H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025

This bill, known as the Interagency Patent Coordination and Improvement Act of 2025, seeks to establish a collaborative framework between the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to enhance the coordination regarding patents, specifically in relation to human drugs and biological products.

Key Components of the Bill

Establishment of an Interagency Task Force

The bill creates an Interagency Task Force on Patents. This task force aims to:

• Facilitate communication and coordination between the USPTO and the FDA regarding patents and their implications for drug approvals.
• Enable the sharing of relevant information related to patents for human drugs and biological products.
• Provide technical assistance and guidance regarding patent examinations and approvals.

Sharing of Information

The task force will promote reciprocal access to information, which includes:

• Providing patent examiners with details about human drug or biological product approvals, including updates and relevant scientific trends.
• Establishing processes for the USPTO to request information from the FDA to aid in patent examinations.
• Regular sharing of information on patent applications, processes, and technical considerations between the two agencies.

Reporting Requirements

Within four years of the bill’s enactment, the USPTO is required to submit a report to both the Senate and House Judiciary Committees that includes:

• The frequency and usefulness of information shared between the FDA and the USPTO for patent examinations.
• Recommendations for potential improvements to the task force’s operations and its interagency collaborations.
• Identification of other federal agencies that may benefit from similar coordination efforts.

Confidentiality Protections

The bill includes provisions to protect confidential information that might be shared between the FDA and USPTO. Key points include:

• Any confidential information shared will maintain its privacy protections, and both agencies must develop protocols to ensure confidentiality.
• Before sharing information, relevant sponsors must be notified and allowed a period to consult with the agency sharing the information.

Impact on Patent Examining Processes

The intended goal of the bill is to improve the quality and efficiency of patent examinations by ensuring that patent examiners have access to the most current and relevant information related to human drugs and biological products. This could lead to more informed decisions regarding patent applications and potentially improve the overall patent review process.

Relevant Companies

• PFE - Pfizer: As a major pharmaceutical company, Pfizer is likely to be impacted due to the direct correlation between patents and drug approvals.
• MRK - Merck & Co.: Merck's operations in drug development and approval processes could be affected by changes in patent coordination.
• JNJ - Johnson & Johnson: Similar to Pfizer and Merck, Johnson & Johnson, being a large player in pharmaceuticals, may see effects on their patent applications and approvals.