[Federal Register: August 7, 1998 (Volume 63, Number 152)]
[Notices]               
[Page 42408]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au98-122]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97E-0461]

 
Determination of Regulatory Review Period for Purposes of Patent 
Extension; Cook GRII<SUP>TM</SUP> Coronary Stent

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 Cook GRII<SUP>TM</SUP> Coronary Stent 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 Cook 
GRII<SUP>TM</SUP> Coronary Stent. Cook GRII<SUP>TM</SUP> Coronary Stent 
is indicated for treatment of acute or threatened closure in patients 
with failed interventional therapy in vessels with reference diameters 
in the range of 2.1 mm to 4.0 mm. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for Cook GRII<SUP>TM</SUP> Coronary Stent (U.S. Patent No. 
5,041,126) from Cook, 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 29, 1997, FDA 
advised the Patent and Trademark Office that this medical device had 
undergone a regulatory review period and that the approval of Cook 
GRII<SUP>TM</SUP> Coronary Stent 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 
Cook GRII<SUP>TM</SUP> Coronary Stent is 511 days. Of this time, 343 
days occurred during the testing phase of the regulatory review period, 
while 168 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: December 20, 1995. 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 (the act) 
(21 U.S.C. 360j(g)) for human tests to begin became effective December 
20, 1995.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): November 26, 
1996. The applicant claims November 23, 1996, as the date the Premarket 
Approval Application (PMA) for Cook GRII<SUP>TM</SUP> Coronary Stent 
(PMA 910030) was initially submitted. However, FDA records indicate 
that PMA 910030 was submitted on November 26, 1996.
    3. The date the application was approved: May 12, 1997. FDA has 
verified the applicant's claim that PMA 910030 was approved on May 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 
application for patent extension, this applicant seeks 341 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before October 6, 1998, 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 3, 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: July 8, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-21089 Filed 8-6-98; 8:45 am]
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