On June 12, 2017, the Supreme Court issued its decision in Sandoz v. Amgen (available here). The Court interpreted 42 U. S. C. § 262(l), enacted as part of the Biologics Price Competition Act of 2009 (BPCIA). The BPCIA governs biosimilars—biologic products that are highly similar to other biologic products already approved by the Food and Drug Administration (FDA). The Court summarized the relevant governing procedure as follows:
Under §262(l), an applicant that seeks FDA approval of a biosimilar must provide its application materials and manufacturing information to the manufacturer of the corresponding biologic within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. The applicant then must give notice to the manufacturer at least 180 days before marketing the biosimilar commercially.
The Supreme Court resolved two questions. First, the Court found that an injunction is not available under federal law to enforce the requirement that an applicant provide its application and manufacturing information to the manufacturer of the biologic, but remanded for consideration of whether an injunction is available under state law.
Second, the Court found that the applicant may provide notice to the manufacturer before obtaining a license from the FDA for its biosimilar. In other words, the applicant need not only provide notice after obtaining the license.