MPEP § 2753 — MPEP § 2753
Current through: 2022-07-01

2753-Application Contents 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Patent Laws, Regulations, Policies & Procedures 

 
 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2753 
 

 
 
 
 
 
 2753 Application Contents [R-01.2024]

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

 
 (a) An application for extension of patent term must be made in
 writing to the Director. A formal application for the extension of patent term
 must include:
 
 (1) A complete identification of the approved product as by
 appropriate chemical and generic name, physical structure or
 characteristics;
 

 (2) A complete identification of the Federal statute including
 the applicable provision of law under which the regulatory review
 occurred;
 

 (3) An identification of the date on which the product received
 permission for commercial marketing or use under the provision of law under
 which the applicable regulatory review period occurred;
 

 (4) In the case of a drug product, an identification of each
 active ingredient in the product and as to each active ingredient, a
 statement that it has not been previously approved for commercial marketing
 or use under the Federal Food, Drug, and Cosmetic Act, the Public Health
 Service Act, or the Virus-Serum-Toxin Act, or a statement of when the active
 ingredient was approved for commercial marketing or use (either alone or in
 combination with other active ingredients), the use for which it was
 approved, and the provision of law under which it was approved.
 

 (5) A statement that the application is being submitted within
 the sixty day period permitted for submission pursuant to §
 1.720(f) and an identification of the date of the last
 day on which the application could be submitted;
 

 (6) A complete identification of the patent for which an
 extension is being sought by the name of the inventor, the patent number,
 the date of issue, and the date of expiration;
 

 (7) A copy of the patent for which an extension is being
 sought, including the entire specification (including claims) and
 drawings;
 

 (8) A copy of any disclaimer, certificate of correction,
 receipt of maintenance fee payment, or reexamination certificate issued in
 the patent;
 

 (9) A statement that the patent claims the approved product, or
 a method of using or manufacturing the approved product, and a showing which
 lists each applicable patent claim and demonstrates the manner in which at
 least one such patent claim reads on:
 
 (i) The approved product, if the listed claims include
 any claim to the approved product;
 

 (ii) The method of using the approved product, if the
 listed claims include any claim to the method of using the approved
 product; and
 

 (iii) The method of manufacturing the approved product, if
 the listed claims include any claim to the method of manufacturing the
 approved product;
 

 
 

 (10) A statement beginning on a new page of the relevant dates
 and information pursuant to 35 U.S.C. 156(g) in
 order to enable the Secretary of Health and Human Services or the Secretary
 of Agriculture, as appropriate, to determine the applicable regulatory
 review period as follows:
 
 (i) For a patent claiming a human drug, antibiotic, or
 human biological product:
 
 (A) The effective date of the investigational new
 drug (IND) application and the IND number;
 

 (B) The date on which a new drug application (NDA)
 or a Product License Application (PLA) was initially submitted
 and the NDA or PLA number; and
 

 (C) The date on which the NDA was approved or the
 Product License issued;
 

 
 

 (ii) For a patent claiming a new animal drug:
 
 (A) The date a major health or environmental
 effects test on the drug was initiated, and any available
 substantiation of that date, or the date of an exemption under
 subsection (j) of Section 512 of the Federal Food, Drug, and
 Cosmetic Act became effective for such animal drug;
 

 (B) The date on which a new animal drug application
 (NADA) was initially submitted and the NADA number; and
 

 (C) The date on which the NADA was approved;

 
 

 (iii) For a patent claiming a veterinary biological
 product:
 
 (A) The date the authority to prepare an
 experimental biological product under the Virus-Serum-Toxin Act
 became effective;
 

 (B) The date an application for a license was
 submitted under the Virus-Serum-Toxin Act; and
 

 (C) The date the license issued;

 
 

 (iv) For a patent claiming a food or color additive:
 
 (A) The date a major health or environmental
 effects test on the additive was initiated and any available
 substantiation of that date;
 

 (B) The date on which a petition for product
 approval under the Federal Food, Drug and Cosmetic Act was
 initially submitted and the petition number; and
 

 (C) The date on which the FDA published a
 Federal Register notice listing the
 additive for use;
 

 
 

 (v) For a patent claiming a medical device:
 
