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 2014-07-01

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  • 2015-01-09; vol. 80 # 6 - Friday, January 9, 2015
    1. 80 FR 1346 - Changes to Patent Term Adjustment in View of the Federal Circuit Decision in Novartis v. Lee
      GPO FDSys XML | Text
      DEPARTMENT OF COMMERCE, United States Patent and Trademark Office
      Final rule.
      Effective date: The changes to 37 CFR 1.703 in this final rule are effective on January 9, 2015, and the changes to 37 CFR 1.704 in this final rule are effective on March 10, 2015. Applicability date: The changes to 37 CFR 1.703 in this final rule apply to any patent granted before, on, or after January 9, 2015. 37 CFR 1.704 as adopted in this final rule applies to all original applications (other than for a design patent) filed on or after May 29, 2000, and to patents issued on such applications, except that 37 CFR 1.704(c)(12) as adopted in this final rule applies only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 is filed on or after March 10, 2015, and 37 CFR 1.704(c)(13) as adopted in this final rule applies only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013.
      37 CFR Part 1

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

Title 37 published on 2014-07-01

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

  • 2015-02-05; vol. 80 # 24 - Thursday, February 5, 2015
    1. 80 FR 6475 - Request for Comments on Enhancing Patent Quality
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      DEPARTMENT OF COMMERCE, United States Patent and Trademark Office
      Request for comments; notice of meeting.
      Comment Deadline Date: To be ensured of consideration, written comments must be received on or before May 6, 2015. The USPTO will hold a Quality Summit on March 25 and 26, 2015 at the Madison Building, USPTO Headquarters, in Alexandria, Virginia. This Summit will be broadcast via webinar and recorded for later viewing. For webinar participants, participation in all Summit sessions, including the group brainstorming sessions, will be possible. See the Supplementary Information section for the proposed agenda. In order to best prepare for the Quality Summit, the USPTO requests that those interested in attending the Quality Summit send an email to WorldClassPatentQuality@uspto.gov indicating their planned attendance by March 18, 2015.
      37 CFR Part 1