Docket Nos. 2015-1499
NEWMAN, LOURIE, CHEN
December 14, 2017
Brief summary: DC’s dismissal of Amgen’s state law unfair competition and conversion claims was affirmed due to preemption by federal law (BCPIA).
Summary: In its 2017 Sandoz v. Amgen decision relating to Sandoz’s eBLA for a biosimilar filrastim product, SCOTUS “held that an injunction under federal law is not available to enforce 42 U.S.C. § 262(l)(2)(A); and a biosimilar applicant may provide the notice required by 42 U.S.C. § 262(l)(8)(A) either before or after receiving FDA approval, i.e., the applicant need not defer giving notice of commercial marketing until FDA licensure of the biosimilar in order to begin the running of the 180-day clock”, reversing-in-part and vacating-in-part the FC’s 2015 decision, and remanding it to the FC for proceedings consistent with SCOTUS’s opinion. SCOTUS instructed the FC to consider “whether California law would treat noncompliance with § 262(l)(2)(A) as ‘unlawful’”. “If the answer is yes,” SCOTUS wrote, “then the court should proceed to determine whether the BPCIA pre-empts any additional remedy available under state law” (e.g., Amgen’s state law unfair competition and conversion claims) “for an applicant’s failure to comply with § 262(l)(2)(A) (and whether Sandoz has forfeited any preemption defense…)”, adding that “[t]he court is also of course free to address the preemption question first by assuming that a remedy under state law exists.” Amgen argued that Sandoz waived its preemption defense but this FC panel disagreed since “Sandoz preserved its ability to assert preemption by pleading the defense in its answer.” The FC panel then “turn[ed] to the question whether Amgen’s state law claims are preempted by the BPCIA”, a “question of law that [it] review[s] de novo” (Ultra-Precision, FC 2015). It concluded that “both field” (where state law “regulates conduct in a field that Congress intended the Federal Government to occupy exclusively”) “and conflict preemption” (where state law conflicts with federal law) “exist here.” The FC panel also concluded “that the BCPIA preempts state law claims predicated on an applicant’s failure to comply with § 262(l)(2)(A)…because biosimilar patent litigation ‘is hardly ‘a field which the States have traditionally occupied’” (Buckman, US 2001), “patents are ‘inherently federal in character’ because a patent ‘originates from, is governed by, and terminates according to federal law’”, and “Congress has granted federal courts ‘exclusive jurisdiction over cases ‘arising under any Act of Congress relating to patents’” (Gunn, US 2013 and 28 USC § 1338(a)). Thus, “assuming arguendo that there are any state-recognized interests in play here, California law must ‘give way to federal law’” (Arizona, US 2012). The FC panel also concluded that “conflict preemption also bars Amgen’s state law claims” since “state law claims ‘clash’ with the BPCIA, and the differences in remedies between the federal scheme and state law claims support concluding that those claims are preempted” and compliance with the BCPIA “in the shadow of 50 States’ tort regimes…could dramatically increase the burdens’ on biosimilar applicants.” The DC’s dismissal of Amgen’s state law unfair competition and conversion claims was affirmed.