The US Supreme Court unanimously ruled in Hikma’s favor in a patent dispute over its “skinny label” generic version of Amarin’s Vascepa. The court held Hikma’s generic did not infringe Amarin’s patents, reviving and reinforcing the protections that allow cheaper knockoffs for specific, non-patented indications. The ruling overturns a lower-court decision that had found infringement based on marketing-related arguments. Vascepa received FDA approval in 2012 for severe hypertriglyceridemia and later expanded indications, while Amarin retained patent protection for a narrower form after earlier patent invalidations. For the industry, the decision is expected to reduce legal uncertainty for other generic entrants relying on carve-outs in labeling, while also shaping how manufacturers manage promotional language tied to approved indications.
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