Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶17

Amarin developed a drug called Vascepa, which contains the active ingredient icosapent ethyl. See 104 F. 4th, at 1372. “In 2012, the [FDA] approved Vascepa for the treatment of severe hypertriglyceridemia (‘the SH indication’),” a condition characterized by very high blood triglyceride levels. Ibid. Vascepa’s label disclosed that its effect “on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined” (the “CV Limitation of Use”) because Vascepa was not yet approved for other uses. Ibid. (internal quotation marks omitted). In the meantime, Amarin continued its research into Vascepa’s potential cardiovascular uses.

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