Determination of Regulatory Review Period for Purposes of Patent Extension; XIENCE V EECSS, 38659-38660 [E9-18530]
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
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 biological product
RECOTHROM (Thrombin, topical
(Recombinant)). RECOTHROM is
indicated as an aid to hemostasis
whenever oozing blood and minor
bleeding from capillaries and small
venules is accessible and control of
bleeding by standard surgical
techniques is ineffective or impractical.
Subsequent to this approval, the Patent
and Trademark Office received patent
term restoration applications for
RECOTHROM (U.S. Patent Nos.
5,476,777, 5,502,034, and 5,527,692)
from ZymoGenetics, Inc., and the Patent
and Trademark Office requested FDA’s
assistance in determining the patents’
eligibilities for patent term restoration.
In a letter dated February 26, 2009, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
RECOTHROM 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
RECOTHROM is 1,511 days. Of this
time, 1,115 days occurred during the
testing phase of the regulatory review
period, while 396 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 (the act) (21 U.S.C.
355(i)) became effective: November 30,
2003. FDA has verified the applicant’s
claims that the date the investigational
new drug application became effective
was on November 30, 2003.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): December 18, 2006. FDA
has verified the applicant’s claims that
the biologics license application (BLA)
for RECOTHROM (BLA 125248/0) was
initially submitted on December 18,
2006.
3. The date the application was
approved: January 17, 2008. FDA has
verified the applicant’s claims that BLA
125248/0 was approved on January 17,
2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
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 952 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 October 5, 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
February 1, 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. E9–18528 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0551]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XIENCE V EECSS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for XIENCE
V EECSS 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.
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
38659
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, XIENCE V EECSS.
XIENCE V EECSS is indicated for
improving coronary luminal diameter in
patients with symptomatic heart disease
due to de novo native coronary artery
lesions (length = 28 millimeters (mm))
with reference vessel diameters of 2.5
mm to 4.25 mm. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for XIENCE V EECSS (U.S.
Patent No. 5,451,233) from Abbott
Cardiovascular Systems, Inc., and the
Patent and Trademark Office requested
E:\FR\FM\04AUN1.SGM
04AUN1
mstockstill on DSKH9S0YB1PROD with NOTICES
38660
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
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
XIENCE V EECSS 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
XIENCE V EECSS is 1,157 days. Of this
time, 759 days occurred during the
testing phase of the regulatory review
period, while 398 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: May 4, 2005. FDA has verified
the applicant’s claim that the date the
investigational device exemption (IDE)
required under section 520(g) of the act
for human tests to begin became
effective on May 4, 2005.
2. The date an application was
initially submitted with respect to the
device under section 515 of the act (21
U.S.C. 360e): June 1, 2007. The
applicant claims the premarket approval
application (PMA) XIENCE V EECSS
(PMA 70015) was submitted in three
modules and that Module 1 was initially
submitted on July 14, 2006. The
applicant claims July 14, 2006, as the
date PMA 70015 was initially
submitted. It is FDA’s position that the
approval phase begins when the
marketing application is complete. A
review of FDA records indicates that
PMA 70015 was submitted as a
complete application on June 1, 2007,
which is considered to be the initially
submitted date for PMA 70015.
3. The date the application was
approved: July 2, 2008. FDA has verified
the applicant’s claim that PMA 70015
was approved on July 2, 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 937 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
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
electronic comments and ask for a
redetermination by October 5, 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
February 1, 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. E9–18530 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0020]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EOVIST
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for EOVIST
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
human drug product.
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,
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
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 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.
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 EOVIST
(gadoxetate disodium). EOVIST is
indicated for intravenous use in T1–
weighted magnetic resonance imaging of
the liver to detect and characterize
lesions in adults with known or
suspected focal liver disease.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for EOVIST
(U.S. Patent No. 6,039,931) from Bayer
Schering Pharma Aktiengesellschaft,
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 26, 2009, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of EOVIST represented the
first permitted commercial marketing or
E:\FR\FM\04AUN1.SGM
04AUN1
Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38659-38660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18530]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-E-0551]
Determination of Regulatory Review Period for Purposes of Patent
Extension; XIENCE V EECSS
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for XIENCE V EECSS 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, XIENCE V
EECSS. XIENCE V EECSS is indicated for improving coronary luminal
diameter in patients with symptomatic heart disease due to de novo
native coronary artery lesions (length = 28 millimeters (mm)) with
reference vessel diameters of 2.5 mm to 4.25 mm. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for XIENCE V EECSS (U.S. Patent No. 5,451,233)
from Abbott Cardiovascular Systems, Inc., and the Patent and Trademark
Office requested
[[Page 38660]]
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 XIENCE V EECSS
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
XIENCE V EECSS is 1,157 days. Of this time, 759 days occurred during
the testing phase of the regulatory review period, while 398 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: May 4, 2005. FDA has verified the applicant's
claim that the date the investigational device exemption (IDE) required
under section 520(g) of the act for human tests to begin became
effective on May 4, 2005.
2. The date an application was initially submitted with respect to
the device under section 515 of the act (21 U.S.C. 360e): June 1, 2007.
The applicant claims the premarket approval application (PMA) XIENCE V
EECSS (PMA 70015) was submitted in three modules and that Module 1 was
initially submitted on July 14, 2006. The applicant claims July 14,
2006, as the date PMA 70015 was initially submitted. It is FDA's
position that the approval phase begins when the marketing application
is complete. A review of FDA records indicates that PMA 70015 was
submitted as a complete application on June 1, 2007, which is
considered to be the initially submitted date for PMA 70015.
3. The date the application was approved: July 2, 2008. FDA has
verified the applicant's claim that PMA 70015 was approved on July 2,
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 937 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 October 5, 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 February 1,
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. E9-18530 Filed 8-3-09; 8:45 am]
BILLING CODE 4160-01-S