MPEP § 2751 — MPEP § 2751
Current through: 2022-07-01

2751-Eligibility Requirements 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2751 
 

 
 
 
 
 
 2751 Eligibility Requirements [R-01.2024]

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

 
 (a) The term of a patent which claims a product, a method of using a
 product, or a method of manufacturing a product shall be extended in accordance
 with this section from the original expiration date of the patent, which shall
 include any patent term adjustment granted under section 154(b)
 if —
 
 (1) the term of the patent has not expired before an
 application is submitted under subsection (d)(1) for its extension;
 

 (2) the term of the patent has never been extended under
 subsection (e)(1) of this section;
 

 (3) an application for extension is submitted by the owner of
 record of the patent or its agent and in accordance with the requirements of
 paragraphs (1) through (4) of subsection (d);
 

 (4) the product has been subject to a regulatory review period
 before its commercial marketing or use;
 

 (5)
 
 (A) except as provided in subparagraph (B) or (C), the
 permission for the commercial marketing or use of the product after
 such regulatory review period is the first permitted commercial
 marketing or use of the product under the provision of law under which
 such regulatory review period occurred;
 

 (B) in the case of a patent which claims a method of
 manufacturing the product which primarily uses recombinant DNA
 technology in the manufacture of the product, the permission for the
 commercial marketing or use of the product after such regulatory
 period is the first permitted commercial marketing or use of a product
 manufactured under the process claimed in the patent; or
 

 (C) for purposes of subparagraph (A), in the case of a
 patent which —
 
 (i) claims a new animal drug or a veterinary
 biological product which (I) is not covered by the claims in any
 other patent which has been extended, and (II) has received
 permission for the commercial marketing or use in
 non-food-producing animals and in food-producing animals,
 and
 

 (ii) was not extended on the basis of the regulatory
 review period for use in non-food-producing animals,
 

 
 

 the permission for the commercial
 marketing or use of the drug or product after the regulatory review
 period for use in food-producing animals is the first permitted
 commercial marketing or use of the drug or product for administration
 to a food-producing animal.
 

 
 

 
 
 

 

 The product referred to in paragraphs (4) and (5) is hereinafter
 in this section referred to as the “approved product.”
 

 

 
 *****

 
 (f) For purposes of this section:
 
 (1) The term “product” means:
 
 (A) A drug product.

 (B) Any medical device, food additive, or color additive
 subject to regulation under the Federal Food, Drug, and Cosmetic
 Act.
 

 
 

 (2) The term “drug product” means the active ingredient of—
 
 (A) a new drug, antibiotic drug, or human biological
 product (as those terms are used in the Federal Food, Drug, and
 Cosmetic Act and the Public Health Service Act) or
 

 (B) a new animal drug or veterinary biological product
 (as those terms are used in the Federal Food, Drug, and Cosmetic Act
 and the Virus-Serum-Toxin Act) which is not primarily manufactured
 using recombinant DNA, recombinant RNA, hybridoma technology, or other
 processes involving site specific genetic manipulation techniques,
 including any salt or ester of the active ingredient, as a single
 entity or in combination with another active ingredient.
 

 
 

 (3) The term “major health or environmental effects test” means
 a test which is reasonably related to the evaluation of the health or
 environmental effects of a product, which requires at least six months to
 conduct, and the data from which is submitted to receive permission for
 commercial marketing or use. Periods of analysis or evaluation of test
 results are not to be included in determining if the conduct of a test
 required at least six months.
 

 (4)
 
 (A) Any reference to section 351 is a reference to
 section 351 of the Public Health Service Act.
 

 (B) Any reference to section 503, 505, 512, or 515 is a
 reference to section 503, 505, 512, or 515 of the Federal Food, Drug
 and Cosmetic Act.
 

 (C) Any reference to the Virus-Serum-Toxin Act is a
 reference to the Act of March 4, 1913 (21 U.S.C. 151 - 158).
 

