Legal Alert: Amgen v. Sanofi

On May 18, the Supreme Court sided with Sanofi in Amgen v. Sanofi, 598 U.S. ____ (2023), a dispute concerning broad functional genus claims for antibodies. The ruling affirmed the Federal Circuit’s reading of the Patent Act’s “enablement” requirement, a requirement that states that a patent must enable someone who is reasonably skilled in the art to use or make the patented invention without undue experimentation.

The Court held that under 35 U.S.C. § 112(a) “Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation.” 598 U.S. ____, at *15. The Court noted that the claims of U.S. Patent Nos. 8,829,165 and 8,859,741 at issue covered “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors].” Id. at *5.  The unanimous opinion states, “If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” Id. at *13.  After analyzing the specification and testimony presented, the Court disagreed with Amgen, which argued that the broad claims are enabled because “scientists can make and use every undisclosed but functional antibody if they simply follow the company’s ‘roadmap’ or its proposal for ‘conservative substitution.’”  Id. at *16. 

The opinion can be found here. For more information, Principals Nicole Williams and Martina Hufnal will present on the decision during an upcoming webinar on June 6.

Co-Authored by: Nicole Williams