Determination of Regulatory Review Period for Purposes of Patent Extension; INTEGRARegister Artificial Skin

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E-0272]

Determination of Regulatory Review Period for Purposes of Patent

Extension; INTEGRA Artificial Skin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the

regulatory review period for INTEGRA Artificial Skin 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,

12420 Parklawn Dr., rm. 1-23, 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 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

INTEGRA Artificial Skin. INTEGRA Artificial Skin is

indicated for the post-excisional treatment of life-threatening full-

thickness or deep partial-thickness thermal injury where sufficient

autograft is not available at the time of excision or not desirable due

to the physiological condition of the patient. Subsequent to this

approval, the Patent and Trademark Office received a patent term

restoration application for INTEGRA Artificial Skin (U.S.

Patent No. 4,947,840) from the Massachusetts Institute of Technology,

and the Patent and Trademark Office requested FDA's assistance in

determining this patent's eligibility for patent term restoration. In a

letter dated March 12, 1997, FDA advised the Patent and Trademark

Office that this medical device had undergone a regulatory review

period and that the approval of INTEGRA Artificial Skin

represented the first commercial marketing of the product. Shortly

thereafter, the Patent and Trademark Office represented that FDA

determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for

INTEGRA Artificial Skin is 4,477 days. Of this time, 3,173

days occurred during the testing phase of the regulatory review period,

while 1,304 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: November 30, 1983. FDA has verified the applicant's claim that

the date the investigational device exemption (IDE), required under

section 520(g)of the Federal Food, Drug, and Cosmetic Act, for human

tests to begin became effective on November 30, 1983.

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): August 6, 1992. The applicant claims May 4, 1990,

as the date the premarket approval application (PMA) for

INTEGRA Artificial Skin (PMA P900033) was initially

submitted. However, FDA records indicate that the PMA P900033, which

was mailed May 4, 1990, was received by FDA on May 7, 1990. However,

FDA notified the applicant that the PMA contained insufficient

information for filing on June 22, 1990. After a number of additional

documents were submitted to the PMA, the PMA was ultimately filed based

on a document received August 6, 1992, which is considered the

initially submitted date for the PMA.

3. The date the application was approved: March 1, 1996. FDA has

verified the applicant's claim that PMA P900033 was approved on March

1, 1996.

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 923 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before October 20, 1997, 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 February 17, 1998, 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

[[Page 44478]]

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: August 14, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health Affairs.

[FR Doc. 97-22266 Filed 8-20-97; 8:45 am]

BILLING CODE 4160-01-F