[Federal Register: May 21, 2007 (Volume 72, Number 97)]
[Notices]
[Page 28498-28499]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my07-52]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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