[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
