On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice Group and co-chair of the firm's appellate practice, will be live tweeting color commentary from the firm’s account, @sternekessler. The Twitter coverage will begin at 9:30 a.m. EDT and continue throughout the proceedings, offering patent practitioners and the interested public objective reporting and analysis of the highly anticipated proceedings in real time.
By way of background, the Supreme Court granted certiorari in Amgen Inc. v. Sanofi in November 2022 to review the enablement requirement of patent law. Under that requirement, a patent’s specification must enable persons of ordinary skill in the art to “make and use” the claimed invention. The specific question presented in Amgen is whether enablement requires a showing that skilled artisans would be able 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.” This question has large ramifications, particularly for biotechnology and pharmaceutical patents, which often involve genus claims to very large classes of molecules. In such cases, the specification may enable a skilled artisan to make any one embodiment without substantial time and effort, but the genus may be so large that making and using all embodiments would be infeasible as a practical matter. The Supreme Court’s decision may provide significant guidance as to whether these sorts of claims are viable.
Read more about the case in the article "Supreme Court Poised To Alter Patentability of Pharmaceutical, Life-Science Innovations," authored by Directors William H. Milliken, Deirdre M. Wells, and Kristina Caggiano Kelly.
Sterne Kessler will continue to provide updates and analysis on this closely watched case up to the Court’s decision and beyond.
