Skinny Labels, Big Savings Act

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.

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Timeline

1. 9 January 2025

   Introduced

   Read twice and referred to the Committee on the Judiciary.

   Source: IntroReferral

2. 9 January 2025

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

2 official files

• Introduced in Senate

  Introduced in Senate · EN · 9 January 2025

  DownloadOpen at official source

• Introduced in Senate

  summary · EN · 9 January 2025

  Open at official source

Sponsors

• Sen. Hickenlooper, John W. [D-CO] · D · Sponsor
• Sen. Welch, Peter [D-VT] · D · Sponsor
• Sen. Cotton, Tom [R-AR] · R · Sponsor
• Sen. Collins, Susan M. [R-ME] · R · Sponsor
• · ssju00 · Standing

Related records

• related to ← Skinny Labels, Big Savings Act