Determination of Regulatory Review Period for Purposes of Patent Extension; BARACLUDE, 8181-8182 [E7-3042]
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Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices
EXJADE 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
EXJADE is 2,288 days. Of this time,
2,103 days occurred during the testing
phase of the regulatory review period,
while 185 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) became effective: July 31, 1999.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 31, 1999.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: May 2, 2005. FDA has
verified the applicant’s claim that the
new drug application (NDA) for EXJADE
(NDA 21–882) was initially submitted
on May 2, 2005.
3. The date the application was
approved: November 2, 2005. FDA has
verified the applicant’s claim that NDA
21–882 was approved on November 2,
2005.
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 648 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 April 24, 2007.
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
August 22, 2007. 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
VerDate Aug<31>2005
15:07 Feb 22, 2007
Jkt 211001
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: February 3, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–3041 Filed 2–22–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0356]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BARACLUDE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BARACLUDE 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 that 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
8181
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 human drug
product 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 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 BARACLUDE
(entecavir). BARACLUDE is indicated
for the treatment of chronic hepatitis B
virus infection in adults with evidence
of active viral replication and either
evidence of persistent elevations in
serum aminotransferases or
histologically active disease.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
BARACLUDE (U.S. Patent No.
5,206,244) from Bristol-Myers Squibb
Co., and the Patent and Trademark
Office requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
September 5, 2006, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of BARACLUDE represented
the first permitted commercial
marketing or use of the product. Shortly
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
BARACLUDE is 2,993 days. Of this
time, 2,811 days occurred during the
testing phase of the regulatory review
period, while 182 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 Cosmetics Act (the act) (21 U.S.C.
355(i)) became effective: January 19,
1997. FDA has verified the applicant’s
E:\FR\FM\23FEN1.SGM
23FEN1
8182
Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices
cprice-sewell on PROD1PC61 with NOTICES
claim that the date the investigational
new drug application became effective
was on January 19, 1997.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: September 29, 2004.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
BARACLUDE (NDA 21–797) was
initially submitted on September 29,
2004.
3. The date the application was
approved: March 29, 2005. FDA has
verified the applicant’s claim that NDA
21–797 was approved on March 29,
2005.
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 1,587 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 April 24, 2007.
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
August 22, 2007. 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: January 25, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–3042 Filed 2–22–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:07 Feb 22, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004E–0300, 2004E–0301,
2004E–0302, 2004E–0303, 2004E–0304,
2004E–0306, 2004E–0426, and 2006E–0206]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; S8 OVER–THE–WIRE
SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for S8
OVER–THE–WIRE SYSTEM 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 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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 approved for marketing the
medical device, S8 OVER–THE–WIRE
SYSTEM. S8 OVER–THE–WIRE
SYSTEM is indicated for improving
coronary luminal diameter in patients
with symptomatic ischemic heart
disease due to discrete de novo or
restenotic lesions with reference vessel
diameters of 3.0—4.0 mm and = 30 mm
in length using direct stenting or
predilatation. Subsequent to this
approval, the Patent and Trademark
Office received patent term restoration
applications for S8 OVER–THE–WIRE
SYSTEM (U.S. Patent Nos. 5,292,331;
5,800,509; 5,836,965; 5,879,382;
5,891,190; 6,159,229; 6,309,402; and
6,344,053) from Medtronic Vascular,
and the Patent and Trademark Office
requested FDA’s assistance in
determining the patents’ eligibilities for
patent term restoration. In letters dated
February 24, 2006, and June 14, 2006,
FDA advised the Patent and Trademark
Office that this medical device had
undergone a regulatory review period
and that the approval of S8 OVER–THE–
WIRE 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
S8 OVER–THE–WIRE SYSTEM is 652
days. Of this time, 477 days occurred
during the testing phase of the
regulatory review period, while 175
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: December 20, 2001. 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 December 20, 2001.
2. The date the application was
initially submitted with respect to the
device under section 515 of the act (21
U.S.C. 360e): April 10, 2003. The
E:\FR\FM\23FEN1.SGM
23FEN1
]]>Agencies
[Federal Register Volume 72, Number 36 (Friday, February 23, 2007)]
[Notices]
[Pages 8181-8182]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3042]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E-0356]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BARACLUDE
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BARACLUDE 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
that 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
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 human drug product 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 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
BARACLUDE (entecavir). BARACLUDE is indicated for the treatment of
chronic hepatitis B virus infection in adults with evidence of active
viral replication and either evidence of persistent elevations in serum
aminotransferases or histologically active disease. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for BARACLUDE (U.S. Patent No. 5,206,244) from
Bristol-Myers Squibb Co., and the Patent and Trademark Office requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated September 5, 2006, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of BARACLUDE
represented the first permitted commercial marketing or use of the
product. Shortly 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
BARACLUDE is 2,993 days. Of this time, 2,811 days occurred during the
testing phase of the regulatory review period, while 182 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 Cosmetics Act (the act) (21 U.S.C. 355(i)) became effective:
January 19, 1997. FDA has verified the applicant's
[[Page 8182]]
claim that the date the investigational new drug application became
effective was on January 19, 1997.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: September 29,
2004. FDA has verified the applicant's claim that the new drug
application (NDA) for BARACLUDE (NDA 21-797) was initially submitted on
September 29, 2004.
3. The date the application was approved: March 29, 2005. FDA has
verified the applicant's claim that NDA 21-797 was approved on March
29, 2005.
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 1,587 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 April 24, 2007. 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 August 22,
2007. 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: January 25, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-3042 Filed 2-22-07; 8:45 am]
BILLING CODE 4160-01-S
