Overview
- The Supreme Court, which heard Hikma v. Amarin on Wednesday, pressed whether calling a product a generic of Vascepa or citing brand sales can count as urging doctors to use it for patented, off-label purposes under a skinny label.
- Several justices questioned the weight of Hikma’s evidence, noting the label text is largely set by the FDA and the press releases targeted investors rather than prescribers, which may not show the required active intent to induce infringement.
- Deputy Solicitor General Malcolm Stewart backed Hikma and warned that letting such public statements trigger lawsuits would chill generic launches by making even basic descriptions of approved products legally risky.
- Questions from Justices Neil Gorsuch and Brett Kavanaugh highlighted broader stakes under the Hatch-Waxman framework, with Kavanaugh citing Henry Waxman’s brief that said the lower court’s approach could unsettle the balance that enabled trillions in generic drug savings.
- The dispute stems from Hikma’s 2023 launch of a generic icosapent ethyl with a narrow use while Amarin sued for induced infringement, and the Federal Circuit later revived the case at the pleadings stage based on Hikma’s “generic version” phrasing and website references.