---
kind: "section"
citation: "9 C.F.R. § 124.20"
title: "9"
number: "124.20"
heading: "Patent term extension calculation."
url: "https://uscodex.org/cfr/9/124.20"
---

# §124.20. Patent term extension calculation.

- (a) As provided in [37 CFR 1.779](/cfr/37/1.779.md) of PTO's regulations, in order to determine a product's regulatory review period, APHIS will review the information in each application to determine the lengths of the following phases of the review period, and will then find their sum:
  - (1) The number of days in the period beginning on the date authorization to prepare an experimental biological product under the Virus-Serum-Toxin Act became effective and ending on the date an application for a license was initially submitted under the Virus-Serum-Toxin Act; and
  - (2) The number of days in the period beginning on the date an application for a license was initially submitted for approval under the Virus-Serum-Toxin Act and ending on the date such license was issued.
- (b) A license application is “initially submitted” on the date it contains sufficient information to allow APHIS to commence review of the application. A product license is issued on the date of the APHIS letter informing the applicant of the issuance. The issuance of a license releases the product for commercial marketing or use.

## Notes

### Authority

Authority: 35 U.S.C. 156; 7 CFR 2.22, 2.80, and 371.4.

### Source

Source: 58 FR 11369, Feb. 25, 1993, unless otherwise noted.