[Federal Register: July 7, 2004 (Volume 69, Number 129)]
[Page 40946]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003E-0257]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) has determined the 
regulatory review period for neotame 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 Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that food additive.

ADDRESSES:  Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:  Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-453-6699.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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. Although only a portion of a regulatory review period may 
count toward the actual amount of extension that the Director 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. 
    FDA recently approved for marketing the food additive neotame. 
Neotame is a nonnutritive sweetener in food. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for neotame (U.S. Patent No. 5,480,668) from 
The NutraSweet 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 July 16, 2003, FDA advised the Patent 
and Trademark Office that this food additive had undergone a regulatory 
review period and that the approval of neotame represented the first 
permitted commercial marketing or use of the product. 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 
neotame is 3,143 days. Of this time, 1,503 days occurred during the 
testing phase of the regulatory review period, 1,640 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 was begun: December 2, 1993. FDA has 
verified the applicant's claim that the test was begun on December 2, 
    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 under section 409 of the Federal Food, 
Drug and Cosmetic Act (21 U.S.C. 348): January 12, 1998. The applicant 
claims December 17, 1997, as the date the petition for neotame was 
initially submitted; however, FDA records indicate that the petition 
was submitted on January 12, 1998.
    3. The date the petition became effective: July 9, 2002. FDA has 
verified the applicant's claim that the regulation for the additive 
became effective/commercial marketing was permitted on July 9, 2002.
    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 973 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by September 7, 2004. Furthermore, any interested person may petition 
FDA for a determination regarding whether the applicant for extension 
acted with due diligence during the regulatory review period by January 
3, 2005. 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 Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 21, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-15275 Filed 7-6-04; 8:45 am]