[Federal Register Volume 72, Number 105 (Friday, June 1, 2007)]
[Notices]
[Pages 30596-30597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10618]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0259]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for X-STOP INTERSPINOUS PROCESS DECOMPRESSION 
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 X-STOP 
INTERSPINOUS PROCESS DECOMPRESSION SYSTEM. X-STOP INTERSPINOUS PROCESS 
DECOMPRESSION SYSTEM is indicated for treatment of patients aged 50 or 
older suffering from neurogenic intermittent claudication secondary to 
a confirmed diagnosis of lumbar spinal stenosis (with x-ray, magnetic 
resonance imaging (MRI), and/or computerized tomography (CT) evidence 
of thickened ligamentum flavum, narrowed lateral recess and/or central 
canal narrowing). The X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM 
is indicated for those patients with moderately impaired physical 
function who experience relief in flexion from their symptoms of leg/
buttock/groin pain, with or without back pain, and have undergone a 
regimen of at least 6 months of nonoperative treatment. The X-STOP 
INTERSPINOUS PROCESS DECOMPRESSION SYSTEM may be implanted at one or 
two lumbar levels in patients in whom operative treatment is indicated 
at no more than two levels. Subsequent to this approval, the Patent and 
Trademark Office received a patent

[[Page 30597]]

term restoration application for X-STOP INTERSPINOUS PROCESS 
DECOMPRESSION SYSTEM (U.S. Patent No. 6,235,030) from St. Francis 
Medical Technologies, 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 December 12, 2006, FDA 
advised the Patent and Trademark Office that this medical device had 
undergone a regulatory review period and that the approval of X-STOP 
INTERSPINOUS PROCESS DECOMPRESSION 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 
X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM is 2,224 days. Of this 
time, 1,538 days occurred during the testing phase of the regulatory 
review period, while 686 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: October 22, 1999. The applicant claims that 
the investigational device exemption (IDE) required under section 
520(g) of the act for human tests to begin became effective on February 
11, 2000. However, FDA records indicate that the IDE was determined 
substantially complete for clinical studies to have begun on October 
22, 1999, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): January 6, 
2004. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for X-STOP INTERSPINOUS PROCESS 
DECOMPRESSION SYSTEM (PMA P040001) was initially submitted January 6, 
2004.
    3. The date the application was approved: November 21, 2005. FDA 
has verified the applicant's claim that PMA P040001 was approved on 
November 21, 2005.
    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 1,053 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 July 31, 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 28, 
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. E7-10618 Filed 5-31-07; 8:45 am]
BILLING CODE 4160-01-S