Determination of Regulatory Review Period for Purposes of Patent Extension; TYKERB, 66647-66648 [E8-26679]
Download as PDF
<![CDATA[
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 218 / Monday, November 10, 2008 / Notices
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 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 IXEMPRA
(ixabepilone). IXEMPRA in combination
with capecitabine is indicated for the
treatment of metastatic or locally
advanced breast cancer in patients after
failure of an anthracycline and a taxane.
IXEMPRA as monotherapy is indicated
for the treatment of metastatic or locally
advanced breast cancer in patients after
failure of an anthracycline, a taxane,
and capecitabine. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for IXEMPRA (U.S. Patent
No. 6,605,599) 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 April 22, 2008, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of IXEMPRA
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
IXEMPRA is 3,002 days. Of this time,
2,818 days occurred during the testing
phase of the regulatory review period,
while 184 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: July 30, 1999.
The applicant claims June 30, 1999, as
the date the investigational new drug
application (IND) became effective.
VerDate Aug<31>2005
17:07 Nov 07, 2008
Jkt 217001
However, FDA records indicate that the
IND effective date was July 30, 1999,
which was thirty days after FDA receipt
of the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: April 16, 2007. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
Ixempra (NDA 22–065) was initially
submitted on April 16, 2007.
3. The date the application was
approved: October 16, 2007. FDA has
verified the applicant’s claim that NDA
22–065 was approved on October 16,
2007.
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 854 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 January 9, 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
May 11, 2009. 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
66647
Dated: October 20, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–26678 Filed 11–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–E–0229]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TYKERB
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
TYKERB 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,
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
E:\FR\FM\10NON1.SGM
10NON1
jlentini on PROD1PC65 with NOTICES
66648
Federal Register / Vol. 73, No. 218 / Monday, November 10, 2008 / Notices
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 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 TYKERB
(lapatinib). TYKERB is indicated in
combination with capecitabine, for the
treatment of patients with advanced or
metastatic breast cancer whose tumors
overexpress HER2 and who have
received prior therapy including an
anthracycline, a taxane, and
trastuzumab. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for TYKERB (U.S. Patent
No. 6,713,485) from SmithKline
Beecham Corp. (doing business as
GlaxoSmithKline), and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated April 28, 2008, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of TYKERB
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
TYKERB is 2,260 days. Of this time,
2,078 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 Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: January 5,
2001. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on January 5, 2001.
VerDate Aug<31>2005
16:09 Nov 07, 2008
Jkt 217001
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: September 13, 2006.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
TYKERB (NDA 22–059) was initially
submitted on September 13, 2006.
3. The date the application was
approved: March 13, 2007. FDA has
verified the applicant’s claim that NDA
22–059 was approved on March 13,
2007.
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 628 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 January 9, 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
May 11, 2009. 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: October 20, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–26679 Filed 11–7–08; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Privacy Act of 1974; New OIG Privacy
Act System of Records: Consolidated
Data Repository
Office of Inspector General
(OIG), HHS.
ACTION: Notice of proposed new Privacy
Act System of Records.
AGENCY:
SUMMARY: The Privacy Act of 1974 (5
U.S.C. 552(e)(4)) requires that all
agencies publish in the Federal Register
a notice of the existence and character
of their system of records. Notice is
hereby given that OIG is adding a new
system of records entitled
‘‘Consolidated Data Repository—HHS–
OIG’’ (09–90–1000).
DATES: Effective Date: This system of
records will become effective without
further notice on December 22, 2008,
unless comments received on or before
that date result in a contrary
determination.
Comment Date: Comments on this
new system of records will be
considered if we receive them at the
addresses provided below no later than
5 p.m. Eastern Standard Time on
December 10, 2008.
ADDRESSES: In commenting, please
reference file code 09–90–1000. Because
of staff and resource limitations, we
cannot accept comments by facsimile
(fax) transmission. However, you may
submit comments using one of the
following three ways (no duplicates,
please):
1. Electronically. You may submit
electronically through the Federal
eRulemaking Portal at https://
www.regulations.gov. (Attachments
should be in Microsoft Word, if
possible.)
2. By regular, express, or overnight
mail. You may mail your printed or
written submissions to the following
address: Office of Inspector General,
Department of Health and Human
Services, Attention: Marco Villagrana,
Room 5541, Cohen Building, 330
Independence Avenue, SW.,
Washington, DC 20201. Please allow
sufficient time for mailed comments to
be received before the close of the
comment period.
3. By hand or courier. You may
deliver, by hand or courier, before the
close of the comment period, your
printed or written comments to the
Office of Inspector General, Department
of Health and Human Services, Cohen
Building, 330 Independence Avenue,
SW., Washington, DC 20201. Because
E:\FR\FM\10NON1.SGM
10NON1
]]>Agencies
[Federal Register Volume 73, Number 218 (Monday, November 10, 2008)]
[Notices]
[Pages 66647-66648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26679]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-E-0229]
Determination of Regulatory Review Period for Purposes of Patent
Extension; TYKERB
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TYKERB 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, 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
[[Page 66648]]
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 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 TYKERB
(lapatinib). TYKERB is indicated in combination with capecitabine, for
the treatment of patients with advanced or metastatic breast cancer
whose tumors overexpress HER2 and who have received prior therapy
including an anthracycline, a taxane, and trastuzumab. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for TYKERB (U.S. Patent No. 6,713,485) from
SmithKline Beecham Corp. (doing business as GlaxoSmithKline), and the
Patent and Trademark Office requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated April 28, 2008, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of TYKERB 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
TYKERB is 2,260 days. Of this time, 2,078 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 Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
January 5, 2001. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
January 5, 2001.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: September 13,
2006. FDA has verified the applicant's claim that the new drug
application (NDA) for TYKERB (NDA 22-059) was initially submitted on
September 13, 2006.
3. The date the application was approved: March 13, 2007. FDA has
verified the applicant's claim that NDA 22-059 was approved on March
13, 2007.
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 628 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 January 9, 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 May 11, 2009.
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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: October 20, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-26679 Filed 11-7-08; 8:45 am]
BILLING CODE 4160-01-S
