[Federal Register Volume 63, Number 197 (Tuesday, October 13, 1998)]
[Notices]
[Page 54720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27392]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0230]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Wiktor Prime Coronary Stent System

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 Wiktor Prime Coronary Stent 
System 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 
Wiktor Prime Coronary Stent System. Wiktor Prime 
Coronary Stent System is indicated for the treatment of abrupt or 
threatened closure in patients with failed interventional therapy in 
native coronary arteries and bypass graft vessels. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for Wiktor Prime Coronary Stent 
System (U.S. Patent No. 4,886,062) from Medtronic, 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 
June 19, 1998, FDA advised the Patent and Trademark Office that this 
medical device had undergone a regulatory review period and that the 
approval of Wiktor Prime Coronary Stent System 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 
Wiktor Prime Coronary Stent System is 2,489 days. Of this 
time, 2,066 days occurred during the testing phase of the regulatory 
review period, while 423 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: September 5, 1990. 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 (21 U.S.C. 
360j(g)) for human tests to begin became effective September 5, 1990.
    2.  The date the 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): May 1, 1996. The applicant claims April 30, 1996, 
as the date the premarket approval application (PMA) for 
Wiktor Prime Coronary Stent System (PMA P960010) was 
initially submitted. However, FDA records indicate that PMA P960010 was 
submitted on May 1, 1996.
    3.  The date the application was approved: June 27, 1997. FDA has 
verified the applicant's claim that PMA P960010 was approved on June 
27, 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 1,347 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before December 14, 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 April 12, 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: September 28, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-27392 Filed 10-9-98; 8:45 am]
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