Determination of Regulatory Review Period for Purposes of Patent Extension; AMPYRA, 12974-12975 [2011-5312]
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12974
Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices
made to reflect a change in the Agenda
portion of the document. There are no
other changes.
FOR FURTHER INFORMATION CONTACT: Olga
I. Claudio, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1611, Silver Spring,
MD 20993–0002, 301–796–7608, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 7, 2011,
FDA announced that a meeting of the
Neurological Devices Panel of the
Medical Devices Advisory Committee
would be held on March 17 and 18,
2011. On page 6625, in the second
column, in the last paragraph, in the
first and second sentences, the ‘‘for the
NovoTTF–100A Treatment Kit,
sponsored by Hogan Lovells US LLP for
NovoCure, Ltd. The NovoTTF–100A
Treatment Kit’’ portion of the document
is changed to read as follows: ‘‘for the
NovoTTF–100A System, sponsored by
NovoCure, Ltd. The NovoTTF–100A
System’’.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: March 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5285 Filed 3–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–E–0483 and FDA–
2010–E–0484]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; AMPYRA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
AMPYRA 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 that human drug product.
Emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:04 Mar 08, 2011
Jkt 223001
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 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 AMPYRA
(dalfampridine). AMPYRA is indicated
to improve walking in patients with
multiple sclerosis. Subsequent to this
approval, the Patent and Trademark
Office received patent term restoration
applications for AMPYRA (U.S. Patent
Nos. 5,370,879 and 5,540,938) from Elan
Pharma International Ltd., and the
Patent and Trademark Office requested
FDA’s assistance in determining the
patents’ eligibility for patent term
ADDRESSES:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
restoration. In a letter dated September
30, 2010, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
AMPYRA 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
AMPYRA is 9,845 days. Of this time,
9,569 days occurred during the testing
phase of the regulatory review period,
while 276 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:
February 10, 1983. The applicant claims
January 1, 1980, as the date the
investigational new drug application
(IND) became effective. However, FDA
records indicate that the IND was
initially placed on clinical hold. The
applicant was informed that the
investigational studies were allowed to
proceed on February 10, 1983, the
effective date 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: April 22, 2009.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
AMPYRA (NDA 22–250) was submitted
on April 22, 2009.
3. The date the application was
approved: January 22, 2010. FDA has
verified the applicant’s claim that NDA
22–250 was approved on January 22,
2010.
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 1,827 and 1,826
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 May 9, 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
September 5, 2011. To meet its burden,
the petition must contain sufficient facts
E:\FR\FM\09MRN1.SGM
09MRN1
Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices
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 https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2011–5312 Filed 3–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0332]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CERVARIX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
CERVARIX 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.
SUMMARY:
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,
Emcdonald on DSK2BSOYB1PROD with NOTICES
ADDRESSES:
VerDate Mar<15>2010
18:04 Mar 08, 2011
Jkt 223001
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 biological product
CERVARIX (human papillomavirus
bivalent (types 16 and 18) vaccine).
CERVARIX is indicated for prevention
of the following diseases caused by
oncogenic human papillomavirus types
16 and 18: cervical cancer; cervical
intraepithelial neoplasia grade 2 or sores
and adenocarcinoma in situ; and
cervical intraepithelial neoplasia grade
1. Subsequent to this approval, the
Patent and Trademark Office received a
patent term restoration application for
CERVARIX (U.S. Patent No. 7,351,533)
from MedImmune, LLC., and the Patent
and Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated October 26, 2010, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
12975
CERVARIX 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
CERVARIX is 4,027 days. Of this time,
3,094 days occurred during the testing
phase of the regulatory review period,
while 933 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: October 9, 1998. The
applicant claims September 8, 1998, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was October 9, 1998,
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, 2007. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
CERVARIX (BLA 125259/0) was
submitted on March 29, 2007.
3. The date the application was
approved: October 16, 2009. FDA has
verified the applicant’s claim that BLA
125259/0 was approved on October 16,
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 562 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 May 9, 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
September 5, 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
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12974-12975]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-E-0483 and FDA-2010-E-0484]
Determination of Regulatory Review Period for Purposes of Patent
Extension; AMPYRA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for AMPYRA 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 that human drug product.
ADDRESSES: Submit electronic comments to
http:[sol][sol]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 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 AMPYRA
(dalfampridine). AMPYRA is indicated to improve walking in patients
with multiple sclerosis. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
AMPYRA (U.S. Patent Nos. 5,370,879 and 5,540,938) from Elan Pharma
International Ltd., and the Patent and Trademark Office requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated September 30, 2010, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of AMPYRA 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
AMPYRA is 9,845 days. Of this time, 9,569 days occurred during the
testing phase of the regulatory review period, while 276 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: February 10, 1983. The applicant claims January 1, 1980, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND was initially
placed on clinical hold. The applicant was informed that the
investigational studies were allowed to proceed on February 10, 1983,
the effective date 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: April 22,
2009. FDA has verified the applicant's claim that the new drug
application (NDA) for AMPYRA (NDA 22-250) was submitted on April 22,
2009.
3. The date the application was approved: January 22, 2010. FDA has
verified the applicant's claim that NDA 22-250 was approved on January
22, 2010.
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 1,827 and 1,826
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 May 9, 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 September 5, 2011. To meet its burden, the petition must contain
sufficient facts
[[Page 12975]]
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 http:[sol][sol]www.regulations.gov may be viewed in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-5312 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P
