BPCIA Notice of Commercial Marketing Requirement Privately Enforceable Via Declaratory Relief Claim

The court denied defendant's motion to dismiss plaintiffs' claim for a declaratory judgment that defendant failed to provide notice of commercial marketing as required by the BPCIA and rejected defendant's argument that plaintiffs could not privately enforce the notice requirement. "Defendant . . . [contends] that Plaintiffs may not privately enforce [the BPCIA notice of commercial marketing requirement]. Defendant argues . . . that Congress did not intend to create a private right of action, and where there is no intent, 'a cause of action does not exist and courts may not create one, no matter how desirable that might be as a policy matter, or how compatible with the statute.' . . . While this motion was pending, the Federal Circuit decided Amgen Inc. v. Apotex Inc., - F.3d - (Fed. Cir. July 5, 2016). . . . The Federal Circuit explicitly acknowledged that [the notice requirement] was 'enforceable by injunction.' . . . Plaintiffs do not seek any monetary damages for a violation of (8)(A). Rather, Plaintiffs explicitly request 'a declaration of its rights under the statute and injunctive relief requiring [Defendant] to provide [Plaintiffs] with legally effective notice of commercial marketing.' Absent the availability of declaratory relief, Plaintiffs would simply seek an injunction. . . . The Federal Circuit has already recognized the availability of injunctive relief for violations of (8)(A). If presented with the question raised by Defendant's motion, it would make sense to come to the same conclusion regarding the availability of declaratory relief."

Amgen Inc. et al v. Hospira, Inc., 1-15-cv-00839 (DED August 5, 2016, Order) (Andrews, J.)