[Code of Federal Regulations]
[Title 37, Volume 1]
[Revised as of July 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 37CFR1.776]

[Page 187-188]
 
              TITLE 37--PATENTS, TRADEMARKS, AND COPYRIGHTS
 
                         DEPARTMENT OF COMMERCE
 
PART 1--RULES OF PRACTICE IN PATENT CASES--Table of Contents
 
           Subpart F--Adjustment and Extension of Patent Term
 
Sec. 1.776  Calculation of patent term extension for a food additive or color additive.

    (a) If a determination is made pursuant to Sec. 1.750 that a patent 
for a food additive or color additive is eligible for extension, the 
term shall be extended by the time as calculated in days in the manner 
indicated by this section. The patent term extension will run from the 
original expiration date of the patent or earlier date set by terminal 
disclaimer (Sec. 1.321).
    (b) The term of the patent for a food additive or color additive 
will be extended by the length of the regulatory review period for the 
product as determined by the Secretary of Health and Human Services, 
reduced as appropriate pursuant to paragraphs (d)(1) through (d)(6) of 
this section.
    (c) The length of the regulatory review period for a food additive 
or color additive will be determined by the Secretary of Health and 
Human Services. Under 35 U.S.C. 156(g)(2)(B), it is the sum of--
    (1) The number of days in the period beginning on the date a major 
health or environmental effects test on the additive was initiated and 
ending on the date a petition was initially submitted with respect to 
the approved product under the Federal Food, Drug, and Cosmetic Act 
requesting the issuance of a regulation for use of the product; and
    (2) The number of days in the period beginning on the date a 
petition was initially submitted with respect to the approved product 
under the Federal Food, Drug, and Cosmetic Act requesting the issuance 
of a regulation for use of the product, and ending on the date such 
regulation became effective or, if objections were filed to such 
regulation, ending on the date such objections were resolved and 
commercial marketing was permitted or, if commercial marketing was 
permitted and later revoked pending further proceedings as a result of 
such objections, ending on the date such proceedings were finally 
resolved and commercial marketing was permitted.
    (d) The term of the patent as extended for a food additive or color 
additive will be determined by
    (1) Subtracting from the number of days determined by the Secretary 
of Health and Human Services to be in the regulatory review period:
    (i) The number of days in the periods of paragraphs (c)(1) and 
(c)(2) of this section which 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 Health and Human Services that 
applicant did not act with due diligence;
    (iii) The number of days equal to 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;
    (2) By adding the number of days determined in paragraph (d)(1) of 
this section to the original term of the patent as shortened by any 
terminal disclaimer;
    (3) By adding 14 years to the date a regulation for use of the 
product became effective or, if objections were filed to such 
regulation, to the date such objections were resolved and commercial 
marketing was permitted or, if commercial marketing was permitted and 
later revoked pending further proceedings as a result of such 
objections, to the date such proceedings were finally resolved and 
commercial marketing was permitted;
    (4) By comparing the dates for the ends of the periods obtained 
pursuant

[[Page 188]]

to paragraphs (d)(2) and (d)(3) of this section with each other and 
selecting the earlier date;
    (5) If the original patent was issued after September 24, 1984,
    (i) By adding 5 years to the original expiration date of the patent 
or earlier date set by terminal disclaimer; and
    (ii) By comparing the dates obtained pursuant to paragraphs (d)(4) 
and (d)(5)(i) of this section with each other and selecting the earlier 
date;
    (6) If the original patent was issued before September 24, 1984, and
    (i) If no major health or environmental effects test was initiated 
and no petition for a regulation or application for registration was 
submitted before September 24, 1984, by--
    (A) Adding 5 years to the original expiration date of the patent or 
earlier date set by terminal disclaimer, and
    (B) By comparing the dates obtained pursuant to paragraphs (d)(4) 
and (d)(6)(i)(A) of this section with each other and selecting the 
earlier date; or
    (ii) If a major health or environmental effects test was initiated 
or a petition for a regulation or application for registration was 
submitted by September 24, 1984, and the commercial marketing or use of 
the product was not approved before September 24, 1984, by--
    (A) Adding 2 years to the original expiration date of the patent or 
earlier date set by terminal disclaimer, and
    (B) By comparing the dates obtained pursuant to paragraphs (d)(4) 
and (d)(6)(ii)(A) of this section with each other and selecting the 
earlier date.