Determination of Regulatory Review Period for Purposes of Patent Extension; Korsuva, 83136-83138 [2023-26106]
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83136
Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices
required to notify FDA, when such
notifications are required, what
information FDA expects manufacturers
to include in such notifications, and
how to submit notifications.
Additionally, FDA describes how FDA
determines that a device is in shortage
and additional actions FDA may take to
help prevent or mitigate a potential
device shortage.
In the draft guidance ‘‘Select Updates
for the 506J Guidance: 506J Device List
and Additional Notifications,’’ FDA
proposes updates to the 506J Guidance.
Specifically, FDA has developed a list of
devices, by FDA product code, for
which a manufacturer of such devices is
required to notify FDA in accordance
with section 506J (hereafter referred to
as the ‘‘506J Device List’’). The 506J
Device List is based on the requirements
under section 506J(a) of the FD&C Act.
In section 2514 of the FY 2023
Omnibus, Congress directed FDA to
issue guidance on the requirements
under section 506J and to include ‘‘a list
of each device product code for which
a manufacturer of such device is
required to notify the Secretary in
accordance with section 506J.’’ Thus,
manufacturers of a device on the 506J
Device List must notify FDA in
accordance with 506J for each such
device. For more information,
manufacturers should see the 506J
Device List web page, available at
https://www.fda.gov/medical-devices/
medical-device-supply-chain-andshortages/506j-device-list. Additionally,
consistent with section 506J(h), FDA is
proposing to clarify for stakeholders that
manufacturers may submit, and FDA
may receive, voluntary notifications
regarding supply chain issues at any
time, unrelated to the declaration or
potential declaration of a PHE.
The guidance documents include
additional voluntary items that
manufacturers could provide the
Agency, including additional
information about device manufacturing
and supply, and updates to initial
notifications.
Respondents may notify FDA about
an interruption or permanent
discontinuance in device manufacturing
(506J notification) on our website at
https://fda-cdrh.my.salesforcesites.com/shortages/.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total
annual
responses
Average burden per
response
(hours)
Total hours
Shortages outreach data collection .............................................................
Information collection under section 506J ...................................................
Additional voluntary collections related to section 506J ..............................
1,000
8,400
8,400
4
1
1
4,000
8,400
8,400
1 ..................................
0.25 (15 minutes) .......
0.25 (15 minutes) .......
4,000
2,100
2,100
Total ......................................................................................................
........................
........................
20,800
.....................................
8,200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
I. Shortages Outreach Data Collection
FDA bases these estimates on our
recent experience and informal direct
contact with respondents. We estimate
up to 1,000 manufacturers, distributors,
healthcare systems, healthcare
providers, group purchasing
organizations, and sterilizers for which
there may be targeted outreach because
their devices may be essential to the
response effort. This targeted outreach
will be conducted periodically either to
obtain primary data or to verify/validate
updated data (although additional
outreach may be undertaken as needed).
The data being requested represent
common data elements that respondents
monitor and track as part of routine
business operations and, therefore, are
readily available. It is anticipated that
for most respondents, the estimated
time to fulfill CDRH’s data request will
not exceed 1 hour per request, or 4
hours per year.
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
II. Information Collection Under
Section 506J of the FD&C Act and
Related Voluntary Collections
Based on current registration and
listing data (approved under OMB
control number 0910–0625), we
estimate the number of respondents that
will submit a notification under section
506J of the FD&C Act to be
approximately 20 percent of currently
VerDate Sep<11>2014
17:19 Nov 27, 2023
Jkt 262001
registered manufacturers. Data from our
Registration and Listing system indicate
that there are approximately 42,000
unique FDA Establishment
Identification registered manufacturers.
Therefore, we estimate 8,400
respondents per year. We believe that
the burden, including the provision of
required information under section 506J
of the FD&C Act, as well as additional
voluntary information (including
additional issues that may impact the
availability of the device, such as
information about critical suppliers,
potential mitigations, production
capacity and market share, and
notification updates), is minimal and
such information is readily available to
respondents. Therefore, we estimate the
burden of this information collection to
be 15 minutes or less per notification.
