Skinny Labels, Big Savings Act

Senate Bill

S. 43

119th Congress

Skinny Labels, Big Savings Act

In Committee

Introduced:Jan 9, 2025

Primary Sponsor

John W. Hickenlooper

Senator

Democratic

CO

Cosponsors

3

Quick Stats

Policy Area

Commerce

Summary

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.

SponsorJohn W. Hickenlooper (D-CO)

Introduced1/9/2025

StatusRead twice and referred to the Committee on the Judiciary.

ChamberSenate

Data from Congress.gov

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Vote Prediction

Skinny Labels, Big Savings Act

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.

Community Breakdown

Pass

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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.

Bill Number: 43
Sponsor: John W. Hickenlooper (D-CO)
Introduced: 1/9/2025
Status: Read twice and referred to the Committee on the Judiciary.
Policy Area: Commerce

Data from Congress.gov

AI-generated summary

Fact Sheet

Title: Skinny Labels, Big Savings Act
Bill Number: 43
Sponsor: John W. Hickenlooper (D-CO)
Status: Read twice and referred to the Committee on the Judiciary.
Introduced: 1/9/2025
Summary: 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.

Data from Congress.gov

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

Skinny Labels, Big Savings ActThis 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.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 GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.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:<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>The bill also applies the safe harbor to similar actions under the Public Health Service Act.

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

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