Document ID: FDA-2008-E-0091-0016
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension: MACROPLASTIQUE IMPLANTS
Posted Date: 2009-02-11T05:00Z

[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6901-6902]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe09-60]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA2008E0091; Docket No. FDA2008E0099; Docket No.
FDA2008E0204]

Determination of Regulatory Review Period for Purposes of Patent
Extension; MACROPLASTIQUE IMPLANTS

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for MACROPLASTIQUE IMPLANTS and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of 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.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
MACROPLASTIQUE IMPLANTS. MACROPLASTIQUE IMPLANTS are indicated for
transurethral injection in the treatment of adult women diagnosed with
stress urinary incontinence (SUI) primarily due to intrinsic sphincter
deficiency (ISD). Subsequent to this approval, the Patent and Trademark
Office received patent term restoration applications for MACROPLASTIQUE
IMPLANTS (U.S. Patent Nos. 5,258,028;. 5,336,263; and 5,571,182) from
Uroplasty, Inc., and the Patent and Trademark Office requested FDA's
assistance in determining these patents' eligibilities for patent term
restoration. In a letter dated May 6, 2008, FDA advised the Patent and
Trademark Office that this medical device had undergone a regulatory
review period and that the approval of MACROPLASTIQUE IMPLANTS
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
MACROPLASTIQUE IMPLANTS is 2,651 days. Of this time, 1,973 days
occurred during the testing phase of the

[[Page 6902]]

regulatory review period, while 678 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: July 30, 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 June 30, 1999.
However, FDA records indicate that the IDE was determined substantially
complete for clinical studies to have begun on July 30, 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 Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): December 22, 2004. The applicant claims December
21, 2004, as the date the premarket approval application (PMA) for
MACROPLASTIQUE IMPLANTS (PMA P040050) was initially submitted. However,
FDA records indicate that PMA P040050 was submitted on December 22,
2004.
    3. The date the application was approved: October 30, 2006. FDA has
verified the applicant's claim that PMA P040050 was approved on October
30, 2006.
    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 1,640 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 April 13, 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 August 10,
2009. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: January 17, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-2903 Filed 2-10-09; 8:45 am]

BILLING CODE 4160-01-S