[Federal Register Volume 62, Number 28 (Tuesday, February 11, 1997)]
[Notices]
[Pages 6263-6264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0387]


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

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 DECTOMAX 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 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 
DECTOMAX (doramectin). DECTOMAX is indicated for cattle treatment and 
control of gastrointestinal roundworms, lungworms, eyeworms, grubs, 
lice, and mange mites, and protection against infection or reinfection 
with Ostertagla ostertagia for up to 21 days. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for DECTOMAX (U.S. Patent No. 5,089,480) from 
Pfizer, Inc., 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 25, 1996, FDA advised the Patent 
and Trademark Office that this animal drug product had undergone a 
regulatory review period and that the approval of DECTOMAX 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 
DECTOMAX is 2,836 days. Of this time, 2,695 days occurred during the 
testing phase of the regulatory review period, while 141 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: October 26, 1988. The 
applicant claims December 7, 1988, 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 October 26, 1988, which is 
considered to be the effective date for the INAD.

[[Page 6264]]

    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the Federal Food, Drug, 
and Cosmetic Act: March 12, 1996. The applicant claims March 7, 1996, 
as the date the new animal drug application (NADA) for DECTOMAX (NADA 
141-061) was initially submitted. However, FDA records indicate that 
the date of FDA's official acknowledgment letter assigning a number to 
the NADA was March 12, 1996, which is considered to be the NADA 
initially submitted date.
    3. The date the application was approved: July 30, 1996. FDA has 
verified the applicant's claim that NADA 141-061 was approved on July 
30, 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 527 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before April 14, 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 August 11, 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:January 31, 1997.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 97-3315 Filed 2-10-97; 8:45 am]
BILLING CODE 4160-01-F