USPTO Discusses Duty Of Disclosure And Duty Of Reasonable Inquiry

• Jurisdiction: United States,Federal
• Law Firm: Foley & Lardner
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Author: Ms Yogeeta Jadhav and Fatih Mercan
• Published date: 22 March 2023

On February 23, 2023, the U.S. Patent and Trademark Office (USPTO) held a virtual panel discussion on the duty of disclosure and duty of reasonable inquiry. While both duties apply regardless of technology area, the discussion supported USPTO initiatives pursuant to President Biden's July 2021 Executive Order on "Promoting Competition in the American Economy" to "promote greater access to medicines for American families." The panel of USPTO representatives outlined specific steps they believe applicants should and should not take to ensure that information material to patentability is shared with the USPTO, with examples focusing on information that may be submitted to FDA.

The Federal Register Notice

The panel discussion built on a July 29, 2022 Federal Register Notice explaining how the duty of candor and good faith in dealing with the USPTO applies to "information and statements material to patentability of a claimed invention and was intended to clarify the duties, including as to materials or statements material to patentability or statements made to the USPTO that are inconsistent with statements submitted to the FDA and other governmental agencies." The Notice was issued in response to a September 2021 letter from Senators Leahy and Tillis, who urged the USPTO to "take steps to reduce patent applicants' making inappropriate conflicting statements in submissions to the [USPTO] and other federal agencies." As discussed in this article, the Notice offered clarification on (a) who has a duty to disclose material information, (b) what material information must be disclosed, (c) what is the duty of reasonable inquiry, and (d) when the duties of disclosure and reasonable inquiry arise in dealings with other government agencies.

The Panel Discussion

The panel discussion was moderated by Dr. Kimberly Braslow, Patent Director, AstraZeneca, and Vice Chair, AIPLA Food and Drug Committee. The panelists consisted of Robert A. Clarke, Mary Till, and Matthew Sked of the USPTO Office of Patent Legal Administration, and Ronald K. Jaicks of the USPTO Office of Enrollment and Discipline (OED).

The discussion included a presentation outlining the duty of candor and good faith (37 CFR ' 1.56(a)), the duty of disclosure (37 CFR ' 1.56 (b) and (c)), and the duty of reasonable inquiry (37 CFR ' 11.18(b)), as well as a review of relevant USPTO rules of professional conduct and disciplinary decisions. The panelists noted that the newly-created FDA-PTO task force would be...