The Federal Circuit reversed the District of Massachusetts's grant of judgment as a matter of law of invalidity for lack of written description and enablement under 35 U.S.C. § 112, reinstating a jury verdict that found Eli Lilly willfully infringed Teva's U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908, which claim methods of treating headache using humanized anti-CGRP antagonist antibodies. The district court had granted JMOL despite acknowledging the jury could have found that murine anti-CGRP antagonist antibodies were known in the art, methods for making and humanizing them were routine, and skilled artisans would understand all humanized anti-CGRP antagonist antibodies would treat headache. The Federal Circuit held that under the clear-and-convincing-evidence standard applicable to invalidity, a reasonable jury could have found adequate written description even though the specification disclosed only one humanized anti-CGRP antagonist antibody species (fremanezumab, the active ingredient in Ajovy), because the claimed genus of humanized anti-CGRP antagonist antibodies was well-known and not itself the invention—the invention was using such antibodies to treat headache.
The decision clarifies the written description analysis for genus claims where the genus is a well-known, pre-existing class of compounds used as a component of the claimed invention rather than the invention itself. Drawing on Ajinomoto Co. v. ITC, In re Herschler, and the plurality in In re Fuetterer, the court distinguished between claims to novel compounds per se (which typically require disclosure of a representative number of species or common structural features) and claims using known compounds in a manner auxiliary to the actual invention. Where the genus is "already well explored" in the art and the specification makes clear that any member would work in the claimed method, the written description requirement does not demand extensive species disclosure. This framework has significant implications for pharmaceutical method-of-treatment claims that employ well-characterized biological molecules, potentially allowing narrower disclosures when the therapeutic application, rather than the therapeutic agent itself, constitutes the inventive contribution. The decision effectively insulates such claims from written description challenges based on Lilly's own IPR arguments that the antibody genus was well-known—a strategic consideration for litigants taking inconsistent positions across parallel proceedings.