MPEP § 2761 — MPEP § 2761
Current through: 2022-07-01

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

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

 Skip over navigation 
 
 
 
 
 
 
 
 search for patents | search for trademarks 

 
 
 
 
 
 
 
 
 
 
 
 Search 
 
 
 

 
 

 
 
 
 
 
 PATENTS 
 
 Patent Search 

 
 Patent Process 

 
 Patent Classification 

 
 Patent Forms 

 
 Statistics 

 
 Electronic Business Center 

 
 Patent Laws, Regulations, Policies & Procedures 

 
 Resources and Guidance 

 
 Office of Data Management 

 
 Announcements 

 
 Initiatives & Events 

 
 International Protection 

 
 Employee Locator 

 
 Contact Patents 

 

 

 
 TRADEMARKS 
 
 Trademark Search 

 
 Trademarks Process 

 
 News & Notices 

 
 Manuals, Guides, Official Gazette 

 
 Laws & Regulations 

 
 Online Filing 

 
 Contact Trademarks 

 

 

 
 IP LAW & POLICY 
 
 Rulemaking 

 
 IP Policy and Enforcement 

 
 Protecting IP Overseas 

 
 Training and Education 

 
 Training Programs & Conferences 

 
 Office of Governmental Affairs 

 
 Office of Chief Economist 

 
 Boards and Counsel 

 

 

 
 PRODUCTS & SERVICES 
 
 Electronic Data Products 

 
 XML Resources 

 
 XML Resources - Retrospective 

 
 USPTO Contact Center Order Form 

 
 Services 

 
 Locate Libraries 

 
 Training/Events 

 
 Online Services Hub 

 

 

 
 INVENTORS 
 
 Patents for Inventors 

 
 Trademarks for Inventors 

 
 Inventors Assistance 

 
 Education and Information 

 
 Scam Prevention 

 
 Pro Se and Pro Bono 

 
 Current Events 

 
 State Resources 

 
 InventorsEye Newsletter 

 

 

 
 NEWS & NOTICES 
 
 Subscription Center 

 
 Press Releases 

 
 Testimony and Speeches 

 
 Director's Forum 

 
 Systems Status 

 
 Emergency Notices 

 
 USPTO Videos 

 
 Official Gazette 

 
 Federal Register Notices 

 
 Event Calendar 

 

 

 
 FAQs 
 
 Patents FAQs 

 
 Trademarks FAQs 

 
 Assignments 

 
 Security 

 
 Musicians and Artists 

 
 Browser Plugins 

 
 Other Web Resources 

 

 

 
 ABOUT US 
 
 USPTO Leadership 

 
 USPTO Organization 

 
 USPTO Offices 

 
 Careers 

 
 Budget, Performance, and Planning 

 
 Statistics 

 
 Vendor Information 

 
 Public Advisory Committees 

 
 National Medal of Technology and Innovation 

 
 IP in Motion 

 
 Contact Us 

 

 

 
 
 

 

 
 

 
 
 
 
 Home Page 

 
 Patents 

 
 Patent Laws, Regulations, Policies & Procedures 

 
 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2761 
 

 
 
 
 
 
 2761 Multiple Applications for Extension of Term of the Same Patent or
 of Different Patents for the Same Regulatory Review Period for a Product [R-01.2024]
 

 
 35 U.S.C. 156 
 Extension of patent term. 

 *****

 
 (c)(4) in no event shall more than one patent be extended under
 subsection (e)(1) for the same regulatory review period for any product.
 

 
 *****

 

 
 37 CFR 1.785 Multiple applications for extension of term of the same patent or of different
 patents for the same regulatory review period for a product. 

 
 (a) Only one patent may be extended for a regulatory review period
 for any product ( § 1.720(h) ). If more than one application for extension of
 the same patent is filed, the certificate of extension of patent term, if
 appropriate, will be issued based upon the first filed application for
 extension.
 

 (b) If more than one application for extension is filed by a single
 applicant which seeks the extension of the term of two or more patents based upon
 the same regulatory review period, and the patents are otherwise eligible for
 extension pursuant to the requirements of this subpart, in the absence of an
 election by the applicant, the certificate of extension of patent term, if
 appropriate, will be issued upon the application for extension of the patent term
 having the earliest date of issuance of those patents for which extension is
 sought.
 

