On July 29, 2022, the U.S. Patent and Trademark Office (PTO) published a Notice on the Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board. The notice was part of the PTO’s response to President Joe Biden’s July 2021 Executive Order on Promoting Competition in the American Economy. It also answered Congress’ call for PTO action following the Federal Circuit’s September 2021 ruling that a drug formulation patent was unenforceable based on a drug manufacturer’s inconsistent disclosures to both the PTO and the FDA. In view of the notice, companies should review the interface between their IP and regulatory functions to confirm that their interoperation (or lack thereof) does not run afoul of a patent applicant’s duties of disclosure and reasonable inquiry to the PTO.
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