[Federal Register Volume 62, Number 3 (Monday, January 6, 1997)]
[Notices]
[Pages 763-764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-138]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0080]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Olean

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for Olean and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of an application to the Commissioner of 
Patents and Trademarks, Department of Commerce, for the extension of a 
patent which claims that food additive product.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1382.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 100-670) generally provide 
that a patent may be extended for a period of up to 5 years so long as 
the patented item (human drug product, animal drug product, medical 
device, food additive, or color additive) was subject to regulatory 
review by FDA before the item was marketed. Under these acts, a 
product's regulatory review period forms the basis for determining the 
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: a 
testing phase and an approval phase. For food and color additives: (1) 
The testing phase begins on the date a major health or environmental 
effects test is begun and ends on the date a petition relying on the 
test and requesting the issuance of a regulation for use of the 
additive under section 409 or 721 of the Federal Food, Drug, and 
Cosmetic Act (the act) is initially submitted to FDA. An 
``environmental effects'' test may be any test which: (a) Is reasonably 
related to the evaluation of the product's health effects, or both; (b) 
produces data necessary for marketing approval; and (c) is conducted 
over a period of not less than 6-months duration, excluding time 
required to analyze or evaluate test results. (2) The approval phase 
begins on the date a petition requesting the issuance of a regulation 
for use of the additive under section 409 or 721 of the act is 
initially submitted to FDA and ends upon whichever of the following 
occurs last: (a) The regulation for the additive becomes final; or (b) 
objections filed against the regulation that result in a stay of 
effectiveness are resolved and commercial marketing is permitted; or 
(c) proceedings resulting from objections to the regulation, after 
commercial marketing has been permitted and later stayed pending 
resolution of the proceedings, are finally resolved and commercial 
marketing is permitted. Although only a portion of a regulatory review 
period may count toward the actual amount of extension that the 
Commissioner of Patents and Trademarks may award (for example, half the 
testing phase must be subtracted as well as any time that may have 
occurred before the patent was issued), FDA's determination of the 
length of a regulatory review period for a color or food additive will 
include all of the testing phase and approval phase as specified in 35 
U.S.C. 156(g)(2)(B).
    FDA recently approved for marketing the food additive product Olean 
(olestra). Olean is used in place of fats and oils in prepackaged 
ready-to-eat savory (i.e., salty or piquant, but not sweet) snacks. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for Olean (U.S. Patent No. 
4,005,196) from Proctor & Gamble Co. and the Patent and Trademark 
Office requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated May 9, 1996, 
FDA advised the Patent and Trademark Office that this food additive 
product had undergone a regulatory review period and that the listing 
of Olean represented the first permitted commercial marketing or use of 
the product. Shortly thereafter, the Patent and Trademark Office 
requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
Olean is 5,418 days. Of this time, 2,191 days occurred during the 
testing phase of the regulatory review period, while 3,227 days 
occurred during the approval phase. These periods of time were derived 
from the following dates:
    1. The date a major health or environmental effects test was begun: 
April 2, 1981. The applicant does not specifically state a date when a 
test involving this food additive product was begun. However, FDA 
records indicate that the test was begun on April 2, 1981.
    2. The date a petition requesting the issuance of a regulation for 
use of the food additive under section 409 of the act was initially 
submitted:  April 1, 1987. FDA has verified the applicant's claim that 
the petition for Olean was initially submitted on April 1, 1987.
    3. The date the regulation for the food additive petition became 
effective:  January 30, 1996. The applicant claims that the regulation 
for the food additive became effective on January 24, 1996. However, 
FDA records indicate that, by its terms, the regulation for the food 
additive became effective on January 30, 1996 (61 FR 3118, January 30, 
1996).
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In this 
application for patent extension, this applicant seeks 730 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before March 7, 1997, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore,

[[Page 764]]

any interested person may petition FDA, on or before July 7, 1997, for 
a determination regarding whether the applicant for extension acted 
with due diligence during the regulatory review period. To meet its 
burden, the petition must contain sufficient facts to merit an FDA 
investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-
42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Dockets 
Management Branch (address above) in three copies (except that 
individuals may submit single copies) and identified with the docket 
number found in brackets in the heading of this document. Comments and 
petitions may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: November 25, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 97-138 Filed 1-3-97; 8:45 am]
BILLING CODE 4160-01-F