[Federal Register: June 1, 2007 (Volume 72, Number 105)]
[Notices]
[Page 30596-30597]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn07-94]
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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.
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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