Document ID: FDA-2009-E-0014-0006
Agency: fda
Document Type: Notice
Title: Determinations of Regulatory Review Periods for Purposes of Patent Extensions: FREESTYLE NAVIGATOR
Posted Date: 2010-12-14T05:00Z

[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77878-77879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31240]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0014]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; FREESTYLE NAVIGATOR

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 FREESTYLE NAVIGATOR 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 electronic comments to http://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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).

[[Page 77879]]

    FDA recently approved for marketing the medical device, FREESTYLE 
NAVIGATOR. FREESTYLE NAVIGATOR is indicated for continually recording 
interstitial fluid glucose levels in people (ages 18 and older) with 
diabetes mellitus for the purpose of improving diabetes management. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for FREESTYLE NAVIGATOR (U.S. 
Patent No. 5,262,035) from Abbott Diabetes Care 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 
February 17, 2010, FDA advised the Patent and Trademark Office that 
this medical device had undergone a regulatory review period and that 
the approval of FREESTYLE NAVIGATOR represented the first permitted 
commercial marketing or use of the product. Thereafter, the Patent and 
Trademark Office requested that the FDA determine the product's 
regulatory review period. FDA has determined that the applicable 
regulatory review period for FREESTYLE NAVIGATOR is 2,320 days. Of this 
time, 750 days occurred during the testing phase of the regulatory 
review period, while 1,570 days occurred during the approval phase. 
These periods of time were derived from the following dates:
    1. The date clinical investigation on humans is begun as approved 
by an institutional review board (IRB) under section 520(g)(3) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) and when no 
investigational device exemption (IDE) is required: November 6, 2001. 
The applicant claims that investigation of the device qualified for a 
non-significant risk study for the purpose of establishing clinical 
data necessary to support a subsequent premarket approval under section 
515 of the FD&C Act. FDA has verified the applicant's claim that the 
device did not require an IDE under section 520(g) of the FD&C act, but 
did require IRB approval, granted November 6, 2001, for human tests to 
begin. This date represents the beginning of the testing phase of the 
regulatory review period.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the FD&C Act (21 U.S.C. 360e): November 
25, 2003. The applicant claims November 24, 2003, as the date the first 
premarket approval application (PMA) for FREESTYLE NAVIGATOR (PMA 
P030048) was initially submitted. However, FDA records indicate that 
PMA P030048 was submitted on November 25, 2003.
    3. The date the application was approved: March 12, 2008. FDA has 
verified the applicant's claim that PMA P050020 was approved on March 
12, 2008.
    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 1,826 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) either electronic or written comments and ask for a 
redetermination by February 14, 2011. 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 June 13, 2011. 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. It is no longer 
necessary to send three copies of mailed comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document. Comments and petitions that have not been 
made publicly available on regulations.gov may be viewed in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31240 Filed 12-13-10; 8:45 am]
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