How To Effectively Use Patent Counsel To Navigate The USPTO's Duty Of Candor Guidance Regarding FDA Submissions

• Published date: 16 December 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Rothwell, Figg, Ernst & Manbeck, P.C.
• Author: Mr Aydin H. Harston and Gary Prato

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 governmental agencies, such as the FDA, in order to obtain licensing or regulatory approval. 'If 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.' Id. The USPTO particularly noted that 'when examining a claim directed to a process of manufacturing a particular drug product that was effectively filed more than one year after FDA approval of the drug product, an examiner may appropriately require an applicant to submit to the USPTO information submitted to the FDA (e.g. in a New Drug Application or Biologics License Application) on how the drug product was manufactured.' Id. at 45766.

This announcement was made in direct response to President Biden's July 2, 2021 Executive Order on Promoting Competition in the American Economy, which, among addressing other issues, expressed concern...