<em> Amarin Pharm., Inc. v. Hikma Pharm. USA Inc. <em>
Amarin Pharmaceuticals wins appeal to federal circuit, allowing suit against Hikma Pharmaceuticals to proceed. Despite FDA approval for a generic drug with a skinny label excluding Vascepa’s uses, Hikma allegedly induced infringement of Amarin’s patented treatments via marketing and labels, leading to physician off-label prescription.
Attribution
Pink Round Medication Pill by Pixabay on Pexels
Amarin Pharmaceuticals first acquired FDA approval for Vascepa, otherwise known as icosapent ethyl in 2012 for the treatment of severe hypertriglyceridemia (“SH indication”). However, the medication required a “limitation of use” warning since the effects of Vascepa on cardiovascular mortality were unknown at the time. After further testing, Amarin discovered that Vascepa could also be used as a treatment to reduce cardiovascular risk in patients with elevated blood triglyceride levels (“CV indication”). This new use, approved in 2019, allowed Amarin to remove the “limitation of use” warning from Vascepa’s label. Following the approval, Amarin filed for U.S. Patent 9,700,537 (“patent ’537”) and U.S. Patent 10,568,861 (“patent ’861”), which outlined methods of treatment for the CV indication.
In 2016, Hikma Pharmaceuticals filed an Abbreviated New Drug Application (“ANDA”) for a generic icosapent ethyl product. This application remained pending until 2019 when the FDA approved Vascepa for CV indication use. The FDA then allowed Hikma to either match Vascepa’s new label or “carve-out” the CV indication. Hikma opted to match the label on their generic medication to the new Vascepa label, and in early 2020 the FDA approved Hikma’s ANDA with a skinny label that referenced only the SH indication. The label included potential side effects for patients with cardiovascular diseases and indicated the medication may be prescribed for purposes other than the ones listed on the label. Hikma issued press releases highlighting their FDA approval, their victory in a Nevada litigation over SH indication against Amarin regarding patent infringement, and Amarin’s Vascepa sales data, branding their product as a “generic equivalent”. Their final 2020 press release approved the generic product only for the SH indication, with a disclaimer on their website reiterating the same and showcasing their “AB” rating from the FDA.
Shortly after Hikma launched their generic product, Amarin sued under 35 U.S.C § 271(b) for induced infringement against patent ’537 and patent ’861. Amarin believed Hikma’s new skinny label combined with their marketing materials encouraged physicians to prescribe Hikma’s generic product off-label to treat patients with CV indication, an infringement on Amarin’s patents. Hikma moved to dismiss the case under Fed. R. Civ. P. 12(b)(6), claiming that Amarin failed to allege facts showing Hikma actively encouraged patent infringement (a required element for induced infringement claims).
Upon reviewing Hikma’s motion, a magistrate judge found Amarin’s claims plausible based on the totality of the provided evidence, a decision Hikma timely objected to. When the district court reviewed the decision de novo, they declined the magistrate’s recommendation and granted Hikma’s motion to dismiss. The district court divided the claim into two; one considering induced infringement based on the skinny label, the other considering infringement based on Hikma’s marketing materials. The court found Amarin’s claims insufficient, despite evidence of intent to infringe by Hikma.
Amarin appealed the approval of the motion to dismiss to the U.S. Court of Appeals for the Federal Circuit. The court emphasized that this case is neither a standard Hatch-Waxman case where a patent owner seeks to find potential future infringement by a generic product not yet on the market, nor a Section viii case, where allegations are based solely on the generic products skinny label. Instead, this suit falls under 35 U.S.C § 271(b), alleging induced infringement based on public statements and the label on an already marketed generic product.
Given the basis of this appeal was a motion for judgment as a matter of law, the Court of Appeals for the Federal Circuit denied to make decisions addressing the validity of Amarin’s allegations and focused only on the plausibility of their allegations. This decision does not address findings or probability of the suit’s underlying questions.
The Court of Appeals for the Federal Circuit, like the magistrate judge, considered the skinny label, press releases and website information collectively and concluded that Amarin’s claims plausibly alleged specific facts indicating Hikma may have encouraged physicians to prescribe the off-label CV indication of Hikma’s generic product instead of Vascepa. The court reversed the lower court’s decision, allowing the suit to proceed.