 (A) The effective date of the investigational
 device exemption (IDE) and the IDE number, if applicable, or the
 date on which the applicant began the first clinical
 investigation involving the device, if no IDE was submitted, and
 any available substantiation of that date;
 

 (B) The date on which the application for product
 approval or notice of completion of a product development
 protocol under Section 515 of the Federal Food, Drug and
 Cosmetic Act was initially submitted and the number of the
 application; and
 

 (C) The date on which the application was approved
 or the protocol declared to be completed;
 

 
 

 
 

 (11) A brief description beginning on a new page of the
 significant 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;
 

 (12) A statement beginning on a new page that in the opinion of
 the applicant the patent is eligible for the extension and a statement as to
 the length of extension claimed, including how the length of extension was
 determined;
 

 (13) A statement that applicant acknowledges a duty to disclose
 to the Director of the United States Patent and Trademark Office and the
 Secretary of Health and Human Services or the Secretary of Agriculture any
 information which is material to the determination of entitlement to the
 extension sought ( see § 1.765 );
 

 (14) The prescribed fee for receiving and acting upon the
 application for extension (see § 1.20(j) ); and
 

 (15) The name, address, telephone number, and email address of
 the person to whom inquiries and correspondence related to the application
 for patent term extension are to be directed.
 

 
 

 (b) The application under this section, and any related submissions
 to the Office, must be submitted using the USPTO patent electronic filing system
 in accordance with the USPTO patent electronic filing system requirements.
 

 (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 .
 

 
 

 37 CFR
 1.740 sets forth the requirements for a formal application for
 extension of patent term. See MPEP § 2752 for a discussion of who may
 apply for a patent term extension. See 37 CFR 1.741 and MPEP § 2754 for a
 description of the information that must be submitted in the patent term extension
 application in order to be accorded a filing date. 
 

 37 CFR
 1.740(a)(1) requires a complete identification of the approved
 product as by appropriate chemical and generic name, physical structure or characteristics
 so as to enable the Director to make a determination of whether the patent claims the
 approved product, or a method of using or manufacturing the approved product.
 

 37 CFR
 1.740(a)(2) requires a complete identification of the federal statute
 including the applicable provision(s) of law under which the regulatory review occurred.
 When the regulatory review of the product took place under more than one federal statute,
 each appropriate statute should be listed. This could apply to a situation where a human
 biological product is tested under an investigational new drug (IND) application pursuant
 to the Federal Food, Drug, and Cosmetic Act, but is approved under the Public Health
 Service Act; or to a situation where approval is sought for use of a particular medical
 device having a specific drug component which may require review under more than a single
 provision of law. The product that forms the basis of an application for patent term
 extension must be either a medical device or a drug product. Any extension granted from the
 application will be based on the review of the product as either a medical device or a drug
 product rather than as a combination of those separate products. See the file history of
 U.S. Patent No. 4,428,744 or U.S. Patent No. 5,891,086 for examples of the application of
 this principle.
 

 The date that a product receives permission for commercial marketing or
 use (which must be identified pursuant to 37 CFR 1.740(a)(3) ) is generally the
 mailing date of the letter from the regulatory agency indicating regulatory approval. For a
 food additive, the approval date is generally the effective date stated in the regulation
 and the date the regulation is published. With respect to drug products where the Secretary
 of Health and Human Services recommends controls under the Controlled Substances Act, the
 drug product cannot legally be marketed until such time as an interim final rule is
 published by the Drug Enforcement Agency (the agency which administers the Controlled
 Substances Act) in the Federal Register scheduling the drug product. This means that the
 date of approval for a drug product, where controls under the Controlled Substances Act
 have been recommended, will be the later of :
 

 
 (1)
 
 (a) the approval date of an application submitted
 for approval of a human biological product under subsection (a) of section 351
 of the Public Health Services Act;
 

 (b) the approval date of an application submitted
 for approval of a human drug under section 505(b) of the Federal Food Drug and
 Cosmetic Act (FFDCA);
 

 (c) the approval date of an application submitted
 for approval of an animal drug under section 512(c) of the FFDCA;
 

 (d) the date of a conditional approval for an
 animal drug under section 571(b) of the FFDCA;
 

 (e) the date a request for indexing is granted
 under section 572(d) of the FFDCA; or 
 

