The U.S. Food and Drug Administration (“FDA”) panel’s unanimous recommendation to approve Sandoz’ application for a filgrastim biosimilar of Amgen’s Neupogen® on Jan. 7, 2015, brings into sharp focus the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) for resolving patent issues. The imminent approval by the FDA of Sandoz’ application now leaves resolution of patent issues for Sandoz to contend with as it prepares to launch its biosimilar filgrastim product. The lawsuit to resolve these issues, however, has just begun.
On July 7, 2014, Sandoz’ application for a filgrastim biosimilar was accepted for review by the FDA. Amgen Inc. v. Sandoz Inc., No. 3:14-cv-04741 (N.D. Cal. Filed Oct. 24, 2014), Sandoz Answer to Complaint and Affirmative Defenses and Counterclaims, ¶ 63. According to the BPCIA, this event triggers a scheme for reciprocal exchanges of patent-related information that is likely to last for about 9 months before patent litigation ensues. 42 U.S.C. §262(l). According to Amgen, under this scheme a patent lawsuit for Sandoz’ filgrastim product would not be initiated prior to about March 18, 2015. Amgen Inc. v. Sandoz Inc., No. 3:14-cv-04741, Amgen’s Complaint, ¶ 64. However, Sandoz’ filgrastim application...
