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Amgen Inc. v. Sandoz Inc.

BPCIA Preempts State Enforcement of “Patent Dance” Provisions

Amgen Inc. v. Sandoz Inc., 2017 U.S. App. LEXIS 25227 (Fed. Cir. Dec. 14, 2017) (Newman, LOURIE, Chen) (N.D. Cal.: Seeborg) (3 of 5 stars)

Fed Cir affirms dismissal of Amgen’s state law claims relating to Sandoz’s noncompliance with § 262(l)(2)(A) of the BPCIA, on preemption grounds. Today’s opinion comes on remand from the Supreme Court (137 S. Ct. 1664 (2017)). At issue was whether Amgen could seek any relief under state law for Sandoz not providing Amgen with its biosimilar application prior to filing. The opinion rejects Amgen’s argument that Sandoz had waived any argument that the BPCIA preempted California law on this point by failing to make it before the district court. The Supreme Court had expressly invited the Federal Circuit to analyze the preemption issue, and even if the Fed Cir did not assess the issue, Sandoz would be able to take it up on remand. The opinion then concludes that the BPCIA preempts any state law remedies for failure to comply with § 262(l)(2)(A). The discussion notes the intrinsically federal nature of patent law, and how states have not traditionally regulated in that area. Applying Arizona, 567 U.S. 387 (2012), and Rice, 331 U.S. 218 (1947), the federal government has “fully occupied” the relevant field of biosimilar patent litigation. The opinion also rejects Amgen’s argument that its state law claims are not in conflict with the BPCIA. Noting that Congress created no injunctive remedy for breach of § 262(l)(2)(A), and reasoning that such must have been intentional, the opinion concludes that applying state law would create a conflict in the method of enforcement.

KEYWORDS: BIOLOGICS; BPCIA; PREEMPTION