Affordable Prescriptions for Patients Act
Sponsored By: Senator Cornyn, John [R-TX]
In Committee
Summary
Limits the number of patents a reference product sponsor may assert against a company seeking to sell a biosimilar under the FDA abbreviated approval pathway. The bill focuses on later-filed patents and manufacturing-related claims while preserving protections for patents that claim methods of using the biologic.
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- Biosimilar applicants: If they complete the required steps under section 351(k) of the Public Health Service Act they would face a narrower set of asserted patents, making litigation smaller and more predictable.
- Reference product sponsors: Could assert no more than 20 eligible patents in a suit and no more than 10 of those issued after the specified date. Eligible patents must claim the biological product, a use, or a manufacturing method and generally include patents filed more than 4 years after approval or manufacturing claims not used by the sponsor.
- Courts and timing: A court may increase the patent cap for the interest of justice or good cause. Good cause examples include a subsection (k) applicant failing to provide required information, a material change to the product or its manufacturing, or a delay in patent issuance.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
New rules for biologic patent lawsuits
If enacted, this would add new limits and rules for biologic patent lawsuits. When a biosimilar applicant finishes the required 351(l) info steps, the brand could sue on at most 20 patents. Only 10 of those could be patents issued after the date in section 351(l)(7)(A). The cap counts only certain listed patents filed more than 4 years after approval, or some manufacturing-method patents. Patents on how to use the drug would not count toward the 20. A court could raise the cap if asked promptly and justice or good cause requires it. Good cause can include missing applicant information, big product or process changes, or patent office delay. The bill would also broaden what counts as infringement for some filings. Patents on the product, its uses, and how it is made could be used. These rules would apply to 351(k) applications submitted on or after enactment.
Sponsors & CoSponsors
Sponsor
Cornyn, John [R-TX]
TX • R
Cosponsors
Sen. Blumenthal, Richard [D-CT]
CT • D
Sponsored 3/13/2025
Sen. Grassley, Chuck [R-IA]
IA • R
Sponsored 3/13/2025
Sen. Durbin, Richard J. [D-IL]
IL • D
Sponsored 3/13/2025
Roll Call Votes
No roll call votes available for this bill.
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