MPEP § 2750 — MPEP § 2750
Current through: 2022-07-01

2750-Patent Term Extension for Delays at other Agencies under 35 U.S.C. 156 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2750 
 

 
 
 
 
 
 2750 Patent Term Extension for Delays at other Agencies under 35 U.S.C.
 156 [R-01.2024]
 

 The right to a patent term extension based upon premarket regulatory
 review is the result of the Drug Price Competition and Patent Term Restoration Act of 1984,
 Public Law 98-417, 98 Stat. 1585 (codified at 21 U.S.C. 355(b), (j), (l); 35 U.S.C. 156 ,
 271 , 282 )(Hatch-Waxman Act). The act sought to eliminate two distortions
 to the normal “patent term produced by the requirement that certain products must receive
 premarket regulatory approval.” Eli Lilly & Co. v. Medtronic Inc., 
 496 U.S. 661, 669, 15 USPQ2d 1121, 1126 (1990). The first distortion was that the patent
 owner loses patent term during the early years of the patent because the product cannot be
 commercially marketed without approval from a regulatory agency. The second distortion
 occurred after the end of the patent term because competitors could not immediately enter
 the market upon expiration of the patent because they were not allowed to begin testing and
 other activities necessary to receive FDA approval before patent expiration. This second
 distortion is embodied in 35 U.S.C. 271(e)(1) which provides a safe harbor for otherwise
 patent infringing conduct that is solely for uses reasonably related to the development and
 submission of information under a Federal law which regulates the manufacture, use, or sale
 of drugs or veterinary biological products.
 

 The part of the act codified as 35 U.S.C. 156 was designed to create
 new incentives for research and development of certain products subject to premarket
 government approval by a regulatory agency. The statute enables the owners of patents on
 certain human drugs, food or color additives, medical devices, animal drugs, and veterinary
 biological products to restore to the terms of those patents some of the time lost while
 awaiting premarket government approval from a regulatory agency. The rights derived from
 extension of the patent term under 35 U.S.C. 156(a) are defined in
 35 U.S.C.
 156(b) , but are not limited to a claim-by-claim basis. Rather,
 subsection(a) of
 156 indicates that “[t]he term of a patent which claims a product, a
 method of using a product, or a method of manufacturing a product shall be extended.” See
 Genetics Institute LLC v. Novartis Vaccines and Diagnostics Inc., 655
 F.3d 1291, 99 USPQ2d 1713 (Fed. Cir. 2011). However, pursuant to 35 U.S.C. 156(b) , if
 the patent claims other products in addition to the approved product, the exclusive patent
 rights to the additional products expire with the original expiration date of the patent.
 See Biogen Int’l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351, 2020
 USPQ2d 10385 (Fed. Cir. 2020) (holding that the scope of rights during the extended period
 only included the active ingredient of an approved product, or an ester or salt thereof,
 and not a deesterified version (metabolite) of the approved product even when the claim
 recited the deesterified version).
 

 In exchange for extension of the term of the patent, Congress
 legislatively overruled Roche Products v. Bolar Pharmaceuticals, 733
 F.2d 858, 221 USPQ 937 (Fed. Cir. 1984) as to products covered by 35 U.S.C. 271(e) and
 provided that it shall not be an act of infringement, for example, to make and test a
 patented drug solely for the purpose of developing and submitting information for an
 Abbreviated New Drug Application (ANDA). 35 U.S.C. 271(e)(1) . See Donald O.
 Beers et al., Generic and Innovator Drugs: A Guide to FDA Approval Requirements, 
 Eighth Edition, Wolters Kluwer Law & Business, 2013, 4.05 for a discussion of the
 Hatch-Waxman Act and infringement litigation. Furthermore, Congress provided that the FDA
 will grant to the marketing applicant a period of 5 years of data exclusivity for any
 active ingredient or salt or ester of the active ingredient which had not been previously
 approved under section 505(b) of the Federal Food, Drug and Cosmetic Act. 21 U.S.C.
 355(j)(4)(D)(ii). See also Lourie, Patent Term Restoration: History, Summary, and
 Appraisal, 40 Food, Drug and Cosmetic L. J. 351, 353-60 (1985). See also
 Lourie, Patent Term Restoration, 66 J. Pat. Off. Soc’y 526 (1984). 
 

 On November 16, 1988, 35 U.S.C. 156 was amended by Public Law
 100-670, essentially to add animal drugs and veterinary biologics to the list of products
 that can form the basis of patent term extension. Animal drug products which are primarily
 manufactured through biotechnology are excluded from the provisions of patent term
 extension. 
 

 On December 3, 1993, 35 U.S.C. 156 was further amended to
 provide for interim extension of a patent where a product claimed by the patent was
 expected to be approved, but not until after the original expiration date of the patent.
 Public Law 103-179, Section 5.
 

 An application for the extension of the term of a patent under
 35 U.S.C.
 156 must be submitted by the owner of record of the patent or its
 agent within the sixty-day period beginning on the date the product received permission for
 commercial marketing or use under the provision of law under which the applicable
 regulatory review period occurred for commercial marketing or use. See 35 U.S.C. 156(d)(1) 
 and MPEP §
 2754.01 . This language regarding the sixty-day period 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
 AIA and 35 U.S.C.
 156 . 
 

 On November 25, 2015, 35 U.S.C. 156(d)(1) was further
 amended by the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L.
 114-89, 129 stat 698 (2015)) to provide that 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.
 

 
 The USPTO initially determines whether the application is
 formally complete and whether the patent is eligible for extension. The statute requires
 the Director of the United States Patent and Trademark Office to notify the Secretary of
 Agriculture or the Secretary of Health and Human Services of the submission of an
 application for extension of patent term which complies with 35 U.S.C. 156 within
 sixty days and to submit to the Secretary a copy of the application. Not later than thirty
 days after receipt of the application from the Director, the Secretary will determine the
 length of the applicable regulatory review period and notify the Director of the
 determination. If the Director determines that the patent is eligible for extension, the
 Director calculates the length of extension for which the patent is eligible under the
 appropriate statutory provision and issues an appropriate Certificate of Extension.
 

 Patent term extensions provided by private relief legislation, public laws
 other than as enacted by 35 U.S.C. 156 , such as former 35 U.S.C. 155 and 155A , are not
 addressed herein.
 

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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 20:50:49