Teva Pharmaceuticals International Gmbh v. Eli Lilly and Company

Case: 24-1094 Document: 100 Page: 1 Filed: 09/30/2026 United States Court of Appeals for the Federal Circuit ______________________ TEVA PHARMACEUTICALS INTERNATIONAL GMBH, TEVA PHARMACEUTICALS USA, INC., Plaintiffs-Appellants v. ELI LILLY AND COMPANY, Defendant-Appellee ______________________ 2024-1094 ______________________ Appeal from the United States District Court for the District of Massachusetts in No. 1:18-cv-12029-ADB, Judge Allison Dale Burroughs. ______________________ ON PETITION FOR REHEARING EN BANC ______________________ JEFFREY A. LAMKEN, MoloLamken LLP, Washington, DC, filed a petition for rehearing en banc for appellee. Also represented by KAYVON GHAYOUMI; CHARLES COLLINS- CHASE, DANIELLE ANDREA DUSZCZYSZYN, J. MICHAEL JAKES, WILLIAM BARRETT RAICH, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC. KEVIN P. MARTIN, Goodwin Procter LLP, Boston, MA, Case: 24-1094 Document: 100 Page: 2 Filed: 09/30/2026 2 TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY filed a response for plaintiffs-appellants. Also represented by ELAINE BLAIS; GABRIEL FERRANTE, New York, NY. ______________________ Before MOORE, Chief Judge, LOURIE, DYK, PROST, REYNA, TARANTO, CHEN, HUGHES, STOLL, CUNNINGHAM, and STARK, Circuit Judges, 1 and ANDREWS, District Judge. 2 DYK, Circuit Judge, dissents from the denial of the peti- tion for rehearing en banc. PER CURIAM. ORDER Eli Lilly and Company filed a petition for rehearing en banc. A response to the petition was invited by the court and filed by Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals International GmbH. IPSEN Biopharmaceuticals, Inc., Merck Sharp & Dohme LLC, Amgen Inc., Sanofi S.A., Johnson & Johnson Nagra USA, Inc., Dennis Burton, David Manuta and Bar- bara Ruskin moved for leave to file briefs as amicus curiae, which the court granted. The petition was first referred as a petition to the panel that heard the appeal, and thereafter the petition was re- ferred to the circuit judges who are in regular active ser- vice. The court conducted a poll on request, and the poll failed. Upon consideration thereof, 1 Circuit Judge Newman did not participate. 2 Honorable Richard G. Andrews, District Judge, United States District Court for the District of Delaware, sitting by designation, participated only in the decision on the petition for panel rehearing. Case: 24-1094 Document: 100 Page: 3 Filed: 09/30/2026 TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. 3 ELI LILLY AND COMPANY IT IS ORDERED THAT: The petition for panel rehearing is denied. The petition for rehearing en banc is denied. FOR THE COURT September 30, 2026 Date Case: 24-1094 Document: 100 Page: 4 Filed: 09/30/2026 United States Court of Appeals for the Federal Circuit ______________________ TEVA PHARMACEUTICALS INTERNATIONAL GMBH, TEVA PHARMACEUTICALS USA, INC., Plaintiffs-Appellants v. ELI LILLY AND COMPANY, Defendant-Appellee ______________________ 2024-1094 ______________________ Appeal from the United States District Court for the District of Massachusetts in No. 1:18-cv-12029-ADB, Judge Allison Dale Burroughs. ______________________ DYK, Circuit Judge, dissenting from denial of petition for rehearing en banc. I respectfully dissent from the court’s denial of en banc rehearing. This case presents important questions as to the scope of the enablement requirement for method claims. The panel’s holding creates confusion as to the en- ablement standards for method claims, will undermine medical innovation by sustaining overly broad claims, and is contrary to Supreme Court enablement precedent. I The claims at issue are claim 30 of U.S. Patent No. 8,586,045 (the “’045 patent”) and claims 5 and 6 of U.S. Case: 24-1094 Document: 100 Page: 5 Filed: 09/30/2026 2 TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY Patent No. 9,884,907, of which claim 30 of the ’045 patent is representative. Teva Pharms. Int’l GmbH v. Eli Lilly & Co., 172 F.4th 1367, 1372 & n.3 (Fed. Cir. 2026). Claim 30 recites a “method for reducing incidence of or treating headache in a human, comprising administering to the hu- man an effective amount of an anti-CGRP antagonist anti- body, wherein said anti-CGRP antagonist antibody is a . . . humanized monoclonal antibody.” Id. at 1372 (omission in original) (quoting ’045 patent claims 17, 30). Thus, the claim recites two functional limitations: (1) an antagonist limitation requiring a “humanized mono- clonal antibody” that functions as an “anti-CGRP antago- nist,” and (2) a treatment limitation in which administering the antibody reduces or treats headache. ’045 patent claims 17, 30. The difficulty of identifying the relevant compounds lies in the first limitation, not the sec- ond limitation. This is so because the second limitation adds nothing of substance to the first limitation. As the panel opinion recognizes, any member of the genus of hu- manized anti-CGRP antagonist antibodies would be effec- tive for treating headache. Teva, 172 F.4th at 1381 (“[T]he specification disclosed that all such antibodies work for that purpose.”). At the same time, the undisputed record shows that the difficulty of identifying compounds with antagonist proper- ties (the first limitation) was considerable. The evidence established that there were a large number of species with potential antagonist properties; that identification and hu- manization of anti-CGRP antibodies required laboratory benchtop and animal testing at substantial costs of time (months) and money (tens of thousands of dollars per anti- body). E.g., J.A. 1344, 4227. 1 The panel explicitly assumes 1 Citations to “J.A.” refer to the Corrected Non-Con- fidential Joint Appendix filed by the parties in this appeal. Dkt. No. 36. Case: 24-1094 Document: 100 Page: 6 Filed: 09/30/2026 TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. 