Affordable Prescriptions for Patients Act
The source supplies the latest action, but no lifecycle stage.
Latest action (21 Jul 2026): Held at the desk.
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
Held at the desk.
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?
- The source does not supply a confirmed lifecycle stage for S. 1041. Check the latest action and official source below.
- Who sponsored S. 1041?
- S. 1041 was sponsored by Sen. Cornyn, John [R-TX] (R-TX), with 3 cosponsors.
- What's the latest action on S. 1041?
- Held at the desk. (21 Jul 2026).
Related bills in Commerce
Critical Infrastructure Manufacturing Feasibility Act
Cybersecurity for Small Businesses Act of 2026
Small Business Payment for Performance Act of 2026
Combating Foreign Threats to Main Street Act of 2026
More bills from Sen. Cornyn, John [R-TX]
Lone Star Coastal National Recreation Area Act
STRONGER Act
A resolution expressing support for the designation of the first week of August 2026, as "National Community Health Center Week", encouraging all people of the United States to participate by visiting their local community health center, and celebrating the important partnership between community health centers and the communities they serve.
Depot Data Transparency Act
Bill100 mirrors the public U.S. legislative record from Congress.gov and GovTrack and adds plain-English AI summaries. It is an information tool, not legal, compliance or lobbying advice, and it is not affiliated with the U.S. Congress or any government agency. AI summaries can simplify or omit detail — every bill links to the official source; verify there before you rely on it.