Determination of Regulatory Review Period for Purposes of Patent Extension; RELYVRIO, 15588-15590 [2024-04480]
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15588
Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
due to failing (stenosed, insufficient, or
combined) of a surgical or transcatheter
bioprosthetic aortic valve, a surgical
bioprosthetic mitral valve, or a native
mitral valve with an annuloplasty ring
who are judged by a Heart Team,
including a cardiac surgeon, to be at
high or greater risk for open surgical
therapy (i.e., predicted risk of surgical
mortality ≥8 percent at 30 days, based
on the Society of Thoracic Surgeons
(STS) risk score and other clinical comorbidities unmeasured by the STS risk
calculator). Subsequent to this approval,
the USPTO received a patent term
restoration application for the SAPIEN 3
ULTRA TRANSCATHETER HEART
VALVE SYSTEM (U.S. Patent No.
7,780,723) from Edwards Lifesciences
Corporation, and the USPTO requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated January 21,
2020, FDA advised the USPTO that this
medical device had undergone a
regulatory review period and that the
approval of the SAPIEN 3 ULTRA
TRANSCATHETER HEART VALVE
SYSTEM 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
the SAPIEN 3 ULTRA
TRANSCATHETER HEART VALVE
SYSTEM is 101 days. Of this time, 0
days occurred during the testing phase
of the regulatory review period, while
101 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: not available. The applicant
claims that the testing phase began on
April 6, 2018. However, FDA is unable
to validate the beginning of a testing
phase. No investigational device
exemption as required under section
520(g) of the FD&C Act for human tests
to begin was referenced, no evidence of
institutional review board approval was
found, and no confirmation of the date
on which the device was first used with
human subjects as part of a clinical
investigation to be filed with FDA to
secure premarket approval of the device
could be determined in available FDA
records.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
VerDate Sep<11>2014
17:45 Mar 01, 2024
Jkt 262001
Act (21 U.S.C. 360e): September 18,
2018. The applicant claims September
14, 2018, as the date the premarket
approval application (PMA) for the
SAPIEN 3 ULTRA TRANSCATHETER
HEART VALVE SYSTEM (PMA
P140031S074) was initially submitted.
However, FDA records indicate that
PMA P140031S074 was submitted on
September 18, 2018.
3. The date the application was
approved: December 27, 2018. FDA has
verified the applicant’s claim that PMA
P140031S074 was approved on
December 27, 2018.
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 184 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.
Dated: February 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04478 Filed 3–1–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2023–E–2603; FDA–
2023–E–2604; FDA–2023–E–2605; and FDA–
2023–E–2606]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RELYVRIO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for RELYVRIO 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 must submit either electronic
or written comments and ask for a
redetermination by May 3, 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
September 3, 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
May 3, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
E:\FR\FM\04MRN1.SGM
04MRN1
Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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–
2023–E–2603; FDA–2023–E–2604;
FDA–2023–E–2605; and FDA–2023–E–
2606 for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; RELYVRIO.’’ 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
VerDate Sep<11>2014
17:45 Mar 01, 2024
Jkt 262001
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:
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
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15589
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, RELYVRIO
(sodium phenylbutyrate and
taurursodiol) indicated for treatment of
amyotrophic lateral sclerosis in adults.
Subsequent to this approval, the USPTO
received patent term restoration
applications for RELYVRIO (U.S. Patent
Nos. 9,872,865; 10,251,896; 10,857,162;
11,071,742; 10,857,162; and 11,071,742)
from Amylyx Pharmaceuticals Inc., and
the USPTO requested FDA’s assistance
in determining the patents’ eligibility
for patent term restoration. In a letter
dated September 28, 2023, FDA advised
the USPTO that this human drug
product had undergone a regulatory
review period and that the approval of
RELYVRIO 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
RELYVRIO is 3,359 days. Of this time,
3,023 days occurred during the testing
phase of the regulatory review period,
while 336 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: July 21, 2013.
The applicant claims April 10, 2017, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was July 21, 2013,
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: October 29, 2021. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
RELYVRIO (NDA 216660) was initially
submitted on October 29, 2021.
3. The date the application was
approved: September 29, 2022. FDA has
verified the applicant’s claim that NDA
216660 was approved on September 29,
2022.
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15590
Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices
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 383 days, 499 days,
803 days, or 1,010 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.
Dated: February 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04480 Filed 3–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2024–N–0970]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments:
Selection of Strain(s) To Be Included in
the 2024 to 2025 Formula for COVID–
19 Vaccines
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:45 Mar 01, 2024
Jkt 262001
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Vaccines and Related
Biological Products Advisory
Committee (the Committee). The general
function of the Committee is to provide
advice and recommendations to FDA on
regulatory issues. On May 16, 2024, the
Committee will meet in open session to
discuss and make recommendations on
the selection of strain(s) to be included
in the 2024–2025 Formula for COVID–
19 vaccines. The meeting will be open
to the public. FDA is establishing a
docket for public comment on this
document.
SUMMARY:
The meeting will be held
virtually on May 16, 2024, from 8:30
a.m. to 4:30 p.m. eastern time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform. The
online web conference meeting will be
available at the following link on the
day of the meeting: https://
youtube.com/live/weaKQiFk_98.
Answers to commonly asked questions
about FDA advisory committee
meetings, may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–0970.
The docket will close on May 15, 2024.
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 May 15, 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.
Comments received on or before May
8, 2024, will be provided to the
Committee. Comments received after
May 8, 2024, and by May 15, 2024, will
be taken into consideration by FDA. In
the event that the meeting is cancelled,
FDA will continue to evaluate any
relevant applications or information,
and consider any comments submitted
to the docket, as appropriate.
You may submit comments as
follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
• 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–
2024–N–0970 for ‘‘Vaccines and Related
Biological Products Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ 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
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 89, Number 43 (Monday, March 4, 2024)]
[Notices]
[Pages 15588-15590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04480]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-E-2603; FDA-2023-E-2604; FDA-2023-E-2605; and
FDA-2023-E-2606]
Determination of Regulatory Review Period for Purposes of Patent
Extension; RELYVRIO
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 RELYVRIO 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 must submit either electronic
or written comments and ask for a redetermination by May 3, 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 September 3, 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 May 3, 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
[[Page 15589]]
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-2023-E-2603; FDA-2023-E-2604; FDA-2023-E-2605; and FDA-2023-E-2606
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; RELYVRIO.'' 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 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, RELYVRIO
(sodium phenylbutyrate and taurursodiol) indicated for treatment of
amyotrophic lateral sclerosis in adults. Subsequent to this approval,
the USPTO received patent term restoration applications for RELYVRIO
(U.S. Patent Nos. 9,872,865; 10,251,896; 10,857,162; 11,071,742;
10,857,162; and 11,071,742) from Amylyx Pharmaceuticals Inc., and the
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated September
28, 2023, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of RELYVRIO
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
RELYVRIO is 3,359 days. Of this time, 3,023 days occurred during the
testing phase of the regulatory review period, while 336 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:
July 21, 2013. The applicant claims April 10, 2017, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was July 21, 2013,
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: October 29,
2021. FDA has verified the applicant's claim that the new drug
application (NDA) for RELYVRIO (NDA 216660) was initially submitted on
October 29, 2021.
3. The date the application was approved: September 29, 2022. FDA
has verified the applicant's claim that NDA 216660 was approved on
September 29, 2022.
[[Page 15590]]
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 383 days, 499 days, 803 days, or 1,010 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: February 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04480 Filed 3-1-24; 8:45 am]
BILLING CODE 4164-01-P
