Solomon Center Scholars Illuminate Stakes of Supreme Court Drug Patent Liability Case
The U.S. Supreme Court has turned a spotlight on generic drug competition by agreeing to hear Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. The dispute relates to a practice known as “skinny labeling,” a pathway Congress created under the Hatch-Waxman Act of 1984 that allows generic drug manufacturers to seek FDA approval for unpatented drug uses of brand-name drugs despite the fact that the brand-name drug might have some patented FDA-approved indications remaining. Labels for such drugs are referred to as “skinny,” because they do not contain all of the approved indications of the brand-name version.
Although the generic label at issue in the Hikma case carved out the patented use, the brand-name drug manufacturer argued that the generic manufacturer nonetheless “induced” patent infringement. For example, the branded drugmaker cites allegations that the generic manufacturer issued press releases calling its product a “generic version” of the brand-name drug and aggregating that drug’s publicly available sales data across all indications.
Research by scholars at the Solomon Center for Health Law and Policy at Yale Law School suggests that allowing these claims to proceed could discourage timely generic competition by increasing the risk of liability for generic manufacturers marketing products with skinny labels. This could in turn reduce access to generic drugs, which play a major role in the U.S. health care system: prescription drug prices often fall 80% or more after a generic enters the market, while the substitution of branded drugs with generics has saved the health care system approximately $1.67 trillion over a recent decade.
In an empirical study published this past March, 2024–25 Solomon Center Student Research Fellow Therese J. Ziaks, Solomon Center Distinguished Visitor Aaron S. Kesselheim, and their colleagues examined whether the use of the skinny labeling pathway changed after the 2021 decision in a different case, GlaxoSmithKline v. Teva, in which a court similarly found generic manufacturer Teva liable for inducing infringement on GlaxoSmithKline’s patents for a brand-name drug based in part on routine promotional practices. The authors found that while 43% of susceptible brand-name drugs had skinny-labeled generic prescriptions from 2015 to 2019, that figure dropped to 20% in 2023—suggesting that the decision had a chilling effect on prescription manufacturers’ use of skinny labeling.
In further articles, including one published last September with 2025–26 Solomon Center Student Research Fellow Jin K. Park, Kesselheim and co-author S. Sean Tu explained that expansive interpretations of inducement liability undermine the congressional compromises embedded in the Hatch-Waxman Act, which sought to balance the need to protect valid patents with the benefits of generic drugs entering the market in a timely fashion. They showed that skinny labeling is not a loophole, but a carefully designed policy tool that has delivered major benefits to patients and the health system while preserving incentives for innovation.
Kesselheim and fellow scholars incorporated these studies into an amicus brief filed in Hikma last March. This research provides important context as the Supreme Court weighs the parties’ arguments. A decision is expected later this year.
About the Solomon Center
The Solomon Center for Health Law and Policy at Yale Law School is the first of its kind to focus on the intersection of law and the governance, practice, and business of health care. The Center brings together leading experts and practitioners from the public and private sectors to address cutting-edge questions of health law and policy, and to train the next generation of top health lawyers, industry leaders, policymakers, and academics.
