In a nonprecedential decision, the U.S. Court of Appeals for the Federal Circuit held that it won’t force the United States Patent and Trademark Office (USPTO) to issue a decision absent the authority to act. Somerset Pharmaceuticals v. Dudas (07-1447).

Somerset tried appealing from district court, which turned down its request to get the Director to issue a patent term extension. The district court said the issue was moot and the Federal Circuit agreed.

Somerset has a patent — Reissue Patent No. RE 34,579 – that is set to expire on August 18, 2007. The patent covers a method of treating depression using its drug product EMSAM®, a transdermal pharmaceutical patch that includes selegiline as the active ingredient.

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). Then, Somerset filed a request for an interim extension under § 156(e)(2).

I guess because it was in a hurry, Somerset filed suit in district court for the seeking to compel John Dudas — the Director of the PTO — to act on its request for interim extension.

Somerset was originally seeking an order compelling the Director to issue a decision on its request for interim extension under § 156(e)(1). Because the Director issued his decision on July 12, 2007, Somerset withdrew its request for interim relief.

Somerset still tried to press its appeal regarding the denial of injunctive relief compelling the Director to grant its request for an interim extension.

Note, though, to establish entitlement to a preliminary injunction you have to have a reasonable likelihood of success on the merits. The Court said Somerset can’t do it in this case.

Section 156(e)(2) provides

If the term of a patent for which an application has been submitted under subsection (d)(1) would expire before a certificate of extension is issued or denied under paragraph (1) respecting the application, the Director shall extend, until such determination is made, the term of the patent for periods of up to one year if he determines that the patent is eligible for extension. (emphasis added)

This 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.”

In this case, the Director denied Somerset’s application for extension. Therefore, the Director has no statutory authority to issue the interim extension. Thus, Somerset can’t show a reasonable likelihood of success on the merits.

Basically, the Federal Circuit said that Somerset is SOL and affirmed.

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