Determination of Regulatory Review Period for Purposes of Patent Extension; INREBIC, 59397-59399 [2021-23388]
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Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
Generally, registered blood
establishments are inspected on a
biennial basis by the Agency. There are
approximately 1,900 registered blood
establishments that manufacture blood
and blood components for transfusion,
all located in the United States, except
a small number of United States military
blood establishments that are located
internationally in order to provide blood
and blood components to United States
military personnel onsite when needed.
The supply chains for blood and blood
components for transfusion are wellestablished and well-understood based
on the nature of the products; namely,
blood is collected from human donors
via venipuncture, separated into
components (if applicable), and stored
at specified temperatures and under the
complete control of each blood
establishment. Additionally, supply
chains for blood and blood components
for transfusion are controlled and secure
from initial donation to final product
delivery to the transfusion site and,
generally, do not involve wholesale
distributors, brokers, or other
intermediaries. Further, many registered
blood establishments voluntarily submit
the amount of blood and blood
components for transfusion
manufactured as part of the Health and
Human Services National Blood
Collection and Utilization Survey
(NBCUS), which, historically, has a high
response rate.1
lotter on DSK11XQN23PROD with NOTICES1
2. Cell and Gene Therapy Products,
Where One Lot Treats a Single Patient
In accordance with section
510(j)(3)(B) of the FD&C Act, FDA is
proposing to exempt cell and gene
therapy products, where one lot treats a
single patient, from the reporting
requirements under section 510(j)(3)(A)
of the FD&C Act. In light of FDA’s
existing visibility into the supply chain
for this category of products, requiring
registrants to report annually under
section 510(j)(3)(A) of the FD&C Act on
the amount of such products
manufactured, prepared, propagated,
compounded, or processed for
commercial distribution, is not needed
to enhance the Agency’s ability to
identify, prevent, and mitigate possible
shortages. As such, FDA has determined
that applying the reporting requirements
under section 510(j)(3)(A) of the FD&C
Act to this category of biological
products is not necessary to protect the
public health.
1 See https://doi.org/10.1111/trf.16449. The
response rate for the 2019 NBCUS was 94 percent
for community-based blood collection facilities and
84 percent for hospital-based blood collection
facilities.
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Manufacturers of cell and gene
therapy products, where one lot treats a
single patient, maintain a highly
controlled and secure supply chain from
initial request for treatment of a patient
to final product delivery to the site
where the treatment occurs. This is
because, due to the nature of these
products, manufacturers implement
strict chain of identity procedures to
track products through the
manufacturing process, to make sure the
correct product gets to the correct
patient. Additionally, the supply chains
for these products are well-established
and well-understood from information
described in the biologics license
application (BLA), and generally do not
involve wholesale distributors, brokers,
or other intermediaries.
Additionally, pursuant to § 600.81 (21
CFR 600.81), the Agency generally
receives lot distribution reports every 6
months from BLA holders. Specifically,
reports submitted to the Agency under
§ 600.81 include, among other
information, the fill lot numbers for the
total number of dosage units of each
strength or potency distributed, the
label lot number (if different from fill lot
number), the number of doses in fill lot/
label lot, and the date of release of fill
lot/label lot for distribution. For this
category of biological products, since
one lot treats a single patient, the lot
distribution reports submitted to the
Agency under § 600.81 represent the
amount of product manufactured for
commercial distribution, and additional
reporting of such information under
section 510(j)(3)(A) of the FD&C Act
would be redundant.
III. Paperwork Reduction Act of 1995
This proposed order contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). Information
collection associated with section
510(j)(3) of the FD&C Act, requiring
each person who registers with FDA
with regard to a drug to report annually
to FDA on the amount of each listed
drug that was manufactured, prepared,
propagated, compounded, or processed
by such person for commercial
distribution, is approved under OMB
control number 0910–0045. If finalized,
we believe the order will reduce burden
associated with the approved
information collection by exempting
these biological product categories from
such reporting requirements. We invite
comment on our assumptions.
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59397
IV. Proposed Effective Date
FDA proposes that any final order
based on this proposed order become
effective 30 days after its date of
publication in the Federal Register.
Dated: October 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23396 Filed 10–26–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–1902; FDA–
2020–E–1903; and FDA–2020–E–1904]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; INREBIC
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for INREBIC 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.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 27, 2021.
