The United States pays high prices for brand-name drugs, but generics — which fill nine out of 10 prescriptions — are relatively cheap. Americans pay less, on average, for generic medicines than people in other peer nations, but the wait for generics can be long. That delay could get longer depending on the Supreme Court case Hikma v. Amarin.
The dispute involves Hikma, a generic drugmaker, and Amarin, maker of Vascepa, a prescription drug made from purified fish oil for people at risk of heart disease. The legal fight centers on “skinny labeling,” a practice that lets generics get FDA approval to market only those uses of a drug that are no longer patented. Skinny labels let generic makers avoid some patent litigation and bring lower-cost alternatives to patients sooner.
More than two dozen generics have used skinny labeling over the past decade, including copies of big-name drugs like Crestor. One study found skinny labeling saved Medicare nearly $15 billion between 2015 and 2021. After some uses of Vascepa lost patent protection, Hikma launched a generic in 2020 with a skinny label covering only the unpatented use. Amarin then sued, accusing Hikma of encouraging prescriptions for Vascepa’s still-patented use — arguing the generic’s marketing effectively promoted infringing uses.
Hikma’s defenders — including more than 70 legal scholars and the federal government’s solicitor general — say Hikma’s statements fall within normal marketing and labeling practices and that skinny labeling is meant to work without exposing generic firms to massive patent liability for routine descriptions of their products. A federal appeals court sided with Amarin, but the Supreme Court agreed to hear the case.
If the Court rules for Amarin, the legal risk tied to skinny labeling could rise. Generic firms might avoid the faster, cheaper skinny-label route and instead wait until all patents fully expire or pursue riskier strategies, delaying competition and keeping prices high for longer. Crestor’s example is instructive: multiple patents might have kept its monopoly until 2022, but skinny labeling allowed competition in 2016, saving patients and insurers billions in a short period.
Some legal experts warn that longer monopolies mean higher costs, reduced access, and worse health outcomes for patients. Others are more cautious. Some believe the financial incentives for using skinny labels are strong enough that companies will find ways to manage any increased litigation risk — potentially continuing to use skinny labels despite occasional lawsuits.
If the Court sides with Hikma, patients likely won’t see immediate price changes. But Amarin argues a ruling for generics could weaken incentives for brand companies to invest in developing new or additional uses for drugs, potentially reducing future “revolutionary and life-saving” discoveries.
Observers point to factors favoring Hikma: the solicitor general’s strong brief supporting the generic, high Supreme Court reversal rates of lower-court decisions, and recent patent-related rulings suggesting the Court will be cautious about broad inducement liability. Still, scholars urge caution in predicting the outcome; the Court could rule broadly for generics, narrowly to preserve the status quo, or in a way that reshapes how companies approach labeling and marketing.
Reporting for this story was supported, in part, by Arnold Ventures. Leslie Walker is a senior reporter for Tradeoffs, a nonprofit news organization that covers health-care tradeoffs.