Amgen Inc. v. Sanofi, No. 21-757 (May 18, 2023) (9-0, Opinion by Justice Gorsuch); U.S. – Patent Nos. 8,829,165; 8,859,741 | Download PDF

Key point(s):

• Claims that cover a vast class that is defined by its function while only being enabled for a small number of species of that class via a method requiring elaborate experimentation do not meet the enablement requirement of §112 of the Patent Act.
• For enablement, a specification need not describe how to make and use every single embodiment within a claimed class, but should disclose some general quality running through the class that gives it a “peculiar fitness for the particular purpose.”
• A specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of theinvention and the underlying art.