Determination of Regulatory Review Period for Purposes of Patent Extension; UBRELVY, 53475-53477 [2022-18753]
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Federal Register / Vol. 87, No. 168 / Wednesday, August 31, 2022 / Notices
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 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 medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(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 medical device will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the
medical device THEROX
DOWNSTREAM SYSTEM. It is
indicated for the preparation and
delivery of SuperSaturated Oxygen
Therapy to targeted ischemic regions
perfused by the patient’s left anterior
descending coronary artery immediately
following revascularization by means of
percutaneous coronary intervention
with stenting that has been completed
within 6 hours after the onset of anterior
acute myocardial infarction symptoms
caused by a left anterior descending
artery infarct lesion. Subsequent to this
approval, the USPTO received patent
term restoration applications for
THEROX DOWNSTREAM SYSTEM
(U.S. Patent Nos. 6,582,387; 7,820,102;
and 8,264,564) from TherOx Inc., and
the USPTO requested FDA’s assistance
in determining the patents’ eligibility
for patent term restoration. In a letter
dated May 24, 2021, FDA advised the
USPTO that this medical device had
undergone a regulatory review period
and that the approval of THEROX
DOWNSTREAM SYSTEM represented
the first permitted commercial
VerDate Sep<11>2014
16:59 Aug 30, 2022
Jkt 256001
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
THEROX DOWNSTREAM SYSTEM is
7,386 days. Of this time, 6,824 days
occurred during the testing phase of the
regulatory review period, while 562
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: January 13, 1999. The
applicant claims that the investigational
device exemptions (IDEs) required
under section 520(g) of the FD&C Act for
human tests to begin became effective
on November 4, 1998, or January 28,
2012. However, FDA records indicate
that the IDE was determined
substantially complete for clinical
studies to have begun on January 13,
1999, which represents the IDE effective
date of the earliest IDE received.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): September 18,
2017. The applicant claims September
21, 2017, as the date the premarket
approval application (PMA) for
THEROX DOWNSTREAM SYSTEM
(PMA P170027) was initially submitted.
However, FDA records indicate that
PMA P170027 was initially submitted
on September 18, 2017.
3. The date the application was
approved: April 2, 2019. FDA has
verified the applicant’s claim that PMA
P170027 was approved on April 2, 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 991 days, 1,591
days, or 1,826 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
PO 00000
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53475
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: August 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18754 Filed 8–30–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2021–E–0382 and FDA–
2021–E–0383]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; UBRELVY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for UBRELVY 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.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by October 31, 2022.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
DATES:
E:\FR\FM\31AUN1.SGM
31AUN1
53476
Federal Register / Vol. 87, No. 168 / Wednesday, August 31, 2022 / Notices
during the regulatory review period by
February 27, 2023. 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
October 31, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
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–
2021–E–0382 and FDA–2021–E–0383
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
VerDate Sep<11>2014
16:59 Aug 30, 2022
Jkt 256001
Extension; UBRELVY.’’ 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 numbers, 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:
PO 00000
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Fmt 4703
Sfmt 4703
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 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
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, UBRELVY
(ubrogepant). UBRELVY is indicated for
the acute treatment of migraine with or
without aura in adults. Subsequent to
this approval, the USPTO received
patent term restoration applications for
UBRELVY (U.S. Patent Nos. 8,912,210
and 9,833,448) from Allergan Sales LLC,
and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated June 8, 2021, FDA advised
the USPTO that this human drug
product had undergone a regulatory
review period and that the approval of
UBRELVY 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
E:\FR\FM\31AUN1.SGM
31AUN1
Federal Register / Vol. 87, No. 168 / Wednesday, August 31, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
UBRELVY is 2,883 days. Of this time,
2,520 days occurred during the testing
phase of the regulatory review period,
while 363 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: February 2,
2012. The applicant claims February 3,
2012, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was February 2, 2012,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: December 26,
2018. FDA has verified the applicant’s
claims that the new drug application
(NDA) for UBRELVY (NDA 211765) was
initially submitted on December 26,
2018.
3. The date the application was
approved: December 23, 2019. FDA has
verified the applicant’s claim that NDA
211765 was approved on December 23,
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 555 days or 774
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
VerDate Sep<11>2014
16:59 Aug 30, 2022
Jkt 256001
53477
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Request for Information: SAMHSA’s
Role in Possible Agency Actions
Regarding Mental Health and
Substance Use Wellbeing in the
Context of Climate Change and Health
Equity
[FR Doc. 2022–18753 Filed 8–30–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Advisory Council, September
19, 2022, 10:00 a.m. to 04:00 p.m.,
National Institutes of Health, Rockledge
II, 6701 Rockledge Drive, Rooms 260 C,
D, E and F, Bethesda, MD 20892, which
was published in the Federal Register
on August 24, 2022, FR Doc 2022–
18262, 87 FR 52000.
