Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (“Amarin”) sued ANDA-holder Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals PLC (“Hikma”) and health insurance provider Health Net, LLC (“Health Net”) for induced infringement of three patents covering methods of use for Amarin’s drug Vascepa®.

Notably, the complaint asserts a novel theory of induced infringement against Health Net. Amarin contends that Health Net induced infringement through its approval and payment process. Health Net covers both Vascepa and the generic, but in some cases requires a higher copay for patients who are prescribed Vascepa. Further, some Health Net plans require prior authorization from a patient’s medical provider before Health Net will cover the prescription of Vascepa or Hikma’s generic. Amarin contends that some criteria for the prior authorization map to the claimed method of reducing the risk of cardiovascular events in certain patients. Amarin thus argues that Health Net knows that Hikma’s generic is being put to an infringing use, and that Health Net is actively encouraging the infringing use through its pricing scheme.

Both Hikma and Health Net moved to dismiss Amarin’s claims. Magistrate Judge Hall recommended that defendants’ motions be denied because plaintiffs have stated plausible claims and should be allowed to proceed with discovery.  In recommending that Health Net’s motion to dismiss be denied, the judge emphasized that Amarin’s claim satisfied the plausibility standard set by Twombly and Iqbal, but that the court drew no conclusions as to the overall likelihood of the claim’s success. The judge noted that the pleadings stage is an inappropriate time to assess whether Health Net’s approval and payment process actually affects physicians’ prescription decisions. Rather, the court must view the allegations in the light most favorable to Amarin, and under that standard, the judge found Amarin’s claims plausible.[1]

While Amarin’s novel inducement theory passed the plausibility standard for pleadings, ANDA holders and third-party payors will have to wait to see whether the merits of the infringement case bear out as the case progresses.

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[1] The report and recommendation also notes that no party cited precedent bearing on Amarin’s novel theory, which further supported the judge’s conclusion that plaintiffs’ claims should not be dismissed as implausible.