On April 20, 2023, the United States Patent and Trademark Office (USPTO) announced several proposed rule changes that would have an impact on patent applicants, patent holders, and patent challengers. A common thread running through several of the rule changes is the requirement of increased disclosure from litigating parties, including disclosures of related parties, ownership interests, and all settlement agreements (and any related or collateral agreements) between the parties. While the proposed rule changes are subject to a public comment period, if implemented, they would (i) introduce several major changes to the process of challenging patents before the Patent Trial and Appeal Board (PTAB) and (ii.) significantly increase USPTO administrative fees.
In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).)