Nov 15, 2021

USA Inc., No. )  Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 9,700,537 (“the ’537 patent”), 8,642,077 (“the ’077 patent”), 10,568,861 (“the ’861 patent”) Nature of Case and Issue(s) Presented:  The patents-in-suit cover methods of using icosapent ethyl to reduce the risk of cardiovascular events in patients. Vascepa currently has two FDA-approved indications: (i) treatment of severe hypertriglyceridemia (the “SH indication”); and (ii) cardiovascular risk reduction (the “CV indication”). Hikma launched a generic version of Vascepa after receiving FDA approval of its ANDA with a “section viii” carve out regarding the patents-in-suit. That is, Hikma represented to the FDA that it would not market its generic product for the uses covered by the patents-in-suit, which at the time of the filing of Hikma’s ANDA, was only the SH indication. But by the time Hikma’s product hit the market, the majority of doctors who prescribed Vascepa did so for uses other than the SH indication, including the CV indication. Amarin alleged that Hikma was aware of that fact and promoted the administration of its product in a way that infringed the patents-in-suit. Moreover, it alleged that insurance provider Health Net was aware that use of Hikma’s generic for the CV indication infringed the patents-in-suit. That was because Health Net’s plans required “Prior Authorization” before it would cover and pay for either Vascepa or Hikma’s generic version, and a medical provider was required to indicate whether the prescription was being given for either the SH or CV indication. Amarin also alleged that Health Net encouraged the use of the allegedly infringing generic by requiring a higher co-pay for Vascepa. Health Net filed a motion to dismiss. Despite acknowledging “[n]either side has cited any case in which a health insurer has been found liable to a pharmaceutical company for inducing infringement of a drug method of use patent,” the court recommended denying Health Net’s motions to dismiss. Why Amarin Prevailed: The court noted that: (i) Health Net might not have taken affirmative acts with the intent to cause infringement; (ii) Health Net’s formulary and pre-authorization actions might not influence providers to prescribe or beneficiaries to use the generic product in an infringing way; or (iii) the plaintiffs’ own pricing decisions might encourage the use of the generic product over the branded product. But the court found that the pleadings stage was an inappropriate time to assess whether Health Net’s approval and payment process affected physicians’ prescription decisions. Since the court must view the allegations in the light most favorable to Amarin at the motion to dismiss stage, the court found Amarin’s claims plausible. While Amarin’s novel inducement theory survived the plausibility standard for pleadings, ANDA holders and third-party insurance providers will have to wait to see how the infringement case pans out as the case moves forward.