Determination of Regulatory Review Period for Purposes of Patent Extension; CORLANOR, 4661-4663 [2018-01979]
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Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices
(e.g., response evaluation criteria in
solid tumors-based endpoints (RECIST))
has become an active area of research.
Alternative metrics that require shorter
periods of observation or provide more
precise assessment of treatment effects
could lead to more rapid completion of
clinical trials and require fewer patients.
Promising among these alternative
metrics are model-based metrics, such
as those based on longitudinal
continuous tumor size measurements.
Additionally, model-informed
approaches can help satisfy a need to
optimize dosing regimens for patients.
Investigations to refine dosing regimens
often occur after new drug approval
and/or are driven by pharmacometric
modeling approaches. There is growing
interest in using model-informed
approaches to help balance the risks and
benefits of oncology products by
identifying optimal dosing regimens,
and broad stakeholder engagement and
discussion around this topic can be
beneficial.
sradovich on DSK3GMQ082PROD with NOTICES
II. Objectives
The objectives of the workshop are to:
1. Discuss ‘‘best practices’’ in
integrating human pharmacokinetic,
pharmacodynamic, efficacy, and safety
data into models that best inform
oncology drug development.
2. Describe novel imaging techniques
and diagnostic and predictive
biomarkers that may be utilized in
oncology drug development.
3. Describe disease- and mechanismspecific early endpoints to predict longterm efficacy.
4. Evaluate the potential to shift from
traditional RECIST-based endpoints
such as Overall Response Rate (ORR)
and Progression Free Survival (PFS) to
modified RECIST approaches (e.g.,
imRECIST for immunotherapies) as well
as to other (model-based) tumor kinetic
metrics to support early decision
making in Phase 1/2 as well as in
confirmatory trials.
5. Discuss potential regulatory
implications of model-informed
decisions in drug development,
including, model-based target
identification, dose/exposure
justification based on preclinical
evidence, dose selection for first-inhuman trials, quality by design, early
clinical study design, dose finding/
titration, confirmatory trials, product
labeling, and post-marketing studies.
A detailed agenda will be posted on
the following website in advance of the
workshop: https://www.fda.gov/
downloads/Drugs/NewsEvents/
UCM589458.pdf.
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III. Registration and Accommodations
Registration: Persons interested in
attending this public workshop must
register online by January 31, 2018, at
https://fdaoce.formstack.com/forms/
isop. Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number.
Registration is free and based on
space availability, with priority given to
early registrants. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 8 a.m.
If you need special accommodations
due to a disability, please contact
Yvonne Knight (see FOR FURTHER
INFORMATION CONTACT) no later than
January 24, 2018.
Streaming Webcast of the Public
Workshop: The meeting will also be
webcast. A live webcast of this
workshop will be available at https://
collaboration.fda.gov/fdaisop/ on the
day of the workshop. 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
workshop is available, it will be
accessible at https://
FDAOCE.formstack.com/forms/isop. It
may be viewed at the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Dated: January 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01992 Filed 1–31–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–1234 and FDA–
2016–E–1257]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CORLANOR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for CORLANOR 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 a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 2, 2018.
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
July 31, 2018. 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 April 2, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 2, 2018. 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
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Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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–
2016–E–1234 and FDA–2016–E–1257
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; CORLANOR.’’ 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
VerDate Sep<11>2014
19:34 Jan 31, 2018
Jkt 244001
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 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.
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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 CORLANOR
(ivabradine hydrochloride). CORLANOR
is indicated to reduce the risk of
hospitalization for worsening heart
failure in patients with stable,
symptomatic chronic heart failure with
left ventricular ejection fraction ≤ 35%
who are in sinus rhythm with resting
heart rate ≥ 70 beats per minute and
either are on maximally tolerated doses
of beta-blockers or have a
contraindication to beta-blocker use.
Subsequent to this approval, the USPTO
received a patent term restoration
application for CORLANOR (U.S. Patent
Nos. 7,879,842 and 7,867,996) from Les
Laboratoires Servier, and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
July 28, 2016, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of CORLANOR
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
CORLANOR is 293 days. Of this time,
0 days occurred during the testing phase
of the regulatory review period, while
293 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 (the FD&C Act) (21
U.S.C. 355(i)) became effective: No
exemption claimed. FDA has verified
the Les Laboratoires Servier claim that
they did not file an investigational new
drug application (IND) with FDA.
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 27, 2014.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
CORLANOR (NDA 206143) was initially
submitted on June 27, 2014.
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Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices
3. The date the application was
approved: April 15, 2015. FDA has
verified the applicant’s claim that NDA
206143 was approved on April 15, 2015.
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 292 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
Nos. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: January 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01979 Filed 1–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sradovich on DSK3GMQ082PROD with NOTICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
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19:34 Jan 31, 2018
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HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS
(the Secretary) is named as the
respondent in all proceedings brought
by the filing of petitions for
compensation under the Program, the
United States Court of Federal Claims is
charged by statute with responsibility
for considering and acting upon the
petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the program in
general, contact Lisa L. Reyes, Acting
Clerk, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, MD 20857; (301) 443–6593,
or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of HHS, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the table) set forth at 42 CFR
100.3. This table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
SUMMARY:
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4663
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111, the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
December 1, 2017, through December
31, 2017. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
In accordance with Section
2112(b)(2), all interested persons may
submit written information relevant to
the issues described above in the case of
the petitions listed below. Any person
choosing to do so should file an original
and three (3) copies of the information
with the Clerk of the U.S. Court of
Federal Claims at the address listed
above (under the heading FOR FURTHER
INFORMATION CONTACT), with a copy to
HRSA addressed to Director, Division of
Injury Compensation Programs,
Healthcare Systems Bureau, 5600
Fishers Lane, 08N146B, Rockville, MD
20857. The Court’s caption (Petitioner’s
Name v. Secretary of HHS) and the
docket number assigned to the petition
should be used as the caption for the
written submission. Chapter 35 of title
44, United States Code, related to
paperwork reduction, does not apply to
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]]>Agencies
[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Notices]
[Pages 4661-4663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01979]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2016-E-1234 and FDA-2016-E-1257]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CORLANOR
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 CORLANOR 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 a patent which claims that human drug
product.
DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
2, 2018. 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 July 31, 2018. 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 April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 2018. 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
[[Page 4662]]
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-2016-E-1234 and FDA-2016-E-1257 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; CORLANOR.'' 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 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 CORLANOR
(ivabradine hydrochloride). CORLANOR is indicated to reduce the risk of
hospitalization for worsening heart failure in patients with stable,
symptomatic chronic heart failure with left ventricular ejection
fraction <= 35% who are in sinus rhythm with resting heart rate >= 70
beats per minute and either are on maximally tolerated doses of beta-
blockers or have a contraindication to beta-blocker use. Subsequent to
this approval, the USPTO received a patent term restoration application
for CORLANOR (U.S. Patent Nos. 7,879,842 and 7,867,996) from Les
Laboratoires Servier, and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated July 28, 2016, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of CORLANOR 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
CORLANOR is 293 days. Of this time, 0 days occurred during the testing
phase of the regulatory review period, while 293 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: No exemption claimed. FDA has verified the Les Laboratoires
Servier claim that they did not file an investigational new drug
application (IND) with FDA.
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 27,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for CORLANOR (NDA 206143) was initially submitted on
June 27, 2014.
[[Page 4663]]
3. The date the application was approved: April 15, 2015. FDA has
verified the applicant's claim that NDA 206143 was approved on April
15, 2015.
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 292 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 Nos. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: January 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01979 Filed 1-31-18; 8:45 am]
BILLING CODE 4164-01-P
