[Federal Register Volume 74, Number 171 (Friday, September 4, 2009)]
[Notices]
[Pages 45865-45866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21424]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0568]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; TALENT ABDOMINAL STENT GRAFT 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 TALENT ABDOMINAL STENT GRAFT 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of 
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

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, TALENT 
ABDOMINAL STENT GRAFT SYSTEM. The TALENT ABDOMINAL STENT GRAFT SYSTEM 
is indicated for the endovascular treatment of abdominal aortic 
aneurysms with or without iliac involvement having: Iliac/femoral 
access vessel morphology that is compatible with vascular access 
techniques, devices, and/or accessories; a proximal aortic neck length 
of >= 10 millimeters (mm); proximal aortic neck angulation <= 60[deg] 
distal iliac artery fixation length of >= 15 mm; an aortic neck 
diameter of 18 to 32 mm and iliac artery diameters of 8 to 22 mm; and 
vessel morphology suitable for endovascular repair. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for TALENT ABDOMINAL STENT GRAFT SYSTEM (U.S. 
Patent No. 6,306,141) 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 
February 18, 2009, FDA advised the Patent and Trademark Office that 
this medical device had undergone a regulatory review period and that 
the approval of TALENT ABDOMINAL STENT GRAFT 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 
TALENT ABDOMINAL STENT GRAFT SYSTEM is 4,024 days. Of this time, 3,843 
days occurred during the testing phase of the regulatory review period, 
while 181 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: April 11, 1997. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section

[[Page 45866]]

520(g) of the act for human tests to begin became effective April 11, 
1997.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): October 18, 
2007. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for TALENT ABDOMINAL STENT GRAFT SYSTEM (PMA 
P070027) was initially submitted October 18, 2007.
    3. The date the application was approved: April 15, 2008. FDA has 
verified the applicant's claim that PMA P070027 was approved on April 
15, 2008.
    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 1,183 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by November 3, 2009. 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 March 
3, 2010. 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: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-21424 Filed 9-3-09; 8:45 am]
BILLING CODE 4160-01-S