[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6901-6902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2903]


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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.

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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