Case 1:18-cv-12029-ADB Document 567 Filed 11/01/22 Page 1 of 5
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`TEVA PHARMACEUTICALS
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`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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`Defendant.
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`Case No. 1:18-cv-12029-ADB
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`ELI LILLY AND COMPANY’S OPPOSITION TO TEVA’S MOTION TO EXCLUDE
`LILLY’S EXPERTS FROM TESTIFYING CONCERNING POST-FILING
`EXPERIMENTATION
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`Case 1:18-cv-12029-ADB Document 567 Filed 11/01/22 Page 2 of 5
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`I.
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`Introduction
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`The Court has already denied Teva’s Motion in Limine No. 1 seeking to exclude post-filing
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`date evidence relating to enablement. ECF No. 535 at 3 (“[B]ecause evidence that post-dates the
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`filing date is not categorically irrelevant to the issues of written description and enablement, Teva’s
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`motion is DENIED.”). In seeking to revisit this ruling, Teva raises only factually and legally
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`unsupported arguments that invite legal error and should be rejected.
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`II.
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`Argument
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`Teva fails to identify any case law supporting its position that an accused infringer must be
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`aware of an asserted patent for its post-filing date experimentation to have relevance for lack of
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`enablement. In Abbott, the Court credited the difficulties of the defendant’s inventors in arriving
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`at the accused Stelara® antibody as supporting lack of enablement. Abbott GmbH & Co. v.
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`Centocor Ortho Biotech, Inc., 971 F. Supp. 2d 171, 181 (D. Mass. 2013), aff’d 759 F.3d 1285
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`(Fed. Cir. 2014). The Court nowhere required the defendant’s inventors to have known of the
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`asserted patents. Nor did the Baxalta court require the defendants’ inventors of the accused
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`antibody (emicizumab) to have known of the asserted patents for their difficulties to support lack
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`of enablement. Baxalta Inc. v. Genentech, Inc., 579 F. Supp. 3d 595, 624 (D. Del. 2022)
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`(“Significantly, it took Chugai over ten years of multi-phased experimentation and the screening
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`of tens of thousands of candidate compounds to discover emicizumab.”). There is, indeed, no basis
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`in the law for excluding the efforts of Lilly’s “large team” of “over 40 people” in making Lilly’s
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`antibody, galcanezumab (Emgality®). See, e.g., Trial Tr., Day 9 at 207:13-208:2.
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`Teva’s motion also operates from a factually flawed presumption: that the common
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`specification of the patents-in-suit allegedly discloses how to make and use an antibody similar to
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`Lilly’s antibody, which could have shortened Lilly’s efforts. Abbott, 971 F. Supp. 2d at 181 (“[T]he
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`fact that the patent did not enable any antibodies like [the accused antibody], this conclusion
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`1
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`

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`Case 1:18-cv-12029-ADB Document 567 Filed 11/01/22 Page 3 of 5
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`supports the jury’s determination that the patent did not enable the full scope of the claimed
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`invention.”). Whether the patents-in-suit contain such a disclosure is precisely the issue currently
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`before the jury—not a basis for excluding evidence. Notably, in its motion, Teva fails to identify
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`any disclosure in its specification directing or enabling a POSA to make Lilly’s galcanezumab or
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`any antibody similar to galcanezumab, as required, which distinguishes Teva’s reliance on
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`Allegan. Mot. at 1; Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1310 (Fed. Cir. 2015) (holding,
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`unlike here, that the patent specifications “provide sufficient guidance” (emphasis added)).
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`Indeed, nowhere does Teva allege that its patents-in-suit disclose the amino acid sequence
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`of galcanezumab (or any antibody close to galcanezumab’s sequence). Teva has admitted no such
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`disclosure exists. ECF No. 400 at SOF 346 (citing Teva Response to RFA No. 3); MorphoSys AG
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`v. Janssen Biotech, Inc., 358 F. Supp. 3d 354, 371-72 (D. Del. 2019) (knowing the sequence of
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`one antibody does not assist with identifying other unique, non-variant antibodies within the scope
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`of the claims). Teva also nowhere alleges that its patents-in-suit disclose how to make any
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`antagonist antibody that binds to CGRP’s mid-region, as Lilly’s galcanezumab does. TX-0001 at
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`49:8-51:3 (’045 Patent, Example 1: “all 12 antibodies target a C-terminal epitope”); Trial Tr., Day
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`3 at 31:24-32:7, 33:2-34:15; TX-3454 at Zeller_FREM_00014559 (“All our mAbs are C-
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`terminal”). Teva further fails to identify any disclosure in the specification purporting that Teva’s
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`named inventors actually invented any new or faster methods for making or humanizing
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`antibodies. Dr. Zeller’s testimony confirms they did not—the Rinat team relied instead on third-
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`party immunization techniques. Trial Tr., Day 2 at 155:21-156:11. It is also undisputed that the
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`specification does not even describe how Teva’s Antibody G1 was made, let alone Lilly’s
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`antibody:
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`2
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`Case 1:18-cv-12029-ADB Document 567 Filed 11/01/22 Page 4 of 5
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`SOF 188: “The specification of the Patents-in-Suit does not
`expressly disclose how Antibody G1 was made.”
