MPEP § 2752 — MPEP § 2752
Current through: 2022-07-01

2752-Patent Term Extension Applicant 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Patent Laws, Regulations, Policies & Procedures 

 
 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2752 
 

 
 
 
 
 
 2752 Patent Term Extension Applicant [R-01.2024]

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

 *****

 
 (d)
 
 (1) To obtain an extension of the term of a patent under this
 section, the owner of record of the patent or its agent shall submit an
 application to the Director. Except as provided in paragraph (5), such an
 application may only be submitted 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, or in the case of a drug product described in subsection
 (i), within the sixty-day period beginning on the covered date (as defined
 in subsection (i)). The application shall contain—
 
 (A) the identity of the approved product and the Federal
 statute under which regulatory review occurred;
 

 (B) the identity of the patent for which an extension is
 being sought and the identity of each claim of such patent which
 claims the approved product or a method of using or manufacturing the
 approved product;
 

 (C) information to enable the Director to determine under
 subsections (a) and (b) 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 period of the extension
 under subsection (g);
 

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

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

 
 
 

 

 For 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.
 

 

 
 *****

 

 (i)
 
 (1) For purposes of this section, if the
 Secretary of Health and Human Services provides notice to the sponsor of an
 application or request for approval, conditional approval, or indexing of a
 drug product for which the Secretary intends to recommend controls under the
 Controlled Substances Act, beginning on the covered date, the drug product
 shall be considered to— 
 
 (A) have been approved or indexed under
 the relevant provision of the Public Health Service Act or Federal
 Food, Drug, and Cosmetic Act; and
 

 (B) have permission for commercial
 marketing or use.
 

 
 

 (2) In this subsection, the term “covered date”
 means 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.
 

 
 

 
 

 
 

 

 
 37 CFR 1.730 Applicant for extension of patent term; signature requirements. 

 
 (a) Any application for extension of a patent term must be submitted
 by the owner of record of the patent or its agent and must comply with the
 requirements of § 1.740 .
 

 (b) If the application is submitted by the patent owner, the
 application must be signed either by:
 
 (1) The patent owner in compliance with §
 3.73(b) of this chapter; or
 

 (2) A registered practitioner on behalf of the patent
 owner.
 

 
 

 (c) If the application is submitted on behalf of the patent owner by
 an agent of the patent owner ( e.g., a licensee of the patent
 owner), the application must be signed by a registered practitioner on behalf of
 the agent. The Office may require proof that the agent is authorized to act on
 behalf of the patent owner.
 

 (d) If the application is signed by a registered practitioner, the
 Office may require proof that the practitioner is authorized to act on behalf of
 the patent owner or agent of the patent owner.
 

 
 

 35 U.S.C.
 156(d)(1) requires that the application for extension of the patent
 term must be submitted by the owner of record of the patent or its agent. If the
 application is filed by an assignee(s), the application papers should refer to the reel(s)
 and frame number(s) of the recorded assignment. A power of attorney from the patent owner
 to any registered practitioner submitting the patent term extension application papers
 should be filed, if the registered practitioner is not already of record in the patent (see
 37 CFR
 1.32 and 37 CFR 1.33 ). The power of attorney may
 be filed as a limited power of attorney specifying that the power is limited to prosecution
 of the application for patent term extension. The USPTO patent electronic filing system
 includes the document description “Limited POA and/or Change of Address for a Patent Term
 Extension Application” (document code PTE.POA) for limited powers of attorney that are
 filed specifically for patent term extension applications. A limited power of attorney
 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 an existing power for
 the underlying patent or establish power for the underlying patent. If an application for
 patent term extension is filed by a registered practitioner not of record, the Office will
 consider the registered practitioner to be acting in a representative capacity in
 accordance with 37 CFR
 1.34 .
 

 If the applicant for patent term extension was not the marketing applicant
 before the regulatory agency, then there must have been an agency relationship between the
 patent owner and the marketing applicant during the regulatory review
 period . To show that such an applicant is authorized to rely upon the
 activities of the marketing applicant before the Food and Drug Administration or the
 Department of Agriculture, it is advisable for the applicant for patent term extension to
 obtain a letter from the marketing applicant specifically authorizing such reliance.
 

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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