Amarin said Tuesday in an SEC filing that it filed a lawsuit against AstraZeneca and its subsidiary Omthera Pharmaceuticals over the planned launch of the severe hypertriglyceridaemia therapy Epanova, alleging that the omega-3 free fatty acid composition violates one of its patents. The drugmaker said that the patent in question was issued by the US Patent and Trademark Office on Tuesday.
Specifically, Amarin argues in its complaint filed in the US District Court for the District of Delaware that Epanova violates a patent covering cholesterol-lowering therapy containing a mixture of eicosapentaenoic acid as free acid and no more than approximately 30 percent docosahexaenoic acid. The company said that it plans to "pursue this litigation vigorously and aggressively protect its intellectual property rights," adding that it is seeking injunctive relief and monetary damages.
Amarin gained FDA approval of Vascepa (icosapent ethyl) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia in 2012, although the company's efforts to expand clearance of the prescription-grade omega-3 fatty acid have been faced with delays. In January, the US regulator said it wouldn't reinstate a special protocol assessment for Amarin's ANCHOR trial of Vascepa, results of which are included in the company's application seeking expanded approval of the therapy in conjunction with statins to treat patients with mixed dyslipidaemia and triglyceride levels between 200 mg/dL and 499 mg/dL.
A marketing application for Epanova was accepted for review by the FDA in September last year, with a final decision expected by the regulator in May. AstraZeneca acquired the therapy via its $323-million purchase of Omthera in 2013.
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