Federal Circuit Affirms Denial of Somerset Pharma's Interim Patent Term Extension on Depression Patch

Somerset Pharmaceuticals v. Dudas, No. 2007-1447 (Fed. Cir. 2007)

The Federal Circuit decided an unusual case yesterday respecting Somerset Pharmaceuticals' application for an interim patent term extension for U.S. Reissue Patent No. RE 34,579.  The '579 patent covers a method of treating depression using Emsam, a transdermal patch that includes selegiline as the active ingredient.

35 USC 156(e)(1) provides for a patent term extension to compensate for delays in FDA regulatory review of a new drug application.  35 USC 156(e)(2) provides for an interim patent term extension if the patent "would expire before a certificate of extension is issued or denied under paragraph (1)."

Somerset's '579 patent is set to expire on August 18, 2007.  In April 2006, Somerset filed a request for patent term extension under Section 156(e)(1) on the '579 patent.  In February of this year, the Patent and Trademark Office had still not ruled on Somerset's request, and therefore Somerset filed a request for an interim patent term extension under Section 156(e)(2).

Shortly thereafter, Somerset filed suit against Mr. Dudas, the director of the PTO, seeking to compel the PTO to rule on its request for an interim patent term extension.  Somerset also filed a motion for preliminary injunction at the same time.  The district court denied Somerset's motion in June, and Somerset promptly appealed to the Federal Circuit.  Meanwhile, on July 12, the PTO denied both Somerset's application for a patent term extension under Section 156(e)(1) and its application an interim extension under Section 156(e)(2).

In yesterday's decision, the Federal Circuit dismissed as moot Somerset's request to compel the PTO to act on its request for an interim patent term extension.  Moreover, the Federal Circuit affirmed the district court's denial of Somerset's motion for a preliminary injunction to compel the PTO to grant Somerset's request for an interim patent term extension, finding that because the PTO denied Somerset's application for a patent term extension under Section 156(e)(1), the PTO has no statutory authority to issue an interim extension.

The Federal Circuit stated expressly that yesterday's opinion does not address any claim that Somerset may have on the underlying merits of the PTO's July 12, 2007 denial of its request for a patent term extension under Section 156(e)(1).  Presumably, Somerset is appealing that decision separately.