Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 1 of 29
`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 1 of 29
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF MASSACHUSETTS
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBHand
`TEVA PHARMACEUTICALSUSA,INC.,
`
`Plaintiffs,
`
`V.
`
`Case No. 1:18-cv-12029-ADB
`
`NeeOOBBSs
`
`ELILILLYAND COMPANY. ae
`
`Defendant.
`
`Leave to File Under Seal Granted on
`May6, 2022 (ECF No. 341)
`
`DEFENDANT ELI LILLY AND COMPANY’S
`MEMORANDUMIN OPPOSITION TO TEVA’S MOTION
`
`FOR PARTIAL SUMMARY JUDGMENT REGARDING JUDICIAL ESTOPPEL
`
`

`

`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 2 of 29
`
`I.
`
`II.
`
`III.
`
`IV.
`
`TABLE OF CONTENTS
`
`INTRODUCTION .............................................................................................................. 1
`
`BACKGROUND ................................................................................................................ 3
`
`A.
`
`B.
`
`C.
`
`D.
`
`The Functionally Defined Genus of Antibodies Used in Teva’s Asserted
`Claims Is Extremely Broad ..................................................................................... 3
`
`The Prior Art Disclosed No Human or Humanized Anti-CGRP Antagonist
`Antibodies ............................................................................................................... 3
`
`In the Antibody IPRs, the PTAB Found That It Would Have Been
`Obvious to Make One Humanized Anti-CGRP Antagonist Antibody ................... 4
`
`In the Antibody Method of Treatment IPRs, Teva Successfully Established
`That Prior Art Anti-CGRP Antibodies and Methods Would Not Have Led
`to Successful Treatment of Migraine ...................................................................... 5
`
`LEGAL STANDARDS ...................................................................................................... 6
`
`ARGUMENT ...................................................................................................................... 7
`
`A.
`
`Teva’s Motion Should Be Denied for Failing to Prove Judicial Estoppel .............. 7
`
`1.
`
`2.
`
`3.
`
`Teva Failed to Address the Different Legal Contexts Between
`Proceedings and Thus Cannot Establish Mutual Exclusivity ..................... 7
`
`Teva Failed to Address Differences in Claim Scope Between
`Proceedings and Thus Cannot Establish Mutual Exclusivity ................... 10
`
`Each of Teva’s Five Requests for Relief Is Deficient ............................... 11
`
`a. Judicial Estoppel Does Not Support Teva’s Request No. 1................ 11
`
`b. Judicial Estoppel Does Not Support Teva’s Request No. 2................ 14
`
`c. Judicial Estoppel Does Not Support Teva’s Request Nos. 3 and 4 .... 16
`
`d. Judicial Estoppel Does Not Support Teva’s Request No. 5................ 17
`
`4.
`
`The Only Party Seeking an Unfair Advantage Is Teva............................. 18
`
`a. Judicial Estoppel Cannot Remedy Teva’s Deficient Specification .... 18
`
`b. Teva’s Requested Relief Would Only Serve to Confuse the Relevant
`Facts and Law ........................................................................................... 18
`
`c. Teva Identifies No Unfair Advantage to Lilly .................................... 19
`
`i
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`

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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 3 of 29
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`B.
`
`Teva’s Motion May Also Be Denied for Failing to Comply with Rule 56 .......... 20
`
`V.
