Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR, 36790-36792 [2017-16516]
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Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Cindy Chee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
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SUPPLEMENTARY INFORMATION: Agenda:
The committee will discuss
supplemental new drug application
(sNDA) 021938/033 SUTENT (sunitinib
malate) oral capsules, submitted by C.P.
Pharmaceuticals International C.V.,
represented by Pfizer, Inc. (authorized
U.S. agent). The proposed indication
(use) for this product is for the adjuvant
treatment of adult patients at high risk
of recurrent renal cell carcinoma
following nephrectomy.
FDA intends to make background
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than 2 business days before the meeting.
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location of the advisory committee
meeting, and the background material
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the meeting. Background material is
available at https://www.fda.gov/
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default.htm. Scroll down to the
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Procedure: Interested persons may
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oral presentations should notify the
contact person and submit a brief
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16518 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–2531]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CINQAIR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for CINQAIR and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
SUMMARY:
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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.
Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 6, 2017.
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
February 5, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 6,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 6, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
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’’).
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Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2016–E–2531 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; CINQAIR.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
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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 Dockets Management
Staff, 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 product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human 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 CINQAIR
(reslizumab). CINQAIR is indicated for
add-on maintenance treatment of
patients with severe asthma aged 18
years and older, and with an
eosinophilic phenotype. Subsequent to
this approval, the USPTO received a
patent term restoration application for
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36791
CINQAIR (U.S. Patent No. RE39,548)
from UCB Celltech, and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
September 26, 2016, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
CINQAIR 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
CINQAIR is 5,685 days. Of this time,
5,325 days occurred during the testing
phase of the regulatory review period,
while 360 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: August 31, 2000. The
applicant claims February 15, 2008, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was August 31, 2000,
which was 30 days after FDA receipt of
the first 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 30, 2015. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
CINQAIR (BLA 761033) was initially
submitted on March 30, 2015.
3. The date the application was
approved: March 23, 2016. FDA has
verified the applicant’s claim that BLA
761033 was approved on March 23,
2016.
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 1,660 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, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in 21 CFR
60.30, any interested person may
petition FDA for a determination
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Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
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
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16516 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0041]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Safety Assurance
Case; Withdrawal of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of a notice that was
published in the Federal Register of
March 15, 2017.
DATES: August 7, 2017.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
March 15, 2017 (82 FR 13817), ‘‘Agency
Information Collection Activities;
Proposed Collection; Comment Request;
Safety Assurance Case,’’ FDA requested
comment on the information collection
associated with safety assurance cases
(SACs).
Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
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SUMMARY:
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including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice.
In the March 15, 2017, Federal
Register notice, FDA proposed to extend
the information collection related to
SACs (OMB control number 0910–
0766). However, we are withdrawing the
notice because, upon further review of
the information collection request (ICR)
associated with the notice and
comments received on the information
collection, we have determined that the
estimated burden expressed in the SAC
ICR is included as part of the estimated
burden for the information collections
in the premarket notification (510(k))
ICR (OMB control number 0910–0120).
Because the information collected for
safety assurance cases is already
included under another information
collection approval, we have
discontinued the ICR and we are
withdrawing the March 15, 2017, notice
requesting comment on the information
collection.
The guidance entitled ‘‘Infusion
Pumps Total Product Life Cycle;
Guidance for Industry and FDA Staff’’
(https://www.fda.gov/ucm/groups/
fdagov-public/@fdagov-meddev-gen/
documents/document/ucm209337.pdf),
which provides recommendations on
the inclusion of safety assurance cases
as part of the premarket submissions for
new, changed, or modified infusion
pumps submitted by device
manufacturers, continues to provide the
Agency’s current thinking on this topic.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16561 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
drug applications (ANDAs). In the
Federal Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site. The
product-specific guidances identified in
this notice were developed using the
process described in that guidance.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
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
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidances; Final
Guidances 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 final
product-specific guidances. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
SUMMARY:
PO 00000
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Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2007–D–0369 for ‘‘Product-Specific
E:\FR\FM\07AUN1.SGM
07AUN1
]]>Agencies
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36790-36792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-E-2531]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CINQAIR
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for CINQAIR 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by October
6, 2017. 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 February 5, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 6, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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'').
[[Page 36791]]
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2016-E-2531 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; CINQAIR.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 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 product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human 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 CINQAIR
(reslizumab). CINQAIR is indicated for add-on maintenance treatment of
patients with severe asthma aged 18 years and older, and with an
eosinophilic phenotype. Subsequent to this approval, the USPTO received
a patent term restoration application for CINQAIR (U.S. Patent No.
RE39,548) from UCB Celltech, and the USPTO requested FDA's assistance
in determining this patent's eligibility for patent term restoration.
In a letter dated September 26, 2016, FDA advised the USPTO that this
human biological product had undergone a regulatory review period and
that the approval of CINQAIR 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
CINQAIR is 5,685 days. Of this time, 5,325 days occurred during the
testing phase of the regulatory review period, while 360 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: August 31,
2000. The applicant claims February 15, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 31, 2000,
which was 30 days after FDA receipt of the first 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 30, 2015. FDA has verified the
applicant's claim that the biologics license application (BLA) for
CINQAIR (BLA 761033) was initially submitted on March 30, 2015.
3. The date the application was approved: March 23, 2016. FDA has
verified the applicant's claim that BLA 761033 was approved on March
23, 2016.
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 1,660 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, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in 21 CFR 60.30, any interested person may petition FDA for a
determination
[[Page 36792]]
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 Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16516 Filed 8-4-17; 8:45 am]
BILLING CODE 4164-01-P
