Determination of Regulatory Review Period for Purposes of Patent Extension; GLYSETSUPTM/SUP

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0077]

Determination of Regulatory Review Period for Purposes of Patent

Extension; GLYSETTM

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 GLYSETTM 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 product

GLYSETTM (miglitol). GLYSETTM is indicated as an

adjunct to diet to improve glycemic control in patients with non-

insulin-dependent diabetes mellitus whose hyperglycemia cannot be

managed with diet alone. GLYSETTM may also be used in

combination with a sulfonylurea when diet plus either

GLYSETTM or a sulfonylurea alone do not result in adequate

glycemic control. Subsequent to this approval, the Patent and Trademark

Office received a patent term restoration application for

GLYSETTM (U.S. Patent No. 4,639,436) from Bayer

Aktiengesellschaft, and the Patent and Trademark Office requested FDA's

assistance in determining this patent's eligibility for patent term

restoration. In a letter dated March 21, 1997, FDA advised the Patent

and Trademark Office that this human drug product had undergone a

regulatory review period and that the approval of GLYSETTM

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

GLYSETTM is 4,900 days. Of this time, 4,544 days occurred

during the testing phase of the regulatory review period, while 356

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: July 22,

1983. FDA has verified the applicant's claim that the date that the

investigational new drug application became effective was on July 22,

1983.

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: December 29, 1995. FDA has verified the applicant's

claim that the new drug application (NDA) for GLYSETTM (NDA

20-682) was initially submitted on December 29, 1995.

3. The date the application was approved: December 18, 1996. FDA

has verified the applicant's claim that NDA

[[Page 38562]]

20-682 was approved on December 18, 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 1,827 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before September 16, 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 January 14, 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 8, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health Affairs.

[FR Doc. 97-18909 Filed 7-17-97; 8:45 am]

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