Working Group on Biosimilars for the Hatch-Waxman Practitioner
(Registration begins at 8:00 AM – Breakfast will be served) The Supreme Court delivered its groundbreaking decision in Sandoz Inc. v. Amgen Inc. in June of 2017, memorializing the first time the Court analyzed the Biologics Price Competition and Innovation Act (BPCIA) for the approval of biosimilar drugs. When discussing the BPCIA, the Court noted that it was a “a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of infringement” related to biosimilar applications, and granted more flexibility to biosimilar companies and filers of abbreviated biologics license applications. This intimate and interactive working group will examine the core components of the Court’s decision, and provide an analysis of biosimilar case law in the progeny that followed. Further, we will explore the approvalprocess and other key points of regulation for the benefit of Hatch-Waxman practitioners. Points of discussion will include:
- An introduction to biologic drugs, biosimilars, the Biologics Price Competition and Innovation Act (BPCIA) abbreviated approval pathway, and statutory language
- Discussing the FDA Draft Guidance documents on biosimilar product development
- Making predictions for the future of biotech patents and biosimilar product development in the U.S.
- Reviewing BPCIA cases at the Federal Circuit and District Court levels