 
 

 (5) The term “informal hearing” has the meaning prescribed for
 such term by section 201(y) of the Federal Food, Drug and Cosmetic Act.
 

 (6) The term “patent” means a patent issued by the United
 States Patent and Trademark Office.
 

 (7) The term “date of enactment” as used in this section means
 September 24, 1984, for human drug product, a medical device, food additive,
 or color additive.
 

 (8) The term “date of enactment” as used in this section means
 the date of enactment of the Generic Animal Drug and Patent Term Restoration
 Act for an animal drug or a veterinary biological product.
 

 
 

 
 *****

 

 
 37 CFR 1.710 Patents subject to extension of the patent term. 

 
 (a) A patent is eligible for extension of the patent term if the
 patent claims a product as defined in paragraph (b) of this section, either alone
 or in combination with other ingredients that read on a composition that received
 permission for commercial marketing or use, or a method of using such a product,
 or a method of manufacturing such a product, and meets all other conditions and
 requirements of this subpart.
 

 (b) The term product referred to in paragraph (a)
 of this section means —  
 
 (1) The active ingredient of a new human drug, antibiotic drug,
 or human biological product (as those terms are used in the Federal Food,
 Drug, and Cosmetic Act and the Public Health Service Act) including any salt
 or ester of the active ingredient, as a single entity or in combination with
 another active ingredient; or
 

 (2) The active ingredient of a new animal drug or veterinary
 biological product (as those terms are used in the Federal Food, Drug, and
 Cosmetic Act and the Virus-Serum-Toxin Act) that is not primarily
 manufactured using recombinant DNA, recombinant RNA, hybridoma technology,
 or other processes including site specific genetic manipulation techniques,
 including any salt or ester of the active ingredient, as a single entity or
 in combination with another active ingredient; or
 

 (3) Any medical device, food additive, or color additive
 subject to regulation under the Federal Food, Drug, and Cosmetic Act.
 

 
 

 
 

 
 37 CFR 1.720 Conditions for extension of patent term. 

 The term of a patent may be extended if:

 
 (a) The patent claims a product or a method of using or manufacturing
 a product as defined in § 1.710 ;
 

 (b) The term of the patent has never been previously extended, except
 for extensions issued pursuant to §§ 1.701 , 1.760 , or
 §
 1.790 ; 
 

 (c) An application for extension is submitted in compliance with
 §
 1.740 ;
 

 (d) The product has been subject to a regulatory review period as
 defined in 35
 U.S.C. 156(g) before its commercial marketing or use;
 

 (e) The product has received permission for commercial marketing or
 use and —
 
 (1) The permission for the commercial marketing or use of the
 product is the first received permission for commercial marketing or use
 under the provision of law under which the applicable regulatory review
 occurred, or
 

 (2) In the case of a patent other than one directed to subject
 matter within § 1.710(b)(2) claiming a
 method of manufacturing the product that primarily uses recombinant DNA
 technology in the manufacture of the product, the permission for the
 commercial marketing or use is the first received permission for the
 commercial marketing or use of a product manufactured under the process
 claimed in the patent, or
 

 (3) In the case of a patent claiming a new animal drug or a
 veterinary biological product that is not covered by the claims in any other
 patent that has been extended, and has received permission for the
 commercial marketing or use in non-food-producing animals and in
 food-producing animals, and was not extended on the basis of the regulatory
 review period for use in non-food-producing animals, the permission for the
 commercial marketing or use of the drug or product after the regulatory
 review period for use in food-producing animals is the first permitted
 commercial marketing or use of the drug or product for administration to a
 food-producing animal.
 

