[Federal Register: March 15, 2004 (Volume 69, Number 50)]
[Page 12160-12161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2003E-0449, 2003E-0448, and 2003E-0411]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for FACTIVE and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of three applications to the Director of 
Patents and Trademarks, Department of Commerce, for the extension of 
three patents that claim that human drug product.

ADDRESSES: Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, 240-453-6699.

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.

[[Page 12161]]

 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 FACTIVE 
(gemifloxacin mesylate). FACTIVE is indicated for the treatment of 
infections caused by susceptible strains of certain designated 
microorganisms in particular conditions. Subsequent to this approval, 
the Patent and Trademark Office received three patent term restoration 
applications for FACTIVE (U.S. Patent Nos. 5,962,468, 5,776,944, and 
5,633,262) from LG Life Sciences, and the Patent and Trademark Office 
requested FDA's assistance in determining these patents' eligibility 
for patent term restoration. In a letter dated November 18, 2003, FDA 
advised the Patent and Trademark Office that this human drug product 
had undergone a regulatory review period and that the approval of 
FACTIVE 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 
FACTIVE is 2,038 days. Of this time, 832 days occurred during the 
testing phase of the regulatory review period, while 1,206 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: 
September 6, 1997. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
September 6, 1997.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: December 16, 
1999. The applicant claims December 15, 1999, as the date the new drug 
application (NDA) for FACTIVE (NDA 21-158) was initially submitted. 
However, FDA records indicate that NDA 21-158 was submitted on December 
16, 1999.
    3. The date the application was approved: April 4, 2003. FDA has 
verified the applicant's claim that NDA 21-158 was approved on April 4, 
    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 each of 
the three applications for patent term extension, this applicant seeks 
659 days of patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by May 14, 2004. 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 13, 
2004. 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 Division of 
Dockets Management. 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 numbers found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 17, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-5759 Filed 3-12-04; 8:45 am]