In a much-anticipated decision, on December 5, 2014, the Federal Circuit issued its ruling in the first case before it involving biosimilars. In that case, Sandoz filed suit in the Northern District of California seeking a declaratory judgment ("DJ") that certain patents were invalid, unenforceable, and would not be infringed by the marketing of a biosimilar to Enbrel. When suit was filed, a 351(k) application had not yet been filed with FDA for approval of the biosimilar. The district court dismissed the DJ action for lack of a justiciable case or controversy and also on the ground that the suit was barred by the patent litigation provisions of the Biologics Price Competition and Innovation Act ("BPCIA"), 42 U.S.C. §262. The latter provisions, which have become known in the industry as the "patent dance," include a specific procedure for parties to litigate patent disputes involving biosimilars after a 351(k) application is filed with FDA. The Federal Circuit affirmed the dismissal on the ground that DJ jurisdiction was lacking, but specifically stated, "[w]e do not address the district court's interpretation of the BPCIA." The decision comes on the heels of a December 1, 2014, dismissal of a similar suit filed by Celltrion in the Southern District of New York involving its biosimilar to Remicade. The district court dismissed the case for lack of DJ jurisdiction and also for being outside the procedures of the BPCIA. As matters now stand, industry continues its wait to see which biosimilar application will be the first to give rise to patent litigation under the "patent dance" provisions of the BPCIA.
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