Affordable Prescriptions for Patients Act
Latest action (21 Jul 2026): Passed Senate with amendments by Unanimous Consent.
What this bill does
S. 1041, the Affordable Prescriptions for Patients Act, would amend federal patent law as it applies to lawsuits over biological drugs (biologics). It would set a cap on the number of patents a brand-name biologic maker ("reference product sponsor") can assert in an infringement lawsuit against a company seeking approval to market a biosimilar version of that drug. Generally, no more than 20 qualifying patents could be asserted, with no more than 10 of those having been issued after a specified statutory date. Courts could allow more patents beyond this limit in certain circumstances, such as when the biosimilar applicant withheld required information, when there was a material change to the product or manufacturing process, or for other good cause. The limit would not apply to patents covering specific medical uses of a product, and it would only apply if the biosimilar applicant completed certain statutory disclosure steps.
The bill primarily affects pharmaceutical companies: makers of brand-name biologics and companies developing biosimilar competitors, as well as courts handling related patent disputes. It would apply to biosimilar applications submitted on or after the law's enactment date.
The bill passed the Senate on July 21, 2026, by unanimous consent with amendments. It now goes to the House of Representatives for consideration before it could become law.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
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.
Timeline
21 Jul 2026
Passed Senate with amendments by Unanimous Consent.
3 Apr 2025
Committee on the Judiciary. Ordered to be reported with amendments favorably.
Common questions
- What does S. 1041 do?
- S. 1041, the Affordable Prescriptions for Patients Act, would amend federal patent law as it applies to lawsuits over biological drugs (biologics). It would set a cap on the number of patents a brand-name biologic maker ("reference product sponsor") can assert in an infringement lawsuit against a company seeking approval to market a biosimilar version of that drug. Generally, no more than 20 qualifying patents could be asserted, with no more than 10 of those having been issued after a specified statutory date. Courts could allow more patents beyond this limit in certain circumstances, such as when the biosimilar applicant withheld required information, when there was a material change to the product or manufacturing process, or for other good cause. The limit would not apply to patents covering specific medical uses of a product, and it would only apply if the biosimilar applicant completed certain statutory disclosure steps. The bill primarily affects pharmaceutical companies: makers of brand-name biologics and companies developing biosimilar competitors, as well as courts handling related patent disputes. It would apply to biosimilar applications submitted on or after the law's enactment date. The bill passed the Senate on July 21, 2026, by unanimous consent with amendments. It now goes to the House of Representatives for consideration before it could become law.
- Has S. 1041 become law?
- Not yet. As of 21 Jul 2026, S. 1041 is passed senate (house next).
- Who sponsored S. 1041?
- S. 1041 was sponsored by Sen. John Cornyn [R-TX] (Republican-TX), with 3 cosponsors.
- What's the latest action on S. 1041?
- Passed Senate with amendments by Unanimous Consent. (21 Jul 2026).
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