In a slip opinion, the Southern District of New York Court recognized that the BPCIA statutory framework governs the dispute resolution process for disputes relating to the manufacture and marketing of biosimilar products (e.g., biologic drugs which are “highly similar” to an already FDA approved “reference product”). While a reference product enjoys exclusivity for a period of twelve years, the BPCIA provides for a relatively quick and inexpensive methodology for biosimilar manufacturers to gain FDA approval for their drugs which have ‘“no clinically meaningful differences’” from the reference product. The BPCIA includes a dispute resolution mechanism that is designed to ensure that patent disputes are resolved before the reference product’s exclusivity period terminates. The dispute resolution process mandated by the BPCIA includes the exchange of information and various notices to the parties. The court noted that, even had it not already found that the matter involved no actual case or controversy, the failure to adhere to the dispute resolution process set forth in the BPCIA will preclude the manufacturer of a biosimilar product from seeking a declaratory judgment of patent invalidity against a reference product sponsor.
Celltrion Healthcare Co., Ltd. V. Kennedy Trust for Rheumatology Research, 2014 WL 6765996 (S.D.N.Y. Dec. 1, 2014).