Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 1 of 22
`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 1 of 22
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF MASSACHUSETTS
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBHand
`TEVA PHARMACEUTICALSUSA,INC.,
`
`Vv.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`Case No. 1:18-cv-12029-ADB
`
`Leave to File Reply Granted
`December30, 2022 (ECF No.637)
`
`Leave to File Under Seal Granted on
`March 10, 2023 (ECF No. 679)
`
`umeeeBSSs
`
`ITS MOTION FOR JUDGMENTAS A MATTER OF LAW UNDER
`
`FED. R. CIV. P. 50(B) AND/OR A NEW_TRIAL UNDER FED. R. CIV. P. 59
`
`ELI LILLY AND COMPANY’S REPLY IN SUPPORT OF
`
`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 2 of 22
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Introduction ..........................................................................................................................1
`
`Teva’s Patents Fail To Adequately Describe the Claimed Genus of Humanized
`Anti-CGRP Antagonist Antibodies Under Ariad and AbbVie .............................................1
`
`A.
`
`B.
`
`Teva’s Patents Disclose No Common Structure Correlated to Function .................1
`
`Teva’s Patents Fail To Disclose Representative Species .........................................2
`
`III.
`
`There Was No Other Legally Sufficient Evidentiary Basis for a Reasonable Jury
`To Find for Teva ..................................................................................................................5
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`The Claimed Genus of Humanized Antibodies Was Not Well-Known ..................5
`
`Whether a POSA “Could” Make More Humanized Anti-CGRP Antagonist
`Antibodies Is Not the Standard for Written Description .........................................6
`
`Unclaimed Rodent Antibodies Are Not Representative Species .............................8
`
`Teva’s Claims Are “Extremely Broad” ...................................................................8
`
`Teva Fails To Distinguish Halliburton ....................................................................9
`
`Teva’s Tangential and Immaterial Credibility Challenges Cannot Avoid
`JMOL .....................................................................................................................10
`
`IV.
`
`V.
`
`VI.
`
`VII.
`
`Teva Lacks Written Description Under Nuvo ....................................................................11
`
`Teva Provides No Legally Sufficient Basis To Sustain the Verdict on Enablement .........12
`
`In the Alternative, the Court Should Grant Lilly’s Request for a New Trial .....................13
`
`Teva’s Wholly Speculative Trial Presentation Negates Its Future Lost Profits
`Award as a Matter of Law .................................................................................................13
`
`VIII. Conclusion .........................................................................................................................15
`
`i
`
`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 3 of 22
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Abbott GmbH & Co. v. Centocor Ortho Biotech Inc.,
`971 F. Supp. 2d 171 (D. Mass. 2013) ....................................................................................4, 6
`
`AbbVie Deutschland GmbH &Co. v. Janssen Biotech, Inc.,
`759 F.3d 1285 (Fed. Cir. 2014)........................................................................................ passim
`
`Amgen Inc. v. Sanofi,
`872 F.3d 1367 (Fed. Cir. 2017)........................................................................................ passim
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc)........................................................................ passim
`
`Baxalta Inc. v. Genentech, Inc.,
`C.A. No. 17-509-TBD, 2018 WL 3742610 (D. Del. Aug. 7, 2018) ..........................................3
`
`Bos. Sci. Corp. v. Johnson & Johnson Inc.,
`679 F. Supp. 2d 539 (D. Del. 2010), aff’d, 647 F.3d 1353 (Fed. Cir. 2011) .............................7
`
`Brooktree Corp. v. Advanced Micro Devices, Inc.,
`977 F.2d 1555 (Fed. Cir. 1992)..........................................................................................14, 15
`
`Eli Lilly & Co v. Teva Pharms. Int’l GmbH,
`8 F.4th 1331 (Fed. Cir. 2021) ..................................................................................................11
`
`Fail-Safe, L.L.C. v A.O. Smith Corp.,
`744 F. Supp. 2d 870 (E.D. Wis. 2010) .....................................................................................15
`
`Guilloty Perez v. Pierluisi,
`339 F.3d 43 (1st Cir. 2003) ......................................................................................................10
