On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) published a Notice in the Federal Register, entitled “Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board.” According to the USPTO, “[t]his notice is 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 [Food and Drug Administration (FDA)] and other governmental agencies.” The Notice addresses who has a duty to disclose material information, what material information must be disclosed, what is the duty of reasonable inquiry, and when the duties of disclosure and reasonable inquiry arise in dealings with other governmental agencies.
Regarding what material information must be disclosed, the Notice reminds applicants and practitioners alike that “[i]n close cases where the materiality or consistency of information is in question, the applicant should consider submitting this information to the USPTO,” with citation to M.P.E.P. § 2004, item 10. In the case of PTAB proceedings, for example, the Notice indicates that “parties should not take a position about the patentability of challenged claims that is inconsistent with positions taken in submissions to other Government agencies regarding the same subject matter.” And, “[i]f a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record.”
Regarding the duty of reasonable inquiry, the Notice indicates that the “reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA.”
Regarding when the duties of disclosure and reasonable inquiry arise in dealings with other governmental agencies, the Notice indicates that “providing material information to other Government agencies, including the FDA, while simultaneously withholding the same information from the USPTO undermines both the intent and spirit of the duty of disclosure and violates those duties.”
For example, “[a]ctivities or documents associated with market testing, marketing, or commercialization by the patent applicant can also be material to patentability, and therefore, when material, should be disclosed to the USPTO.” “Similarly, each individual with a duty to disclose, or party with a duty of reasonable inquiry, should review documents it receives from other Government agencies to determine whether the information should be submitted to the USPTO.”
In the context of seeking FDA approval to market a generic drug, the Notice indicates that “to assist USPTO staff in evaluating patentability effectively and efficiently, the party receiving a paragraph IV certification should review such documents to determine whether they are material to the patentability of any pending matters before the USPTO….” The Notice cautions that “[d]eliberate schemes or established practices to prevent” disclosure of material information “is not acting in accordance with candor and good faith” before the USPTO.
According to the USPTO, “[f]or example, walling off the patent prosecution practitioners from the attorneys seeking FDA approval, as a way to prevent material information from being exchanged between the practitioners and attorneys, is inappropriate.” And, “[t]hough the FDA compiles paragraph IV certifications and publishes a list on its website, submitting this list to the USPTO does not satisfy the duty of disclosure for any material information submitted with the paragraph IV certification.” This is because “[t]hese lists do not include patent numbers, relevant claims, or an explanation of the basis for the certification. Therefore, information and documents submitted with the paragraph IV certification that are material to patentability or to issues in proceedings pending before the USPTO, including the PTAB, must be submitted directly to the USPTO….”
Details are provided in the Federal Register published on July 29, 2022, available here: https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-16299.pdf