MPEP § 2755 — MPEP § 2755
Current through: 2022-07-01

2755-Eligibility Determination 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

 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 2755 
 

 
 
 
 
 
 2755 Eligibility Determination [R-01.2024]

 
 37 CFR 1.750 Determination of eligibility for extension of patent term. 

 A determination as to whether a patent is eligible for extension may be
 made by the Director solely on the basis of the representations contained in the
 application for extension filed in compliance with § 1.740 or § 1.790 . This
 determination may be delegated to appropriate Patent and Trademark Office officials and
 may be made at any time before the certificate of extension is issued. The Director or
 other appropriate officials may require from applicant further information or make such
 independent inquiries as desired before a final determination is made on whether a
 patent is eligible for extension. In an application for extension filed in compliance
 with §
 1.740 , a notice will be mailed to applicant containing the
 determination as to the eligibility of the patent for extension and the period of time
 of the extension, if any. This notice shall constitute the final determination as to the
 eligibility and any period of extension of the patent. A single request for
 reconsideration of a final determination may be made if filed by the applicant within
 such time as may be set in the notice of final determination or, if no time is set,
 within one month from the date of the final determination. The time periods set forth
 herein are subject to the provisions of § 1.136 .
 

 

 The determination as to whether a patent is eligible for an extension may
 be made solely from the representations contained in the application for patent term
 extension. However, under 37 CFR 1.750 , further information may be required or inquiry made of
 applicant before a final determination is made on whether a patent is eligible for
 extension. In circumstances where further information is required by the Office, the
 applicant will be given a time period within which to respond. The failure to provide a
 response within the time period provided may result in a final determination adverse to the
 granting of an extension of patent term unless the response period is extended. An
 extension of time to respond may be requested under the provisions of 37 CFR 1.136 . The
 USPTO patent electronic filing system includes the document description “Response to
 request for information sent under 37 CFR 1.750” (document code TERM.INF.RES) which is to
 be used for responses to requests for information under 37 CFR 1.750 . Under appropriate
 circumstances, e.g., if time is of the essence for a particular reason, a request for
 information may contain a statement that the provisions of 37 CFR 1.136(a) are
 not available. The intentional failure to provide the information requested may result in
 an adverse final determination.
 

 A final determination may be made at any time after an application is
 filed. A single request for reconsideration of a final determination may be filed within
 one month or within such other time period set in the final determination. This period of
 time may be extended under the provisions of 37 CFR 1.136(a) . A notice will be
 mailed to applicant containing the determination as to eligibility of the patent for
 extension and the period of time of the extension of the term, if any. This notice shall
 constitute the final determination as to eligibility and any period of extension of the
 patent term. If no request for reconsideration is filed within the time period set in the
 notice of final determination, the certificate of patent term extension will be issued in
 due course. See MPEP §
 2758 .
 

 
 2755.01 Interim Extension of Patent Term During the Processing of the
 Application [R-01.2024]
 

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

 *****

 
 (e)
 
 (2) If the term of a patent for which an application has
 been submitted under subsection (d)(1) would expire before a certificate
 of extension is issued or denied under paragraph (1) respecting the
 application, the Director shall extend, until such determination is made,
 the term of the patent for periods of up to one year if he determines
 that the patent is eligible for extension.
 

 
 

 
 *****

 

 
 37 CFR 1.760 Interim extension of patent term under 35 U.S.C. 156(e)(2). 

 An applicant who has filed a formal application for extension in
 compliance with §
 1.740 may request one or more interim extensions for periods of
 up to one year each pending a final determination on the application pursuant to
 §
 1.750 . Any such request should be filed at least three months
 prior to the expiration date of the patent. The Director may issue interim
 extensions, without a request by the applicant, for periods of up to one year each
 until a final determination is made. The patent owner or agent will be notified when
 an interim extension is granted and notice of the extension will be published in the
 Official Gazette of the United States Patent and Trademark
 Office. The notice will be recorded in the official file of the patent
 and will be considered as part of the original patent. In no event will the interim
 extensions granted under this section be longer than the maximum period for extension
 to which the applicant would be eligible.
 

