The Supreme Court's Sandoz v Amgen Ruling Raises as Many Questions as It Resolves

On June 28, Elaine Blais and Willy Jay, partners at Goodwin Proctor LLP, held a webinar discussing the Supreme Court’s Decision in the case of Sandoz v Amgen. While the court provided some much-needed clarity surrounding requirements of the Biologics Price Competition and Innovation Act (BPCIA) “patent dance,” as Blais and Jay pointed out, the court’s ruling left a number of important questions unresolved.

Among key issues raised by Sandoz v Amgen—and not addressed by the court—are those related to state law. The Supreme Court remanded to the federal circuit the questions of whether Sandoz’s conduct was unlawful in the State of California, whether federal law preempts any state-law remedy in the case, and whether Sandoz has forfeited any preemption defense. As Blais and Jay pointed out, we don’t have enough clarity on who will answer these questions: the district court or the federal circuit.

As the industry looks past the particulars of this case and toward implications for the future, and as litigants explore whether state laws can provide an injunctive remedy that federal law does not, the question arises of which state laws will be applied, and who will decide the future of state-law cases.

The court also declined to confront issues of what would happen should an applicant complete only some steps of the patent dance. At several steps of the information exchange process, an applicant’s failure to take action during a prescribed time period can open the door for the reference product’s sponsor to bring an action against the applicant. It is as yet unclear what would become of the sponsor’s ability to bring such actions in the case of an incomplete patent dance.

Additional unresolved questions related to an incomplete information exchange process include what will happen to the 2 phases of BPCIA litigation should a biosimilar applicant terminate the first wave litigation by serving notice of commercial marketing to the reference product’s sponsor. Typically, the second wave of litigation is triggered by such notice, but it is unclear whether the initial wave of litigation would continue in such a scenario, or whether a preliminary injunction be available.

Finally, it remains unclear whether the FDA will participate as an amicus curiae (literally a “friend of the court” who serves as an impartial advisor) to assist in clarifying some of these issues. Anthony Yang, who served as amicus curiae in Sandoz v Amgen, indicated that the FDA had been petitioned to involve itself in creating patent rules, but had declined. Perhaps Justice Stephen Breyer’s request that the FDA make its opinions known in resolving these questions will prompt the agency to break its long silence on patent issues.