March 14, 2016 Articles

Shall We Dance? FDA Biosimilar Approval Process Litigation Options

The litigation options available to biologic innovators and biosimilar applicants are in flux as district courts and the Federal Circuit interpret the BPCIA

By Henrik (Rik) D. Parker

In 2010, as part of the Affordable Care Act, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA), which created, among other things, an abbreviated pathway for obtaining U.S. Food and Drug Administration (FDA) approval of biosimilars. While the BPCIA has similarities to the earlier Hatch-Waxman Act, which applies to small molecule drugs, there are significant differences. For example, there is neither an automatic 30-month stay of approval of the abbreviated biologics license application (aBLA) upon initiation of patent litigation under the BPCIA as there is with abbreviated new drug applications (ANDAs) under Hatch-Waxman, nor an Orange Book equivalent where the owner of the original biologic would need to list any patents covering its products, their manufacture, and their uses. Instead, the BPCIA contains a complicated set of litigation provisions centered around what has come to be called "the patent dance," as well as other provisions dealing with the giving of a 180-day notice of intended commercial marketing. These various provisions allow certain kinds of litigation while precluding others. (It should be noted that parsing the provisions of the BPCIA and of the complementary 35 U.S.C. section 271(e)(2)(C) and (e)(6) is difficult due to the extensive internal cross-referencing.)

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