The U.S. Supreme Court sided unanimously with Hikma in a ‘skinny label’ patent dispute over Amarin’s Vascepa. The court held Hikma’s generic version did not infringe patents tied to Amarin’s remaining protected indication, upending a prior decision that had found infringement. The ruling reinforces the skinny-label framework that supports generic availability for specific indications while limiting exposure where branded patents cover other uses. Vascepa’s FDA status includes both approvals and subsequent label expansions, which factored into the litigation over how generics are marketed and prescribed. The decision has immediate implications for generic drugmakers and branded companies defending line-of-use or marketing-related infringement theories.
Get the Daily Brief