We previously reported on the oral argument in Sandoz v. Amgen. Today Justice Thomas delivered the opinion for a unanimous U.S. Supreme Court in Sandoz v. Amgen. Briefly, the Supreme Court held that notice of commercial marketing may be given prior to FDA approval, siding with Sandoz and reversing the Federal Circuit on that issue.
The Court also held that no injunction is available under federal law to force compliance with the patent dance. However, the Court stated that an injunction might be available under state law, but the Court also left open the possibility that such a state-law injunction might be preempted by federal law. Both of those questions are remanded to the Federal Circuit to reconsider.
Stay tuned for further analysis on this very important decision.