Case: Patents/Summary Judgment (D.D.C.)

The District of the District of Columbia denied Norwich Pharmaceuticals Inc.'s motion for summary judgment and granted the government and intervenors’ cross-motions for summary judgment on this action challenging the Food and Drug Administration’s decision to grant only tentative approval to its ANDA for rifaximin tablets, due to Actavis Laboratories FL Inc.'s 180-day exclusivity period to market the same drug in the same form. The court rejected Norwich’s arguments that Actavis forfeited its exclusivity for failure to market, or that this exclusivity is forfeited for failure to obtain tentative approval.