Determination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME, 54829-54831 [2024-14538]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 127 / Tuesday, July 2, 2024 / Notices
Statutory Authority: Ms. L. v. U.S.
Immigration and Customs Enforcement
(2023) Settlement Agreement (Section
IV.B.), available at: https://
www.justice.gov/opa/file/1319516/
dl?inline.
Elizabeth Leo,
Policy Branch Chief, Office of Grants Policy,
Office of Administration.
[FR Doc. 2024–14591 Filed 6–28–24; 11:15 am]
BILLING CODE 4184–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget (OMB) Review; Revisions
to Two Information Collections:
Medical Assessment Form and Dental
Assessment Form (OMB #0970–0466)
and Mental Health Assessment Form
and Public Health Investigation Forms,
Tuberculosis and Non-Tuberculosis
Illness (OMB #0970–0509)
Office of Refugee Resettlement,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families (ACF) is
proposing a change of the described
potential uses of data for two
information collections: Medical
Assessment Form and Dental
Assessment Form (OMB #: 0970–0466)
and Mental Health Assessment Form
and Public Health Investigation Forms,
Tuberculosis and Non-Tuberculosis
Illness (OMB: #0970–0509).
DATES: Comments due August 1, 2024.
OMB has agreed to make a decision
about the updates to these collections of
information following a public comment
period of 30 days. Therefore, a comment
is best assured of having its full effect
if ACF receives it within 30 days of
publication.
SUMMARY:
You can obtain copies of the
proposed changes and submit comments
by emailing infocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: The following two ORR
information collections capture health
data on children in ORR care:
• Medical Assessment Form and Dental
Assessment Form
• Mental Health Assessment Form and
Public Health Investigation Form:
lotter on DSK11XQN23PROD with NOTICES1
ADDRESSES:
VerDate Sep<11>2014
17:34 Jul 01, 2024
Jkt 262001
Active TB, and Public Health
Investigation Form: Non-TB Illness
The current description of purpose
and use of the data collected states that
confidential and sensitive health
information will only be shared with
external stakeholders (including other
Federal agencies) for public health
purposes (e.g., contact investigations to
identify children exposed to a
reportable infectious disease). However,
ORR has identified a need to share the
health data of specific unaccompanied
children with the Department of
Homeland Security (DHS) which falls
outside of the stated limitations. The
need to communicate with DHS occurs
when a newly referred child arrives at
an ORR facility ill or requires emergent/
urgent healthcare services shortly after
placement and ORR was not notified in
advance. For DHS to investigate the
event, ORR must share confidential and
sensitive health information including
the child’s alien number, name, signs/
symptoms, diagnoses, and date of
diagnosis. The goal of this data sharing
effort is to identify areas of potential
improvement in delivery of healthcare
services and continuity of care for
children transferred from DHS to Health
and Human Services custody.
Respondents: Healthcare providers
(pediatricians, medical specialists, and
dentists), mental health professionals
(psychiatrists, psychiatric nurse
practitioners or physician’s assistants,
licensed psychologist or any other
community based licensed mental
health provider (e.g., social worker),
care provider program staff.
Annual Burden Estimates: No
changes. For current burden estimates,
see information below:
• https://www.reginfo.gov/public/do/
PRAViewICR?ref_nbr=202312-0970002
• https://www.reginfo.gov/public/do/
PRAViewICR?ref_nbr=202312-0970003
Authority: 6 U.S.C. 279: Exhibit 1,
part A.2 of the Flores Settlement
Agreement (Jenny Lisette Flores, et al.,
v. Janet Reno, Attorney General of the
United States, et al., Case No. CV 85–
4544–RJK [C.D. Cal. 1996]).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–14556 Filed 7–1–24; 8:45 am]
BILLING CODE 4184–45–P
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
54829
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2023–E–3130 and FDA–
2023–E–3135]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XENPOZYME
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for XENPOZYME 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
biological 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 September 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
December 30, 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
September 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
confidential information that you or a
E:\FR\FM\02JYN1.SGM
02JYN1
54830
Federal Register / Vol. 89, No. 127 / Tuesday, July 2, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–3130 and FDA–2023–E–3135
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; XENPOZYME.’’ 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
VerDate Sep<11>2014
17:34 Jul 01, 2024
Jkt 262001
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 biologic product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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 biological 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 biologic product XENPOZYME
(olipudase alfa-rcpc). XENPOZYME is
indicated for treatment of non-central
nervous system manifestations of acid
sphingomyelinase deficiency in adult
and pediatric patients. Subsequent to
this approval, the USPTO received a
patent term restoration application for
XENPOZYME (U.S. Patent Nos.