`
`Halliburton Oil Well Cementing Co. v. Walker,
`329 U.S. 1 (1946) .......................................................................................................................9
`
`Holland Furniture Co. v. Perkins Glue Co.,
`277 U.S. 245 (1928) ...................................................................................................................9
`
`In re Hyatt,
`708 F.2d 712 (Fed. Cir. 1983)..................................................................................................10
`
`Idenix Pharms. LLC v. Gilead Scis. Inc.,
`941 F.3d 1149 (Fed. Cir. 2019)................................................................................................13
`
`ii
`
`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 4 of 22
`
`Juno Therapeutics, Inc. v. Kite Pharma, Inc.,
`10 F.4th 1330 (Fed. Cir. 2021) ..............................................................................................5, 9
`
`Lam, Inc. v. Johns-Manville Corp.,
`718 F.2d 1056 (Fed. Cir. 1983)................................................................................................15
`
`MorphoSys AG v. Janssen Biotech, Inc.,
`358 F. Supp. 3d 354 (D. Del. 2019) .........................................................................................13
`
`Nuvo Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy’s Lab’ys Inc.,
`923 F.3d 1368 (Fed. Cir. 2019)................................................................................................12
`
`O’Reilly v. Morse,
`56 U.S. 62 (1853) .................................................................................................................9, 10
`
`Oiness v. Walgreen Co.,
`88 F.3d 1025 (Fed. Cir. 1996)............................................................................................14, 15
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`843 F.3d 1315 (Fed. Cir. 2016)..................................................................................................5
`
`Reeves v. Sanderson Plumbing Prods., Inc.,
`530 U.S. 133 (2000) .................................................................................................................11
`
`Regents of the Univ. of Minn. v. Gilead Scis. Inc.,
`No. 21-2168, 2023 WL 2358853 (Fed. Cir. Mar. 6, 2023) ........................................................4
`
`In re Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) ...................................................................................................6
`
`Standard Oil Co. v. Am. Cyanamid Co.,
`774 F.2d 448 (Fed. Cir. 1985)....................................................................................................7
`
`Teva Pharms. Int’l GmbH v. Eli Lilly & Co.,
`8 F.4th 1349 (Fed. Cir. 2021) ....................................................................................................9
`
`Wyeth & Cordis Corp. v. Abbott Lab’ys,
`720 F.3d 1380 (Fed. Cir. 2013)................................................................................................12
`
`Federal Statutes
`
`35 U.S.C. § 112, ¶ 1 .........................................................................................................................7
`
`35 U.S.C. § 112, ¶ 6 .......................................................................................................................10
`
`iii
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`

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`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 5 of 22
`
`TABLE OF ABBREVIATIONS
`
`Description
`Abbreviation
`U.S. Patent No. 8,586,045
`’045 patent
`U.S. Patent No. 9,884,907
`’907 patent
`U.S. Patent No. 9,884,908
`’908 patent
`Bold and italicized Emphasis added unless indicated otherwise
`BBB
`Blood-brain barrier
`Br.
`Eli Lilly and Company’s Memorandum in Support of Its Motion for
`Judgment as a Matter of Law Under Fed. R. Civ. P. 50(B) and/or a New
`Trial Under Fed. R. Civ. P. 59
`Calcitonin gene-related peptide
`Closed cranial window
`Refers to Exhibits to the accompanying Declaration of Emily R.
`Gabranski in Support of Lilly’s Motion for Judgment as a Matter of
`Law Under Fed. R. Civ. P. 50(b) and/or a New Trial Under Fed. R.
`Civ. P. 59, unless otherwise noted
`Inter partes review
`Judgment as a matter of law
`Eli Lilly and Company
`Plaintiffs’ Opposition to Eli Lilly and Company’s Motion for Judgment
`as a Matter of Law Under Fed. R. Civ. P. 50(B) and/or a New Trial
`Under Fed. R. Civ. P. 59
`Person of ordinary skill in the art
`POSA
`Patent Trial and Appeal Board
`PTAB
`PTX-___ or TX___ Refers to exhibits admitted during trial
`Teva
`Teva Pharmaceuticals International GmbH and Teva Pharmaceuticals
`USA, Inc.
