Determination of Regulatory Review Period for Purposes of Patent Extension; EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM, 62593-62595 [2018-26282]
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
indicated for treatment of primary
biliary cholangitis in combination with
ursodeoxycholic acid (UDCA) in adults
with an inadequate response to UDCA,
or as monotherapy in adults unable to
tolerate UDCA. Subsequent to this
approval, the USPTO received a patent
term restoration application for
OCALIVA (U.S. Patent No. 7,138,390)
from Intercept Pharmaceuticals, Inc. and
the USPTO requested FDA’s assistance
in determining the patent’s eligibility
for patent term restoration. In a letter
dated September 20, 2017, FDA advised
the USPTO that this human drug
product had undergone a regulatory
review period and that the approval of
OCALIVA 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
OCALIVA is 3,742 days. Of this time,
3,408 days occurred during the testing
phase of the regulatory review period,
while 334 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 1, 2006.
The applicant claims February 26, 2006,
as the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was March 1, 2006,
which was 30 days after FDA receipt of
the IND.
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 29, 2015.
The applicant claims June 26, 2015, as
the date the new drug application
(NDA) for OCALIVA (NDA 207999) was
initially submitted. However, FDA
records indicate that NDA 207999 was
submitted on June 29, 2015.
3. The date the application was
approved: May 27, 2016. FDA has
verified the applicant’s claim that NDA
207999 was approved on May 27, 2016.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,826 days of patent
term extension.
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III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26288 Filed 12–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–3547]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EXABLATE NEURO MODEL
4000 TYPE 1.0 SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for EXABLATE NEURO MODEL 4000
TYPE 1.0 SYSTEM (EXABLATE) and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
SUMMARY:
PO 00000
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62593
patent which claims that medical
device.
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 4, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
June 3, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 4,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 4, 2019.
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
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:
E:\FR\FM\04DEN1.SGM
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62594
Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
• 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–
2017–E–3547 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; EXABLATE.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
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17:36 Dec 03, 2018
Jkt 247001
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 medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(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 medical device will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the
medical device EXABLATE. EXABLATE
is indicated for use in the unilateral
thalamotomy treatment of idiopathic
essential tremor patients with
medication-refractory tremor. Patients
must be at least age 22. The designated
area in the brain responsible for the
movement disorder symptoms (ventralis
intermedius) must be identified and
accessible for targeted thermal ablation
by the EXABLATE device. Subsequent
to this approval, the USPTO received a
patent term restoration application for
EXABLATE (U.S. Patent No. 6,612,988)
from Brigham and Women’s Hospital,
PO 00000
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Fmt 4703
Sfmt 4703
Inc. and InSightec, Ltd., and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
August 1, 2017, FDA advised the
USPTO that this medical device had
undergone a regulatory review period
and that the approval of EXABLATE
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
EXABLATE is 2,050 days. Of this time,
1,785 days occurred during the testing
phase of the regulatory review period,
while 265 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)) involving this device became
effective: December 2, 2010. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) required under section
520(g) of the FD&C Act for human tests
to begin became effective was December
2, 2010.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): October 21, 2015.
The applicant claims October 20, 2015,
as the date the premarket approval
application (PMA) for EXABLATE
(PMA P150038) was initially submitted.
However, FDA records indicate that
PMA P150038 was submitted on
October 21, 2015.
3. The date the application was
approved: July 11, 2016. FDA has
verified the applicant’s claim that PMA
P150038 was approved on July 11, 2016.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,158 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
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26282 Filed 12–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation for Written Comments on
Proposed Objectives for Healthy
People 2030; Correction
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, Office of Disease Prevention and
Health Promotion.
ACTION: Notice; correction.
AGENCY:
The Department of Health and
Human Services published a document
in the Federal Register of November 27,
2018, concerning request for comments
on the proposed Healthy People 2030
objectives. The document contained an
incorrect date.
