The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On the first question considered, the Court held that a biologic reference product sponsor (“RPS”) cannot seek enforcement of 42 U.S.C. §262(l)(2)(A) by injunction under federal law. This section is the first step of the so-called “patent dance,” and requires a biosimilar applicant to disclose its aBLA and related manufacturing information to the RPS. The Supreme Court agreed with the Federal Circuit that the BPCIA, at §262(l)(9)(C), provides the exclusive federal remedy for failure to disclose the required information by authorizing an RPS to bring an immediate declaratory-judgement action. The Federal Circuit erred, however, in its reliance on 35 U.S.C. §271(e)(4) as precluding state law remedies. As the Supreme Court explained, failure to disclose the aBLA and related information is not part of the artificial act of infringement established in §271(e)(2), and therefore the exclusive remedies outlined in §271(e)(4) do not apply. Instead, the Supreme Court remanded the issue back to the Federal Circuit to determine whether an injunction is available under state law to enforce §262(l)(2)(A), or whether state law enforcement is preempted by the BPCIA. If the Federal Circuit does determine that state-law remedies are pre-empted, biosimilar applicants will be able to continue withholding information required by the BPCIA without threat of enforcement of that provision.

The Court’s analysis of the second question, regarding the 180-day notice provisions of the statute, was more straightforward. The Court held that the Federal Circuit had misinterpreted the statutory language by imposing a requirement for FDA approval before proper notice could be given. According to the opinion, the reference in the statute to a licensed biosimilar product was to the term “commercial marketing” not “notice,” and thus just imposed the requirement that a product be licensed before it is marketed. With this interpretation the notice was not tied to a product having been licensed before notice was given, as the Federal Circuit had held, but to the unremarkable reality that the product had to be licensed before it was sold. Outside this question of statutory interpretation the Court identified the policy arguments raised by the parties and the government, and refused to be persuaded by the plausible contentions set forth therein. Rather, the Court recommended that Congress is the appropriate body for making these policy distinctions and advised the parties to go there to effect a change in the law.

Decided June 12, 2017

The opinion can be found at https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf.