Determination of Regulatory Review Period for Purposes of Patent Extension; FREESTYLE NAVIGATOR, 77878-77879 [2010-31240]
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srobinson on DSKHWCL6B1PROD with NOTICES
77878
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices
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 (for example, 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 human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product VIBATIV
(televancin hydrochloride). VIBATIV is
indicated for treatment of adult patients
with complicated skin and skin
structure infections caused by
susceptible Gram-positive bacteria.
Subsequent to this approval, the Patent
and Trademark Office received patent
term restoration applications for
VIBATIV (U.S. Patent Nos. 6,635,618;
6,872,701; and 7,208,471) from
Theravance, Inc., and the Patent and
Trademark Office requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated March 3, 2010, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of VIBATIV
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
VIBATIV is 2,635 days. Of this time,
1,637 days occurred during the testing
phase of the regulatory review period,
while 998 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: June 27, 2002.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on June 27, 2002.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: December 19,
2006. The applicant claims December 7,
2006, as the date the new drug
application (NDA) for VIBATIV (NDA
22–110) was initially submitted.
However, FDA records indicate that
NDA 22–110 was submitted on
December 19, 2006.
3. The date the application was
approved: September 11, 2009. FDA has
VerDate Mar<15>2010
17:09 Dec 13, 2010
Jkt 223001
verified the applicant’s claim that NDA
22–110 was approved on September 11,
2009.
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 applications for patent extension,
this applicant seeks 719, 828, or 863
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. 2010–31250 Filed 12–13–10; 8:45 am]
BILLING CODE 4160–01–P
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.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
ACTION:
Notice.
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.
SUMMARY:
Submit electronic
comments to https://
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.
ADDRESSES:
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.
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).
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14DEN1.SGM
14DEN1
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices
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
VerDate Mar<15>2010
17:09 Dec 13, 2010
Jkt 223001
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]
BILLING CODE 4160–01–P
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
77879
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–E–0037 and FDA–
2010–E–0038]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SAMSCA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SAMSCA 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 human drug product.
ADDRESSES: Submit electronic
comments to https://
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 human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
SUMMARY:
E:\FR\FM\14DEN1.SGM
14DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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]
BILLING CODE 4160-01-P
