[Federal Register: March 15, 2004 (Volume 69, Number 50)]
[Notices]
[Page 12160-12161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr04-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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,
2003.
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]
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