[Federal Register Volume 68, Number 62 (Tuesday, April 1, 2003)]
[Notices]
[Pages 15730-15731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E-1404]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; LEVULAN KERASTICK

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 LEVULAN KERASTICK 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 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

[[Page 15731]]

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 LEVULAN 
KERASTICK (aminolevulinic acid HCl). THE LEVULAN KERASTICK for topical 
solution plus blue light illumination using the BLU-U Blue Light 
Photodynamic Therapy Illuminator is indicated for the treatment of 
nonhyperkeratotic actinic keratoses of the face or scalp. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for LEVULAN KERASTICK (U.S. Patent No. 
5,079,262) from DUSA Pharmaceuticals, Inc., 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 LEVULAN KERASTICK 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 
LEVULAN KERASTICK is 2,528 days. Of this time, 2,007 days occurred 
during the testing phase of the regulatory review period, while 521 
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: 
January 2, 1993. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
January 2, 1993.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the act: July 1, 1998. FDA 
has verified the applicant's claim that the new drug application (NDA) 
for LEVULAN KERASTICK (NDA 20-965) was initially submitted on July 1, 
1998.
    3. The date the application was approved: December 3, 1999. FDA has 
verified the applicant's claim that NDA 20-965 was approved on December 
3, 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 1,524 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 or electronic comments and ask for a redetermination by June 2, 
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 September 29, 
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 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: February 7, 2003.
Jane A. Axelrad,
Associate Director of Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-7711 Filed 3-31-03; 8:45 am]
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