S43Referred 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
2025-01-09
Introduced
3
Cosponsors
S
ⓘ
Type

Sponsor

John W. Hickenlooper
John W. Hickenlooper
Democrat · CO · Senator
Votes with party: 82.4% (905 recorded votes)
Top industries funding sponsor:
  • Climate & Environment$19k

Full profile: /officials/H000273

Source: Congress.gov · FEC

Cosponsors (3)

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

3 cosponsors on record at Congress.gov. The named list is syncing into Govwatch and will appear here shortly — view on Congress.gov in the meantime.

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 →

Read twice and referred to the Committee on the Judiciary.

2025-01-09

Source: Congress.gov

Committee Activity

Currently in

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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