[Federal Register Volume 59, Number 140 (Friday, July 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17814]


[[Page Unknown]]

[Federal Register: July 22, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94E-0158]

 

Determination of Regulatory Review Period for Purposes of Patent 
Extension; Cattlyst 50 Type A Medicated Article

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 Cattlyst 50 Type A Medicated 
Article 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 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 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 
Cattlyst 50 Type A Medicated Article (laidlomycin propionate 
potassium). Cattlyst 50 Type A Medicated Article is indicated 
for improved feed efficiency and increased rate of weight gain. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for Cattlyst 50 Type A 
Medicated Article (U.S. Patent No. 4,431,665) from Syntex (U.S.A), 
Inc., and requested FDA's assistance in determining the patent's 
eligibility for patent term restoration. FDA, in a letter dated May 19, 
1994, advised the Patent and Trademark Office that this animal drug 
product had undergone a regulatory review period and that the approval 
of Cattlyst 50 Type A medicated Article represented the first 
permitted commercial marketing or use of the product. Shortly 
thereafter, the Patent and Trademark Office requested that the FDA 
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
Cattlyst 50 Type A Medicated Article is 4,253 days. Of this 
time, 3,762 days occurred during the testing phase of the regulatory 
review period, while 491 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 14, 1982. FDA has 
verified the applicant's claim that the date the investigational new 
animal drug application (INAD) became effective was July 14, 1982.
    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: October 30, 1992. FDA has verified the applicant's 
claim that the date the new animal drug application (NADA) for 
Cattlyst 50 Type A Medicated Article (NADA 141-025) was 
initially submitted was October 30, 1992.
    3. The date the application was approved: March 4, 1994. FDA has 
verified the applicant's claim that NADA 141-025 was approved on March 
4, 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 3 years of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before September 20, 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 January 25, 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: July 14, 1994.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-17814 Filed 7-21-94; 8:45 am]
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