Determination of Regulatory Review Period for Purposes of Patent Extension; MonostrutSUPTM/SUP Cardiac Valve Prosthesis

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0779]

Determination of Regulatory Review Period for Purposes of Patent

Extension; MonostrutTM Cardiac Valve Prosthesis

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 MonostrutTM Cardiac Valve

Prosthesis 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

MonostrutTM Cardiac Valve Prosthesis. MonostrutTM

Cardiac Valve Prosthesis is indicated for the replacement of

malfunctioning native or prosthetic mitral (sizes 27, 29, 31, and 33

millimeters (mm)) or aortic (sizes 21, 23, 25, 27, 29, 31, and 33 mm)

heart valves. Subsequent to this approval, the Patent and Trademark

Office received a patent term restoration application for

MonostrutTM Cardiac Valve Prosthesis (U.S. Patent No.

4,343,049) from Alliance Medical Products Ltd., and the Patent and

Trademark Office requested FDA's assistance in determining this

[[Page 27274]]

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

September 29, 1998, FDA advised the Patent and Trademark Office that

this medical device had undergone a regulatory review period, and that

the approval of MonostrutTM Cardiac Valve Prosthesis

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

MonostrutTM Cardiac Valve Prosthesis is 5,620 days. Of this

time, 1,729 days occurred during the testing phase of the regulatory

review period, while 3,891 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: May 14, 1982. FDA has verified the applicant's claim that the

date the investigational device exemption 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 May 14, 1982.

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

the device under section 515 of the act (21 U.S.C. 360e): February 5,

1987. The applicant claims May 8, 1986, as the date the premarket

approval application (PMA) for MonostrutTM Cardiac Valve

Prosthesis (PMA P970002) was initially submitted. However, FDA records

indicate that PMA P970002 was submitted on February 5, 1987.

3. The date the application was approved: September 30, 1997. FDA

has verified the applicant's claim that PMA P970002 was approved on

September 30, 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 730 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before July 19, 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 15, 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 4, 1999.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 99-12528 Filed 5-18-99; 8:45 am]

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