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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E-0315]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Nuflor

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 Nuflor 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

[[Page 60107]]

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

Nuflor (florfenicol). Nuflor is indicated for

treatment of bovine respiratory disease (BRD), associated with

Pasteurella haemolytica, P. multocida, and Haemophilus somnus.

Subsequent to this approval, the Patent and Trademark Office received a

patent term restoration application for Nuflor (U.S. Patent

No. 4,235,892) from Schering Corp. and the Patent and Trademark Office

requested FDA's assistance in determining the patent's eligibility for

patent term restoration. In a letter dated September 17, 1996, FDA

advised the Patent and Trademark Office that this animal drug product

had undergone a regulatory review period and that the approval of

Nuflor 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

Nuflor is 4,209 days. Of this time, 4,205 days occurred

during the testing phase of the regulatory review period, while 4 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: November 23, 1984. FDA has

verified the applicant's claim that November 23, 1984, was the date

that the investigational new animal drug application became effective.

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: May 28, 1996. FDA has verified the applicant's claim

that May 28, 1996, was the date that the new animal drug application

(NADA) for Nuflor (NADA 141-063) was initially submitted.

3. The date the animal drug was approved: May 31, 1996. FDA has

verified the applicant's claim that NADA 141-063 was approved on May

31, 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 1,096 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before January 27, 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 May 27, 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: November 18, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96-30196 Filed 11-25-96; 8:45 am]

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