MPEP § 2754 — MPEP § 2754
Current through: 2022-07-01

2754-Filing Date 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

 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 2754 
 

 
 
 
 
 
 2754 Filing Date [R-01.2024]

 
 37 CFR 1.741 Complete application given a filing date; petition procedure. 

 
 (a) The filing date of an application for extension of a patent term
 is the date on which a complete application is received in the Office via the
 USPTO patent electronic filing system or filed pursuant to the procedure set forth
 in §
 1.8(a)(1)(i)(C) and (a)(1)(ii) . A complete
 application must include:
 
 (1) An identification of the approved product;

 (2) An identification of each Federal statute under which
 regulatory review occurred;
 

 (3) An identification of the patent for which an extension is
 being sought;
 

 (4) An identification of each claim of the patent which claims
 the approved product or a method of using or manufacturing the approved
 product;
 

 (5) Sufficient information to enable the Director to determine
 under subsections (a) and (b) of 35 U.S.C. 156 the
 eligibility of a patent for extension, and the rights that will be derived
 from the extension, and information to enable the Director and the Secretary
 of Health and Human Services or the Secretary of Agriculture to determine
 the length of the regulatory review period; and
 

 (6) A brief description of the activities undertaken by the
 marketing applicant during the applicable regulatory review period with
 respect to the approved product and the significant dates applicable to such
 activities.
 

 
 

 (b) If an application for extension of patent term is incomplete
 under this section, the Office will so notify the applicant. If applicant requests
 review of a notice that an application is incomplete, or review of the filing date
 accorded an application under this section, applicant must file a petition
 pursuant to this paragraph accompanied by the fee set forth in §
 1.17(f) within two months of the mail date of the notice
 that the application is incomplete, or the notice according the filing date
 complained of. Unless the notice indicates otherwise, this time period may be
 extended under the provisions of § 1.136 .
 

 
 
 I. FILING DATE ACCORDED An application for patent term extension under 35 U.S.C. 156 must
 be submitted using the USPTO patent electronic filing system in accordance with the
 USPTO patent electronic filing system requirements.
 

 As set forth in 37 CFR 1.741(a) , the filing date
 of an application for patent term extension is the date on which a complete application
 is received in the USPTO via the USPTO patent electronic filing system or filed pursuant
 to the certificate of transmission procedure set forth in § 1.8(a)(1)(i)(C) 
 and (a)(1)(ii) .
 

 II. COMPLETE APPLICATION The term “complete application” is defined in 37 CFR 1.741(a) 
 and is an application meeting the requirements set forth in 35 U.S.C.
 156(d)(1) . For the establishment of a filing date, the distinction
 between the requirements of 37 CFR 1.740 and the requirements of
 37 CFR
 1.741 is important. While the requirements of 37 CFR 1.740 may
 be satisfied outside the 60-day filing period, the requirements of 37 CFR 1.741 are
 mandated by 35 U.S.C.
 156 and must be satisfied within the 60-day filing period for the
 establishment of the filing date. The Office will consider each of these statutory
 requirements to be satisfied in an application which provides sufficient information,
 directed to each requirement, to act on the application, even though further information
 may be desired by the USPTO or the regulatory agency before a final determination of
 eligibility and length of patent term extension is made.
 

 III. INFORMAL APPLICATION 
 37 CFR 1.740 Formal requirements for application for extension of patent term; correction
 of informalities. 

 *****

 
 (c) If an application for extension of patent term is informal
 under this section, the Office will so notify the applicant. The applicant has
 two months from the mail date of the notice, or such time as is set in the
 notice, within which to correct the informality. Unless the notice indicates
 otherwise, this time period may be extended under the provisions of
 §
 1.136 .
 

 
 

 If the application does not meet all the formal requirements of
 37 CFR
 1.740(a) (see MPEP § 2753 ), the applicant will be
 notified of the informalities and may seek to have that holding reviewed under
 37 CFR
 1.740(c) or to correct the informality. The time periods set forth
 therein are subject to the provisions of 37 CFR 1.136 , unless otherwise
 stated in the notice.
 

 Note that if the application satisfies the requirements of 37 CFR 1.741 ,
 the application filing date will have been established even if the application is
 held to be informal under 37 CFR 1.740 .
 

