Determination of Regulatory Review Period for Purposes of Patent Extension; COTELLIC, 7054-7056 [2018-03218]
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Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
II. Topics for Discussion at the Public
Meeting
As mandated by section 502(d) of the
FDA Reauthorization Act of 2017
(FDARA), this FDA meeting on the
development and labeling of pediatric
medical devices is being convened with
representatives from the medical device
industry, academia, recipients of
funding under section 305 of the
Pediatric Medical Device Safety and
Improvement Act of 2007, medical
provider organizations, and
organizations representing patients and
consumers (see Pub. L. 110–85; 42
U.S.C. 282 note).
As directly outlined in FDARA, the
meeting shall include consideration of
ways to: (1) Improve research
infrastructure and research networks to
facilitate the conduct of clinical studies
of devices for pediatric populations that
would result in the approval or
clearance, and labeling of medical
devices for such populations; (2)
appropriately use extrapolation under
section 515A(b) of the FD&C Act (21
U.S.C. 360e–1(b)); (3) enhance the
appropriate use of postmarket registries
and data to increase pediatric medical
device labeling; (4) increase FDA
assistance to medical device
manufacturers in developing devices for
pediatric populations that are approved
or cleared, and labeled, for their use;
and (5) identify current barriers to
pediatric device development and
incentives to address such barriers.
A detailed agenda will be posted on
the following website in advance of the
workshop at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
Select this event from the list of items
provided.
daltland on DSKBBV9HB2PROD with NOTICES
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit FDA’s Medical
Devices News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number.
Registration is free, and in-person
attendance is based on space
availability, with priority given to early
registrants. Persons interested in
attending this public meeting must
register by August 6, 2018, 3 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
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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 7:30 a.m. We will let
registrants know if registration closes
before the day of the public meeting.
If you need special accommodations
due to a disability, please contact Peggy
Roney at the Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5231, Silver Spring,
MD 20993–0002, 301–796–5671,
Peggy.Roney@fda.hhs.gov, no later than
June 1, 2018.
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. FDA will
do its best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. We encourage
persons who are interested in making an
oral presentation during a public
comment session to indicate their intent
on the registration form by 3 p.m.
Eastern Time on June 29, 2018. Based
on the number of applicants for oral
presentations, FDA will distribute the
available time equally among all
presenters and inform selected
presenters of the public presentation
agenda by July 6, 2018. If selected for
presentation, any presentation materials
must be emailed to Victoria Wagman at
Victoria.wagman@fda.hhs.gov no later
than July 13, 2018. No commercial or
promotional material will be permitted
to be presented or distributed at the
public meeting.
Streaming Webcast of the public
meeting: This public meeting will also
be webcast. The webcast link will be
available on the registration web page
after August 6, 2018. Please visit FDA’s
Medical Devices News & Events—
Workshops & Conferences calendar
(https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm) and select this event from
the list of items provided. Organizations
are requested to register all participants
but view using one connection per
location.
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/
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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). A link to the
transcript will also be available on the
internet at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this public workshop from the
posted events list.)
IV. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov.
1. FDA’s guidance for Industry and FDA
Staff: ‘‘Premarket Assessment of Pediatric
Medical Devices,’’ available at https://
www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm089742.pdf.
2. FDA’s guidance for Industry and FDA
Staff: ‘‘Providing Information about Pediatric
Uses of Medical Devices,’’ available at
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
UCM339465.pdf.
3. FDA’s guidance for Industry and FDA
Staff: ‘‘Leveraging Existing Clinical Data for
Extrapolation to Pediatric Uses of Medical
Devices,’’ available at https://www.fda.gov/
ucm/groups/fdagov-public/@fdagov-meddevgen/documents/document/ucm444591.pdf.
Dated: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03215 Filed 2–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–2512 and FDA–
2016–E–2511]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; COTELLIC
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
SUMMARY:
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determined the regulatory review period
for COTELLIC 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 (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 17, 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
August 15, 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 17,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 17, 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
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
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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–2512 and FDA–2016–E–2511
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; COTELLIC.’’ 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 between 9 a.m.
and 4 p.m., Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
PO 00000
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7055
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.
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 COTELLIC
(cobimetinib). COTELLIC is indicated
for treatment of patients with
unresectable or metastatic melanoma
with a BRAF V600E or V600K mutation,
E:\FR\FM\16FEN1.SGM
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Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
in combination with vemurafenib.
Subsequent to this approval, the USPTO
received patent term restoration
applications for COTELLIC (U.S. Patent
Nos. 7,803,839 and 8,362,002) from
Exelixis, Inc., and the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated September
26, 2016, FDA advised the USPTO that
this human drug product had undergone
a regulatory review period and that the
approval of COTELLIC represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
daltland on DSKBBV9HB2PROD with NOTICES
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
COTELLIC is 3,219 days. Of this time,
2,884 days occurred during the testing
phase of the regulatory review period,
while 335 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: January 19,
2007. FDA has verified the Exelixis, Inc.
claim that January 19, 2007, is the date
the investigational new drug application
became effective.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: December 11, 2014.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
COTELLIC (NDA 206192) was initially
submitted on December 11, 2014.
3. The date the application was
approved: November 10, 2015. FDA has
verified the applicant’s claim that NDA
206192 was approved on November 10,
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 1,013 days or 676
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
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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.
Dated: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03218 Filed 2–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1540]
Migraine: Developing Drugs for Acute
Treatment; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Migraine: Developing Drugs for Acute
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of prescription
drugs for the acute treatment of
migraine. This guidance focuses on
specific drug development and trial
design issues that are unique to the
study of prescription drugs for the acute
treatment of migraine. This guidance
finalizes the draft guidance of the same
name issued October 22, 2014.
DATES: The announcement of the
guidance is published in the Federal
Register on February 16, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
PO 00000
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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–
2014–D–1540 for ‘‘Migraine: Developing
Drugs for Acute Treatment; Guidance
for Industry; Availability.’’ Received
comments 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
E:\FR\FM\16FEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7054-7056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03218]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2016-E-2512 and FDA-2016-E-2511]
Determination of Regulatory Review Period for Purposes of Patent
Extension; COTELLIC
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
[[Page 7055]]
determined the regulatory review period for COTELLIC 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 (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
17, 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 August 15, 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 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 17, 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 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-2512 and FDA-2016-E-2511 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; COTELLIC.'' 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 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 COTELLIC
(cobimetinib). COTELLIC is indicated for treatment of patients with
unresectable or metastatic melanoma with a BRAF V600E or V600K
mutation,
[[Page 7056]]
in combination with vemurafenib. Subsequent to this approval, the USPTO
received patent term restoration applications for COTELLIC (U.S. Patent
Nos. 7,803,839 and 8,362,002) from Exelixis, Inc., and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated September 26, 2016, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of COTELLIC 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
COTELLIC is 3,219 days. Of this time, 2,884 days occurred during the
testing phase of the regulatory review period, while 335 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:
January 19, 2007. FDA has verified the Exelixis, Inc. claim that
January 19, 2007, is the date the investigational new drug application
became effective.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 11,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for COTELLIC (NDA 206192) was initially submitted on
December 11, 2014.
3. The date the application was approved: November 10, 2015. FDA
has verified the applicant's claim that NDA 206192 was approved on
November 10, 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 1,013 days or 676 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: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03218 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P