 
 

 (f) The application is submitted within the sixty-day period
 beginning on the date the product first received permission for commercial
 marketing or use under the provisions of law under which the applicable regulatory
 review period occurred; or in the case of a patent claiming a method of
 manufacturing the product which primarily uses recombinant DNA technology in the
 manufacture of the product, the application for extension is submitted within the
 sixty-day period beginning on the date of the first permitted commercial marketing
 or use of a product manufactured under the process claimed in the patent; or in
 the case of a patent that claims a new animal drug or a veterinary biological
 product that is not covered by the claims in any other patent that has been
 extended, and said drug or product has received permission for the commercial
 marketing or use in non-food-producing animals, the application for extension is
 submitted within the sixty-day period beginning on the date of the first permitted
 commercial marketing or use of the drug or product for administration to a
 food-producing animal;
 

 (g) The term of the patent, including any interim extension issued
 pursuant to §
 1.790 , has not expired before the submission of an
 application in compliance with § 1.741 ; and
 

 (h) No other patent term has been extended for the same regulatory
 review period for the product.
 

 
 

 35 U.S.C.
 156(a) sets forth what patents can be extended and the conditions
 under which they may be extended. 37 CFR 1.710 also addresses the patents
 that may be extended, and 37 CFR 1.720 describes the conditions under which a patent may be
 extended. As set forth in 35 U.S.C. 156 and 37 CFR 1.710 , a patent which claims a
 human drug product, medical device, food or color additive first approved for marketing or
 use after September 24, 1984, or an animal drug or veterinary biological product (which was
 not primarily manufactured through biotechnology) first approved for marketing or use after
 November 16, 1988, may qualify for patent term extension. Furthermore, 35 U.S.C.
 156(a)(1)-(5) require that the applicant establish that:
 

 
 
 
 (1) the patent has not expired before an application under
 35 U.S.C.
 156(d) was filed (this may be an application for patent
 term extension under subsection (d)(1) or an application for interim extension
 under subsection (d)(5));
 

 
 

 
 
 (2) the patent has never been extended under 35 U.S.C.
 156(e)(1) ; 
 

 
 

 
 
 (3) the application for extension is submitted by the owner of
 record of the patent or its agent to the Office within 60 days of regulatory
 agency approval of the commercial marketing application and the application
 includes details relating to the patent, the approved product, and the
 regulatory review time spent in securing regulatory agency approval;
 

 
 

 
 
 (4) the product has been subject to a regulatory review period
 within the meaning of 35 U.S.C. 156(g) before its
 commercial marketing or use;
 

 
 

 
 
 (5) the approval is the first permitted commercial marketing or
 use of the product ( 35 U.S.C. 156(a)(5)(A) ),
 except in the case of human drug products manufactured using recombinant DNA
 technology where the provisions of 35 U.S.C. 156(a)(5)(B) 
 apply, or in the case of a new animal drug or a veterinary biological product
 where the provisions of 35 U.S.C. 156(a)(5)(C) 
 apply.
 

 
 

 
 35 U.S.C.
 156(c)(4) also requires that no other patent term has been extended
 for the same regulatory review period for the product. See MPEP § 2761 . 
 

 I. TERMINALLY DISCLAIMED PATENTS ARE ELIGIBLE A patent may be extended under 35 U.S.C. 156 , even though it has
 been terminally disclaimed. A patent term extension under 35 U.S.C. 156 is a
 limited extension of the patent rights associated with the approved product that is
 attached onto the original term of the patent. See 35 U.S.C. 156(b) . Only one patent
 may be extended for a regulatory review period for any product, and 35 U.S.C. 156 sets
 the expiration date of a patent term extension. Although 35 U.S.C.
 154(b)(2) (June 8, 1995) precludes a patent from being extended
 under 35 U.S.C.
 154(b) if the patent has been terminally disclaimed due to an
 obviousness-type double patenting rejection (see MPEP § 2720 ), there is no such
 exclusion in 35 U.S.C.
 156 . Additionally, 35 U.S.C. 154(b)(2)(B) ) (May 29,
 2000) provides that a patent cannot be adjusted beyond the date set by the disclaimer
 (see MPEP §
 2730 ), but there is no similar provision in 35 U.S.C. 156 .
 Thus, patents may receive a patent term extension under 35 U.S.C. 156 
 beyond an expiration date set by a terminal disclaimer. See Merck & Co.,
 Inc. v. Hi-Tech Pharmacal, Co., Inc., 482 F.3d 1317, 82 USPQ2d 1203 (Fed.
 Cir. 2007). For the impact of PTE on double patenting, see MPEP § 804.05.
 

