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The PTO Can Only Extend a Patent Term in the Interim Under 35 U.S.C. § 156(e)(2) When the Patent Would Expire Before a Denial of an Extension Under § 156(d)1)

07-1447
October 04, 2007

Decision icon Decision

Last Month at the Federal Circuit - November 2007

Judges: Michel, Prost, Moore (author)

[Appealed from: D. Del., Chief Judge Sleet]

In Somerset Pharmaceuticals, Inc. v. Dudas, No. 07-1447 (Fed. Cir. Oct. 4, 2007) (precedential opinion), the Federal Circuit dismissed Somerset Pharmaceuticals, Inc.’s (“Somerset”) request to compel the PTO to issue a decision as moot and affirmed the district court’s denial of Somerset’s motion for a preliminary injunction seeking to compel the PTO to grant its request for an interim patent term extension.

Somerset owns U.S. Reissue Patent No. RE 34,579 (“the ’579 patent”), which was set to expire on August 18, 2007. Somerset obtained marketing approval from the FDA for its drug product EMSAM®, a transdermal pharmaceutical patch. A method of treating depression using that patch is allegedly covered by the ’579 patent. Somerset filed a Patent Term Extension Application with the PTO on April 27, 2006, seeking to extend the term of the ’579 patent under 35 U.S.C. § 156(d)(1), and filed a request for an interim extension under 35 U.S.C. § 156(e)(2) on February 21, 2007. Shortly thereafter, Somerset filed suit in the district court and moved for a preliminary injunction, seeking to compel the PTO to act on, and grant, its request for an interim extension. The district court denied Somerset’s motion. Somerset appealed.

On appeal, Somerset originally sought an order compelling the PTO to issue a decision on its request for an interim extension. While the appeal was pending, however, the PTO denied Somerset’s application for interim extension and its application for term extension on the merits. Accordingly, Somerset withdrew the portion of its appeal that sought to compel the PTO to act on its request for interim relief. As a result, the Federal Circuit dismissed that aspect of Somerset’s appeal as moot.

With respect to Somerset’s appeal regarding the denial of injunctive relief compelling the PTO to grant its request for an interim extension, the Federal Circuit affirmed. The Court held that the district court had not abused its discretion in denying Somerset’s motion for a preliminary injunction. The Court observed that to establish entitlement to a preliminary injunction, a movant must establish a reasonable likelihood of success on the merits, and that, Somerset could not so establish. It noted that section 156(e)(2) “only gives the [PTO] 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.’” Slip op. at 3 (second alteration in original) (citation omitted). In this case, noted the Court, because the PTO denied Somerset’s application for an extension, the PTO had no statutory authority to issue the interim extension Somerset sought. Accordingly, the Court concluded that Somerset had not demonstrated a reasonable likelihood of success on the merits and affirmed the district court’s denial of Somerset’s motion for a preliminary injunction.