`U.S. Patent Nos. 8,586,045; 9,884,907; and 9,884,908
`
`CGRP
`CCW
`Ex. ____
`
`IPR
`JMOL
`Lilly
`Opp.
`
`Teva’s patents
`
`iv
`
`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 6 of 22
`
`I.
`
`Introduction
`
`Unable to challenge the striking similarities between this case and AbbVie Deutschland
`
`GmbH &Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300-01 (Fed. Cir. 2014), Teva resorts to
`
`incorrectly contending (with no cited authority) that the precedential decision of AbbVie is
`
`somehow “not the law.” Teva then attempts to backfill its written description with rodent
`
`antibodies outside the scope of the claims and the possibility that others could make additional,
`
`undescribed humanized antibodies, but these arguments also violate controlling precedent. Teva’s
`
`reliance on bare credibility challenges relating to tangential issues is further misplaced and fails to
`
`identify any legally sufficient evidentiary basis on which a reasonable jury could have found in
`
`Teva’s favor, warranting JMOL for lack of written description. The Court should likewise grant
`
`Lilly’s motion for JMOL of lack of enablement and no future lost profits, as Teva’s responses
`
`there are similarly evasive, unsubstantiated, and fail to comport with Federal Circuit precedent.
`
`II.
`
`Teva’s Patents Fail To Adequately Describe the Claimed Genus of Humanized
`Anti-CGRP Antagonist Antibodies Under Ariad and AbbVie
`
`Teva does not dispute that its asserted patents must adequately describe the genus of
`
`humanized antibodies necessary for performing the claimed treatment methods. See Br. 15-16
`
`(quoting Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350, 1355 (Fed. Cir. 2010) (en
`
`banc)). The written-description test for such a genus is well established, requiring disclosure of
`
`either (i) a representative number of species within the genus or (ii) a common structure correlated
`
`with the claimed functions. Ariad, 598 F.3d at 1355; AbbVie, 759 F.3d at 1301. Applying this
`
`standard, no reasonable jury could have found Teva’s disclosure sufficient.
`
`A.
`
`Teva’s Patents Disclose No Common Structure Correlated to Function
`
`Both parties’ witnesses testified that there is no structural feature—e.g., amino acid
`
`sequence or otherwise—that is common to the claimed antibody genus and correlated with the
`
`1
`
`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 7 of 22
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`claimed functions of binding to CGRP, antagonizing CGRP, and treating migraine. Br. 12-13; see
`
`Tr. 15-147:8-11 (Hale); Tr. 3-35:10-18 (Zeller); Tr. 11-115:1-17, 117:9-120:4 (McDonnell). Teva
`
`does nothing to address this structure-function deficiency, instead merely listing purported
`
`structures having no correlation to the claimed functions (i.e., (1) Y-shaped structure, (2) generic
`
`structures recited in the ’907 and ’908 patent claims, (3) humanization, and (4) paratope). Opp. 23.
`
`One need look no further than the testimony of Teva’s witnesses to confirm that (1) all
`
`antibodies, not just anti-CGRP antagonists, have a Y-shape; (2) all IgG antibodies, not just anti-
`
`CGRP antagonists, have the generic structural features recited in the ’907 and ’908 patent claims
`
`(e.g., heavy chains, light chains, CDRs, etc.); and (3) humanization is not specific to anti-CGRP
`
`antagonist antibodies. Tr. 2-123:4-13 (Rosenthal); Tr. 15-88:23-89:16 (Hale discussing humanized
`
`antibodies that do not bind CGRP); see also Tr. 11-117:9-119:24 (McDonnell). Nor did any Teva
`
`witness rebut Dr. McDonnell’s testimony that bare references to a “paratope” fail to identify any
`
`structure or sequence necessary to form a CGRP binding site. Tr. 11-119:6-16. Tellingly, Teva
`
`does not even allege that any of these purported structural features are correlated with the claimed
`
`functions, and thus the jury verdict cannot be sustained on this part of the written-description test.
