Business Litigation Report - January 2018

January 2018: Federal Circuit Issues Important Decision On Written Description And Enablement In Amgen Inc. v. Sanof -

In Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), the Federal Circuit acknowledged the relevance of post-priority date evidence in determining whether claims satisfy the written description and enablement requirements, rejected the “newly characterized antigen” test as a means of proving written description of monoclonal antibodies, and commented on the proper application of the standards for considering permanent injunctions in the medical context. This decision provides crucial clarity on important issues in the ever growing area of biologic drugs, but also offers valuable guidance for all patent litigation.

The Patent -

Amgen brought suit against Sanofi for infringement of two patents through its Praluent® alirocumab product. Id. at 1372. The two asserted patents (U.S. Patent Nos. 8,829,165 and 8,859,741) generally relate to monoclonal antibodies that help reduce lowdensity lipoprotein (“LDL”) cholesterol by inhibiting PCSK9—a naturally occurring protein that causes the destruction of LDL receptors responsible for extracting LDL from the bloodstream. Id. at 1371. The relevant claims of those patents are directed to the entire genus of monoclonal antibodies that bind to specific amino acid residues on PCSK9 and block PCSK9 from binding to LDL receptors. Id. at 1372.