Determination of Regulatory Review Period for Purposes of Patent Extension; PirsueSUPTM Aqueous Gel

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 93E-0387]

Determination of Regulatory Review Period for Purposes of Patent

Extension; PirsueTM Aqueous Gel

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 PirsueTM Aqueous Gel 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

PirsueTM Aqueous Gel (pirlimycin hydrochloride). PirsueTM

Aqueous Gel is indicated for lactating dairy cattle for treatment of

clinical and subclinical mastitis. Subsequent to this approval, the

Patent and Trademark Office received a patent term restoration

application for PirsueTM Aqueous Gel (U.S. Patent No. 4,278,789)

from The Upjohn Co. and requested FDA's assistance in determining the

patent's eligibility for patent term restoration. In a letter dated

November 14, 1993, FDA advised the Patent and Trademark Office that

this animal drug product had undergone a regulatory review period and

that the approval of PirsueTM Aqueous Gel represented the first

permitted commercial marketing or use 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

PirsueTM Aqueous Gel is 3,860 days. Of this time, 3,778 days

occurred during the testing phase of the regulatory review period,

while 82 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: February 17, 1983. The

applicant claims March 8, 1983, 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 February 17, 1983, which is

considered to be the effective date for the INAD.

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: June 21, 1993. The applicant claims June 17, 1993, as

the date the new animal drug application (NADA) 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

June 21, 1993, which is considered to be the initial submission date

for the NADA 141-036.

3. The date the application was approved: September 10, 1993. FDA

has verified the applicant's claim that NADA 141-036 was approved on

September 10, 1993.

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 1,095 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before May 2, 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 August 30, 1994, 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 24, 1994.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 94-4801 Filed 3-2-94; 8:45 am]

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