Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEXXA, 66671-66673 [2019-26251]
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
while minimizing the risk that safety
concerns would be raised by FDA
during application review. They have
also cited a perceived risk aversion on
the part of drug developers, such that
novel excipients may be avoided in drug
development programs, even when the
excipients have potential public health
benefits.
With this information in mind, FDA’s
Center for Drug Evaluation and Research
is considering developing a pilot
program for the toxicological and
quality evaluation of novel excipients.
The Agency seeks information and
comment on several aspects of such a
program before deciding whether to
develop it.
jbell on DSKJLSW7X2PROD with NOTICES
II. Possible Approach To Reviewing
Novel Excipients
FDA is considering establishing a
pilot program that would review a
limited number of submissions per year.
Any program developed by the Agency
would be voluntary. FDA recognition of
a novel excipient would not be
necessary for the novel excipient to be
included in a finished drug product
described in an IND, an NDA, or a BLA.
Generally, FDA anticipates that a
submission to a potential novel
excipient review program would
include toxicological studies supporting
the safety of the novel excipient at
anticipated levels and duration of
exposure, by anticipated routes of
administration. Additionally, FDA
anticipates that submitters would
provide identification and control
information, including compositional
and purity specifications for the novel
excipient (see Excipients guidance).
FDA recognition of a novel excipient
would mean that, based on a review of
safety, manufacturing, and
compositional information, FDA has
determined that the proposed context of
use (e.g., acute or chronic exposure by
specified route(s) of administration up
to specified amounts) is expected to be
safe. This determination would obviate
the need for FDA review of the
excipient in the context of an IND if its
use in the investigational product is
consistent with the recognized context
of use. In the case of an NDA or a BLA
seeking marketing approval or licensure
of a finished drug or biological product
containing a recognized excipient, FDA
would review all information in the
application relating to safety of the
finished product. FDA expects that
excipients reviewed under this program,
after they are used in approved
formulations, would be listed in the
Inactive Ingredient Database.
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III. Requested Information and
Comments
Interested persons are invited to
provide detailed comment on all aspects
of this issue. Please read the information
above regarding the submission of
comments and confidential information.
FDA is particularly interested in
responses to the following questions:
1. What drug development challenges
do drug sponsors encounter that could
be addressed by using novel excipients?
2. Can stakeholders identify examples
(specific or general) of novel excipients
that have potential public health
benefits?
3. FDA anticipates that a novel
excipient recognition program would be
limited to excipients that do not have a
well-established history of safe use in
food and that have potential public
health benefits. We would be interested
in stakeholder comment on these
criteria.
4. Would FDA recognition of a novel
excipient be sufficient to overcome any
reluctance on the part of drug
developers to use the novel excipient in
a drug development program? Do drug
development sponsors also look for a
history of safe use in marketed drug
products?
5. FDA envisions that an individual
excipient manufacturer participating in
a novel excipient recognition program
would submit a complete package of
safety data and certain chemistry,
manufacturing, and controls
information to support FDA’s
recognition of a novel excipient. This
data and information would be based
upon nonclinical studies of sufficient
quality and quantity to allow for a safety
evaluation, consistent with the
Excipients guidance. We would be
interested in stakeholder comment on
this approach.
6. Are there adequate incentives for
excipient manufacturers to engage in
this process, particularly in situations in
which multiple manufacturers may be
undertaking to develop closely related
novel excipients? If not, what incentives
would encourage excipient
manufacturers to engage in this process?
7. What information, if any, should
FDA affirmatively disclose about a
novel excipient evaluated under an
eventual program in order to ensure the
success of the program? For example,
should FDA’s evaluation be posted and
explained publicly? Please note that
FDA would handle disclosure of
information submitted under the
program in accordance with applicable
law.
