[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