 A patent term extension under 35 U.S.C. 156 “is
 valid so long as the extended patent is otherwise valid without the extension.”
 Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 1375, 128 USPQ2d
 1752 (Fed. Cir. 2018). Therefore, obviousness-type double patenting cannot be used to
 negate patent term extension under 35 U.S.C. 156 when the potential
 reference patent could not have been used to challenge the unextended term of the patent
 that received the extension.
 

 II. MEANING OF “PRODUCT” AS DEFINED IN 35 U.S.C. 156(f) As required by 35 U.S.C. 156(a) , patents eligible
 for extension of patent term are those which: 
 

 
 (A) claim a “product” as defined in 35 U.S.C.
 156(f)(1) , or a method of using such a product, or a method
 of manufacturing such a product, and 
 

 (B) meet all other conditions and requirements of the statute. 

 
 The term “claims a product” is not synonymous with “infringed by a
 product.” A patent which claims a metabolite of an approved drug does not claim the
 approved drug. Hoechst-Roussel Pharmaceuticals Inc. v. Lehman, 109
 F.3d 756, 759, 42 USPQ2d 1220, 1223 (Fed. Cir. 1997). Where extension of a patent is
 sought based upon regulatory review under section 515 of the Federal Food Drug and
 Cosmetic Act of a medical device, the patent claims must include some physical structure
 of a device in order for the patent to be said to claim the product (or a method of
 using the product) thereby rendering the patent eligible for extension.
 Angiotech Pharms. Inc. v. Lee, 191 F. Supp. 3d 509 (E.D. Va.
 2016).
 

 The term “product” means:

 
 (A) The active ingredient of a new human drug, antibiotic drug, or
 human biological product (as those terms are used in the Federal Food, Drug, and
 Cosmetic Act and the Public Health Service Act) including any salt or ester of the
 active ingredient, as a single entity or in combination with another active
 ingredient; or
 

 (B) The active ingredient of a new animal drug or veterinary
 biological product (as those terms are used in the Federal Food, Drug, and
 Cosmetic Act and the Virus-Serum-Toxin Act) that is not primarily manufactured
 using recombinant DNA, recombinant RNA, hybridoma technology, or other processes
 including site specific genetic manipulation techniques, including any salt or
 ester of the active ingredient, as a single entity or in combination with another
 active ingredient; or
 

 (C) Any medical device, food additive, or color additive subject to
 regulation under the Federal Food, Drug, and Cosmetic Act. 
 

 
 See 21 CFR 60.3(b) for definitions of terms such as active ingredient,
 color additive, food additive, human drug product, and medical device.
 

 Essentially, a “product” is a “drug product,” medical device, food
 additive, or color additive requiring Food and Drug Administration or Department of
 Agriculture (Animal and Plant Health Inspection Service) approval of an order or
 regulation prior to commercial marketing or use. “Drug product” is further defined as
 the active ingredient of a human drug, animal drug (excluding those primarily
 manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other
 processes including site specific genetic manipulation techniques), or biological
 product (as defined by the Federal Food, Drug and Cosmetics Act and the Public Health
 Service Act) including any salt or ester of the active ingredient, as a single entity or
 in combination with another active ingredient. “The active ingredient of a given drug
 product is defined by what is approved and is specified on the drug's label.”
 Biogen Int’l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351, 1356,
 2020 USPQ2d 10385 (Fed. Cir. 2020) (citing 21 U.S.C. 352(e)(1)(A)(ii) and 21 CFR
 201.100(b)(4)).
 

