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

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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