Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCE, 6583-6585 [2018-02992]
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Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices
research, drug development, and
regulatory review. Small population
sizes, possible limited scientific
understanding of the disease of interest,
and a lack of market incentives often
preclude more traditional clinical trial
or analytical approaches from being
pursued. To help collaboratively
address these barriers, FDA is working
with stakeholders to solicit feedback on
promising designs and methodologies
for use in the development of rare
disease treatments that can form the
basis of formal guidance documents.
daltland on DSKBBV9HB2PROD with NOTICES
II. Topics for Discussion at the Public
Workshop
During the public workshop, speakers
and participants will discuss a range of
tools and methods that can be used in
the development of treatments for rare
diseases and small patient populations.
The meeting will include both
presentations by panelists and
dedicated time for questions and
comments from attendees. Topics will
include: Master protocols, use of
external controls in single-arm trials,
analytical tools for trials with multiple
or novel endpoints, and best practices
for leveraging Bayesian statistics and
adaptive study designs.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, visit the following website:
https://healthpolicy.duke.edu/events/
innovative-tools-and-statisticalmethods-treatment-development-raredisease-settings. If you are unable to
attend the meeting in person, you can
register to view a live webcast of the
meeting. There will be no onsite
registration. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by 5 p.m. EDT on Thursday,
March 15, 2018. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization.
If you need special accommodations
due to a disability, please contact Sarah
Supsiri at the Duke-Margolis Center for
Health Policy (phone: 202–791–9561,
email: sarah.supsiri@duke.edu) no later
than March 12, 2018.
Streaming webcast of the public
workshop: This public workshop will
also be webcast. Archived video footage
will also be available at the DukeMargolis website following the
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Jkt 244001
workshop (https://
healthpolicy.duke.edu/events/
innovative-tools-and-statisticalmethods-treatment-development-raredisease-settings). Persons interested in
viewing the live webcast must register
online before 5 p.m. EDT on March 18,
2018 (see Registration). Early
registration is recommended because
webcast connections are limited.
Organizations are requested to register
all participants, but to view using one
connection per location whenever
possible. Webcast participants will be
sent technical system requirements in
advance of the event. Prior to joining the
streaming webcast of the public
workshop, it is recommended that you
review these technical system
requirements.
Transcripts: Please be advised that
transcripts will not be available.
Other Issues for Consideration: A 1hour lunch break is scheduled, but food
will not be provided. There are multiple
restaurants within walking distance of
the DoubleTree by Hilton Hotel, 8727
Colesville Rd., Silver Spring, MD 20910.
All event materials will be provided
to registered attendees via email prior to
the workshop and will be publicly
available at the Duke-Margolis Center
for Health Policy website (https://
healthpolicy.duke.edu/events/
innovative-tools-and-statisticalmethods-treatment-development-raredisease-settings).
Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02990 Filed 2–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–E–2576]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; JARDIANCE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined the regulatory review period
for JARDIANCE 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
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
6583
of Commerce, for the extension of a
patent which claims that human drug
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 April 16, 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 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. 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 13, 2018. See
‘‘Petitions’’ in the SUPPLEMENTARY
INFORMATION section for more
information.
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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6584
Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices
daltland on DSKBBV9HB2PROD 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 No. FDA–
2015–E–2576 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; JARDIANCE.’’
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
22:07 Feb 13, 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 drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of 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 drug 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 drug product JARDIANCE
(empagliflozin). JARDIANCE is
indicated as an adjunct to diet and
exercise to improve glycemic control in
adults with type 2 diabetes mellitus.
Subsequent to this approval, the USPTO
received a patent term restoration
application for JARDIANCE (U.S. Patent
No. 7,579,449) from Boehringer
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
Ingelheim International GmbH, and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
October 15, 2015, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
JARDIANCE 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
JARDIANCE is 2,275 days. Of this time,
1,760 days occurred during the testing
phase of the regulatory review period,
while 515 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: May 11,
2008. The applicant claims May 10,
2008, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was May 11, 2008,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: March 5, 2013.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
JARDIANCE (NDA 204629) was initially
submitted on March 5, 2013.
3. The date the application was
approved: August 1, 2014. FDA has
verified the applicant’s claim that NDA
204629 was approved on August 1,
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 application for patent extension,
this applicant seeks 1,001 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
E:\FR\FM\14FEN1.SGM
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Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices
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 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02992 Filed 2–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Health Professions
Student Loan (HPSL) Program and
Nursing Student Loan (NSL) Program
Administrative Requirements
(Regulations and Policy). OMB No.
