Supreme Court to Consider Enablement Requirement

By on November 10, 2022
Posted In Cert Alert, Patents

The Supreme Court of the United States agreed to consider how much a patent must disclose in order to meet the enablement requirement under 35 U.S.C. § 112. Amgen Inc., et al. v. Sanofi, et al., Case No. 21-757 (Supr. Ct. Nov. 4, 2022) (certiorari granted). The question presented is as follows:

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.

Amgen owns two patents that describe antibodies that bind to PCSK9 protein and lower LDL cholesterol levels by blocking PCSK9 from binding to LDL receptors. After a jury determined that Sanofi failed to prove that the asserted claims were invalid for lack of enablement, the district court granted Sanofi’s post-trial motion for invalidity based on lack of enablement. The US Court of Appeals for the Federal Circuit affirmed, finding that the scope of the claims encompassed millions of antibodies and that the patent thus did not meet the enablement requirement because practicing the full scope of the claims would require “undue experimentation.”

The Supreme Court declined to consider the first question presented in Amgen’s petition: whether enablement should be a question of law (under current Federal Circuit precedent) or be designated a question of fact to be decided by a jury. In granting certiorari, the Supreme Court proceeded contrary to the recommendation of the US Solicitor General.

Amol Parikh
Amol Parikh concentrates his practice on intellectual property litigation, counseling and procurement. He draws on his trial and litigation experience in combination with his engineering training to quickly identify intellectual property issues and develop creative strategies to address them. Amol’s work on behalf of clients has earned him recognition in many industry publications. Most recently, Amol was recognized in February 2019 with the International Law Office’s “2019 Client Choice Award” for Intellectual Property in Illinois. The award recognizes “excellent client care” and the “ability to add real value to clients’ business above and beyond the other players in the market,” and winners may only be nominated by corporate counsel. Read Amol Parikh's full bio.

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