Patent Docs: Somerset Pharmaceuticals, Inc. v. Dudas (Fed. Cir. 2007): " In a nonprecedential opinion, the Federal Circuit affirmed the District Court of Delaware's denial of Somerset's request for preliminary injunction to compel the Director of the USPTO to grant an interim patent term extension. Somerset is the owner of U.S. Patent No.
RE34,579 ("Method of treating depression," issued April 5, 1994), which is set to expire on August 18, 2007. Somerset sought an extension in term of the '579 patent after receiving FDA approval to market Emsam
®, a transdermal patch containing selgline; the '579 patent covers methods of treating depression using Somerset's patch.
On April 27, 2006, pursuant to 35 U.S.C. § 156(d)(1), which authorizes an applicant to file for an extension of patent term based on regulatory delay, Somerset filed an application for term extension with the USPTO. On February 21, 2007, Somerset filed a request for interim extension under § 156(e)(2), which authorizes the Director, where a patent is set to expire before a certificate of extension can be either granted or denied, to extend the term of a patent for up to one year until such a decision is made, provided that the patent is eligible for extension.
On May 22, 2007, with no decision from the USPTO in hand, Somerset filed suit in the District Court of Delaware to compel the Director to act on - and grant - its request for interim extension. Somerset also moved for a preliminary injunction for the same relief. The District Court denied the preliminary injunction on June 29, 2007. Somerset appealed to the CAFC, moving for, and receiving, an expedited briefing schedule. The motion for expedited briefing was granted on July 12, and on that same day the Director denied Somerset's application for interim extension as well as its original application for term extension under § 156(d)(1).
In view of the USPTO's decision, Sommerset withdrew the portion of its appeal directed at compelling the Director to act on its request for interim extension, and as such, the CAFC dismissed that portion of the appeal as moot. Sommerset nevertheless maintained the appeal insofar as it sought injunctive relief to compel the Director to grant the interim extension.
The CAFC affirmed the lower court's denial of preliminary injunction on the basis that Somerset could not show a reasonable likelihood of success. The statute authorizing the Director to grant an interim extension, noted the CAFC, only did so in situations where a certificate of extension could not be granted or denied prior to expiration of the patent at issue. Because the USPTO had already denied Somerset's original application for extension, the Director had no authority to grant an interim extension, and Somerset therefore had no reasonable likelihood of success on the merits. The CAFC did add in a footnote, however, that nothing in their opinion was intended to address the merits of the Director's decision to deny a term extension.
Somerset Pharmaceuticals, Inc. v. Dudas (Fed. Cir. 2007)
Nonprecedential disposition
Panel: Chief Judge Michel and Circuit Judges Prost and Moore
Opinion by Circuit Judge Moore
Additional information regarding this case can be found at Orange Book Blog ."
