Supreme Court Reaffirms Enablement Standard

The US Supreme Court has doubled down on its existing approach to enablement, the requirement that a patent must describe an invention “in such full, clear, concise, and exact terms” that a person having ordinary skill in the art (PHOSITA) can “make and use” it. In Amgen v. Sanofi, the Court agreed with the Federal Circuit and the District of Delaware that claims from two antibody patents related to a cholesterol-lowering drug were invalid on this basis. While the claims encompassed an entire genus of possible antibodies, the Court concluded in a unanimous opinion that the patent required too much experimentation by a PHOSITA to recreate the antibodies described in the patents—rejecting both of the described approaches for doing so as “little more than two research assignments”.