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 was recommended for approval by the FDA panel on Jan. 7, 2015.

This situation highlights how narrowly the current statutory scheme limits the ability of biosimilar applicants to resolve patent issues before FDA approval. Prior to filing an application for approval of a biosimilar product, an applicant’s activities are shielded from patent infringement by 35 U.S.C. § 271(e)(1), which provides a broad “safe harbor” for what would otherwise be infringing activity. Sandoz Inc. v. Amgen Inc., 112 U.S.P.Q.2d 2004, 2008 (Fed. Cir. 2014). This “safe harbor” is in effect at least until the biosimilar application is filed. Id. The “safe harbor” was relied upon by the Federal Circuit in ruling that a prospective biosimilar applicant does not meet the Article III requirement for “immediacy and reality” that would allow them to resolve patent issues via a Declaratory Judgment action. Id.

Subsequently, once a biosimilar application is filed, the BPCIA precludes the applicant from bringing a Declaratory Judgment action until after providing notice of commercial marketing. 42 U.S.C. §262(l)(8)(9). According to at least one court, this notice cannot be given prior to FDA approval. Sandoz Inc. v. Amgen Inc., No.C-13-2904, 2013 WL 6000069, at *2 (N.D. Cal. Nov. 12, 2013).

The strategy Sandoz adopted for its filgrastim application precipitated a patent infringement lawsuit by Amgen on Oct. 24, 2014. Sandoz provided timely notice to Amgen after the FDA accepted its filgrastim application for review, but ultimately decided not to allow Amgen’s attorneys to inspect that application and would not provide manufacturing information. Amgen Inc. v. Sandoz Inc., No 3:14-cv-04741, Sandoz’s Answer, ¶ 67. Amgen filed suit alleging infringement of U.S. Patent No. 6,162,427, which expires on Dec. 12, 2016. Although this lawsuit likely was filed sooner than would be the case had the BPCIA scheme been followed, it is likely to be several years after FDA approval before the related patent issues are resolved.

There are a variety of strategies available for resolving patent issues prior to product launches. Contact a Husch Blackwell attorney for more information about these possibilities.