Determination of Regulatory Review Period for Purposes of Patent Extension; RealitySUPTM Female Condom

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 93E-0290]

Determination of Regulatory Review Period for Purposes of Patent

Extension; RealityTM Female Condom

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 RealityTM Female Condom 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 a 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

RealityTM Female Condom. The RealityTM Female Condom is

indicated for use to help prevent pregnancy and sexually transmitted

diseases, including the human immunodeficiency virus (HIV) infection,

during vaginal intercourse. Subsequent to this approval, the Patent and

Trademark Office received a patent term restoration application for the

RealityTM Female Condom (U.S. Patent No. 4,735,621) from Chartex

International Plc, 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 August 10, 1993, advised the Patent

and Trademark Office that this medical device had undergone a

regulatory review period, and that the approval of the RealityTM

Female Condom represented the first commercial marketing or use 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

RealityTM Female Condom is 2,017 days. Of this time, 1,460 days

occurred during the testing phase of the regulatory review period,

while 557 days occurred during the approval phase. These periods of

time were derived from the following dates:

1. The date on which the first clinical trial on the device was

begun: October 31, 1987. The clinical trial cited by the applicant was

conducted outside the United States and was not subject to FDA's

requirement for an investigational device exemption (IDE) under section

520(g) of the Federal Food, Drug and Cosmetic Act (the act) nor FDA's

requirement for an institutional review board (IRB) approval under

section 520(g) (3) of the act. Therefore, the testing phase begins on

the date the device is first used with human subjects as part of a

clinical investigation to be filed with FDA to secure premarket

approval of the device (21 CFR 60.22(c)(1)(iii)). The applicant has

stated that the date on which the device was first used with human

subjects as part of a clinical investigation to be filed with FDA to

secure premarket approval of the device was October 31, 1987. Because

of the circumstances previously described for the clinical trial cited

by the applicant, FDA has no record in which to review this date (21

CFR 60.20(c)(6)). Although FDA cannot, therefore, confirm that testing

began as stated by the applicant, FDA is using this date as the start

of the testing phase.

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

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

Act: October 29, 1991. FDA has verified the applicant's claim that the

premarket approval application (PMA) for the RealityTM Female

Condom (PMA P910064) was initially submitted on October 29, 1991.

3. The date the application was approved: May 7, 1993. FDA has

verified the applicant's claim that PMA P910064 was approved on May 7,

1993.

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 762 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before August 15, 1994, 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 December 12, 1994, 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: June 8, 1994.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 94-14445 Filed 6-13-94; 8:45 am]

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