`
`Conclusion ........................................................................................................................ 20
`
`
`
`
`
`
`ii
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`

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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 4 of 29
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc.,
`971 F. Supp. 2d 171 (D. Mass. 2013), aff’d 759 F.3d 1285 (Fed. Cir. 2014).................. passim
`
`Alt. Sys. Concepts, Inc. v. Synopsys, Inc.,
`374 F.3d 23 (1st Cir. 2004) ........................................................................................................6
`
`Amgen Inc. v. Sanofi,
`872 F.3d 1367 (Fed. Cir. 2017)..........................................................................................18, 19
`
`Amgen, Inc. v. F. Hoffman-La Roche Ltd.,
`581 F. Supp. 2d 160 (D. Mass. 2008) ......................................................................................12
`
`Amgen, Inc. v. Sanofi,
`No. 14-cv-1317, 2019 WL 259099 (D. Del. Jan. 18, 2019) ......................................6, 9, 12, 15
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc)..............................................................13, 14, 15, 19
`
`Asarco, LLC v. Noranda Mining, Inc.,
`844 F.3d 1201 (10th Cir. 2017) .................................................................................................6
`
`Bos. Sci. Corp. v. Johnson & Johnson,
`647 F.3d 1353 (Fed. Cir. 2011)............................................................................................8, 12
`
`Cleveland v. Policy Mgmt. Corp.,
`526 U.S. 795 (1999) ...............................................................................................................2, 6
`
`Cross Med. Prod., Inc. v. Medtronic Sofamor Danek, Inc.,
`424 F.3d 1293 (Fed. Cir. 2005)................................................................................................10
`
`Duggan v. Martello,
`No. 18-cv-12277, 2021 WL 4295828 (D. Mass. Sept. 21, 2021) ..............................................7
`
`Egenera, Inc. v. Cisco Sys., Inc.,
`972 F.3d 1367 (Fed. Cir. 2020)................................................................................7, 10, 13, 16
`
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`8 F.4th 1331 (Fed. Cir. 2021) ....................................................................................................6
`
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`IPR2018-01422, 2020 WL 806932 (PTAB Feb. 18, 2020) ............................................. passim
`
`iii
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`

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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 5 of 29
`
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`IPR2018-01710, 2020 WL 1540364 (PTAB Mar. 31, 2020) ................................................5, 6
`
`Juno Therapeutics, Inc. v. Kite Pharma, Inc.,
`10 F.4th 1330 (Fed. Cir. 2021) ..................................................................................................8
`
`Lampi Corp. v. Am. Power Prods., Inc.,
`228 F.3d 1365 (Fed. Cir. 2000)..................................................................................................6
`
`New Hampshire v. Maine,
`532 U.S. 742 (2001) .....................................................................................................1, 6, 7, 19
`
`Paper, Allied-Indus., Chem. & Energy Workers Int’l Union, AFL-CIO, CLC v.
`Allied Textile Cos.,
`235 F. Supp. 2d 8 (D. Me. 2002) ...................................................................................7, 12, 15
`
`Pariseau v. Capt. John Boats,
`No. 09-cv-10624, 2011 WL 1560975 (D. Mass. Apr. 25, 2011) .............................................20
`
`Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd.,
`323 F. Supp. 3d 566 (D. Del. 2018), aff’d 945 F.3d 1184 (Fed. Cir. 2019) ..............................9
`
`RFF Family P’ship, LP v. Ross,
`814 F.3d 520 (1st Cir. 2016) ....................................................................................................11
`
`Selkow v. 7-Eleven, Inc.,
`No. 8:11-cv-456, 2012 WL 2054872 (M.D. Fla. June 7, 2012) ..............................................20
`
`Sexual Minorities Uganda v. Lively,
`899 F.3d 28 (1st Cir. 2018) ........................................................................................6, 7, 10, 18
`
`Teva Pharms. Int’l GmbH v. Eli Lilly & Co.,
`8 F.4th 1349 (Fed. Cir. 2021) ....................................................................................................3
`
`United States v. Diebold, Inc.,
`369 U.S. 654 (1962) ...................................................................................................................6
`
`United States v. Tailwind Sport Corp.,
`234 F. Supp. 3d 180 (D.D.C. 2017) .........................................................................................20
`
`Univ. of Rochester v. G.D. Searle & Co.,
`358 F.3d 916 (Fed. Cir 2004).....................................................................................................1
`
`Wyeth & Cordis Corp. v. Abbott Lab’ys,
`720 F.3d 1380 (Fed. Cir. 2013)......................................................................................8, 15, 18
`
`Federal Statutes
`
`35 U.S.C. § 102 ..............................................................................................................................12
`iv
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`

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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 6 of 29
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`35 U.S.C. § 103 ...................................................................................................................... passim
`
`35 U.S.C. § 112 ...................................................................................................................... passim
`
`Rules
`
`Fed. R. Civ. P. 56 .....................................................................................................................14, 20
`
`Other Authorities
`
`Wright & Miller, Federal Practice and Procedure § 596-97 (2d ed. 2002) .....................................7
`
`
`
`v
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`

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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 7 of 29
`
`Abbreviation
`‘210 patent
`
`’951 patent
`
`Bold and italicized
`CGRP
`IPR
`Lilly
`Patents-in-suit
`POSA
`PTAB
`
`RSUMF
`
`Teva
`
`Br.
