Determination of Regulatory Review Period for Purposes of Patent Extension; OMNARIS, 26999-27000 [E8-10466]
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26999
Federal Register / Vol. 73, No. 92 / Monday, May 12, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Questionnaire
Screener
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
35,000
1
35,000
0.0055
192.5
1,000
Survey
1
1,000
0.167
167
Total
359.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with consumer surveys
that are similar to this proposed survey.
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: May 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–10467 Filed 5–9–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–E–0398] (formerly
Docket No. 2007E–0131)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; OMNARIS
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Total Hours
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
OMNARIS 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
VerDate Aug<31>2005
17:54 May 09, 2008
Jkt 214001
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 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 approved for marketing the
human drug product OMNARIS
(ciclesonide). OMNARIS is indicated for
the treatment of nasal symptoms
associated with seasonal and perennial
allergic rhinitis in adults and
adolescents 12 years of age and older.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
OMNARIS (U.S. Patent No. 5,482,934)
from Altana Pharma 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 May 16, 2007, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of OMNARIS
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
OMNARIS is 3,196 days. Of this time,
2,893 days occurred during the testing
phase of the regulatory review period,
while 303 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 21,
1998. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on January 21, 1998.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 22, 2005.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
OMNARIS (NDA 22–004) was initially
submitted on December 22, 2005.
3. The date the application was
approved: October 20, 2006. FDA has
verified the applicant’s claim that NDA
22–004 was approved on October 20,
2006.
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 1,748 days of patent
term extension.
E:\FR\FM\12MYN1.SGM
12MYN1
27000
Federal Register / Vol. 73, No. 92 / Monday, May 12, 2008 / Notices
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 July 11, 2008.
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
November 10, 2008. 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 through FDMS only.
Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–10466 Filed 5–9–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–E–0047] (formerly
Docket No. 2007E–0139)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VECTIBIX
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
VECTIBIX 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
VerDate Aug<31>2005
17:54 May 09, 2008
Jkt 214001
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human biological
product.
ADDRESSES: Submit written or electronic
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
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 VECTIBIX
(panitumumab). VECTIBIX is indicated
for the treatment of EGFR-expressing,
metastatic colorectal carcinoma with
disease progression on or following
fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
regimens. Subsequent to this approval,
the Patent and
Trademark Office received a patent
term restoration application for
VECTIBIX (U.S. Patent No. 6,235,883)
from Amgen Fremont 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 May 16,
2007, FDA advised the Patent and
Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of VECTIBIX 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
VECTIBIX is 2,662 days. Of this time,
2,479 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: June 16, 1999. The
applicant claims June 19, 1999, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 16, 1999,
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): March 29, 2006. The
applicant claims December 15, 2005, as
the date the original biologics license
application (BLA) for VECTIBIX (BLA
125147/0) was initially submitted.
However, FDA records indicate that
BLA 125147/0 was submitted in several
modules under the continuous
marketing application pilot program. It
is FDA’s position that the approval
phase begins when the marketing
application is complete for review. The
final module of the BLA making it
complete for review was submitted on
March 29, 2006.
3. The date the application was
approved: September 27, 2006. FDA has
verified the applicant’s claim that BLA
125147/0 was approved on September
27, 2006.
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
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 73, Number 92 (Monday, May 12, 2008)]
[Notices]
[Pages 26999-27000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10466]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-E-0398] (formerly Docket No. 2007E-0131)
Determination of Regulatory Review Period for Purposes of Patent
Extension; OMNARIS
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for OMNARIS 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 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 approved for marketing the human drug product OMNARIS
(ciclesonide). OMNARIS is indicated for the treatment of nasal symptoms
associated with seasonal and perennial allergic rhinitis in adults and
adolescents 12 years of age and older. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for OMNARIS (U.S. Patent No. 5,482,934) from Altana Pharma
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 May 16, 2007, FDA advised the Patent and Trademark Office
that this human drug product had undergone a regulatory review period
and that the approval of OMNARIS 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
OMNARIS is 3,196 days. Of this time, 2,893 days occurred during the
testing phase of the regulatory review period, while 303 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 21, 1998. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
January 21, 1998.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: December 22,
2005. FDA has verified the applicant's claim that the new drug
application (NDA) for OMNARIS (NDA 22-004) was initially submitted on
December 22, 2005.
3. The date the application was approved: October 20, 2006. FDA has
verified the applicant's claim that NDA 22-004 was approved on October
20, 2006.
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 1,748 days of
patent term extension.
[[Page 27000]]
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 July 11, 2008. 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 November 10,
2008. 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
through FDMS only.
Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-10466 Filed 5-9-08; 8:45 am]
BILLING CODE 4160-01-S
