Spurred by President Biden's call for action to increase drug competition and a 2021 letter addressed to the U.S. Patent and Trademark Office (USPTO) by Senators Leahy and Tillis requesting the USPTO "to take action to require applicants to disclose relevant statements they have made to other agencies relating to inventions discussed in their patent applications or about prior art that is being applied in the patent examination process,"¹ the USPTO recently issued a Notice² that clarifies the duties of disclosure and reasonable inquiry, which can concern information submitted to the U.S. Food and Drug Administration (FDA) and other government agencies that are material to the patentability of a claimed invention.

Duty of Disclosure

The duty to disclose³ applies to matters pending before the USPTO and extends broadly to each inventor and any individual who is substantively involved with matters pending before the USPTO, including in connection with the preparation or prosecution of a patent application, a reexamination proceeding, a reissue application, or a proceeding before the Patent Trial and Appeal Board. The duty to disclose not only applies to information that establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim, but also to information that refutes or is inconsistent with a position the applicant takes involving the claimed subject matter.

Each individual with a duty to disclose should review documents it...

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