`
`Ariad, 598 F.3d at 1350; AbbVie, 759 F.3d at 1301 (a “structure-function correlation” is required).
`
`B.
`
`Teva’s Patents Fail To Disclose Representative Species
`
`Having failed the common-structure test, Teva’s patents “must adequately describe
`
`representative antibodies to reflect the structural diversity of the claimed genus.” AbbVie, 759
`
`F.3d at 1301 (the “patents must at least describe some species representative of antibodies that are
`
`structurally similar to [the defendant’s antibody]”). Here again, no reasonable jury applying the
`
`correct law could have found Teva’s disclosure adequate.
`
`Teva nowhere disputes the tremendous structural diversity of antibodies within the claimed
`
`genus. That diversity is illustrated by the stark structural differences between Lilly’s Emgality®
`2
`
`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 8 of 22
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`and Teva’s Antibody G1 (and G1 variants), including their vastly different amino acid sequences,
`
`different V gene families, different epitopes, and different CDRs. See Br. 8-11 (Tables 1 and 2);
`
`Tr. 15-145:8-15 (Hale: “Q. [Y]ou did not dispute Dr. McDonnell’s sequence calculations
`
`contrasting Lilly’s antibody galcanezumab with the antibody G1, correct? A. Correct.”). In
`
`contrast to the great structural diversity encompassed by the claims, the only humanized antibodies
`
`disclosed in Teva’s patents are at least 95% identical in their variable domains, representing just
`
`“a corner of the genus” claimed. AbbVie, 759 F.3d at 1300; Tr. 11-86:21-88:16 (McDonnell).
`
`AbbVie’s analogous record presented “no evidence to show any described antibody to be
`
`structurally similar to, and thus representative of, [the defendant’s antibody].” 759 F.3d at 1301.
`
`The same conclusion is warranted here.
`
`Unable to challenge the striking similarities between the trial record here and in AbbVie
`
`(see Br. 8-11 (Tables 1 and 2)), Teva asserts that the binding precedent of AbbVie is somehow “not
`
`the law” (Opp. 15-16). But Teva identifies no authority overruling the legal requirements stated in
`
`AbbVie nor any other reason for this Court to ignore it. In any event, the Federal Circuit has since
`
`reaffirmed the “common-sense logic” underlying AbbVie’s holding. Amgen Inc. v. Sanofi, 872
`
`F.3d 1367, 1374 (Fed. Cir. 2017); see also Baxalta Inc. v. Genentech, Inc., 2018 WL 3742610, at
`
`*7 (D. Del. Aug. 7, 2018) (Dyk, J., sitting by designation, applying AbbVie’s requirement for
`
`structurally representative antibody species).
`
`Teva contends that both AbbVie and Lilly conflate the two-prong test articulated in Ariad.
`
`Opp. 16. Teva is wrong. It is precisely because Teva failed to disclose any common structure
`
`(supra § II.A) that it must disclose a variety of species representing the diverse (i.e., not common)
`
`antibody structures encompassed by the claimed genus. Indeed, the Federal Circuit just restated
`
`that the representative species must allow a POSA to “visualize or recognize the members of the
`
`3
`
`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 9 of 22
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`genus.” Regents of the Univ. of Minn. v. Gilead Scis. Inc., No. 21-2168, 2023 WL 2358853, at *3
`
`(Fed. Cir. Mar. 6, 2023). That principle was endorsed in this district, where the Court held that the
`
`“key question is whether the disclosed species represent the variety in the genus” claimed. Abbott
`
`GmbH & Co. v. Centocor Ortho Biotech Inc., 971 F. Supp. 2d 171, 179 (D. Mass. 2013) (emphasis
`
`in original). The Federal Circuit’s affirmance of Abbott—requiring disclosure of “some species
`
`representative of antibodies that are structurally similar to [the defendant’s antibody]” is indeed
`
`the law and must be applied here. AbbVie, 759 F.3d at 1301; Ariad, 598 F.3d at 1350 (a patentee
`
`must “describe a variety of materials . . . showing that one has invented a genus.”).
