Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253, 21298-21299 [2010-9512]
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Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Notices
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Dated: April 15, 2010.
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National Institutes of Health.
[FR Doc. 2010–9374 Filed 4–22–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2009–E–0172 and FDA–
2009–E–0174]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VIMPAT —NDA 22–253
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
VIMPAT based on new drug application
(NDA) 22–253 for VIMPAT TABLETS
and is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of applications to the
Director of Patents and Trademarks,
Department of Commerce, for the
extensions of patents which claim the
human drug product, VIMPAT. The
regulatory review period determination
for VIMPAT Injection is publishing in
this issue of the Federal Register.
VerDate Nov<24>2008
15:23 Apr 22, 2010
Jkt 220001
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, VIMPAT
(lacosamide). VIMPAT tablets are
indicated as adjunctive therapy in the
treatment of partial-onset seizures in
patients with epilepsy aged 17 years and
older. Subsequent to this approval, the
Patent and Trademark Office received
patent term restoration applications for
VIMPAT (U.S. Patent Nos. 5,654,301
and RE38,551) from Research
Corporation Technologies, Inc., and the
Patent and Trademark Office requested
ADDRESSES:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated September
29, 2009, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
VIMPAT 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
VIMPAT is 3,452 days. Of this time,
3,055 days occurred during the testing
phase of the regulatory review period,
while 397 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: May 19, 1999.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on May 19, 1999.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: September 28, 2007.
FDA has verified the applicant’s claim
that the new drug application (NDA 22–
253) for VIMPAT tablets was submitted
on September 28, 2007.
3. The date the application was
approved: October 28, 2008. FDA has
verified the applicant’s claim that NDA
22–253 was approved on October 28,
2008.
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 22, 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
October 20, 2010. 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.
E:\FR\FM\23APN1.SGM
23APN1
Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Notices
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 numbers 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: March 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–9512 Filed 4–22–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2009–E–0175 and FDA–
2009–E–0173]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VIMPAT—NDA 22–254
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
VIMPAT based on new drug application
(NDA) 22–254 for VIMPAT injection
and is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of applications to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of patents which claim the
human drug product, VIMPAT. The
regulatory review period determination
for VIMPAT Tablets is publishing in
this issue of the Federal Register.
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 0993–0002,
301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
VerDate Nov<24>2008
15:23 Apr 22, 2010
Jkt 220001
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 VIMPAT
(lacosamide). VIMPAT injection is
indicated as adjunctive therapy in the
treatment of partial-onset seizures in
patients with epilepsy aged 17 years and
older when oral administration is
temporarily not feasible. Subsequent to
this approval, the Patent and Trademark
Office received patent term restoration
applications for VIMPAT (U.S. Patent
Nos. 5,654,301 and RE38,551) from
Research Corporation Technologies,
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
September 29, 2009, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of VIMPAT 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
VIMPAT is 3,452 days. Of this time,
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
21299
3,055 days occurred during the testing
phase of the regulatory review period,
while, 397 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: May 19, 1999.
The applicant claims November 14,
2003, as the date an investigational new
drug application (IND) became effective.
However, according to FDA records, this
IND was not the first IND received for
this active ingredient. In general, FDA
has used the first IND of the active
ingredient of the drug product as the
beginning of the testing phase, if
information derived from this first IND
was or could have been relied on or was
relevant for approval to market the drug
product. FDA records indicate that the
effective date of the first IND for
lacosamide was May 19, 1999, which
was 30 days after FDA receipt of this
first IND. This is the same IND and the
same date FDA determined was the
beginning of the regulatory review
period for Vimpat Tablets approved
under new drug application (NDA) 22–
253. The regulatory review period
determination for VIMPAT Tablets is
publishing in this issue of the Federal
Register.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: September 28, 2007.
FDA has verified the applicant’s claim
that the new drug application (NDA)
22–254 for VIMPAT injection was
submitted on September 28, 2007.
3. The date the application was
approved: October 28, 2008. FDA has
verified the applicant’s claim that NDA
22–254 was approved on October 28,
2008.
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 applications for patent extension,
this applicant seeks 1,104 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 22, 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
October 20, 2010. To meet its burden,
E:\FR\FM\23APN1.SGM
23APN1
]]>Agencies
[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Notices]
[Pages 21298-21299]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2009-E-0172 and FDA-2009-E-0174]
Determination of Regulatory Review Period for Purposes of Patent
Extension; VIMPAT --NDA 22-253
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for VIMPAT based on new drug application (NDA)
22-253 for VIMPAT TABLETS and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extensions of patents
which claim the human drug product, VIMPAT. The regulatory review
period determination for VIMPAT Injection is publishing in this issue
of the Federal Register.
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, VIMPAT
(lacosamide). VIMPAT tablets are indicated as adjunctive therapy in the
treatment of partial-onset seizures in patients with epilepsy aged 17
years and older. Subsequent to this approval, the Patent and Trademark
Office received patent term restoration applications for VIMPAT (U.S.
Patent Nos. 5,654,301 and RE38,551) from Research Corporation
Technologies, Inc., and the Patent and Trademark Office requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated September 29, 2009, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of VIMPAT 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
VIMPAT is 3,452 days. Of this time, 3,055 days occurred during the
testing phase of the regulatory review period, while 397 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:
May 19, 1999. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 19,
1999.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: September 28,
2007. FDA has verified the applicant's claim that the new drug
application (NDA 22-253) for VIMPAT tablets was submitted on September
28, 2007.
3. The date the application was approved: October 28, 2008. FDA has
verified the applicant's claim that NDA 22-253 was approved on October
28, 2008.
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 22, 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 October 20,
2010. 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.
[[Page 21299]]
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 numbers 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: March 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-9512 Filed 4-22-10; 8:45 am]
BILLING CODE 4160-01-S
