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This bill amends title 35 of the United States Code to limit the number of patents a reference product sponsor can assert in patent infringement lawsuits against biosimilar applicants, aiming to prevent product hopping and reduce prescription drug costs. Sec. 2, Title 35 amendments: The bill adds a new paragraph (7) to section 271(e) of title 35, limiting a reference product sponsor to asserting no more than 20 patents in an infringement action against a biosimilar applicant, with no more than 10 of those patents having issued after a specified date. The patents must claim the biological product, its use, or its manufacture, and must have a filing date more than 4 years after the reference product's approval or involve a manufacturing method not used by the sponsor. A court may increase this limit if the request is timely and the interest of justice or good cause is shown, such as the applicant failing to provide required information or a material change to the product. The limit applies only if the biosimilar applicant completes all required actions under the Public Health Service Act, and does not apply to patents claiming methods of using the product in therapy, diagnosis, or prophylaxis. The amendments apply to biosimilar applications submitted on or after the bill's enactment date. The bill also amends the Social Security Act to increase the Medicare Improvement Fund from $0 to $1,800,000,000.
Summary of the bill text as introduced in House (Jul 18, 2024), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.
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Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.