Determination of Regulatory Review Period for Purposes of Patent Extension; XEPI, 41996-41998 [2020-15013]
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Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. 240–402–7500,
240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Patricia Stewart, Office of Operations,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993; 301–796–4735, patricia.stewart@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is holding a public meeting to
share high-level findings from a
recently-completed interim assessment
of FDA’s hiring process, conducted by a
qualified, independent contractor with
expertise in assessing transformation of
human resources operations. FDA
recognizes that the critical work to
protect public health is made possible
in part by the Agency’s ability to attract
and retain a talented, diverse, and
dedicated workforce. As FDA continues
to fulfil its strategic mission, it is
imperative that the Agency identify and
leverage the talent, skills, and diversity
within—and outside of—the Agency.
These priorities are reflected in FDA’s
plan to enhance its hiring and retention
programs; recruit qualified candidates
with diverse backgrounds, experiences,
and talents; provide internal
development opportunities; and further
enhance the Agency’s ability to nurture
a supportive and fair work environment.
The public meeting will provide an
update on FDA’s progress toward
PDUFA (Prescription Drug User Fee
Act) and BsUFA (Biosimilar User Fee
Act) user fee hiring and retention
commitments and solicit input on
actions with regards to the hiring
process. To view the evaluation
assessment report, please visit here:
https://www.fda.gov/industry/
prescription-drug-user-fee-amendments/
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fda-interim-hiring-and-retentionassessment-report.
This public meeting is intended to
meet performance commitments
included in PDUFA VI and BsUFA II.
These user fee programs were
reauthorized as part of the FDA
Reauthorization Act of 2017 (FDARA)
(Pub. L. 115–52) signed by the President
on August 18, 2017. The complete set of
performance goals for each program are
available at:
• PDUFA VI program: https://
www.fda.gov/downloads/ForIndustry/
UserFees/PrescriptionDrugUserFee/
UCM511438.pdf and
• BsUFA II program: https://
www.fda.gov/downloads/forindustry/
userfees/biosimilaruserfeeactbsufa/
ucm521121.pdf.
II. Topics for Discussion at the Public
Meeting
This public meeting will provide FDA
the opportunity to update interested
public stakeholders on topics related to
the FDA hiring and retention programs.
Booz Allen Hamilton will present their
findings and recommendations that are
outlined in the Interim Hiring and
Retention Assessment report and FDA
will provide an update on the Agency’s
progress in addressing the findings from
the independent third-party evaluation
that was published June 5, 2020. To
view the evaluation assessment report,
please visit here: https://www.fda.gov/
industry/prescription-drug-user-feeamendments/fda-interim-hiring-andretention-assessment-report
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website to register: https://
www.eventbrite.com/e/fda-hiring-andretention-interim-assessment-publicmeeting-registration-106125275556.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Persons interested in attending this
public meeting must register by July 28,
2020, 11:59 p.m. Eastern Time.
If you need special accommodations
due to a disability (e.g. Closed
Captioning), please contact Patricia
Stewart (see FOR FURTHER INFORMATION
CONTACT) no later than July 22, 2020.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session, and which
topic(s) you wish to address. We will do
our best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
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presentations and request time for a
joint presentation. Following the close
of registration, we will determine the
amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants by
July 27, 2020. All requests to make oral
presentations must be received by July
22, 2020, 11:59 p.m. Eastern Time. If
selected for presentation, any
presentation materials must be emailed
to Patricia Stewart (see FOR FURTHER
INFORMATION CONTACT) no later than July
28, 2020. No commercial or promotional
material will be permitted to be
presented at the public meeting.
Streaming Webcast of the Public
Meeting: The webcast for this public
meeting is at https://
collaboration.fda.gov/
fdapublicmeeting073020/.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES).
Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14980 Filed 7–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–E–4463]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XEPI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for XEPI 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.
SUMMARY:
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Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices
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Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by September 11, 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
January 11, 2021. 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 September 11,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 11, 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:
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• 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–
2018–E–4463 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; XEPI.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
PO 00000
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41997
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 product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, XEPI
(ozenoxacin). XEPI is indicated for
topical treatment of impetigo due to
Staphylococcus aureus or Streptococcus
pyogenes in adult and pediatric patients
2 months of age and older. Subsequent
to this approval, the USPTO received a
patent term restoration application for
XEPI (U.S. Patent No. 6,335,447) from
Toyama Chemical Co., Ltd., and the
USPTO requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
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Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices
May 13, 2019, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of XEPI
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
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II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
XEPI is 2,819 days. Of this time, 2,282
days occurred during the testing phase
of the regulatory review period, while
537 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: March 26,
2010. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was March 26, 2010.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: June 23, 2016.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
XEPI (NDA 208945) was initially
submitted on June 23, 2016.
