Federal Circuit Appeals

On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No. 2015-1499.

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting paternally-inherited cell-free DNA (“cffDNA”) in maternal plasma or serum were not directed to patent eligible subject matter, and, therefore, were invalid. 

On June 22, 2015, the Supreme Court issued its decision in Kimble v. Marvel Entertainment, LLC, upholding the rule, first announced in Brulotte v. Thys Co., 379 U. S. 29 (1964), that an agreement allowing a patent owner to collect royalty payments after a patent’s expiration is unlawful per se.

On May 22, 2015, in a much-watched case, the Second Circuit upheld a preliminary injunction against Actavis PLC and its wholly owned subsidiary, Forest Laboratories, LLC (collectively “Actavis” or “Forest”), finding that Actavis’s “hard switch” strategy to launch an extended-release version of its blockbuster Alzheimer’s therapy and delist the immediate-release version would likely violate Section 2 of the Sherman Act.