The United States Patent and Trademark Office (USPTO) issued updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the Food and Drug Administration (FDA). The Notice did not constitute new rule making and instead aims to clarify the obligations of patent applicants and attorneys to disclose all relevant information to the USPTO. However, in light of the Notice, patent applicants and patent owners should expect to see an increase in the number of patent examiner requests for further documents and information, and invalidity or unenforceability challenges from third parties based on a failure to disclosure or for alleged inconsistent statements made to other governmental regulatory agencies such as the FDA.
Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability. Specifically, 37 CFR 1.56(a) and 1.555(A) state that the duty to disclose applies to '[e]ach individual associated with the filing and prosecuting of a patent application' and '[e]ach individual associated with the patent owner in a reexamination proceeding.' Fed. Reg. Vol. 87, No. 145 at 45765. Specifically, this announcement was designed to remind current or would be applicants that this duty to disclose extends to statements made to other...
