Sandoz Inc. v. Amgen Inc.
U.S. Supreme Court · decided June 12, 2017 · Supreme Court Database (Spaeth)
- Decided
- June 12, 2017
- Term
- October Term 2016
- Vote
- 9–0
- Majority author
- Justice Thomas
- Issue area
- Economic Activity
- Disposition
- Reversed and remanded
- Outcome
- Petitioning party won
- Ideological direction
- Liberal
Opinion excerpt
Justice THOMAS delivered the opinion of the Court. These cases involve 42 U.S.C. § 262(l ), which was enacted as part of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), 124 Stat. 808. The BPCIA governs a type of drug called a biosimilar, which is a biologic product that is highly similar to a biologic product that has already been approved by the Food and Drug Administration (FDA). 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 first question presented by these cases is whether the requirement that an applicant provide its application and manufacturing information to the manufacturer of the biologic is enforceable by injunction. We conclude that an injunction is not available under federal law, but we remand for the court below to decide whether an injunction is available under state law. The second question is whether the applicant must give notice to the manufacturer after, rather than before, obtaining a license from the FDA for its biosimilar. We conclude that an applicant may provide…
Excerpt of a 33,287-character opinion. The full text and citation network load in the interactive viewer above.