`
`Having claimed so broadly as to cover Emgality®, Teva must have disclosed “some species
`
`representative of antibodies that are structurally similar to” Emgality®. AbbVie, 759 F.3d at 1301.
`
`But as in AbbVie, there is “no evidence” here showing that the disclosed antibodies are structurally
`
`similar to Emgality® or remotely representative of the structural diversity encompassed by the
`
`claimed genus. Id. The Court need go no further, as this clears the legal threshold for JMOL—all
`
`asserted claims should be held invalid. See id.; Ariad, 598 F.3d at 1350 (reversing denial of JMOL
`
`where the specification failed to disclose the required “variety of species that accomplish the
`
`result” recited in challenged method claims).
`
`Finally, Teva improperly speculates that the jury could have found that the structural
`
`“differences Dr. McDonnell identified were not important.” Opp. 18. That only further invites
`
`legal error. As explained (Br. 11), such arguments have already been rejected in AbbVie and Juno,
`
`which Teva did not address in its opposition.1 AbbVie, 759 F.3d at 1301 (rejecting argument that
`
`1 Having no witness advance its theory at trial, Teva presents pure attorney argument that G1 could
`be representative of Emgality® if their “full sequence” were compared. Opp. 18. As Dr. McDonnell
`unequivocally explained, such a comparison is irrelevant: the variable domains (and their CDRs)
`“individual [to] different antibodies” matter, not full sequences, which would make “any IgG
`antibody in the world” look the same. Tr. 12-65:22-67:6, 74:8-75:10; Tr. 11-52:25-53:22.
`4
`
`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 10 of 22
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`structural differences are “irrelevant”); Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th
`
`1330, 1337 (Fed. Cir. 2021) (rejecting argument that all claimed antibody fragments “do the same
`
`thing” as “far too general” to avoid JMOL of invalidity).
`
`III.
`
`There Was No Other Legally Sufficient Evidentiary Basis for a Reasonable
`Jury To Find for Teva
`
`Teva’s additional arguments contradict precedent and
`
`the
`
`trial record, further
`
`demonstrating that no reasonable jury applying the correct standards could have found for Teva.
`
`A.
`
`The Claimed Genus of Humanized Antibodies Was Not Well-Known
`
`Teva seeks to fix its deficient patent specification by relying on an inaccurate
`
`characterization of the prior art. Teva wrongly asserts that “the entire class of anti-CGRP
`
`antagonist antibodies was well-known to a POSA” and that Teva’s patents thus “need not teach
`
`. . . what is well known in the art.” Opp. 9, 21; see also id. at 7, 11, 14, 26, 27. But Teva’s argument
`
`contradicts the uniform testimony of both parties’ witnesses that the claimed humanized antibodies
`
`were not known in the art. Br. 16-17 (citing, e.g., Tr. 3-28:6-9 (Zeller: “Q. [H]umanized anti-CGRP
`
`antibodies were not a previously known class of compound, correct? A. That is correct.”); Tr. 15-
`
`144:17-24 (Hale: “Q. [Y]ou did not identify any examples of humanized anti-CGRP antagonist
`
`antibodies in the prior art, correct? A. Correct.”)). Teva’s flawed position that a reasonable jury
`
`could have believed that the claimed genus of antibodies was well-known in the prior art—when
`
`even Teva’s own inventors and experts testified that no such antibodies existed—confirms that
`
`JMOL is warranted. Br. 16-17; Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`
`843 F.3d 1315, 1336-38 (Fed. Cir. 2016) (holding that no reasonable jury could have upheld patent
`
`validity contrary to admissions from the patentee’s own expert).
