MPEP § 2758 — MPEP § 2758
Current through: 2022-07-01

2758-Notice of Final Determination - Calculation of Patent Term Extension 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2758 
 

 
 
 
 
 
 2758 Notice of Final Determination - Calculation of Patent Term
 Extension [R-01.2024]
 

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

 *****

 
 (c) The term of a patent eligible for extension under subsection (a)
 shall be extended by the time equal to the regulatory review period for the
 approved product which period occurs after the date the patent is issued, except
 that—
 
 (1) each period of the regulatory review period shall be
 reduced by any period determined under subsection (d)(2)(B) during which the
 applicant for the patent extension did not act with due diligence during
 such period of the regulatory review period;
 

 (2) after any reduction required by paragraph (1), the period
 of extension shall include only one-half of the time remaining in the
 periods described in paragraphs (1)(B)(i), (2)(B)(i), (3)(B)(i), (4)(B)(i),
 and (5)(B)(i) of subsection (g);
 

 (3) if the period remaining in the term of a patent after the
 date of the approval of the approved product under the provision of law
 under which such regulatory review occurred when added to the regulatory
 review period as revised under paragraphs (1) and (2) exceeds fourteen
 years, the period of extension shall be reduced so that the total of both
 such periods does not exceed fourteen years, and
 

 (4) in no event shall more than one patent be extended under
 subsection (e)(1) for the same regulatory review period for any product.
 

 
 

 *****

 (g) For purposes of this section, the term “regulatory
 review period” has the following meanings:
 
 *****

 (6) A period determined under any of the preceding paragraphs
 is subject to the following limitations:
 
 (A) If the patent involved was issued after the date of
 the enactment of this section, the period of extension determined on
 the basis of the regulatory review period determined under any such
 paragraph may not exceed five years.
 

 (B) If the patent involved was issued before the date of
 the enactment of this section and —
 
 (i) no request for an exemption described in
 paragraph (1)(B) or (4)(B) was submitted and no request for the
 authority described in paragraph (5)(B) was submitted,
 

 (ii) no major health or environmental effects test
 described in paragraph (2)(B) or (4)(B) was initiated and no
 petition for a regulation or application for registration
 described in such paragraph was submitted, or
 

 (iii) no clinical investigation described in
 paragraph (3) was begun or product development protocol
 described in such paragraph was submitted, 
 

 
 
 

 

 before such date for the approved
 product the period of extension determined on the basis of the
 regulatory review period determined under any such paragraph may not
 exceed five years.
 

 

 (C) If the patent involved was issued before the date of
 the enactment of this section and if an action described in
 subparagraph (B) was taken before the date of the enactment of this
 section with respect to the approved product and the commercial
 marketing or use of the product has not been approved before such
 date, the period of extension determined on the basis of the
 regulatory review period determined under such paragraph may not
 exceed two years or in the case of an approved product which is a new
 animal drug or veterinary biological product (as those terms are used
 in the Federal Food, Drug, and Cosmetic Act or the Virus-Serum-Toxin
 Act), three years.
 

 
 

 
 

 
 *****

 

 After reviewing the information provided by the regulatory agency, if the
 Office determines the patent to be eligible for extension, the Office then calculates the
 length of extension for which the patent is eligible under the appropriate statutory
 provisions ( 35 U.S.C.
 156(c) ; 37 CFR 1.750 ). The length of extension
 is subject to the limitations of 35 U.S.C. 156(c)(3) and
 35 U.S.C.
 156(g)(6) . A Notice of Final Determination is mailed to applicant
 which states the length of extension for which the application has been determined to be
 eligible and the calculations used to determine the length of extension. The notice
 provides a period, usually one month, in which the applicant can request reconsideration of
 any aspect of the Office determination as to eligibility or the length of extension for
 which the application has been found eligible.
 

 If the application has been determined to be ineligible for patent term
 extension, an appropriate Determination of Ineligibility is mailed to applicant which
 dismisses the application and sets forth the basis for the dismissal. The applicant is
 given a period, usually one month, in which to seek reconsideration of the determination.
 If a final determination of ineligibility denies the application for patent term extension,
 the only remaining remedy is to pursue court action under 5 U.S.C. 704 for patent term
 extension. 
 

 If the patent is found to be eligible for extension, the Notice of Final
 Determination may include text similar to the following:
 

 
 
 A determination has been made that U.S. Patent No. ___, which claims
 the human drug ___, is eligible for patent term extension under 35 U.S.C. 156 . The
 period of extension has been determined to be ___.
 

 A single request for reconsideration of this final determination as to
 the length of extension of the term of the patent may be made if filed within
 one month of the date of this notice. Extensions of time under
 37 CFR
 1.136(a) are not applicable to this time period. In the absence of
 such request for reconsideration, the Director will issue a certificate of extension,
 under seal, for a period of ___ days.
 

 The period of extension has been calculated using the FDA
 determination of the length of the regulatory review period published in the Federal
 Register of ___. Under 35 U.S.C. 156(c) 

 Period of Extension = RRP - PGRRP - DD - ½ (TP -
 PGTP) 1 

 1 Consistent with 35 U.S.C. 156(c) , “RRP” is the total
 number of days in the regulatory review period, “PGRRP” is the number of days of the RRP
 which were on and before the date on which the patent issued, “DD” is the number of days
 of the RRP that the applicant did not act with due diligence, “TP” is the testing phase
 period described in paragraphs (1)(B)(i), (2)(B)(i), (3)(B)(i), (4)(B)(i), and (5)(B)(i)
 of subsection (g) of 35 U.S.C. 156 , and “PGTP” is the number of days of the TP which
 were on and before the date on which the patent issued, wherein half days are ignored
 for purposes of the subtraction of ½ (TP - PGTP).
 

