US Supreme Court Agrees to Review Patent Enablement CaseNovember 10, 2022

Last Friday, the Supreme Court accepted Amgen’s request to review Section 112 of the Patent Act and consider how much a patent specification must disclose to meet enablement requirements. Specifically, the Court will review whether a patent must disclose enough information for the skilled artisan to “reach the full scope” of the claims, or whether it is sufficient that the skilled artisan be able to “make and use” the invention.

Amgen had sued Sanofi and Regeneron Pharmaceuticals (collectively, “Sanofi”) over their cholesterol drug Praluent, which competes with Amgen’s drug Repatha. Amgen alleged that Praluent infringes two of their patents. Sanofi countered that the patents at issue are invalid for lack of enablement and written description. A jury twice found that the patents were not invalid after an appeal by Sanofi and a remand back to the district court. After the second trial, the district court granted Sanofi’s motion for Judgment as a Matter of Law overturning the jury’s verdict and finding the patents invalid. Amgen appealed to the Federal Circuit wherein the Federal Circuit agreed with the district court and found that the claims of Amgen’s patents do not meet the enablement requirements because reaching the full claim scope would require undue experimentation.

Amgen’s claims at issue are directed to a genus of antibodies that bind to a particular region on a specific protein. There are potentially multitudes of unknown antibodies that the claims may cover. The Federal Circuit held that identifying the undisclosed embodiments requires undue experimentation and therefore the claims are far broader than the specification of the patent and invalid.

Interestingly, the Supreme Court did not accept Amgen’s request to review whether or not enablement is a question of fact for the jury or a question of law to be decided by a judge.

The Supreme Court has not addressed the enablement requirement in quite some time. Additionally, attacks on the validity of patents for failure to satisfy the enablement requirement have increased, particularly in the biotechnology industry. This case is likely to have a wide-ranging impact. The Supreme Court is expected to render its decision on the appropriate enablement standard by the summer of 2023.

Julie L. Spieker is an Intellectual Property Attorney in the MVS Biotechnology & Chemical Practice Group as well as the Mechanical and Electrical Practice Group. To learn more, visit our MVS website , or contact Julie directly via email .