The U.S. Court of Appeals for the Federal Circuit reinstated a $177 million jury verdict in Teva Pharmaceuticals International GmbH v. Eli Lilly and Company on April 16, 2026, reversing a district court’s grant of JMOL. The decision clarifies how Amgen Inc. v. Sanofi (2023) applies to method-of-treatment claims for well-known antibody classes.
The CGRP Pathway and the Competing Migraine Drugs
Calcitonin gene-related peptide (CGRP) is a neuropeptide that promotes vasodilation and trigeminal vascular activation during migraine episodes. Teva holds three patents that claim methods of using humanized anti-CGRP antagonist antibodies to treat headache: U.S. Patent No. 8,586,045, 9,884,907, and 9,884,908. Teva’s AJOVY (fremanezumab) and Lilly’s Emgality (galcanezumab) both received FDA approval in September 2018. Teva sued Lilly in the District of Massachusetts alleging infringement of all three patents.
Jury Verdict and District Court JMOL
The jury found willful infringement and awarded Teva $177 million in damages. The district court then granted Lilly’s JMOL motion, concluding that Teva’s specifications failed to enable the claimed genus of humanized anti-CGRP antagonist antibodies under the rigorous standard articulated in Amgen Inc. v. Sanofi (2023).
Federal Circuit Reversal: Method Claims Are Not Governed by Amgen’s Full Framework
The Federal Circuit reversed in Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, No. 24-1094 (Fed. Cir. Apr. 16, 2026). In Amgen, the Supreme Court applied strict enablement to composition claims directed to “the antibodies themselves.” Teva’s claims cover only the method of using such antibodies to treat headache. Since anti-CGRP antibodies were well-known at the 2006 priority date, a reasonable jury could find adequate enablement for the method claims without requiring exhaustive antibody-by-antibody disclosure.
Willful Infringement and Remand
The Federal Circuit reinstated the willful infringement finding. The court remanded on certain claim-construction issues that Lilly preserved, so the final damages figure may be subject to further proceedings.
Implications for Pharmaceutical Patent Practice
First, it clarifies the scope of Amgen: its strictest application is reserved for composition claims. As Patently-O noted, method claimants meeting the art baseline are not required to do “extra credit” work to satisfy enablement.
Second, the decision highlights the strategic value of method-of-treatment claiming. Where the technology was well-known at the priority date, method claims may carry significantly less enablement risk than composition claims targeting the same antibody genus.
Third, in the CGRP space — where Teva (AJOVY), Lilly (Emgality), and Amgen (Aimovig) are all active — the ruling has direct bearing on patent enforcement and licensing dynamics. The pharmaceutical industry is watching the remand closely, given broader implications for antibody-based therapeutics.
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