Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT INJECTION New Drug Application 205837, 67945-67947 [2019-26812]
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Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current re´sume´s. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Nomination Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nominations
must include a current, complete
re´sume´ or curriculum vitae for each
nominee and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process.)
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for a nonvoting
representative of industry interests are
encouraged from the mammography
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26735 Filed 12–11–19; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–2525]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BRIVIACT INJECTION New
Drug Application 205837
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BRIVIACT INJECTION 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 the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 10, 2020.
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
June 9, 2020. 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 February 10,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 10, 2020.
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.
DATES:
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
PO 00000
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Fmt 4703
Sfmt 4703
67945
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–
2016–E–2525 for Determination of
Regulatory Review Period for Purposes
of Patent Extension; BRIVIACT
INJECTION. 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.
• 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
E:\FR\FM\12DEN1.SGM
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67946
Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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:
khammond on DSKJM1Z7X2PROD with 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, if a patent is
eligible for extension under these Acts,
the 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 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 the drug
VerDate Sep<11>2014
17:56 Dec 11, 2019
Jkt 250001
product ‘‘was approved’’ within the
meaning of 35 U.S.C. 156. In the case of
a drug recommended for controls under
the Controlled Substances Act (CSA),
for purposes of patent term extension
the date of approval is the later of the
date the application to market the drug
is approved or the date of issuance of
the interim final rule controlling the
drug. See 35 U.S.C. 156(i). 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, BRIVIACT
INJECTION (brivaracetam) under new
drug application (NDA) 205837.
BRIVIACT INJECTION is indicated for
treatment of partial-onset seizures in
patients 16 years of age and older with
epilepsy. Subsequent to this approval,
the USPTO received a patent term
restoration application for BRIVIACT
INJECTION (U.S. Patent No. 6,784,197)
from UCB Biopharma SPRL and the
USPTO requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
January 18, 2017, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
BRIVIACT INJECTION, NDA 205837,
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
BRIVIACT INJECTION, NDA 205837, is
4,293 days. Of this time, 3,753 days
occurred during the testing phase of the
regulatory review period, while 540
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: August 12,
2004. The applicant claims November
30, 2008, as the date the investigational
new drug application (IND) became
effective. However, according to FDA
records, this IND was not the first IND
received for this active ingredient. In
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
general, FDA has used the first IND
submitted for investigation of the active
ingredient of the drug product as the
beginning of the testing phase, if
information derived from this first IND
was or could have been relied on or was
relevant for approval to market the drug
product. FDA records indicate that the
effective date of the first IND for
brivaracetam was August 12, 2004,
which was 30 days after FDA receipt of
this first IND. This is the same IND and
the same date FDA determined was the
beginning of the regulatory review
period for BRIVIACT ORAL TABLETS
approved under NDA 205836 and for
BRIVIACT ORAL SOLUTION approved
under NDA 205838. The regulatory
review period determinations for
BRIVIACT ORAL TABLETS and
BRIVIACT ORAL SOLUTION are
publishing in this issue of the Federal
Register.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: November 20,
2014. FDA has verified the applicant’s
claim that NDA 205837 for BRIVIACT
INJECTION was initially submitted on
November 20, 2014.
3. For a drug recommended for
controls under the CSA, the later of the
date the new drug application was
approved under section 505 of the
FD&C Act or the date of issuance of the
interim final rule controlling the drug:
May 12, 2016. FDA has verified the
applicant’s claim that NDA 205837 was
approved on February 18, 2016. FDA
has also verified that the date of
issuance of the interim final rule
controlling the drug, placing
brivaracetam in Schedule V of the CSA
as revised by the Improving Regulatory
Transparency for New Medical
Therapies Act, was May 12, 2016.
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 1,547 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
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Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26812 Filed 12–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–2528]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BRIVIACT ORAL TABLETS,
New Drug Application 205836
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BRIVIACT ORAL TABLETS 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 the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 10, 2020.
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
June 9, 2020. See ‘‘Petitions’’ in the
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:56 Dec 11, 2019
Jkt 250001
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 February 10,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 10, 2020.
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–
2016–E–2528 for ‘‘Determination of
Regulatory Review Period for Purposes
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
67947
of Patent Extension; BRIVIACT ORAL
TABLETS.’’ 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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:
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Pages 67945-67947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26812]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-E-2525]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BRIVIACT INJECTION New Drug Application 205837
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 BRIVIACT INJECTION 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
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 10, 2020. 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 June 9, 2020.
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 February 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 10, 2020. 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-2016-E-2525 for Determination of Regulatory Review Period for
Purposes of Patent Extension; BRIVIACT INJECTION. 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.
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
[[Page 67946]]
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.gpo.gov/fdsys/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.
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, if a patent
is eligible for extension under these Acts, the 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 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 the drug product ``was approved'' within the meaning of
35 U.S.C. 156. In the case of a drug recommended for controls under the
Controlled Substances Act (CSA), for purposes of patent term extension
the date of approval is the later of the date the application to market
the drug is approved or the date of issuance of the interim final rule
controlling the drug. See 35 U.S.C. 156(i). 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, BRIVIACT
INJECTION (brivaracetam) under new drug application (NDA) 205837.
BRIVIACT INJECTION is indicated for treatment of partial-onset seizures
in patients 16 years of age and older with epilepsy. Subsequent to this
approval, the USPTO received a patent term restoration application for
BRIVIACT INJECTION (U.S. Patent No. 6,784,197) from UCB Biopharma SPRL
and the USPTO requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated January 18,
2017, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of BRIVIACT INJECTION,
NDA 205837, 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
BRIVIACT INJECTION, NDA 205837, is 4,293 days. Of this time, 3,753 days
occurred during the testing phase of the regulatory review period,
while 540 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:
August 12, 2004. The applicant claims November 30, 2008, as the date
the investigational new drug application (IND) became effective.
However, according to FDA records, this IND was not the first IND
received for this active ingredient. In general, FDA has used the first
IND submitted for investigation of the active ingredient of the drug
product as the beginning of the testing phase, if information derived
from this first IND was or could have been relied on or was relevant
for approval to market the drug product. FDA records indicate that the
effective date of the first IND for brivaracetam was August 12, 2004,
which was 30 days after FDA receipt of this first IND. This is the same
IND and the same date FDA determined was the beginning of the
regulatory review period for BRIVIACT ORAL TABLETS approved under NDA
205836 and for BRIVIACT ORAL SOLUTION approved under NDA 205838. The
regulatory review period determinations for BRIVIACT ORAL TABLETS and
BRIVIACT ORAL SOLUTION are publishing in this issue of the Federal
Register.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: November
20, 2014. FDA has verified the applicant's claim that NDA 205837 for
BRIVIACT INJECTION was initially submitted on November 20, 2014.
3. For a drug recommended for controls under the CSA, the later of
the date the new drug application was approved under section 505 of the
FD&C Act or the date of issuance of the interim final rule controlling
the drug: May 12, 2016. FDA has verified the applicant's claim that NDA
205837 was approved on February 18, 2016. FDA has also verified that
the date of issuance of the interim final rule controlling the drug,
placing brivaracetam in Schedule V of the CSA as revised by the
Improving Regulatory Transparency for New Medical Therapies Act, was
May 12, 2016.
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 1,547 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
[[Page 67947]]
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: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26812 Filed 12-11-19; 8:45 am]
BILLING CODE 4164-01-P