In a significant development within the field of Intellectual Property, the US Court of Appeals for the Federal Circuit has invalidated another series of antibody genus claims. The case was described as being “materially indistinguishable” from those in the 2023 Supreme Court of the United States case, Amgen v. Sanofi.
The Federal Circuit concluded that patent claims covering a class of antibodies targeting functions of blood clotting factors were invalid due to a lack of enablement. This echoed closely the reasoning followed by fellow Circuit Judge Dyk, who sat by designation in the district court.
The ruling brings into sharp focus the increasing pressure on legal professionals serving in the biotechnology and pharmaceutical sectors to ensure their patents sufficiently disclose an invention in order to claim a broad antibody class. The novel argument that the claims lacked a full and enabling disclosure was used to successfully invalidate the patents in question.
This case adds yet another dimension to a growing body of law on antibody patenting and re-emphasizes the critical role of both the inventive concept and the level of enablement in patent drafting and litigation. Firms must now adjust their patent strategy to prioritize clear and comprehensive descriptions of their inventions and the inventive concept associated.
Firms contemplating broad antibody patents should proceed with caution and consider the implications of this decision. While the provision of sufficient information pertaining to at least one exemplary embodiment is well understood, this judgment makes clear that this approach may not always be sufficient to provide an adequately broad claim to antibody genus.
The full details on this judicial decision can be found here.