J. Morgan Kirley, Shareholder –
August 1, 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.