37 CFR § 1.710 — Patents subject to extension of the patent (MPEP Coverage Index) – BlueIron IP
37 CFR § 1.710 Patents subject to extension of the patent
This page consolidates MPEP guidance interpreting 37 CFR § 1.710, including 4 rules from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Summary
This section covers applications and petitions for Hatch-Waxman patent term extensions under 37 CFR 1.710, detailing the eligibility criteria and key compliance obligations for filing such applications or petitions.
What this section covers
- Defines applications and petitions for Hatch-Waxman patent term extensions under 37 CFR 1.710 – 1.791 and 1.182 or 1.183.
Key obligations
- File applications or petitions for Hatch-Waxman patent term extensions under 37 CFR 1.710.
- Ensure the application or petition meets all statutory and regulatory requirements for patent term extension.
- Adhere to the specific provisions of 37 CFR 1.710 and related sections for Hatch-Waxman patent term extensions.
Practice notes
- Ensure all necessary information and documentation are included in the application or petition for Hatch-Waxman patent term extension.
- Timely file the application or petition to avoid loss of rights for Hatch-Waxman patent term extension.
Official MPEP § 1.710 — Patents subject to extension of the patent
Source: USPTOLast Modified: 10/30/2024 08:50:22
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.
[Added 52 FR 9394, Mar. 24, 1987, effective May 26, 1987; amended, 54 FR 30375, July 20, 1989, effective Aug. 22, 1989]