## Facts

- Amgen sold filgrastim (Neupogen), a biologic product; Sandoz sought FDA licensure for Zarxio as a biosimilar under the Biologics Price Competition and Innovation Act (BPCIA).
- In 2014, Sandoz submitted a biosimilar application to the FDA under 42 U.S.C. § 262(k), and the FDA accepted it for review on July 7, 2014.
- On July 8, 2014, Sandoz notified Amgen of the filing and its intent to market immediately upon approval, but refused to provide its application and manufacturing information under § 262(l)(2)(A), inviting Amgen to sue for patent infringement.
- Amgen alleged Sandoz violated § 262(l)(2)(A) and California unfair competition law, and argued Sandoz’s pre-licensure notice did not satisfy the 180-day notice requirement in § 262(l)(8)(A).
- The FDA licensed Zarxio on March 6, 2015; Sandoz provided a same-day marketing notice.
- The Federal Circuit held no federal injunction was available to compel the § 262(l)(2)(A) information exchange, but held notice under § 262(l)(8)(A) was effective only after licensure and enjoined launch until 180 days after the post-licensure notice.

## Issues

1. Whether § 262(l)(2)(A) can be enforced by a federal injunction compelling a biosimilar applicant to provide its application and manufacturing information to the reference product sponsor.
2. Whether § 262(l)(8)(A)’s 180-day notice of commercial marketing is effective if given before FDA licensure, or must be given only after licensure.
3. Whether state-law remedies may be available for failure to provide § 262(l)(2)(A) information, consistent with federal preemption limits.

## Decision

- The Supreme Court held that § 262(l)(2)(A) is not enforceable by federal injunction; the BPCIA supplies specified consequences for noncompliance, including an immediate patent declaratory-judgment route.
- The Court held that notice under § 262(l)(8)(A) may be given before FDA licensure; the statute requires only that the product be licensed by the time of first commercial marketing.
- The Court vacated and remanded for further consideration of whether state-law remedies could apply to noncompliance with § 262(l)(2)(A) and whether such remedies are preempted.
- The Federal Circuit’s judgment was vacated in part, reversed in part, and remanded.

## Legal Principles

- When a statute provides specific consequences and remedies for noncompliance, courts generally may not add extra federal remedies such as injunctive relief beyond the statutory scheme.
- Under the BPCIA, failure to provide the § 262(l)(2)(A) application/manufacturing information triggers patent-litigation consequences (including immediate declaratory-judgment litigation) rather than a freestanding federal injunction compelling disclosure.
- Section 262(l)(8)(A) permits pre-licensure notice because “licensed under subsection (k)” modifies “biological product,” and the notice requirement is tied to the date of first commercial marketing, not the date notice is sent.
- Questions about using state law to enforce BPCIA-related duties require analysis of state-law elements and federal preemption.

## Conclusion

The Court interpreted the BPCIA to bar a federal injunction compelling participation in the § 262(l)(2)(A) information exchange and to allow the 180-day commercial-marketing notice to be given before FDA licensure, while leaving open on remand whether state-law enforcement theories survive preemption.


Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017)