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 2014-07-01

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.

  • 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