Code of Federal Regulations Title 37. Patents, Trademarks, and Copyrights § 37.1.779 Calculation of patent term extension for a veterinary biological product

(i) The number of days in the periods of paragraphs (c)(1) and (c)(2) of this section that were on and before the date on which the patent issued;

(ii) The number of days in the periods of paragraphs (c)(1) and (c)(2) of this section during which it is determined under 35 U.S.C. 156(d)(2)(B) by the Secretary of Agriculture that applicant did not act with due diligence;

(iii) One-half the number of days remaining in the period defined by paragraph (c)(1) of this section after that period is reduced in accordance with paragraphs (d)(1)(i) and (ii) of this section;  half days will be ignored for purposes of subtraction;

(i) Adding 5 years to the original expiration date of the patent or any earlier date set by terminal disclaimer;  and

(ii) Comparing the dates obtained pursuant to paragraphs (d)(4) and (d)(5)(i) of this section with each other and selecting the earlier date;

(i) If no request for the authority to prepare an experimental biological product under the Virus–Serum–Toxin Act was submitted before November 16, 1988, by—

(ii) If a request for the authority to prepare an experimental biological product under the Virus–Serum–Toxin Act was submitted before November 16, 1988, and the commercial marketing or use of the product was not approved before November 16, 1988, by—