{"data":{"id":"us/9-cfr-124.20","jurisdiction":"us","citation":"9 CFR 124.20","heading":"Patent term extension calculation.","body":"(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:\n(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\n(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.\n(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.","path":["Title 9—Animals and Animal Products","CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE","SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS","PART 124—PATENT TERM RESTORATION","Subpart C—Regulatory Review Period"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-9.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:03Z","sha256":"f430bb9c0a0423b4b5176c8e5c0fe0e60b8ea8e4b845e7b05ff4775ba0434c10","source_id":"us-cfr","stale":true,"prev":"us/9-cfr-124.10","next":"us/9-cfr-124.21"},"notice":"GroundRules: Original legal text. Not legal advice."}