Sponsors (2)
The bill increases patent transparency for patients and regulators and protects transferred trade secrets, but it imposes new compliance costs and enforcement risks on drug developers and may complicate patent litigation and enforcement.
Patients with chronic conditions will face fewer surprise patent challenges to marketed drugs because sponsors must disclose patent-relevant information consistently to FDA and USPTO, improving patent transparency.
Hospitals and health systems (and other healthcare regulators) will gain additional patent/exclusivity information at FDA, improving regulators' ability to evaluate drug exclusivity and related safety or access decisions.
Small business drug sponsors and inventors will have additional confidential data transferred from FDA protected by the USPTO, preserving trade-secret protections for sponsors' sensitive information.
Small drug developers and sponsors will face increased compliance costs and administrative burden to synchronize FDA and USPTO filings and provide new certifications, likely raising development expenses and potentially increasing drug prices over time.
Small businesses risk FDA enforcement (prohibited-act sanctions) for failing to provide the new certifications, increasing regulatory/legal risk for companies that miss paperwork or compliance requirements.
Hospitals, health systems, and other stakeholders may face increased patent litigation complexity because the bill creates a defense that allows accused infringers to assert invalidity/non-infringement if owners failed to disclose to FDA/USPTO, potentially destabilizing existing patent enforcement.
Based on analysis of 2 sections of legislative text.
Requires sponsors to submit and certify consistent patent-related information to both FDA and USPTO, makes missing certifications an FD&C Act violation, and adds a patent-defense for disclosure failures.
Introduced August 1, 2025 by Margaret Wood Hassan · Last progress August 1, 2025
Requires drug sponsors and patent owners to submit the same patent-related information and certifications to both the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). It makes failure to provide the required certifications an unlawful act under the Federal Food, Drug, and Cosmetic Act and creates a new patent-defense for accused infringers if a patent owner negligently or intentionally withheld required information from FDA or USPTO. The bill phases in requirements for pending applications and limits retroactive application to materials submitted before enactment, and directs the USPTO to treat submitted materials as confidential or trade secret.