Legis Daily

Skinny Labels, Big Savings Act

USA119th CongressS-43| Senate 
| Updated: 1/9/2025
John W. Hickenlooper

John W. Hickenlooper

Democratic Senator

Colorado

Cosponsors (3)
Tom Cotton (Republican)Peter Welch (Democratic)Susan M. Collins (Republican)

Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This legislation, titled the "Skinny Labels, Big Savings Act," amends title 35 of the United States Code to create a safe harbor from infringement of method of use patents for certain drug and biological products. This safe harbor applies to actions taken by generic drug and biosimilar manufacturers when their products are not approved for, and their labeling or marketing does not reference, a specific patented condition or method of use. The goal is to prevent patent holders from blocking the market entry of generic or biosimilar versions that only seek approval for non-patented uses. Specifically, the bill protects activities such as submitting applications for generic drugs (under section 505(j) or 505(b)(2) of the Federal Food, Drug, and Cosmetic Act) or biosimilar biological products (under section 351(k) of the Public Health Service Act). It also covers the promotion, commercial marketing, or description of these products as generic, therapeutically equivalent, biosimilar, or interchangeable, provided that such actions do not reference the patented conditions of use. The provisions of this Act apply retroactively to conduct occurring before, on, or after its enactment date, and to all pending judicial or other proceedings.
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Timeline

Bill from Previous Congress

S 118-5573
Skinny Labels, Big Savings Act
Jan 9, 2025
Introduced in Senate
Jan 9, 2025
Read twice and referred to the Committee on the Judiciary.
Dec 5, 2025

Latest Companion Bill Action

HR 119-6485
Introduced in House
  • Bill from Previous Congress

    S 118-5573
    Skinny Labels, Big Savings Act


  • January 9, 2025
    Introduced in Senate


  • January 9, 2025
    Read twice and referred to the Committee on the Judiciary.


  • December 5, 2025

    Latest Companion Bill Action

    HR 119-6485
    Introduced in House

Commerce

Skinny Labels, Big Savings Act

USA119th CongressS-43| Senate 
| Updated: 1/9/2025
This legislation, titled the "Skinny Labels, Big Savings Act," amends title 35 of the United States Code to create a safe harbor from infringement of method of use patents for certain drug and biological products. This safe harbor applies to actions taken by generic drug and biosimilar manufacturers when their products are not approved for, and their labeling or marketing does not reference, a specific patented condition or method of use. The goal is to prevent patent holders from blocking the market entry of generic or biosimilar versions that only seek approval for non-patented uses. Specifically, the bill protects activities such as submitting applications for generic drugs (under section 505(j) or 505(b)(2) of the Federal Food, Drug, and Cosmetic Act) or biosimilar biological products (under section 351(k) of the Public Health Service Act). It also covers the promotion, commercial marketing, or description of these products as generic, therapeutically equivalent, biosimilar, or interchangeable, provided that such actions do not reference the patented conditions of use. The provisions of this Act apply retroactively to conduct occurring before, on, or after its enactment date, and to all pending judicial or other proceedings.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 118-5573
Skinny Labels, Big Savings Act
Jan 9, 2025
Introduced in Senate
Jan 9, 2025
Read twice and referred to the Committee on the Judiciary.
Dec 5, 2025

Latest Companion Bill Action

HR 119-6485
Introduced in House
  • Bill from Previous Congress

    S 118-5573
    Skinny Labels, Big Savings Act


  • January 9, 2025
    Introduced in Senate


  • January 9, 2025
    Read twice and referred to the Committee on the Judiciary.


  • December 5, 2025

    Latest Companion Bill Action

    HR 119-6485
    Introduced in House
John W. Hickenlooper

John W. Hickenlooper

Democratic Senator

Colorado

Cosponsors (3)
Tom Cotton (Republican)Peter Welch (Democratic)Susan M. Collins (Republican)

Judiciary Committee

Commerce

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted