Determination of Regulatory Review Period for Purposes of Patent Extension; AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0292]

Determination of Regulatory Review Period for Purposes of Patent

Extension; AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION

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 AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION

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 AQUEOUS ARYL

FLUOROPHOSPHITE SUSPENSION (2,2'-ethylidenebis(4,6-di-

tertbutylpheny)fluorophosphonite). AQUEOUS ARYL FLUOROPHOSPHITE

SUSPENSION is used as an antioxidant in adhesives and in the

preparation of polymers intended for contact with food. Subsequent to

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

restoration application for AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION

(U.S. Patent No. 4,867,907) from Albemarle Corp., 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 21, 1997, FDA advised the Patent and Trademark Office that this

food additive had undergone a regulatory review period and that the

approval of AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION 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

AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION is 2,930 days. Of this time,

935 days occurred during the testing phase of the regulatory review

period, 1,995 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:

January 9, 1989. The applicant claims July 21, 1986, as the date the

test was begun. However, FDA records indicate that the test was begun

on January 9, 1989.

[[Page 41581]]

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

for use of the food additive under section 409 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 348) was initially submitted: August

1, 1991. The applicant claims August 1, 1991, as the date the petition

for AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION was initially submitted.

3. The date the regulation for the food additive petition became

effective: January 15, 1997. FDA has verified the applicant's claim

that the regulation for the food additive became effective on January

15, 1997.

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 1,268 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before October 5, 1998, 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 February 1, 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: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-20707 Filed 8-3-98; 8:45 am]

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