The Federal Circuit today ruled decisively in favor of Sandoz in the long-running battle with Amgen over whether state law can be used to compel a biosimilar applicant to participate in the BPCIA’s “patent dance.” The panel unanimously held that the answer is no, because federal law preempts any such state-law theory. The opinion by Judge Lourie relied on both field and conflict preemption. The decision was not specific to the principles of California law on which Amgen had relied; it appears to close the door to any state-law attempt to enforce the steps of the patent dance with an injunction or to penalize noncompliance.
Big Molecule Watch has previously covered this case at the Supreme Court and on remand. A more detailed analysis of the decision will follow soon.