In a recent Order, Judge Gregory M. Sleet granted defendants’ motion to dismiss pursuant to Rule 12(b)(1). Amarin Pharmaceuticals Ireland Ltd. v. Omthera Pharmaceuticals, Inc., C.A. No. 14-791-GMS (D. Del. Nov. 14, 2014). Plaintiff sought a declaratory judgment that defendants’ Epanova™ product infringes U.S. Patent No. 8,663,663 (the “’663 patent”), but Judge Sleet concluded the declaratory judgment action was not ripe for judicial review.
Judge Sleet first explained that while “FDA approval of Epanova™ does provide some amount of support” for plaintiff’s position on the existence of a justiciable controversy, “it is not dispositive.” Id. at 2 n.1. Judge Sleet also found that “defendants’ advanced marketing of the accused product is insufficient to meet [plaintiff’s] burden in this specific instance.” Id. The claims of the ’663 patent at issue were only method claims. Id. Judge Sleet agreed with defendants’ argument that the “method claims ‘turn on physiological responses that have not occurred, in patients that do not yet exist, operating under the care of unidentified doctors, who have not yet prescribed a drug that is not yet on the market’ and cannot, therefore, provide the requisite immediacy” to support the exercise of declaratory judgment jurisdiction. Id. at 2-3 n.1. Judge Sleet additionally noted that “[w]hile it is possible that Epanova™ could enter the market within the ‘timeframe of this lawsuit’ the court does not find that assertion sufficient to prove launch of the product is imminent.” Id. at 3 n.1.