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

prev | next
§ 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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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

Title 37 published on 16-May-2018 03:41

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

  • 2018-01-19; vol. 83 # 13 - Friday, January 19, 2018
    1. 83 FR 2759 - Changes To Eliminate Unnecessary Regulations
      GPO FDSys XML | Text
      DEPARTMENT OF COMMERCE, United States Patent and Trademark Office
      Notice of proposed rulemaking.
      Written comments must be received on or before February 20, 2018.
      37 CFR Parts 1 and 42

Pages

The section you are viewing is cited by the following CFR sections.