[Federal Register Volume 72, Number 59 (Wednesday, March 28, 2007)]
[Notices]
[Pages 14582-14583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2003E-0243 and 2003E-0244]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

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 INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED 
FUSION DEVICE and is publishing this notice of that determination as 
required by law. FDA has made the determination because of the 
submission of two applications to the Director of Patents and 
Trademarks, Department of Commerce, for the extension of patents which 
claim 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 recently approved for marketing the medical device INFUSE BONE 
GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE. INFUSE BONE GRAFT/LT-CAGE 
LUMBAR TAPERED FUSION DEVICE is indicated for spinal fusion procedures 
in skeletally mature patients with degenerative disc disease (DDD) at 
one level from L4--S1. Subsequent to this approval, the Patent and 
Trademark Office received two patent term restoration applications for 
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (U.S. Patent 
Nos. 5,782,919 and 5,984,967)) from SDGI Holdings, Inc., and the Patent 
and Trademark Office requested FDA's assistance in determining these 
patents' eligibility for patent term restoration. In a letter dated 
April 6, 2004, FDA advised the Patent and Trademark Office that this 
medical device had undergone a regulatory review period and that the 
approval of INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE 
represented the first permitted

[[Page 14583]]

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 
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE is 2,052 days. 
Of this time, 1,515 days occurred during the testing phase of the 
regulatory review period, while 537 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: November 20, 1996. 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 November 20, 1996.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): January 12, 
2001. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED 
FUSION DEVICE (PMA P000058) was initially submitted January 12, 2001.
    3. The date the application was approved: July 2, 2002. FDA has 
verified the applicant's claim that PMA P000058 was approved on July 2, 
2002.
    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 463 days of 
patent term extension for U.S. Patent No. 5,984,967 or 347 days of 
patent term extension for U.S. Patent No. 5,782,919.
    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 May 29, 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 September 24, 
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: March 12, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-5635 Filed 3-27-07; 8:45 am]
BILLING CODE 4160-01-S