WASHINGTON, D.C. — The U.S. Supreme Court is scheduled to hear Hikma v. Amarin, a case concerning the skinny labeling strategy used by generic drugmakers to bring cheaper versions of brand-name medications to market for unpatented uses. The court granted review following a petition from Hikma, a generic drugmaker, after a federal circuit court ruled in favor of Amarin, the maker of Vascepa, a brand-name drug made from purified fish oil for people at high risk of heart disease.

Under skinny labeling, when a brand-name drug loses its patents on some but not all uses, a generic competitor can obtain skinny label approval from the Food and Drug Administration to sell the medication for the unpatented uses. Amarin patented Vascepa for use in two patient groups: those at very high risk of heart disease and those at lower risk. After the patent on Vascepa for higher-risk patients expired, Hikma launched its generic version with skinny label approval in 2020. Amarin sued Hikma for encouraging doctors to prescribe the generic version for the still-patented use as well as the unpatented use.

Generic medications fill nine out of every ten prescriptions in the United States, and Americans pay less on average for generic medications than people in any other peer nation. Some brand-name drug monopolies last decades before a generic can enter the market. In the last decade, more than two dozen copycat medicines have entered the market using skinny labeling. A study found that skinny labeling saved Medicare nearly $15 billion between 2015 and 2021.

More than seventy legal scholars and the U.S. solicitor general filed briefs defending Hikma. "The skinny label pathway cannot function as Congress intended if a generic manufacturer's anodyne descriptions of its product create a serious risk of massive patent liability," the solicitor general wrote in a brief filed with the court.

Sean Tu, a University of Alabama law professor who co-authored a legal brief siding with Hikma, said a ruling for Amarin could affect drug access. "We're going to see brand firms get longer monopolies, which means higher prices for patients, which means less access to these medications, which ultimately means that patients suffer with poorer health outcomes," Tu said.

Jake Sherkow, a University of Illinois law professor, offered a different assessment of the potential impact. "I've heard a lot of 'the sky is falling' arguments in a lot of different areas of law, and the sky has yet to fall," Sherkow said. He added, "Even if [a generic drugmaker] gets sued, it's better to get sued and get approval than to not get approval."

A decision in favor of Amarin could increase the legal risk of skinny labeling for generic companies, potentially leading them to wait until all patents on a drug have expired before entering the market. Data show that the Supreme Court overturns lower court decisions approximately 70% of the time.