[Federal Register Volume 59, Number 42 (Thursday, March 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4801]


[[Page Unknown]]

[Federal Register: March 3, 1994]


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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]
BILLING CODE 4160-01-F