`
`USPTO
`
`TABLE OF ABBREVIATIONS
`
`
`Description
`U.S. Patent No. 9,890,210, one of Teva’s antibody patents no longer
`asserted in this case after the PTAB found, and the Federal Circuit
`affirmed, obviousness of all asserted claims.
`U.S. Patent No. 9,266,951, one of Teva’s antibody patents no longer
`asserted in this case after the PTAB found, and the Federal Circuit
`affirmed, obviousness of all asserted claims.
`emphasis added unless indicated otherwise
`calcitonin gene-related peptide
`inter partes review
`Eli Lilly and Company
`U.S. Patent Nos. 8,586,045; 9,884,907; and 9,884,908
`person of ordinary skill in the art
`Patent Trial and Appeal Board of the U.S. Patent and Trademark
`Office
`Citation to paragraph number(s) of Defendant Eli Lilly and Company’s
`Response to Plaintiffs’ LR 56.1 Statement of Undisputed Material
`Facts in Support of Their Motion for Summary Judgment Regarding
`Judicial Estoppel
`Teva Pharmaceuticals International GmbH and Teva Pharmaceuticals
`USA, Inc.
`Teva’s Memorandum of Law in Support of Motion for Partial
`Summary Judgment Regarding Judicial Estoppel (ECF No. 315)
`U.S. Patent and Trademark Office
`
`vi
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`

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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 8 of 29
`
`I.
`
`INTRODUCTION
`
`Teva inappropriately seeks to use judicial estoppel to plug a fatal hole in its patents-in-suit:
`
`the named inventors’ failure to describe and enable the full scope of the genus of humanized and/or
`
`human anti-CGRP antagonist antibodies necessary for carrying out the claimed treatment methods.
`
`Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir 2004) (“Without such a
`
`compound, it is impossible to carry out the claimed method of treatment.”). Indeed, despite broadly
`
`claiming the use of any humanized or human anti-CGRP antagonist antibody, the specification of
`
`the patents-in-suit discloses just one humanized antagonist antibody and no human antibodies.
`
`To pursue its objective, Teva asks the Court to hold five purported “facts” as established
`
`in this case: that anti-CGRP antagonist antibodies were “well known” (Teva’s Request No. 1) and
`
`that techniques for making, humanizing, and screening antibodies were “routine” or
`
`“conventional” (Teva’s Request Nos. 2-5). Br. 20. Based on these alleged “facts,” Teva contends
`
`that a genus of humanized or human anti-CGRP antagonist antibodies was known as of 2005-2006
`
`and thus need not have been disclosed in the specification (Br. 14-15)—directly contradicting
`
`Teva’s admissions during discovery that humanized and human anti-CGRP antibodies were not
`
`known in the art. Teva’s motion is thus entirely detached from reality.
`
`Moreover, judicial estoppel cannot apply unless the moving party meets the high burden
`
`of establishing that its opponent took a position clearly inconsistent (i.e., irreconcilable or mutually
`
`exclusive) with a position taken in an earlier case. New Hampshire v. Maine, 532 U.S. 742, 750
`
`(2001). It also cannot apply unless the court clearly accepted that position. Id. Teva proved neither.
