Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶21

Soon after Hikma began marketing its generic drug, Amarin filed suit in the District of Delaware, alleging that Hikma had actively induced others to infringe Amarin’s patent for the CV-indication method of use. Amarin alleged that the totality of Hikma’s statements across several documents encouraged infringing uses. 578 F. Supp. 3d 642, 645–647 (2022). First, the label omitted the CV Limitation of Use and retained information about a clinical study in which some of the patients were taking statins. Second, the patient information leaflet that accompanied the label warned against possible side effects for “people who have heart (cardiovascular) disease”—the target population for Vascepa’s patented CV-indication method of use—and noted that “[m]edicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.” 2 App. 124–125. Third, Hikma’s website…

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