[Federal Register Volume 68, Number 30 (Thursday, February 13, 2003)]
[Notices]
[Pages 7381-7382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3555]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E-1249]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for

[[Page 7382]]

Avandia 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 that claims that human drug 
product.

ADDRESSES: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3460.

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 human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug product. 
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 human drug product will include all of the testing 
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product Avandia 
(rosiglitazone maleate). Avandia is indicated for use in combination 
with a sulfonylurea in patients with type 2 diabetes mellitus when diet 
and exercise with either single agent does not achieve adequate 
glycemic control. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for Avandia (U.S. 
Patent No. 5,002,953) from Smithkline Beecham 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 
April 26, 2000, FDA advised the Patent and Trademark Office that this 
human drug product had undergone a regulatory review period and that 
the approval of Avandia 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 
Avandia is 2,042 days. Of this time, 1,859 days occurred during the 
testing phase of the regulatory review period, while 183 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: 
October 23, 1993. The applicant claims October 22, 1993, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was October 
23, 1993, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the act: November 24, 1998. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for Avandia (NDA 21-071) was initially submitted on November 24, 
1998.
    3. The date the application was approved: May 25, 1999. FDA has 
verified the applicant's claim that NDA 21-071 was approved on May 25, 
1999.
    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 1,021 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Dockets Management Branch (see ADDRESSES) 
written comments and ask for a redetermination by April 14, 2003. 
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 August 12, 2003. 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. Three copies of any information are to be submitted, 
except that individuals may submit a single copy. Copies 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 Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 13, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-3555 Filed 2-12-03; 8:45 am]
BILLING CODE 4160-01-S