Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS, 102912-102914 [2024-29964]
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
biologic developers. FDA regulations in
21 CFR parts 210 and 211 govern
current good manufacturing practice in
the manufacturing, processing, packing,
or holding of drugs and finished
pharmaceuticals (including medical
gases and active pharmaceutical
ingredients), respectively. Applicable
information collection and attendant
burden are currently discussed,
accounted for, and approved in OMB
control number 0910–0139.
We are revising the information
collection to include the AMT
Designation Program within the scope of
activity, as authorized by section 506L
of the FD&C Act, and account for
attendant burden. Requests for AMT
designation are reviewed by FDA to
evaluate whether the data and
information submitted meets the criteria
established in section 506L of the FD&C
Act. If a request for AMT designation is
granted, then future new drug
application (NDA), abbreviated new
drug application (ANDA), or biologics
license application (BLA) applicants
may use or reference the designated
AMT, noting specific application of the
designated AMT to specific product
development and inclusion in NDA,
ANDA, or BLA submissions describing
development and manufacturing
processes. Also required by section
506L of the FD&C Act, we engaged with
our stakeholders in a public meeting on
June 8, 2023 (April 24, 2023, 88 FR
24807), to discuss innovative
manufacturing technologies for drug
and biological products and included a
discussion of the AMT Designation
Program. For more information
regarding AMT, we invite readers to
visit our website at https://www.fda.gov/
emergency-preparedness-and-response/
mcm-issues/advanced-manufacturing,
which includes regular updates on
Agency implementation of its AMT
Designation Program.
Finally, section 506L of the FD&C Act
also provides for the issuance of
guidance. In the Federal Register of
December 13, 2023 (88 FR 86333), we
issued the draft guidance document
entitled ‘‘Advanced Manufacturing
Technologies Designation Program,’’ to
communicate the goals, scope, and
framework of the new program. We
invited public comment under both our
good guidance practices regulation in 21
CFR 10.115, and applicable PRA
regulations in 5 CFR part 1320 and
received a few comments. The
comments included some requests for
procedural clarification but focused
mostly on requests for clarification of
technical specifications and
technologies that might qualify for AMT
designation. Although we have updated
the guidance document to address a
number of public comments, we
continue to implement the program and
refine Agency processes.
FDA estimates the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Section 506L(c) FD&C Act
Number of
respondents
Number of
responses per
respondents
Total annual
responses
Average
burden per
response
Total
hours
Submitting AMT designation requests; FDA Guidance for
Industry, section III.B ........................................................
20
1
20
10
200
1 There
are no capital or operating and maintenance costs associated with the information collection.
Based on our experience with similar
information collection activities that
involve requests for FDA
determinations, along with related
preliminary and followup
communications, we assume 10 hours is
needed to complete the activities
provided for in section 506L of the
FD&C Act and discussed in the
referenced guidance document.
Although we have received fewer than
10 requests for AMT designation thus
far, we are hopeful that 20 respondents
will submit requests for AMT
designation under the program.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–29954 Filed 12–17–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2024–E–0195; FDA–
2024–E–0196; FDA–2024–E–0197; FDA–
2024–E–0198]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SOHONOS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for SOHONOS and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
SUMMARY:
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incorrect may submit either electronic
or written comments and ask for a
redetermination by February 18, 2025.
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
June 16, 2025. 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
February 18, 2025. 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,
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
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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–
2024–E–0195, FDA–2024–E–0196,
FDA–2024–E–0197, and FDA–2024–E–
0198 for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; SOHONOS.’’ 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
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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. 6200, 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 biological 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
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102913
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, SOHONOS
(palovarotene) indicated for reduction
in the volume of new heterotopic
ossification in adults and children aged
8 years and older for females and 10
years and older for males with
fibrodysplasia ossificans progressiva.
Subsequent to this approval, the USPTO
received patent term restoration
applications for SOHONOS (U.S. Patent
Nos. 9,314,439 and 10,292,954 filed by
Ipsen Biopharmsaceuticals, Inc. (agent
of Thomas Jefferson University), and
U.S. Patent Nos. 10,864,194 and
11,622,959, filed by Ipsen
Biopharmaceuticals, Inc. (agent of
Clementia Pharmaceuticals Inc.)), and
the USPTO requested FDA’s assistance
in determining the patents’ eligibility
for patent term restoration. In a letter
dated February l6, 2024, FDA advised
the USPTO that this human drug
product had undergone a regulatory
review period and that the approval of
SOHONOS 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
SOHONOS is 7,526 days. Of this time,
6,657 days occurred during the testing
phase of the regulatory review period,
while 869 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: January 9,
2003. The applicant claims April 27,
2014, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was January 9, 2003,
which was 30 days after FDA receipt of
an earlier IND.
