This bill provides a safe harbor protecting generic and biosimilar drug manufacturers from patent infringement claims when they use skinny labels, which omit patent-protected uses of a drug to bring cheaper alternatives to market sooner.
Latest Action
Read twice and referred to the Committee on the Judiciary.
AI Summary
Plain-English explanation of this bill
This bill provides a safe harbor protecting generic and biosimilar drug manufacturers from patent infringement claims when they use skinny labels, which omit patent-protected uses of a drug to bring cheaper alternatives to market sooner.
Last updated: 1/5/2026
Official Summary
Congressional Research Service summary
<p><strong>Skinny Labels, Big Savings Act</strong></p><p>This bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs.</p><p>Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in <em>GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.</em>, a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.</p><p>The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act:</p><ul><li>submitting or seeking approval of a skinny label for a generic or biosimilar drug;</li><li>promoting or commercially marketing a drug with skinny labeling approved by the FDA; or</li><li>describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.</li></ul><p>The bill also applies the safe harbor to similar actions under the Public Health Service Act.</p>
Key Points
Main provisions of the bill
Protects generic drug makers using skinny labels
Creates safe harbor from patent infringement claims
Allows generics to omit patented uses from labeling
Reduces drug costs through earlier generic availability
Addresses court ruling on skinny label liability
How This Impacts Americans
Potential effects on citizens and communities
Generic drug manufacturers would have clearer legal protection. Consumers would benefit from more affordable generic medications reaching the market. Brand-name drug companies would face reduced ability to delay generics.
Policy Areas
Primary Policy Area
Commerce
Scope & Jurisdiction
Jurisdiction Level
federal
Congressional Session
119th Congress
Citation Reference
43, 119th Congress (2025). "Skinny Labels, Big Savings Act". Source: Voter's Right Platform. https://votersright.org/bills/118-s-43
