37 CFR § 1.790 — Interim extension of patent term under35 (MPEP Coverage Index) – BlueIron IP
37 CFR § 1.790 Interim extension of patent term under35
Source: Patent Rule (37 CFR)BlueIron Update:
This page consolidates MPEP guidance interpreting 37 CFR § 1.790, including 22 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
The interim patent term extension process allows patent holders to temporarily extend patent terms during ongoing regulatory review periods for products requiring approval.
What this section covers
- Outlines the procedural mechanism for requesting an interim extension of patent term before final product approval.
- Defines the eligibility criteria for obtaining interim patent term extensions.
Key obligations
- Submit a formal application that demonstrates the ongoing regulatory review period.
- Include a specific statement confirming that the regulatory review period remains incomplete.
- Comply with the specific regulatory review period requirements under applicable patent term extension regulations.
Practice notes
- Thoroughly document the ongoing regulatory review to substantiate the interim extension request.
- Recognize that the Director will evaluate the extension request primarily based on the submitted representations.
Official MPEP § 1.790 — Interim extension of patent term under35
Source: USPTOLast Modified: 10/30/2024 08:50:22
1.790 Interim extension of patent term under 35 U.S.C. 156(d)(5) .
- (a) An owner of record of a patent or its agent who reasonably expects that the applicable regulatory review period, described in 35 U.S.C. 156(g) (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect may submit one or more applications for interim extensions for periods of up to one year each. In no event will the interim extensions granted under this section be longer than the maximum period of extension to which the applicant would be entitled under 35 U.S.C. 156(c) .
- (b) Any application for interim extension under this section must be filed using the USPTO patent electronic filing system in accordance with the USPTO patent electronic filing system requirements.
- (c) Complete initial applications for interim
extension under this section must:
- (1) Be filed during the period beginning 6 months and ending 15 days before the patent term is due to expire, and include a statement that the initial application is being submitted within the period and an identification of the date of the last day on which the initial application could be submitted;
- (2) Include all of the information required for a formal application under § 1.740 and a complete application under § 1.741 , except as follows:
- (3) Include a statement that the applicable regulatory review period, described in 35 U.S.C. 156(g) (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has begun for the product that is the subject of the patent.
- (d) Each subsequent application for
interim extension:
- (1) Must be filed during the period beginning 60 days before and ending 30 days before the expiration of the preceding interim extension and include a statement that it is being submitted within the period and an identification of the date of the last day on which it could be submitted;
- (2) May be limited in content to a request for a subsequent interim extension along with any materials or information required under §§ 1.740 and 1.741 that are not present in the preceding interim extension application; and
- (3) Must include a statement that the applicable regulatory review period, described in 35 U.S.C. 156(g) (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has not been completed.
[Added, 60 FR 25615, May 12, 1995, effective July 11, 1995; revised 88 FR 13028, Mar. 2, 2023, effective May 1, 2023]
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- Patent Term Adjustment
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| MPEP Section | Rules |
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| MPEP § 2751 | |
| MPEP § 2755 | |
| MPEP § 2755.02 |