 A “drug product” means the active ingredient found in the final dosage
 form prior to administration of the product to the patient, not the resultant form the
 drug may take after administration. See Hoechst-Roussel, 109 F.3d at
 759 n.3 (“For purposes of patent term extension, this active ingredient must be present
 in the drug product when administered.”). In addition, a patent to a drug product having
 one form of an active ingredient may qualify for an extension even though another form
 of the underlying chemical moiety was previously approved and commercially marketed or
 used. For example, a drug product having the ester form of a particular chemical moiety
 is a different drug product from the same chemical moiety in a salt form, even though
 both the salt and the ester are used to treat the same disease condition by the same
 mechanism. See PhotoCure v. Kappos, 603 F.3d 1372, 95 USPQ2d 1250
 (Fed. Cir. 2010); see also Glaxo Operations UK Ltd. v. Quigg, 894
 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990) (holding that a patent which claimed an ester
 of the acid cefuroxime was eligible for extension regardless of previous approvals of
 two salts of cefuroxime). Similarly, a deesterified version of an approved drug product
 having the same active moiety is not the same drug product under 35 U.S.C. 156(f) .
 Biogen Int’l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351, 2020
 USPQ2d 10385 (Fed. Cir. 2020). Thus, eligibility for patent term extension for a patent
 which claims a product subject to regulatory review as set forth in 35 U.S.C. 156(g) 
 turns on the question of whether the product, i.e., the active ingredient of the drug
 product, present in the final dosage form was previously approved by FDA, as required by
 35 U.S.C.
 156(a)(5)(A) . If neither the active ingredient of the drug
 product, nor any salt or ester of that active ingredient has been previously approved by
 FDA, then the approval of the product complies with 35 U.S.C. 156(a)(5)(A) and a patent
 claiming such a product, a method of using such a product or a method of manufacturing
 such a product should be eligible for patent term extension.
 

 Furthermore, a “drug product” is the active ingredient of a particular
 new drug, rather than the entire composition of the drug product approved by the Food
 and Drug Administration. See Fisons plc v. Quigg, 1988 U.S. Dist.
 LEXIS 10935; 8 USPQ2d 1491, 1495 (D.D.C. 1988); aff’d., 876 F.2d 99,
 110; 10 USPQ2d 1869, 1870 (Fed. Cir. 1989). 
 

 A patent is considered to claim the product at least in those
 situations where the patent claims the active ingredient per se, 
 generically or specifically, or claims a composition or formulation which contains the
 active ingredient(s) and reads on the composition or formulation approved for commercial
 marketing or use.
 

 III. NO PREVIOUS EXTENSIONS (WITH LIMITED EXCEPTIONS) 37 CFR
 1.720(b) explains that patent term extension pursuant to
 35 U.S.C.
 156 is available only if the term of the patent has never been
 previously extended, except for extensions issued pursuant to 37 CFR 1.701 ,
 1.760 , or 1.790 . An extension issued pursuant
 to 37 CFR
 1.701 is an extension of the patent due to administrative delay
 within the Office. Note that the term of a patent is “adjusted,” not extended, pursuant
 to 37 CFR
 1.702 - 1.705 . An extension issued pursuant
 to 37 CFR
 1.760 is an interim extension under 35 U.S.C.
 156(e)(2) . An extension issued pursuant to 37 CFR 1.790 is an
 interim extension under 35 U.S.C. 156(d)(5) .
 

 IV. REGULATORY REVIEW PERIOD 37 CFR
 1.720(d) restates the statutory requirement set forth in
 35 U.S.C.
 156(a)(4) . The regulatory review period must have been a
 regulatory review period defined by the statute. A regulatory review period under
 section 510(k) of the Federal Food, Drug and Cosmetic Act is not a regulatory review
 period which gives rise to eligibility for patent term extension under 35 U.S.C. 156 .
 In re Nitinol Medical Technologies Inc., 17 USPQ2d 1492, 1492-1493
 (Comm’r Pat. & Tm. 1990). See also Baxter Diagnostics v. AVL Scientific
 Corp., 798 F. Supp. 612, 619-620; 25 USPQ2d 1428, 1434 (C.D. Cal.
 1992)(Congress intended only Class III medical devices to be eligible for patent term
 extension).
 

