[Federal Register Volume 72, Number 36 (Friday, February 23, 2007)]
[Notices]
[Pages 8182-8183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2004E-0300, 2004E-0301, 2004E-0302, 2004E-0303, 2004E-
0304, 2004E-0306, 2004E-0426, and 2006E-0206]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; S8 OVER-THE-WIRE 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 S8 OVER-THE-WIRE SYSTEM and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of applications to the Director 
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 Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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 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 Director 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 approved for marketing the medical device, S8 OVER-THE-WIRE 
SYSTEM. S8 OVER-THE-WIRE SYSTEM is indicated for improving coronary 
luminal diameter in patients with symptomatic ischemic heart disease 
due to discrete de novo or restenotic lesions with reference vessel 
diameters of 3.0--4.0 mm and = 30 mm in length using direct stenting or 
predilatation. Subsequent to this approval, the Patent and Trademark 
Office received patent term restoration applications for S8 OVER-THE-
WIRE SYSTEM (U.S. Patent Nos. 5,292,331; 5,800,509; 5,836,965; 
5,879,382; 5,891,190; 6,159,229; 6,309,402; and 6,344,053) from 
Medtronic Vascular, and the Patent and Trademark Office requested FDA's 
assistance in determining the patents' eligibilities for patent term 
restoration. In letters dated February 24, 2006, and June 14, 2006, FDA 
advised the Patent and Trademark Office that this medical device had 
undergone a regulatory review period and that the approval of S8 OVER-
THE-WIRE SYSTEM represented the first permitted commercial marketing or 
use of the product. 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 
S8 OVER-THE-WIRE SYSTEM is 652 days. Of this time, 477 days occurred 
during the testing phase of the regulatory review period, while 175 
days occurred during the approval phase. These periods of time were 
derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this 
device became effective: December 20, 2001. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section 520(g) of the act for human tests to begin 
became effective December 20, 2001.
    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 10, 
2003. The

[[Page 8183]]

applicant claims April 9, 2003, as the date the premarket approval 
application (PMA) for S8 OVER-THE-WIRE SYSTEM (PMA P030009) was 
initially submitted. However, FDA records indicate that PMA P030009 was 
submitted on April 10, 2003.
    3. The date the application was approved: October 1, 2003. FDA has 
verified the applicant's claim that PMA P030009 was approved on October 
1, 2003.
    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 
applications for patent extension, this applicant seeks 413 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by April 24, 2007. Furthermore, any interested person may petition FDA 
for a determination regarding whether the applicant for extension acted 
with due diligence during the regulatory review period by August 22, 
2007. 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 Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 25, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-3127 Filed 2-22-07; 8:45 am]
BILLING CODE 4160-01-S