Determination of Regulatory Review Period for Purposes of Patent Extension; CPIRegister VentakRegister PRxRegister AICD System

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 94E-0315]

Determination of Regulatory Review Period for Purposes of Patent

Extension; CPI Ventak PRx AICD 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 CPI Ventak

PRx AICD 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, rm.

1-23, 12420 Parklawn Dr., 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 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

CPI Ventak PRx AICD System. CPI

Ventak PRx AICD System is indicated for the

treatment of patients with ventricular fibrillation and/or ventricular

tachyarrhythmias who are at high risk of sudden cardiac death.

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

patent term restoration application for CPI Ventak

PRx AICD System (U.S. Patent No. 4,407,288) from Cardiac

Pacemakers, Inc., and the Patent and Trademark Office requested FDA's

assistance in determining this patent's eligibility for patent term

restoration. FDA, in a letter dated September 21, 1994, advised the

Patent and Trademark Office that this medical device had undergone a

regulatory review period and that the approval of CPI

Ventak PRx AICD System represented the first

commercial marketing of the product. Shortly thereafter, the Patent and

Trademark Office requested that the FDA determine the product's

regulatory review period.

FDA has determined that the applicable regulatory review period for

CPI Ventak PRx AICD System is 1,306 days.

Of this time, 398 days occurred during the testing phase of the

regulatory review period, while 908 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: November 21, 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 (the act)

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

November 21, 1990.

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

the device under section 515 of the act (21 U.S.C. 360e): December 23,

1991. The applicant claims December 20, 1991, as the date the premarket

approval application (PMA) for CPI Ventak

PRx AICD (PMA P910077) was initially submitted. However, FDA

records indicate that PMA P910077 was submitted on December 23, 1991.

3. The date the application was approved: June 17, 1994. FDA has

verified the applicant's claim that PMA P910077 was approved on June

17, 1994.

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 394 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before January 17, 1995, 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 May 15, 1995, 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. 41-2, 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: November 3, 1994.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 94-28064 Filed 11-14-94; 8:45 am]

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