June 27, 2016Published Article

Unwrapping The BPCIA Patent Dance Riddle For Biosimilar Companies

Biosimilar Development

In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”). This act was passed to facilitate the entry of biosimilar drugs into the market by allowing for submission of an abbreviated Biologics License Application (“aBLA”) to a previously approved and licensed reference product (owned by a reference product sponsor). The BPCIA contains two parts. The first, found at 42 U.S.C. § 262(k), addresses the regulatory aspects of the new regime, and the second, found at 42 U.S.C. § 262(l), addresses certain patent resolution issues. This second part, often referred to as the “patent dance,” lays out the steps and schedule during which a biosimilar applicant and reference product sponsor exchange certain (confidential) information regarding the aBLA.

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