3. The date the application was
approved: December 11, 2017. FDA has
verified the applicant’s claim that NDA
208945 was approved on December 11,
2017.
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 1,678 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
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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: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15013 Filed 7–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3708]
InvaGen Pharmaceuticals, Inc.;
Withdrawal of Approval of an
Abbreviated New Drug Application for
Trandolapril Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is withdrawing approval of an
abbreviated new drug application
(ANDA) for trandolapril tablets. The
basis for the withdrawal is that the
holder of the ANDA has repeatedly
failed to submit the required data to
support a finding of bioequivalence for
this ANDA. The holder of the ANDA
has waived its opportunity for a hearing.
DATES: Withdrawal of approval is
applicable July 13, 2020.
FOR FURTHER INFORMATION CONTACT:
Jennifer Forde, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
348–3035.
SUPPLEMENTARY INFORMATION: FDA’s
Office of Generic Drugs (OGD) approved
ANDA 078320, held by InvaGen
Pharmaceuticals, Inc. (InvaGen), for a
generic version of trandolapril tablets, 1
milligram (mg), 2 mg, and 4 mg, under
the requirements of section 505(j) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(j)) and FDA’s
implementing regulations. OGD
SUMMARY:
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approved ANDA 078320 on June 12,
2007. In a notice published in the
Federal Register of October 28, 2019 (84
FR 57736), CDER notified InvaGen of
CDER’s proposal to issue an order,
under section 505(e) of the FD&C Act
and § 314.150 (21 CFR 314.150),
withdrawing approval of ANDA 078320
and all amendments and supplements to
it on the grounds that InvaGen has
failed to submit the required
bioequivalence data necessary to
demonstrate the bioequivalence of its
drug product. In its October 28, 2019,
notice of opportunity for a hearing
(NOOH), CDER provided InvaGen with
an opportunity to request a hearing to
show why approval of ANDA 078320
should not be withdrawn.
As noted in the October 28, 2019,
NOOH, FDA issued a letter to InvaGen
on August 9, 2011, regarding ANDA
078320 because this drug product
application was supported by
bioequivalence studies with the
bioanalytical analysis conducted by
Cetero Research at the Houston, TX, site
between April 1, 2005, and June 15,
2010. As FDA noted in its August 9,
2011, correspondence, inspection
findings regarding Cetero Research’s
bioequivalence studies raised significant
concerns about the validity of the
reported results of the analytical studies
conducted between April 2005 and June
2010 in support of drug applications,
and as such, steps needed to be taken to
demonstrate the bioequivalence of
InvaGen’s drug product approved under
ANDA 078320. FDA informed InvaGen
that ANDA 078320 needed to be
supplemented by conducting new
bioequivalence studies or re-assaying
the samples from the original
bioequivalence study. FDA
recommended to InvaGen that the
results of the requested bioequivalence
studies or re-assays be submitted to
ANDA 078320 within 6 months of the
date of the August 9, 2011, letter.
Although the October 28, 2019,
NOOH states that FDA did not receive
a response from InvaGen to the August
9, 2011, letter from FDA, upon further
review, additional correspondence
between InvaGen and FDA has been
identified. In a letter to FDA dated
August 12, 2011, InvaGen requested a 6month extension for submitting
bioequivalence study data for ANDA
078320. On September 21, 2011, FDA
issued a letter to InvaGen
acknowledging InvaGen’s August 12,
2011, request for an extension. In a
letter to FDA dated September 6, 2012,
InvaGen requested an additional 6month extension to submit
bioequivalence study data; and in a
letter to FDA dated October 4, 2012,
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]]>Agencies
[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41996-41998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15013]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-E-4463]
Determination of Regulatory Review Period for Purposes of Patent
Extension; XEPI
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 XEPI 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.
[[Page 41997]]
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.
DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by September 11,
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 January 11, 2021.
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 September 11, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 11, 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-2018-E-4463 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; XEPI.'' Received comments, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, XEPI
(ozenoxacin). XEPI is indicated for topical treatment of impetigo due
to Staphylococcus aureus or Streptococcus pyogenes in adult and
pediatric patients 2 months of age and older. Subsequent to this
approval, the USPTO received a patent term restoration application for
XEPI (U.S. Patent No. 6,335,447) from Toyama Chemical Co., Ltd., and
the USPTO requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated
[[Page 41998]]
May 13, 2019, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of XEPI
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
XEPI is 2,819 days. Of this time, 2,282 days occurred during the
testing phase of the regulatory review period, while 537 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:
March 26, 2010. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was March 26,
2010.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 23,
2016. FDA has verified the applicant's claim that the new drug
application (NDA) for XEPI (NDA 208945) was initially submitted on June
23, 2016.
3. The date the application was approved: December 11, 2017. FDA
has verified the applicant's claim that NDA 208945 was approved on
December 11, 2017.
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 1,678 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: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15013 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P
