Press Release June 29, 2017

Goodwin Publishes Updated Guide to the Biosimilars Patent Dance

Goodwin, a leading Global 50 law firm, announced today the release of its updated Guide to the Biosimilars Patent Dance in view of the recent Supreme Court decision in Sandoz v. Amgen. This 2017 version of the Guide provides a user-friendly format, simplifying the complex statutory scheme of the so-called “patent dance” codified in subsection 262(l) of the Biologics Price 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 the FDA.

The BPCIA provisions of the patent dance have been the subject of much litigation and judicial interpretation over the past year. The Guide lays out the parameters of how and when litigation may proceed, and the impact of compliance with certain steps on future patent litigation.

“As the legal terrain surrounding the interpretation of the BPCIA and the patent dance continues to evolve, we hope the updated Guide will continue to be an excellent resource for decoding what one appellate court has called ‘a riddle wrapped in a mystery inside an enigma,” said Nicholas Mitrokostas, partner in Goodwin’s Intellectual Property Litigation Practice. “Importantly, in Sandoz v. Amgen the Court clarified that a biosimilar applicant need not wait for FDA approval to provide its notice of commercial marketing, but can do so at any time, either before or after receiving FDA approval,” said Cynthia Hardman, also a partner in Goodwin’s Intellectual Property Litigation Practice.

Goodwin is committed to helping companies and investors understand the complex, developing biosimilars landscape. In-house attorneys and executives can request a gratis copy of the Guide, by clicking here.

For the latest biosimilars updates and analyses on regulatory issues, litigation, legislation and other news, please follow Goodwin’s Big Molecule Watch blog, now on Twitter @Big_Molecule.

Goodwin’s Intellectual Property Litigation Practice has been named by Law360 as one of its “Practice Groups of the Year” for three consecutive years and recognized in the National Law Journal’s 2016 "Intellectual Property Hot List." Goodwin’s IP Practice has worked with clients to secure preliminary injunctions, declaratory and summary judgments, favorable results in Markman proceedings, advantageous settlements, victories at trial and appellate relief. Goodwin attorneys routinely work with clients to take cases from pre-suit investigations through discovery and trials.