3 ELI LILLY AND COMPANY for this reason that the genus of anti-CGRP antagonist an- tibodies was not enabled. Teva, 172 F.4th at 1381 (“[W]e will assume that . . . the amount of time and expense re- quired to make (and humanize) all anti-CGRP antagonist antibodies would have constituted undue experimenta- tion . . . .”). A claim that requires undue experimentation is not enabled. In re Wands, 858 F.2d 731, 736–37 (Fed. Cir. 1988); Wyeth & Cordis Corp. v. Abbott Lab’ys, 720 F.3d 1380, 1384 (Fed. Cir. 2013). The opinion indeed recognizes that “if the asserted claims were to the genus of humanized anti-CGRP antago- nist antibodies themselves[,] . . . this case would resemble Amgen [Inc. v. Sanofi, 598 U.S. 594 (2023)].” Teva, 172 F.4th at 1381. In Amgen, the Supreme Court ex- plained that to enable the full scope of a claimed genus of antibodies, a patentee must do more than define the screening process for identifying the antibody compositions that successfully bind to a target. 598 U.S. at 610, 614. The panel nonetheless concludes that this case is dif- ferent from Amgen for two reasons. First, because anti- CGRP antagonist antibodies were “well known”—even if not enabled—the panel holds that the specification enables the treatment of headache using such antibodies. Teva, 172 F.4th at 1380–82. It was only well known that such a genus exists, but as the panel recognizes, the genus is “not, itself, the invention.” Id. at 1374. The invention required identification of the various antibody species with antago- nist qualities. It was not well known which antibody spe- cies had such antagonist qualities. It is established that a genus may be well known but the specific embodiments with the desired qualities are not enabled by knowledge of the genus. See Wyeth, 720 F.3d at 1383–86 (concluding that a class of compounds effective for treatment was known but that undisclosed individual species of the claimed genus were not enabled). Case: 24-1094 Document: 100 Page: 7 Filed: 09/30/2026 4 TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY Second, the panel opinion examines the scope of the as- serted claims and concludes that they “do not claim hu- manized anti-CGRP antagonist antibodies themselves; instead, they claim only the use of such antibodies for the different, limited purpose of treating headache.” Teva, 172 F.4th at 1381. The panel thus treats the claimed headache-treatment method as narrower than a claim to the underlying genus of antibodies and requires correspondingly narrower ena- blement. This simply makes no sense. Where the record does not suggest uses for the underlying compounds other than to treat headache, see J.A. 16410, 16447, the practical scope of the method claim is equal to the scope of the com- pound. The method claim here is not effectively narrower than the compound claim. Even if it were, the compound still must be enabled since the compound is indisputably a claim limitation. A patent “must enable the full scope of the invention as defined by its claims.” Amgen, 598 U.S. at 610. “This important doctrine prevents both inadequate disclosure of an invention and overbroad claiming that might otherwise attempt to cover more than was actually invented.” MagSil Corp. v. Hitachi Glob. Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012). “[A] patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of cover- age.” Id. In order for a person of ordinary skill in the art to prac- tice the whole claimed method, the patent would need to enable the recited anti-CGRP antagonist antibodies. Claiming a method of use that depends on a recited compo- nent cannot excuse the enablement requirement of the component. Both the antagonist limitation and the treat- ment limitation are defined functionally in claim 30. There is no support for the panel’s approach, which concludes that the method claim is enabled because one functional limitation (treating headache) is enabled while the other functional limitation (the underlying compound) is not. Case: 24-1094 Document: 100 Page: 8 Filed: 09/30/2026 TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. 5 ELI LILLY AND COMPANY II As amici note, the opinion creates an “end-run around Amgen” and has resulted in guidance urging patent practi- tioners to use “creative claim drafting to skirt the disclo- sure requirements of Amgen.” Amicus Br. of Johnson & Johnson and Nagra USA LLC at 10–12, Dkt. No. 91. In Amgen itself, the principal use of the claimed PCSK9- blocking antibodies was to lower cholesterol. Amgen, 598 U.S. at 598–99. The Supreme Court held that the ge- nus of PCSK9-blocking antibodies was not enabled. Id. at 613–14. Had Amgen simply claimed a cholesterol-low- ering method using such antibodies, the scope of Amgen’s patent would not have been meaningfully narrowed; the PCSK9-blocking antibodies were not useful if not used for treating cholesterol. Yet according to the panel opinion in this case, the patentee in Amgen could have evaded the en- ablement requirement by doing exactly that. Amici representing the pharmaceutical industry, not known for urging onerous requirements for patentability, view the panel decision as confusing and erroneous. Amici predict that the result “risks foreclosing entire fields of in- dependent scientific development, chilling innovation pre- cisely where it is needed most,” Amicus Br. of Merck Sharp & Dohme LLC & Ipsen Biopharmaceuticals, Inc. at 11, Dkt. No. 86, and that “[a]llowing this type of method claim to proliferate may block research programs for undevel- oped treatments or disincentivize companies from invest- ing in product development,” Amicus Br. of Johnson & Johnson and Nagra USA LLC at 14. Amgen and Sanofi argue that “differing outcomes” between this case and Amgen “will create uncertainty for future decisionmakers, the USPTO, and the industry—ultimately harming pa- tients.” Amicus Br. of Amgen Inc. & Sanofi S.A. at 14, Dkt. No. 90. I respectfully dissent from the denial of rehearing en banc.