Determination of Regulatory Review Period for Purposes of Patent Extension; Rezurock, 83558-83560 [2023-26358]
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Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices
USPTO requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
September 21, 2022, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
Koselugo represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
khammond on DSKJM1Z7X2PROD with NOTICES
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
Koselugo is 5,100 days. Of this time,
4,889 days occurred during the testing
phase of the regulatory review period,
while 211 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: April 26, 2006.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on April 26, 2006.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: September 13, 2019.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Koselugo (NDA 213756) was initially
submitted on September 13, 2019.
3. The date the application was
approved: April 10, 2020. FDA has
verified the applicant’s claim that NDA
213756 was approved on April 10, 2020.
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 927 days, 1,550
days, or 5 years 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:
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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: November 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26324 Filed 11–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–E–2089]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Rezurock
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for Rezurock 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 (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,
SUMMARY:
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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–2089 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; REZUROCK.’’
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
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Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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.
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:
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 Rezurock
(belumosudil mesylate). Rezurock is
indicated for the treatment of adult and
pediatric patients 12 years and older
with chronic graft-versus-host disease
after failure of at least two prior lines of
systemic therapy. Subsequent to this
approval, the USPTO received a patent
term restoration application for
Rezurock (U.S. Patent No. 8,357,693)
from Kadmon Pharmaceuticals, LLC
(agent for Surface Logix, LLC), and the
USPTO requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
September 13, 2022, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
Rezurock represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
I. Background
II. Determination of Regulatory Review
Period
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
FDA has determined that the
applicable regulatory review period for
Rezurock is 4,327 days. Of this time,
4,037 days occurred during the testing
phase of the regulatory review period,
while 290 days occurred during the
approval phase. These periods of time
were derived from the following dates:
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83559
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: September 12,
2009. The applicant claims January 8,
2016, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was September 12,
2009, which was 30 days after FDA
receipt of an earlier IND.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: September 30, 2020.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Rezurock (NDA 214783) was initially
submitted on September 30, 2020.
3. The date the application was
approved: July 16, 2021. FDA has
verified the applicant’s claim that NDA
214783 was approved on July 16, 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 1,154 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.
E:\FR\FM\30NON1.SGM
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83560
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices
Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
meeting virtually will be posted at least
one week prior to the meeting at: https://
www.hhs.gov/paccarb.
[FR Doc. 2023–26358 Filed 11–29–23; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
Jomana Musmar, M.S., Ph.D.,
Designated Federal Officer, Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria, Office of
the Assistant Secretary for Health, U.S.
Department of Health and Human
Services, 1101 Wootton Parkway,
Rockville, MD 20852. Phone: 202–746–
1512; Email: CARB@hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meetings of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a virtual meeting is scheduled to be
held for the Presidential Advisory
Council on Combating AntibioticResistant Bacteria (PACCARB). The
meeting will be open to the public and
will be streamed live on hhs.gov/live. A
pre-registered public comment session
will be held during the meeting. Preregistration is required for members of
the public who wish to present their
comments live during the virtual
meeting. Individuals who wish to
provide written public comment should
send an email to CARB@hhs.gov that
includes their written comments.
Registration information is available on
the website https://www.hhs.gov/paccarb
and should be completed by December
18, 2023 for the December 20, 2023
virtual Public Meeting. Additional
information about registering for the
meeting and providing public comment
can be obtained at https://www.hhs.gov/
paccarb on the Upcoming Meetings
page. HHS is also giving notice of the
appointment of 16 new PACCARB
councilmembers that will be sworn-in
in preparation of the December 20, 2023
virtual public meeting.
DATES: The meeting is scheduled to be
held on December 20, 2023, from 9 a.m.
to 4 p.m. ET (times are tentative and
subject to change). The confirmed times
and agenda items for the meeting will be
posted on the website for the PACCARB
at https://www.hhs.gov/paccarb when
this information becomes available. Preregistration for attending the meeting is
strongly suggested and should be
completed no later than December 18,
2023.
ADDRESSES: The virtual meeting can be
accessed through a live webcast on the
day of the meeting. Additional
instructions regarding attending this
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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17:22 Nov 29, 2023
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The
Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(PACCARB), established by Executive
Order 13676, is continued by section
505 of Public Law 116–22, the
Pandemic and All-Hazards
Preparedness and Advancing Innovation
Act of 2019 (PAHPAIA). Activities and
duties of the PACCARB are governed by
the provisions of the Federal Advisory
Committee Act (FACA), Public Law 92–
463, as amended (5 U.S.C. app.), which
sets forth standards for the formation
and use of federal advisory committees.
