Bill · S. 43· Senate(119-S-43)
Skinny Labels, Big Savings Act
- Introduced
- 1/9/2025
- Last activity
- 1/9/2025 — Read twice and referred to the Committee on the Judiciary.
- Sponsored by
- John Hickenlooper
- Cosponsors
- - 1 - 2
- Introduced
- In Committee
What this bill would do
The "Skinny Labels, Big Savings Act" aims to amend title 35 of the United States Code. It seeks to establish a safe harbor from patent infringement regarding method of use claims for drugs or biological products. This safe harbor would apply to the submission of applications, the promotion or marketing of products, and the description of products as generics or biosimilars. The protections are contingent upon the labeling not referencing specific patented conditions of use. This act applies to conduct occurring before, on, or after its enactment date.
Yes· 3 of 5
Does this lower the price of prescription medicines?+6
By providing a safe harbor for generic and biosimilar products to enter the market without infringing on method-of-use patents, the bill facilitates competition that lowers drug prices.
Would households on low incomes be better off under this?+5
Lower prescription drug costs through increased competition provide financial relief to low-income households.
Would middle-income households be better off under this?+5
The bill helps lower drug costs which reduces out-of-pocket expenses for middle-income families.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Safe Harbor for Drug Applications: Under Section 2, subsection (h)(1)(A), the act allows for submitting or seeking approval of certain applications without it being considered patent infringement, provided specific statements are included regarding the method of use claims.
-
Commercial Marketing Protections: Section 2, subsection (h)(1)(B) allows for the promotion or commercial marketing of drug products using approved labeling without being deemed an act of infringement.
-
Generic and Biosimilar Descriptions: Under Section 2, subsection (h)(1)(C), companies can describe drug products as generics or therapeutically equivalent to a listed drug without infringement. Similarly, Section 2, subsection (i)(1)(B) allows for describing biological products as biosimilar or interchangeable with a reference product.
-
Biological Product Promotion: Section 2, subsection (i)(1)(C) provides that promoting or commercially marketing a biological product with approved labeling shall not be an act of infringement.
Potential Negative Impacts for People
-
Restrictions on Labeling and Promotion: Under Section 2, subsection (h)(2), 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 that was identified by the patent owner.
-
Limitations on Biological Products: Per Section 2, subsection (i)(2), the protections for biological products apply only if the labeling, promotion, or commercial marketing does not reference the condition or conditions of use claimed in the patent and specifically reflected in the prescribing information.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Low Income Households+5Good For Middle Class Households+5
- Healthcare
- Reduces Prescription Drug Costs+6
- Education And Technology
- Improves Intellectual Property Fairness+4
- Economy And Finance
- Improves Small Business Support+3
- 1/9/2025
- Read twice and referred to the Committee on the Judiciary.
- 3 Cosponsors added.
- Introduced in Senate
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.
Susan CollinsRepublican · Maine
Tom CottonRepublican · Arkansas
Peter WelchDemocrat · Vermont