[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Notices]
[Pages 44032-44033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999E-5113]


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

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 CLINACOX 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 animal 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.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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 animal drug products, the 
testing phase begins on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360b(j)) became effective and runs until the approval 
phase begins. The approval phase starts with the initial submission of 
an application to market the animal 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 an animal 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA approved for marketing the animal drug product CLINACOX 
(diclazuril). CLINACOX is indicated for use in broiler chickens, for 
the prevention of coccidicosis caused by

[[Page 44033]]

Eimeria tenella, E. necatrix, E. acervulina, E. brunette, E. mitis 
(mivati), and E. maxima. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
CLINACOX (U.S. Patent No. 4,631,278) from Janssen Pharmaceutica N.V., 
and the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated October 4, 2000, FDA advised the Patent and Trademark 
Office that this animal drug product had undergone a regulatory review 
period and that the approval of CLINACOX 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 
CLINACOX is 5,111 days. Of this time, 1,749 days occurred during the 
testing phase of the regulatory review period, 3,362 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 512(j) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(j)), involving this 
animal drug product, became effective: April 25, 1985. FDA has verified 
the applicant's claim that the date the investigational new animal drug 
application became effective was on April 25, 1985.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the act: February 6, 
1990. The applicant claims January 31, 1990, as the date the new animal 
drug application (NADA) for CLINACOX (NADA 140-951) was initially 
submitted. However, FDA records indicate that NADA 140-951 was 
officially acknowledged and assigned the NADA number on February 6, 
1990, which is considered to be the NADA initially submitted date.
    3. The date the application was approved: April 21, 1999. FDA has 
verified the applicant's claim that NADA 140-951 was approved on April 
21, 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 1,096 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 October 2, 2006. 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 30, 
2007. 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: July 20, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-12572 Filed 8-2-06; 8:45 am]
BILLING CODE 4160-01-S