[Federal Register Volume 59, Number 171 (Tuesday, September 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21789]


[[Page Unknown]]

[Federal Register: September 6, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94E-0221]

 

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

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 Aviax 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 
Commissioner of Patents and Trademarks, Department of Commerce, for the 
extension of a patent which claims that animal drug product.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian Malkin, Office of Health Affairs 
(HFY-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-443-1382.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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 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 Commissioner 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 recently approved for marketing the animal drug product 
Aviax (semduramicin sodium). Aviax is indicated for 
prevention of coccidiosis in broiler chickens. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for Aviax (U.S. Patent No. 4,804,680) 
from Pfizer Inc. and requested FDA's assistance in determining the 
patent's eligibility for patent term restoration. FDA, in a letter 
dated July 8, 1994, advised the Patent and Trademark Office that this 
animal drug product had undergone a regulatory review period and that 
the approval of Aviax 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 
Aviax is 2,438 days. Of this time, 736 days occurred during 
the testing phase of the regulatory review period, while 1,702 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 became effective: July 9, 1987. The applicant 
claims October 1, 1987, as the date the investigational new animal drug 
application (INAD) became effective. However, FDA records indicate that 
the date of FDA's official acknowledgement letter assigning a number to 
the INAD was July 9, 1987, which is considered to be the effective date 
for the INAD.
    2. The date the application was initially submitted with respect to 
the animal drug product application under section 512(b) of the Federal 
Food, Drug, and Cosmetic Act: July 13, 1989. The applicant claims July 
12, 1989, as the date the new animal drug application (NADA) for 
Aviax (NADA 140-940) was initially submitted. However, a 
review of FDA records reveals that the date of FDA's official 
acknowledgement letter assigning a number to the NADA was July 13, 
1989, which is considered to be the initially submitted date for the 
NADA.
    3. The date the application was approved: March 10, 1994. FDA has 
verified the applicant's claim that NADA 140-940 was approved on March 
10, 1994.
    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 755 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before November 7, 1994, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before March 6, 1995, for a determination regarding whether the 
applicant for extension acted with due diligence during the regulatory 
review period. 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 Dockets 
Management Branch (address above) in three copies (except that 
individuals may submit single copies) and identified with the docket 
number found in brackets in the heading of this document. Comments and 
petitions may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: August 25, 1994.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-21789 Filed 9-2-94; 8:45 am]
BILLING CODE 4160-01-F