Partners David McCombs, Dina Blikshteyn, and Eugene Goryunov and Associate Matthew Beck authored an article in Drug Discovery Online, a publication of Life Science Connect, discussing the possible implications that stem from a U.S. Supreme Court unanimous ruling in Amgen Inc. v. Sanofi on the Section 112 enablement requirement for patents.
Read an excerpt below:
In May 2023, a unanimous U.S. Supreme Court in Amgen Inc. v. Sanofi issued a ruling on the Section 112 enablement requirement for patents. Section 112 requires a patent applicant to describe the claimed invention “in such full, clear, concise, and exact terms as to enable any [person of ordinary skill in the art…to make and use the [invention].” While patents in Amgen pertained to antibodies, the Court’s decision is likely to have implications in other areas, including artificial intelligence (AI) systems.
Background
In 2014, Amgen obtained two patents that claimed an entire genera of antibodies that bind to specific amino acids and help reduce levels of cholesterol. Amgen identified the amino acid sequences of 26 antibodies that perform the claimed functions — what Amgen called its “roadmap” technique — and disclosed two methods of making other antibodies that also perform those functions — what Amgen called its “conservative substitution” technique. The “roadmap” technique directed scientists to generate and test a range of antibodies through several processes of elimination to determine whether they perform the functions described in the claims. The “conservative substitution” technique directed scientists to start with an antibody known to perform the claimed functions, replace the amino acids with amino acids known to have similar properties, and test the resulting antibody to see if it performs the claimed functions.
To read the full article on Drug Discovery Online, click here.
