks to exclude is evidence that
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`undermines Lilly’s expert’s opinion. The opinions of Drs. Blumenfeld and Hill at issue in this
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`motion have no tendency to confuse the jury. Lilly has failed to identify any risk of unfair
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`prejudice, let alone a risk substantial enough to justify excluding evidence that is highly probative
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`of the written description and enablement disputes in this case.
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`III.
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`CONCLUSION
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`For these reasons, Teva requests that the court deny Lilly’s Motion in limine to preclude
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`Teva from presenting arguments and evidence regarding (1) the prevalence of migraine
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`encountered in clinical practice and (2) whether migraine is representative of the headaches that a
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`person of ordinary skill in the art would encounter in clinical practice.
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`6
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 10 of 11
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`Dated: September 29, 2022
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`I. Neel Chatterjee (pro hac vice)
`GOODWIN PROCTER LLP
`601 Marshall St.
`Redwood City, CA 94063
`Tel.: (650) 752-3100
`Fax: (650) 853-1038
`nchatterjee@goodwinlaw.com
`
`Natasha E. Daughtrey (pro hac vice)
`Sean M. Anderson (pro hac vice)
`GOODWIN PROCTER LLP
`601 S. Figueroa St.
`Los Angeles, CA 90017
`Tel.: (213) 426-2500
`Fax: (213) 623-1673
`ndaughtrey@goodwinlaw.com
`sanderson@goodwinlaw.com
`
`Madeline R. DiLascia (pro hac vice)
`GOODWIN PROCTER LLP
`1900 N Street N.W.
`Washington, D.C. 20036
`Tel.: (202) 346-4000
`Fax: (202) 204-7250
`mdilascia@goodwinlaw.com
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`Respectfully Submitted,
`
`/s/ Elaine Herrmann Blais
`Douglas J. Kline (BBO# 556680)
`Elaine Herrmann Blais (BBO# 656142)
`Robert Frederickson III (BBO# 670111)
`Molly Grammel (BBO# 688439)
`Joshua S. Weinger (BBO# 690814)
`Alexandra Lu (BBO# 691114)
`Eric T. Romeo (BBO# 691591)
`Kathleen A. McGuinness (BBO# 693760)
`Tara R. Thigpen (BBO# 707508)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`Fax: (617) 523-1231
`dkline@goodwinlaw.com
`eblais@goodwinlaw.com
`rfrederickson@goodwinlaw.com
`mgrammel@goodwinlaw.com
`jweinger@goodwinlaw.com
`alu@goodwinlaw.com
`eromeo@goodwinlaw.com
`kmcguinness@goodwinlaw.com
`tthigpen@goodwinlaw.com
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`Attorneys for Plaintiffs
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`Case 1:18-cv-12029-ADB Document 508 Filed 09/29/22 Page 11 of 11
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`CERTIFICATE OF SERVICE
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`I, Elaine Herrmann Blais, hereby certify that this document filed through the ECF system
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`will be sent electronically to the registered participants as identified on the Notice of Electronic
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`Filing (“NEF”) and paper copies will be sent to those indicated as non-registered participants on
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`September 29, 2022.
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`
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`/s/ Elaine Herrmann Blais
`Elaine Herrmann Blais (BBO# 656142)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`Fax: (617) 523-1231
`eblais@goodwinlaw.com
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