[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77878-77879]
From the Federal Register Online via the Government Publishing 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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