The Supreme Court has granted Amgen’s Petition for a Writ of Certiorari, agreeing to address what it means to provide an enabling disclosure. In particular, Amgen asked the Court to address:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort.”

Section 112 of the Patent Act requires a patent’s specification to “enable any person skilled in the art… to make and use” the patented invention. 35 U.S.C. § 112(a). In Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s grant of Judgment as a Matter of Law of lack of enablement, finding that “after weighing the Wands factors, the [district] court did not err in concluding that undue experimentation would be required to practice the full scope of these claims.” 987 F.3d 1080, 1088 (Fed. Cir. 2021). Amgen has requested that the Supreme Court clarify whether enablement requires that the specification:

  • Teach those skilled in the art to make and use the claimed invention using the “roadmap” provided in the specification; or
  • Enable those skilled in the art to practice the full scope of the claimed invention without undue experimentation.

This case is sure to be closely watched by those in the biologics space, where claiming a molecule based upon its “function” is a common claim strategy.