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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 95E-0385]

Determination of Regulatory Review Period for Purposes of Patent

Extension; PRECOSETM

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 PRECOSETM 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

[[Page 27086]]

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

PRECOSETM (acarbose). PRECOSETM is indicated as an adjunct to

diet to lower blood glucose in patients with noninsulin-dependent

diabetes mellitus who hyperglycemia cannot be managed by diet alone.

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

patent term restoration application for PRECOSETM (U.S. Patent No.

4,904,769) from Bayer AG, and the Patent and Trademark Office requested

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

term restoration. In a letter dated December 27, 1995, FDA advised the

Patent and Trademark Office that this human drug product had undergone

a regulatory review period that the approval of PRECOSETM

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

PRECOSETM is 5,647 days. Of this time, 3,789 days occurred during

the testing phase of the regulatory review period, while 1,858 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 23,

1980. FDA has verified the applicant's claim that the date that the

investigational new drug application became effective was on March 23,

1980.

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 6, 1990. The applicant claims August 9, 1990,

as the date the new drug application (NDA) for PRECOSETM (NDA 20-

086) was initially submitted. However, FDA records indicate that NDA

20-086 for the active ingredient in PRECOSETM (acarbose) was

received by the agency on August 6, 1990. This NDA was withdrawn on

August 28, 1991. A subsequent NDA for PRECOSETM (NDA 20-482) was

received on September 6, 1994. Therefore, NDA 20-086 signifies the end

of the testing phase and the beginning of the approval phase for

PRECOSETM, while NDA 20-482 signifies the end of the approval

phase. The NDA initially submitted date is August 6, 1990.

3. The date the application was approved: September 6, 1995. FDA

verified the applicant's claim that NDA 20-482 was approved on

September 6, 1995.

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 922 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before July 29, 1996, 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 November 26, 1996, 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: May 16, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96-13535 Filed 5-29-96; 8:45 am]

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