Sandoz Inc. v. Amgen Inc.

Sandoz v. Amgen, decided June 12th, 2017. A unanimous Supreme Court, in an opinion by Justice Thomas, reviewed the Federal Circuit and decided two questions about the biosimilar "patent dance" under the Biologics Price Competition and Innovation Act. First, the Act's requirement that a biosimilar applicant hand over its application and manufacturing information to the reference-product sponsor is not enforceable by injunction under federal law. Second, an applicant may give its 180-day notice of commercial marketing before — not only after — the FDA licenses the biosimilar. Here's the brief.

Amgen has marketed a filgrastim biologic called Neupogen since 1991, and claims patents on methods of manufacturing and using filgrastim. The BPCIA created an abbreviated FDA pathway for biosimilars, together with a choreographed exchange of information and a sequence of patent litigation — the so-called patent dance. Two steps matter here. Under section 262(l)(2)(A), within 20 days of the FDA accepting a biosimilar application, the applicant "shall provide" its application and manufacturing information to the sponsor. And under section 262(l)(8)(A), the applicant must give the sponsor 180 days' notice before marketing the biosimilar commercially.

Sandoz sought FDA approval for a filgrastim biosimilar, Zarxio, with Neupogen as the reference product. Sandoz told Amgen it would not turn over its application and manufacturing information, and invited Amgen to sue immediately. It also gave notice of commercial marketing before the FDA had licensed Zarxio. Amgen sued for patent infringement and under California's unfair competition law, and sought injunctions to enforce both BPCIA steps. A divided Federal Circuit held that the disclosure requirement could not be enforced by injunction, but that notice was effective only after licensure — and enjoined Sandoz accordingly. Both sides sought review.

Two questions reached the Court. First: is the section 262(l)(2)(A) disclosure requirement enforceable by injunction? Second: may an applicant give the section 262(l)(8)(A) notice of commercial marketing before the biosimilar is licensed?

The framework was the BPCIA's own remedial structure. Section 271(e)(4) supplies the "only remedies" for an act of artificial infringement — but failing to disclose, the Court noted, is not itself an act of artificial infringement. Separately, section 262(l)(9)(C) gives the sponsor, and only the sponsor, an immediate declaratory-judgment action when the applicant withholds its application and manufacturing information. The notice question turned on a single sentence.

On the first question, the Court agreed with the Federal Circuit's result but not its reasoning. Because withholding the information is not artificial infringement, section 271(e)(4) supplies no remedy for it. The remedy Congress did supply is section 262(l)(9)(C) — the sponsor's immediate declaratory-judgment action — and that remedy, the Court held, is exclusive as a matter of federal law.

The Court drew support from statutory context: Congress expressly authorized injunctions to enforce the BPCIA's confidentiality rules, but not its disclosure requirement — a choice the Court presumed deliberate. Whether an injunction might issue under state law, the Court left open — vacating that portion and remanding for the Federal Circuit to decide whether California's unfair competition law reaches the conduct, and whether the BPCIA preempts any state remedy.

On the second question, the Court reversed. The phrase "licensed under subsection (k)" modifies "commercial marketing," not "notice" — so licensure fixes when marketing may begin, not when notice may be given. Read that way, the provision sets a single timing requirement: notice at least 180 days before marketing.

Justice Breyer concurred, adding that Congress may have implicitly delegated to the FDA authority to interpret these same terms.

Sandoz v. Amgen was the Court's first construction of the BPCIA's patent-dance provisions. It established that the disclosure step, though written in mandatory terms, carries no federal injunctive remedy — the sponsor's federal recourse is the declaratory-judgment action Congress specified. And by allowing notice of commercial marketing before licensure, it removed what the Federal Circuit had treated as an additional, post-licensure delay on biosimilar entry. In doing so it confirmed that the applicant, not the sponsor, retains substantial control over the timing of the second phase of litigation. The decision reads the BPCIA as a closed, carefully calibrated remedial scheme, and leaves the state-law question — and the statute's finer administration — to the court below and to the FDA.

Sandoz v. Amgen, 582 U.S. 1, decided June 12th, 2017. I'm Kyle Coleman. Thanks for watching.