 
 

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

 
 37 CFR
 1.740(a)(4) provides that for drug products, each active ingredient
 must be identified and there must be an indication of the use for which the product was
 approved. For each active ingredient, a statement must be made that either the active
 ingredient was not previously approved for commercial marketing or use under the Federal
 Food, Drug and Cosmetic Act, or that the active ingredient was approved for commercial
 marketing or use (either alone or in combination with other active ingredients) and the
 provision of law under which it was approved. The information is especially necessary for a
 determination of eligibility where, for example, the application is based on a second or
 subsequent approval of an active ingredient, but the first approval was for administration
 to a food-producing animal.
 

 In accordance with 37 CFR 1.740(a)(5) , the application
 must be submitted within the sixty day period permitted for submission pursuant to
 37 CFR
 1.720(f) ; see MPEP § 2754.01 . If the sixty day period
 ends on a Saturday, Sunday or federal holiday, then the last day on which the application
 could be submitted will be considered to be the next business day following the Saturday,
 Sunday or federal holiday. See 37 CFR 1.7 . The starting date of the
 sixty-day period as recited in 35 U.S.C. 156(d)(1) has been clarified
 by the America Invents Act where the Act provides that, “[f]or purposes of determining the
 date on which a product receives permission under the second sentence of this paragraph, 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 receive
 such permission on the next business day. For purposes of the preceding sentence, the term
 'business day' means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any
 legal holiday under section 6103 of title 5.” See Section 37 of the American Invents Act
 and 35 U.S.C.
 156 . 
 

 Under the November 25, 2015 amendments to 156(d)(1), the
 time period for submission for an application for patent term extension, 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, is the sixty-day period
 beginning on the “covered date,” where the “covered date” 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.
 

 
 However, applicants are cautioned to avoid filing an
 application for patent term extension on the last day for filing to avoid the application
 being denied because the filing deadline was inadvertently missed. 
 

 The expiration date of the patent for which an extension is sought as
 identified pursuant to 37
 CFR 1.740(a)(6) should be the expiration date according to the law
 ( 35 U.S.C.
 154 ) at the time of filing of the application for patent term
 extension, and should take into account any patent term adjustment under 35 U.S.C. 154(b) as
 well as any terminal disclaimer. It is recommended that the application shows how the
 expiration date was calculated. For example, 20 years from filing of the parent
 non-provisional application (filing date of August 16, 2005), plus 240 days of patent term
 adjustment yields an expiration date of April 13, 2026, in the absence of any terminal
 disclaimer which would further limit the term.
 

 Pursuant to 37 CFR 1.740(a)(9) , the application for
 patent term extension need only explain how one product claim of the patent claims the
 approved product, if there is a claim to the product. In addition, the application need
 only explain how one method of use claim of the patent claims the method of use of the
 approved product, if there is a claim to the method of use of the product. Lastly, the
 application need only explain how one claim of the patent claims the method of
 manufacturing the approved product, if there is a claim to the method of manufacturing the
 approved product. At most, a showing explaining three claims is required. However, each
 claim that claims the approved product, the method of use of the approved product, or the
 method of manufacturing the approved product must be listed. See 35 U.S.C.
 156(d)(1)(B) . 
 

 The showing should clearly demonstrate how the product, method of use
 and/or method of manufacture claim reads on the approved product, should all three patent
 claim types be present in a patent for which term extension is being sought. For example,
 where a generic chemical structure is used in the claim to define the claimed invention, a
 listing of variables and substituents which correspond to the approved product is
 appropriate. Where a claim uses the “means for” language permitted by pre-AIA 35 U.S.C. 112, paragraph
 6 , or 35 U.S.C. 112(f) for patents granted on
 AIA applications, reference to the column and line number of the patent text and any
 drawing reference numbers, as well as a description of any relevant equivalents, is also
 appropriate. Another example that may be helpful for demonstrating that a patent claims a
 medical device is to use a claim chart to describe how, using an element by element
 approach, the patent claims the approved medical device or a component of the approved
 medical device.
 

