Amgen, Sandoz File Supplemental Briefs in Ongoing Appeal

Following the Supreme Court’s recent decision in the case of Sandoz v Amgen, both drug makers this week filed supplemental briefs in compliance with a Federal Circuit court order. These briefs state the parties’ opinions on the appropriate action to be taken after the Supreme Court remanded the case to the lower courts.

In its brief, Amgen said that Sandoz’s refusal to provide its abbreviated Biologics License Application for its biosimilar filgrastim was a violation of the Biologics Price Competition and Innovation Act (BPCIA), and was therefore “unlawful” and “wrongful.” It stated that the failure of Sandoz to comply with the patent dance is sufficient to vacate the district court’s previous dismissal of Amgen’s claim against Sandoz under California’s laws concerning unfair competition. It also 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 a failure to comply with its provisions. Furthermore, Amgen claims that Sandoz has waived any preemption defense in the past, so it should not be allowed to argue preemption now.

Sandoz, in its brief, said that the court should affirm the dismissal of Amgen’s claims under state laws, because, it claims, state laws are preempted by the BPCIA. “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,” Sandoz said. “As the Supreme Court recognized, Congress chose which remedies to provide and chose not to provide others.” Sandoz asked that the case be remanded directly to the district court rather than be made the subject of a separate appellate proceeding.

Ha Kung Wong, JD, told The Center for Biosimilars^® in a recent interview, “[The Supreme Court] remanded the question to the Federal Circuit as to whether an injunction may be available under state law, and specifically whether an injunction for failure to provide the initial disclosures was available under California’s unfair competition law. That’s one question that was deliberately left unanswered by the Court in Sandoz.”

The issue of whether the BPCIA preempts remedies under state law could be informed by an amicus brief; as Big Molecule Watch reports, the United States is considering filing such a brief in the case to address the question of preemption. The court has extended the window for amicus brief filing until September 11, 2017.