 
 2754.01 Deadline for Filing an Application Under 35 U.S.C. 156(d)(1) [R-01.2024]

 An application for patent term extension under 35 U.S.C.
 156(d)(1) may only be filed within the sixty-day period beginning
 on the date the product received permission under the provision of law under which the
 applicable regulatory review period occurred for commercial marketing or use. The
 statutory time period is not extendable and cannot be waived or excused. See U.S. Patent
 No. 4,486,425 (application for patent term extension was filed after the end of the
 60-day period and was therefore denied). In a 2008 final agency action, the USPTO
 clarified its understanding that in view of the “beginning on” language of the statute,
 the first day of the sixty-day period is the day that the marketing applicant received
 approval from the regulatory agency. In other words, day one of the sixty-day period is
 the approval date, not the day after approval. In re: Pat. Term
 Extension Application for U.S. Pat. No. 5,817,338, 2008 WL 5477176, at *8 (Comm’r Pat.
 2008). This understanding is grounded in the Federal Circuit’s explanation of the
 statutory language: “ [S]ection 156(d)(1) admits of no other meaning than that the
 sixty-day period begins on the FDA approval date.” Unimed, Inc. v.
 Quigg, 888 F.2d 826, 828, 12 USPQ2d 1644, 1646 (Fed. Cir. 1989). Thus, for
 example, if a marketing applicant receives approval from the regulatory agency prior to
 4:30 P.M., Eastern Time, on the business day July 10, 2023 (day one of the count of
 sixty days), the application for patent term extension must be filed by September 7,
 2023, in order to meet the timeliness requirement of 35 U.S.C. 156(d)(1) .
 

 For purposes of determining the date the product
 received permission under the provision of law under which the applicable regulatory
 review period occurred for commercial marketing or use, if such permission is
 transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day
 that is not a business day, the product shall be deemed to have received such permission
 on the next business day. The term “business day” in this context means any Monday,
 Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under 5 U.S.C.
 6103.
 

 For drug products the approval date is the date of a
 letter by the Food and Drug Administration indicating that the application has been
 approved, even if the letter requires further action before the drug can be marketed.
 Mead Johnson Pharmaceutical Group v. Bowen, 838 F.2d 1332, 1336; 6
 USPQ2d 1565, 1568 (D.C. Cir. 1988). For food or color additives, the relevant date is
 the effective date of the regulation or order, which is set forth in the regulation or
 order, and generally is the date that the regulation or order is published, e.g., in the
 Federal Register. See 21 U.S.C. 348(e). This date will generally be later than the date
 the approval is communicated to the marketing applicant. However, in the case of drug
 products for which the Secretary of Health and Human Services intends to recommend
 controls under the Controlled Substances Act, the time period is as described below.
 

 Where the regulatory review is of a drug product for
 which the Secretary of Health and Human Services intends to recommend controls under the
 Controlled Substances Act, the sixty-day period of 35 U.S.C. 156(d)(1) begins on the
 “covered date,” where the “covered date” (defined in 35 U.S.C.
 156(i)(2) ) is the later of:
 

 
 (A) the date an application is approved—
 
 (i) under section 351(a)(2)(C) of the Public
 Health Service Act; or 
 

 (ii) under section 505(b) or 512(c) of the
 Federal Food, Drug, and Cosmetic Act;
 

 
 

 (B) the date an application is conditionally approved
 under section 571(b) of the Federal Food, Drug, and Cosmetic Act;
 

 (C) the date a request for indexing is granted under
 section 572(d) of the Federal Food, Drug, and Cosmetic Act; or
 

 (D) the date of issuance of the interim final rule
 controlling the drug under section 201(j) of the Controlled Substances Act.
 

 
 

 
 2754.02 Filing Window for an Application Under 35 U.S.C. 156(d)(5) [R-01.2024]

 A first application for interim extension under 35 U.S.C.
 156(d)(5) (to extend the patent term before product approval) must
 be filed using the USPTO patent electronic filing system (Patent Center) within the
 period beginning six months and ending fifteen days before the patent is due to expire.
 Each subsequent application for interim extension must be filed using the USPTO patent
 electronic filing system during the period beginning sixty days before and ending thirty
 days before the expiration of the preceding interim extension. 35 U.S.C.
 156(d)(5)(C) . An interim extension granted under 35 U.S.C.
 156(d)(5) terminates sixty days after permission for commercial
 marketing or use of the product is granted. However, if within the sixty-day period any
 additional information needed for an application for patent term extension under
 35 U.S.C.
 156(d)(1) is submitted, the patent may be further extended. See
 35 U.S.C.
 156(d)(5)(E) and 37 CFR 1.791 . The additional
 information required to be submitted includes the fee for an application for patent term
 extension under 35
 U.S.C. 156(d)(1) , identification of the date the product received
 permission for commercial marketing or use, a statement that the application is being
 submitted within sixty days of such date, and identification of the last date that the
 application could be submitted.
 

 When the interim extension lapses under
 35 U.S.C.
 156(d)(5) because the product has received permission for
 commercial marketing or use, an interim extension pursuant to the provisions of
 35 U.S.C.
 156(e)(2) can be granted provided that the patent owner or its
 agent promptly files an application under 35 U.S.C. 156(d)(1) with sufficient
 time to permit the Office to grant an interim extension under 35 U.S.C.
 156(e)(2) . See 37 CFR 1.740(a)(3) and (5) . However,
 if the product is not approved within the period of interim extension under
 35 U.S.C.
 156(d)(5) , a new request for interim extension under
 35 U.S.C.
 156(d)(5) must be filed and another interim extension granted to
 keep the patent in force. An applicant is generally limited to four one-year interim
 extensions.
 

 See MPEP
 § 2755.02 for additional information pertaining to the interim
 extension of patent term under 35 U.S.C. 156(d)(5) .
 

 

 
 2754.03 [Removed and Reserved] [R-]

 

 [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