Supreme Court Issues Decision In Amgen v. Sanofi

On May 18, 2023, the Supreme Court issued a decision in Amgen Inc. et al. v. Sanofi et al., Number 21-757, holding that a patent claiming an entire class of processes, machines, manufactures, or compositions of matter must teach those skilled in the art to "make and use the entire class," while noting that the "specification may call for a reasonable amount of experimentation to make and use a patented invention."

Background

The patents at issue in the case involve antibodies that can reduce levels of low-density lipoprotein (LDL) cholesterol by inhibiting PCSK9 - a protein that binds to and degrades LDL receptors in the bloodstream. In 2011, Amgen obtained a patent for the antibody deployed in its cholesterol drug Repatha, and in 2014 it obtained related additional patents. These later patents claimed "the entire genus" of antibodies that (1) "bind to specific amino acid residues on PCSK9," and (2) "block PCSK9 from binding to [LDL receptors]." Amgen brought