`
`Teva’s attempt to distinguish Amgen, AbbVie, and Juno based on this “well-known genus”
`
`theory thus also fails. Opp. 12-13. As in those cases, Teva’s claims are directed to a novel genus
`
`5
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`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 11 of 22
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`of antibodies previously unknown to a POSA, which must therefore be described. E.g., Tr. 3-28:6-
`
`9 (Zeller); Tr. 15-144:17-24 (Hale). As in those cases, Teva’s patents merely instruct a POSA to
`
`make undescribed antibodies using a variety of prior art technologies. TX-1 at 37:35-38:3. While
`
`Teva alleges that none of those cases involved “a class of antibodies . . . that was previously
`
`determined to be obvious,” Teva overlooks AbbVie and thus is wrong there too. Opp. 12-13. In
`
`that case, the court found the claimed antibody genus both obvious and inadequately described,
`
`thus reinforcing that a disclosure like Teva’s—that at most renders a claimed genus obvious—
`
`provides inadequate written description. Abbott, 971 F. Supp. 2d at 174, aff’d, 759 F.3d at 1290.
`
`B.
`
`Whether a POSA “Could” Make More Humanized Anti-CGRP
`Antagonist Antibodies Is Not the Standard for Written Description
`
`Inviting further legal error, Teva argues that the named inventors did not need to describe
`
`more because a POSA “could” make additional humanized anti-CGRP antagonist antibodies using
`
`prior art techniques. Opp. 1-3, 13-16, 19-21. The Federal Circuit has already concluded that ability-
`
`to-make-and-use arguments like Teva’s run “afoul of what is perhaps the core ruling of Ariad”—
`
`i.e., the existence of a written description requirement separate from the make-and-use enablement
`
`standard. Amgen, 872 F.3d at 1377-78 (“to satisfy the statutory requirement of a description of the
`
`invention, it is not enough for the specification to show how to make and use the invention”).
`
`As the Federal Circuit and its predecessor have held for decades, the mere possibility that
`
`a POSA could make compounds within a claimed genus is not an adequate description of those
`
`compounds. See In re Ruschig, 379 F.2d 990, 995 (C.C.P.A. 1967) (the question is not whether a
`
`POSA could make a claimed compound, “but whether the specification discloses the compound
`
`to [the POSA]”); Amgen, 872 F.3d at 1377-78 (same); Ariad, 598 F.3d at 1352 (same). Lilly
`
`explained these principles at length in its opening brief (see Br. 19-20), but Teva never responded
`
`to them. Undeterred, Teva asserts repeatedly that more humanized antibodies within the scope of
`
`6
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`

`

`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 12 of 22
`
`the claims “could” be made:
`
`“Antibodies . . . could be
`rapidly identified” (Opp. 3)
`
`“a POSA could humanize
`them” (id.)
`“antibodies that could have
`been routinely humanized”
`(id. at 16)
`“you would be able
`humanize it” (id.)
`
`to
`
`“antibodies that could be
`routinely humanized” (id. at
`13)
`“antibodies that could be
`routinely humanized” (id.)
`“antibodies that could be
`humanized” (id. at 20)
`
`“these could have been routinely
`humanized” (id. at 14)
`
`“antibodies that could be
`routinely humanized” (id.)
`“a POSA could readily
`humanize them” (id.)
`
`“could be routinely
`humanized” (id. at 21)
`
`“antibodies . . . that could be
`routinely humanized” (id.)
`
`But the law is crystal clear: that an “antibody could easily be ‘produced’” is insufficient to “deem
`
`any antibody within the claim adequately described.” Amgen, 872 F.3d at 1377. By relying on the
`
`possibility of others “making” more antibodies as a substitute for written description of those
`
`antibodies, Teva violates en banc Federal Circuit precedent. Ariad, 598 F.3d at 1352.
`
`Moreover, no reasonable jury could have concluded that a POSA would have been able to
`
`make representative antibodies spanning the claimed genus. The named inventors, who possess at
`
`least ordinary skill (if not more), did not and could not make antagonist antibodies that bind the
`
`mid-region of CGRP, like Emgality®, despite years of trying. Br. 13-14; see Standard Oil Co. v.
`
`Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985) (inventors have greater than ordinary skill).
