Last week, the Supreme Court issued an opinion in Amgen Inc. et al. v. Sanofi et al., No. 21-757 (May 18, 2023), affirming a Federal Circuit decision invalidating claims 19 and 29 of U.S. Patent 8,829,165 (“’165 Patent”) and claim 7 of U.S. Patent 8,859,741 (“’741 Patent”) for lack of enablement under 35 U.S.C. § 112(a).
In 2014, Amgen obtained the ’165 and ’741 Patents claiming the genus of antibodies that (1) “bind to specific amino acid residues on PCSK9” and (2) “block PCSK9 from binding to [LDL receptors].” In those patents, Amgen disclosed the amino acid sequences of 26 different antibodies, depicted the three-dimensional structure of 2 of those 26 antibodies, and provided two methods of making other, undisclosed antibodies performing those functions – the “roadmap” and “conservative substitution” methods.
The “roadmap” method directed scientists to generate antibodies in the lab and then test those antibodies following a series of sequential steps to identify antibodies that perform the claimed functions. The “conservative substitution” method required scientists to start with an antibody known to perform the claimed functions, substitute select amino acids, and confirm the new antibody maintained the claimed functions.
Amgen sued Sanofi for infringement of the ‘165 and ‘741 Patents and Sanofi counterclaimed, arguing that the asserted claims were invalid on enablement grounds. Amgen admitted that it sought to claim an entire universe of antibodies defined by their function. Sanofi did not dispute that the 26 antibodies with disclosed amino acid sequences were enabled. The Court was left to address whether simply following Amgen’s “roadmap,” or its proposal for “conservative substitution” enabled the full scope of the claimed genus. The Court’s evaluation noted “[a] specification may call for a reasonable amount of experimentation to make and use a claimed invention, and reasonableness in any case will depend on the nature of the invention and the underlying art.” Ultimately, the Court upheld the Federal Circuit’s decision, finding that the 26 disclosed antibodies and the roadmap and conservative substitution methods were not sufficient to enable the full scope of the claims, “even allowing for a reasonable degree of experimentation,” because the disclosed methods “amount to little more than two research assignments.”