The New Follow-On-Biologics Law: A Section by Section Analysis of the Patent Litigation Provisions in the Biologies Price Competition and Innovation Act of 2009

摘要

An abbreviated approval pathway for biosimilar biological products (often called "follow-on biologies") has been enacted into law as one part of the healthcare legislation recently passed by Congress and signed by the President. The new approval pathway, the Biologies Price Competition and Innovation Act of 2009, contains detailed procedures for identifying patents relevant to a given follow-on biologic application and resolving disputes concerning those patents before the application's approval. This article analyzes those patent-related provisions, focusing on the procedures by which the patents relevant to a given application to market a biosimilar product are identified, how and when those patents may be asserted in litigation, and the relief available to the patentee. The article also points out various ways in which the patent-related provisions of the new biosimilars pathway differ from those of the Hatch-Waxman Act, which governs the approval of generic versions of small molecule drugs.