`
`First, Lilly has not taken inconsistent positions. Teva’s motion seeks to contort Lilly’s
`
`positions taken in challenging different patents under a different legal theory (obviousness under
`
`35 U.S.C. § 103), and directly apply them in this case involving separate patents and separate legal
`
`theories (written description and enablement under 35 U.S.C. § 112). But context is critical.
`1
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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 9 of 29
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`Cleveland v. Policy Mgmt. Corp., 526 U.S. 795, 797 (1999) (vacating judicial estoppel holding
`
`because “two seemingly divergent statutory contentions are often consistent, each with the other”).
`
`Here, that context is controlled by the statutory requirements at issue: a patent claim is
`
`invalid under § 103 if a single antibody within the scope of the claims is obvious, whereas § 112
`
`requires Teva’s specification to describe and enable use of the full scope of antibodies covered by
`
`its vast, functionally defined claims. As this Court has previously explained, for example, there is
`
`no inconsistency where claims are (i) invalid because making and screening one antibody within
`
`the scope of the claims would have been obvious in view of prior-art methods and (ii) also invalid
`
`under § 112 because, despite those known methods, it would still require undue experimentation
`
`to make and use the full scope of the claimed subject matter. Abbott GmbH & Co. v. Centocor
`
`Ortho Biotech, Inc., 971 F. Supp. 2d 171 (D. Mass. 2013), aff’d 759 F.3d 1285 (Fed. Cir. 2014).
`
`Second, Teva fails to demonstrate that the PTAB accepted any arguments matching its five
`
`requested “facts.” Selectively quoting from the PTAB’s decision, Teva’s Request No. 1 seeks to
`
`establish that “anti-CGRP antagonist antibodies” were well-known, without specifying whether
`
`such antibodies were human, humanized, or murine (i.e., mouse or rat) antibodies. The PTAB’s
`
`decision was clear, however, that the prior art disclosed only a few murine antibodies, which are
`
`outside the scope of the asserted claims in this case. Similar defects permeate Teva’s Request
`
`Nos. 2-5, which seek to establish that it would have been “routine” to make, humanize, and screen
`
`an unspecified number of antibodies. The PTAB, in contrast, found only that it would have been
`
`obvious to make one antibody within the scope of Teva’s claims.
`
`Lilly thus respectfully requests that the Court deny Teva’s unmeritorious judicial estoppel
`
`motion. The Court may also deny Teva’s motion as procedurally improper: summary judgment is
`
`not a suitable vehicle for resolving non-dispositive fact issues, which is all Teva requests here.
`
`2
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`

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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 10 of 29
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`II.
`
`BACKGROUND
`A.
`
`The Functionally Defined Genus of Antibodies Used in Teva’s Asserted
`Claims Is Extremely Broad
`
`Notwithstanding that its specification discloses only a single humanized anti-CGRP
`
`antagonist antibody and no human antibodies, Teva’s patents-in-suit claim the use of any
`
`humanized and/or human anti-CGRP antagonist antibodies for treating migraine and a vast array
`
`of other headache disorders at any dose (i.e., “effective amount”) that works. ECF No. 295 at SOF
`
`186, 251. The Federal Circuit, in affirming the invalidity of related Teva patents, emphasized that
`
`this functionally claimed antibody genus is “extremely broad.” Teva Pharms. Int’l GmbH v. Eli
`
`Lilly & Co., 8 F.4th 1349, 1363 (Fed. Cir. 2021). Indeed, the number of antibodies potentially
`
`covered by the full scope of the asserted claims is vast, exceeding the number of stars in our galaxy.
`
`ECF No. 295 at SOF 59-62. The diversity of the antibody genus is also increased by encompassing
`
`antibodies for use in the claimed methods regardless of antibody class, antibody format (e.g.,
`
`fragments), binding affinity, and epitope. Teva, 8 F.4th at 1363; ECF No. 295 at SOF 276-283.
