United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2022_register executive 2022-07-29 article Notices D09002ee1c7a2f7b5 D09002ee1c7a2f835 United States Department of Commerce originator org United States Government Agency or Subagency United States Patent and Trademark Office originator org United States Government Agency or Subagency 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. 87 FR 45764 https://www.govinfo.gov/app/details/FR-2022-07-29/2022-16299 2022-16299 FR29JY22-51 3510-16-P Docket No. PTO-P-2021-0058 https://www.govinfo.gov/app/details/FR-2022-07-29/2022-16299 https://www.govinfo.gov/content/pkg/FR-2022-07-29/html/2022-16299.htm https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-16299.pdf 4 p. 45764 45767 87 FR 45764 Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board; Federal Register Vol. 87, Issue NOTICE 2022-16299 DEPARTMENT OF COMMERCE Patent and Trademark Office Docket No. PTO-P-2021-0058 3510-16-P 2022-16299 Notice.

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.

Ali Salimi, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patents, at 571-272-0909. Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board, Vol. 87, no. 145 Office of the Federal Register, National Archives and Records Administration 2022-07-29 continuing daily deposited born digital 1268 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-07-29 P0b002ee1b69ec756 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR29JY22 https://www.govinfo.gov/app/details/FR-2022-07-29 https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/FR-2022-07-29.pdf https://www.govinfo.gov/content/pkg/FR-2022-07-29/xml/FR-2022-07-29.xml fdlp 45623 46881 DGPO 2022-07-29 2024-05-29 FR-2022-07-29 machine generated eng FR FR-2022-07-29 87 145