The U.S. Supreme Court unanimously rules in favor of Hikma Pharmaceuticals in a patent dispute with Amarin Pharma involving “skinny label” litigation. Amarin holds patents for icosapent ethyl (Vascepa), an anti-hypertriglyceridemia drug. Hikma seeks to market a generic version with a narrower prescribing information (“skinny label”) that omits certain indications covered by Amarin’s patents.
In the Court’s decision, it holds that Amarin has not shown enough evidence to establish that Hikma’s proposed “skinny label” product infringes Amarin’s patents. The ruling is described as setting or reinforcing standards for how patent holders must prove infringement in cases involving generic drugs that use tailored labeling rather than fully substituting the branded label.
The decision has broader implications for how drugmakers and courts evaluate patent claims tied to labeling and for the ongoing wave of lawsuits that rely on skinny label theories of infringement. The outlets report that the Court’s ruling backs Hikma’s position and narrows the pathway for similar claims by patent holders in this context.
