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 looking into how they can collaborate and open lines of interagency communication to complete their missions while still preserving confidentiality of protected information submitted to FDA, while OED will provide an understanding of ethical obligations in light of the rules, guidance and court cases.
The Prohibition Against Inconsistent Positions
The panelists stressed that the July 2022 Federal Register Notice only explained the current rules, to clarify the duties before the USPTO, how they are interpreted by USPTO, and how they are applied, and did not change any existing rules. For example, the panelists stated that current rules already prohibit applicants from taking inconsistent positions before different federal agencies, such as by providing material information to the FDA while simultaneously withholding the same information from the USPTO. For instance, in Bruno Independent Living Aids, Inc. v. Acorn Mobility Services, Ltd., 394 F.3d 1348, 1354 (Fed. Cir. 2005), the Federal Circuit inferred intent to deceive and found inequitable conduct when an official involved in both FDA and USPTO submissions disclosed what was found to be material prior art to the FDA but not to the USPTO.
The panelists also emphasized that current rules prohibit deliberate schemes to prevent individuals with a duty to disclose from obtaining knowledge of material information. For instance, they stated that walling off patent prosecution practitioners from attorneys seeking FDA approval as a way to prevent material information from being conveyed to a practitioner with a duty of disclosure would be inappropriate. See, e.g., Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933) (patent owner's suit dismissed where the patent owner paid a third party to keep a prior use secret); Precision Instruments Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945) (suit dismissed where patent owner actively suppressed evidence of perjury to the USPTO).
The panelists took the position that applicants should have an open line of communication between patent, regulatory, and litigation counsel, so that information material to patentability of any pending claims would be disclosed to the USPTO. For example, referencing Belcher Pharms., LLC v. Hospira, Inc., 11 F.4th 1345 (Fed. Cir. 2021), Mary Till noted that while there has not been a deluge of cases or disciplinary action related to the duty of disclosure in this context, one can learn from Belcher what should have happened to take consistent positions before the FDA and the USPTO.
The Duty of Reasonable Inquiry
Turning to the duty of reasonable inquiry, the panel explained that 37 CFR § 1.56(c) and § 11.18 neither require a practitioner to perform an extensive hunt for material information nor condone creating a wall between different counsel to prevent information sharing, but rather support an in-between approach of analyzing the facts of a given case and making an inquiry that is reasonable under the circumstances.
As an example of "reasonable" inquiry, the panel stated that even if clinical trials are done overseas for approval outside the United States, they may generate information material to patentability of pending U.S. claims, and so should be considered. The panelists also stated that if both patent protection and FDA approval are being sought for a specific product or service, an improvement on the product, a new formulation, a new patient population, or a new indication, care should be taken that the positions taken before the USPTO and FDA are not inconsistent. For example, panelists suggested practitioners consider the scope of the claims and filing date of the application and make a determination if information being submitted to FDA impacts patentability of any pending claims. In this regard, the panelists reiterated that practitioners should ensure that inconsistent statements are not being made to different agencies and that there are no deliberate schemes or established practices to prevent individuals encompassed by 37 CFR § 1.56(c) from obtaining knowledge of material information.
Addressing circumstances under which a "paragraph IV" letter served on a patent holder by an Abbreviated New Drug Application (ANDA) filer may be material, Mary Till stated that if there are pending applications related to the same active ingredient, it is possible that statements made in the paragraph IV letter could be material to patentability of pending claims. Recognizing confidentiality concerns, it was noted that the USPTO does have procedures for submitting confidential information under seal. However, if the information is found to be material to patentability, the information will become public when a patent is granted. See MPEP § 724.04.
The panelists also noted that an Examiner may require an applicant to submit information that is not material to patentability, as outlined in MPEP § 704.10 and § 704.11. As discussed in the Notice, an Examiner may appropriately require an applicant to submit to the USPTO information that has been submitted to the FDA (e.g., in a New Drug Application or Biologics License Application), such as information regarding how the drug product was manufactured when the claims relate to a manufacturing process, especially where the patent application has an effective filing date more than one year after FDA approval of the drug product.
With regard to disciplinary actions, the panel explained that the duty of reasonable inquiry may require enquiry of a party outside the scope of § 1.56(c) and that the duty under § 11.18 has a broader reach, but the OED will only prosecute individuals, not entities or law firms.
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