`
`B.
`
`The Prior Art Disclosed No Human or Humanized Anti-CGRP
`Antagonist Antibodies
`
`The prior art provided no human or humanized anti-CGRP antagonist antibodies. In
`
`discovery, Teva attested: “humanized anti-CGRP antibodies were not known in the prior art.” ECF
`
`No. 295 at SOF 159. Teva and its experts also acknowledge that there were no known human anti-
`
`CGRP antibodies. Id. at SOF 155-156.
`
`While Teva’s experts have pointed to murine anti-CGRP antagonist antibodies in the prior
`
`art, they are outside the scope of the claims and few in number (i.e., six at most). Id. at SOF 168;
`
`RSUMF ¶¶ 65-81. The amino acid sequences of these murine antibodies were unknown, and there
`
`was no other structural information reported in the prior art. ECF No. 295 at SOF 169. None were
`
`reported to successfully treat any disease. Id. at SOF 160-165. Nor did any bind the mid-region of
`
`3
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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 11 of 29
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`CGRP. Id. at SOF 170. Indeed, the only reported antibody binding to the mid-region of CGRP
`
`enhanced its biological activity, i.e., it was not an antagonist. Id. at SOF 171.
`
`
`
`
`
`
`
`C.
`
`In the Antibody IPRs, the PTAB Found That It Would Have Been
`Obvious to Make One Humanized Anti-CGRP Antagonist Antibody
`
`Lilly filed IPR petitions against Teva’s six previously asserted and related patents claiming
`
`a vast genus of human or humanized anti-CGRP antagonist antibodies. Id. at SOF 2, 15-21. In
`
`these Antibody IPRs, Lilly asserted, and the PTAB agreed, that it would have been obvious to
`
`make a murine antibody and humanize it to produce a humanized antibody within the scope of
`
`Teva’s claims. Id. at SOF 18-21. Teva acknowledges that the issue in the Antibody IPRs was
`
`whether it would have been obvious to make a single claimed antibody. See, e.g., Br. 4 (the “central
`
`issue” was the obviousness of “making a humanized antibody”); id. 5 (“a ‘humanized’ antibody”);
`
`id. 19 (“Lilly had shown” obviousness of “a humanized anti-CGRP antagonist antibody”); see also
`
`RSUMF ¶ 14 (“an anti-CGRP antagonist antibody”), ¶ 19 (“the claimed antibody”), ¶ 28
`
`(“a humanized” antibody), ¶ 35 (“an anti-CGRP antibody”), ¶ 46 (“humanize an antibody”), ¶ 49
`
`(“making a murine antibody” and “humanizing it”).
`
`Citing three prior art references discussing only a handful of murine antibodies, the PTAB
`
`found “that anti-CGRP antagonist antibodies were well known in the art, and that the art
`
`encouraged the development of humanized anti-CGRP antibodies.” Eli Lilly & Co. v. Teva
`
`Pharms. Int’l GmbH, IPR2018-01422, 2020 WL 806932, at *40 (PTAB Feb. 18, 2020). Quoting
`
`Teva’s IPR expert, Dr. Tomlinson, the PTAB also found that a POSA would have reasonably
`
`expected to make such a humanized antibody, notwithstanding that humanization is “not a process
`
`to be taken lightly … you’re not guaranteed to be successful.” Id. at *42.
`
`4
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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 12 of 29
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`The PTAB did not hold that humanized or human anti-CGRP antagonist antibodies were
`
`well known (or known at all). The PTAB also did not hold that the structural and functional
`
`diversity of murine anti-CGRP antagonist antibodies was known. Indeed, the PTAB did not find
`
`that the amino acid sequence of any such antibody was known. The PTAB did not find that murine
`
`anti-CGRP antagonist antibodies of any and all antibody classes, fragments, affinities, and epitopes
`
`were known. Nor did the PTAB find that making a humanized or human antibody was fast, easy,
`
`or trivial. In the Antibody IPRs, the PTAB also did not evaluate whether an antibody would work
`
`for treating migraine or any other headache disorder, as required by the asserted claims in this case.
