USPTO Lacks Authority For Interim Term Extension After Request Denied

The U.S. Court of Appeals for the Federal Circuit affirmed a district court’s denial of a preliminary injunction seeking to compel the director of the U.S. Patent and Trademark Office (USPTO), Jon W. Dudas, to grant a request for an interim patent term extension. Somerset Pharmaceuticals, Inc. v. Dudas, Case No. 07-1447 (Fed. Cir., July 31, 2007) (Moore, J.).

Somerset Pharmaceuticals is owner of U.S. Reissue Patent No. RE 34,579 (the ’579 patent), which expired on August 18, 2007. Somerset obtained marketing approval from the U.S. Food and Drug Administration (FDA) for its drug product EMSAM^®, a transdermal pharmaceutical patch that includes selegiline as the active ingredient.

In April 2007, Somerset filed a Patent Term Extension Application with the USPTO seeking to extend the term of the ’579 patent under 35 U.S.C. § 156. Section 156 provides for the extension of the term of a patent covering an approved product for a portion of the regulatory review process. Earlier, Somerset