Affordable Prescriptions for Patients Act

U.S. Congress · S1041 · Introduced

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What the bill says

S1041 · U.S. Congress · Introduced

Introduced 2025-03-13. Latest action: Held at the desk.

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Summary (plain-language)

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.

Sponsors

Text versions

  • Introduced in Senate — 2025-03-13 — XML
  • Reported to Senate — 2025-04-10 — XML
  • Engrossed in Senate — 2026-07-21 — XML

What analysts say

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What politicians say

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Action History

DateAction
2026-07-21Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.
2026-07-21Passed Senate with amendments by Unanimous Consent. (consideration: CR S4198-4199; text: CR S4199)
2026-07-21Message on Senate action sent to the House.
2026-07-21Received in the House.
2026-07-21Held at the desk.
2025-04-10Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.
2025-04-10Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
2025-04-03Committee on the Judiciary. Ordered to be reported with amendments favorably.
2025-03-13Introduced in Senate
2025-03-13Read twice and referred to the Committee on the Judiciary.

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