CAFC Reissues Opinion Affirming Denial of PI to Force Interim Patent Term Extension as Precedential

Somerset Pharm., Inc. v. Dudas (Fed. Cir. 2007) (reissued as precedential)

    By Sherri Oslick --

The Federal Circuit has now reissued its earlier Somerset opinion as precedential; a summary of the original, non-precedential opinion can be found in our earlier post here.  In view of the CAFC's recent reissue of the identical opinion as precedential, a brief revisit is in order.

Somerset had applied for a patent term extension on U.S. Patent No. RE34,579, covering methods of using Emsam®, a transdermal patch containing selgline, to treat depression.  Six months prior to the expiration date of the patent, with no ruling yet on their original patent term extension application, Somerset applied for an interim patent term extension, a discretionary solution where a patent expiration is imminent.  One month later, Somerset filed suit in the District Court of Delaware to compel the Director to act on - and to grant - the interim extension.  Somerset also moved for a preliminary injunction for the same relief.  The District Court denied the preliminary injunction and Somerset appealed.

While on appeal and prior to briefing, both Somerset's application for interim patent extension, as well as their original application for extension, were denied.  Somerset withdrew its appeal as moot insofar as it pertained to compelling the Director to act on the application for interim extension, but moved forward with the appeal as it pertained to compelling the Director to grant the request for interim extension.

The CAFC affirmed the District Court's denial of the PI based on the inability of Somerset to show reasonable likelihood of success on the merits.  The statute authorizing interim patent term extension, reasoned the CAFC, only provided for such an extension where a certificate of extension could not be granted or denied prior to expiration of the patent.  Because Somerset's certificate has already been denied, a petition for interim patent term extension was not statutorily authorized and as such, Somerset had no reasonable likelihood of success.