The U.S. Supreme Court has agreed to hear a high-stakes patent dispute involving Amarin Pharma’s blockbuster cardiovascular drug, Vascepa, a case that could significantly affect how generic drugs are labeled and marketed in the United States. At the center of the dispute is the concept of “skinny labels,” which allow generic drugmakers to avoid infringing patents by omitting protected uses from their FDA-approved labeling while still offering the drug for unpatented indications.
The case stems from Amarin’s lawsuit against Hikma Pharmaceuticals, which markets a generic version of Vascepa approved only for treating severe hypertriglyceridemia. Although Hikma’s FDA-approved label excluded Vascepa’s patented cardiovascular uses, Amarin alleged that Hikma encouraged doctors to prescribe the generic drug for those patented uses through public statements, press releases, and marketing materials referring to the product as “generic Vascepa.” While a federal district court initially dismissed the lawsuit, the U.S. Court of Appeals for the Federal Circuit revived it in 2024, finding that Hikma’s public messaging could have induced patent infringement.
Hikma appealed to the Supreme Court, warning that the Federal Circuit’s ruling threatens the viability of skinny labels and could chill generic drug competition. The company argued that brand-name manufacturers could now rely on almost any public statement to sue generic competitors for induced infringement, even when generics comply with FDA labeling requirements. Hikma has welcomed the Supreme Court’s decision to review the case, calling it critical to preserving access to affordable generic medicines.
The case has drawn broader attention because of its potential impact on pharmaceutical innovation, patent enforcement, and healthcare costs. The Trump administration supported Hikma’s appeal, stating that the Federal Circuit’s decision disrupts the balance Congress intended between patent protection and generic competition. With Vascepa generating over $228 million in revenue for Amarin in 2024, the Supreme Court’s ruling could reshape how pharmaceutical companies navigate patent rights, marketing practices, and competition in the years ahead.
