Federal Circuit Keeps Sandoz Biosimilar Off the Market for Now

Foley & Lardner LLP

The Federal Circuit is set to hear oral arguments in Amgen v. Sandoz on June 3, but in the meantime has granted Amgen’s motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market until it renders its decision. Amgen’s appeal relates to the district court decision that denied its motion for a preliminary injunction, and decided that virtually all of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA) are optional. (I wrote about the district court’s decision in this article.)

The non-precedential order granting Amgen’s motion is straight forward:

Amgen Inc. et al. move for an injunction “preventing Sandoz [Inc.] from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until this Court resolves the appeal.” Sandoz opposes.

Upon consideration thereof, IT IS ORDERED THAT:

(1) The motion is granted, effective immediately.

(2) The parties are directed to respond concerning what amount of a bond, if any, should be posted for each day that the injunction is in place. Sandoz shall file, within seven days of this order, a document not to exceed 10 pages explaining what amount of bond should be posted. Amgen shall file, within seven days of Sandoz’s filing, a response not to exceed 10 pages. The bond amount will be determined by subsequent order of the court.

The Federal Circuit is reviewing Amgen’s appeal on an expedited schedule, but since this is the court’s first look at the BPCIA it is not clear how quickly it will decide the important issues presented.

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