 Pursuant to 37 CFR 1.740(a)(10) , the patent term
 extension applicant must provide a statement to enable the Secretary of Health and Human
 Services or the Secretary of Agriculture, as appropriate, to determine the applicable
 regulatory period. In cases where there is no regulatory event to reflect the commencement
 of the testing or approval phase of the regulatory review period, applicants should include
 in the application the dates that they claim initiate either the approval or the testing
 phases and an explanation of their reasonable bases for why they conclude that these dates
 are the relevant dates. For instance, when the clinical trials are conducted outside of the
 United States, the testing phase for a medical device begins on the date the clinical
 investigation involving the device began. An applicant should include an explanation as to
 why the date claimed is the date on which such clinical investigations commenced. If the
 applicant has any means of substantiating that date, that information should be included in
 the application.
 

 37 CFR
 1.740(a)(11) requires a brief description of the activities of the
 marketing applicant before the regulatory agency. This description should include an
 identification of significant communications of substance with the regulatory agency and
 the dates of such communications. For example, these activities would include the dates of
 the submissions of new data to the FDA, communications between FDA and the applicant with
 respect to the appropriate protocols for testing the product, and communications between
 FDA and the applicant that are attempts to define the particular requirements for
 premarketing approval for this particular product. The applicant is not required to
 establish the existence of due diligence during the regulatory review period in order to
 have a complete application.
 

 As stated above in MPEP § 2752 , the marketing applicant must
 have been an agent of the patent owner, if not the same entity as the patent owner.
 Accordingly, the Office will not assist the patent owner in obtaining information required
 in an application for patent term extension from the marketing applicant. It is sufficient
 that the description of the activities briefly identify those significant activities
 undertaken by the marketing applicant directed toward regulatory approval, and a submission
 of insignificant details or identification of non-substantive communications is not
 required.
 

 37 CFR
 1.740(a)(12) requires that the extension applicant state the length
 of extension claimed and show how the length of extension was calculated, including whether
 the 14-year limit of 35
 U.S.C. 156(c)(3) or the five-year limit of 35 U.S.C.
 156(g)(6)(A) applies.
 

 37 CFR 1.740(a)(13) requires a
 statement by the applicant acknowledging a duty to disclose to the Director the United
 States Patent and Trademark Office and the Secretary of Health and Human Services or the
 Secretary of Agriculture any information which is material to the determination of the
 entitlement to the extension sought. See MPEP §
 2001.06(e) regarding duty of disclosure related to regulatory
 review.
 

 37 CFR 1.740(a)(14) requires payment of
 the prescribed fee ( 37
 CFR 1.20(j) ) for receiving and acting upon the application for
 extension. It is preferable that an authorization to charge a deposit account for the fee
 under 37 CFR
 1.20(j) be included in the application. Alternatively, the fee can be
 paid via the Office’s online Financial Manager system.
 

 37 CFR
 1.740(a)(15) requires the patent term extension applicant to provide
 the name, address, telephone number, and email address of the person to whom inquiries and
 correspondence related to the patent term extension application are to be directed. The
 USPTO uses the information provided under 37 CFR 1.740(a)(15) strictly for
 inquiries and correspondence regarding the patent term extension application. If a patent
 term extension applicant subsequently wishes to change the 37 CFR 1.740(a)(15) 
 correspondence address, or any of the other information provided under 37 CFR 1.740(a)(15) ,
 a document should be filed referencing 37 CFR 1.740(a)(15) and using the
 document description “Limited POA and/or Change of Address for a Patent Term Extension
 Application” (document code PTE.POA). A change of address filed using the document
 description “Limited POA and/or Change of Address for a Patent Term Extension Application”
 (document code PTE.POA) will not change the correspondence address for the underlying
 patent. Patent term extension applicants are reminded to separately file a change of
 address with any relevant regulatory agency to timely receive copies of correspondence from
 that agency.
 

 To change the address to be used only for correspondence in the patent
 file unrelated to the patent term extension application, including maintenance fee
 reminders, a change of address under 37 CFR 1.33 should be filed using, for
 example, the document description “Change of Address” (document code C.AD). In general,
 37 CFR
 1.33 requires a change of address to be signed by the patent
 applicant or a patent practitioner of record.
 

 [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 

 

 

 
 

 
 
 

 
 

 

 
 
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 Last Modified: 
 
 03/09/2026 20:50:49