Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al., No. 2023-1169 (Fed. Cir. (D. Del.) June 25, 2024). Opinion by Lourie, joined by Moore and Albright (sitting by designation).
Amarin markets and sells icosapent ethyl, an ethyl ester of an omega-3 fatty acid commonly found in fish oils, under the brand name Vascepa®. In 2012, the FDA approved Vascepa for the treatment of severe hypertriglyceridemia (“the SH indication”), and in 2019, the FDA approved it for reducing cardiovascular risk in certain patients (“the CV indication”).
In 2016, when Vascepa was approved for just the SH indication, Hikma submitted an Abbreviated New Drug Application (“ANDA”) for approval of its generic product. That ANDA remained pending in 2019 when the FDA approved Vascepa for the CV indication. Hikma then filed a statement that “carved out” the CV indication, and thus sought FDA approval of a “skinny label” for its generic product that would include only the SH indication. The FDA approved Hikma’s ANDA, including its proposed skinny label.
Throughout 2020, Hikma issued a series of press releases marketing its generic product. For example, Hikma issued press releases referring to its product as the “generic version” of Vascepa or “the generic equivalent to Vascepa.” Hikma also provided sales information for Vascepa, using sales figures that accounted for sales of Vascepa for all uses, including the CV indication (which made up more than 75% of Vascepa’s sales). When Hikma officially launched its generic product, it issued a press release stating that the FDA-approved generic was indicated for the SH indication and “is not approved for any other indication for the reference listed drug VASCEPA®.”
After receiving FDA approval, Hikma began marketing the generic product on its website. Hikma listed the product under the “Therapeutic Category: Hypertriglyceridemia” and indicated that it was “AB” rated by the FDA. Below the product summary, in small letters, Hikma provided a disclaimer: “Hikma’s generic version is indicated for fewer than all approved indications of the Reference Listed Drug.”
Amarin sued Hikma for inducing infringement of two patents relating to the CV indication. Amarin asserted that the content of Hikma’s product label, press releases, and website evidenced Hikma’s specific intent to actively encourage physicians to directly infringe the patents by prescribing its generic product for the off-label CV indication. Hikma moved to dismiss the complaint under Rule 12(b)(6) for failure to state a claim, and the district court granted the motion. Amarin appealed.
The Federal Circuit reversed, emphasizing that the case reached the court “at its most nascent stage: on a motion to dismiss … where we are tasked with reviewing allegations, not findings, for plausibility, not probability." The court explained that “a generic manufacturer can be liable for inducing infringement of a patented method even if it has attempted to ‘carve out’ the patented indications from its label under 21 U.S.C. § 355(j)(2)(A)(viii), where, as here, other evidence is asserted with regard to inducement.” The court thus focused on whether Amarin’s complaint plausibly pleaded that Hikma “actively” induced healthcare providers’ direct infringement. Accepting all well-pleaded facts as true and drawing all reasonable inferences in Amarin’s favor, the Federal Circuit concluded that it did.
The Federal Circuit ruled that while the label alone may not have been enough to survive a motion to dismiss, the label together with Hikma’s press releases and website provided sufficient factual allegations to survive the motion. For example, the court explained that it is “at least plausible that a physician could read Hikma’s press releases—touting sales figures attributable largely to an infringing use, and calling Hikma’s product the ‘generic version’ of a drug that is indicated ‘in part’ for the SH indication—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.” Similarly, the court stated that “it is at least plausible that a physician may recognize that, by marketing its drug in the broad therapeutic category of ‘Hypertriglyceridemia’ on its website, Hikma was encouraging prescribing the drug for an off-label use.”