The USPTO's Increasing Focus On FDA Submissions And The Duty Of Disclosure

• Published date: 19 August 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Goodwin Procter LLP
• Author: Mr Shovon Ashraf and Sabrina Poulos

The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application before the USPTO. This Duty requires that these individuals disclose to the USPTO any information known to them that is material to the prosecution of a patent application. The USPTO has recently clarified that the Duty of Disclosure includes disclosure of statements made to other governmental agencies (e.g., the FDA) that are inconsistent with disclosures made to the USPTO. Further, Congress is currently considering a bill that that will enable USPTO examiners to access relevant public and non-public information submitted to the Food and Drug Administration (FDA).

Duty of Disclosure, Candor and Good Faith

Commonly, the Duty of Disclosure is understood to apply to third party references published prior to the earliest filing date of an application ('prior art'). The Duty of Disclosure also includes a duty to disclose any known public disclosures (e.g., talks, poster presentations, offer to sell, etc.) of the claimed inventions, when such disclosures are made prior to the earliest filing date of an application.

However, the Duty of Disclosure applies more broadly. The Duty requires disclosure of information that 'establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or ' refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability.'¹

On September 9, 2021, Senators Leahy and Tillis wrote to the Director of the PTO expressing concern that applicants were not fully complying with the Duty of Disclosure.² 'Unfortunately, it has come to our attention that some patent applicants may, in certain circumstances, make significantly different statements in submissions to other federal agencies that conflict directly with those made at the U.S. Patent and Trademark Office (PTO).' Specifically, the letter was concerned that statements to the FDA in support of drug approval (e.g., asserting that a drug product is the same as a prior product already approved) can directly contradict statement made to the USPTO is support of patentability (e.g., asserting that a claimed molecule or formulation or use is innovative). Disclosure to the FDA are often made in confidential submissions...