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 had filed a request for an interim extension under § 156(e)(2), which requires the director of the USPTO to grant up to a one-year extension under certain conditions prior to a determination on the merits. Somerset also filed suit and a motion for a preliminary injunction seeking to compel the director to act on and grant its request for interim extension. The district court denied that motion on June 29, 2007.
On appeal, Somerset moved to expedite the briefing schedule, which was granted on July 12. On that same day, the director denied both of Somerset’s applications for interim patent term extension and for term extension on the merits, rendering moot that portion of the appeal seeking to compel the director to act on the request for interim relief.
Reviewing the plain language of the statute, the Court concluded that Somerset cannot establish a reasonable likelihood of success on the merits. Section 156(e)(2) gives the director authority to grant an interim extension when the patent for which a term extension is sought "would expire before a certificate of extension is … denied." The Court reasoned that, because Somerset’s application for extension had been denied on the merits, the director has no statutory authority to issue the interim extension. In a footnote, the Court noted that nothing in its opinion was intended to address any claim that Somerset may have on the underlying merits of the director’s action.
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