 

 If the original term of the patent for which extension is sought will
 expire before a final decision to issue a certificate of extension can be made, and a
 determination is made that the patent is eligible for extension, 35 U.S.C. 156 
 provides that the Director may issue an interim extension of the patent term for up to
 one year pending a final decision on the application for extension. Should additional
 time be necessary, additional interim extensions of up to one year may be granted by the
 Director. The length of any interim extension is discretionary with the Director so long
 as it is for one year or less. Its length should be set to provide time for completion
 of any outstanding requirements. See In re Reckitt & Colman Products
 Ltd., 230 USPQ 369, 372 (Comm’r Pat. & Tm. 1986). The Director may
 issue an interim extension under 35 U.S.C. 156(e)(2) with or without
 a request from the applicant. However, it is a best practice for the applicant for term
 extension to track the expiration dates of any patents for which extension has been
 sought and timely file a request for interim extension under 37 CFR 1.760 in
 order for the Office to timely grant an interim extension under 35 U.S.C.
 156(e)(2) .
 

 Where a determination is made that the patent is not eligible for
 patent term extension, an interim extension of the patent term is not warranted under
 35 U.S.C.
 156(e)(2) . See In re Alcon Laboratories Inc., 
 13 USPQ2d 1115, 1123 (Comm’r. Pat.& Tm. 1989).
 

 Where an interim extension has been granted and it is subsequently
 determined that the patent is not eligible for patent term extension, the interim
 extension may be vacated ab initio as ineligible under
 35 U.S.C.
 156(e)(2) . See In re Reckitt & Colman Products
 Ltd., 230 USPQ at 370. 
 

 While 37 CFR 1.760 provides that a request
 for an interim extension by the applicant under 35 U.S.C. 156(e)(2) “should” be
 filed three months prior to the expiration of the patent, this time frame is not
 mandatory. Any request filed within a shorter period of time will be considered, upon a
 proper showing, where it is not possible to make an earlier request. However, for an
 interim extension to be granted, the application for extension, in compliance with
 37 CFR
 1.741 , must have been filed prior to the expiration date of the
 patent. In no event will an interim extension be granted for a period of patent term
 extension longer than the period of extension to which the patent would be eligible.
 

 A notice of each interim extension granted will be issued to the
 applicant for patent term extension. The notice will be recorded in the official file of
 the patent and will be considered as part of the original patent.
 

 In circumstances where extensions of multiple patents
 have been sought based on a single regulatory review period as per 37 CFR 1.785 ,
 multiple interim extensions under 35 U.S.C. 156(e)(2) are permitted.
 This is possible because 35 U.S.C. 156(c)(4) recites the
 prohibition that, “in no event shall more than one patent be extended under
 subsection
 (e)(1) for the same regulatory review period for any product.” The
 language “under subsection (e)(1) ” refers to the certificate of extension only.
 This language was added in 1993 by section 5 of Public Law 103-179, which was the same
 time when the interim extension provisions of 35 U.S.C. 156(d)(5) were added, so
 as to distinguish a final certificate of extension from interim extensions granted under
 either 35 U.S.C.
 156(e)(2) or 35 U.S.C. 156(d)(5) .
 

 

 
 2755.02 Interim Extension of Patent Term Before Product
 Approval [R-01.2024]
 

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

 *****

 
 (d) 
 
 (5)
 
 (A) If the owner of record of the patent or its agent
 reasonably expects that the applicable regulatory review period
 described in paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii),
 (4)(B)(ii), or (5)(B)(ii) of subsection (g) that began for a
 product that is the subject of such patent may extend beyond the
 expiration of the patent term in effect, the owner or its agent may
 submit an application to the Director for an interim extension
 during the period beginning 6 months, and ending 15 days before
 such term is due to expire. The application shall contain—
 
 (i) the identity of the product subject to
 regulatory review and the Federal statute under which such
 review is occurring;
 

 (ii) the identity of the patent for which
 interim extension is being sought and the identity of each
 claim of such patent which claims the product under
 regulatory review or a method of using or manufacturing the
 product;
 

 (iii) information to enable the Director to
 determine under subsection (a)(1), (2), and (3) the
 eligibility of a patent for extension;
 

 (iv) a brief description of the activities
 undertaken by the applicant during the applicable regulatory
 review period to date with respect to the product under
 review and the significant dates applicable to such
 activities; and
 

 (v) such patent or other information as the
 Director may require.
 

 
 

 
 

 
 
 (B) If the Director determines that, except for
 permission to market or use the product commercially, the patent
 would be eligible for an extension of the patent term under this
 section, the Director shall publish in the Federal Register a
 notice of such determination, including the identity of the product
 under regulatory review, and shall issue to the applicant a
 certificate of interim extension for a period of not more than 1
 year.
 

