[Federal Register Volume 62, Number 162 (Thursday, August 21, 1997)]
[Notices]
[Pages 44477-44478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22266]


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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<Register> Artificial Skin

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 INTEGRA<Register> 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<Register> Artificial Skin. INTEGRA<Register> 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<Register> 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<Register> 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<Register> 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<Register> 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