New Patent Task Force Mandates FDA Data Sharing with USPTO: Confidential Drug Info Gets 30-Day Notice Before Disclosure

This new legislation, the Interagency Patent Coordination and Improvement Act of 2025, is setting up a formal system to make sure the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) start talking to each other, especially when it comes to patents for human drugs and biological products. Essentially, it creates a new group, the Interagency Task Force on Patents, whose main job is to share information so patent examiners can do a better job of reviewing applications for new medicines (Section 4).

The Patent Examiner’s New Study Guide

The core idea here is efficiency and accuracy. When a company applies for a patent, the examiner needs to know if the invention is truly new and hasn't already been disclosed (this is called 'prior art'). The FDA often holds crucial data—like clinical trial results, approval documents, and labeling details—that can prove whether an invention was already known or in use. This bill recognizes that patent examiners are currently working with one hand tied behind their back, and giving them access to FDA data will help them make smarter decisions. For the public, this theoretically means fewer weak patents are granted, which can help keep competition healthy in the pharmaceutical market.

Building the Bridge Between Agencies

Section 4 establishes the Task Force, requiring the Director of the USPTO and the Commissioner of the FDA to formalize an agreement to coordinate all decisions related to these specialized patents. This isn't just about sharing documents; the Task Force is mandated to share processes, track updates on new drugs and technologies, and hold joint meetings and training sessions. Think of it as forcing two federal departments that usually operate in separate silos to finally merge their project management systems. Crucially, the USPTO Director can now specifically request available FDA information to help patent examiners evaluate applications, especially after an initial patent rejection.

The Confidentiality Catch: Who Pays the Cost?

While better coordination sounds great, the bill steps right into a minefield: confidential business information. Drug companies share highly sensitive, proprietary data with the FDA during the approval process. This bill allows patent examiners to access relevant FDA application, approval, patent, and labeling information, and even confidential communications between the FDA and the drug sponsor, if it is “absolutely necessary” for the USPTO to do its job right (Section 4). This is a big deal for drug sponsors, who rely on keeping their development secrets locked down.

The legislation includes a safeguard, but it’s one that will make legal teams nervous. Before either agency shares confidential information, the company that owns the drug or biological product must get 30 days’ notice to discuss the disclosure. The Task Force must also develop strict rules to prevent accidental leaks and determine penalties if they happen. For companies, this means their proprietary data, which they thought was safe with the FDA, is now potentially accessible to another agency, even with the 30-day heads-up. The vagueness of the term “absolutely necessary” could lead to broad interpretations of when this sensitive information needs to be shared, creating a new layer of risk for anyone developing new medicines.

The Four-Year Check-In

To ensure this Task Force isn't just another bureaucratic exercise, Section 3 requires the USPTO Director to send a detailed report to Congress within four years of the law’s enactment. This report must cover how often the FDA data is shared, how examiners are actually using it, and which types of data are most helpful. This built-in accountability mechanism forces the agencies to track their progress and gives Congress a chance to adjust the Task Force's mission or funding down the line. It also requires the Director to suggest other federal agencies that the USPTO should coordinate with next, signaling that this FDA partnership might just be the first step in a much larger government-wide effort to harmonize patent review with regulatory data.