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S. 1041 119th Congress Senate

Affordable Prescriptions for Patients Act

Official title: A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes.

Introduced: March 13, 2025 Introduced by: John Cornyn Republican · Texas See on congress.gov
Commerce Civil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulation
More subjectsShow fewer subjects
Health care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsManufacturingPrescription drugs
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 10, 2025
Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
Apr 10, 2025
Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.
Apr 3, 2025
Committee on the Judiciary. Ordered to be reported with amendments favorably.
Mar 13, 2025
Read twice and referred to the Committee on the Judiciary.
Mar 13, 2025
Introduced in Senate
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What's happening now April 10, 2025

Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.

 Plain-English summary Congressional Research Service

Affordable Prescriptions for Patients Act

This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.)

The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug.

The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.

 Hearings & markups 1
 Related & companion bills 2
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 241

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

Bodies those filers lobbied

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APA
U.S. Congress. (2026). S. 1041: Affordable Prescriptions for Patients Act. 119th Congress. Open America. https://openamerica.io/bill/119-S-1041/
MLA
"S. 1041: Affordable Prescriptions for Patients Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-1041/.
Bluebook (legal)
S. 1041, 119th Cong. (2026), https://openamerica.io/bill/119-S-1041/.
Markdown link
[S. 1041: Affordable Prescriptions for Patients Act](https://openamerica.io/bill/119-S-1041/)
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