Since the last OMB approval, we have
updated the Number of Respondents
and Average Burden per Response for
the Shortages Outreach Data Collection
element based on our recent experience
with the information collection and
informal direct contact with
respondents. The updates result in an
adjustment of an additional 3,000 hours
and 2,000 responses annually.
PO 00000
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Dated: November 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26199 Filed 11–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–E–2101]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Korsuva
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for Korsuva 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.
SUMMARY:
E:\FR\FM\28NON1.SGM
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Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by January 29, 2024.
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
May 28, 2024. 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. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 29, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:19 Nov 27, 2023
Jkt 262001
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–
2022–E–2101 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; KORSUVA.’’
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
PO 00000
Frm 00065
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83137
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 or biologic 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, Korsuva
(difelikefalin acetate). Korsuva is
indicated for the treatment of moderateto-severe pruritus associated with
chronic kidney disease in adults
undergoing hemodialysis. Subsequent to
this approval, the USPTO received a
patent term restoration application for
Korsuva (U.S. Patent No. 7,402,564)
from Cara Therapeutics, Inc., and the
USPTO requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
September 28, 2022, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of Korsuva
represented the first permitted
E:\FR\FM\28NON1.SGM
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83138
Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
lotter on DSK11XQN23PROD with NOTICES1
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
Korsuva is 4,625 days. Of this time,
4,381 days occurred during the testing
phase of the regulatory review period,
while 244 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: December 26,
2008. The applicant claims January 16,
2009, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was December 26,
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
of the FD&C Act: December 23, 2020.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Korsuva (NDA 214916) was initially
submitted on December 23, 2020.
3. The date the application was
approved: August 23, 2021. FDA has
verified the applicant’s claim that NDA
214916 was approved on August 23,
2021.
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 1,827 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
VerDate Sep<11>2014
17:19 Nov 27, 2023
Jkt 262001
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: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26106 Filed 11–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2022–E–2188 and FDA–
2022–E–2189]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Tavneos
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for Tavneos 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
patents which claim that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by January 29, 2024.
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
May 28, 2024. 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. The https://
www.regulations.gov electronic filing
system will accept comments until
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
11:59 p.m. Eastern Time at the end of
January 29, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received 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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2022–E–2188 and FDA–2022–E–2189
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; TAVNEOS.’’ 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, 240–402–7500.
E:\FR\FM\28NON1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83136-83138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26106]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-E-2101]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Korsuva
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 Korsuva 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.
[[Page 83137]]
DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 29, 2024.
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 May 28, 2024. 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. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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 identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-E-2101 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; KORSUVA.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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 or biologic 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, Korsuva
(difelikefalin acetate). Korsuva is indicated for the treatment of
moderate-to-severe pruritus associated with chronic kidney disease in
adults undergoing hemodialysis. Subsequent to this approval, the USPTO
received a patent term restoration application for Korsuva (U.S. Patent
No. 7,402,564) from Cara Therapeutics, Inc., and the USPTO requested
FDA's assistance in determining the patent's eligibility for patent
term restoration. In a letter dated September 28, 2022, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of Korsuva represented the first permitted
[[Page 83138]]
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
Korsuva is 4,625 days. Of this time, 4,381 days occurred during the
testing phase of the regulatory review period, while 244 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:
December 26, 2008. The applicant claims January 16, 2009, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was December
26, 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 of the FD&C Act: December 23,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for Korsuva (NDA 214916) was initially submitted on
December 23, 2020.
3. The date the application was approved: August 23, 2021. FDA has
verified the applicant's claim that NDA 214916 was approved on August
23, 2021.
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 1,827 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: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26106 Filed 11-27-23; 8:45 am]
BILLING CODE 4164-01-P