 If the product is alleged to be a medical device, then regulatory
 review must have occurred under section 515, and not section 505, of the Federal Food,
 Drug and Cosmetic Act. Devices reviewed under the Humanitarian Device Exemption are
 considered to be reviewed under section 515. Drug products are not reviewed under
 section 515.
 

 If more than one application for patent term extension is filed based
 upon a single regulatory review period, election will be required of a single patent.
 See MPEP §
 2761 . 
 

 V. FIRST PERMITTED MARKETING OR USE 37 CFR
 1.720(e) follows 35 U.S.C. 156(a)(5) , and sets forth
 that the approval under the relevant provision of law must have been the first permitted
 marketing or use of the product under the provision of law, unless the product is for
 use in food producing animals as explained below. See In re Patent Term
 Extension Application, U.S. Patent No. 3,849,549, 226 USPQ 283, 284 (Pat.
 & Tm. Office 1985). If the product is a human drug product, then the approval of the
 active ingredient must be the first permitted commercial marketing or use of the active
 ingredient as a single entity or in combination with another active ingredient under the
 provision of law under which regulatory review occurred.
 

 Where a product contains multiple active ingredients, if any one active
 ingredient has not been previously approved, it can form the basis of an extension of
 patent term provided the patent claims that ingredient. See In re Alcon
 Laboratories Inc., 13 USPQ2d 1115, 1121 (Comm’r Pat. & Tm. 1989) for
 examples of products having different combinations of active ingredients. A different
 ratio of hormones is not a different active ingredient for purposes of 35 U.S.C. 156 .
 Furthermore, an approved product having two active ingredients will not be considered to
 have a single active ingredient made of the two active ingredients. See Arnold
 Partnership v. Dudas, 362 F.3d 1338, 70 USPQ2d 1311 (Fed. Cir. 2004). A
 combination of two previously approved active ingredients does not comply with the first
 permitted commercial marketing or use requirement of 35 U.S.C. 156(a)(5) where the
 combination is alleged to be a single active ingredient because the two active
 ingredients display a pharmacological interaction. See Avanir Pharm. v.
 Kappos, No. 1:12cv69 (E.D. Va. March 21, 2012), transcript from Motions
 Hearing in U.S. Patent No. 5,206,248 (dated March 21, 2012). In considering whether a
 patent claiming an enantiomer, where the enantiomer was subject to pre-market regulatory
 review, is barred from receiving patent term extension in light of the previous approval
 of the racemate of the drug product, the court indicated that an enantiomer was a
 separate drug product from the racemate and each approved product could be the basis for
 extension of a patent that claims the product. See Ortho-McNeil Pharmaceutical
 Inc. v. Lupin Pharmaceuticals Inc., 603 F.3d 1377, 95 USPQ2d 1246 (Fed.
 Cir. 2010). 
 

 As to 35 U.S.C. 156(a)(5)(C) , which is addressed in 37 CFR
 1.720(e)(3) , the term of a patent directed to a new animal drug or
 veterinary biological product may be extended based on a second or subsequent approval
 of the active ingredient provided all the following conditions exist:
 

 
 (A) the patent claims the drug or product;

 (B) the drug or product is not covered by the claims in any other
 patent that has been extended;
 

 (C) the patent term was not extended on the basis of the regulatory
 review period for use in non-food producing animals; and
 

 (D) the second or subsequent approval was the first permitted
 commercial marketing or use of the drug or product for administration to a
 food-producing animal. In this case, the application must be filed within sixty
 days of the first approval for administration to a food-producing animal.
 

 
 For animal drugs or products, prior approval for use in a non-food
 producing animal will not make a patent ineligible for patent term extension based upon
 a later approval of the drug or product for use in food producing animals, if the later
 approval is the first approval of the drug or product for use in food producing animals.
 
 

 [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 20:49:41