The District of Delaware recently held that branded biologic companies may pursue a private cause of action to address a biosimilar applicant’s anticipated violation of the commercial marketing notice requirement under 42 U.S.C. § 262(1)(8)(A).

In Amgen Inc. et al. v. Hospira, Inc., Civ. Action No. 15-839 (D. Del.), the Plaintiffs filed a patent infringement lawsuit based on the Defendant’s filing of a biosimilar application with the FDA.  In addition to the patent claims, the Plaintiffs sought a declaratory judgment that Defendant’s anticipated refusal to give notice of commercial marketing would violate 42 U.S.C. § 262(1)(8)(A), and requested that the Court grant injunctive relief requiring the Defendant to provide Plaintiffs with legally effective notice of commercial marketing.

42 U.S.C. § 262(1)(8)(A) of the BPCIA provides that a biosimilar “applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the [proposed product].”  According to Plaintiffs’ allegations, the Defendant (1) provided Plaintiffs with notice of its intention to commercially market its biological product prior to the FDA approving its biosimilar application, and (2) adopted the position that no further notice is required or will be given.  Plaintiffs asserted that Defendant’s position fails to adhere to the Federal Circuit’s decision in Amgen v. Sandoz, which requires notice to be produced after FDA approval.

Defendants filed a motion dismiss Plaintiffs’ declaratory judgment claim based on Federal Rule of Civil Procedure 12(b)(1) and 12(b)(6), arguing that there is no private right for Plaintiffs to enforce 42 U.S.C. § 262(1)(8)(A).  Judge Andrews of the District of Delaware denied Defendant’s motion relying heavily on the Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 2016-1308, 2016 U.S. App. LEXIS 12353 (Fed. Cir. July 5, 2016) which ANDA Advisors discussed here.  In that case, the Federal Circuit affirmed a district court’s issuance of an injunction that required Apotex to provide Amgen with 180 days’ notice before the date of the first commercial marketing of the biological product approved by the FDA.  See id. at *4.  The Federal Circuit specifically held that, the commercial marketing provision is mandatory and enforceable by injunction. . . .”  Id.  In the instant case, the Defendant sought to distinguish Amgen/Apotex on the basis that the Federal Circuit did not squarely address whether 42 U.S.C. § 262(1)(8)(A) creates a private right of action.  Judge Andrews, however, rejected Defendant’s argument.    Although he acknowledged that Apotex had not specifically argued Defendant’s no-private-action position, Judge Andrews concluded that the Federal Circuit has “recognized the availability of injunctive relief for violations of (8)(A).”

The takeaway:  Biosimilar applicants’ efforts to avoid the 180-day notice requirement under the BPCIA are being consistently rejected, and the prudent course of action, despite the inherent extension of exclusivity it causes—is to comply with the notice requirements under 42 U.S.C. § 262(1)(8)(A).