Articles

Why the Amgen Case Might Be About More Than Enablement

Thomson Reuters Westlaw Today May 26, 2023
Author: William H. Milliken

For months now, patent practitioners around the country have been closely watching Amgen v. Sanofi, a Supreme Court case concerning patent law’s enablement requirement, codified at 35 U.S.C.A. § 112(a). The enablement requirement mandates that a patent specification describe “the invention” and “the manner and process of making and using it” with sufficient detail to “enable” a person with ordinary skill in the relevant field “to make and use” the invention.

Prior to the grant of certiorari in Amgen, the Supreme Court had not considered the enablement requirement in well over 50 years (since before the modern Patent Act was passed). The patent world — having no indication of how the modern Supreme Court might view enablement law — thus had to be prepared for anything.