WASHINGTON (August 19, 2025) — Recently, Senators Maggie Hassan (D-NH) and Josh Hawley (R-MO) introduced the Medication Affordability and Patent Integrity Act, S. 2658, which would mandate that life sciences innovators submit extensive and often confidential information related to drug approval to the U.S. Patent and Trademark Office (USPTO). The bill would also require companies to provide detailed certifications that all information is submitted to both the Food and Drug Administration (FDA) and the USPTO, and that the information is consistent.
Today, Frank Cullen, Executive Director of the Council for Innovation Promotion, issued the following statement urging lawmakers to oppose the bill:
“C4IP shares Congress’s and the American people’s concern for affordable healthcare. However, the Medication Affordability and Patent Integrity Act does not advance that goal. Instead, it attempts to solve a problem that does not exist — there is no evidence of significant withholding by the life sciences industry of information pertinent to the FDA and the USPTO. Existing safeguards already deter misbehavior: inequitable conduct during the patent evaluation process renders patents unenforceable at the USPTO, and the FDA can withhold or withdraw approval if fraudulent data was submitted with an application.
“Rather than create a more transparent system, this bill threatens to flood the USPTO with FDA data that is irrelevant to the work of the USPTO. This would burden an already resource-constrained agency and hinder both patent examination and drug approval. Patients would pay the price by having to wait even longer for breakthrough therapies and medications.
“Furthermore, unintentional failures to comply with the complex new rules under this bill could be weaponized to invalidate patents. This puts life sciences innovators at risk and erodes the incentives needed to invest in time- and resource-intensive biopharma R&D and bring new medicines to market. By forcing FDA disclosure of sensitive drug approval data to the USPTO (which is required to make all such data publicly available), the bill also threatens to undermine trade secrets and weaken long-standing protections for proprietary data.
“For the sake of America’s future medicines and patient health, Congress should reject this burdensome and unnecessary legislation. Instead, lawmakers should focus on preserving an effective, well-functioning IP and regulatory framework that continues to drive innovation and deliver lifesaving treatments.”
About the Council for Innovation Promotion: The Council for Innovation Promotion is a bipartisan coalition dedicated to promoting strong and effective intellectual property rights that drive innovation, boost economic competitiveness, and improve lives everywhere.