On August 6, 2015, Amgen sued Apotex in the US District Court for the Southern District of Florida for patent infringement related to Apotex’s pegfilgrastim product, which is purported to be biosimilar to Neulasta®. What is unique about this suit, in view of previous biosimlars litigations, is that Amgen brought suit after they and Apotex actually participated in the “patent dance” as set forth in 42 USC §§ 262(l)(2)-(5) of the Biologics Price Competition and Innovation Act (BPCIA).
Apotex announced that the US FDA had accepted its application for biosimilar Neulasta® for review on December 17, 2014. According to the complaint, beginning in December 2014, the parties engaged in the exchange of information and statements as required by the BPCIA. As a result of the patent exchanges, the parties agreed to the inclusion of two U.S. patents in the infringement action: U.S. Pat. Nos. 5,824,784 and 8,952,138...
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