In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize biosimilars applicants who fail to disclose information about their abbreviated Biologics License Applications (“aBLAs”) or manufacturing processes as required by 42 U.S.C. § 262(l)(2)(A).
Amgen’s State Law Claims
This is the latest in a line of BPCIA decisions arising out of Sandoz’s application to market a biosimilar version of Amgen’s Neupogen (filgrastim) biologic. (For more complete coverage of the facts and prior proceedings, see our prior coverage, including the Supreme Court and Federal Circuit opinions.) In relevant part, after filing its aBLA, Sandoz refused to provide Amgen with a copy of its aBLA and manufacturing information as required by § 262(l)(2)(A). Amgen then filed suit, asserting both patent infringement under the BPCIA as well as state law claims under California law, including a claim for unfair competition. Sandoz asserted, among its many defenses, an affirmative defense that Amgen’s state law claims are preempted by the federal BPCIA. However, neither the district court nor the Federal Circuit addressed preemption on the merits. On June 12, 2017, the Supreme Court ruled that the BPCIA’s “patent dance” information exchange provisions are optional and that an aBLA applicant may refuse to provide a reference product sponsor with a copy of the aBLA and manufacturing information required by § 262(l)(2)(A). The Court, however, remanded to the Federal Circuit for a determination of whether the BPCIA preempts Amgen’s state law claims.
Amgen’s State Law Claims Are Preempted by BPCIA under Both “Field” and “Conflict” Preemption
On remand the Federal Circuit concluded that the BPCIA preempts Amgen’s state law claims under the doctrines of both “field” and “conflict” preemption. Under field preemption, “state law is pre-empted where it regulates conduct in a field that congress intended the Federal Government to occupy exclusively.” English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990). The court here observed the complex, comprehensive, and pervasive statutory scheme of the BPCIA and inferred that Congress intended to leave no room for state law to supplement the field of biosimilar patent litigation.
Similarly, conflict preemption occurs “where it is impossible for a private party to comply with both state and federal requirements, or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Id. The court first observed such a conflict because state law may provide remedies for noncompliance with § 262(l)(2)(A) that the BPCIA does not. It also observed that requiring biosimilar applicants to comply with the BPCIA’s “detailed regulatory regime” in addition to 50 potentially different state-law tort regimes could “dramatically” increase the burden on biosimilar applicants beyond those Congress intended when enacting the BPCIA.
This latest ruling would seem to preclude future attempts by litigants to enforce the BPCIA patent dance provisions via state laws claims such as unfair competition or conversion. But stay tuned for further coverage as a number of other BPCIA issues continue to make their way through the courts in this rapidly evolving area of law.