9 CFR § 124.20 - Patent term extension calculation.

---
identifier: "/us/cfr/t9/s124.20"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "9 CFR § 124.20 - Patent term extension calculation."
title_number: 9
title_name: "Animals and Animal Products"
section_number: "124.20"
section_name: "Patent term extension calculation."
chapter_name: "ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE"
subchapter_number: "E"
subchapter_name: "VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS"
part_number: "124"
part_name: "PATENT TERM RESTORATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "35 U.S.C. 156; 7 CFR 2.22, 2.80, and 371.4."
regulatory_source: "58 FR 11369, Feb. 25, 1993, unless otherwise noted."
cfr_part: "124"
---


# 124.20 Patent term extension calculation.

(a) As provided in 37 CFR 1.779 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.