PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in Senate · Mar 13, 2025
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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Sen. Cornyn, John [R-TX] · R–TX
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Held at the desk.
Received in the House.
Message on Senate action sent to the House.
Passed Senate with amendments by Unanimous Consent. (consideration: CR S4198-4199; text: CR S4199)
Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.
Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.
Committee on the Judiciary. Ordered to be reported with amendments favorably.
Read twice and referred to the Committee on the Judiciary.
Introduced in Senate
Primary sources
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Source last updated: Aug 10, 2026. Consult Congress.gov for the current record.
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