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ARTICLE · 25 NOVEMBER 2013

No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Action Before Biosimilars Application Is Filed

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The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price Competition and Innovation Act of 2009 ("BPCIA") by obtaining a declaratory judgment of patent invalidity before even submitting a biosimilars application.

United StatesIntellectual Property
Peter Reichertz
Peter Reichertz
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The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price Competition and Innovation Act of 2009 ("BPCIA") by obtaining a declaratory judgment of patent invalidity before even submitting a biosimilars application.  See Sandoz Inc. v. Amgen Inc., Civil No. 13-2894 MMC, _____ USLW _____ (N.D. Cal. 2013).

In that case, Sandoz sought a declaratory judgment that certain patents for Amgen's ENBREL® (etanercept) product were invalid before it had filed a biosimilars application with FDA; it was, instead, in the process of conducting required clinical trials with the intent to file a biosimilar application under Section 351(k) of the Public Health Service Act.  Amgen moved to dismiss, alleging that a case or controversy did not exist, and secondly that the district court lacked authority to consider such a dispute until

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