8,314,319 and 8,658,162) from Genzyme
Corporation and Icahn School of
Medicine at Mount Sinai, and the
USPTO requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
January 18, 2024, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
XENPOZYME 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
XENPOZYME is 5,971 days. Of this
time, 5,669 days occurred during the
testing phase of the regulatory review
period, while 302 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 (21 U.S.C. 355(i))
became effective: April 28, 2006. The
applicant claims May 4, 2006, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was April 28, 2006,
which was the first date after receipt of
the IND that the investigational studies
were allowed to proceed.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): November 3, 2021. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
XENPOZYME (BLA 761261) was
E:\FR\FM\02JYN1.SGM
02JYN1
Federal Register / Vol. 89, No. 127 / Tuesday, July 2, 2024 / Notices
initially submitted on November 3,
2021.
3. The date the application was
approved: August 31, 2022. FDA has
verified the applicant’s claim that BLA
761261 was approved on August 31,
2022.
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 1,827 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
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
Nos. 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: June 27, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–14538 Filed 7–1–24; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:34 Jul 01, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2023–E–1833 and FDA–
2023–E–1746]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TEZSPIRE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TEZSPIRE 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
biological 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 September 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
December 30, 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
September 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
confidential information that you or a
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
54831
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–1833 and FDA–2023–E–1746
‘‘For Determination of Regulatory
Review Period for Purposes of Patent
Extension; TEZSPIRE.’’ 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
E:\FR\FM\02JYN1.SGM
02JYN1
]]>Agencies
[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54829-54831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14538]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-E-3130 and FDA-2023-E-3135]
Determination of Regulatory Review Period for Purposes of Patent
Extension; XENPOZYME
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 XENPOZYME 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
biological 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 September 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 December 30, 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 September 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 confidential information that you or a
[[Page 54830]]
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-3130 and FDA-2023-E-3135 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; XENPOZYME.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product XENPOZYME
(olipudase alfa-rcpc). XENPOZYME is indicated for treatment of non-
central nervous system manifestations of acid sphingomyelinase
deficiency in adult and pediatric patients. Subsequent to this
approval, the USPTO received a patent term restoration application for
XENPOZYME (U.S. Patent Nos. 8,314,319 and 8,658,162) from Genzyme
Corporation and Icahn School of Medicine at Mount Sinai, and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated January 18, 2024, FDA
advised the USPTO that this human biological product had undergone a
regulatory review period and that the approval of XENPOZYME 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
XENPOZYME is 5,971 days. Of this time, 5,669 days occurred during the
testing phase of the regulatory review period, while 302 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 (21 U.S.C. 355(i)) became effective: April 28,
2006. The applicant claims May 4, 2006, as the date the investigational
new drug application (IND) became effective. However, FDA records
indicate that the IND effective date was April 28, 2006, which was the
first date after receipt of the IND that the investigational studies
were allowed to proceed.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): November 3, 2021. FDA has verified the
applicant's claim that the biologics license application (BLA) for
XENPOZYME (BLA 761261) was
[[Page 54831]]
initially submitted on November 3, 2021.
3. The date the application was approved: August 31, 2022. FDA has
verified the applicant's claim that BLA 761261 was approved on August
31, 2022.
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 1,827 days of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket Nos. 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: June 27, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-14538 Filed 7-1-24; 8:45 am]
BILLING CODE 4164-01-P
