Interagency Patent Coordination and Improvement Act of 2025
Description
This bill would create a task force to improve information sharing between the USPTO and FDA regarding drug and biologic patents.
Summary
What it does
This bill would establish the Interagency Task Force on Patents to facilitate communication between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) regarding patents for human drugs and biological products. The task force would be responsible for sharing information on how each agency evaluates applications and would create a formal process for the USPTO to request and receive technical data from the FDA to assist patent examiners. Additionally, the proposal requires the USPTO to support the FDA in its administrative role of maintaining patent listings.
Who is affected
The bill primarily affects the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA), which are required to coordinate through a new interagency task force. Patent examiners at the USPTO and officials at the FDA are impacted by new requirements to share information regarding the evaluation of patent and drug applications. Additionally, the legislation affects entities involved in the development and patenting of human drugs, biological products, and related new technologies.
Key provisions
- Establishment of the Interagency Task Force on Patents. Creates a task force to facilitate coordination and communication between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) regarding patents for human drugs and biological products.
- Information sharing on agency processes and approvals. Directs the task force to share information concerning how each agency evaluates applications and to provide updates on new approvals for patents, drugs, biological products, and technologies.
- Interagency patent application support. Establishes a formal process for the USPTO to request and receive relevant information from the FDA to assist patent examiners in their duties.
- Technical assistance for patent listing. Requires the USPTO to provide assistance to the FDA in its ministerial capacity of listing patents.
Fiscal impact
Not applicable: No CBO cost estimate available
Effective dates
Not applicable: Official Summary does not address effective dates
Relationship to existing law
The bill modifies the administrative relationship between the U.S. Patent and Trademark Office and the Food and Drug Administration by formalizing information-sharing protocols regarding patent applications, drug approvals, and the ministerial listing of patents.
Stated purpose
This bill aims to enhance coordination and communication between the U.S. Patent and Trademark Office and the Food and Drug Administration regarding patents for human drugs and biological products. It establishes an interagency task force to facilitate information sharing on agency processes, application evaluations, and new product approvals.