Determination of Regulatory Review Period for Purposes of Patent Extension; AlbunexRegister

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 94E-0360]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Albunex

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 Albunex 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 [[Page 11672]] 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

Albunex. Albunex is indicated as an aid for

ultrasound contrast enhancement of ventricular chambers and improvement

of endocardial border definition in patients with suboptimal echoes

undergoing ventricular function and regional wall motion studies.

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

patent term restoration application for Albunex (U.S. Patent

No. 4,844,882) from Molecular Biosystems, 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

December 19, 1994, FDA advised the Patent and Trademark Office that

this medical device had undergone a regulatory review period and that

the approval of Albunex represented the first commercial

marketing 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

Albunex is 2,397 days. Of this time, 975 days occurred during

the testing phase of the regulatory review period, while 1,422 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: January 14, 1988. The applicant claims that the investigational

device exemption (IDE) required under section 520(g) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) for human tests to

begin became effective on August 18, 1987. However, FDA records

indicate that IDE was conditionally approved on January 14, 1988, which

represents the IDE effective date.

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

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

Act (21 U.S.C. 360e): September 14, 1990. The applicant claims

September 11, 1990, as the date the premarket approval application

(PMA) for Albunex (PMA P900059) was initially submitted.

However, FDA records indicate that PMA P900059 was submitted on

September 14, 1990.

3. The date the application was approved: August 5, 1994. FDA has

verified the applicant's claim that PMA P900059 was approved on August

5, 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 763 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before May 1, 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 August 29, 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. 41-42, 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: February 24, 1995.

Allen B. Duncan,

Acting Associate Commissioner for Health Affairs.

[FR Doc. 95-5183 Filed 3-1-95; 8:45 am]

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