 (C) The owner of record of a patent, or its agent, for
 which an interim extension has been granted under subparagraph (B),
 may apply for not more than 4 subsequent interim extensions under
 this paragraph, except that, in the case of a patent subject to
 subsection (g)(6)(C), the owner of record of the patent, or its
 agent, may apply for only 1 subsequent interim extension under this
 paragraph. Each such subsequent application shall be made during
 the period beginning 60 days before, and ending 30 days before, the
 expiration of the preceding interim extension.
 

 (D) Each certificate of interim extension under this
 paragraph shall be recorded in the official file of the patent and
 shall be considered part of the original patent.
 

 (E) Any interim extension granted under this paragraph
 shall terminate at the end of the 60-day period beginning on the
 date on which the product involved receives permission for
 commercial marketing or use, except that, if within that 60-day
 period, the applicant notifies the Director of such permission and
 submits any additional information under paragraph (1) of this
 subsection not previously contained in the application for interim
 extension, the patent shall be further extended, in accordance with
 the provisions of this section—
 
 (i) for not to exceed 5 years from the date of
 expiration of the original patent term; or
 

 (ii) if the patent is subject to subsection
 (g)(6)(C), from the date on which the product involved
 receives approval for commercial marketing or use.
 

 
 

 (F) The rights derived from any patent the term of
 which is extended under this paragraph shall, during the period of
 interim extension—
 
 (i) in the case of a patent which claims a
 product, be limited to any use then under regulatory
 review;
 

 (ii) in the case of a patent which claims a
 method of using a product, be limited to any use claimed by
 the patent then under regulatory review; and
 

 (iii) in the case of a patent which claims a
 method of manufacturing a product, be limited to the method
 of manufacturing as used to make the product then under
 regulatory review.
 

 
 

 
 

 
 

 
 *****

 

 
 37 CFR 1.790 Interim extension of patent term under 35 U.S.C. 156(d)(5). 

 
 (a) An owner of record of a patent or its agent who reasonably
 expects that the applicable regulatory review period described in
 35 U.S.C.
 156(g)(1)(B)(ii) , (2)(B)(ii) ,
 (3)(B)(ii) , (4)(B)(ii) , or
 (5)(B)(ii) that began for a product that is the subject
 of such patent may extend beyond the expiration of the patent term in effect
 may submit one or more applications for interim extensions for periods of up to
 one year each. In no event will the interim extensions granted under this
 section be longer than the maximum period of extension to which the applicant
 would be entitled under 35 U.S.C. 156(c) .
 

 (b) Any application for interim extension under this section must
 be filed using the USPTO patent electronic filing system in accordance with the
 USPTO patent electronic filing system requirements.
 

 (c) Complete initial applications for interim extension under this
 section must:
 
 (1) Be filed during the period beginning 6
 months and ending 15 days before the patent term is due to expire, and
 include a statement that the initial application is being submitted
 within the period and an identification of the date of the last day on
 which the initial application could be submitted;
 

 (2) Include all of the information required
 for a formal application under § 1.740 and a
 complete application under § 1.741 , except as
 follows:
 
 (i) Paragraphs (a)(1), (2), (4), and
 (6) through (15) of §§ 1.740 and
 1.741 shall be
 read in the context of a product currently undergoing regulatory
 review; and
 

 (ii) Paragraphs (a)(3) and (5) of
 § 1.740 are not
 applicable to an application for interim extension under this
 section; and
 

 
 

 (3) Include a statement that the applicable
 regulatory review period, described in 35 U.S.C.
 156(g)(1)(B)(ii) , (2)(B)(ii) , (3)(B)(ii) ,
 (4)(B)(ii) , or (5)(B)(ii) , has begun
 for the product that is the subject of the patent.
 

 
 

 (d) Each subsequent application for interim
 extension:
 
 (1) Must be filed during the period beginning
 60 days before and ending 30 days before the expiration of the preceding
 interim extension and include a statement that it is being submitted
 within the period and an identification of the date of the last day on
 which it could be submitted;
 

 (2) May be limited in content to a request
 for a subsequent interim extension along with any materials or
 information required under §§ 1.740 and
 1.741 that are not present in the preceding
 interim extension application; and
 

 (3) Must include a statement that the
 applicable regulatory review period, described in 35 U.S.C.
 156(g)(1)(B)(ii) , (2)(B)(ii) , (3)(B)(ii) ,
 (4)(B)(ii) , or (5)(B)(ii) , has not
 been completed.
 

