IP Law Daily, VITAL BRIEFING: Senate passes bill to limit patents asserted against biosimilars applicants, (Jul 24, 2026)
Bipartisan legislation intended to accelerate approval and introduction of lower-cost alternatives to branded biologic drugs now heads to House of Representatives. A Vital Briefing article breaks down the bill’s provisions and impacts.
The Senate has unanimously passed a bill aimed at speeding the market entry of lower-cost biosimilar alternatives to branded biologic drugs. The proposed “Affordable Prescriptions for Patients Act” (S. 1041) would limit the number of patents a branded biologics manufacturer can assert against applicants seeking FDA approval for biosimilars.
If the legislation becomes law, it would provide that a sponsor of an approved biologic that sues a biosimilar applicant for patent infringement may assert no more than 20 patents total. The limitation applies only to patents that claim the biological product itself; claim a use of the biological product; claim a manufacturing method or manufacturing product related to the biologic; and are included on the patent lists exchanged during the biosimilar approval process. Courts would be permitted to increase the number if good cause is shown.
The bill would also expand the scope of potential patent infringement triggered by a biosimilar application submission. A biosimilar filing would be deemed an act of infringement not only for patents claiming the biologic itself or its uses, but also for patents claiming (1) methods of using the biological product and (2) methods or products used to manufacture the biological product.
If enacted, the measure would limit the ability of biologic drug makers to assert large numbers of patents (“patent thickets”) in a single infringement case against a biosimilar applicant. This could reduce the costs for biosimilars applicants and could speed up the introduction of new, cheaper biosimilars. At the same time, branded biologics makers would still be able to assert important product, manufacturing, and treatment-use patents.
The bill’s sponsor, Sen. John Cornyn (R-Tex.) said in a media release, “By putting an end to the anti-competitive practice of patent thicketing, this legislation would encourage innovation, ensure generics can enter the market, and prevent prescription costs from increasing, and I urge the House to swiftly send it to President Trump’s desk to become law.”
The article, titled “Senate passes legislation addressing ‘patent thickets’ that impede marketing of new biosimilars,” is available here.
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