Sandoz Inc. v. Amgen Inc.

Sandoz filed a biologics license application for a biosimilar of Amgen's filgrastim product, Neupogen. Sandoz declined to provide its application and manufacturing information to Amgen under the BPCIA's "patent dance" and gave notice of commercial marketing before FDA approval. Amgen sued, alleging patent infringement and violations of the BPCIA. The district court granted a preliminary injunction, the Federal Circuit reversed in part, and the Supreme Court granted certiorari. The Court unanimously held that the BPCIA's requirement to disclose the application is not enforceable by injunction; the remedy for noncompliance is limited to declaratory judgment. On the notice issue, the Court ruled that the 180-day notice of commercial marketing must be given only after FDA licensure.

The Supreme Court reversed the Federal Circuit's holding that the disclosure requirement was enforceable by injunction, ruling that the remedy is limited to declaratory judgment and other non-injunctive relief. It affirmed the requirement that the 180-day notice may only be given after FDA licensure, reversing the Federal Circuit on that point. The case was remanded for further proceedings consistent with this opinion.

1. Whether a biosimilar applicant must provide its biologics license application and manufacturing information to the reference product sponsor under 42 U.S.C. §262(l)(2)(A). 2. Whether an applicant's 180-day notice of commercial marketing under §262(l)(8)(A) is effective only if given after the product is licensed by the FDA.

The decision accelerated biosimilar market entry by removing the threat of an injunction for failing to disclose application materials, while preserving the post-approval 180-day waiting period for patent litigation. It reduced legal uncertainty and costs for biosimilar developers, promoted competition, and was expected to lower biologic drug prices. The ruling also shaped subsequent biosimilar disputes and reinforced the regulatory framework established by the BPCIA.