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
April 25, 2022. 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. Electronic comments must
be submitted on or before December 27,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 27, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
DATES:
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59398
Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
service acceptance receipt is on or
before that date.
lotter on DSK11XQN23PROD with NOTICES1
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
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–
2020–E–1902, FDA–2020–E–1903, and
FDA–2020–E–1904 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
INREBIC.’’ 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
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16:47 Oct 26, 2021
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comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
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
PO 00000
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Sfmt 4703
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, INREBIC
(fedratinib), indicated for the treatment
of adult patients with intermediate-2 or
high-risk primary or secondary (postpolycythemia vera or post-essential
thrombocythemia) myelofibrosis.
Subsequent to this approval, the USPTO
received patent term restoration
applications for INREBIC (U.S. Patent
Nos. 7,528,143; 7,825,246; and
8,138,199) from Impact Biomedicines,
Inc., and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated January 4, 2021, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of INREBIC 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
INREBIC is 4,285 days. Of this time,
4,059 days occurred during the testing
phase of the regulatory review period,
while 226 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: November 24,
2007. FDA has verified the applicant’s
claims that the date the investigational
new drug application became effective
was on November 24, 2007.
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Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: January 3, 2019. FDA
has verified the applicant’s claims that
the new drug application (NDA) for
INREBIC (NDA 212327) was initially
submitted on January 3, 2019.
3. The date the application was
approved: August 16, 2019. FDA has
verified the applicant’s claims that NDA
212327 was approved on August 16,
2019.
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 1,271 days, 1,523
days or 1,796 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
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: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23388 Filed 10–26–21; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1021]
Notice to Public of Website Location of
Center for Devices and Radiological
Health Fiscal Year 2022 Proposed
Guidance Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the website location where
the Agency will post two lists of
guidance documents that the Center for
Devices and Radiological Health (CDRH
or the Center) intends to publish in
fiscal year (FY) 2022. In addition, FDA
has established a docket where
interested persons may comment on the
priority of topics for guidance, provide
comments and/or propose draft
language for those topics, suggest topics
for new or different guidance
documents, comment on the
applicability of guidance documents
that have issued previously, and
provide any other comments that could
benefit the CDRH guidance program and
its engagement with stakeholders. This
feedback is critical to the CDRH
guidance program to ensure that we
meet stakeholders’ needs.
DATES: Submit either electronic or
written comments by November 26,
2021.
SUMMARY:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 27,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 27, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
ADDRESSES:
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
59399
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–
2012–N–1021 for ‘‘Notice to Public of
website Location of CDRH Fiscal Year
2021 Proposed Guidance Development.’’
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
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]]>Agencies
[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59397-59399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23388]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-E-1902; FDA-2020-E-1903; and FDA-2020-E-1904]
Determination of Regulatory Review Period for Purposes of Patent
Extension; INREBIC
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 INREBIC 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
the SUPPLEMENTARY INFORMATION) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 27, 2021. 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 April 25,
2022. 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. Electronic comments
must be submitted on or before December 27, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 27, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
[[Page 59398]]
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2020-E-1902, FDA-2020-E-1903, and FDA-2020-E-1904 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; INREBIC.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, INREBIC
(fedratinib), indicated for the treatment of adult patients with
intermediate-2 or high-risk primary or secondary (post-polycythemia
vera or post-essential thrombocythemia) myelofibrosis. Subsequent to
this approval, the USPTO received patent term restoration applications
for INREBIC (U.S. Patent Nos. 7,528,143; 7,825,246; and 8,138,199) from
Impact Biomedicines, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated January 4, 2021, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of INREBIC 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
INREBIC is 4,285 days. Of this time, 4,059 days occurred during the
testing phase of the regulatory review period, while 226 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:
November 24, 2007. FDA has verified the applicant's claims that the
date the investigational new drug application became effective was on
November 24, 2007.
[[Page 59399]]
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: January 3,
2019. FDA has verified the applicant's claims that the new drug
application (NDA) for INREBIC (NDA 212327) was initially submitted on
January 3, 2019.
3. The date the application was approved: August 16, 2019. FDA has
verified the applicant's claims that NDA 212327 was approved on August
16, 2019.
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 1,271 days, 1,523 days or 1,796 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: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23388 Filed 10-26-21; 8:45 am]
BILLING CODE 4164-01-P
