[Federal Register Volume 63, Number 244 (Monday, December 21, 1998)]
[Notices]
[Pages 70411-70412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33638]
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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
[[Page 70412]]
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]
BILLING CODE 4160-01-F
