MPEP § 2762 — MPEP § 2762
Current through: 2022-07-01

2762-Duty of Disclosure in Patent Term Extension Proceedings 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2762 
 

 
 
 
 
 
 2762 Duty of Disclosure in Patent Term Extension
 Proceedings [R-01.2024]
 

 
 37 CFR 1.765 Duty of disclosure in patent term extension proceedings. 

 
 (a) A duty of candor and good faith toward the Patent and Trademark
 Office and the Secretary of Health and Human Services or the Secretary of
 Agriculture rests on the patent owner or its agent, on each attorney or agent who
 represents the patent owner and on every other individual who is substantively
 involved on behalf of the patent owner in a patent term extension proceeding. All
 such individuals who are aware, or become aware, of material information adverse
 to a determination of entitlement to the extension sought, which has not been
 previously made of record in the patent term extension proceeding must bring such
 information to the attention of the Office or the Secretary, as appropriate, in
 accordance with paragraph (b) of this section, as soon as it is practical to do so
 after the individual becomes aware of the information. Information is material
 where there is a substantial likelihood that the Office or the Secretary would
 consider it important in determinations to be made in the patent term extension
 proceeding.
 

 (b) Disclosures pursuant to this section must be accompanied by a
 copy of each written document which is being disclosed. The disclosure must be
 made to the Office or the Secretary, as appropriate, unless the disclosure is
 material to determinations to be made by both the Office and the Secretary, in
 which case duplicate copies, certified as such, must be filed in the Office and
 with the Secretary. Disclosures pursuant to this section may be made to the Office
 or the Secretary, as appropriate, through an attorney or agent having
 responsibility on behalf of the patent owner or its agent for the patent term
 extension proceeding or through a patent owner acting on his or her own behalf.
 Disclosure to such an attorney, agent or patent owner shall satisfy the duty of
 any other individual. Such an attorney, agent or patent owner has no duty to
 transmit information which is not material to the determination of entitlement to
 the extension sought.
 

 (c) No patent will be determined eligible for extension and no
 extension will be issued if it is determined that fraud on the Office or the
 Secretary was practiced or attempted or the duty of disclosure was violated
 through bad faith or gross negligence in connection with the patent term extension
 proceeding. If it is established by clear and convincing evidence that any fraud
 was practiced or attempted on the Office or the Secretary in connection with the
 patent term extension proceeding or that there was any violation of the duty of
 disclosure through bad faith or gross negligence in connection with the patent
 term extension proceeding, a final determination will be made pursuant to
 §
 1.750 that the patent is not eligible for extension.
 

 
 *****

 

 A duty of candor and good faith toward the USPTO, the Secretary of Health
 and Human Services, and the Secretary of Agriculture rests on the patent owner or its
 agent, on each attorney or agent who represents the patent owner, and on every other
 individual who is substantively involved on behalf of the patent owner in a patent term
 extension proceeding. All such individuals who are aware, or become aware, of material
 information adverse to a determination of entitlement to the extension sought, which has
 not been previously made of record in the patent term extension proceeding, must bring such
 information to the attention of the Office or the Secretary, as appropriate, as soon as it
 is practicable to do so after the individual becomes aware of the information. Information
 is “material” when there is a substantial likelihood that the Office or the Secretary would
 consider it important in determinations to be made in the patent term extension proceeding.
 Any such material information should be submitted to the Director of the United States
 Patent and Trademark Office, the Secretary of Health and Human Services, or the Secretary
 of Agriculture, as appropriate, accompanied by a copy of each written document being
 disclosed. The information may be submitted through a registered practitioner. The USPTO
 patent electronic filing system includes the document description “Disclosure Under 37 CFR
 1.765 in a Patent Term Extension Application” (document code TERM.PTE.DIS) for disclosures
 to the USPTO under 37 CFR
 1.765 .
 

 A determination of eligibility for an extension or the issuance of a
 certificate will not be made if clear and convincing evidence of fraud or attempted fraud
 on the Office or a Secretary is determined to be present, or the duty of disclosure is
 determined to have been violated through bad faith or gross negligence in connection with
 the patent term extension proceeding. Since the determination as to whether a patent is
 eligible for extension may be made solely on the basis of the representations made in the
 application for extension, a final determination to refuse a patent term extension because
 of fraud or a violation of the duty of disclosure is expected to be rare. See
 MPEP §
 2010 .
 

