37 CFR 1.720 - Conditions for extension of patent term.

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There are 5 Updates appearing in the Federal Register for 37 CFR 1. View below or at eCFR (GPOAccess)
§ 1.720 Conditions for extension of patent term.
The term of a patent may be extended if:
(a) The patent claims a product or a method of using or manufacturing a product as defined in § 1.710;
(b) The term of the patent has never been previously extended, except for extensions issued pursuant to §§ 1.701, 1.760, or § 1.790;
(c) An application for extension is submitted in compliance with § 1.740;
(d) The product has been subject to a regulatory review period as defined in 35 U.S.C. 156(g) before its commercial marketing or use;
(e) The product has received permission for commercial marketing or use and—
(1) The permission for the commercial marketing or use of the product is the first received permission for commercial marketing or use under the provision of law under which the applicable regulatory review occurred, or
(2) In the case of a patent other than one directed to subject matter within § 1.710(b)(2) claiming a method of manufacturing the product that primarily uses recombinant DNA technology in the manufacture of the product, the permission for the commercial marketing or use is the first received permission for the commercial marketing or use of a product manufactured under the process claimed in the patent, or
(3) In the case of a patent claiming a new animal drug or a veterinary biological product that is not covered by the claims in any other patent that has been extended, and has received permission for the commercial marketing or use in non-food-producing animals and in food-producing animals, and was not extended on the basis of the regulatory review period for use in non-food-producing animals, the permission for the commercial marketing or use of the drug or product after the regulatory review period for use in food-producing animals is the first permitted commercial marketing or use of the drug or product for administration to a food-producing animal.
(f) The application is submitted within the sixty-day period beginning on the date the product first received permission for commercial marketing or use under the provisions of law under which the applicable regulatory review period occurred; or in the case of a patent claiming a method of manufacturing the product which primarily uses recombinant DNA technology in the manufacture of the product, the application for extension is submitted within the sixty-day period beginning on the date of the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent; or in the case of a patent that claims a new animal drug or a veterinary biological product that is not covered by the claims in any other patent that has been extended, and said drug or product has received permission for the commercial marketing or use in non-food-producing animals, the application for extension is submitted within the sixty-day period beginning on the date of the first permitted commercial marketing or use of the drug or product for administration to a food-producing animal;
(g) The term of the patent, including any interim extension issued pursuant to § 1.790, has not expired before the submission of an application in compliance with § 1.741; and
(h) No other patent term has been extended for the same regulatory review period for the product.
[52 FR 9394, Mar. 24, 1987, as amended at 54 FR 30380, July 20, 1989; 65 FR 54679, Sept. 8, 2000]

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.

  • 2014-06-18; vol. 79 # 117 - Wednesday, June 18, 2014
    1. 79 FR 34681 - 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
      Notice of proposed rulemaking.
      Comment Deadline Date: Written comments must be received on or before August 18, 2014.
      37 CFR Part 1