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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E-0385]

Determination of Regulatory Review Period for Purposes of Patent

Extension; ULTIVATM

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 ULTIVATM 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 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 human drug products, the

testing phase begins when the exemption to permit the clinical

investigations of the drug becomes effective and runs until the

approval phase begins. The approval phase starts

[[Page 6550]]

with the initial submission of an application to market the human 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 a human drug 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 drug product

ULTIVATM (remifentanil hydrochloride). ULTIVATM is indicated

for intravenous administration as follows: (1) As an analgesic agent

for use during the induction and maintenance of general anesthesia for

inpatient and outpatient procedures, and for continuation as an

analgesic into the immediate postoperative period under the direct

supervision of an anesthesia practitioner in a postoperative anesthesia

care unit or intensive care setting; and (2) as an analgesic component

of monitored anesthesia care. Subsequent to this approval, the Patent

and Trademark Office received a patent term restoration application for

ULTIVATM (U.S. Patent No. 5,019,583) from Glaxo Wellcome, Inc.,

and the Patent and Trademark Office requested FDA's assistance in

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

letter dated November 4, 1996, FDA advised the Patent and Trademark

Office that this human drug product had undergone a regulatory review

period and that the approval of ULTIVATM 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

ULTIVATM is 2,222 days. Of this time, 1,920 days occurred during

the testing phase of the regulatory review period, while 302 days

occurred during the approval phase. These periods of time were derived

from the following dates:

1. The date an exemption under section 505(i) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: June 14,

1990. FDA has verified the applicant's claim that the date that the

investigational new drug application became effective was on June 14,

1990.

2. The date the application was initially submitted with respect to

the human drug product under section 505(b) of the Federal Food, Drug,

and Cosmetic Act: September 15, 1995. FDA has verified the applicant's

claim that the new drug application (NDA) for ULTIVATM (NDA 20-

630) was initially submitted on September 15, 1995.

3. The date the human drug was approved: July 12, 1996. FDA has

verified the applicant's claim that NDA 20-630 was approved on July 12,

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 1,088 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before April 14, 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 5, 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: January 31, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97-3417 Filed 2-11-97; 8:45 am]

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