Jake Holdreith

On Monday, March 27, the Supreme Court will hear oral argument in Amgen v. Sanofi, a case with the parties and 27 Amici, including the United States, weighing in on whether and how the Court should address the enablement requirement of Section 112 in the context of genus claims, and in particular, genus claims to antibodies in the pharmaceutical sciences. Depending on how the court focuses its analysis, the opinion could be as narrow as how the jury instruction should read for pharmaceutical antibody claims written in the form of “a binding site plus a function.” But some of the briefs invite the court to loosen the constraints of Section 112 by eliminating the requirement of enablement of the “full scope” of the claimed embodiments in favor of a test focused on the “make and use the invention” language in the statute without the “full scope of the claimed embodiments” language the courts have used for years, with implications not just for pharma but for any art that uses functional or genus claiming.