Determination of Regulatory Review Period for Purposes of Patent Extension; Therma ChoiceSUPTM/SUP Uterine Ballon Therapy System

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 98E-0485 and 98E-0850]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Therma ChoiceTM Uterine Ballon Therapy 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 Therma ChoiceTM Uterine Ballon

Therapy 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,

[[Page 29047]]

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 Therma

ChoiceTM Uterine Ballon Therapy System. Therma

ChoiceTM Uterine Ballon Therapy System is indicated for use

as a thermal ablation device intended to ablate the endometrial lining

of the uterus in premenopausal women with menorrhagia (excessive

uterine bleeding) due to benign causes for whom childbearing is

complete. Subsequent to this approval, the Patent and Trademark Office

received patent term restoration applications for Therma

ChoiceTM Uterine Ballon Therapy System (U.S. Patent Nos.

5,105,808 and 4,949,718) from Gynelab Products, Inc., and the Patent

and Trademark Office requested FDA's assistance in determining these

patents' eligibility for patent term restoration. In a letter dated

December 17, 1998, FDA advised the Patent and Trademark Office that

this medical device had undergone a regulatory review period and that

the approval of Therma ChoiceTM Uterine Ballon Therapy

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

Therma ChoiceTM Uterine Ballon Therapy System is 1,031 days.

Of this time, 852 days occurred during the testing phase of the

regulatory review period, while 179 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: February 17, 1995. 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 30, 1994. However, FDA

records indicate that the IDE was determined substantially complete for

clinical studies to have begun on February 17, 1995, 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): June 17,

1997. The applicant claims June 16, 1997, as the date the premarket

approval application (PMA) for Therma ChoiceTM Uterine

Ballon Therapy System (PMA P970021) was initially submitted. However,

FDA records indicate that PMA P970021 was submitted on June 17, 1997.

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

has verified the applicant's claim that PMA P970021 was approved on

December 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

applications for patent extension, this applicant seeks 446 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before July 27, 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 November 24, 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: May 7, 1999.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 99-13671 Filed 5-27-99; 8:45 am]

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