U.S. Argues Amgen’s State Law Claim Preempted by BPCIA, Supporting Sandoz

Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports the position taken by Sandoz and the Biosimilars Council that Amgen’s state-law claim for an injunction under California’s Unfair Competition Law (“UCL”) or tort damages to enforce compliance with the BPCIA’s patent dance disclosure provisions is preempted by federal law and is therefore unenforceable.  The Government relies on both field preemption and conflict preemption.

First, the United States’ amicus brief asserts that “[t]he BPCIA preempts any state-law remedies for an applicant’s decision not to make the disclosures identified in Section 262(l)(2)(A)” because “Section 262(l) and other federal statutes occupy the field of federal patent litigation, precluding states from regulating the procedures concerning such litigation.”  According to the Government, “[t]ogether with the pre-existing body of federal laws and rules governing the adjudication of federal patent claims, the BPCIA leaves the states no room to prescribe or enforce procedural rules pertaining to biosimilar patent infringement claims.”

Second, the United States further reasons that “[a]llowing additional state law remedies also would impair important objectives the BPCIA’s patent-related provisions are designed to achieve.” The Government argues that enforcing compliance with the BPCIA through the UCL “would obstruct the BPCIA’s purposes and objectives” because “[e]ven assuming dubitante that Sandoz acted ‘unlawfully’ under the UCL on this view of the BPCIA, a state-law injunction compelling the applicant to make initial disclosures under § 262(l)(2)(A) would block ‘a path expressly contemplated by the BPCIA,’ and deprive the applicant of a choice the BPCIA was designed to provide.”  Furthermore, the Government states, “even if Sandoz acted ‘unlawfully’ under the UCL on [Judge Newman’s] view of the BPCIA, the requested state-law injunction would still undermine Congress’s determination not to authorize additional remedies for noncompliance with § 262(l)(2)(A) beyond the remedy specified in the BPCIA.”

Although the United States’ amicus brief supports Sandoz’s position that Amgen’s state-law claim is preempted, the brief does not take a firm position on whether Sandoz’s conduct was “unlawful” under the California’s UCL, and takes no position on Amgen’s argument that Sandoz has waived any preemption defense.