 
 2762.01 Duty of Disclosure When a Terminal Disclaimer is
 Filed During Patent Term Extension Proceedings [R-01.2024]
 

 It is possible that during the processing of a patent
 term extension, the patent owner becomes aware of situations where the filing of a
 terminal disclaimer might be necessary or desired. For example, if patent infringement
 litigation has commenced and the accused infringer advances that the patent is invalid
 on the basis of nonstatutory obviousness type double patenting, then the patent owner
 might choose to file a terminal disclaimer to preempt the defense if the patent that is
 the basis for the nonstatutory obviousness type double patenting has not expired.
 Boehringer Ingelheim Int’l GmbH v. Barr Laboratories Inc., 592
 F.3d 1340, 93 USPQ2d 1417, 1422-23 (Fed. Cir. 2010). When a terminal disclaimer is filed
 for a patent during the processing of an application for patent term extension, any
 required updates to information already of record should be made pursuant to
 37 CFR
 1.765 . For example, if the calculation of term changes because the
 patent’s expiration date changes, then an updated calculation of the term should be
 submitted for the application for patent term extension via the USPTO patent electronic
 filing system. Patent owners can use the USPTO terminal disclaimer forms (e.g., forms
 PTO/SB/25a or PTO/SB/26a) available at www.uspto.gov . Alternatively, patent owners can draft and file a
 self-prepared terminal disclaimer that meets the requirements of 37 CFR 1.321 .
 See MPEP §
 1490 .
 

 

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 2701-Patent Term 

 2702-2709-[Reserved] 

 2710-Term Extensions or Adjustments for Delays Within the USPTO Under 35 U.S.C. 154 

 2711-2719-[Reserved] 

 2720-Applications Filed Between June 8, 1995, and May 28, 2000 

 2721-2729-[Reserved] 

 2730-Applications Filed on or After May 29, 2000; Grounds for Adjustment 

 2731-Period of Adjustment 

 2732-Reduction of Period of Adjustment of Patent Term 

 2733-Patent Term Adjustment Determination 

 2734-Application for Patent Term Adjustment; Due Care Showing 

 2735-[Reserved] 

 2736-Third-Party Papers 

 2737-2749-[Reserved] 

 2750-Patent Term Extension for Delays at other Agencies under 35 U.S.C. 156 

 2751-Eligibility Requirements 

 2752-Patent Term Extension Applicant 

 2753-Application Contents 

 2754-Filing Date 
 2754.01-Deadline for Filing an Application Under 35 U.S.C. 156(d)(1) 

 2754.02-Filing Window for an Application Under 35 U.S.C. 156(d)(5) 

 2754.03-[Removed and Reserved] 

 
 

 2755-Eligibility Determination 
 2755.01-Interim Extension of Patent Term During the Processing of the Application 

 2755.02-Interim Extension of Patent Term Before Product Approval 

 
 

 2756-Correspondence Between the USPTO and the Regulatory Agency 

 2757-Regulatory Agency Determination of the Length of the Regulatory Review Period 
 2757.01-Due Diligence Determination 

 
 

 2758-Notice of Final Determination - Calculation of Patent Term Extension 

 2759-Certificate of Extension of Patent Term 

 2760-Trade Secret, Confidential, and Protective Order Material 

 2761-Multiple Applications for Extension of Term of the Same Patent or of Different Patents for the Same Regulatory Review Period
 for a Product 

 2762-Duty of Disclosure in Patent Term Extension Proceedings 
 2762.01-Duty of Disclosure When a Terminal Disclaimer is Filed During Patent Term Extension Proceedings 

 
 

 2763-Limitation of Third-Party Participation 

 2764-Express Withdrawal of Application for Extension of Patent Term 

 2765-Petition for Stay in Processing of Patent Term Extension Application 

 2766-Processing of Patent Term Extension Applications When Reissue Has Been Filed 

 

 

 
 

 
 
 

 
 

 

 
 
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 Last Modified: 
 
 03/09/2026 20:49:41