Bill · H.R. 6485· House(119-HR-6485)
Skinny Labels, Big Savings Act
- Introduced
- 12/5/2025
- Last activity
- 12/5/2025 — Referred to the House Committee on the Judiciary.
- Sponsored by
- Ben Cline
- Cosponsors
- - 3 - 3
- Introduced
- In Committee
What this bill would do
The "Skinny Labels, Big Savings Act" proposes to amend title 35 of the United States Code regarding patent infringement. It seeks to create a safe harbor for certain actions related to drugs and biological products. This safe harbor would protect against claims of direct, induced, or contributory infringement of method of use patents. The provisions apply to submitting applications, promoting, or commercially marketing products with specific labeling. It also covers describing products as generics or biosimilars under certain conditions.
Yes
Does this lower the price of prescription medicines?+6
By creating a safe harbor for method of use patents, the bill encourages competition from lower-cost generics and biosimilars.
Would households on low incomes be better off under this?+4
The promotion of generic and biosimilar drugs may lead to lower costs for essential medicines.
Does this make it easier to run a small business?+4
The safe harbor provisions facilitate market entry for generic and biosimilar manufacturers.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Safe Harbor for Application Submission: Under Section 2, subsection (h)(1)(A), entities can submit or seek approval for applications under the Federal Food, Drug, and Cosmetic Act without being liable for patent infringement of a method of use claim, provided the application includes a specific statement regarding the patent.
-
Protection for Marketing and Promotion: Section 2, subsection (h)(1)(B) allows for the promotion or commercial marketing of a drug product using approved labeling without infringing on method of use patents.
-
Generic and Biosimilar Availability: Section 2, subsection (h)(1)(C) allows for the description of a drug product as a generic or therapeutically equivalent to a listed drug without infringement, provided it follows specific application guidelines. Similarly, Section s 2, subsection (i)(1)(B) allows for describing biological products as biosimilar or interchangeable with a reference product, provided they are not approved for the patented condition.
Potential Negative Impacts for People
- Restrictions on Labeling and Promotion: According to Section 2, subsection (h)(1) and (i)(1), the safe harbor only applies if the labeling, promotion, or commercial marketing does not reference the specific condition or conditions of use claimed in the patent. This limits how products can be described or marketed.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Reduces Prescription Drug Costs+6
- Demographic And Interest Groups
- Good For Low Income Households+4
- Economy And Finance
- Improves Small Business Support+4
- 6/23/2026
- 1 Cosponsor added.
- 6/15/2026
- 1 Cosponsor added.
- 5/19/2026
- 1 Cosponsor added.
- 4/20/2026
- 2 Cosponsors added.
- 12/5/2025
- Referred to the House Committee on the Judiciary.
- 1 Cosponsor added.
- Introduced in House
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Angie CraigDemocrat · Minnesota
Glenn GrothmanRepublican · Wisconsin
Jennifer KiggansRepublican · Virginia
Zoe LofgrenDemocrat · California
August PflugerRepublican · Texas
Thomas SuozziDemocrat · New York