Determination of Regulatory Review Period for Purposes of Patent Extension; AZILECT, 24073-24074 [E8-9591]
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Federal Register / Vol. 73, No. 85 / Thursday, May 1, 2008 / Notices
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 medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. 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 (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 medical device will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA recently approved for marketing
the medical device, ARTEFILL.
ARTEFILL is indicated for correction of
nasolabial folds. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for ARTEFILL (U.S. Patent
No. 5,344,452) from Artes Medical USA,
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 medical
device had undergone a regulatory
review period and that the approval of
ARTEFILL represented the first
permitted commercial marketing or use
VerDate Aug<31>2005
17:13 Apr 30, 2008
Jkt 214001
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
ARTEFILL is 3,530 days. Of this time,
1,859 days occurred during the testing
phase of the regulatory review period,
while 1671 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360j(g)) involving this device became
effective: February 28, 1997. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) required under section
520(g) of the act for human tests to begin
became effective February 28, 1997.
2. The date an application was
initially submitted with respect to the
device under section 515 of the act (21
U.S.C. 360e): April 1, 2002. FDA has
verified the applicant’s claim that the
premarket approval application (PMA)
for ARTEFILL (PMA P020012) was
initially submitted April 1, 2002.
3. The date the application was
approved: October 27, 2006. FDA has
verified the applicant’s claim that PMA
P020012 was approved on October 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
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) written or
electronic comments and ask for a
redetermination by June 30, 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
October 28, 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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
24073
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: April 21, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–9592 Filed 4–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–E–0196] (formerly
Docket No. 2006E–0500)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; AZILECT
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
AZILECT 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
E:\FR\FM\01MYN1.SGM
01MYN1
pwalker on PROD1PC71 with NOTICES
24074
Federal Register / Vol. 73, No. 85 / Thursday, May 1, 2008 / Notices
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 AZILECT
(rasagiline mesylate). AZILECT is
indicated for the treatment of the signs
and symptoms of idiopathic Parkinson’s
disease as initial monotherapy and as
adjunct therapy to levodopa.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
AZILECT (U.S. Patent No. 5,453,446)
from Teva Pharmaceutical 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
February 6, 2007, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of AZILECT 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
AZILECT is 4,269 days. Of this time,
3,284 days occurred during the testing
phase of the regulatory review period,
while 985 days occurred during the
VerDate Aug<31>2005
17:13 Apr 30, 2008
Jkt 214001
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: September 9,
1994. The applicant claims September
12, 1994, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
September 9, 1994, 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: September 5, 2003.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Azilect (NDA 21–641) was initially
submitted on September 5, 2003.
3. The date the application was
approved: May 16, 2006. FDA has
verified the applicant’s claim that NDA
21–641 was approved on May 16, 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 1,827 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) written or
electronic comments and ask for a
redetermination by June 30, 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
October 28, 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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: April 21, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–9591 Filed 4–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Anesthesiology and Respiratory
Therapy Devices Panel of the Medical
Devices Advisory Committee; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anesthesiology
and Respiratory Therapy Devices Panel
of the Medical Devices Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 12, 2008, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, & C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Neel J. Patel, Center
for Devices and Radiological Health
(HFZ–480), Food and Drug
Administration, 9200 Corporate Blvd.,
240–276–3700, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512624. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss,
make recommendations and vote on a
E:\FR\FM\01MYN1.SGM
01MYN1
]]>Agencies
[Federal Register Volume 73, Number 85 (Thursday, May 1, 2008)]
[Notices]
[Pages 24073-24074]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9591]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-E-0196] (formerly Docket No. 2006E-0500)
Determination of Regulatory Review Period for Purposes of Patent
Extension; AZILECT
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for AZILECT 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
[[Page 24074]]
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 AZILECT
(rasagiline mesylate). AZILECT is indicated for the treatment of the
signs and symptoms of idiopathic Parkinson's disease as initial
monotherapy and as adjunct therapy to levodopa. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for AZILECT (U.S. Patent No. 5,453,446) from
Teva Pharmaceutical 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 February 6,
2007, FDA advised the Patent and Trademark Office that this human drug
product had undergone a regulatory review period and that the approval
of AZILECT 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
AZILECT is 4,269 days. Of this time, 3,284 days occurred during the
testing phase of the regulatory review period, while 985 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:
September 9, 1994. The applicant claims September 12, 1994, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was September
9, 1994, 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: September 5,
2003. FDA has verified the applicant's claim that the new drug
application (NDA) for Azilect (NDA 21-641) was initially submitted on
September 5, 2003.
3. The date the application was approved: May 16, 2006. FDA has
verified the applicant's claim that NDA 21-641 was approved on May 16,
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 1,827 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) written or electronic comments and ask for a redetermination
by June 30, 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 October 28,
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 only
through FDMS at https://www.regulations.gov.
Dated: April 21, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-9591 Filed 4-30-08; 8:45 am]
BILLING CODE 4160-01-S
