[Federal Register Volume 68, Number 75 (Friday, April 18, 2003)]
[Notices]
[Pages 19212-19213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E-1248]


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

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 TIKOSYN and is publishing this notice of 
that determination as required by law. FDA has made the determination

[[Page 19213]]

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 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 TIKOSYN 
(methanesulfonamide). TIKOSYN is approved for the following 
indications: (1) Maintenance of normal sinus rhythm (delay in time to 
recurrence of atrial fibrillation/atrial flutter (AF/AFl)) in patients 
with AF/AFl of greater than 1 week duration who have been converted to 
normal sinus rhythm; and (2) conversion of AF/AFl to normal sinus 
rhythm. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for TIKOSYN (U.S. Patent 
No. 4,959,366) from Pfizer, 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 TIKOSYN 
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 
TIKOSYN is 3,350 days. Of this time, 2,778 days occurred during the 
testing phase of the regulatory review period, while 572 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: 
August 1, 1990. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on August 
1, 1990.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: March 9, 1998. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for TIKOSYN (NDA 20-931) was initially submitted on March 9, 
1998.
    3. The date the application was approved: October 1, 1999. FDA has 
verified the applicant's claim that NDA 20-931 was approved on October 
1, 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 1,827 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 
17, 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 15, 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 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 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. 03-9578 Filed 4-17-03; 8:45 am]
BILLING CODE 4160-01-S