Amarin Pharm., Inc. v. Hikma Pharms. USA Inc.

Vascepa® (icosapent ethyl)

January 4, 2022

GENERICally Speaking

Case Name: Amarin Pharm., Inc. v. Hikma Pharms. USA Inc., No. 20-1630-RGA-JLH, 2022 WL 605734 (D. Del. Jan. 4. 2022) (Andrews, J.)

Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 8,642,077 (“the 077 patent”), 9,700,537 (“the 537 patent”), and 10,568,861 (“the 861 patent”)

Nature of the Case and Issue(s) Presented: Amarin sold Vascepa, which was indicated for the treatment of severe hypertriglyceridemia (“SH indication”) and cardiovascular risk reduction (“CV indication”). Amarin’s patents covered only the CV indication. Hikma received FDA approval for the SH indication, but filed a section viii “skinny label” carve-out for the CV indication. Amarin pleaded that Hikma’s label was “not-skinny-enough” and along with Hikma’s public statements, induced infringement of the patents-in-suit. Amarin also alleged that Health Net, an insurer that provided coverage for Vascepa and Hikma’s generic version, induced infringement. Defendants moved to dismiss. The court granted Hikma’s motion to dismiss and denied Health Net’s motion to dismiss.

Why Hikma Prevailed: The court did not agree with Amarin’s argument that Hikma’s label and Hikma’s public statements both induced infringement of the patents-in-suit. Amarin argued that Hikma’s label satisfied the CV indication because it: (i) contained a notice regarding side effects for patients with CV disease; and (ii) failed to state that Hikma’s generic product should not be used for the CV indication. As to the first argument, the court found that Hikma’s notice regarding side effects was a warning and thus not an instruction to use icosapent ethyl to reduce cardiovascular risk. As to the second argument, the court explained that the Federal Circuit had consistently rejected arguments that generic labels must contain a “clear statement” discouraging use of the patented (i.e., carved out) indication. The court further explained that even if Amarin were correct—that Hikma’s silence on its label regarding CV risk communicated to the public that icosapent ethyl could be used to reduce CV risk—merely describing an infringing mode was not tantamount to recommending, encouraging, or promoting an infringing use.

Amarin also argued that Hikma’s public statements induced infringement. In particular, Amarin pointed to a Hikma press release stating that its product was the “generic equivalent to Vascepa®” and that it “is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe . . . hypertriglyceridemia.” Hikma’s website also stated that its generic product was “AB rated” in the “Therapeutic Category: Hypertriglyceridemia.” The court explained that although Hikma’s press releases might be relevant to intent, they did not show actual inducement. In other words, because Hikma said its product was “AB Rated” in a category that included both patented and non-patented uses, Amarin could not plead induced infringement.   

Why the Court Denied Health Net’s Motion: The court disagreed with Health Net’s argument that Amarin failed to allege: (1) knowledge of the patents; or (ii) that with that knowledge, Health Net had had specific intent to induce another’s infringement of those patents. As to knowledge, although Amarin’s pre-suit letter to Health Net did not specify patent numbers, it did state that it had patent exclusivity for the CV indication and that the patents associated with the CV indication were readily available on the FDA’s Orange Book. As to specific intent, the court found that the complaint plausibly alleged that formulary selection and the prior-authorization process could be affirmative acts under the law of induced infringement. In particular, the court explained that Health Net’s prior-authorization form supported an inference of specific intent because it listed the patented indication on the generic-icosapent-ethyl-capsules form.

Oren D. Langer


Managing Partner, New York Office

Related Publications

First Quarter
ANDA Approvals
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
ANDA Litigation Settlements
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
Generic Launches
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
New ANDA Cases
GENERICally Speaking Hatch Waxman Bulletin
Feb. 24, 2023
Jazz Pharms., Inc. v. Avadel CNS Pharms.
GENERICally Speaking Hatch Waxman Bulletin
Back to Top