Determination of Regulatory Review Period for Purposes of Patent Extension; TALENT ABDOMINAL STENT GRAFT SYSTEM, 45865-45866 [E9-21424]
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Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: November 17, 2005.
FDA has verified the applicant’s claim
that the new drug application (NDA)
21–911 for BANZEL was initially
submitted on November 17, 2005.
3. The date the application was
approved: November 14, 2008. FDA has
verified the applicant’s claim that NDA
21–911 was approved on November 14,
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 819 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 November 3, 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
March 3, 2010. 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.
Dated: June 23, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–21428 Filed 9–3–09; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
17:16 Sep 03, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0568]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TALENT ABDOMINAL
STENT GRAFT SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
TALENT ABDOMINAL STENT GRAFT
SYSTEM 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 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 https://
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
PO 00000
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Fmt 4703
Sfmt 4703
45865
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, TALENT
ABDOMINAL STENT GRAFT SYSTEM.
The TALENT ABDOMINAL STENT
GRAFT SYSTEM is indicated for the
endovascular treatment of abdominal
aortic aneurysms with or without iliac
involvement having: Iliac/femoral
access vessel morphology that is
compatible with vascular access
techniques, devices, and/or accessories;
a proximal aortic neck length of ≥ 10
millimeters (mm); proximal aortic neck
angulation ≤ 60° distal iliac artery
fixation length of ≥ 15 mm; an aortic
neck diameter of 18 to 32 mm and iliac
artery diameters of 8 to 22 mm; and
vessel morphology suitable for
endovascular repair. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for TALENT ABDOMINAL
STENT GRAFT SYSTEM (U.S. Patent
No. 6,306,141) from Medtronic, 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 18, 2009, FDA advised the
Patent and Trademark Office that this
medical device had undergone a
regulatory review period and that the
approval of TALENT ABDOMINAL
STENT GRAFT SYSTEM 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
TALENT ABDOMINAL STENT GRAFT
SYSTEM is 4,024 days. Of this time,
3,843 days occurred during the testing
phase of the regulatory review period,
while 181 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: April 11, 1997. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) required under section
E:\FR\FM\04SEN1.SGM
04SEN1
45866
Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
520(g) of the act for human tests to begin
became effective April 11, 1997.
2. The date an application was
initially submitted with respect to the
device under section 515 of the act (21
U.S.C. 360e): October 18, 2007. FDA has
verified the applicant’s claim that the
premarket approval application (PMA)
for TALENT ABDOMINAL STENT
GRAFT SYSTEM (PMA P070027) was
initially submitted October 18, 2007.
3. The date the application was
approved: April 15, 2008. FDA has
verified the applicant’s claim that PMA
P070027 was approved on April 15,
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 1,183 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 November 3, 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
March 3, 2010. 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.
Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–21424 Filed 9–3–09; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
17:16 Sep 03, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Antigenic Chimeric Tick-Borne
Encephalitis Virus/Dengue Virus Type 4
Recombinant Viruses
Description of Technology: The tickborne encephalitis virus (TBEV)
complex is a group of viruses that can
cause severe neutrotropic disease and
up to thirty percent (30%) mortality.
While these viruses can be found in
many parts of the world, the largest
impact of the disease occurs in Europe
and Russia, where approximately
fourteen thousand (14,000) hospitalized
TBEV cases occur annually. TBEV is in
the family Flaviviridae, genus flavivirus
and is composed of a positive-sense
single stranded RNA genome that
contains 5′ and 3′ non-coding regions
and a single open reading frame
encoding ten (10) proteins. At present,
a vaccine or FDA approved antiviral
therapy is not available.
The inventors have previously
developed a WNV/Dengue4Delta30
antigenic chimeric virus as a live
attenuated virus vaccine candidate that
contains the WNV premembrane and
envelope (prM and E) proteins on a
dengue virus type 4 (DEN4) genetic
background with a thirty nucleotide
deletion (Delta30) in the DEN4 3′-UTR.
