Determination of Regulatory Review Period for Purposes of Patent Extension; CLARINEX, 43159-43160 [05-14695]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 142 (Tuesday, July 26, 2005)]
[Notices]
[Pages 43159-43160]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002E-0097] (formerly Docket No. 02E-0097)


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 43160]]

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for CLARINEX 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 
which 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 https://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. 
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 CLARINEX 
(desloratadine). CLARINEX is indicated for the relief of the nasal and 
non-nasal symptoms of allergic rhinitis in patients 12 years of age and 
older, and for the symptomatic relief of pruritis, reduction in the 
number and size of hives, in patients with chronic, idiopathic 
urticaria 12 years of age and older. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for CLARINEX (U.S. Patent No. 4,659,716) from Schering 
Corp., and the Patent and Trademark Office requested FDA's assistance 
in determining this patent's eligibility for patent term restoration. 
In a letter dated April 26, 2002, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of CLARINEX 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 
CLARINEX is 1,354 days. Of this time, 561 days occurred during the 
testing phase of the regulatory review period, while 793 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: 
April 9, 1998. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on April 9, 
1998.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: October 21, 
1999. FDA has verified the applicant's claim that the new drug 
application (NDA) for CLARINEX (NDA 21-165) was initially submitted on 
October 21, 1999.
    3. The date the application was approved: December 21, 2001. FDA 
has verified the applicant's claim that NDA 21-165 was approved on 
December 21, 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 1,074 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 September 26, 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 January 
23, 2006. 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 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: June 29, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 05-14695 Filed 7-25-05; 8:45 am]
BILLING CODE 4160-01-S