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`Response: “Teva does not dispute that paragraph 188 is factually
`accurate in that the generation of G1 is not specifically disclosed in
`the specification.”
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`ECF No. 400 at SOF 188. Teva thus fails to identify any meaningful information in its patents-in-
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`suit that would have guided anyone to make an antibody similar to Lilly’s galcanezumab
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`(Emgality®), much less shorten the efforts of Lilly’s inventors and antibody development team.
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`Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1283 (Fed. Cir. 2007) (“Although
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`the knowledge of one skilled in the art is indeed relevant, the novel aspect of an invention must be
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`enabled in the patent.”).
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`Accordingly, Teva incorrectly attempts to create from whole cloth an unsupported
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`exception to Amgen’s clear pronouncement that post-priority-date evidence “should not [be]
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`excluded simply because it post-date[s] the claims’ priority date.” Amgen Inc. v. Sanofi, 872 F.3d
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`1367, 1374 (Fed. Cir. 2017); ECF No. 535 at 3. Teva courts similar legal error as occurred in
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`Amgen, and thus Teva’s motion should be denied. 872 F.3d at 1374; see also Plant Genetic Sys.,
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`N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1344 (Fed. Cir. 2003) (“Report of a first success
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`after [the filing date] indicates failure or difficulty [on] or before the [filing date],” supporting lack
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`of enablement); Monsanto Co. v. Bayer Bioscience N.V., No. 4:00-cv-01915, 2005 WL 5989796,
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`at *16 (E.D. Mo. Oct. 28, 2005) (denying motion in limine to exclude post-filing date evidence).
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`III.
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`CONCLUSION
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`Teva presents no basis for revisiting or modifying the Court’s previous decision on Teva’s
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`Motion in Limine No. 1. Lilly respectfully requests that Teva’s motion be denied.
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`3
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`Case 1:18-cv-12029-ADB Document 567 Filed 11/01/22 Page 5 of 5
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`Dated: November 1, 2022
`
` /s/ Andrea L. Martin
`Andrea L. Martin (BBO 666117)
`BURNS & LEVINSON LLP
`125 High Street
`Boston, MA 02110-1624
`(617) 345-3000
`amartin@burnslev.com
`
`William B. Raich
`Danielle A. Duszczyszyn
`Denise Main
`Pier D. DeRoo
`Matthew Luneack
`Yoonjin Lee
`Sydney Kestle
`J. Michael Jakes
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`William.Raich@finnegan.com
`Danielle.Duszczyszyn@finnegan.com
`Denise.Main@finnegan.com
`Pier.DeRoo@finnegan.com
`Matthew.Luneack@finnegan.com
`Yoonjin.Lee@finnegan.com
`Sydney.Kestle@finnegan.com
`Mike.Jakes@finnegan.com
`
`Charles E. Lipsey
`Ryan O’Quinn
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`1875 Explorer Street
`Suite 800
`Reston, VA 20190-6023
`Charles.Lipsey@finnegan.com
`Oquinnr@finnegan.com
`
`Emily R. Gabranski (BBO 694417)
`Marta Garcia Daneshvar
`Lulu Wang (BBO 704042)
`Li Zhang
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`2 Seaport Lane
`Boston, MA 02210-2001
`Emily.Gabranski@finnegan.com
`Marta.Garcia@finnegan.com
`Lulu.Wang@finnegan.com
`
`Attorneys for Defendant
`Eli Lilly and Company
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`CERTIFICATE OF SERVICE
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`I, Andrea L. Martin, hereby certify that this document filed through the ECF system will
`be sent electronically to the registered participants as identified on the Notice of Electronic Filing
`(NEF) and paper copies will be sent to those indicated as non-registered participants on
`November 1, 2022.
`
`/s/Andrea L. Martin
`Andrea L. Martin, Esq.
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`4
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