Sandoz Inc. v. Amgen Inc.
198 L. Ed. 2d 114
| SCOTUS | 2017Background
- BPCIA § 262(l) governs biosimilar FDA approvals and prelitigation patent disputes between biosimilar applicants and reference biologic sponsors.
- § 262(l)(2)(A) requires the applicant to provide its application and manufacturing information to the sponsor within 20 days after FDA accepts the application; § 262(l)(2)(B) allows additional information requests.
- § 262(l)(8) requires the applicant to give at least 180 days' notice before first commercial marketing; the timing of licensure affects when marketing may commence.
- The cases center on whether § 262(l)(2)(A) can be enforced by federal or state injunctions, and whether prelicensure notice is permissible.
- Amgen sued Sandoz for patent infringement and challenged BPCIA remedies; the district court and Federal Circuit addressed injunctions and notice timing.
- Sandoz received FDA acceptance for Zarxio; Amgen sought to enjoin marketing and questioned prelicensure notice validity under California unfair competition law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Can § 262(l)(2)(A) be enforced by injunction under federal or state law? | Amgen argues the disclosure remedy can be enforced via injunctive relief; federal and state remedies may apply. | Sandoz contends no federal injunction exists and California law provides no remedy under the BPCIA framework. | No federal injunction; remand for state-law review. |
| Whether prelicensure notice under § 262(l)(8)(A) is permissible or must occur after licensure? | Amgen argues notice must follow licensure; timing constrains enforcement. | Sandoz maintains prelicensure notice is valid and triggers later timing. | Prelicensure notice is permissible; notice can occur before licensure. |
Key Cases Cited
- Winter v. NRDC, 555 U.S. 7 (U.S. 2008) (balancing equities for injunctions in extraordinary cases)
- Great-West Life & Annuity Ins. Co. v. Knudson, 534 U.S. 204 (U.S. 2002) (statutory remedies and preemption in private suits)
- Touche Ross & Co. v. Redington, 442 U.S. 560 (U.S. 1979) (statutory interpretation and private remedies)
- Karahalios v. Federal Employees, 489 U.S. 527 (U.S. 1989) (strong presumption against implied remedies when statute provides explicit remedy)
- Amgen Inc. v. Sandoz, Inc., 137 S. Ct. 836 (S. Ct. 2017) (Supreme Court consolidation on biosimilar notice and disclosure remedies)
- Amgen Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir. 2015) (Federal Circuit on injunctions and notice timing under BPCIA)
- Rose v. Bank of America, N.A., 57 Cal.4th 390 (Cal. 2013) (California unfair competition law and expressively exclusive remedies)
- Loeffler v. Target Corp., 58 Cal.4th 1081 (Cal. 2014) (unlawful conduct under California unfair competition law requires statute-specific analysis)
- Sandoz, Inc. v. Amgen, Inc., F.3d 1347 (Fed. Cir. 2015) (preliminary injunction and notice timing under § 262(l))