Supreme Court holds antibody claim scope up to the bright light of enablement

The Supreme Court recently released a decision in Amgen Inc. v. Sanofi that may have implications for how and when prospective patentees draft claims and specifications. The Supreme Court affirmed both the District Court of Delaware and the Federal Circuit, finding that claims of two patents to Amgen failed to meet statutory enablement requirements, and were therefore invalid.

Amgen owns U.S. Patent No. 8,829,165 and U.S. Patent No. 8,859,741 (the ’165 and ’741 patents respectively). These patents claimed the entire genus of antibodies that could bind to specific amino acid residues on PCKS9 (a naturally occurring protein), as well as block PCSK9 from binding to LDL receptors in the body. Amgen then produced the drug Repatha while Sanofi produced the drug Praluent, both of which served these functions, but with a different antibodies. Amgen then sued Sanofi for patent infringement.

The Supreme Court addressed the issue of whether the disclosure of 26 specific antibodies having the above-described functions would enable the full scope of the patent claims, which were directed to effectively every antibody having those functions. At the core of this case is 35 U.S.C. §112(a), which requires a specification to include a written description of the invention that would allow a person having ordinary skill in the art to make and use the invention without undergoing undue experimentation. While Amgen laid out processes to create antibodies in their specifications, the Supreme Court held that these processes were essentially instructions to a trial-and-error process of experimentation that were not particular enough to satisfy enablement requirements.

This decision serves to reaffirm for antibodies in particular what the Supreme Court has already held in previous cases: if a class of subject matter is claimed, the patent’s specification must enable a person skilled in the art to make and use the entire class. Life science patent applicants should take care when claiming a genus of antibodies, in view of the enablement requirement.