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: March 31, 2021. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
SOHONOS (NDA 215559) was initially
submitted on March 31, 2021.
3. The date the application was
approved: August 16, 2023. FDA has
verified the applicant’s claim that NDA
215559 was approved on August 16,
2023.
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 69 days 1,209 days
or 1,773 days of patent term extension.
III. Petitions
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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.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–29964 Filed 12–17–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0119]
Fiscal Year 2025 Generic Drug Science
and Research Initiatives Workshop;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the following public
workshop entitled ‘‘FY 2025 Generic
Drug Science and Research Initiatives
Workshop.’’ The purpose of the public
workshop is to provide an overview of
the status of science and research
initiatives for generic drugs and an
opportunity for public input on these
initiatives. FDA is seeking this input
from a variety of interested parties—
industry, academia, patient advocates,
professional societies, and other
interested parties—as it fulfills its
commitment under the Generic Drug
User Fee Amendments of 2022 (GDUFA
III) to develop an annual list of science
and research initiatives specific to
generic drugs. FDA will take the
information it obtains from the public
workshop into account in developing its
fiscal year (FY) 2026 Generic Drug User
Fee Amendments (GDUFA) science and
research initiatives.
DATES: The public workshop will be
held on June 3 and 4, 2025. Either
electronic or written comments on this
public workshop must be submitted by
July 7, 2025. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held in person and will be accessible
virtually. Registrants will have an
opportunity to indicate their interest in
attending the public workshop in
person. If there are restrictions imposed
by applicable health guidelines for inperson gatherings, or seating capacity
limitations, registrants interested in
attending the public workshop in
person will be contacted. The public
workshop will be held at the FDA White
Oak Campus, 10903 New Hampshire
Ave., Bldg. 31 Conference Center, the
Great Room (Rm. 1503, sections B and
C), Silver Spring, MD 20993–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
SUMMARY:
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performed. For parking and security
Information, please refer to https://
www.fda.gov/about-fda/visitorinformation.
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 July 7, 2025. 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–
2023–N–0119 for ‘‘FY 2025 Generic
Drug Science and Research Initiatives
Workshop; Public Workshop; Request
for Comments.’’ Received comments,
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]]>Agencies
[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102912-102914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29964]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-E-0195; FDA-2024-E-0196; FDA-2024-E-0197; FDA-
2024-E-0198]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SOHONOS
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 SOHONOS and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human 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 February 18, 2025.
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 June 16, 2025. 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 February 18, 2025. 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,
[[Page 102913]]
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-2024-E-0195, FDA-2024-E-0196, FDA-2024-E-0197, and FDA-2024-E-0198
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; SOHONOS.'' 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. 6200, 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 biological 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, SOHONOS
(palovarotene) indicated for reduction in the volume of new heterotopic
ossification in adults and children aged 8 years and older for females
and 10 years and older for males with fibrodysplasia ossificans
progressiva. Subsequent to this approval, the USPTO received patent
term restoration applications for SOHONOS (U.S. Patent Nos. 9,314,439
and 10,292,954 filed by Ipsen Biopharmsaceuticals, Inc. (agent of
Thomas Jefferson University), and U.S. Patent Nos. 10,864,194 and
11,622,959, filed by Ipsen Biopharmaceuticals, Inc. (agent of Clementia
Pharmaceuticals Inc.)), and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated February l6, 2024, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of SOHONOS 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
SOHONOS is 7,526 days. Of this time, 6,657 days occurred during the
testing phase of the regulatory review period, while 869 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 9, 2003. The applicant claims April 27, 2014, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was January 9, 2003,
which was 30 days after FDA receipt of an earlier IND.
[[Page 102914]]
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: March 31,
2021. FDA has verified the applicant's claim that the new drug
application (NDA) for SOHONOS (NDA 215559) was initially submitted on
March 31, 2021.
3. The date the application was approved: August 16, 2023. FDA has
verified the applicant's claim that NDA 215559 was approved on August
16, 2023.
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 69 days 1,209 days or 1,773 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: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-29964 Filed 12-17-24; 8:45 am]
BILLING CODE 4164-01-P
