# 37 CFR § 1.710: Patents subject to extension of the patent term

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-37-1.710

## Section

- **Citation:** 37 CFR § 1.710
- **Heading:** Patents subject to extension of the patent term
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 37—Patents, Trademarks, and Copyrights > CHAPTER I—UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE > SUBCHAPTER A—GENERAL > PART 1—RULES OF PRACTICE IN PATENT CASES > Subpart F—Adjustment and Extension of Patent Term > Extension of Patent Term Due to Regulatory Review

## Text

(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]

## Nearby sections

- [37 CFR § 1.701 § 1.701 Extension of patent term due to examination delay under the Uruguay Round Agreements Act (original applications, other than designs, filed on or after June 8, 1995, and before May 29, 2000).](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.701.md)
- [37 CFR § 1.702 § 1.702 Grounds for adjustment of patent term due to examination delay under the Patent Term Guarantee Act of 1999 (original applications, other than designs, filed on or after May 29, 2000).](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.702.md)
- [37 CFR § 1.703 § 1.703 Period of adjustment of patent term due to examination delay.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.703.md)
- [37 CFR § 1.704 § 1.704 Reduction of period of adjustment of patent term.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.704.md)
- [37 CFR § 1.705 § 1.705 Patent term adjustment determination.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.705.md)
- [37 CFR § 1.710 § 1.710 Patents subject to extension of the patent term.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.710.md)
- [37 CFR § 1.720 § 1.720 Conditions for extension of patent term.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.720.md)
- [37 CFR § 1.730 § 1.730 Applicant for extension of patent term; signature requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.730.md)
- [37 CFR § 1.740 § 1.740 Formal requirements for application for extension of patent term; correction of informalities.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.740.md)
- [37 CFR § 1.741 § 1.741 Complete application given a filing date; petition procedure.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.741.md)
- [37 CFR § 1.750 § 1.750 Determination of eligibility for extension of patent term.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.750.md)
- [37 CFR § 1.760 § 1.760 Interim extension of patent term under 35 U.S.C. 156(e)(2).](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.760.md)
- [37 CFR § 1.765 § 1.765 Duty of disclosure in patent term extension proceedings.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.765.md)
- [37 CFR § 1.770 § 1.770 Express withdrawal of application for extension of patent term.](https://www.frixlaw.com/law-library/statutes/ecfr-37-1.770.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-37-1.710. Check the current official text before relying on it. Not legal advice.