Amarin Pharma, Inc. v. West-Ward Pharms. Int’l Ltd.

Case Name: Amarin Pharma, Inc. v. West-Ward Pharms. Int’l Ltd., No. 2:16-cv-02525-MMD-NJK, 2019 U.S. Dist. LEXIS 186911, (D. Nev. Oct. 28, 2019) (Du, J)

Drug Product and Patent(s)-in-Suit: Vascepa® (ethyl-eicosapentaenoic acid); U.S. Patents Nos. 8,293,728 (“the ’728 patent”), 8,318,715 (“the ’715 patent”), 8,357,677 (“the ’677 patent”), 8,367,652 (“the ’652 patent”), 8,431,560 (“the ’560 patent”), and 8,518,929 (“the ’929 patent”)

Nature of the Case and Issue(s) Presented: Vascepa is an oral drug formulation that reduces triglyceride levels in adult patients with severe hypertriglyceridemia. The patents-in-suit all cover a method of treating hypertriglyceridemia using ethyl-eicosapentaenoic acid (“EPA”). Plaintiffs sought to prevent defendants from launching generic Vascepa. The court granted summary judgment of no contributory infringement, but denied summary judgment of no inducement. The court also granted summary judgment as to prevent Defendants from asserting a written-description defense at trial.

Why Defendants Prevailed: Defendants argued that they could not contributorily infringe the asserted claims because their drugs as described in the proposed labeling are capable of the substantial non-infringing use of reducing triglycerides in less than twelve weeks. Defendants pointed to plaintiff’s clinical data showing reduction of triglycerides peaking around four weeks, the specifications of the patents-in-suit’s claiming of a reduction in triglycerides in as little as one week, and concessions from Amarin’s infringement expert that 5% of his patients use Vascepa for less than 12 weeks, and that it would not be prohibited by the FDA to prescribe Vascepa for less than 12 weeks. As such, the court granted summary judgment of no contributory infringement, as Defendant’s proposed generic drugs may be used in substantial, non-infringing ways. The Court noted that “even if it only happens about 5% of the time, reducing triglycerides in less than 12 weeks using Defendants’ ANDA drugs would not be ‘unusual, far-fetched, illusory, occasional, aberrant, or experimental.’”

As to inducement, defendants argued they would not induce infringement of the asserted claims because their proposed labeling did not encourage doctors to prescribe the drugs for at least 12 weeks, a limitation contained in all of the asserted claims. But the court denied summary judgment of no inducement, as Amarin’s expert provided a plausible interpretation of the labeling that doctors would understand as requiring treatment for at least 12 weeks.