On April 16, 2026, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in a patent dispute between Teva Pharmaceuticals (“Teva”) and Eli Lilly & Co. (“Lilly”). The case stems from a 2018 lawsuit in which Teva alleged that Lilly infringed three patents related to methods of using certain antibodies to treat headaches, including migraines. Teva developed and markets Ajovy®, an antibody that treats and prevents migraines. Lilly markets a competing product, Emgality®.
At the ensuing 2022 trial in the District of Massachusetts, the jury returned a verdict for Teva, finding that Lilly willfully infringed the asserted claims and did not prove them invalid for lack of written description or enablement. The jury accordingly awarded Teva $176.5 million in damages. Following the trial, the District Court overturned the jury’s verdict on validity, reasoning that the patents did not provide enough information “to support the very broad scope of these asserted claims.”
The Federal Circuit disagreed. In its unanimous precedential decision, the panel reversed the District Court’s ruling, reinstated the jury’s verdict and damages award, and remanded.
Addressing written description—which requires showing that the inventors possessed the claimed invention—the Federal Circuit explained that the patents are directed not to the antibodies themselves, but to methods of using them to treat migraines. The Federal Circuit further noted that the antibodies, as well as the processes for making and humanizing them, were well established. The appeals court reasoned that a skilled artisan would have understood from the specification, read in view of the knowledge in the prior art, that all humanized antibodies from the relevant genus would have worked for the claimed method, and that the antibodies in that genus were well-known. In light of this, the Federal Circuit concluded that a jury could have reasonably found that the patents disclosed enough information to show that inventors had possession of the invention. The Federal Circuit held: “we conclude that JMOL [judgment as a matter of law] of no written description was improper.”
Regarding enablement—which requires showing that the patents would enable a skilled person to make and use the invention—the Federal Circuit rejected Lilly’s argument on appeal that the patents amounted to a “research assignment” of “screening and testing” candidate antibodies to find those that have the biological activity needed to be used in the claimed method. The Federal Circuit reasoned that this argument “might be more persuasive” if the patents were directed to the antibodies themselves. But since the genus of antibodies with that activity was already “well-known” and the patents “claim only the use of such antibodies for the different, limited purpose of treating headache,” the “more relevant research assignment” of determining which “antibodies treat headache” had already been completed because “the specification disclosed that all such antibodies work for that purpose.” The Federal Circuit held: “In sum, given the nature of the asserted claims and the jury’s supportable findings, we conclude that JMOL of no enablement was improper.”
Stay tuned to Big Molecule Watch for further updates.
The post Federal Circuit Reverses JMOL and Reinstates Jury Verdict in Teva v. Lilly appeared first on Big Molecule Watch.