Denial of interim patent term extension affirmed
October 05, 2007

In a decision rereleased as precedential yesterday, the Federal Circuit affirmed a district court’s denial of a preliminary injunction seeking to compel the Director of the United States Patent and Trademark Office to grant a request for an interim patent term extension under 35 U.S.C. § 156(e)(2).Somerset Pharmaceuticals, Inc. ("Somerset") is the owner of a reissue patent that expired August 18, 2007 (at the time the appeal was heard, it was still valid). The patent is directed towards a method of treating depression using a pharmaceutical patch that includes selegiline as an active ingredient.

Somerset filed a Patent Term Extension application under 35 U.S.C. § 156(d)(1) with the USPTO, and a subsequent request for an interim extension under 35 U.S.C. § 156(e)(2). Somerset then filed suit seeking to compel the Director of the USPTO to act on and grant the request for interim extension. A motion for preliminary injunction was filed consistent with the prayer for relief. The district court ultimately denied Somerset's motion. After filing its appeal, Somerset's application for interim patent term extension and application for patent term extension were denied by the USPTO.The Federal Circuit affirmed, noting that it reviews the denial of a preliminary injunction for an abuse of discretion. Citing § 156(e)(2), the court stated that "[t]his section only gives the Director the authority to extend a patent's term beyond that provided for by section 154 when the patent for which a term extension is sought 'would expire before a certificate of extension is . . . denied.'" Because the Director had denied Somerset's application for extension, the Director had no statutory authority to issue the interim extension sought by Sommerset. The Federal Circuit accordingly held that Sommerset had not demonstrated a reasonable likelihood of success on the merits, and affirmed the district court's denial of Sommerset's motion for preliminary injunction.Interestingly, this is the second case in a month that the Federal Circuit has reissued as a precedential decision. The first dealt with obviousness.To read the full decision in Somerset Pharms., Inc. v. Dudas, click here.

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