The October 5, 2017 Federal Circuit decision in
Amgen Inc. v. Sanofi is getting a lot of attention for
its
commercial impact, because the court vacated the permanent
injunction that prevented Sanofi and Regeneron from marketing their
cholesterol-lowering Praluent® (alirocumab) product, which will
compete with Amgen's Repatha® (evolocumab) product. But the
decision also addresses several important legal issues, including
questioning the USPTO's practice of granting
broad antibody claims.
The Antibody Claims At Issue
The patents at issue were U.S. Patent Nos. 8,829,165
and 8,859,741. Claim 1 of the '741 patent is set forth
below:
1. An isolated monoclonal antibody
that binds to PCSK9, wherein the isolated monoclonal antibody binds
an epitope on PCSK9 comprising at least one of residues 237 or 238
of SEQ ID NO: 3, and wherein the monoclonal antibody blocks binding
of PCSK9 to LDLR.
