Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board

Issuing agencies

Abstract

The duty of candor and good faith in dealing with the United States Patent and Trademark Office (USPTO) includes the duty to disclose to the USPTO information material to the patentability of a claimed invention. Each party submitting a paper to the USPTO has an additional duty to perform an inquiry that is reasonable under the circumstances, including reviewing documents to identify information that is material to the patentability of a claimed invention. The USPTO relies on each individual who is subject to these duties to abide by them. The duties are imposed to assist patent examiners and administrative patent judges in evaluating patentability effectively and efficiently. The duties promote robust and reliable patents, and drive competition and economic growth. In the pharmaceutical space, the duties promote robust and reliable patents that incentivize and protect innovation that brings life-saving drugs to the American people while not unnecessarily delaying more affordable generic drugs. This notice is intended to clarify the duties, including as to materials or statements material to patentability or statements made to the USPTO that are inconsistent with statements submitted to the FDA and other governmental agencies.