The U.S. Supreme Court announced on January 16, 2026 that it will hear a patent dispute between Amarin Corporation and Hikma Pharmaceuticals over the use of a so‑called “skinny label” for the drug Vascepa. The skinny‑label strategy allows a generic manufacturer to market a drug with a narrower label that excludes a patented indication, thereby avoiding direct infringement of method‑of‑treatment patents.
Amarin’s Vascepa was originally approved for severe hypertriglyceridemia, but the company later secured patents for its use in reducing cardiovascular risk. Hikma launched a generic version of Vascepa that carried only the hypertriglyceridemia label, while Amarin alleged that Hikma’s marketing statements and press releases encouraged use of the generic for the cardiovascular indication, thereby inducing infringement. The case centers on whether such inducement can be established when the label itself omits the patented use.
The legal battle has already produced mixed outcomes. A district court dismissed Amarin’s induced‑infringement claims, but the U.S. Court of Appeals for the Federal Circuit reversed that decision, finding that Amarin had plausibly alleged inducement based on Hikma’s marketing. The Solicitor General’s office urged the Supreme Court to hear the case, arguing that the Federal Circuit’s approach could undermine the skinny‑label pathway that the Hatch‑Waxman Act was designed to protect.
A ruling in favor of Amarin would reinforce the company’s ability to protect its cardiovascular‑risk indication and could limit generic competition that relies on skinny labels. Conversely, a decision favoring Hikma would broaden the scope of skinny‑label use, potentially eroding exclusivity for branded drugs with multiple indications and reshaping how pharmaceutical companies structure their patent portfolios and marketing strategies.
Beyond Amarin, the outcome could set a precedent for induced‑infringement liability in the context of skinny labels, influencing the interpretation of the Hatch‑Waxman Act and affecting the broader pharmaceutical industry’s approach to generic entry and patent protection.
The Supreme Court’s decision will be closely watched by investors, regulators, and competitors alike, as it could redefine the balance between encouraging generic competition and safeguarding patent rights in the drug market.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.