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

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 after Sandoz had filed an application with FDA for its biosimilar of ENBREL® and gone through the patent exchange process required by BPCIA.

While the district courts do have jurisdiction to entertain declaratory judgments, Judge Chesney ruled that that jurisdiction was limited with regard to patent disputes due to Section 351 of the Public Health Service Act ("PHSA"). She stated:

"Specifically, with limited exceptions not applicable here, neither a reference product sponsor, such as Amgen, nor an applicant, such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily-mandated exchanges of information. See 42 U.S.C. §§ 262(1)(2)-(6).

Here, Sandoz does not contend, and cannot contend, it has complied with its obligations under §§ 262(1)(2)-(6), because, as it concedes in its compliant and opposition, it has not, to date, filed an application with the FDA. Rather, citing § 262(1)(8), Sandoz argues § 262 "provides [declaratory judgment] actions can be filed by either party upon the biosimilar manufacturer's notice of commercial marketing, which Sandoz has given here."

See page 3. Sandoz's argument failed as the notice of commercial marketing could only be given after the biosimilar was licensed, and that even then, it would be required to go through the patent exchange process set forth in Section 351, before seeking declaratory relief.

In addition, she ruled that no case or controversy existed since Amgen had not threated to sue Sandoz. And she...