Goodwin announced today the release of its Guide to the Biosimilars Patent Dance, which lays out in a user-friendly format the complex statutory scheme of the so-called “patent dance” codified in subsection 262(l) of the Biologics Competition and Innovation Act (BPCIA). The BPCIA’s patent dance dictates a schedule of timed steps according to which both parties—the biosimilar applicant and the reference product sponsor—may disclose and exchange certain information relating to potential patent disputes once a biosimilars application has been accepted by FDA.
These important BPCIA provisions of the patent dance have been the subject of much litigation and judicial interpretation over the past several months. The Guide simplifies the patent dance and lays out in an easy-to-understand format the parameters of how and when litigation may proceed, and the impact of compliance with certain steps on future patent litigation.
“The legal terrain surrounding the interpretation of the BPCIA continues to change in the new world of biosimilars, and the patent dance is a key part of the complex statutory structure for litigating patent disputes on biosimilar drug products,” said Nicholas Mitrokostas, partner in Goodwin’s Intellectual Property Litigation Practice. “We hope the Guide will be an excellent resource for decoding what one appellate court has called ‘a riddle wrapped in a mystery inside an enigma.’”
“As litigation continues to shape the patent dance process, the Guide will be an important tool to understanding what steps must be taken on the path to launch a biosimilar product,” added Cynthia Hardman, partner in Goodwin’s Intellectual Property Litigation Practice.
In-house attorneys and executives can request a gratis copy of the Guide, as well as a gratis copy of Goodwin’s Biosimilars: A Guide to Regulatory and Intellectual Property Issues publication. For the latest biosimilars updates and analyses on regulatory issues, litigation, legislation, and other news please follow Goodwin’s Big Molecule Watch blog.