[Federal Register Volume 62, Number 52 (Tuesday, March 18, 1997)]
[Notices]
[Pages 12831-12832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6719]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96E-0504]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BAYTRIL
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 BAYTRIL 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,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Brian J. 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 (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
[[Page 12832]]
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
BAYTRIL (enrofloxacin). BAYTRIL is indicated for
chickens to control mortality associated with Escherichia coli
susceptible to enrofloxacin, and for turkeys to control mortality
associated with E. coli and Pasturella multocida (fowl cholera)
susceptible to enrofloxacin. Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
BAYTRIL (U.S. Patent No. 4,670,444) from Bayer
Aktiengesellschaft and requested FDA's assistance in determining the
patent's eligibility for patent term restoration. In a letter dated
January 21, 1997, FDA advised the Patent and Trademark Office that this
animal drug product had undergone a regulatory review period and that
the approval of BAYTRIL represented the first commercial
marketing 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
BAYTRIL is 4,334 days. Of this time, 648 days occurred during
the testing phase of the regulatory review period, while 3,686 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: November 24, 1984. The
applicant claims November 20, 1984, as the date the investigational new
animal drug application (INAD) became effective. However, FDA records
indicate that the date of FDA's official acknowledgment letter
assigning a number to the INAD was November 24, 1984, which is
considered to be the effective date for the INAD.
2. The date the application was initially submitted with respect to
the human drug product under section 512(b) of the Federal Food, Drug,
and Cosmetic Act: September 2, 1986. The applicant claims August 26,
1986, as the date the new animal drug application (NADA) for
BAYTRIL (NADA 140-828) was initially submitted. However, a
review of FDA records reveals that the date of FDA's official
acknowledgment letter assigning a number to the NADA was September 2,
1986, which is considered to be the initially submitted date for the
NADA.
3. The date the animal drug was approved: October 4, 1996. FDA has
verified the applicant's claim that NADA 140-828 was approved on
October 4, 1996.
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 1,827 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before May 19, 1997, 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 September 15, 1997, 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: March 6, 1997.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 97-6719 Filed 3-17-97; 8:45 am]
BILLING CODE 4160-01-F
