Vascepa – USA

Vascepa – USA

On Aug. 03, 2021, Delaware Court denied Defendant’s motion to dismiss on pleadings based on failure to state a claim.

 

Plaintiffs (Amarin pharma / Mochida pharma) sued Defendants (Hikma pharma / Health Net) for infringement of US 9,700,537, US 8,642,077, and US 10,568,861 under 35 U.S.C. § 271(b) – induced infringement. These patents are listed in OB for the product, Vascepa (icosapent ethyl) capsule. Vascepa is approved for two indications: (1) treatment of severe hypertriglyceridemia (approved in 2012); and (2) cardiovascular risk reduction (approved in 2019). Hikma launched the generic product in Nov. 2020 with “skinny label”, ie keeping hypertriglyceridemia indication and carving out patented cardiovascular indication by filing section-viii. Hikma then issued press releases in 2020 regarding its generic product. In press release, Hikma referred to its product as a “generic version” Vascepa® and as “AB rated.” The press release further stated that the prior year’s “US sales of Vascepa® were approximately $919 million.” The Vascepa sales figure cited by Hikma in the press release included sales for the Cardiovascular indication also.

 

Plaintiffs filed suit against Hikma as well as Health Net which is a health insurance provider. Defendants moved to dismiss the complaint under rule 12(b)6 for failure to state a claim.

 

Court said that, to state a claim of induced infringement under § 271(b), the complaint must plausibly allege that (1) there has been direct infringement, (2) the defendant knowingly induced infringement, and (3) the defendant possessed the intent to encourage another’s infringement. Court agreed that the First Amended Complaint correctly alleged that Hikma’s product label, press releases, and website encourage infringement of the asserted patents. Complaint also alleged that Hikma is aware that the majority of Vascepa prescriptions are for uses other than the hypertriglyceridemia indication. Those allegations, taken together and viewed in the light most favorable to Plaintiffs, plausibly suggest that Hikma’s label and public statements could instruct and/or encourage third parties to use its product for the Cardiovascular indication. Hikma urged the Court to resolve this case at the pleadings stage, pointing out that the contents of its label and public statements are undisputed. But there is a real dispute about what those contents communicate to others. Therefore, it is not appropriate to resolve it on a motion to dismiss. Thus, Hikma’s motion to dismiss was denied.

 

With respect to inclusion of Health Net as a party, Court said that this is a novel theory. Neither 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. Viewing the allegations in the light most favorable to Plaintiffs, and in the absence of precedent to the contrary, Court cannot say at this stage that Plaintiffs’ theory is so implausible as to require dismissal at the pleadings stage. Thus, Health Net’s motion to dismiss was also denied.

 

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