I received notice from PriorSmart today that on June 28, 2011 the case Somaxon Pharmaceuticals Inc. v. Mylan Inc. et. al. was filed in the U.S. District Court for the District of Delaware (Civil Action No. 1:11-cv-00571-UNA). The following is excerpted from the complaint provided by PriorSmart:
This is an action for patent infringement of U.S. Patent No. 7,915,307...This action relates to an Abbreviated New Drug Application ("ANDA") filed by Mylan Pharmaceuticals, Inc. with the U.S. Food and Drug Administration ("FDA") seeking FDA approval to market generic versions of the 3 mg and 6 mg forms of Somaxon's SILENOR (R) drug product.
By letter dated June 8, 2011, Mylan notified Somaxon that Mylan had submitted ANDA No. 202-337 to the FDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 355(j)) seeking approval to engage in the commercial manufacture, use, and sale of 3 mg and 6 mg doxepin hydrochloride tablets before the expiration of the '307 patent.
Among the relief sought by Somaxon is "an order...providing that the effective date of any approval of Mylan's ANDA No. 202-337 shall be a date which is not earlier than the expiration date of the '307 patent, including any extensions and/or additional periods of exclusivity to which Somaxon is or becomes entitled.
Read the full complaint here.