Friday, December 15, 2017

Injunctive Remedy Under State Law Not Available in Biosimilar Litigation

The Supreme Court instructed the Federal Circuit to determine whether California law would treat noncompliance with § 262(l)(2)(A) as “unlawful.” If the answer is yes, then the court should proceed to determine whether the BPCIA pre-empts any additional remedy available under state law for an applicant’s failure to comply with § 262(l)(2)(A) (and whether Sandoz has forfeited any preemption defense, see 794 F.3d, at 1360, n. 5). .

Federal Circuit's Holding:

As previously discussed, Amgen seeks through state law to impose penalties on Sandoz unavailable under the BPCIA for failure to comply with § 262(l)(2)(A)’s disclosure requirements. This “conflict in the method of enforcement” between the BPCIA and state law creates “an obstacle to the regulatory system Congress chose.” Arizona, 567 U.S. at 406. We must assume that Congress acted intentionally when it did not provide an injunctive remedy for breach of § 262(l)(2)(A)’s disclosure requirements. See Sandoz, 137 S. Ct. at 1675. Where, as here, “Congress made a deliberate choice not to impose” certain penalties for noncompliance with federal law, state laws imposing those penalties “would interfere with the careful balance struck by Congress.” Arizona, 567 U.S. at 405– 06.

Amgen’s reliance on Rodime is misplaced. In Rodime, we determined that the patent laws did not preempt patentee’s state law claims for tortious interference with prospective economic advantage and unfair competition based on the accused infringer’s alleged efforts to dissuade other companies from taking a license to the asserted patent. 174 F.3d at 1306. Our statement, applied to the facts of Rodime, that “[t]he patent laws will not preempt such claims if they include additional elements not found in the federal patent law cause of action and if they are not an impermissible attempt to offer patent-like protection to subject matter addressed by federal law,” id., does not immunize state law claims in other types of cases from ordinary principles of preemption. As discussed supra, the preemption analysis here demonstrates that Amgen’s state law claims conflict with the BPCIA and intrude upon a field, biosimilar patent litigation, that Congress reserved for the federal government.

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