Amgen Inc. v. Sandoz Inc. Federal Circuit Decision on BPCIA
On July 21, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in Amgen Inc. v. Sandoz Inc., interpreting key provisions in the Biologics Price Competition and Innovation Act ("BPCIA"). In a previous client alert,1 we provided background on the BPCIA and the District Court decision in the Amgen case. In short, the District Court held that: (1) the BPCIA's patent negotiation provisions (often termed the "patent dance") are not mandatory; and (2) the BPCIA permits biosimilar applicants to provide the required notice of commercial marketing before they receive FDA approval. In a 2-1 decision accompanied by two partial dissents, the Federal Circuit affirmed on the first issue, but reversed on the second, holding that notice must come after FDA licensure.