Determination of Regulatory Review Period for Purposes of Patent Extension; Neuro Cybernetic Prosthesis (NCPRegister) System

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0228]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Neuro Cybernetic Prosthesis (NCP) 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 Neuro Cybernetic Prosthesis

(NCP) 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 Neuro

Cybernetic Prosthesis (NCP) System. Neuro Cybernetic

Prosthesis (NCP) System is indicated for use as an adjunctive

therapy in reducing the frequency of seizures in adults and adolescents

over 12 years of age with partial onset seizures, which are refractory

to antiepileptic medications. Subsequent to this approval, the Patent

and Trademark Office received a patent term restoration application for

Neuro Cybernetic Prosthesis (NCP) System (U.S. Patent No.

4,867,164) from Cyberonics, 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 May 22, 1998, FDA advised

the Patent and Trademark Office that this medical device had undergone

a regulatory review period and that the approval of Neuro Cybernetic

Prosthesis (NCP) 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

Neuro Cybernetic Prosthesis (NCP) System is 3,237 days. Of

this time, 3,066 days occurred during the testing phase of the

regulatory review period, while 171 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 6, 1988. The applicant claims that 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 15, 1988. However, FDA

records indicate that the IDE was determined substantially complete for

clinical studies to have begun on September 6, 1988, which represents

the IDE effective date.

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

the device under section 515 of the act (21 U.S.C. 360e): January 27,

1997. The applicant claims December 16, 1991, as the date the premarket

approval application (PMA) for Neuro Cybernetic Prosthesis

(NCP) System (PMA 910070) was initially submitted. However,

FDA records indicate that PMA 910070 submitted on December 6, 1991, was

incomplete. FDA refused this application and notified the applicant of

this fact by letter dated February 11, 1992. The completed PMA was then

submitted and renumbered PMA 970003 on January 27, 1997, which is

considered to be the PMA initially submitted date.

3. The date the application was approved: July 16, 1997. FDA has

verified the applicant's claim that PMA 970003 was approved on July 16,

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 1,761 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before January 11, 1999, 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 10, 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

[[Page 63067]]

(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 2, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-30005 Filed 11-9-98; 8:45 am]

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