BPCIA Precludes Declaratory Relief Claim of Invalidity by Biosimilar Drug Applicant

The court granted defendant's motion to dismiss plaintiff's declaratory relief action because of the statutory dispute resolution under the Biologics Price Competition and Innovation Act. "Even if the Court were to find that [plaintiff] had engaged in sufficient meaningful preparation to market [its drug] and that the threat of injury was sufficiently demonstrable, the Court would still exercise its discretion to decline to hear this case in light of the existence of the BPCIA statutory framework for the resolution of patent disputes in the licensing of biosimilars. . . . The BPCIA purposefully keys its dispute resolution procedures to the occurrence of certain events on the path to FDA approval. [Plaintiff] has failed to show why this carefully crafted and well-timed procedure should be avoided here."

Celltrion Healthcare Co., Ltd. et al v. The Kennedy Trust for Rheumatology Research, 1-14-cv-02256 (NYSD December 1, 2014, Order) (Crotty, J.)