S-1041-119
Held at the desk.
Sponsored by John Cornyn (R-TX)
What it does
This bill would amend federal patent law (Title 35, U.S. Code) to limit the number of patents that a brand-name biological drug maker (the "reference product sponsor") can assert in an infringement lawsuit against a company seeking approval to sell a biosimilar version of that drug. The cap would be set at 20 total patents, with no more than 10 of those patents allowed to have been issued more than 4 years after the original drug's approval date. Courts would retain discretion to raise the cap under specific circumstances, such as when the biosimilar applicant fails to provide required product information or makes material changes to its product.
Who benefits
Biosimilar drug manufacturers seeking to enter the market with lower-cost alternatives to brand-name biologics. Patients who use biologic drugs (e.g., treatments for rheumatoid arthritis, cancer, diabetes, and other conditions) and who may benefit from lower prices if biosimilar competition increases. Insurers, pharmacy benefit managers, and government health programs (Medicare, Medicaid) that pay for high-cost biologics. Employers and workers whose health plans cover biologic drugs. Taxpayers who fund federal health programs.
Who is hurt
Brand-name biologic drug manufacturers (reference product sponsors) who would lose the ability to assert their full patent portfolios in infringement litigation, potentially accelerating biosimilar market entry. Patent attorneys and litigation firms that specialize in pharmaceutical patent disputes, who may see reduced caseloads. Innovator companies that argue robust patent protection funds future research and development of new biologic therapies. Investors in brand-name biologic companies who may see reduced revenue projections if biosimilar competition increases sooner.
Supporters argue
Supporters argue that brand-name biologic manufacturers have used a practice known as "patent thicketing" — filing large clusters of overlapping patents — to block biosimilar competition far beyond what is needed to protect genuine innovation. They contend that the average biologic drug faces more than 100 patent claims in litigation, and that this bill's 20-patent cap would streamline disputes while still protecting legitimate intellectual property. With biologic drugs representing some of the most expensive treatments in the U.S. — some costing hundreds of thousands of dollars annually — supporters argue that enabling faster biosimilar entry could generate billions in savings for patients and federal health programs.
Opponents argue
Opponents argue that limiting the number of patents a company can assert in court restricts a constitutionally protected property right and could deter the enormous investment required to develop biologic drugs, which often cost over $1 billion to bring to market. They contend that each patent in a portfolio may protect a genuinely distinct innovation — such as a manufacturing process or delivery method — and that an arbitrary numerical cap could allow biosimilar makers to infringe valid patents without consequence. Critics also argue that courts already have tools to manage complex patent litigation and that Congress should not substitute a blunt numerical limit for case-by-case judicial judgment.
Constitutional context
Congress has broad authority to define the scope of patent rights under the Patent Clause (Art. I, §8, cl. 8) and to regulate pharmaceutical market entry under the Commerce Clause (Art. I, §8, cl. 3). However, restricting a patent holder's ability to enforce issued patents could raise questions under the Takings Clause (5th Amendment) if courts find that the cap effectively destroys the economic value of validly issued patents — a question that remains unsettled in the context of patent litigation caps.
Checks and balances
Congress would gain authority to define the litigation rights of patent holders; federal courts retain a check through their discretion to raise the patent cap for good cause, and through independent judicial review of agency and statutory interpretation under Loper Bright v. Raimondo (2024).
Historical precedent
A prior version of the Affordable Prescriptions for Patients Act passed the Senate Judiciary Committee in the 116th and 117th Congresses but did not receive a full Senate floor vote, making this a recurring legislative effort without an enacted predecessor.