What are the disclosure requirements for information related to regulatory review, such as FDA submissions?

Information submitted to regulatory review bodies, such as the U.S. Food & Drug Administration (FDA), may be material to pending patent applications or reexamination proceedings and should be disclosed to the USPTO. The MPEP states:

“Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is material to any pending patent application or reexamination proceeding, such documentation should be submitted for Office review.”

Key points to consider:

• Assertions made to regulatory bodies that contradict those made to the USPTO may be material
• If the application’s filing date is after FDA marketing approval, and the applicant intends to list the patent in the Orange Book, this information should be disclosed
• Parties have a duty to perform a reasonable inquiry, which may include reviewing documents submitted to or received from other government agencies
• Failure to disclose material information from regulatory submissions could result in sanctions or other actions

It’s crucial to review regulatory submissions for material information and disclose it to the USPTO to comply with the duty of disclosure.

To learn more:

• Regulatory Review
• FDA
• Duty of Disclosure
• Material Information
• Orange Book
• Reasonable Inquiry