July 22, 2015
In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz’s obligation to disclose information related to its application, and whether Sandoz could effectively provide notice of commercial marketing before FDA approval. The Federal Circuit decided that certain information-sharing requirements of the BPCIA are optional, because Amgen, the reference product sponsor (RPS) in this case, can obtain such information through discovery following suit for patent infringement, and that is the sole remedy contemplated by the BPCIA. The Federal Circuit also concluded that the biosimilar applicant, Sandoz, may only provide effective notice of commercial marketing after grant of FDA licensure, even though this may, in some situations, result in an additional 180 days of exclusivity in excess of the twelve years of exclusivity provided in the BPCIA. The Federal Circuit’s conclusions impact biosimilar applicants by providing additional business options for companies to examine.

To view the full alert, click here.