[Federal Register Volume 72, Number 97 (Monday, May 21, 2007)]
[Notices]
[Pages 28498-28499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002E-0156]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; GALILEO INTRAVASCULAR RADIOTHERAPY 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 GALILEO INTRAVASCULAR RADIOTHERAPY 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 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-007), 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 recently approved for marketing the medical device, GALILEO 
INTRAVASCULAR RADIOTHERAPY SYSTEM. GALILEO INTRAVASCULAR RADIOTHERAPY 
SYSTEM is indicated to deliver beta radiation to the site of successful 
percutaneous coronary intervention (PCI) for the treatment of in-stent 
restenosis in native coronary arteries with discrete lesions <= 47 
millimeters (mm) in a reference vessel diameter 2.4 mm to 3.7 mm. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for GALILEO INTRAVASCULAR 
RADIOTHERAPY SYSTEM (U.S. Patent No. 5,199,939) from Guidant 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 October 31, 2002, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of GALILEO INTRAVASCULAR RADIOTHERAPY 
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 
GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM is 1,523 days. Of this time, 
1,203 days occurred during the testing phase of the regulatory review 
period, while 320 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: September 3, 1997. 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 September 3, 1997.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): December 18, 
2000. The applicant claims March 13, 2000, as the date the premarket 
approval application (PMA) for GALILEO INTRAVASCULAR RADIOTHERAPY 
SYSTEM (PMA P000052) was initially submitted. However, FDA records 
indicate that PMA P000052 was completely submitted on December 18, 
2000.
    3. The date the application was approved: November 2, 2001. FDA has 
verified the applicant's claim that PMA P000052 was approved on 
November 2, 2001.
    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.

[[Page 28499]]

In its application for patent extension, this applicant seeks 1,062 
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 July 20, 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 November 19, 
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: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-9720 Filed 5-18-07; 8:45 am]
BILLING CODE 4160-01-S