US Department of Justice Files Amicus Brief in Amgen v Sandoz

On Monday, the United States filed an amicus brief with the Federal Circuit in the case of Amgen v Sandoz. The brief addresses whether the Biologics Price Competition and Innovation Act (BPCIA) preempts additional remedies under state law for an applicant’s failure to comply with the so-called “patent dance.” Acting Assistant Attorney General Chad A. Readler, Deputy Assistant Attorney General Hashim M. Mooppan, and attorneys Scott R. McIntosh and Lowell V. Sturgill, Jr, wrote the brief for the US Department of Justice (DOJ).

The United States took the position that the BPCIA preempts any state-law remedies for a biosimilar applicant’s failure to comply with the patent dance. “The procedures governing the presentation of patent claims and defenses are controlled by federal laws and the Federal Rules of Civil Procedure. As a result, states lack the authority to proscribe their own procedural rules for federal patent litigation or their own remedies for violations,” the brief states. The DOJ went on to say that “States have no more authority to regulate [BPCIA] rules than they have over any other aspect of federal patent litigation.”

Furthermore, the DOJ indicated that allowing a reference product sponsor to sue under state law to force compliance with the patent dance would interfere with the goals of the BPCIA, which include expediting the resolution of patent disputes over biosimilars. “Congress imposed short and fixed statutory time limits on each of the prescribed steps” of the patent dance, the brief states, “leading to the commencement of patent litigation no more than roughly 250 days after FDA accepts the applicant’s biosimilar application for review. To allow a private party to sue under state law…would undermine that timetable by allowing for potentially lengthy collateral litigation over compliance.”

The DOJ’s brief generally supports Sandoz’s position in the ongoing remanded appeal of the Supreme Court’s decision in Sandoz v Amgen. In Sandoz’s supplemental brief, ordered by the Federal Circuit, Sandoz claimed that “Allowing the 50 states to overlay their own disparate remedies onto the BPCIA’s complex procedural scheme would disrupt the careful balance struck by Congress.”

The DOJ did not, however, take a position on whether Sandoz had acted unlawfully in not complying with the patent dance. Neither did it weigh in on whether Sandoz had previously waived a preemption defense, as argued by Amgen in its own supplemental brief.

Amgen, meanwhile, has claimed that the BPCIA does not preempt any state law remedies for a failure to comply with the patent dance because the BPCIA does not provide a remedy of its own for such a refusal to engage in the information exchange process.