Determination of Regulatory Review Period for Purposes of Patent Extension; MULTAQ, 76991-76992 [2010-31064]
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Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices
applicant’s claim that there was no
investigational new drug application for
COARTEM.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C act: June 27, 2008.
FDA has verified the applicant’s claim
that the new drug application (NDA)
22–268 was submitted on June 27, 2008.
3. The date the application was
approved: April 7, 2009. FDA has
verified the applicant’s claim that NDA
22–268 was approved on April 7, 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 284 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 February 8,
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 June 8, 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: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–31074 Filed 12–9–10; 8:45 am]
BILLING CODE 4160–01–P
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18:39 Dec 09, 2010
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–E–0039 and FDA–
2010–E–0040]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; MULTAQ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
MULTAQ 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 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.
SUMMARY:
PO 00000
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76991
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 MULTAQ
(dronedarone hydrochloride). MULTAQ
is indicated to reduce the risk of
cardiovascular hospitalization in
patients with paroxysmal or persistent
atrial fibrillation (AF) or atrial flutter
(AFL), with a recent episode of AF/AFL
and associated cardiovascular risk
factors who are in sinus rhythm or who
will be cardioverted. Subsequent to this
approval, the Patent and Trademark
Office received patent term restoration
applications for MULTAQ (U.S. Patent
Nos. 5,223,510 and 7,323,493) from
Sanofi-Aventis, and the Patent and
Trademark Office requested FDA’s
assistance in determining the patents’
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 MULTAQ
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
MULTAQ is 5,076 days. Of this time,
3,593 days occurred during the testing
phase of the regulatory review period,
while 1,483 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 FFD&C act) (21
U.S.C. 355(i)) became effective: August
10, 1995. FDA has verified the
applicant’s claim that the date the
investigational new drug application
became effective was on August 10,
1995.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FFD&C act: June 10, 2005.
FDA has verified the applicant’s claim
that the first new drug application
(NDA) for MULTAQ (NDA 21–913) was
submitted on June 10, 2005.
E:\FR\FM\10DEN1.SGM
10DEN1
76992
Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices
3. The date the application was
approved: July 1, 2009. FDA has verified
the applicant’s claim that NDA 21–425
for MULTAQ was approved on July 1,
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 applications for patent extension,
this applicant seeks 519 days and 5
years, respectively, 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 February 8,
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 June 8, 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.
mstockstill on DSKH9S0YB1PROD with NOTICES
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–31064 Filed 12–9–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–D–0072] (formerly
Docket No. 2005D–0042)
Guidance for the Public, FDA Advisory
Committee Members, and FDA Staff:
The Open Public Hearing at FDA
Advisory Committee Meetings;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Guidance for the Public, FDA Advisory
Committee Members, and FDA Staff:
The Open Public Hearing at FDA
Advisory Committee Meetings.’’ We are
issuing the guidance to provide
information on how the public may
participate at the open public hearing
(OPH) portion of FDA advisory
committee meetings. The guidance also
provides recommendations regarding
financial disclosure by persons
participating in the OPH portion of
advisory committee meetings.
DATES: Submit electronic or written
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Special Medical Programs,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5103,
Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Michael Ortwerth, Office of Special
Medical Programs, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5103, Silver Spring,
MD 20993, e-mail:
Michael.Ortwerth@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In the February 15, 2005, issue of the
Federal Register (70 FR 7747), FDA
issued a notice announcing the
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18:39 Dec 09, 2010
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availability of a draft guidance entitled
‘‘The Open Public Hearing; FDA
Advisory Committee Meetings.’’ The
guidance is intended for members of the
public who choose to participate in the
OPH portion of an FDA advisory
committee meeting.
FDA issues guidance documents for
FDA staff, applicants and sponsors of
regulated products, and the public that
describe the agency’s current thinking
on a regulatory matter, including its
interpretation of, and policies regarding,
statutes and regulations. FDA’s advisory
committees provide independent expert
advice and recommendations to the
agency on scientific, technical, and
policy matters related to FDA-regulated
products. Although advisory
committees provide recommendations
to FDA, FDA makes the final decisions
on any matters considered by an
advisory committee (21 CFR 14.5).
Under 21 CFR 14.25(a), every meeting of
an FDA advisory committee includes an
OPH session during which interested
persons may present relevant
information or views orally or in
writing. The hearing session is
conducted in accordance with the
procedures set forth in 21 CFR 14.29.
FDA encourages participation from all
public stakeholders in our
decisionmaking processes. We issued
the draft guidance to answer questions
about how the public may participate at
an OPH session. Participants may
include, but are not limited to, general
members of the public, individuals or
spokespersons from the regulated
industry, consumer advocacy groups,
and professional organizations,
societies, and associations. The
guidance provides information on such
matters as how to submit a request to
speak at an OPH session, logistical
procedures, and disclosure of financial
relationships relevant to the meeting
topic.
We received two comments on the
draft guidance. In response to the
comments and at our own initiative, we
have revised the guidance in several
respects, including with regard to how
the OPH session is conducted and
instructions regarding financial
disclosure.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
thinking on participation in the OPH
portion of FDA advisory committee
meetings. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
E:\FR\FM\10DEN1.SGM
10DEN1
]]>Agencies
[Federal Register Volume 75, Number 237 (Friday, December 10, 2010)]
[Notices]
[Pages 76991-76992]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31064]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-E-0039 and FDA-2010-E-0040]
Determination of Regulatory Review Period for Purposes of Patent
Extension; MULTAQ
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for MULTAQ 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 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 MULTAQ
(dronedarone hydrochloride). MULTAQ is indicated to reduce the risk of
cardiovascular hospitalization in patients with paroxysmal or
persistent atrial fibrillation (AF) or atrial flutter (AFL), with a
recent episode of AF/AFL and associated cardiovascular risk factors who
are in sinus rhythm or who will be cardioverted. Subsequent to this
approval, the Patent and Trademark Office received patent term
restoration applications for MULTAQ (U.S. Patent Nos. 5,223,510 and
7,323,493) from Sanofi-Aventis, and the Patent and Trademark Office
requested FDA's assistance in determining the patents' 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 MULTAQ
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
MULTAQ is 5,076 days. Of this time, 3,593 days occurred during the
testing phase of the regulatory review period, while 1,483 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 FFD&C act) (21 U.S.C. 355(i)) became
effective: August 10, 1995. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on August 10, 1995.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FFD&C act: June 10,
2005. FDA has verified the applicant's claim that the first new drug
application (NDA) for MULTAQ (NDA 21-913) was submitted on June 10,
2005.
[[Page 76992]]
3. The date the application was approved: July 1, 2009. FDA has
verified the applicant's claim that NDA 21-425 for MULTAQ was approved
on July 1, 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
applications for patent extension, this applicant seeks 519 days and 5
years, respectively, 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 February 8, 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 June 8, 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: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31064 Filed 12-9-10; 8:45 am]
BILLING CODE 4160-01-P
