On September 30, 2026, the Federal Circuit denied Eli Lilly’s petition for rehearing en banc of CAFC Appeal No. 24-1094, which reversed the District Court’s grant of judgment as a matter of law that found claims of Teva’s U.S. Patent Nos. 8,546,045, 9,884,907, and 9,884,908 invalid for lack of written description and enablement (previously reported Federal Circuit Reverses JMOL of Invalidity of Teva’s Ajovy^® Patents).

The asserted patents are directed to methods of treating headache using humanized anti-CGRP antagonist antibodies. The patents are associated with Teva’s migraine treatment Ajovy^® (fremanezumab).  The jury previously found that Eli Lilly willfully infringed the asserted claims by selling its drug Emgality^® (galcanezumab-gnlm).

The Court did not issue an opinion with its denial.  However, Judge Dyk issued a dissent writing that the case presented important questions as to the scope of the enablement requirement for method claims.  Judge Dyk stated that, “[t]he panel’s holding creates confusion as to the enablement standards for method claims, will undermine medical innovation by sustaining overly broad claims, and is contrary to Supreme Court enablement precedent.”  He found that the asserted claims had two functional limitations, a compound and treating headaches; while he agreed that the treatment limitation was enabled, he did not find the compound limitation was enabled.  Judge Dyk agreed with amici that the opinion creates an “end-run around Amgen [v. Sanofi]” where claiming a method of using a compound can avoid the enablement requirement for the compound without meaningfully narrowing what is claimed.

Teva reported U.S. sales of $295M for Ajovy^® in 2025.

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