Determination of Regulatory Review Period for Purposes of Patent Extension; WiktorRegister Prime Coronary Stent System

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0230]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Wiktor Prime Coronary Stent System

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 Wiktor Prime Coronary Stent

System 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

Wiktor Prime Coronary Stent System. Wiktor Prime

Coronary Stent System is indicated for the treatment of abrupt or

threatened closure in patients with failed interventional therapy in

native coronary arteries and bypass graft vessels. Subsequent to this

approval, the Patent and Trademark Office received a patent term

restoration application for Wiktor Prime Coronary Stent

System (U.S. Patent No. 4,886,062) from Medtronic, 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

June 19, 1998, FDA advised the Patent and Trademark Office that this

medical device had undergone a regulatory review period and that the

approval of Wiktor Prime Coronary Stent System 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

Wiktor Prime Coronary Stent System is 2,489 days. Of this

time, 2,066 days occurred during the testing phase of the regulatory

review period, while 423 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: September 5, 1990. 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 (21 U.S.C.

360j(g)) for human tests to begin became effective September 5, 1990.

2. The date the application was initially submitted with respect

to the device under section 515 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360e): May 1, 1996. The applicant claims April 30, 1996,

as the date the premarket approval application (PMA) for

Wiktor Prime Coronary Stent System (PMA P960010) was

initially submitted. However, FDA records indicate that PMA P960010 was

submitted on May 1, 1996.

3. The date the application was approved: June 27, 1997. FDA has

verified the applicant's claim that PMA P960010 was approved on June

27, 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 1,347 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before December 14, 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 April 12, 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: September 28, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-27392 Filed 10-9-98; 8:45 am]

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