[Federal Register Volume 68, Number 25 (Thursday, February 6, 2003)]
[Notices]
[Page 6176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2970]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E-1238]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for TEMODAR 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 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-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 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 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 TEMODAR 
(temozolomide). TEMODAR is indicated for the treatment of adult 
patients with refractory anaplastic astrocytoma, i.e., patients at 
first relapse who have experienced disease progression on a drug 
regimen containing a nitrosourea and procarbazine. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for TEMODAR (U.S. Patent No. 5,260,291) from 
Schering 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 13, 2000, FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of TEMODAR 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 
TEMODAR is 2,032 days. Of this time, 1,668 days occurred during the 
testing phase of the regulatory review period, while 364 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: 
January 19, 1994. The applicant claims January 20, 1994, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was January 
19, 1994, 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(b) of the act: August 13, 
1998. The applicant claims August 12, 1998, as the date the new drug 
application (NDA) for TEMODAR (NDA 21-029) was initially submitted. 
However, FDA records indicate that NDA 21-029 was submitted on August 
13, 1998.
    3. The date the application was approved: August 11, 1999. FDA has 
verified the applicant's claim that NDA 21-029 was approved on August 
11, 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 1,136 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 or electronic comments and ask for a redetermination by April 
7, 2003. Furthermore, any interested person may petition FDA by for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period August 5, 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 (see ADDRESSES). Three copies of any information are 
to be submitted, except that individuals may submit single copies. 
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: January 13, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-2970 Filed 2-5-03; 8:45 am]
BILLING CODE 4160-01-S