On Wednesday, June 28, 2017, at 12:00 PM EST, Goodwin will host a webinar discussing the Supreme Court’s Decision in Sandoz v. Amgen.
On June 12, the Supreme Court decided Sandoz v. Amgen, which presented the Justices with multiple significant questions about the correct interpretation and application of the biosimilars statute, the Biologics Price Competition and Innovation Act. The Supreme Court’s decision was unanimous, but did not completely resolve all the issues in the case. The Court held that there is no federal right to sue for an injunction forcing a biosimilar applicant to participate in the information exchange set out in the statute (the “patent dance”). But the Court left open the possibility that an injunction might be available under state law – and also that federal law might forbid such a state-law injunction.
In addition, the Court agreed with Sandoz and reversed the Federal Circuit’s holding on the timing of a notice of commercial marketing. The Federal Circuit had held that notice of commercial marketing can be given only after FDA approval of the biosimilar product, so no biosimilar could launch until 180 days after approval. The Court held that a notice can be given at any time, so if notice is given early enough, a biosimilar can launch on the day of approval.
Join us for a lively discussion about the case as Goodwin partners Elaine Blais and Willy Jay analyze the outcome and discuss what is likely to happen next, along with how the decision impacts biosimilars strategy going forward.
Register for the Webinar by clicking here.