State of the BPCIA after the Supreme Court′s ruling in Amgen v. Sandoz

11^th European Biosimilars Congress

April 26-27, 2018 Rome, Italy

Joanna T Brougher

BioPharma Law Group PLLC, USA

Posters & Accepted Abstracts: J Bioanal Biomed

Abstract :

On June 12, 2017, the United States Supreme Court, in a unanimous opinion, reversed the Federal Circuit in Sandoz Inc. v. Amgen Inc., interpreting two â�?�?patent danceâ�? provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This decision permits manufacturers of biosimilars to begin marketing their biosimilar product prior to FDA approval and deprives the owner of the reference product of a means to force disclosure of the method used to manufacture the biosimilar. While the Supreme Courtâ�?�?s decision is largely seen as a victory for manufacturers of biosimilars who now have fewer obstacles to overcome in reaching the market, there are still many unanswered questions remaining following the decision. Some of the major topics that will be covered are: 1. an overview of the BPCIA. 2. recent court decisions. 3. who will â�?�?danceâ�? now? 4. potential litigation strategies 5. unanswered questions. joannabrougher@gmail.com