37 CFR 1.710 - Patents subject to extension of the patent term.

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§ 1.710 Patents subject to extension of the patent term.
(a) A patent is eligible for extension of the patent term if the patent claims a product as defined in paragraph (b) of this section, either alone or in combination with other ingredients that read on a composition that received permission for commercial marketing or use, or a method of using such a product, or a method of manufacturing such a product, and meets all other conditions and requirements of this subpart.
(b) The term product referred to in paragraph (a) of this section means—
(1) The active ingredient of a new human drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or
(2) The active ingredient of a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Virus-Serum-Toxin Act) that is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes including site specific genetic manipulation techniques, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or
(3) Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act.
[54 FR 30379, July 20, 1989]

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.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-11-14; vol. 79 # 220 - Friday, November 14, 2014
    1. 79 FR 68121 - Changes to Continued Prosecution Application Practice
      GPO FDSys XML | Text
      DEPARTMENT OF COMMERCE, Patent and Trademark Office
      Final rule.
      Effective Date: This final rule is effective on November 14, 2014. The continued prosecution application interim rule published on March 5, 2014 at 79 FR 12384 was effective on March 5, 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.

  • 2014-11-14; vol. 79 # 220 - Friday, November 14, 2014
    1. 79 FR 68121 - Changes to Continued Prosecution Application Practice
      GPO FDSys XML | Text
      DEPARTMENT OF COMMERCE, Patent and Trademark Office
      Final rule.
      Effective Date: This final rule is effective on November 14, 2014. The continued prosecution application interim rule published on March 5, 2014 at 79 FR 12384 was effective on March 5, 2014.
      37 CFR Part 1