 
 

 
 

 
 37 CFR 1.791 Termination of interim extension granted prior to regulatory approval of a
 product for commercial marketing or use. 

 Any interim extension granted under 35 U.S.C.
 156(d)(5) terminates at the end of the 60-day period beginning
 on the date on which the product involved receives permission for commercial
 marketing or use. If within that 60-day period the patent owner or its agent files an
 application for extension under §§ 1.740 and 1.741 including
 any additional information required under 35 U.S.C. 156(d)(1) not contained
 in the application for interim extension, the patent shall be further extended in
 accordance with the provisions of 35 U.S.C. 156 .
 

 

 If a patent that claims a product which is undergoing the approval
 phase of regulatory review as defined by 35 U.S.C. 156(g)(1)(B)(ii) ,
 (2)(B)(ii) , (3)(B)(ii) , (4)(B)(ii) , and
 (5)(B)(ii) is expected to expire before approval is granted,
 interim patent term extension is available under 35 U.S.C. 156(d)(5) . The application
 for patent term extension that must be submitted is generally the same as would be filed
 had the product been approved, except that the approval date is not required to be set
 forth. See 37 CFR
 1.790 for the complete requirements of an interim patent term
 extension under 35
 U.S.C. 156(d)(5) . In addition, interim extensions under
 35 U.S.C.
 156(d)(5) of multiple patents based on a single ongoing regulatory
 review period are permitted, for the same reason that multiple interim extensions under
 35 U.S.C.
 156(e)(2) are permitted, i.e., 35 U.S.C. 156(c)(4) prohibits only
 multiple certificates of extension under 35 U.S.C. 156(e)(1) , as discussed at
 MPEP §
 2755.01 .
 

 Processing of an application for interim patent term extension under
 35 U.S.C.
 156(d)(5) is performed in the Office of Patent Legal
 Administration and is similar to other applications for patent term extension, except
 that the Office is not required to seek the advice of the relevant regulatory agency.
 The relevant agency, however, is normally consulted before an interim extension is
 granted or before the application is denied. The fee for an application for patent term
 extension under 35
 U.S.C. 156(d)(5) is set forth in 37 CFR 1.20(j)(2) ,
 and the fee for a subsequent application is set forth in 37 CFR 1.20(j)(3) .
 Copies of an application for interim extension are maintained in the same manner as
 applications for patent term extension. As required by 35 U.S.C.
 156(d)(5)(B) , a determination that a patent is eligible for
 extension under 35
 U.S.C. 156 , but for regulatory approval, is published in the
 Federal Register. A sample order granting a second interim extension follows:
 

 
 UNITED STATES PATENT AND TRADEMARK OFFICE 
 In re___

 Request for Patent Term Extension ORDER GRANTING U.S. Patent No.___
 INTERIM EXTENSION
 

 On __, patent owner __, filed an application under 35 U.S.C.
 156(d)(5) for interim extension of the term of U.S. Patent No. __. The
 patent claims the active ingredient __ in the human drug product “___.” The
 application indicates that the product is currently undergoing a regulatory review
 before the Food and Drug Administration for permission to market or use the product
 commercially. The original term of the patent expired on ___. On ___, the patent was
 granted an first interim extension under 35 U.S.C.
 156(d)(5) for a period of one year.
 

 Review of the application indicates that except for receipt of
 permission to market or use the product commercially, the subject patent would be
 eligible for an extension of the patent term under 35 U.S.C.
 156 . Since it is apparent that the regulatory review period may
 extend beyond the date of expiration of the patent, as extended by the first interim
 extension, a second interim extension of the patent term under 35 U.S.C.
 156(d)(5) is appropriate.
 

 An interim extension under 35 U.S.C.
 156(d)(5) of the term of U.S. Patent No. __ is granted for a period of one
 year from the extended expiration date of the patent.
 

 

 

 As seen from the example given, a series of one-year interim
 extensions may be granted if requested in a timely manner (in the window of time between
 thirty and sixty days before the extended expiration date).
 

 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, except,
 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. 35 U.S.C. 156(d)(5)(E) . 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) .
 

 

 [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 20:50:49