Amgen Inc. v. Sandoz Inc.
877 F.3d 1315
Fed. Cir.2017Background
- Amgen sued Sandoz after Sandoz filed an aBLA for a filgrastim biosimilar and declined to provide its aBLA and manufacturing information to Amgen under 42 U.S.C. § 262(l)(2)(A); Sandoz also gave notice of commercial marketing before FDA licensure.
- District court held Sandoz’s conduct was permitted by the BPCIA, dismissed Amgen’s California unfair-competition (UCL) and conversion claims, and granted partial judgment to Sandoz on BPCIA interpretation issues.
- The Federal Circuit initially affirmed dismissal of state-law claims but limited remedies under the BPCIA; the Supreme Court reversed in part, holding (1) notice of commercial marketing may be given before or after licensure and (2) federal injunctive relief is not available to enforce § 262(l)(2)(A), and remanded for consideration whether California law would treat noncompliance as “unlawful” and whether BPCIA preempts state remedies.
- On remand this Federal Circuit panel considered whether Sandoz waived its preemption defense and whether the BPCIA preempts Amgen’s state-law claims that seek injunctions/damages for alleged failure to comply with § 262(l)(2)(A).
- The court concluded Sandoz did not forfeit the preemption defense and held that the BPCIA preempts Amgen’s state-law UCL and conversion claims on both field and conflict preemption grounds, affirming dismissal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Waiver of preemption defense | Amgen: Sandoz waived preemption by not pressing it below; affirmative defenses can be forfeited | Sandoz: Preemption was pleaded in its answer; issue fully briefed on remand and is of great public importance | Court: No waiver; discretion to decide; Sandoz preserved defense in its answer and Supreme Court invited resolution on remand |
| Field preemption — does BPCIA occupy the field of biosimilar patent enforcement? | Amgen: Federal statute doesn’t preempt state remedies because patent law does not fully preempt state unfair-competition claims; state remedies address harms federal scheme doesn’t | Sandoz: BPCIA creates a comprehensive federal scheme for biosimilar approval and patent dispute resolution, including consequences for noncompliance, indicating exclusive federal occupation | Court: Held field preemption — BPCIA’s detailed, comprehensive scheme shows Congress intended federal exclusivity in this field |
| Conflict preemption — do state remedies conflict with BPCIA objectives? | Amgen: State claims don’t clash with BPCIA; they add elements and seek distinct relief independent of patent rulings | Sandoz: State penalties (injunctions, damages) would upset Congress’s calibrated remedy choices (e.g., § 262(l)(9)(C)) and multiply inconsistent state remedies | Court: Held conflict preemption — state remedies frustrate the federal enforcement balance and impose penalties Congress chose not to provide |
| Availability of state-law remedies for failure to provide aBLA (§ 262(l)(2)(A)) | Amgen: Failure to disclose is “unlawful” under California UCL and supports conversion; state law can supply remedies federal law omits | Sandoz: BPCIA prescribes exclusive federal consequences (e.g., § 262(l)(9)(C)); states cannot add injunctive/damages remedies | Court: State-law remedies are preempted; federal scheme’s exclusive remedy and absence of injunction/damages displace state enforcement |
Key Cases Cited
- Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017) (Supreme Court decision on notice timing and availability of federal injunction under the BPCIA)
- Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947) (field preemption principles; pervasive federal regulation inference)
- Arizona v. United States, 567 U.S. 387 (2012) (preemption where federal interest dominates field; state remedies conflict with federal scheme)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (federal character of certain regulatory/patent-related fields limits state-law claims)
- English v. Gen. Elec. Co., 496 U.S. 72 (1990) (overview of preemption doctrines)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (Congressional intent is the ultimate touchstone in preemption analysis)
- Gunn v. Minton, 568 U.S. 251 (2013) (patent law’s federal character and exclusive federal jurisdiction over patent causes of action)
- Amalgamated Ass'n v. Lockridge, 403 U.S. 274 (1971) (conflict in remedy techniques can disrupt federal regulatory scheme)