Determination of Regulatory Review Period for Purposes of Patent Extension; SELZENTRY, 6638-6639 [E9-2813]
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Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human biologic product MIRCERA
(methoxy polyethylene glycol-epoetin
beta). MIRCERA is indicated for the
treatment of anemia associated with
chronic renal failure, including patients
on dialysis and patients not on dialysis.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
MIRCERA (U.S. Patent No. 6,583,272)
from Hoffmann-La Roche 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 April 22,
2008, FDA advised the Patent and
Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of MIRCERA 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
MIRCERA is 2,140 days. Of this time,
1,565 days occurred during the testing
phase of the regulatory review period,
while 575 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 (21 U.S.C. 355(i))
became effective: January 6, 2002. The
applicant claims January 3, 2002, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was January 6, 2002,
which was 30 days after FDA receipt of
the IND.
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): April 19, 2006. The
applicant claims April 18, 2006, as the
date the biologics license application
(BLA) for MIRCERA (BLA B125164/0)
was initially submitted. However, FDA
records indicate that BLA B125164/0
was submitted on April 19, 2006.
3. The date the application was
approved: November 14, 2007. FDA has
verified the applicant’s claim that BLA
B125164/0 was approved on November
14, 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
VerDate Nov<24>2008
18:25 Feb 09, 2009
Jkt 217001
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 5 years 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 13, 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
August 10, 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.
Dated: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–2812 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0194]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SELZENTRY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SELZENTRY 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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
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 SELZENTRY
(maraviroc). SELZENTRY is indicated
for combination antiretroviral treatment
of adults infected with only CCR5-tropic
HIV–1 detectable, who have evidence of
viral replication and HIV–1 strains
resistant to multiple antiretroviral
agents. Subsequent to this approval, the
Patent and Trademark Office received a
patent term restoration application for
SELZENTRY (U.S. Patent No. 6,667,314)
from Pfizer Inc., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
E:\FR\FM\10FEN1.SGM
10FEN1
erowe on PROD1PC63 with NOTICES
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
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 SELZENTRY
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
SELZENTRY is 1,524 days. Of this time,
1,294 days occurred during the testing
phase of the regulatory review period,
while 230 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: June 6, 2003.
The applicant claims June 10, 2003, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 6, 2003,
which was 30 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: December 20, 2006.
The applicant claims December 19,
2006, as the date the new drug
application (NDA) for SELZENTRY
(NDA 22–128) was initially submitted.
However, FDA records indicate that
NDA 22–128 was submitted on
December 20, 2006.
3. The date the application was
approved: August 6, 2007. FDA has
verified the applicant’s claim that NDA
22–128 was approved on August 6,
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 73 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 13, 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
August 10, 2009. To meet its burden, the
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
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: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–2813 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0112]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VETMEDIN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
VETMEDIN 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
animal 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
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
6639
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 animal drug
products, the testing phase begins on
the earlier date when either a major
environmental effects test was initiated
for the drug or when an exemption
under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360b(j)) became effective and
runs until the approval phase begins.
The approval phase starts with the
initial submission of an application to
market the animal 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
an animal drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
FDA recently approved for marketing
the animal drug product VETMEDIN
(pimobendan). VETMEDIN is indicated
for the management of the signs of mild,
moderate, or severe (modified NYHA
Class II, III, or IV) congestive heart
failure in dogs due to atrioventricular
valvular insufficiency or dilated
cardiomyopathy. VETMEDIN is
indicated for use with concurrent
therapy for congestive heart failure (e.g.,
furosemide, etc.) as appropriate on a
case-by-case basis. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for VETMEDIN (U.S. Patent
No. 5,364,646) from Dr. Karl Thomae
GmbH, and the Patent and Trademark
Office requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
May 6, 2008, FDA advised the Patent
and Trademark Office that this animal
drug product had undergone a
regulatory review period and that the
approval of VETMEDIN represented the
first permitted commercial marketing or
use of the product. Shortly thereafter,
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6638-6639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2813]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-E-0194]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SELZENTRY
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SELZENTRY 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 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
SELZENTRY (maraviroc). SELZENTRY is indicated for combination
antiretroviral treatment of adults infected with only CCR5-tropic HIV-1
detectable, who have evidence of viral replication and HIV-1 strains
resistant to multiple antiretroviral agents. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for SELZENTRY (U.S. Patent No. 6,667,314) from
Pfizer Inc., and the Patent and Trademark Office requested FDA's
assistance in determining this patent's
[[Page 6639]]
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 SELZENTRY 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
SELZENTRY is 1,524 days. Of this time, 1,294 days occurred during the
testing phase of the regulatory review period, while 230 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:
June 6, 2003. The applicant claims June 10, 2003, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was June 6, 2003,
which was 30 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: December 20,
2006. The applicant claims December 19, 2006, as the date the new drug
application (NDA) for SELZENTRY (NDA 22-128) was initially submitted.
However, FDA records indicate that NDA 22-128 was submitted on December
20, 2006.
3. The date the application was approved: August 6, 2007. FDA has
verified the applicant's claim that NDA 22-128 was approved on August
6, 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 73 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 13, 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 August 10,
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.
Dated: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-2813 Filed 2-9-09; 8:45 am]
BILLING CODE 4160-01-S
