On April 14, 2015 the Biotechnology Industry Organization (BIO) filed an amicus curiae brief with the Court of Appeals for the Federal Circuit1 in support of remand or reversal of the Amgen v. Sandoz lower court’s ruling that both notice provisions of the Biologics Price Competition and Innovation Act (“BPCIA” or “the Act”) are optional. BIO urges the Court to consider not just the circumstances of this first case involving a biologic in which data exclusivity has already expired, but also the circumstances to which this statute must be applied for the coming decades. Since BIO played a leading role in the effort to establish the statutory pathway for the abbreviated approval process for biosimilars and the corresponding support for innovation in the BPCIA, it stressed Congress’ intent when creating the Act – namely to balance the interests of biosimilar applicants and reference product sponsors. Interestingly, both Amgen and Sandoz are members of BIO.

In BIO’s view, the BPCIA patent dispute resolution process must be interpreted to require notice to the reference product sponsor of the initial submission of the biosimilar application and notice of potential commercial marketing upon approval. This interpretation, BIO argues, is in accordance with the Act’s purpose - to provide a significant and real opportunity to resolve patent issues prior to the launch of a biosimilar...