This bill creates an Interagency Task Force on Patents to coordinate work between the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) for human drugs and biological products. The task force is added to title 35 of the U.S. Code as a new section 15. The Director of the USPTO and the FDA Commissioner must sign or update a memorandum of understanding to run the task force. Members will be employees from both agencies with relevant technical, medical, scientific, or administrative expertise.
The task force will share information about each agency's review processes, new approvals, technologies, prior art, and scientific developments. The USPTO may request and the FDA shall provide appropriate information or access to product application, approval, patent, and labeling information, including some information that is not currently public, when needed for patent examination. The USPTO will help the FDA with the ministerial role of listing patents. The bill requires protocols to protect confidential information, including notice to a product sponsor with 30 days to consult before certain information is shared. The Director must keep shared information separate from pending patent applications. The bill also directs the USPTO Director to report to congressional judiciary committees within four years about how often FDA information is shared and used, which methods and types of information are most useful, any recommended changes, and other agencies to consider for coordination.
No publicly available information on costs or funding. The bill text does not include a budget estimate or specify new funding.
The bill says patent examiners can benefit from additional information that other agencies hold. Supporters in the bill text argue that sharing FDA technical and regulatory information can help examiners assess prior art and the state of science and improve accuracy and consistency in patent-related representations.
No publicly available information.