The United States Patent and Trademark Office (“USPTO”) issued a notice to clarify disclosure duties owed to it entitled Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board (“the Notice”).

Parties have a duty of candor and good faith to the USPTO. This duty broadly applies to all individuals associated with the filing and prosecution of a patent application, individuals associated with patent owners during reexamination proceedings, and parties involved in Patent Trial and Appeal Board (“PTAB”) proceedings, including inter partes review and post grant proceedings. 37 C.F.R §§ 1.56, 1.555, 42.11(a) (2022).

The “duty of disclosure” and “duty of reasonable inquiry” arise from the foregoing candor and good faith requirements.

Parties before the USPTO must perform an inquiry that is reasonable under the circumstances when presenting a paper to the USPTO to represent it is factually and legally supported. See 37 C.F.R. §§ 1.4(d)(4)(i), 11.18(b). Information material to the patentability of a claim must be disclosed to the USPTO or the PTAB. Materiality is defined at 37 C.F.R. § 1.56(b), and the Notice cautions that the practitioner should err on the side of disclosure in close cases, and correct inconsistent disclosures made among different Government agencies.

These duties have specific application to New Drug Applicants. As an example, the Notice describes reviewing documents submitted or received from the FDA as a part of a reasonable inquiry. It specifically tasks the party receiving paragraph IV certification notice letters to review the documents cited and to submit information material to patentability to the USPTO or to the PTAB in any pending proceedings to comply with 37 C.F.R. §§ 1.56, 1.555, 42.11(a) or (c), and 11.18(b)(2).

Practitioners before the USPTO should conduct reasonable inquiries with respect to their submissions moving forward. Failing to perform the requisite inquiry or violating the duty of candor can result in sanctions or actions under 37 C.F.R. § 11.18(c) or findings of inequitable conduct. Further, paragraph IV filers who face pending continuation applications should investigate whether the patentee is remaining vigilant to adhere to its USPTO responsibilities.