Determination of Regulatory Review Period for Purposes of Patent Extension; NUBEQA, 58670-58672 [2021-23074]
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
voluntary standards which reflect
industry’s usual and customary business
practice.
TABLE 7—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS
21 CFR section
(unless otherwise stated)
PHS guideline section
Description
2.2.1 ..........................................
2.5 .............................................
3.1.1 and 3.1.6 ..........................
Document offsite collaborations ................................................
Sponsor ensures counseling patient + family + contacts .........
Document well-characterized health history and lineage of
source animals.
Registration with and import permit from the Centers for Disease Control and Prevention.
Document collaboration with accredited microbiology labs ......
Procedures to ensure the humane care of animals .................
Procedures consistent for accreditation by the Association for
Assessment and Accreditation of Laboratory Animal Care
International (AAALAC International) and consistent with
the National Research Council’s (NRC) Guide.
Herd health maintenance and surveillance to be documented,
available, and in accordance with documented procedures;
record standard veterinary care.
Animal facility SOPs ..................................................................
Validate assay methods ............................................................
Procurement and processing of xenografts using documented
aseptic conditions.
Develop, implement, and enforce SOPs for procurement and
screening processes.
Communicate to FDA animal necropsy findings pertinent to
health of recipient.
PHS specimens to be linked to health records; provide to
FDA justification for types of tissues, cells, and plasma,
and quantities of plasma and leukocytes collected.
Surveillance of xenotransplant recipient; sponsor ensures
documentation of surveillance program life-long (justify >2
yrs.); investigator case histories (2 yrs. after investigation is
discontinued).
Sponsor to justify amount and type of reserve samples ..........
System for prompt retrieval of PHS specimens and linkage to
medical records (recipient and source animal).
Notify FDA of a clinical episode potentially representing a
xenogeneic infection.
Document collaborations (transfer of obligation) ......................
Develop educational materials (sponsor provides investigators
with information needed to conduct investigation properly).
Sponsor to keep records of receipt, shipment, and disposition
of investigative drug; investigator to keep records of case
histories.
3.1.8 ..........................................
3.2.2 ..........................................
3.2.3 ..........................................
3.2.4 ..........................................
3.2.5, 3.4, and 3.4.1 ..................
3.2.6 ..........................................
3.3.3 ..........................................
3.6.1 ..........................................
3.6.2 ..........................................
3.6.4 ..........................................
3.7.1 ..........................................
4.1.1 ..........................................
4.1.2 ..........................................
4.1.2.2 .......................................
4.1.2.3 .......................................
4.2.2.1 .......................................
4.2.3.1 .......................................
4.3 .............................................
1 The
312.52.
312.62(c).
312.23(a)(7)(a) and 211.84.
42 CFR 71.53.
312.52.
9 CFR parts 1, 2, and 3 and PHS Policy.1
AAALAC International Rules of Accreditation 2
and NRC Guide.3
211.100 and 211.122.
PHS Policy.1
211.160(a)
211.100 and 211.122.
211.84(d) and 211.122(c).
312.32(c).
312.23(a)(6).
312.23(a)(6)(iii)(f) and (g), and 312.62(b) and
(c).
211.122.
312.57(a).
312.32.
312.52.
312.50.
312.57 and 312.62(b).
‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (https://olaw.nih.gov/policies-laws/phs-policy.htm).
International Rules of Accreditation (https://www.aaalac.org/accreditation-program/rules-of-accreditation/).
NRC’s ‘‘Guide for the Care and Use of Laboratory Animals.’’
2 AAALAC
3 The
lotter on DSK11XQN23PROD with NOTICES1
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate
other than to adjust total burden hours
by one hour, from 60 to 59 total burden
hours, to address an inadvertent error in
disclosure burden in the previous
submissions to OMB.
Dated: October 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–1910]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NUBEQA
AGENCY:
ACTION:
[FR Doc. 2021–23086 Filed 10–21–21; 8:45 am]
17:47 Oct 21, 2021
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for NUBEQA and is publishing this
notice of that determination as required
SUMMARY:
BILLING CODE 4164–01–P
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by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 21, 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
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
April 20, 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 21,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 21, 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.
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 No. FDA–
2020–E–1910 for ‘‘Determination of
VerDate Sep<11>2014
17:47 Oct 21, 2021
Jkt 256001
Regulatory Review Period for Purposes
of Patent Extension; NUBEQA.’’
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 § 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:
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58671
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, NUBEQA
(darolutamide), indicated for the
treatment of patients with nonmetastatic castration-resistant prostate
cancer. Subsequent to this approval, the
USPTO received a patent term
restoration application for NUBEQA
(U.S. Patent No. 8,975,254) from Orion
Corporation, and the USPTO requested
FDA’s assistance in determining the
patent’s eligibility for patent term
restoration. In a letter dated May 24,
2021, FDA advised the USPTO that this
human drug product had undergone a
regulatory review period and that the
approval of NUBEQA 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
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
lotter on DSK11XQN23PROD with NOTICES1
NUBEQA is 2,576 days. Of this time,
2,420 days occurred during the testing
phase of the regulatory review period,
while 156 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 13, 2012.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 13, 2012.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: February 26, 2019.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
NUBEQA (NDA 212099) was initially
submitted on February 26, 2019.
3. The date the application was
approved: July 30, 2019. FDA has
verified the applicant’s claim that NDA
212099 was approved on July 30, 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 application for patent extension,
this applicant seeks 879 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.
VerDate Sep<11>2014
17:47 Oct 21, 2021
Jkt 256001
Dated: October 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23074 Filed 10–21–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0548]
Data Standards for Drug and Biological
Product Submissions Containing RealWorld Data; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Data
Standards for Drug and Biological
Product Submissions Containing RealWorld Data.’’ This guidance provides
recommendations to sponsors to help
support compliance with the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) when submitting study data
derived from real-world data (RWD)
sources in applicable regulatory
submissions using standards specified
in the Data Standards Catalog (Catalog).
FDA is publishing this draft guidance as
part of a series of guidance documents
under its program to evaluate the use of
real-world evidence (RWE) in regulatory
decision making.
DATES: Submit either electronic or
written comments on the draft guidance
by December 21, 2021 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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–
2021–D–0548 for ‘‘Data Standards for
Drug and Biological Product
Submissions Containing Real-World
Data.’’ Received comments 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
E:\FR\FM\22OCN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58670-58672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23074]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-E-1910]
Determination of Regulatory Review Period for Purposes of Patent
Extension; NUBEQA
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 NUBEQA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.
DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by December 21, 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
[[Page 58671]]
April 20, 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 21, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 21, 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.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-E-1910 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NUBEQA.'' 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, NUBEQA
(darolutamide), indicated for the treatment of patients with non-
metastatic castration-resistant prostate cancer. Subsequent to this
approval, the USPTO received a patent term restoration application for
NUBEQA (U.S. Patent No. 8,975,254) from Orion Corporation, and the
USPTO requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated May 24,
2021, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of NUBEQA 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
[[Page 58672]]
NUBEQA is 2,576 days. Of this time, 2,420 days occurred during the
testing phase of the regulatory review period, while 156 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 13, 2012. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 13,
2012.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: February 26,
2019. FDA has verified the applicant's claim that the new drug
application (NDA) for NUBEQA (NDA 212099) was initially submitted on
February 26, 2019.
3. The date the application was approved: July 30, 2019. FDA has
verified the applicant's claim that NDA 212099 was approved on July 30,
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 application for patent extension,
this applicant seeks 879 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: October 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23074 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P
