Determination of Regulatory Review Period for Purposes of Patent Extension; Tisseel VH Kit

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0791]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Tisseel VH Kit

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 Tisseel VH Kit 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 human biological product.

ADDRESSES: Written comments and petitions should be directed to the

Dockets Management Branch (HFA-305), Food and Drug Administration, 5630

Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health

Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301-827-6620.

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 human biological products, the

testing phase begins when the exemption to permit the clinical

investigations of the biological becomes effective and runs until the

approval phase begins. The approval phase starts with the initial

submission of an application to market the human biological product and

continues until FDA grants permission to market the biological 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 a human biological product will include all of the testing

phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing the human biological product

Tisseel VH Kit. Tisseel VH Kit is indicated for use as an adjunct to

hemostasis in surgeries involving cardiopulmonary bypass and treatment

of splenic injuries due to blunt or penetrating trauma to the abdomen,

when control of bleeding by conventional surgical techniques, including

suture, ligature, and cautery is ineffective or impractical, and also

as an adjunct for the closure of colostomies. Subsequent to this

approval, the Patent and Trademark Office received a patent term

restoration application for Tisseel VH Kit (U.S. Patent No. 4,362,567)

from Immuno Aktiengesellschaft fur chemsih-medizinshe Produkte, and the

Patent and Trademark Office requested FDA's assistance in determining

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

dated October 7, 1998, FDA advised the Patent and Trademark Office that

this human biological product had undergone a regulatory review period

and that the approval of Tisseel VH Kit 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

Tisseel VH Kit is 5,065 days. Of this time, 1,203 days occurred during

the testing phase of the regulatory review

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period, while 3,862 days occurred during the approval phase. These

periods of time were derived from the following dates:

1. The date an exemption under section 351 of the Public Health

Service Act became effective: June 20, 1984. FDA has verified the

applicant's claim that the date the investigational new drug

application became effective was on June 20, 1984.

2. The date the application was initially submitted with respect

to the human biological product under section 351 of the Public Health

Service Act: October 5, 1987. FDA has verified the applicant's claim

that the product license application (PLA) for Tisseel VH Kit (PLA 87-

0509) was initially submitted on October 5, 1987.

3. The date the application was approved: May 1, 1998. FDA has

verified the applicant's claim that PLA 87-0509 was approved on May 1,

1998.

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 1,827 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before January 25, 1999, 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 24, 1999, 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 4, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-31413 Filed 11-24-98; 8:45 am]

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