The PACCARB shall advise and
provide information and
recommendations to the Secretary of
Health and Human Services (Secretary)
regarding programs and policies
intended to reduce or combat antibioticresistant bacteria that may present a
public health threat and improve
capabilities to prevent, diagnose,
mitigate, or treat such resistance. The
PACCARB shall function solely for
advisory purposes.
Such advice, information, and
recommendations may be related to
improving: the effectiveness of
antibiotics; research and advanced
research on, and the development of,
improved and innovative methods for
combating or reducing antibiotic
resistance, including new treatments,
rapid point-of-care diagnostics,
alternatives to antibiotics, including
alternatives to animal antibiotics, and
antimicrobial stewardship activities;
surveillance of antibiotic-resistant
bacterial infections, including publicly
available and up-to-date information on
resistance to antibiotics; education for
health care providers and the public
with respect to up-to-date information
on antibiotic resistance and ways to
reduce or combat such resistance to
antibiotics related to humans and
animals; methods to prevent or reduce
the transmission of antibiotic-resistant
bacterial infections; including
stewardship programs; and coordination
with respect to international efforts in
order to inform and advance the United
SUPPLEMENTARY INFORMATION:
PO 00000
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States capabilities to combat antibiotic
resistance.
The Advisory Council is authorized to
consist of at least 30 members,
including the voting and non-voting
members and the Chair and Vice Chair.
The current composition of the
Advisory Council consists of 15 voting
members, including the Chair and Vice
Chair, eight non-voting liaison
representative members, and 12 nonvoting ex-officio members. In March of
2023, the terms of 16 councilmembers
ended, and an announcement was
published August 1, 2022 and closed on
September 19, 2022 to solicit
nominations to fill the open PACCARB
positions, nine of which were in the
voting member category, including the
Chair and Vice-Chair positions, while
the remaining seven were in the nonvoting liaison member category. These
positions have been filled and the new
PACCARB members will be sworn-in in
preparation for the December 20, 2023,
virtual public meeting. Newly
appointed voting members were
selected to serve four-year terms, and
non-voting liaison members were
appointed to serve for two-year terms.
The full roster of councilmembers,
including the 16 new members, can be
found on the Membership page at https://
www.hhs.gov/paccarb.
The December 20, 2023, virtual public
meeting will be dedicated to current
global U.S. federal efforts to combat
antimicrobial resistance in response to a
task from the Secretary given to the
PACCARB in 2023. The signed task
letter from the Secretary can be found at
https://www.hhs.gov/paccarb. The
meeting agenda will be posted on the
PACCARB website at https://
www.hhs.gov/paccarb when it has been
finalized. All agenda items and times
are tentative and subject to change.
Instructions regarding attending the
meeting virtually will be posted at least
one week prior to the meeting at: https://
www.hhs.gov/paccarb.
Members of the public will have the
opportunity to provide comments
during the December meeting by preregistering online at https://
www.hhs.gov/paccarb. Pre-registration
is required for participation in this
session with limited spots available.
Written public comments can also be
emailed to CARB@hhs.gov by midnight
December 18, 2023 and should be
limited to no more than one page. All
public comments received prior to
December 18, 2023, will be provided to
the PACCARB members. Additionally,
companies and/or organizations
involved in combating antibiotic
resistance have an opportunity to
present their work to members of the
E:\FR\FM\30NON1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83558-83560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-E-2089]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Rezurock
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 Rezurock 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 (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-2089 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; REZUROCK.'' 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
[[Page 83559]]
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 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 Rezurock
(belumosudil mesylate). Rezurock is indicated for the treatment of
adult and pediatric patients 12 years and older with chronic graft-
versus-host disease after failure of at least two prior lines of
systemic therapy. Subsequent to this approval, the USPTO received a
patent term restoration application for Rezurock (U.S. Patent No.
8,357,693) from Kadmon Pharmaceuticals, LLC (agent for Surface Logix,
LLC), and the USPTO requested FDA's assistance in determining the
patent's eligibility for patent term restoration. In a letter dated
September 13, 2022, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
Rezurock 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
Rezurock is 4,327 days. Of this time, 4,037 days occurred during the
testing phase of the regulatory review period, while 290 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:
September 12, 2009. The applicant claims January 8, 2016, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was September
12, 2009, which was 30 days after FDA receipt of an earlier IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: September 30,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for Rezurock (NDA 214783) was initially submitted on
September 30, 2020.
3. The date the application was approved: July 16, 2021. FDA has
verified the applicant's claim that NDA 214783 was approved on July 16,
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 1,154 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.
[[Page 83560]]
Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26358 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P
