[Federal Register Volume 63, Number 71 (Tuesday, April 14, 1998)]
[Notices]
[Pages 18204-18205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97E-0109]


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

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 LEVAQUINTM 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: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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 
LEVAQUINTM (levofloxacin). LEVAQUINTM is 
indicated for the treatment of adults ( 18 years of age) 
with mild, moderate, and severe infections caused by susceptible 
strains of the designated microorganisms in the conditions: Acute 
maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus 
influenzae, or Moraxella catarrhalis; Community-acquired pneumonia due 
to Staphylococcus aureus, S. pneumoniae, H. influenzae, H. 
parainfluenzae, Klebsiella pneumoniae, M. catarrhalis, Chlamydia 
pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae; 
Uncomplicated skin and skin structure infections (mild to moderate) 
including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound 
infections, due to S. aureus or S. pyrogenes; Complicated urinary tract 
infections (mild to moderate) due to Enterococcus faecalis, 
Enterobacter cloacae, Escherichia coli, K. pneumoniae, Proteus 
mirabilis, or Pseudomonas aeruginosa; Acute pyelonephritis (mild to 
moderate) caused by E. coli. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
LEVAQUINTM (U.S. Patent No. 5,053,407) from Daiichi 
Pharmaceutical Co., 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 July 18, 1997, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of 
LEVAQUINTM represented the first permitted commercial 
marketing or use of the product. Shortly thereafter, the Patent and 
Trademark Office requested that the FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
LEVAQUINTM is 2,059 days. Of this time, 1,693 days occurred 
during the testing phase of the regulatory review period, 366 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 (21 U.S.C. 355) became effective: May 4, 1991. 
The applicant claims May 3, 1991, as the date the investigational new 
drug application (IND) became effective. However, FDA records indicate 
that the IND effective date was May 4, 1991, 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 of the Federal Food, Drug, and 
Cosmetic Act: December 21, 1995. FDA has verified the applicant's claim 
that the new drug application (NDA) for LEVAQUINTM NDA 20-
634 was initially submitted on December 21, 1995.
    3. The date the application was approved: December 20, 1996. FDA 
has verified the applicant's claim that NDA 20-634 was approved on 
December 20, 1996.
    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,

[[Page 18205]]

this applicant seeks 811 days of patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before June 15, 1998, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before October 13, 1998, for a determination regarding whether 
the applicant for extension acted with due diligence during the 
regulatory review period. 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 (address above) in three copies (except that 
individuals may submit single copies) and 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, 1998.
 Thomas J. McGinnis,
 Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-9703 Filed 4-13-98; 8:45 am]
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