Skinny Labels, Big Savings Act

Ben Cline

Republican · VA · Representative

Source: Congress.gov · FEC

• Zoe Lofgren (D-CA-18)Original· 2025-12-05
• Jennifer A. Kiggans (R-VA-2)· 2026-04-20
• Thomas R. Suozzi (D-NY-3)· 2026-04-20

Referred to the House Committee on the Judiciary.

2025-12-05

Source: Congress.gov

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.

• HR7730Bankruptcy Threshold Adjustment Act
  Referred to Committee · 2026-08-27
• HR10016Veterans Entrepreneurship Act of 2026
  Referred to Committee · 2026-08-03
• HR9701Daughters of the American Revolution Membership Integrity Act.
  Referred to Committee · 2026-07-15
• HR2675Protecting Our Courts from Foreign Manipulation Act
  Referred to Committee · 2026-06-15