HR6485Referred to Committee

Skinny Labels, Big Savings Act

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-12-05
Introduced
4
Cosponsors
HR
ⓘ
Type

Sponsor

Ben Cline
Ben Cline
Republican · VA · Representative
Votes with party: 94.0% (547 recorded votes)

Full profile: /officials/C001118

Source: Congress.gov · FEC

Cosponsors (4)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Referred to the House Committee on the Judiciary.

2025-12-05

Source: Congress.gov

Committee Activity

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Plain-English Summary

Skinny Labels, Big Savings Act 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. 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: submitting or seeking approval of a skinny label for a generic or biosimilar drug; promoting or commercially marketing a drug with skinny labeling approved by the FDA; or describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug. The bill also applies the safe harbor to similar actions under the Public Health Service Act.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Commerce
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