[Federal Register: August 1, 2003 (Volume 68, Number 148)]
[Notices]
[Page 45245-45246]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au03-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E-0036]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SPECTRACEF
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 SPECTRACEF 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 Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda/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 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
SPECTRACEF (cefditoren pivoxil). SPECTRACEF is indicated for treatment
of acute exacerbation of chronic bronchitis, pharyngitis/tonsillitis,
and uncomplicated skin and skin structure infections. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for SPECTRACEF (U.S. Patent No. 4,839,350) from
Meiji Seika Kaisha, 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 February 4, 2003, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of SPECTRACEF
represented the first permitted commercial marketing or use of the
[[Page 45246]]
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
SPECTRACEF is 1,461 days. Of this time, 851 days occurred during the
testing phase of the regulatory review period, while 610 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:
August 31, 1997. The applicant claims August 30, 1997, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 31, 1997,
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(b) of the act: December 29,
1999. FDA has verified the applicant's claim that the new drug
application (NDA) for SPECTRACEF (NDA 21-222) was initially submitted
on December 29, 1999.
3. The date the application was approved: August 29, 2001. FDA has
verified the applicant's claim that NDA 21-222 was approved on August
29, 2001.
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 1,032 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 January 29, 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 January
29, 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. Copies 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: July 14, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-19621 Filed 7-31-03; 8:45 am]
BILLING CODE 4160-01-S