 Since the regulatory review period began __, before the patent issued
 ___, only that portion of the regulatory review period occurring after the date the
 patent issued has been considered in the above determination of the length of the
 extension period 35 U.S.C. 156(c) . (From __ to ___ is___ days; this period is
 subtracted for the number of days occurring in the testing phase according to the FDA
 determination of the length of the regulatory review period.) No determination of a lack
 of due diligence under 35 U.S.C. 156(c)(1 ) was made.
 

 The 14 year exception of 35 U.S.C. 156(c)(3) operates to
 limit the term of the extension in the present situation because it provides that the
 period remaining in the term of the patent measured from the date of approval of the
 approved product (___) when added to the period of extension calculated above (___ days)
 cannot exceed fourteen years. The period of extension is thus limited to ___, by
 operation of 35 U.S.C.
 156(c)(3) . Since the patent term ( 35 U.S.C. 154 )
 would expire on ___, the period of extension is the number of days to extend the term of
 the patent from its expiration date to and including ___, or ___ days.
 

 The limitations of 35 U.S.C. 156(g)(6) do not operate
 to further reduce the period of extension determined above.
 

 

 

 See MPEP §
 2759 for further information pertaining to the issuance of a
 certificate of extension. 
 

 A patent term extension generally extends the patent from its “original
 expiration date,” as defined by 35 U.S.C. 154 to include extension
 under former 35 U.S.C. 154(b) (for applications filed between June 8, 1995 and May 28,
 2000) and patent term adjustment under 35 U.S.C. 154(b) (for applications
 filed on or after May 29, 2000), and in view of any applicable terminal disclaimer.
 

 No certificate or extension will be issued if the term of a patent cannot
 be extended, even though the patent is otherwise determined to be eligible for extension.
 In such situations the notice of final determination would issue indicating that no
 certificate will issue.
 

 I. CALCULATION OF PATENT TERM EXTENSION The procedure for calculating the length of the patent term extension
 is set forth for human drugs, antibiotic drugs, and human biological products in
 37 CFR
 1.775 ; for food or color additives in 37 CFR 1.776 ; for
 medical devices in 37
 CFR 1.777 ; for animal drug products in 37 CFR 1.778 ; and
 for veterinary biological products in 37 CFR 1.779 . The length of patent
 term extension is the length of the regulatory review period as determined by the
 Secretary of Health and Human Services or the Secretary of Agriculture, but reduced,
 where appropriate, by the time periods provided in 37 CFR 1.775 - 1.779 . The Office
 will rely on the Secretary’s determination of the length of the regulatory review period
 when calculating the length of the extension period under 37 CFR 1.775 -
 1.779 .
 

 Any part of the regulatory review period which occurs before the patent
 was granted will not be counted toward patent term extension. Any period in which the
 marketing applicant failed to exercise due diligence, thereby unnecessarily adding to
 the length of the regulatory review period after the patent issued, will not be
 considered in determining the length of the extension period. In making the calculation
 of the extension period, half days will be ignored and thus will not be subtracted from
 the regulatory review period.
 

 For products other than animal drug or veterinary biological products,
 the calculated extension period cannot exceed any of the following statutory maximum
 periods of extension:
 

 
 (A) If the period remaining in the term of the patent after the date
 of approval of the approved product when added to the calculated regulatory review
 period exceeds fourteen years, the period of extension shall be reduced so that
 the total of both such periods does not exceed fourteen 
 years;
 

 (B) If the patent involved was issued after 
 September 24, 1984, (the date of enactment of the statute), the calculated period
 of extension may not exceed five years;
 

 (C) If the patent involved was issued before 
 September 24, 1984, (the date of enactment of the statute), and the regulatory
 review period proceeding started after this date, the
 calculated period of extension may not exceed five years ;
 and 
 

 (D) If the patent involved was issued before 
 September 24, 1984, (the date of enactment of the statute), and the regulatory
 review period proceeding started before this date, and the
 commercial marketing or use of the product has been approved
 after such date, the calculated period of extension may
 not exceed two years.
 

 
 For animal drug or veterinary biological products, the calculated
 extension period cannot exceed any of the following statutory maximum periods of
 extension:
 

 
 (A) If the period remaining in the term of the patent after the date
 of approval of the approved product when added to the calculated regulatory review
 period exceeds fourteen years, the period of extension shall be reduced so that
 the total of both such periods does not exceed fourteen 
 years;
 

 (B) If the patent involved was issued after 
 November 16, 1988, the calculated period of extension may not exceed
 five years;
 

 (C) If the patent involved was issued before 
 November 16, 1988, and the regulatory review period proceeding started
 after this date, the calculated period of extension may
 not exceed five years; and
 

 (D) If the patent involved was issued before 
 November 16, 1988, and the regulatory review period proceeding started
 before this date, and the commercial marketing or use of
 the product has been approved after such date, the
 calculated period of extension may not exceed three 
 years.
 

 
 The patent term extension of a patent that issued before September 24,
 1984, where the regulatory review period began and ended before September 24, 1984,
 would only be a function of the regulatory review period and the fourteen-year limit,
 and may be extended for more than five years. Hoechst Aktiengesellschaft v.
 Quigg, 917 F.2d 522, 525, 16 USPQ2d 1549, 1551 (Fed. Cir. 1990).
 

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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