Divided Federal Circuit: No Commercial Marketing Of Biologic Without FDA License
(August 18, 2015, 10:54 AM EDT) -- WASHINGTON, D.C. — A divided panel of the Federal Circuit U.S. Court of Appeals on July 21 affirmed dismissal of California state unfair competition law (UCL) and conversion claims, but vacated a California federal judge’s interpretation of the Biologics Price Competition and Innovation Act (BPCIA) as permitting commercial marketing of a biologic before receiving U.S. Food and Drug Administration approval (Amgen Inc. et al. v. Sandoz Inc. et al., No. 15-1499, Fed. Cir.).
(Decision available. Document #16-150803-011Z.)
According to Circuit Judges Alan D. Lourie, Pauline Newman...