Determination of Regulatory Review Period for Purposes of Patent Extension; RAXIBACUMAB, 77643-77645 [2015-31400]
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Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
used in a variety of settings including,
but not limited to, physician’s office
laboratory, anti-coagulation clinic,
patient bedside, hospital emergency
department, and prescription home use.
The purpose of POC PT/INR testing is
to monitor warfarin and to provide
immediate information to physicians
about the patient’s anticoagulation
status so that this information can be
integrated into appropriate treatment
decisions that can improve patient
outcomes. POC PT/INR testing is
increasingly being viewed as a testing
modality with performance expectations
similar to that of traditional laboratory
testing. From a regulatory standpoint,
POC PT/INR devices have been
reviewed and cleared for prescription
use under appropriate professional
supervision or prescription home use
(patient self-testing), depending on the
claimed intended use. For this
workshop, both settings will be open for
discussion.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
II. Topics for Discussion at the Public
Workshop
This public workshop will consist of
presentations covering the topics listed
in this document. Following the
presentations, there will be a moderated
panel discussion where participants
will be asked to provide their
perspectives. The workshop panel
discussion will focus on identifying
potential solutions to address the
scientific and regulatory challenges
associated with POC PT/INR devices. In
advance of the meeting, FDA plans to
post a discussion paper outlining FDA’s
current thinking on the various topics
mentioned in the following list, and
invite comment on this from the
community.
Topics to be discussed at the public
workshop include, but are not limited
to, the following:
• Current regulatory process involved
with the clearance of POC PT/INR
devices.
• Current benefit/risk balance of POC
PT/INR devices.
• Technological differences amongst
marketed POC PT/INR devices,
advantages and limitations of each
technology, and comparability of test
results obtained using different
technologies.
• Challenges associated with
correlating results from whole blood
POC PT/INR devices to conventional
plasma-based laboratory tests.
• Appropriate study design for
validation and usability studies from the
perspectives of the Agency,
manufacturers and end users to help
improve our understanding of the
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accuracy, reliability and safety of POC
PT/INR devices.
• Types of quality control and the test
system elements assessed by the
controls.
• Challenges associated with different
sample matrices (venous, fingerstick,
arterial).
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
this public workshop must register
online by 4 p.m., January 15, 2016. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. If time and
space permits, onsite registration on the
day of the public workshop will be
provided beginning at 7 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan, Center for Devices and
Radiological Health, Office of
Communication and Education, 301–
796–5661, email: Susan.Monahan@
fda.hhs.gov no later than January 11,
2016.
To register for the public workshop,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number. Those without
Internet access should contact Susan
Monahan (contact for special
accommodations) to register. Registrants
will receive confirmation after they have
been accepted. You will be notified if
you are on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. The Webcast link will
be available on the workshop Web page
after January 18, 2016. Please visit
FDA’s Medical Devices News &
Events—Workshops & Conferences
calendar at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this public workshop from the
posted events list.) If you have never
attended a Connect Pro event before,
test your connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
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77643
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov. A link to the
transcripts will also be available
approximately 45 days after the public
workshop on the Internet at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list).
Dated: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31404 Filed 12–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–E–1575]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RAXIBACUMAB
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
RAXIBACUMAB 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 the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 16, 2016.
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 13, 2016. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
SUMMARY:
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77644
ADDRESSES:
Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
You may submit comments
as follows:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–E–1575 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; RAXIBACUMAB’’.
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
VerDate Sep<11>2014
17:08 Dec 14, 2015
Jkt 238001
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential’’. Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 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. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
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.
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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 USPTO 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 has approved for marketing the
human biologic product
RAXIBACUMAB (raxibacumab).
RAXIBACUMAB is indicated for
treatment of adult and pediatric patients
with inhalational anthrax due to
Bacillus anthracis in combination with
appropriate antibacterial drugs, and for
prophylaxis of inhalational anthrax
when alternative therapies are not
available or are not appropriate.
Subsequent to this approval, the USPTO
received a patent term restoration
application for RAXIBACUMAB (U.S.
