Case 1:18-cv-12029-ADB Document 584 Filed 11/06/22 Page 1 of 7
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
`
`
`Plaintiffs,
`
`
`v.
`
`ELI LILLY AND COMPANY,
`
`
`
`
`Civil Action No.
`1:18-cv-12029-ADB
`
`
`
`
`
`
`Defendant.
`
`
`
`TEVA’S RESPONSE TO ELI LILLY AND COMPANY’S
`SUPPLEMENTAL BRIEF REGARDING THE JURY CHARGE
`
`
`
`

`

`Case 1:18-cv-12029-ADB Document 584 Filed 11/06/22 Page 2 of 7
`
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION .............................................................................................................. 1
`ARGUMENT ...................................................................................................................... 1
`CONCLUSION ................................................................................................................... 3
`
`
`
`
`I.
`II.
`III.
`
`
`
`i
`
`

`

`Case 1:18-cv-12029-ADB Document 584 Filed 11/06/22 Page 3 of 7
`
`
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010)..................................................................................................1
`
`Bayer Healthcare LLC v. Baxalta Inc.,
`989 F.3d 964 (Fed. Cir. 2021)....................................................................................................1
`
`Koito Mfg. Co. v. Turn-Key-Tech, LLC,
`381 F.3d 1142 (Fed. Cir. 2004)..................................................................................................2
`
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997)..................................................................................................1
`
`Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd.,
`323 F. Supp. 3d 566 (D. Del. 2018) ...........................................................................................2
`
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988)....................................................................................................2
`
`
`
`ii
`
`

`

`Case 1:18-cv-12029-ADB Document 584 Filed 11/06/22 Page 4 of 7
`
`
`
`I.
`
`INTRODUCTION
`
`Teva respectfully submits this response to Lilly’s supplemental brief regarding the draft
`
`jury charge. ECF No. 583.
`
`II. ARGUMENT
`
`Lilly is badly confusing two very different concepts. The standard for written description
`
`requires that the claimed invention be described in the specification, not just be obvious in light of
`
`some different invention described in the specification. Therefore, if the specification nowhere
`
`described the invention of a method of treatment using humanized anti-CGRP antagonist
`
`antibodies—for example, if the specification only described the invention as the use of murine
`
`antibodies—then whether it would be obvious to use humanized antibodies could be insufficient
`
`for written description purposes. That is the point of the Lockwood and Ariad decisions Lilly cites.
`
`See ECF No. 583 at 3 (citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed.
`
`Cir. 2010)); Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
`
`But of course here, the specification does describe the invention as a method of using
`
`humanized anti-CGRP antagonist antibodies, so the “obviousness” case law on which Lilly relies
`
`is entirely inapplicable. What Lilly is mistakenly trying to do is take that body of inapplicable
`
`law, and use it argue that a POSA in reading the written description would not combine the
`
`teachings of the prior art in support of the invention that is described—in this case, for example,
`
`that a POSA could not—as a matter of law—combine knowledge of numerous murine anti-CGRP
`
`antagonist antibodies, and knowledge of routine humanization techniques, to understand what
`
`tools could be used to perform the described and claimed method of using humanized anti-CGRP
`
`antagonist antibodies. None of the cases Lilly cites stand for that very different proposition, and
`
`the law is to the contrary. As the Court knows, “[a] patent need not teach, and preferably omits,
`
`1
`
`

`

`Case 1:18-cv-12029-ADB Document 584 Filed 11/06/22 Page 5 of 7
`
`
`
`what is well known in the art.” Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964, 982 (Fed.
`
`Cir. 2021); In re Wands, 858 F.2d 731, 735 (Fed. Cir. 1988) (“A patent need not disclose what is
`
`well known in the art.”); Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1156 (Fed. Cir.
`
`2004). Therefore, having described the invention as a method of using humanized anti-CGRP
`
`antagonist antibodies, the applicants did not need to further describe all the details concerning
`
`murine antibodies and humanization that already would have been known to a POSA.
`
`Lilly might try to argue as a factual matter that a POSA would not have viewed the murine
`
`antibodies as particularly relevant to humanized antibodies—Teva, and the PTO in issuing the
`
`patents and the PTAB in finding that a POSA would have been motivated to create the humanized
`
`antibodies used in the claims, obviously disagreed—but Lilly’s factual position does not impact
`
`the applicable law. In that regard, the Pernix case that Lilly attaches to its email is easily
`
`distinguishable. See ECF No. 583 at 5 (citing Pernix Ireland Pain DAC v. Alvogen Malta
`
`Operations Ltd., 323 F. Supp. 3d 566, 626–27 (D. Del. 2018)). There, the court, sitting as fact
`
`finder in a bench trial, concluded as a factual matter that “the identity of the hydrocodone
`
`formulations that would have a similar effect on subjects with and without hepatic impairment was
`
`not known.” Pernix, 323 F. Supp. at 626. Here, of course, the PTAB previously found that a
`
`POSA would have known of anti-CGRP antagonist antibodies that could be used in the invention,
`
`and been motivated to humanize them. The jury is entitled to draw the same conclusion. Nowhere
`
`does Pernix state that, in a method of use claim, where a POSA would have been motivated to take
`
`a prior art composition and modify it in the manner required by the claimed invention, nonetheless,
`
`as a matter of law, the prior art composition should be ignored, which seems to be the position
`
`Lilly’s “obviousness” argument asserts.
`
`2
`
`

`

`Case 1:18-cv-12029-ADB Document 584 Filed 11/06/22 Page 6 of 7
`
`
`
`III. CONCLUSION
`
`The Court therefore should keep the language on pages 33–34 of the Court’s proposed final
`
`jury instruction, which Lilly seeks to strike.
`
`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)
`Kevin P. Martin (BBO# 655222)
`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
`kmartin@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
`
`
`Attorneys for Plaintiffs
`
`
`
`
`
`
`
`Dated: November 6, 2022
`
`
`
`
`
`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
`
`Audie Soucy (pro hac vice)
`Grace P. Truong (pro hac vice)
`Gabriel B. Ferrante (pro hac vice)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 8th Ave
`New York, NY 10018
`Tel.: (212) 813-8800
`Fax: (212) 355-3333
`asoucy@goodwinlaw.com
`gtruong@goodwinlaw.com
`gferrante@goodwinlaw.com
`
`
`3
`
`

`

`Case 1:18-cv-12029-ADB Document 584 Filed 11/06/22 Page 7 of 7
`
`
`
`CERTIFICATE OF SERVICE
`
`I, Elaine Herrmann Blais, 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 6, 2022.
`
`
`
`
`
`/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
`
`4
`
`