2758 Notice of Final Determination - Calculation of Patent Term Extension [R-01.2024]
35 U.S.C. 156 Extension of patent term.
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- (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.
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- (g) For purposes of this section, the term “regulatory
review period” has the following meanings:
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- (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.
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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
1Consistent 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 EXTENSIONThe 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).
