A Republican bill with 2 Democratic cosponsors · See all 3 cosponsors
Last activity — Held at the desk.
Passed one chamber, waiting for the other to take it up
Passed one chamber, and the other has not yet sent it to a committee or put it on its calendar.
The other chamber will hand it to a committee, place it on its calendar, or leave it where it is. Nothing has been decided, and a bill can sit here indefinitely.
Its path through Congress
- Introduced
- Passed Senate unanimous consent
- Awaiting House
The Senate by unanimous consent (no one objected, so there was no vote): no senator's position on it was recorded.
What this bill would do
The "Affordable Prescriptions for Patients Act" aims to amend title 35 of the United States Code regarding patent infringement of biological products. It modifies how infringement is defined for certain submissions to include patents claiming the product, its use, or its manufacturing methods. The bill sets specific limits on the number of patents a reference product sponsor can assert in an infringement action against a subsection (k) applicant. Specifically, it limits the sponsor to a total of 20 patents, with restrictions on how many can be issued after a certain date. These changes are intended to address patent infringement related to biological products.
Yes· 3 of 6
- Scored +7
Does this lower the price of prescription medicines?
Limiting the number of patents a sponsor can assert against biosimilars encourages competition and helps lower drug prices.
- Scored +5
Would households on low incomes be better off under this?
Lower drug costs through competition can disproportionately benefit low-income households.
- Scored +5
Would retired people be better off under this?
Reducing costs for biological products can help retirees on fixed incomes.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Limitation of Patent Assertions: The bill limits a reference product sponsor to asserting a total of not more than 20 patents in an action against a subsection (k) applicant (Section 2, subsection a, paragraph 1, subparagraph A). This could prevent a single sponsor from using an excessive number of patents to challenge a competitor.
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Restrictions on Recent Patents: Of the 20 patents allowed, no more than 10 can have issued after the date specified in section 351(l)(7)(A) of the Public Health Service Act (Section 2, subsection a, paragraph 1, subparagraph A). This limits the ability to use newly issued patents in legal actions.
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Exclusions for Treatment Methods: The patent limitations do not apply to patents that claim a method for using a biological product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment (Section 2, subsection a, paragraph 1, subparagraph E, clause ii).
Potential Negative Impacts for People
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Expanded Definition of Infringement: The act of infringement is extended to include patents that claim the biological product, a method of using the product, or a method or product used to manufacture the product (Section 2, subsection a, paragraph 1). This could expand the scope of what constitutes an infringement.
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Increased Patent Counts via Court Discretion: A court has the authority to increase the number of patents a sponsor can assert if the request is made without undue delay and the interest of justice requires it, or if good cause is shown (Section 2, subsection a, paragraph 1, subparagraph C).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Tap or hover a score for the reason it gave.
- Demographic And Interest Groups
- Would households on low incomes be better off under this? — Lower drug costs through competition can disproportionately benefit low-income households. Would retired people be better off under this? — Reducing costs for biological products can help retirees on fixed incomes. Would middle-income households be better off under this? — Reduced prescription costs help alleviate the financial burden on middle-class families.
- Healthcare
- Does this lower the price of prescription medicines? — Limiting the number of patents a sponsor can assert against biosimilars encourages competition and helps lower drug prices.
- Economy And Finance
- Does this give people more protection from unfair business practices? — By limiting patent thickets, the bill facilitates faster market entry for biosimilars, which can lower consumer costs.
- Education And Technology
- Does this make patent and copyright rules fairer? — By capping the number of patents used to block competitors, it creates a fairer landscape for biosimilar applicants.
- 7/21/2026
- Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.
- Passed Senate with amendments by Unanimous Consent. (consideration: CR S4198-4199; text: CR S4199)
- Message on Senate action sent to the House.
- Held at the desk.
- Received in the House.
- 4/10/2025
- Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
- 4/3/2025
- Committee on the Judiciary. Ordered to be reported with amendments favorably.
- 3/13/2025
- Read twice and referred to the Committee on the Judiciary.
- 3 Cosponsors added.
- Introduced in Senate
2 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Richard BlumenthalDemocrat · Connecticut
Richard DurbinDemocrat · Illinois
Chuck GrassleyRepublican · Iowa