Amgen v. Sanofi (Federal Circuit 2021) — Antibody Claims Fail Enablement for Genus Claiming Entire Functional Class
The Federal Circuit affirmed that Amgen’s antibody patents directed to an entire genus of antibodies binding to a specific PCSK9 epitope lacked adequate enablement — holding that claiming a broad functional genus of antibodies without enabling the full scope of the claim requires undue experimentation and is invalid under § 112(a).