The Federal Circuit yesterday granted Amgen’s motion for a preliminary injunction to keep Sandoz’s biosimilar form of Neupogen off the market until the Court renders its decision on the merits of the appeal. The parties had previously agreed to an expedited briefing schedule, and oral arguments are set to be heard on June 3. FDA previously approved Sandoz’s biosimilar application on March 6 of this year, but Sandoz had agreed not to market the product until May 11 absent judicial intervention. The Federal Circuit’s decision today will keep the biosimilar off the market for at least a few more weeks. Given that this will be the Federal Circuit’s first decision interpreting several key provisions of the Biologics Price Competition and Innovation Act (BPCIA), it is difficult to speculate exactly when the Court will render a final decision.

The order granting the preliminary injunction does not provide any insight into the Court’s reasoning. It states simply that “[t]he motion is granted, effective immediately,” and the parties are directed to brief the issue of “what amount of a bond, if any, should be posted for each day that the injunction is in place.”