Determination of Regulatory Review Period for Purposes of Patent Extension; Cook GRIISUPTM/SUP Coronary Stent

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0461]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Cook GRIITM Coronary Stent

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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

regulatory review period for Cook GRIITM Coronary Stent 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 medical device.

ADDRESSES: Written comments and petitions should be directed to the

Dockets Management Branch (HFA-305), Food and Drug Administration, 5630

Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health

Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301-827-6620.

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 medical devices, the testing

phase begins with a clinical investigation of the device and runs until

the approval phase begins. The approval phase starts with the initial

submission of an application to market the device and continues until

permission to market the device is granted. 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

(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 medical device will include

all of the testing phase and approval phase as specified in 35 U.S.C.

156(g)(3)(B).

FDA recently approved for marketing the medical device Cook

GRIITM Coronary Stent. Cook GRIITM Coronary Stent

is indicated for treatment of acute or threatened closure in patients

with failed interventional therapy in vessels with reference diameters

in the range of 2.1 mm to 4.0 mm. Subsequent to this approval, the

Patent and Trademark Office received a patent term restoration

application for Cook GRIITM Coronary Stent (U.S. Patent No.

5,041,126) from Cook, 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 December 29, 1997, FDA

advised the Patent and Trademark Office that this medical device had

undergone a regulatory review period and that the approval of Cook

GRIITM Coronary Stent 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

Cook GRIITM Coronary Stent is 511 days. Of this time, 343

days occurred during the testing phase of the regulatory review period,

while 168 days occurred during the approval phase. These periods of

time were derived from the following dates:

1. The date a clinical investigation involving this device was

begun: December 20, 1995. FDA has verified the applicant's claim that

the date the investigational device exemption (IDE) required under

section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360j(g)) for human tests to begin became effective December

20, 1995.

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

the device under section 515 of the act (21 U.S.C. 360e): November 26,

1996. The applicant claims November 23, 1996, as the date the Premarket

Approval Application (PMA) for Cook GRIITM Coronary Stent

(PMA 910030) was initially submitted. However, FDA records indicate

that PMA 910030 was submitted on November 26, 1996.

3. The date the application was approved: May 12, 1997. FDA has

verified the applicant's claim that PMA 910030 was approved on May 12,

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 341 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before October 6, 1998, 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 February 3, 1999, 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, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-21089 Filed 8-6-98; 8:45 am]

BILLING CODE 4160-01-F