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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0788]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Sucralose

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined

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the regulatory review period for Sucralose 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.

ADDRESSES: Written comments and petitions should be directed to the

Dockets Management Branch (HFA-305), Food and Drug Administration, 5630

Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health

Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301-827-6620.

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 additives, the testing

phase begins when a major health or environmental effects test

involving the food additive begins and runs until the approval phase

begins. The approval phase starts with the initial submission of a

petition requesting the issuance of a regulation for use of the food

additive and continues until FDA grants permission to market the food

additive product. 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 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 Sucralose

(sucralose). Sucralose is used as a nonnutritive sweetener in food

where standards of identity do not preclude such use. Subsequent to

this approval, the Patent and Trademark Office received a patent term

restoration application for Sucralose (U.S. Patent No. 4,435,440) from

Tate & Lyle PLC, and the Patent and Trademark Office requested FDA's

assistance in determining this patent's eligibility for patent term

restoration. In a letter dated October 7, 1998, FDA advised the Patent

and Trademark Office that this food additive had undergone a regulatory

review period and that the approval of Sucralose 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

Sucralose is 5,332 days. Of this time, 1,260 days occurred during the

testing phase of the regulatory review period, while 4,072 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 (``test'')

involving this food additive additive product was begun: August 30,

1983. FDA has verified the applicant's claim that the test was begun on

August 30, 1983.

2. The date the petition requesting the issuance of a regulation

for use of the additive (``petition'') was initially submitted with

respect to the food additive additive product under section 409 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348): February 9, 1987.

FDA has verified the applicant's claim that the petition was initially

submitted on February 9, 1987.

3. The date the petition became effective: April 3, 1998. FDA has

verified the applicant's claim that the regulation for the additive

became effective on April 3, 1998.

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 its

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 February 19, 1999, submit to the Dockets

Management Branch (address above) written comments and ask for a

redetermination. Furthermore, any interested person may petition FDA,

on or before June 21, 1999, 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: December 4, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-33638 Filed 12-18-98; 8:45 am]

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