Determination of Regulatory Review Period for Purposes of Patent Extension; PRELAYSUPTM/SUP and REZULINSUPTM/SUP

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0145]

Determination of Regulatory Review Period for Purposes of Patent

Extension; PRELAYTM and REZULINTM

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 PRELAYTM and

REZULINTM 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 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 products

PRELAYTM and REZULINTM (troglitazone).

PRELAYTM and REZULINTM are indicated for use in

patients with type II diabetes currently on insulin therapy whose

hyperglycemia is inadequately controlled (HbAlc>8.5%)

despite insulin therapy of over 30 units per day given as multiple

injections. Subsequent to this approval, the Patent and Trademark

Office received a patent term restoration application for

PRELAYTM and REZULINTM (U.S. Patent No.

4,572,912) from Sankyo Co., Ltd., and the Patent and Trademark Office

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

patent term restoration. In a letter dated January 21, 1997, FDA

advised the Patent and Trademark

[[Page 46502]]

Office that these human drug products had undergone a regulatory review

period and that the approvals of PRELAYTM and

REZULINTM represented the first permitted commercial

marketing or use of the products. Shortly thereafter, the Patent and

Trademark Office requested that the FDA determine the product's

regulatory review period.

FDA has determined that the applicable regulatory review period for

PRELAYTM and REZULINTM is 2,885 days. Of this

time, 2,703 days occurred during the testing phase of the regulatory

review period, while 182 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: March 9,

1989. FDA has verified the applicant's claim that the date that the

investigational new drug application became effective was on March 9,

1989.

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: August 1, 1996. The applicant claims July 31, 1996,

as the date the New Drug Applications (NDA's) for PRELAYTM

(NDA 20-719) and REZULINTM (NDA 20-720) were initially

submitted. However, FDA records indicate that NDA's 20-719 and 20-720

were submitted on August 1, 1996.

3. The date the application was approved: January 29, 1997. FDA has

verified the applicant's claim that NDA's 20-719 and 20-720 were

approved on January 29, 1997.

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 1,534 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before November 3, 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 March 2, 1998, 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: July 24, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health Affairs.

[FR Doc. 97-23244 Filed 9-2-97; 8:45 am]

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