`
`Teva does not deny their lack of success (Opp. 21),2 but argues that actual reduction to practice
`
`(i.e., actually making mid-region binding antibodies) is not required. Opp. 22. The problem for
`
`Teva is that they tried but failed: the named inventors “could not have described a knowledge that
`
`they did not possess.” Bos. Sci. Corp. v. Johnson & Johnson Inc., 679 F. Supp. 2d 539, 555 (D.
`
`Del. 2010), aff’d, 647 F.3d 1353 (Fed. Cir. 2011).
`
`2 Even if, as Teva argues, the named inventors “set . . . aside” their work to focus on other priorities
`(Opp. 22), this too confirms that they never succeeded in making antibodies like galcanezumab,
`and therefore “are not entitled to a patent” under § 112, ¶ 1. Ariad, 598 F.3d at 1352-53 (“[A]
`patent is . . . not a reward for the search, but compensation for its successful conclusion.”); Br. 14.
`7
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`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 13 of 22
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`C.
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`Unclaimed Rodent Antibodies Are Not Representative Species
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`Next, Teva points to unclaimed rodent antibodies as supposedly providing written
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`description for the claimed humanized antibodies. Opp. 2, 13-15, 18-21. This argument also fails.
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`As both parties’ experts testified, rodent antibodies are not humanized, and thus they are
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`irrelevant to the representative species analysis because they are not “within the scope of the
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`genus” claimed, as required. Ariad, 598 F.3d at 1350; Tr. 11-69:18-23, 148:9-12 (McDonnell:
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`“They are not humanized antibodies,” thus, “do not fall within the scope of the claims”); Tr. 15-
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`67:16-18 (Hill); Tr. 15-163:2-14 (Hale: rodent antibodies are “not . . . part of the scope of the
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`claim”). Moreover, the uncontroverted evidence at trial established that those rodent antibodies
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`could not have been humanized or visualized because their amino acid sequences were unknown.
`
`See Tr. 15-67:19-21 (Hill: “Q. And none of the references you’ve identified report the amino acid
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`sequence of the rodent antibodies tested, correct? A. Correct, yes.”); Tr. 11-71:3-12 (McDonnell:
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`“Without that sequence information, you can’t undertake the humanization process.”). But in any
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`event, whether the rodent antibodies “could be humanized,” as Teva asserts, is irrelevant as
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`discussed above. Supra § III.B; Amgen, 872 F.3d at 1377-78 (that an antibody “could easily be
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`‘produced’” is insufficient for written description).
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`G1’s variants are similarly irrelevant. They were not shown to antagonize CGRP, as
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`required by the claims. And even if they had been, they are so similar to G1 (i.e., at least 95%
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`identical in their variable domains) they cannot be representative of Emgality® and the structurally
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`diverse genus of claimed antibodies. Tr. 11-84:3-14, 147:24-148:8 (McDonnell).
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`D.
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`Teva’s Claims Are “Extremely Broad”
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`Teva also improperly tries to shift the goalposts for analyzing written description by
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`contending that the antibody limitations of the asserted claims are “limited” in scope. Opp. 11-12.
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`But the Federal Circuit has already evaluated the exact same claim limitations and found Teva’s
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`8
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`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 14 of 22
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`“functionally claimed antibodies” to be “extremely broad” in scope. Teva Pharms. Int’l GmbH v.
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`Eli Lilly & Co., 8 F.4th 1349, 1362-63 (Fed. Cir. 2021). Moreover, Teva’s witnesses repeatedly
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`testified that the asserted claims cover “any” and “all function blocking antibodies.” Tr. 3-52:5-12
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`(Zeller); Tr. 3-150:13-22 (Abdiche). As noted above, the issue here is not whether functional
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`antibodies “could” be made. Supra § III.B. The fatal flaw is that species representing the structural
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`diversity of such antibodies have not been described. AbbVie, 759 F.3d at 1300-01.
