Determination of Regulatory Review Period for Purposes of Patent Extension; SAPHRIS, 55331-55332 [2010-22519]
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Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices
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VerDate Mar<15>2010
16:29 Sep 09, 2010
Jkt 220001
comments and recommendations must
be submitted in one of the following
ways by November 9, 2010:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
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Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: September 3, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–22593 Filed 9–9–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0041]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SAPHRIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SAPHRIS 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,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
55331
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 SAPHRIS
(asenapine). SAPHRIS is an atypical
antipsychotic indicated for acute
treatment of schizophrenia in adults and
acute treatment of manic or mixed
episodes associated with bipolar I
disorder in adults. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for SAPHRIS (U.S. Patent
No. 5,763,476) from NV Organon, 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 SAPHRIS 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:
E:\FR\FM\10SEN1.SGM
10SEN1
srobinson on DSKHWCL6B1PROD with NOTICES
55332
Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices
FDA has determined that the
applicable regulatory review period for
SAPHRIS is 4,547 days. Of this time,
3,833 days occurred during the testing
phase of the regulatory review period,
while 714 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: March 4, 1997.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on March 4, 1997.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: August 31, 2007. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
SAPHRIS (NDA 22–117) was submitted
on August 31, 2007.
3. The date the application was
approved: August 13, 2009. FDA has
verified the applicant’s claim that NDA
22–117 was approved on August 13,
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 1,827 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 November 9,
2010. 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 March 9, 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
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
VerDate Mar<15>2010
16:29 Sep 09, 2010
Jkt 220001
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: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–22519 Filed 9–9–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0527]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ULORIC
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ULORIC 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,
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
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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 ULORIC
(febuxostat). ULORIC is indicated for
chronic management of hyperuricemia
in patients with gout. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for ULORIC (U.S. Patent No.
5,614,520) from Teijin Pharma 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
February 17, 2010, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of ULORIC 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
ULORIC is 3,395 days. Of this time,
1,873 days occurred during the testing
phase of the regulatory review period,
while 1,522 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: October 31,
1999. The applicant claims April 28,
1999, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was October 31, 1999,
which was 30 days after FDA receipt of
the active IND.
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 75, Number 175 (Friday, September 10, 2010)]
[Notices]
[Pages 55331-55332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22519]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-E-0041]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SAPHRIS
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SAPHRIS 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, 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 SAPHRIS
(asenapine). SAPHRIS is an atypical antipsychotic indicated for acute
treatment of schizophrenia in adults and acute treatment of manic or
mixed episodes associated with bipolar I disorder in adults. Subsequent
to this approval, the Patent and Trademark Office received a patent
term restoration application for SAPHRIS (U.S. Patent No. 5,763,476)
from NV Organon, 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 SAPHRIS 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.
[[Page 55332]]
FDA has determined that the applicable regulatory review period for
SAPHRIS is 4,547 days. Of this time, 3,833 days occurred during the
testing phase of the regulatory review period, while 714 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:
March 4, 1997. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on March 4,
1997.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: August 31,
2007. FDA has verified the applicant's claim that the new drug
application (NDA) for SAPHRIS (NDA 22-117) was submitted on August 31,
2007.
3. The date the application was approved: August 13, 2009. FDA has
verified the applicant's claim that NDA 22-117 was approved on August
13, 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 1,827 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 November 9, 2010. 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 March 9, 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 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: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-22519 Filed 9-9-10; 8:45 am]
BILLING CODE 4160-01-S
