[Federal Register Volume 67, Number 94 (Wednesday, May 15, 2002)]
[Notices]
[Page 34721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12092]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E-1345]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ACTOS 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.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of 
Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-3565.

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 ACTOS 
(proglitazone hydrochloride). ACTOS is indicated for the improvement of 
glycemic control in patients with Type 2 diabetes as monotherapy, or in 
combination with a sulfonylurea, metformin or insulin when diet and the 
single agent does not result in adequate glycemic control. Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for ACTOS (U.S. Patent No. 4,687,777) from 
Takeda Chemical Industries, Ltd., and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated January 17, 2001, FDA 
advised the Patent and Trademark Office that this human drug product 
had undergone a regulatory review period and that the approval of ACTOS 
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 
ACTOS is 3,556 days. Of this time, 3,374 days occurred during the 
testing phase of the regulatory review period, while 182 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: 
October 21, 1989. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
October 21, 1989.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: January 15, 
1999. FDA has verified the applicant's claim that the new drug 
application (NDA) for ACTOS (NDA 21-073) was initially submitted on 
January 15, 1999.
    3. The date the application was approved: July 15, 1999. FDA has 
verified the applicant's claim that NDA 21-073 was approved on July 15, 
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 1,826 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (see ADDRESSES) 
written comments and ask for a redetermination by July 15, 2002. 
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 November 12, 2002. 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 (see ADDRESSES). Three copies of any 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 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: April 22, 2002.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-12092 Filed 5-14-02; 8:45 am]
BILLING CODE 4160-01-S