`
`Id. at *23 n.51 (“[W]e determine that it is not necessary to inquire in these proceedings whether
`
`there would have been a reasonable expectation of success for treatment….”). Instead, that issue
`
`was reserved for the Antibody Method of Treatment IPRs, discussed below.
`
`D.
`
`In the Antibody Method of Treatment IPRs, Teva Successfully
`Established That Prior Art Anti-CGRP Antibodies and Methods
`Would Not Have Led to Successful Treatment of Migraine
`
`Lilly also filed IPR petitions against the three patents-in-suit. Those patent claims include
`
`limitations not present in Teva’s antibody patents, including that an “effective amount” of a human
`
`or humanized anti-CGRP antagonist antibody must “treat” headache disorders including migraine.
`
`ECF No. 295 at SOF 1, 3-14, 22-24.
`
`At Teva’s insistence, the PTAB found that the prior art would not have led a POSA to
`
`expect that such an antibody could treat migraine. Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`
`IPR2018-01710, 2020 WL 1540364, at *63 (PTAB Mar. 31, 2020) (“Although Queen establishes
`
`the ability of a POSA to make a humanized anti-CGRP antibody, Queen does not remedy the
`
`deficiencies of [the prior art] because the claims are directed to methods of administering the anti-
`
`CGRP antibody and achievement of a beneficial or desired result.”). Specifically, the PTAB
`
`concluded that a POSA would not have had “a reasonable expectation of success in using an
`5
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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 13 of 29
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`antibody treatment in view of … the uncertainty in whether anti-CGRP antibodies needed to cross
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`the blood-brain barrier to reduce incidence of or treat headache such as migraine.” Id. at *59. The
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`blood brain barrier (BBB) is a physical barrier that was understood to prevent antibodies from
`
`crossing into the brain. ECF No. 295 at SOF 126-148. Teva again prevailed on that position at the
`
`Federal Circuit. Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1348 (Fed. Cir. 2021).
`
`III. LEGAL STANDARDS
`
`When a court analyzes judicial estoppel at summary judgment, all ambiguities and all
`
`factual inferences must be drawn in a light most favorable to the nonmoving party. Amgen, Inc. v.
`
`Sanofi, No. 14-cv-1317, 2019 WL 259099, at *2 (D. Del. Jan. 18, 2019); United States v. Diebold,
`
`Inc., 369 U.S. 654, 655 (1962). Judicial estoppel is a harsh, discretionary remedy that courts apply
`
`“with caution” and reluctance. Sexual Minorities Uganda v. Lively, 899 F.3d 28, 32 (1st Cir. 2018);
`
`Asarco, LLC v. Noranda Mining, Inc., 844 F.3d 1201, 1207-08 (10th Cir. 2017).
`
`Judicial estoppel generally requires analyzing three factors. First, estoppel cannot apply
`
`unless a party takes a position “clearly inconsistent” with an earlier one. New Hampshire, 532 U.S.
`
`at 750. The mere “appearance of inconsistency” is insufficient. Lampi Corp. v. Am. Power Prods.,
`
`Inc., 228 F.3d 1365, 1377 (Fed. Cir. 2000). The moving party must meet the high burden of
`
`establishing that the two positions are irreconcilable, i.e., mutually exclusive. Alt. Sys. Concepts,
`
`Inc. v. Synopsys, Inc., 374 F.3d 23, 33 (1st Cir. 2004). That analysis requires evaluating the relevant
`
`legal context because “two seemingly divergent statutory contentions are often consistent, each
`
`with the other.” Cleveland, 526 U.S. at 797; Amgen, 2019 WL 259099, at *6 (finding no
`
`inconsistency between an earlier position that “generating antibodies was routine” and a later
`
`position “that making additional antibodies requires undue experimentation” under § 112).