Using a similar strategy, the inventors
PO 00000
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Fmt 4703
Sfmt 4703
have generated an antigenic chimeric
virus, TBEV/DEN4Delta30. This
chimeric virus also contains attenuating
mutations within the E and
nonstructural NS5 proteins. Preclinical
testing results with the derived virus
indicate that chimerization of TBEV
with DEN4Delta30 and introduction of
the attenuating mutations decreased
neuroinvasiveness and neurovirulence
in mice. The TBEV/DEN4delta30
vaccine candidate was safe,
immunogenic, and provided protection
in monkeys against challenge with TBE
viruses.
This application claims live
attenuated chimeric TBEV/DEN4Delta30
vaccine compositions. Also claimed are
methods of treating or preventing TBEV
infection in a mammalian host, methods
of producing a subunit vaccine
composition, isolated polynucleotides
comprising a nucleotide sequence
encoding a TBEV immunogen, methods
for detecting TBEV infection in a
biological sample and infectious
chimeric TBEV.
Applications: Development of TickBorne Encephalitis Virus vaccines,
therapeutics and diagnostics.
Advantages: Live attenuated chimeric
vaccine, known regulatory pathway,
potential for lasting immunity with
fewer doses.
Development Status: Vaccine
candidates have been synthesized and
preclinical studies have been
performed.
Inventors: Alexander G. Pletnev,
Amber R. Engel, Brian R. Murphy
(NIAID).
Patent Status: U.S. Provisional
Application No. 61/181,982 filed 28
May 2009 (HHS Reference No. E–078–
2009/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID is seeking statements of
capability or interest from parties
interested in collaborative research in
preclinical study of the long-term
immunity induced by the TBEV/DEN4
vaccine candidate against highly
virulent TBE viruses and in the clinical
trials of this vaccine in humans. Please
contact Michael Piziali, NIAID Office of
Technology Development, at 301–496–
2644 for more information.
Monoclonal Antibodies That React
With the Capsule of Bacillus
anthracis
Description of Technology: Bacillus
anthracis is the causative agent of
anthrax and is surrounded by a
E:\FR\FM\04SEN1.SGM
04SEN1
Agencies
[Federal Register Volume 74, Number 171 (Friday, September 4, 2009)]
[Notices]
[Pages 45865-45866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21424]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-E-0568]
Determination of Regulatory Review Period for Purposes of Patent
Extension; TALENT ABDOMINAL STENT GRAFT SYSTEM
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TALENT ABDOMINAL STENT GRAFT SYSTEM 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 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 https://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, TALENT
ABDOMINAL STENT GRAFT SYSTEM. The TALENT ABDOMINAL STENT GRAFT SYSTEM
is indicated for the endovascular treatment of abdominal aortic
aneurysms with or without iliac involvement having: Iliac/femoral
access vessel morphology that is compatible with vascular access
techniques, devices, and/or accessories; a proximal aortic neck length
of >= 10 millimeters (mm); proximal aortic neck angulation <= 60[deg]
distal iliac artery fixation length of >= 15 mm; an aortic neck
diameter of 18 to 32 mm and iliac artery diameters of 8 to 22 mm; and
vessel morphology suitable for endovascular repair. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for TALENT ABDOMINAL STENT GRAFT SYSTEM (U.S.
Patent No. 6,306,141) from Medtronic, 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 18, 2009, FDA advised the Patent and Trademark Office that
this medical device had undergone a regulatory review period and that
the approval of TALENT ABDOMINAL STENT GRAFT SYSTEM 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
TALENT ABDOMINAL STENT GRAFT SYSTEM is 4,024 days. Of this time, 3,843
days occurred during the testing phase of the regulatory review period,
while 181 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: April 11, 1997. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section
[[Page 45866]]
520(g) of the act for human tests to begin became effective April 11,
1997.
2. The date an application was initially submitted with respect to
the device under section 515 of the act (21 U.S.C. 360e): October 18,
2007. FDA has verified the applicant's claim that the premarket
approval application (PMA) for TALENT ABDOMINAL STENT GRAFT SYSTEM (PMA
P070027) was initially submitted October 18, 2007.
3. The date the application was approved: April 15, 2008. FDA has
verified the applicant's claim that PMA P070027 was approved on April
15, 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 1,183 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 November 3, 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 March
3, 2010. 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.
Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-21424 Filed 9-3-09; 8:45 am]
BILLING CODE 4160-01-S