This bill establishes a new Interagency Task Force on Patents , bringing together the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). This task force aims to improve coordination, communication, and information sharing between the two agencies concerning patents for human drugs and biological products. Its primary goal is to ensure greater accuracy and consistency in patent representations and to provide patent examiners with crucial information housed at the FDA, recognizing that patent decisions often intersect with FDA data. Composed of employees from both agencies with relevant expertise, the task force will operate under a memorandum of understanding. Key activities include sharing general processes, review considerations, and evaluation methods through routine meetings and training sessions, alongside exchanging information on new patent and product approvals, technologies, prior art, and scientific trends. A crucial provision requires the FDA to provide the USPTO with information regarding public availability of drug approval data and, when necessary, access to relevant non-public product application and labeling information for patent examination purposes. Additionally, the FDA Commissioner will consult with or furnish specific information to the USPTO Director upon request to assist patent examiners. To protect sensitive data, the task force must establish rigorous confidentiality protocols , including a 30-day notice period for sponsors before sharing information and procedures for the USPTO Director to safeguard confidential data separately from pending applications. Within four years of enactment, the USPTO Director must report to Congress on the task force's effectiveness, identifying useful information-sharing methods and recommending any necessary changes or further interagency coordination opportunities.
Administrative remediesDepartment of CommerceDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Intellectual propertyIntergovernmental relations
Interagency Patent Coordination and Improvement Act of 2025
USA119th CongressS-1097| Senate
| Updated: 4/10/2025
This bill establishes a new Interagency Task Force on Patents , bringing together the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). This task force aims to improve coordination, communication, and information sharing between the two agencies concerning patents for human drugs and biological products. Its primary goal is to ensure greater accuracy and consistency in patent representations and to provide patent examiners with crucial information housed at the FDA, recognizing that patent decisions often intersect with FDA data. Composed of employees from both agencies with relevant expertise, the task force will operate under a memorandum of understanding. Key activities include sharing general processes, review considerations, and evaluation methods through routine meetings and training sessions, alongside exchanging information on new patent and product approvals, technologies, prior art, and scientific trends. A crucial provision requires the FDA to provide the USPTO with information regarding public availability of drug approval data and, when necessary, access to relevant non-public product application and labeling information for patent examination purposes. Additionally, the FDA Commissioner will consult with or furnish specific information to the USPTO Director upon request to assist patent examiners. To protect sensitive data, the task force must establish rigorous confidentiality protocols , including a 30-day notice period for sponsors before sharing information and procedures for the USPTO Director to safeguard confidential data separately from pending applications. Within four years of enactment, the USPTO Director must report to Congress on the task force's effectiveness, identifying useful information-sharing methods and recommending any necessary changes or further interagency coordination opportunities.
Administrative remediesDepartment of CommerceDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Intellectual propertyIntergovernmental relations