Determination of Regulatory Review Period for Purposes of Patent Extension; SYLVANT, 6866-6868 [2018-03126]
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6866
Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
SUMMARY:
Food and Drug Administration
[Docket Nos. FDA–2011–N–0424; FDA–
2014–N–0192; FDA–2008–N–0094; FDA–
2010–N–0062; FDA–2010–N–0588; FDA–
2010–N–0110; FDA–2010–N–0493; FDA–
2017–N–1095; FDA–2013–D–0349; FDA–
2016–N–2683]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Notice.
Food and Drug Administration,
HHS.
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Temporary Marketing Permit Applications ..............................................................................................................
Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors with Interest in Exporting ....
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have
been Revoked, Suspended, or Modified by the EPA ..........................................................................................
Medical Devices; Exception from General Requirements for Informed Consent ...................................................
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile ......
Prescription Drug Advertisements ...........................................................................................................................
Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe
and Effective and Not Misbranded ......................................................................................................................
Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices ......................
Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market
Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format ...........................
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration ......................
Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
extension of a patent which claims that
human biological product.
[FR Doc. 2018–03128 Filed 2–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–E–2362 and FDA–
2014–E–2363]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SYLVANT
AGENCY:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SYLVANT 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 the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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19:01 Feb 14, 2018
Jkt 244001
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 April 16,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 16, 2018. 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:
Food and Drug Administration,
HHS.
ACTION:
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 April 16, 2018.
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
August 14, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0133
0910–0509
11/30/2020
11/30/2020
0910–0562
0910–0586
0910–0614
0910–0686
11/30/2020
11/30/2020
11/30/2020
11/30/2020
0910–0688
0910–0769
11/30/2020
11/30/2020
0910–0771
0910–0847
11/30/2020
11/30/2020
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’’).
E:\FR\FM\15FEN1.SGM
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Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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 Nos. FDA–
2014–E–2362 and FDA–2014–E–2363
For Determination of Regulatory Review
Period for Purposes of Patent Extension;
SYLVANT. 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 § 10.20 (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
VerDate Sep<11>2014
19:01 Feb 14, 2018
Jkt 244001
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 human
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 human
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 biological product SYLVANT
(siltuximab). SYLVANT is indicated for
the treatment of patients with
multicentric Castleman’s disease who
are human immunodeficiency virus
negative and human herpesvirus-8
negative. Subsequent to this approval,
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
6867
the USPTO received patent term
restoration applications for SYLVANT
(U.S. Patent Nos. 7,612,182 and
7,291,721) from Janssen Biotech, Inc.,
and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated October 30, 2015, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of SYLVANT 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
SYLVANT is 3,747 days. Of this time,
3,510 days occurred during the testing
phase of the regulatory review period,
while 237 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 (FD&C Act) (21 U.S.C.
355(i)) became effective: January 21,
2004. The applicant claims January 8,
2004, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was January 21, 2004,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biologic product under section
351 of the Public Health Service Act (42
U.S.C. 262): August 30, 2013. FDA has
verified the applicant’s claim that the
biologic license application (BLA) for
SYLVANT (BLA 125496/0) was initially
submitted on August 30, 2013.
3. The date the application was
approved: April 23, 2014. FDA has
verified the applicant’s claim that BLA
125496/0 was approved on April 23,
2014.
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 applications for patent extension,
this applicant seeks 936 or 1,300 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 § 60.30 (21
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15FEN1
6868
Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices
CFR 60.30), 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
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (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: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03126 Filed 2–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–1301; FDA–
2016–E–1302; and FDA–2016–E–1299]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ORKAMBI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ORKAMBI 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 drug
product.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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 April 16, 2018.
Furthermore, any interested person may
DATES:
VerDate Sep<11>2014
19:01 Feb 14, 2018
Jkt 244001
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 14, 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 April 16,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 16, 2018. 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’’).
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2016–E–1301; FDA–2016–E–1302; and
FDA–2016–E–1299 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
ORKAMBI.’’ 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 § 10.20 (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
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,
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6866-6868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03126]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-E-2362 and FDA-2014-E-2363]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SYLVANT
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SYLVANT 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 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 April
16, 2018. 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 August 14, 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 April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. 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 6867]]
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 Nos.
FDA-2014-E-2362 and FDA-2014-E-2363 For Determination of Regulatory
Review Period for Purposes of Patent Extension; SYLVANT. 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 Sec. 10.20 (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 human 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 human
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 biological product SYLVANT
(siltuximab). SYLVANT is indicated for the treatment of patients with
multicentric Castleman's disease who are human immunodeficiency virus
negative and human herpesvirus-8 negative. Subsequent to this approval,
the USPTO received patent term restoration applications for SYLVANT
(U.S. Patent Nos. 7,612,182 and 7,291,721) from Janssen Biotech, Inc.,
and the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated October 30,
2015, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of SYLVANT
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
SYLVANT is 3,747 days. Of this time, 3,510 days occurred during the
testing phase of the regulatory review period, while 237 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 (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 21, 2004. The applicant claims January 8, 2004, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was January 21, 2004,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human biologic product under section 351 of the Public Health
Service Act (42 U.S.C. 262): August 30, 2013. FDA has verified the
applicant's claim that the biologic license application (BLA) for
SYLVANT (BLA 125496/0) was initially submitted on August 30, 2013.
3. The date the application was approved: April 23, 2014. FDA has
verified the applicant's claim that BLA 125496/0 was approved on April
23, 2014.
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 applications for patent extension,
this applicant seeks 936 or 1,300 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 Sec. 60.30 (21
[[Page 6868]]
CFR 60.30), 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 comply with all the requirements of Sec. 60.30, including but not
limited to: Must be timely (see DATES), must be filed in accordance
with Sec. 10.20, must contain sufficient facts to merit an FDA
investigation, and must certify that a true and complete copy of the
petition has been served upon the patent applicant. (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: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03126 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P
