[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Notices]
[Pages 7023-7024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3172]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99E-0241]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Wallstent Coronary Endoprosthesis

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 Wallstent Coronary Endoprosthesis 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: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Regulatory Policy 
Staff (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-5645.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 100-670) generally provide 
that a patent may be extended for a period of

[[Page 7024]]

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 Wallstent 
Coronary Endoprosthesis. Wallstent Coronary Endoprosthesis is indicated 
for use following suboptimal percutaneous transluminal angioplasty of 
common and/or external iliac artery stenotic lesions. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for Wallstent Coronary Endoprosthesis (U.S. 
Patent No. 4,954,126) from Boston Scientific Corp., 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 9, 1999, FDA advised the Patent and Trademark Office that this 
medical device had undergone a regulatory review period and that the 
approval of Wallstent Coronary Endoprosthesis 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 
Wallstent Coronary Endoprosthesis is 1,533 days. Of this time, 1,351 
days occurred during the testing phase of the regulatory review period, 
while 182 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: July 21, 1994. 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 July 21, 1994.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): April 1, 
1998. The applicant claims March 31, 1998, as the date the premarket 
approval application (PMA) for Wallstent Coronary Endoprosthesis (PMA 
P980009) was initially submitted. However, FDA records indicate that 
PMA P980009 was submitted on April 1, 1998.
    3. The date the application was approved: September 29, 1998. FDA 
has verified the applicant's claim that PMA P980009 was approved on 
September 29, 1998.
    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 857 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before April 11, 2000, 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 9, 2000, 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: December 23, 1999.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 00-3172 Filed 2-10-00; 8:45 am]
BILLING CODE 4160-01-F