Sandoz Inc. v. Amgen Inc.

In this decision, as discussed in more detail in the current Holman Report, the Supreme Court interprets two provisions of 42 U. S. C. 262(l), which governs the statutory scheme for preparing to adjudicate, and then adjudicating, claims of infringement brought by the sponsor of an approved biologic against a biosimilar applicant under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), often referred to as the BPCIA's "patent dance.'' The first provision requires that the applicant "shall provide'' the sponsor with a copy of the application and information about how the biosimilar is manufactured within 20 days after FDA accepts the application for review. The Court held that when a biosimilar applicant fails to provide this information to the sponsor, the sponsor's only remedy under federal law is an action for a declaratory judgment of infringement; the requirement is not enforceable by an injunction. The Court remanded to the Federal Circuit to determine whether applicant's failure to provide the information might be enforceable by an injunction under California state law. The second provision at issue states that the applicant must give notice to the sponsor at least 180 days before commencing to market the biosimilar commercially. In the decision below, the Federal Circuit had held that the 180 days' notice could only be given after the biosimilar had received FDA approval. The Court reversed on this point, holding that the applicant may provide notice either before or after receiving FDA approval. Thus, it is possible under some circumstances for an applicant to begin marketing its biosimilar earlier than 180 days after approval.