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66671
Dated: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26266 Filed 12–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–E–1059; FDA–
2019–E–1060; and FDA–2019–E–1061]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ANDEXXA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ANDEXXA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of
patents which claims that human
biological 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 3, 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 2, 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 3,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 3, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\05DEN1.SGM
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66672
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
• 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–
2019–E–1059; FDA–2019–E–1060; and
FDA–2019–E–1061 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
ANDEXXA.’’ 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
VerDate Sep<11>2014
17:38 Dec 04, 2019
Jkt 250001
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:
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 human
biological products, the testing phase
begins when the exemption to permit
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product ANDEXXA
(coagulation factor Xa (recombinant)
inactivated-zhzo). ANDEXXA is
indicated for patients treated with
rivaroxaban or apixaban, when reversal
of anticoagulation is needed, due to lifethreatening or uncontrolled bleeding.
This indication is approved under
accelerated approval based on the
change from baseline in anti-human
Factor Xa activity in healthy volunteers.
An improvement in hemostasis has not
been established. Continued approval
for this indication may be contingent
upon the results of studies to
demonstrate an improvement in
hemostasis in patients.
Subsequent to this approval, the
USPTO received a patent term
restoration application for ANDEXXA
(U.S. Patent Nos. 8,153,590; 8,889,129;
and 9,388,401) from Portola
Pharmaceuticals, Inc., and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
May 13, 2019, FDA advised the USPTO
that this human biological product had
undergone a regulatory review period
and that the approval of ANDEXXA
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
ANDEXXA is 2,171 days. Of this time,
1,302 days occurred during the testing
phase of the regulatory review period,
while 869 days occurred during the
approval phase. These periods of time
were derived from the following dates:
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: May 25, 2012. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
May 25, 2012.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): December 17, 2015. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for ANDEXXA (BLA 125586) was
initially submitted on December 17,
2015.
3. The date the application was
approved: May 3, 2018. FDA has
verified the applicant’s claim that BLA
125586 was approved on May 3, 2018.
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 661 days, 693 days,
or 1,066 days of patent term extension.
jbell on DSKJLSW7X2PROD with NOTICES
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
17:38 Dec 04, 2019
Jkt 250001
Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26251 Filed 12–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0731]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Human Cells,
Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements for FDA
regulations related to human cells,
tissues, and cellular and tissue-based
products (HCT/Ps) involving
establishment registration and listing;
eligibility determination for donors; and
current good tissue practice (CGTP).
SUMMARY:
Submit either electronic or
written comments on the collection of
information by February 3, 2020.
DATES:
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 3,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 3, 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.
ADDRESSES:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
66673
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–
2013–N–0731 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Human
Cells, Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice.’’ 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
E:\FR\FM\05DEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66671-66673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26251]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2019-E-1059; FDA-2019-E-1060; and FDA-2019-E-1061]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ANDEXXA
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 ANDEXXA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of patents which claims that human
biological 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 3, 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 2, 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 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 3, 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:
[[Page 66672]]
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-2019-E-1059; FDA-2019-E-1060; and FDA-2019-E-1061 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; ANDEXXA.'' 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 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 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 human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the human biologic product ANDEXXA
(coagulation factor Xa (recombinant) inactivated-zhzo). ANDEXXA is
indicated for patients treated with rivaroxaban or apixaban, when
reversal of anticoagulation is needed, due to life-threatening or
uncontrolled bleeding. This indication is approved under accelerated
approval based on the change from baseline in anti-human Factor Xa
activity in healthy volunteers. An improvement in hemostasis has not
been established. Continued approval for this indication may be
contingent upon the results of studies to demonstrate an improvement in
hemostasis in patients.
Subsequent to this approval, the USPTO received a patent term
restoration application for ANDEXXA (U.S. Patent Nos. 8,153,590;
8,889,129; and 9,388,401) from Portola Pharmaceuticals, Inc., and the
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated May 13,
2019, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of ANDEXXA
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
ANDEXXA is 2,171 days. Of this time, 1,302 days occurred during the
testing phase of the regulatory review period, while 869 days occurred
during the approval phase. These periods of time were derived from the
following dates:
[[Page 66673]]
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 25,
2012. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 25,
2012.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 17, 2015. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ANDEXXA (BLA 125586) was initially submitted on December 17, 2015.
3. The date the application was approved: May 3, 2018. FDA has
verified the applicant's claim that BLA 125586 was approved on May 3,
2018.
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 661 days, 693 days, or 1,066 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: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26251 Filed 12-4-19; 8:45 am]
BILLING CODE 4164-01-P
