Determination of Regulatory Review Period for Purposes of Patent Extension; TALTZ, 54108-54110 [2018-23438]
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54108
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
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Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. The guidance may also be
obtained by mail by calling CBER at 1–
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the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Mehul
Mehta, Center for Drug Evaluation and
Research, Food and Drug
Administration, Bldg. 51, Rm. 2178,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–1573.
Regarding the ICH: Amanda Roache,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1176, Silver Spring,
MD 20993–0002, 301–796–4548.
SUPPLEMENTARY INFORMATION:
khammond on DSK30JT082PROD with NOTICES
I. Background
In recent years, regulatory authorities
and industry associations from around
the world have participated in many
important initiatives to promote
international harmonization of
regulatory requirements under the ICH.
FDA has participated in several ICH
meetings designed to enhance
harmonization, and FDA is committed
to seeking scientifically based
harmonized technical procedures for
pharmaceutical development. One of
the goals of harmonization is to identify
and reduce differences in technical
requirements for drug development
among regulatory Agencies.
ICH was established to provide an
opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products for human use
among regulators around the world. The
six founding members of the ICH are the
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18:32 Oct 25, 2018
Jkt 247001
European Commission; the European
Federation of Pharmaceutical Industries
Associations; FDA; the Japanese
Ministry of Health, Labour, and Welfare;
the Japanese Pharmaceutical
Manufacturers Association; and the
Pharmaceutical Research and
Manufacturers of America. The
Standing Members of the ICH
Association include Health Canada and
Swissmedic. Any party eligible as a
Member in accordance with the ICH
Articles of Association can apply for
membership in writing to the ICH
Secretariat. The ICH Secretariat, which
coordinates the preparation of
documentation, operates as an
international nonprofit organization and
is funded by the Members of the ICH
Association.
The ICH Assembly is the overarching
body of the Association and includes
representatives from each of the ICH
members and observers. The Assembly
is responsible for the endorsement of
draft guidelines and adoption of final
guidelines. FDA publishes ICH
guidelines as FDA guidance.
In May 2018, the ICH Assembly
endorsed the draft guideline entitled
‘‘Biopharmaceutics Classification
System-Based Biowaivers’’ and agreed
that the guideline should be made
available for public comment. The draft
guideline is the product of the
Multidisciplinary M9 Expert Working
Group of the ICH. Comments about this
draft will be considered by FDA and the
Multidisciplinary M9 Expert Working
Group.
The draft guidance provides guidance
on the biopharmaceutics classification
of drug substances and the BCS-based
waiver of in vivo BE studies for drug
products.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Biopharmaceutics Classification
System-Based Biowaivers.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.regulations.gov, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
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RegulatoryInformation/Guidances/
default.htm.
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23425 Filed 10–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–E–4274; FDA–
2016–E–3887]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TALTZ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TALTZ 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 (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 26, 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
April 24, 2019. 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 December 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 26, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\26OCN1.SGM
26OCN1
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
khammond on DSK30JT082PROD with NOTICES
• 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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2017–E–4274 and FDA–2016–E–3887
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; TALTZ.’’ 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
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18:32 Oct 25, 2018
Jkt 247001
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,
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
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54109
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 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 TALTZ
(ixekizumab). TALTZ is indicated for
treatment of adults with moderate-tosevere plaque psoriasis who are
candidates for systemic therapy or
phototherapy. Subsequent to this
approval, the USPTO received patent
term restoration applications for TALTZ
(U.S. Patent Nos. 7,838,638 and
8,110,191) from Eli Lilly and Company,
and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated September 20, 2017, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of TALTZ 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
TALTZ is 3,036 days. Of this time, 2,670
days occurred during the testing phase
of the regulatory review period, while
366 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: December 1, 2007. The
applicant claims December 2, 2007, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was December 1,
2007, 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
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54110
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
U.S.C. 262): March 23, 2015. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
TALTZ (BLA 125521) was initially
submitted on March 23, 2015.
3. The date the application was
approved: March 22, 2016. FDA has
verified the applicant’s claim that BLA
125521 was approved on March 22,
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 applications for patent extension,
this applicant seeks 1,156 days or 935
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
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.
khammond on DSK30JT082PROD with NOTICES
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23438 Filed 10–25–18; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:32 Oct 25, 2018
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0902]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Product Labeling; Medication Guide
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
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,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on regulations
requiring distribution of patient
labeling, called Medication Guides, for
certain products that pose a serious and
significant public health concern.
DATES: Submit either electronic or
written comments on the collection of
information by December 26, 2018.
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 December 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 26, 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.
SUMMARY:
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,
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0902 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Prescription Drug Product Labeling;
Medication Guide Requirements.’’
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
E:\FR\FM\26OCN1.SGM
26OCN1
]]>Agencies
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54108-54110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23438]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2017-E-4274; FDA-2016-E-3887]
Determination of Regulatory Review Period for Purposes of Patent
Extension; TALTZ
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 TALTZ 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 26, 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 April 24,
2019. 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 December 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 26, 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:
[[Page 54109]]
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 identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2017-E-4274 and FDA-2016-E-3887 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; TALTZ.'' 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 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 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 TALTZ
(ixekizumab). TALTZ is indicated for treatment of adults with moderate-
to-severe plaque psoriasis who are candidates for systemic therapy or
phototherapy. Subsequent to this approval, the USPTO received patent
term restoration applications for TALTZ (U.S. Patent Nos. 7,838,638 and
8,110,191) from Eli Lilly and Company, and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated September 20, 2017, FDA advised the
USPTO that this human biological product had undergone a regulatory
review period and that the approval of TALTZ 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
TALTZ is 3,036 days. Of this time, 2,670 days occurred during the
testing phase of the regulatory review period, while 366 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: December 1,
2007. The applicant claims December 2, 2007, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was December 1, 2007,
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
[[Page 54110]]
U.S.C. 262): March 23, 2015. FDA has verified the applicant's claim
that the biologics license application (BLA) for TALTZ (BLA 125521) was
initially submitted on March 23, 2015.
3. The date the application was approved: March 22, 2016. FDA has
verified the applicant's claim that BLA 125521 was approved on March
22, 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 applications for patent extension,
this applicant seeks 1,156 days or 935 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 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: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23438 Filed 10-25-18; 8:45 am]
BILLING CODE 4164-01-P
