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35 U.S.C. 2(b)(2), unless otherwise noted.
24 FR 10332, Dec. 22, 1959, unless otherwise noted.
35 U.S.C. 2(b)(2), 154, and 156.
52 FR 9394, Mar. 24, 1987, unless otherwise noted.
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1. In Patent and Trademark Office publications and usage the part number is omitted from the numbers of §§ 1.1 to 1.352 and the numbers to the right of the decimal point correspond with the respective rule numbers.
2. For nomenclature changes to part 1, see 68 FR 14335, Mar. 25, 2003; 87 FR 68904, Nov. 17, 2022.
(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]
Part 2 is placed in the separate grouping of parts pertaining to trademarks regulations.
Part 6 is placed in the separate grouping of parts pertaining to trademarks regulations.
Part 7 is placed in the separate grouping of parts pertaining to trademarks regulations.
Part 1 is placed in the separate grouping of parts pertaining to patents regulations.
Part 3 pertaining to both patents and trademarks is placed in the grouping pertaining to patents regulations.
Part 4 is placed in the separate grouping of parts pertaining to patents regulations.
Part 5 is placed in the separate grouping of parts pertaining to patents regulations.