This notice is being amended to
remove the visitor testing requirement
for entering NIH facilities due to CDC
updates published August 11, 2022,
regarding screening testing. The meeting
is open to the public.
Information is also available on the
Institute’s/Center’s home page: https://
public.csr.nih.gov/AboutCSR/
Organization/CSRAdvisoryCouncil,
where an agenda and any additional
information for the meeting will be
posted when available.
The meeting will be videocast and can
be accessed from the NIH Videocasting
website (https://videocast.nih.gov/
watch=45767).
Dated: August 25, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–18785 Filed 8–30–22; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
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Substance Abuse and Mental Health
Services Administration
Substance Abuse and Mental
Health Services Administration
(SAMHSA), Department of Health and
Human Services (HHS).
ACTION: Notice of request for
information.
AGENCY:
SAMHSA seeks input from
members of the public about how it can
best address the behavioral health
impacts of climate change and health
equity considerations. Behavioral health
includes mental health conditions and
substance use disorders. SAMHSA
specifically seeks input on suggested
priorities, resources, partners and
collaborating agencies and
organizations.
SUMMARY:
Comments on this notice must be
received by October 31, 2022.
ADDRESSES: Please submit all responses
via email to ClimateChange@
SAMHSA.HHS.gov as a Word
document, Portable Document Format
(PDF) or in the body of an email. Please
include ‘‘Request for Information:
SAMHSA’s Role in Climate Change’’ in
the subject line of the message.
FOR FURTHER INFORMATION CONTACT:
Mitchell Berger, Public Health Advisor,
Telephone: 240–276–1757, Email:
Mitchell.Berger@SAMHSA.HHS.gov, or
Maggie Jarry, Emergency Management
Specialist, Email: Maggie.Jarry@
samhsa.hhs.gov.
DATES:
In January
2021, President Biden signed Executive
Order 14008, Tackling the Climate
Crisis at Home and Abroad. Recognizing
that ‘‘we face a climate crisis that
threatens our people and communities,
public health and economy, and,
starkly, our ability to live on planet
Earth,’’ the Order called for a
‘‘government-wide approach’’ to climate
change and development of agency
action plans to ‘‘bolster adaptation and
increase resilience to the impacts of
climate change.’’ 1
President Biden also in January 2021
signed Executive Order 13985,
Advancing Racial Equity and Support
for Underserved Communities Through
the Federal Government, which called
upon Agencies to take steps to enhance
SUPPLEMENTARY INFORMATION:
E:\FR\FM\31AUN1.SGM
31AUN1
]]>Agencies
[Federal Register Volume 87, Number 168 (Wednesday, August 31, 2022)]
[Notices]
[Pages 53475-53477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18753]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2021-E-0382 and FDA-2021-E-0383]
Determination of Regulatory Review Period for Purposes of Patent
Extension; UBRELVY
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 UBRELVY 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 must submit either electronic
or written comments and ask for a redetermination by October 31, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
[[Page 53476]]
during the regulatory review period by February 27, 2023. 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 October 31, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2021-E-0382 and FDA-2021-E-0383 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; UBRELVY.'' 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 numbers, 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 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 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, UBRELVY
(ubrogepant). UBRELVY is indicated for the acute treatment of migraine
with or without aura in adults. Subsequent to this approval, the USPTO
received patent term restoration applications for UBRELVY (U.S. Patent
Nos. 8,912,210 and 9,833,448) from Allergan Sales LLC, and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated June 8, 2021, FDA advised
the USPTO that this human drug product had undergone a regulatory
review period and that the approval of UBRELVY 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 53477]]
UBRELVY is 2,883 days. Of this time, 2,520 days occurred during the
testing phase of the regulatory review period, while 363 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:
February 2, 2012. The applicant claims February 3, 2012, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was February
2, 2012, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
26, 2018. FDA has verified the applicant's claims that the new drug
application (NDA) for UBRELVY (NDA 211765) was initially submitted on
December 26, 2018.
3. The date the application was approved: December 23, 2019. FDA
has verified the applicant's claim that NDA 211765 was approved on
December 23, 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 555 days or 774 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: August 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18753 Filed 8-30-22; 8:45 am]
BILLING CODE 4164-01-P
