Federal Circuit Interprets Two Important Infringement Provisions

In a single decision issued for companion cases Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. and Momenta Pharmaceuticals, Inc. v Amphastar Pharmaceuticals, Inc., the Federal Circuit interpreted two important sections of the infringement statute, 35 USC § 271. In one portion of its decision, the court adopted a literal interpretation of § 271(g), holding that the statute only applies if the accused product was synthesized by a patented process. In another portion of its decision, the court decided that the post-manufacture testing at issue constituted "routine" post-approval activities that were not protected by the safe harbor of § 271(e)(1). In so doing, the court backpedaled from its 2012 decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., where it held that Amphastar's activities were "anything but routine."