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Each ‘patent dance’ dispute between biologics and biosimilars companies will present its own nuances in the process of solving the mystery, argue Lisa Pensabene and Daniel O'Boyle of O’Melveny & Myers.
Winston Churchill’s October 1939 comment on the actions of Russia, “a riddle wrapped in a mystery inside an enigma”, was borrowed by US Court of Appeals for the Federal Circuit judge Alan Lourie to describe the patent resolution procedures of the act that governs biosimilars, the Biologics Price Competition and Innovation Act (BPCIA), in the 2015 case Amgen v Sandoz. The process to “unravel the riddle, solve the mystery, and comprehend the enigma” of the BPCIA is continuing, he said.
The BPCIA “established an abbreviated pathway for regulatory approval of follow-on biological products that are ‘highly similar’ to a previously approved product (‘reference product’)”, ie, biosimilars, Lourie noted. The drafting goal was to balance “innovation and consumer interests”, according to the act. A biosimilar applicant may submit an Abbreviated Biologic Licensing Application (aBLA) that relies in part on the approved licence of a reference product. In return, the reference product sponsor (RPS) receives 12 years of marketing exclusivity after first licensing, and the biosimilar applicant may not file its aBLA until four years after that.
This period of up to eight years was envisioned as available for the BPCIA’s patent dispute resolution procedures “to ensure that litigation surrounding relevant patents will be resolved expeditiously and prior to the launch of the biosimilar product, providing certainty to the applicant, the reference product manufacturer, and the public at large,” according to Democrat politician Anna Eshoo in 2009. Specifically, to create a jurisdictional mechanism for the parties to begin patent litigation during the time between aBLA filing and approval, the BPCIA created an artificial act of infringement for the act of filing an aBLA.
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Lisa Pensabene, Daniel O'Boyle, O’Melveny & Myers, patent, patent dance, BPCIA, Sandoz, FDA,