S. 1097: Interagency Patent Coordination and Improvement Act of 2025

The "Interagency Patent Coordination and Improvement Act of 2025" proposes the creation of a new interagency task force to enhance collaboration between two key federal entities: the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). This cooperative effort aims to improve the handling and evaluation of patents relevant to human drugs and biological products.

Key Provisions of the Bill

• Establishment of an Interagency Task Force: The bill establishes a task force that facilitates communication and coordination between the USPTO and the FDA regarding patents. The task force will consist of appointed employees from both agencies who possess relevant expertise.
• Information Sharing: The task force is tasked with sharing information related to patent evaluations, FDA processes, new drug approvals, technology advancements, and scientific developments. This will include routine meetings and workshops.
• Improved Access to Information for Patent Examiners: The USPTO will have a system in place to request relevant information from the FDA to assist patent examiners in their assessments. This may include updates on drug approvals and product labeling information.
• Confidentiality Protections: The bill emphasizes maintaining confidentiality while sharing sensitive information between the USPTO and FDA. Appropriate protocols will be established to prevent unauthorized disclosures.

Reports and Assessments

The Director of the USPTO is required to submit a report within four years of the bill’s enactment. This report will include:

• The frequency and usefulness of information shared between the FDA and USPTO.
• Identification of effective methods and types of information shared.
• Recommendations for potential changes in the task force's operations, funding, or legislative provisions.
• Identification of additional federal agencies that may benefit from similar coordination efforts.

Purpose and Background

The task force is expected to address the need for improved accuracy and consistency in patent applications and the related information submitted to different federal agencies. It acknowledges that patent examiners can benefit from additional insights provided by the FDA to better assess applications, especially those involving human drugs and biological products.

Additional Considerations

While the task force will enhance coordination between the two agencies, it will not interfere with the FDA's current responsibilities regarding patent listing and management. It is designed to assist rather than replace existing processes.

Relevant Companies

• PFE - Pfizer Inc.: A major pharmaceutical company that develops and produces a wide range of drugs and vaccines; the coordination of patent information could affect its intellectual property strategy and drug approvals.
• UNH - UnitedHealth Group Incorporated: As a major healthcare provider, any changes in drug patenting processes may influence its drug coverage policies and negotiations with pharmaceutical companies.
• JNJ - Johnson & Johnson: This well-established pharmaceutical and consumer goods company would be impacted by any changes in patent examination processes that pertain to its wide array of healthcare products.