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`Attempting to re-do claim construction, Teva makes an unsupported proclamation that the
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`humanized limitation “narrows” the scope of the claimed antibody genus to those that can be
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`obtained using known methods and procedures described in its patents. Opp. 12. But Teva’s
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`claims, as construed, are not limited to those methods. ECF No. 101 at 33. Indeed, Lilly made
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`Emgality® using methods not disclosed in Teva’s patents. Tr. 8-201:16-203:11 (Benschop); Tr. 9-
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`216:20-219:16, 10-18:24-22:16 (Darling); TX-3082; TX-3006. Teva’s sham distinction over
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`Amgen, AbbVie, and Juno based on purported differences in antibody generation similarly fails, as
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`those claims, like Teva’s, are not so limited. Opp. 12-13; 872 F.3d at 1372; 759 F.3d at 1292; 10
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`F.4th at 1334. And Teva’s argument that Dr. McDonnell’s calculations were erroneous because
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`they did not reflect the “animal immunization method disclosed by the patents” fails for the same
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`reason. Opp. 12. No reasonable jury could have found that the scope of the asserted claims is
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`anything less than “extremely broad.” Teva, 8 F.4th at 1362-63.
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`E.
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`Teva Fails To Distinguish Halliburton
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`Teva’s asserted claims also violate longstanding Supreme Court precedent holding that
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`purely functional claims like Teva’s are invalid as a matter of law. O’Reilly v. Morse, 56 U.S. 62,
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`113 (1853); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 257 (1928); Halliburton
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`Oil Well Cementing Co. v. Walker, 329 U.S. 1, 9 (1946) (describing a claim’s “most crucial
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`element” by “what it will do, rather than in terms of its own physical characteristics . . . is invalid
`9
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`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 15 of 22
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`as a violation of [the predecessor of 35 U.S.C. § 112]”).
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`While 35 U.S.C. § 112, ¶ 6 was enacted in response to Halliburton, that statute applies only
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`to “combination” claims involving multiple steps, not single-step method claims like Teva’s. As
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`the Federal Circuit has recognized, ¶ 6 did not abrogate the broader rule applied in Halliburton
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`and O’Reilly to consistently invalidate functional, single-step claims as unlawfully covering “every
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`conceivable means for achieving the stated result.” In re Hyatt, 708 F.2d 712, 714-15 (Fed. Cir.
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`1983) (citing O’Reilly, 56 U.S. at 112); id. at 714 n.5 (“single means claims have been regarded
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`as improper ever since” O’Reilly); Ariad, 598 F.3d at 1346 n.4 (relying on O’Reilly).
`
`F.
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`Teva’s Tangential and Immaterial Credibility Challenges Cannot Avoid
`JMOL
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`The standard for JMOL requires assessing whether there was a “legally sufficient
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`evidentiary basis for a reasonable jury to find for the [non-moving] party.” Guilloty Perez v.
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`Pierluisi, 339 F.3d 43, 50 (1st Cir. 2003). It does not allow Teva to avoid JMOL by raising
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`tangential credibility arguments, which do not bear on or remedy the core insufficiency of the trial
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`record to support the verdict under controlling law, as Teva urges here.
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`Indeed, nothing about Lilly’s JMOL challenge “assumes that the jury needed to credit Dr.
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`McDonnell over Teva’s experts” (Opp. 6) for the simple reason that Teva’s fact and expert
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`witnesses never disputed his core testimony about the lack of common structure and representative
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`species under Ariad and AbbVie. Supra § II; see, e.g., Tr. 15-145:8-15 (Hale: “Q. [Y]ou did not
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`dispute Dr. McDonnell’s sequence calculations contrasting Lilly’s antibody galcanezumab with
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`the antibody G1, correct? A. Correct.”); id. at 144:17-24 (“Q. [Y]ou did not identify any examples
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`of humanized anti-CGRP antagonist antibodies in the prior art, correct? A. Correct.”); Tr. 3-52:5-
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`12 (Zeller: the claims broadly cover “all antibodies, all function blocking antibodies”).
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`On JMOL, the Court should give credence to such “evidence supporting the moving party
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`10
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`Case 1:18-cv-12029-ADB Document 686 Filed 03/15/23 Page 16 of 22
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`that is uncontradicted and unimpeached.” Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S.
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`133, 150-51 (2000). Even Teva’s incorrect contention that Dr. McDonnell considered only a
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`portion of