Determination of Regulatory Review Period for Purposes of Patent Extension; ILARIS, 76739-76740 [2010-30992]
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices
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comments will become a matter of
public record.
Dated: November 30, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–30902 Filed 12–8–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0047]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ILARIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for ILARIS
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 biological product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:35 Dec 08, 2010
Jkt 223001
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
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 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological 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 biological 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 biologic product ILARIS
(canakinumab). ILARIS is indicated for
the treatment of Cryopyrin Associated
Periodic Syndromes in adults and
children 4 years of age and older
including Familial Cold
Autoinflammatory Syndrome and
Muckle-Wells Syndrome. Subsequent to
this approval, the Patent and Trademark
Office received a patent term restoration
application for ILARIS (U.S. Patent No.
7,446,175) from Novartis AG, and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated March 24,
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
76739
2010, FDA advised the Patent and
Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of ILARIS 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
ILARIS is 1,072 days. Of this time, 889
days occurred during the testing phase
of the regulatory review period, while
183 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: July 13, 2006. The
applicant claims July 12, 2006, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was July 13, 2006,
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: December 17, 2008. The
applicant claims December 15, 2008, as
the date the biologics license
application (BLA) for ILARIS (BLA
125319) was initially submitted.
However, FDA records indicate that
BLA 125319 was submitted on
December 17, 2008.
3. The date the application was
approved: June 17, 2009. FDA has
verified the applicant’s claim that BLA
125319 was approved on June 17, 2009.
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 177 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) either
electronic or written comments and ask
for a redetermination by February 7,
2011. 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 June 7, 2011. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
E:\FR\FM\09DEN1.SGM
09DEN1
76740
Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices
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.
Interested persons may submit to the
Division of Dockets Management (SEE
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–30992 Filed 12–8–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0044]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BEPREVE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BEPREVE 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 electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:35 Dec 08, 2010
Jkt 223001
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 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 BEPREVE
(bepotastine besilate). BEPREVE is
indicated for the treatment of itching
associated with allergic conjunctivitis.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
BEPREVE (U.S. Patent No. 6,780,877)
from Ube Industries, Ltd., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated March 3,
2010, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
BEPREVE 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.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
FDA has determined that the
applicable regulatory review period for
BEPREVE is 964 days. Of this time, 663
days occurred during the testing phase
of the regulatory review period, while
301 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 FD & C Act) (21
U.S.C. 355(i)) became effective: January
20, 2007. The applicant claims January
19, 2007, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
January 20, 2007, 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 FD & C Act: November 12,
2008. FDA has verified the applicant’s
claim that the new drug application
(NDA) 22–288 was submitted on
November 12, 2008.
3. The date the application was
approved: September 8, 2009. FDA has
verified the applicant’s claim that NDA
22–288 was approved on September 8,
2009.
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 631 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) either
electronic or written comments and ask
for a redetermination by February 7,
2011. 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 June 7, 2011. 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Notices]
[Pages 76739-76740]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-E-0047]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ILARIS
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ILARIS 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 biological product.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
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 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological 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 biological 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 biologic product
ILARIS (canakinumab). ILARIS is indicated for the treatment of
Cryopyrin Associated Periodic Syndromes in adults and children 4 years
of age and older including Familial Cold Autoinflammatory Syndrome and
Muckle-Wells Syndrome. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
ILARIS (U.S. Patent No. 7,446,175) from Novartis AG, and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
March 24, 2010, FDA advised the Patent and Trademark Office that this
human biological product had undergone a regulatory review period and
that the approval of ILARIS 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
ILARIS is 1,072 days. Of this time, 889 days occurred during the
testing phase of the regulatory review period, while 183 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: July 13,
2006. The applicant claims July 12, 2006, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was July 13, 2006,
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: December 17, 2008. The applicant claims
December 15, 2008, as the date the biologics license application (BLA)
for ILARIS (BLA 125319) was initially submitted. However, FDA records
indicate that BLA 125319 was submitted on December 17, 2008.
3. The date the application was approved: June 17, 2009. FDA has
verified the applicant's claim that BLA 125319 was approved on June 17,
2009.
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 177 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) either electronic or written comments and ask for a
redetermination by February 7, 2011. 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 June 7, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA
[[Page 76740]]
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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments.
However, if you submit a written petition, you must submit three
copies of the petition. Identify comments with the docket number found
in brackets in the heading of this document. Comments and petitions
that have not been made publicly available on regulations.gov may be
viewed in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-30992 Filed 12-8-10; 8:45 am]
BILLING CODE 4160-01-P
