[Federal Register: November 2, 2004 (Volume 69, Number 211)]
[Notices]
[Page 63547-63548]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002E-0340]
Determination of Regulatory Review Period for Purposes of Patent
Extension; GANIRELIX ACETATE INJECTION (Formerly ANTAGON)
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 GANIRELIX ACETATE INJECTION 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
[[Page 63548]]
extension of a patent that claims 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 V. 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.
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
GANIRELIX ACETATE INJECTION (ganirelix acetate). GANIRELIX ACETATE
INJECTION is indicated for the inhibition of premature LH surges in
women undergoing controlled ovarian hyperstimulation. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for GANIRELIX ACETATE INJECTION (U.S. Patent
No. 4,801,577) from Syntex, and the Patent and Trademark Office
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated December 30, 2002, FDA
advised the Patent and Trademark Office that this human drug product
had undergone a regulatory review period and that the approval of
GANIRELIX ACETATE INJECTION 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
GANIRELIX ACETATE INJECTION is 3,558 days. Of this time, 3,376 days
occurred during the testing phase of the regulatory review period,
while 182 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:
November 2, 1989. The applicant claims October 3, 1989, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was November 2, 1989,
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 act: January 29, 1999.
The applicant claims January 28, 1999, as the date the new drug
application (NDA) for GANIRELIX ACETATE INJECTION (NDA 21-057) was
initially submitted. However, FDA records indicate that NDA 21-057 was
submitted on January 29, 1999.
3. The date the application was approved: July 29, 1999. FDA has
verified the applicant's claim that NDA 21-057 was approved on July 29,
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 5 years 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 January 3, 2005. 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 May 2, 2005.
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 (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 Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: October 15, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-24378 Filed 11-1-04; 8:45 am]
BILLING CODE 4160-01-S