37 CFR 1.776 - Calculation of patent term extension for a food additive or color additive.

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§ 1.776 Calculation of patent term extension for a food additive or color additive.
(a) If a determination is made pursuant to § 1.750 that a patent for a food additive or color additive is eligible for extension, the term shall be extended by the time as calculated in days in the manner indicated by this section. The patent term extension will run from the original expiration date of the patent or earlier date set by terminal disclaimer (§ 1.321).
(b) The term of the patent for a food additive or color additive will be extended by the length of the regulatory review period for the product as determined by the Secretary of Health and Human Services, reduced as appropriate pursuant to paragraphs (d)(1) through (d)(6) of this section.
(c) The length of the regulatory review period for a food additive or color additive will be determined by the Secretary of Health and Human Services. Under 35 U.S.C. 156(g)(2)(B), it is the sum of—
(1) The number of days in the period beginning on the date a major health or environmental effects test on the additive was initiated and ending on the date a petition was initially submitted with respect to the approved product under the Federal Food, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product; and
(2) The number of days in the period beginning on the date a petition was initially submitted with respect to the approved product under the Federal Food, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and ending on the date such regulation became effective or, if objections were filed to such regulation, ending on the date such objections were resolved and commercial marketing was permitted or, if commercial marketing was permitted and later revoked pending further proceedings as a result of such objections, ending on the date such proceedings were finally resolved and commercial marketing was permitted.
(d) The term of the patent as extended for a food additive or color additive will be determined by
(1) Subtracting from the number of days determined by the Secretary of Health and Human Services to be in the regulatory review period:
(i) The number of days in the periods of paragraphs (c)(1) and (c)(2) of this section which were on and before the date on which the patent issued;
(ii) The number of days in the periods of paragraphs (c)(1) and (c)(2) of this section during which it is determined under 35 U.S.C. 156(d)(2)(B) by the Secretary of Health and Human Services that applicant did not act with due diligence;
(iii) The number of days equal to one-half the number of days remaining in the period defined by paragraph (c)(1) of this section after that period is reduced in accordance with paragraphs (d)(1) (i) and (ii) of this section; half days will be ignored for purposes of subtraction;
(2) By adding the number of days determined in paragraph (d)(1) of this section to the original term of the patent as shortened by any terminal disclaimer;
(3) By adding 14 years to the date a regulation for use of the product became effective or, if objections were filed to such regulation, to the date such objections were resolved and commercial marketing was permitted or, if commercial marketing was permitted and later revoked pending further proceedings as a result of such objections, to the date such proceedings were finally resolved and commercial marketing was permitted;
(4) By comparing the dates for the ends of the periods obtained pursuant to paragraphs (d)(2) and (d)(3) of this section with each other and selecting the earlier date;
(5) If the original patent was issued after September 24, 1984,
(i) By adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer; and
(ii) By comparing the dates obtained pursuant to paragraphs (d)(4) and (d)(5)(i) of this section with each other and selecting the earlier date;
(6) If the original patent was issued before September 24, 1984, and
(i) If no major health or environmental effects test was initiated and no petition for a regulation or application for registration was submitted before September 24, 1984, by—
(A) Adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer, and
(B) By comparing the dates obtained pursuant to paragraphs (d)(4) and (d)(6)(i)(A) of this section with each other and selecting the earlier date; or
(ii) If a major health or environmental effects test was initiated or a petition for a regulation or application for registration was submitted by September 24, 1984, and the commercial marketing or use of the product was not approved before September 24, 1984, by—
(A) Adding 2 years to the original expiration date of the patent or earlier date set by terminal disclaimer, and
(B) By comparing the dates obtained pursuant to paragraphs (d)(4) and (d)(6)(ii)(A) of this section with each other and selecting the earlier date.

Title 37 published on 2013-07-01

The following are only the Rules published in the Federal Register after the published date of Title 37.

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  • 2014-05-15; vol. 79 # 94 - Thursday, May 15, 2014
    1. 79 FR 27755 - Revisions To Implement the Patent Term Adjustment Provisions of the Leahy-Smith America Invents Act Technical Corrections Act
      GPO FDSys XML | Text
      DEPARTMENT OF COMMERCE, United States Patent and Trademark Office
      Final rule.
      Effective Date: This final rule is effective on May 15, 2014. The interim rule, published April 1, 2013, at 78 FR 19416, was effective on April 1, 2013. Applicability Date: The amendments to 37 CFR 1.702, 1.703, and 1.705 apply to any patent granted on or after January 14, 2013. The amendment to 37 CFR 1.704 applies to any application in which a notice of allowance was mailed on or after April 1, 2013. The optional procedure for requesting a patent term adjustment recalculation applies only to patents issued between January 14, 2013, and May 20, 2014, that resulted directly from international applications, and the request must be filed no later than July 31, 2014.
      37 CFR Part 1

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United States Code
U.S. Code: Title 35 - PATENTS

Title 37 published on 2013-07-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 37 CFR 1 after this date.

  • 2014-07-11; vol. 79 # 133 - Friday, July 11, 2014
    1. 79 FR 40035 - Changes To Facilitate Applicant's Authorization of Access to Unpublished U.S. Patent Applications by Foreign Intellectual Property Offices
      GPO FDSys XML | Text
      DEPARTMENT OF COMMERCE, Patent and Trademark Office
      Notice of proposed rulemaking.
      Written comments must be received on or before September 9, 2014.
      37 CFR Part 1