0915-0047-Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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22:07 Feb 13, 2018
Jkt 244001
Comments on this ICR should be
received no later than March 16, 2018.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Health Professions Student Loan (HPSL)
Program and Nursing Student Loan
(NSL) Program Administrative
Requirements (Regulations and Policy).
OMB No. 0915-0047-Revision.
Abstract: The HPSL Program, as
authorized by Public Health Service
(PHS) Act Sections 721–722 and 725–
735, provides long-term, low-interest
loans to students attending schools of
medicine, osteopathic medicine,
dentistry, veterinary medicine,
optometry, podiatric medicine, and
pharmacy. The NSL Program, as
authorized by PHS Act Sections 835–
842, provides long-term, low-interest
loans to students who attend eligible
schools of nursing in programs leading
to a diploma and degrees in nursing,
including an associate degree, a
baccalaureate degree, or graduate degree
in nursing. It also contains a number of
recordkeeping and reporting
requirements for academic institutions
and loan applicants. The applicable
regulations for these programs under 42
CFR part 57 implement and detail the
various statutory requirements (see
chart below). In an effort to consolidate
information collection requests and
achieve greater programmatic efficiency,
HRSA is incorporating the Deferment
Form (Deferment-HRSA Form 519) and
the Annual Operating Report (AOR–
HRSA Form 501) both formerly
incorporated under OMB No. 0915–
0044, into this information collection
request. As a result, the OMB No. 0915–
0044 package will be discontinued.
Need and Proposed Use of the
Information: Participating HPSL and
NSL schools are responsible for
DATES:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
6585
determining eligibility of applicants,
making loans, and collecting monies
owed by borrowers on their outstanding
loans. The Deferment Form (DefermentHRSA Form 519), provides the schools
with documentation of a borrower’s
deferment status, as detailed for the
HPSL Program under 42 CFR part
57.210 and for NSL under 42 CFR part
57.310. The Annual Operating Report
(AOR–HRSA Form 501), provides HHS
with information from participating
schools (including schools that are no
longer disbursing loans but are required
to report and maintain program records,
student records, and repayment records
until all student loans are repaid in full
and all monies due to the Federal
Government are returned) relating to
HPSL and NSL Program operations and
financial activities. Moreover, the HPSL
and NSL Program requirements are
essential for assuring that borrowers are
aware of their rights and
responsibilities, academic institutions
have accurate records of the history and
status of each loan account in order to
pursue aggressive collection efforts to
reduce default rates, and that academic
institutions maintain adequate records
for audit and assessment purposes to
help HHS safeguard federal funds
expended through the Federal Capital
Contribution (FCC). Academic
institutions are free to use improved
information technology to manage the
information required by the regulations.
Likely Respondents: Financial Aid
Directors working at institutions
participating in the HPSL and NSL
Programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
E:\FR\FM\14FEN1.SGM
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Agencies
[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6583-6585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-E-2576]
Determination of Regulatory Review Period for Purposes of Patent
Extension; JARDIANCE
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined the regulatory review period for JARDIANCE 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.
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 April
16, 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. 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 13, 2018. See ``Petitions'' in the
SUPPLEMENTARY INFORMATION section for more information.
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 6584]]
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-2015-E-2576 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; JARDIANCE.'' 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of 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
drug 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 drug product JARDIANCE
(empagliflozin). JARDIANCE is indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes
mellitus. Subsequent to this approval, the USPTO received a patent term
restoration application for JARDIANCE (U.S. Patent No. 7,579,449) from
Boehringer Ingelheim International GmbH, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated October 15, 2015, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of JARDIANCE 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
JARDIANCE is 2,275 days. Of this time, 1,760 days occurred during the
testing phase of the regulatory review period, while 515 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: May 11, 2008. The applicant claims May 10, 2008, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was May 11,
2008, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: March 5,
2013. FDA has verified the applicant's claim that the new drug
application (NDA) for JARDIANCE (NDA 204629) was initially submitted on
March 5, 2013.
3. The date the application was approved: August 1, 2014. FDA has
verified the applicant's claim that NDA 204629 was approved on August
1, 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 application for patent extension,
this applicant seeks 1,001 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
[[Page 6585]]
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 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02992 Filed 2-13-18; 8:45 am]
BILLING CODE 4164-01-P