[Federal Register Volume 68, Number 76 (Monday, April 21, 2003)]
[Notices]
[Pages 19548-19549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9663]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0031]


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

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 EXELON 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 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 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

[[Page 19549]]

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 EXELON 
(rivastigmine tartrate). EXELON is indicated for the treatment of mild 
to moderate dementia of the Alzheimer's type. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for EXELON (U.S. Patent No. 4,948,807) from 
Novartis, and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated May 2, 2001, FDA advised the Patent and 
Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of EXELON 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 
EXELON is 3,424 days. Of this time, 2,313 days occurred during the 
testing phase of the regulatory review period, while 1,111 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: 
December 8, 1990. The applicant claims November 7, 1990, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was December 
8, 1990, 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: April 7, 1997. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for EXELON (NDA 20-823) was initially submitted on April 7, 1997.
    3. The date the application was approved: April 21, 2000. FDA has 
verified the applicant's claim that NDA 20-823 was approved on April 
21, 2000.
    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 1,825 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 June 
20, 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 October 20, 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 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: March 31, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-9663 Filed 4-18-03; 8:45 am]
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