Federal Circuit Revives $177 Million Jury Verdict in Teva v. Eli Lilly CGRP Patent Dispute, Distinguishing Amgen

The U.S. Court of Appeals for the Federal Circuit on April 16, 2026 reversed a district court’s grant of judgment as a matter of law (JMOL), reinstating a jury verdict that Eli Lilly and Company willfully infringed three Teva Pharmaceuticals International patents covering methods of treating headache with humanized anti-CGRP antagonist antibodies. Writing for a unanimous panel in Case No. 24-1094, Judge Prost articulated a framework that distinguishes, for purposes of 35 U.S.C. § 112 written description and enablement analysis, between claims directed to a genus of compounds and claims directed to a method of using a well-known genus for a specific, disclosed purpose.

Background

Teva filed suit in the District of Delaware in September 2018, alleging that Lilly’s Emgality (galcanezumab) product infringed U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908. The patents, carrying a November 2006 priority date, claim methods of reducing the incidence of headache by administering humanized anti-CGRP antagonist antibodies.

A jury found willful infringement and awarded $177 million in damages. The district court subsequently granted JMOL for Lilly, holding that the asserted claims failed both the written description and enablement requirements of 35 U.S.C. § 112. Teva appealed.

The Federal Circuit’s Analysis

The central legal question was how to apply the Supreme Court’s 2023 decision in Amgen Inc. v. Sanofi, 598 U.S. 594, which set a demanding enablement standard for broad functional antibody genus claims. Judge Prost declined to extend Amgen to Teva’s patents, drawing a structural distinction the district court had overlooked.

Teva’s claims do not seek to own the genus of humanized anti-CGRP antagonist antibodies for all purposes. They claim only the use of those antibodies for the specific, limited purpose of treating headache—a purpose the specification disclosed all members of the genus would serve. Because the claims are directed to a method of using a well-known genus rather than to the genus itself, the Federal Circuit held, both § 112 inquiries are evaluated differently.

On written description, the court found substantial evidence supported the jury’s conclusion that the specification adequately disclosed the structural features necessary for an antibody to function as a humanized anti-CGRP antagonist. On enablement, the court reasoned that method-of-use claims do not require enabling a practitioner to make each compound in the genus; the demanding Amgen standard that asks whether the full scope of a compound genus can be synthesized does not translate to a method claim limited to a specific, known utility.

Willful Infringement and Damages

The Federal Circuit also reinstated the jury’s willful infringement finding. The court determined that there was sufficient evidence for the jury to conclude Lilly continued marketing Emgality with knowledge of Teva’s patents and an objectively unreasonable belief in non-infringement. The $177 million damages verdict is accordingly restored.

Implications for Biopharmaceutical Patent Strategy

The decision carries significant consequences for patent prosecution and litigation strategy in the biopharmaceutical sector. Since Amgen, practitioners and patent holders have faced heightened uncertainty about the validity of broad antibody genus claims. This ruling clarifies that the Amgen framework governs claims to compounds themselves but does not apply with equal force to method-of-use claims directed to a well-characterized genus performing a known function.

Three practical points emerge. First, claiming a well-known genus for a specific, fully disclosed therapeutic use offers a path around Amgen‘s strictest requirements, provided the specification demonstrates the entire genus achieves that specific use. Second, applicants seeking to protect antibody-based therapies should assess whether method-of-use claiming provides a more defensible alternative to broad compound genus claims. Third, the decision does not disturb Amgen itself: the demanding standard for claims directed to a genus of novel compounds for all uses remains intact.

The case will return to the district court for proceedings consistent with the Federal Circuit’s opinion, potentially including enhanced damages given the willful infringement finding.