 (c) If an application for extension is filed which seeks the
 extension of the term of a patent based upon the same regulatory review period as
 that relied upon in one or more applications for extension pursuant to the
 requirements of this subpart, the certificate of extension of patent term will be
 issued on the application only if the patent owner or its agent is the holder of
 the regulatory approval granted with respect to the regulatory review period.
 

 (d) An application for extension shall be considered complete and
 formal regardless of whether it contains the identification of the holder of the
 regulatory approval granted with respect to the regulatory review period. When an
 application contains such information, or is amended to contain such information,
 it will be considered in determining whether an application is eligible for an
 extension under this section. A request may be made of any applicant to supply
 such information within a non-extendable period of not less than one month
 whenever multiple applications for extension of more than one patent are received
 and rely upon the same regulatory review period. Failure to provide such
 information within the period for reply set shall be regarded as conclusively
 establishing that the applicant is not the holder of the regulatory approval.
 

 (e) Determinations made under this section shall be included in the
 notice of final determination of eligibility for extension of the patent term
 pursuant to §
 1.750 and shall be regarded as part of that
 determination.
 

 
 

 Only one patent may be extended for a single regulatory review period for
 any product. If more than one application for extension is filed for a single patent by
 different applicants, the certificate of extension of the term of the patent, if
 appropriate, would be issued to the first filed eligible application for extension of
 patent term. If a single applicant files more than one eligible application for patent term
 extension for a single patent based on the regulatory review period of different products,
 then the final determination under 37 CFR 1.750 will provide a period of
 time (usually one month) for the PTE applicant to elect the product for which extension is
 desired. An express withdrawal of the applications for extension of the nonelected products
 should accompany the election. The final determination will indicate that if the PTE
 applicant fails to elect a single product within the set time period, the Office will issue
 a certificate of extension for the patent for a specified one of the products.
 

 If more than one eligible application for extension is filed by a single
 applicant for the extension of the terms of different patents based on the same regulatory
 review period for a product, then the final determination under 37 CFR 1.750 will
 provide a period of time (usually one month) for the PTE applicant to elect the patent for
 extension. This period of time may be extended under the provisions of 37 CFR 1.136(a) . An
 express withdrawal of the application(s) for extension of the nonelected patent(s) should
 accompany the election. In the absence of a timely election, the certificate of extension
 will be issued for the application for extension of the patent having the earliest date of
 issuance.
 

 If applications for extension are filed by different applicants for the
 extension of the terms of different patents based upon the same regulatory review period of
 a product, the certificate of extension will be issued on the application of the holder of
 the regulatory approval (marketing applicant). If the marketing applicant is not an
 applicant for extension, the certificate of extension will issue to the applicant for
 extension which holds an express authorization from the marketing applicant to rely upon
 the regulatory review period as the basis for the application for extension. See also
 37 CFR
 1.785(d) .
 

 When multiple applications for term extension are filed for
 different patents based on the same regulatory review period, it is incumbent upon the
 applicant for term extension to inform the Office of the various applications for term
 extension, pursuant to 37
 CFR 1.740(a)(13) and 37 CFR 1.765 .
 

 [top] 

 

 

 
 

 
 

 

 

 

 
 
 
 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 

 

 

 
 

 
 
 

 
 

 

 
 
 Accessibility 

 Privacy Policy 

 Terms of Use 

 Security 

 Emergencies/Security Alerts 

 Information Quality Guidelines 

 
 

 
 
 Federal Activities Inventory Reform (FAIR) Act 

 Notification and Federal Employee Antidiscrimination and Retaliation (NoFEAR) Act 

 Budget & Performance 

 Freedom of Information Act (FOIA) 

 
 

 
 
 Department of Commerce NoFEAR Act Report 

 Regulations.gov 

 STOP!Fakes.gov 

 Department of Commerce 

 USA.gov 

 
 

 
 
 Strategy Targeting Organized Piracy (STOP!) 

 Careers 

 Site Index 

 Contact Us 

 Submit Feedback 

 
 

 
 This page is owned by Patents.

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