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

Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2024 WL 3152087 (Fed. Cir. June 25, 2024) (Circuit Judges Moore, Lourie, and Albright presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews, J.) 

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

Nature of the Case and Issue(s) Presented: In 2012, FDA approved Vascepa for the treatment of severe hypertriglyceridemia (“SH”). Vascepa’s label included an express “limitation of use” that the effect of Vascepa on cardiovascular mortality and morbidity in patients with SH had not been determined. Nonetheless, ongoing clinical testing demonstrated that Vascepa was capable of lowering triglyceride levels without increasing “bad” cholesterol, and Amarin continued its research into potential cardiovascular uses of the drug. In 2019, FDA approved Vascepa for a second indication to reduce cardiovascular (“CV”) risk. Amarin then added the CV indication to the Vascepa label and removed the CV limitation of use. It also timely listed in the Orange Book the patents-in-suit, which claim methods directed to the CV indication.

In 2016, when Vascepa was still only approved for treating SH, Hikma submitted an ANDA seeking approval to make and sell generic icosapent ethyl. In 2019, when the FDA approved the Amarin’s CV indication, Hikma was required to either amend its proposed label to match the revised Vascepa label or “carve-out” that indication. Hikma elected the carve out option and sought approval only for the SH indication. FDA approved Hikma’s ANDA on May 21, 2020. Hikma’s original proposed label included the CV limitation of use, but its amended label removed the limitation around the same time it submitted its section viii statement carving out the uses covered by the asserted patents.

In November 2020, Amarin sued Hikma, alleging that Hikma had induced infringement of the patents-in-suit. Amarin relied on the content of Hikma’s press releases, website, and product label as evidence of Hikma’s specific intent to actively encourage physicians to directly infringe the asserted patents by prescribing its generic icosapent ethyl product for the off-label CV indication, an indication for which Hikma did not get FDA approval. Hikma moved to dismiss. The magistrate judge’s report and recommendation recommended denying the motion. The district court declined to adopt the magistrate judge’s recommendation and granted Hikma’s motion to dismiss. Amarin appealed, and the Federal Circuit reversed because Amarin’s allegations plausibly state a claim for induced infringement.

Why Amarin Prevailed: The Federal Circuit made a point, first and foremost, to note that (i) this is not a traditional Hatch-Waxman case but a “run of the mill” induced infringement case; and (ii) unlike any of the other section viii-related decisions, this case does not reach the appellate stage after a trial or preliminary injunction motion, but rather after resolution of a Rule 12 motion without the benefit of discovery.

Amarin’s complaint pleads the requisite elements of induced infringement. Thus, the question on appeal was whether those elements were plausible and whether Hikma “actively” induced doctors’ direct infringement. In finding in the affirmative, the Federal Circuit relied on Hikma’s proposed label, website, press releases

Hikma’s proposed label.  The clinical studies section describes statin-treated patients with the same cardiovascular event history and lipid levels covered by the asserted patents would be understood by physicians as a teaching that the product could be prescribed to treat cardiovascular risk. That is particularly so because the patient population for the SH indication overlaps with that for the CV indication Additionally, while FDA’s approval of the CV indication allowed Amarin to remove the CV limitation of use from its label, it did not so authorize Hikma. Put another way, Hikma’s removal of the CV limitation of use (despite not being approved for the CV Indication), as well as its warning of potential side effects for patients with cardiovascular disease, communicate to physicians that Hikma’s generic product could be used for the off-label CV indication.

Hikma’s website and press releases. Hikma’s website promotes its product as AB-rated in the therapeutic category “Hypertriglyceridemia,” a category that is broad enough to encompass both infringing and non-infringing uses. Hikma’s press releases, on the other hand, consistently referred to Hikma’s product as a “generic equivalent to Vascepa®,” “generic Vascepa®,” or “Hikma’s generic version of Vascepa®,” without any indication that its product was AB-rated. The press releases also referred to Vascepa as indicated “in part” for the SH indication. Amarin’s complaint also alleged that Hikma touted sales figures for Vascepa that Hikma knew were largely attributable to the off-label CV indication. Without the benefit of discovery and testimony, the Federal Circuit had to accept as true Amarin’s allegations and all reasonable inferences supported by those allegations. Therefore, it is at least plausible that a physician could read Hikma’s press releases as an instruction or encouragement to prescribe that drug for any of the approved uses of icosapent ethyl, particularly where the label suggests that the drug may be effective for an overlapping patient population.