Biosimilar Patent Disputes: What Sandoz Appeal May Clarify
September 5, 2014, 11:21 AM EDT
Law360, New York (September 5, 2014, 11:21 AM EDT) -- Despite the more than four years since enactment of the Biologics Price Competition and Innovation Act, very little has been decided as to how the act will be applied and implemented. The U.S. Food and Drug Administration continues to seek to develop its own examination guidelines and only recently did the FDA accept the first biosimilar applications.
Key uncharted territory of the Biologics Act is the framework it provides for adjudicating patent disputes between an innovator and an entity seeking approval of an alleged biosimilar. The...