`
`Second, judicial estoppel cannot apply unless the court also accepted the party’s earlier
`
`position, such that there would be a “perception that either the first or the second court was misled.”
`6
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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 14 of 29
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`New Hampshire, 532 U.S. at 750-51 (the primary goal of judicial estoppel is to avoid the “risk of
`
`inconsistent court determinations”). Mere surmise about what a court accepted is insufficient—the
`
`“showing of judicial acceptance must be a strong one.” Egenera, Inc. v. Cisco Sys., Inc., 972 F.3d
`
`1367, 1379 (Fed. Cir. 2020). Third, courts often inquire whether a party would gain an unfair
`
`advantage absent application of judicial estoppel. Id. The Court also has discretion to weigh the
`
`equities against the moving party. See Duggan v. Martello, No. 18-cv-12277, 2021 WL 4295828,
`
`at *8-9 (D. Mass. Sept. 21, 2021); Sexual Minorities, 899 F.3d at 32-33 (judicial estoppel is
`
`inappropriate if it would confer an “undue benefit” on the moving party or “imping[e] on the truth-
`
`seeking function of the court.”).
`
`IV. ARGUMENT
`A.
`
`Teva’s Motion Should Be Denied for Failing to Prove Judicial Estoppel
`1.
`
`Teva Failed to Address the Different Legal Contexts Between
`Proceedings and Thus Cannot Establish Mutual Exclusivity
`
`It is hornbook law that a party seeking judicial estoppel “must take care to recognize that
`
`[any] seeming inconsistencies may be explained by the different legal standards that may
`
`masquerade under similar legal expressions.” Paper, Allied-Indus., Chem. & Energy Workers Int’l
`
`Union, AFL-CIO, CLC v. Allied Textile Cos., 235 F. Supp. 2d 8, 21 (D. Me. 2002) (quoting Wright
`
`& Miller, Federal Practice and Procedure § 596-97 (2d ed. 2002)). By wielding expressions such
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`as “routine,” “conventional,” and “well known” without regard for their different contexts under
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`§ 103 and § 112, Teva failed to establish any inconsistency in Lilly’s positions. See Br. 16-20.
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`Under § 103, a functionally defined antibody claim is invalid if a “single embodiment
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`falling within the scope of the claims is obvious.” Abbott, 971 F. Supp. 2d at 182. When a patent
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`claim contains only functional requirements, as here, a POSA “need not [be able to] predict the
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`Case 1:18-cv-12029-ADB Document 356 Filed 05/10/22 Page 15 of 29
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`structure” of that single embodiment rendering the claims obvious. Id. at 185. All that is required
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`is that a POSA could “get[] some antibody that fell within the claims.” Id.
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`Written description under § 112, by comparison, requires a patent specification to provide
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`a detailed disclosure of the structural and functional variety of the entire scope of a claimed
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`antibody genus. Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021).
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`In particular, the specification must disclose either (1) a representative number of species falling
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`within the genus or (2) structural features correlated to the claimed function and common among
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`members of the genus, so that a POSA can visualize or recognize the genus’s members. Abbott,
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`971 F. Supp. 2d at 175. When background prior art is considered in the context of written
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`description, the issue thus is not whether some compounds potentially useful in the claimed
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`treatment methods were merely “well known,” but whether the claimed genus itself was “so well
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`known as to excuse including a more detailed disclosure” in the specification. Bos. Sci. Corp. v.
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`Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011); see also Abbott, 971 F. Supp. 2d at
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`179 (“The key question is whether the disclosed [antibodies] represent the variety in the genus.”).
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`Similarly, for enablement under § 112, the specification must enable a POSA to make and
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`use the full scope of the asserted claims. Wyeth & Cordis Corp. v. Abbott Lab’ys, 720 F.3d 1380,
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`1384 (Fed. Cir. 2013). With broad functional genus claims like Teva’s, it is often of little
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`importance whether certain techniques are “routine” or “conventional,” as Teva asserts, because
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`as a matter of law it is not routine or conventional to iteratively perform those techniques across
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`the full scope of the claims—e.g., making and testing thousands or more compounds to determine
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`if they satisfy the functional requirements of the claims. Id. at 1385-86 (even “accepting as true
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`that one of ordinary skill could routinely use the assays” needed to make and screen compounds,
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`there is “no genuine dispute that practicing the full scope of [functionally defined method] claims
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`would require more than routine experimentation.”).
