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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0066]

Determination of Regulatory Review Period for Purposes of Patent

Extension; ARICEPTTM

AGENCY: Food and Drug Administration, HHS.

[[Page 38565]]

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the

regulatory review period for ARICEPTTM 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

ARICEPTTM (donepezil hydrochloride). ARICEPTTM is

indicated for the treatment of mild to moderate dementia of the

Alzheimer's type. Subsequent to this approval, the Patent and Trademark

Office received a patent term restoration application for

ARICEPTTM (U.S. Patent No. 4,895,841) from Eisai 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 April 10, 1997, FDA advised the Patent and Trademark

Office that this human drug product had undergone a regulatory review

period and the approval of ARICEPTTM 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

ARICEPTTM is 2,135 days. Of this time, 1,900 days occurred

during the testing phase of the regulatory review period, while 235

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: January 23,

1991. The applicant claims January 19, 1991, as the date the

investigational new drug application (IND) became effective. However,

FDA records indicate that the IND effective date was January 23, 1991,

which was 30 days after FDA receipt of the IND.

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: April 5, 1996. The applicant claims March 29, 1996,

as the date the new drug application (NDA) for ARICEPTTM

(NDA 20-690) was initially submitted. However, FDA records indicate

that NDA 20-690 was submitted on April 5, 1996, the date the NDA and

user fee payment was received.

3. The date the application was approved: November 25, 1996. FDA

has verified the applicant's claim that NDA 20-690 was approved on

November 25, 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 888 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. 97-18916 Filed 7-17-97; 8:45 am]

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