Patent No. 7,906,119) from Human
Genome Sciences, and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
January 31, 2014, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
RAXIBACUMAB represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
RAXIBACUMAB is 3,465 days. Of this
time, 2,154 days occurred during the
testing phase of the regulatory review
period, while 1,311 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))
E:\FR\FM\15DEN1.SGM
15DEN1
Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
became effective: June 22, 2003. The
applicant claims July 18, 2003, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 22, 2003,
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): May 14, 2009. The
applicant claims June 15, 2012, as the
date the biologics license application
(BLA) for RAXIBACUMAB (BLA
125349/0) was initially submitted.
However, FDA records indicate that
BLA 125349/0 was submitted on May
14, 2009.
3. The date the application was
approved: December 14, 2012. FDA has
verified the applicant’s claim that BLA
125349/0 was approved on December
14, 2012.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 412 days of patent
term extension.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). 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. To meet its burden, the petition
must be timely (see DATES) and 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.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. 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.
VerDate Sep<11>2014
17:08 Dec 14, 2015
Jkt 238001
Dated: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31400 Filed 12–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1143]
Use of Nucleic Acid Tests To Reduce
the Risk of Transmission of West Nile
Virus From Living Donors of Human
Cells, Tissues, and Cellular and
Tissue-Based Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Use of Nucleic Acid
Tests to Reduce the Risk of
Transmission of West Nile Virus from
Living Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products
(HCT/Ps); Draft Guidance for Industry.’’
The draft guidance document provides
establishments that make donor
eligibility determinations for donors of
HCT/Ps with recommendations for
testing living donors for West Nile Virus
(WNV). The draft guidance recommends
the use of an FDA-licensed nucleic acid
test (NAT) to test living donors of HCT/
Ps for evidence of infection with WNV.
The guidance does not provide
recommendations regarding testing of
cadaveric HCT/P donors for WNV. The
draft guidance replaces the draft
guidance entitled ‘‘Draft Guidance for
Industry: Use of Nucleic Acid Tests to
Reduce the Risk of Transmission of
West Nile Virus from Donors of Human
Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps)’’ dated
October 2013. The donor testing
recommendations in the draft guidance,
when finalized, will supplement the
donor screening recommendations for
WNV (which will remain in place) and
supersede the ‘‘West Nile Virus (WNV)’’
section in Appendix 6 of the guidance
entitled ‘‘Guidance for Industry:
Eligibility Determination for Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)’’ dated
August 2007 (2007 Donor Eligibility
Guidance).
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
DATES:
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77645
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 14,
2016.
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–D–1143 for ‘‘Use of Nucleic Acid
Tests to Reduce the Risk of
Transmission of West Nile Virus from
Living Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products
(HCT/Ps); Draft Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
E:\FR\FM\15DEN1.SGM
15DEN1
]]>Agencies
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77643-77645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31400]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-E-1575]
Determination of Regulatory Review Period for Purposes of Patent
Extension; RAXIBACUMAB
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for RAXIBACUMAB 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 the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.
DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 16, 2016. 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 13,
2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.
[[Page 77644]]
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-E-1575 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; RAXIBACUMAB''. Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential''. Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 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. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
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 USPTO 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 has approved for marketing the human biologic product
RAXIBACUMAB (raxibacumab). RAXIBACUMAB is indicated for treatment of
adult and pediatric patients with inhalational anthrax due to Bacillus
anthracis in combination with appropriate antibacterial drugs, and for
prophylaxis of inhalational anthrax when alternative therapies are not
available or are not appropriate. Subsequent to this approval, the
USPTO received a patent term restoration application for RAXIBACUMAB
(U.S. Patent No. 7,906,119) from Human Genome Sciences, and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated January 31, 2014, FDA
advised the USPTO that this human biological product had undergone a
regulatory review period and that the approval of RAXIBACUMAB
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.
II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for
RAXIBACUMAB is 3,465 days. Of this time, 2,154 days occurred during the
testing phase of the regulatory review period, while 1,311 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))
[[Page 77645]]
became effective: June 22, 2003. The applicant claims July 18, 2003, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was June 22, 2003, 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): May 14, 2009. The applicant claims June
15, 2012, as the date the biologics license application (BLA) for
RAXIBACUMAB (BLA 125349/0) was initially submitted. However, FDA
records indicate that BLA 125349/0 was submitted on May 14, 2009.
3. The date the application was approved: December 14, 2012. FDA
has verified the applicant's claim that BLA 125349/0 was approved on
December 14, 2012.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 412 days of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and 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.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31400 Filed 12-14-15; 8:45 am]
BILLING CODE 4164-01-P