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`In view of these different statutory standards, this Court has illustrated that there is no
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`inconsistency with common facts leading to different findings supporting invalidity under both
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`§ 103 and § 112, i.e., these two statutes can and do work together in certain contexts. Abbott, 971
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`F. Supp. 2d at 180-81, 86. Applying § 103, the Court held that claims directed to a genus of
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`functionally defined antibodies would have been obvious because predictable prior art techniques
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`would have led a POSA to make one antibody within the scope of the claims, even if the
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`characteristics of that antibody could not be predicted. Id. at 185. Applying § 112, the Court held
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`that the specification did not disclose the necessary characteristics (e.g., amino acid sequences and
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`binding epitopes) of antibodies spanning the breadth of a functionally claimed genus as required
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`for written description, and that making antibodies across the full scope of the claims would have
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`been unpredictable, requiring undue experimentation. Id. at 180-81; accord Pernix Ireland Pain
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`DAC v. Alvogen Malta Operations Ltd., 323 F. Supp. 3d 566, 595-96, 624 (D. Del. 2018), aff’d
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`945 F.3d 1184, 1195 (Fed. Cir. 2019) (“In context, there is no inconsistency between the district
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`court’s findings underlying its obviousness and lack of written description determinations.”).
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`These principles have been addressed in the specific context of judicial estoppel. In Amgen,
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`the court resoundingly rejected plaintiff’s attempt to judicially estop a defendant from pursuing
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`written-description and enablement arguments in view of the defendant’s previous positions before
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`the USPTO that “generating antibodies was routine” and that a “routine technique” was used to
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`screen antibodies. Amgen, 2019 WL 259099, at *5-7. The court found no inconsistency with those
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`positions and the defendant’s § 112 position that making antibodies across the full scope of
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`functionally defined antibody claims nonetheless “requires undue experimentation.” Id.
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`The Court should deny Teva’s motion for similar reasons, as Teva’s out-of-context use of
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`terms like “routine,” “conventional,” and “well known” fatally infects each and every one of the
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`purported “facts” that it requests the Court deem established in this case. Br. at 20.
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`2.
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`Teva Failed to Address Differences in Claim Scope Between
`Proceedings and Thus Cannot Establish Mutual Exclusivity
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`Teva also failed to demonstrate any mutual exclusivity in Lilly’s positions for a second
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`independent reason: it ignored the significant differences between Teva’s asserted claims and those
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`invalidated in the Antibody IPRs, See Egenera, 972 F.3d at 1379 (reversing judicial estoppel where
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`an allegedly inconsistent position was taken in the context of claims of different scope); Cross
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`Med. Prod., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1316 (Fed. Cir. 2005)
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`(declining to apply judicial estoppel based on arguments relating to two different patent claims
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`having different scope).
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`Whereas the Antibody IPRs involved claims requiring only human and/or human anti-
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`CGRP antagonist antibodies, the asserted claims here are directed to administering an “effective
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`amount” of antibodies that work to “treat” migraine and other headache disorders. ECF No. 101
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`at 30-31. Those are important, additional functional requirements of the claimed antibodies—Teva
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`successfully argued in the Antibody Method of Treatment IPRs that the prior art would not have
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`provided a POSA with a reasonable expectation that anti-CGRP antibodies could treat migraine.
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`Supra § II.D. It is thus inappropriate and potentially misleading to take findings about prior-art
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`antibodies and techniques from the Antibody IPRs, which did not consider efficacy, and apply
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`them here, as Teva requests, when Teva previously succeeded in establishing that such pri