FOR FURTHER INFORMATION CONTACT:
Ayanna Johnson, HP2030@hhs.gov.
SUMMARY:
Correction
In the Federal Register of November
27, 2018, in FR Doc. 2018–25836, on
pages 60876–60877, correct the ‘‘Dates’’
caption to read:
DATES: Written comments must be
submitted by January 17, 2019.
Dated: November 27, 2018.
Don Wright,
Deputy Assistant Secretary for Health
(Disease Prevention and Health Promotion).
[FR Doc. 2018–26299 Filed 12–3–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Substance Abuse and Mental Health
Services Administration
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; National Research Mentoring Network
(NRMN) U24 Center Applications.
Date: December 12, 2018.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3AN18, 45 Center
Drive, Bethesda, MD 20892.
Contact Person: Rebecca H. Johnson,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18C, Bethesda,
MD 20892, 301–594–2771, johnsonrh@
nigms.nih.gov.
This notice is being published less
than 15 days prior to the meeting due
to the timing limitations imposed by the
review and funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
Dated: November 28, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–26281 Filed 12–3–18; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4150–32–P
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Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine Drug
Testing for Federal Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITF) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines).
A notice listing all currently HHScertified laboratories and IITFs is
published in the Federal Register
during the first week of each month. If
any laboratory or IITF certification is
suspended or revoked, the laboratory or
IITF will be omitted from subsequent
lists until such time as it is restored to
full certification under the Mandatory
Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
internet at https://www.samhsa.gov/
workplace.
FOR FURTHER INFORMATION CONTACT:
Charles LoDico, Division of Workplace
Programs, SAMHSA/CSAP, 5600
Fishers Lane, Room 16N02C, Rockville,
Maryland 20857; 240–276–2600 (voice).
SUPPLEMENTARY INFORMATION: The
Department of Health and Human
Services (HHS) notifies federal agencies
of the laboratories and Instrumented
Initial Testing Facilities (IITF) currently
certified to meet the standards of the
Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Mandatory Guidelines). The Mandatory
Guidelines were first published in the
Federal Register on April 11, 1988 (53
FR 11970), and subsequently revised in
the Federal Register on June 9, 1994 (59
FR 29908); September 30, 1997 (62 FR
51118); April 13, 2004 (69 FR 19644);
November 25, 2008 (73 FR 71858);
December 10, 2008 (73 FR 75122); April
30, 2010 (75 FR 22809); and on January
23, 2017 (82 FR 7920).
The Mandatory Guidelines were
initially developed in accordance with
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62593-62595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26282]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-E-3547]
Determination of Regulatory Review Period for Purposes of Patent
Extension; EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM
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 EXABLATE NEURO MODEL 4000
TYPE 1.0 SYSTEM (EXABLATE) and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that medical device.
DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 4, 2019. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 3, 2019.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 4, 2019. 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:
[[Page 62594]]
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-2017-E-3547 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; EXABLATE.'' 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device EXABLATE.
EXABLATE is indicated for use in the unilateral thalamotomy treatment
of idiopathic essential tremor patients with medication-refractory
tremor. Patients must be at least age 22. The designated area in the
brain responsible for the movement disorder symptoms (ventralis
intermedius) must be identified and accessible for targeted thermal
ablation by the EXABLATE device. Subsequent to this approval, the USPTO
received a patent term restoration application for EXABLATE (U.S.
Patent No. 6,612,988) from Brigham and Women's Hospital, Inc. and
InSightec, Ltd., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated August 1, 2017, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of EXABLATE 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
EXABLATE is 2,050 days. Of this time, 1,785 days occurred during the
testing phase of the regulatory review period, while 265 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: December 2, 2010. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective was December 2, 2010.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): October
21, 2015. The applicant claims October 20, 2015, as the date the
premarket approval application (PMA) for EXABLATE (PMA P150038) was
initially submitted. However, FDA records indicate that PMA P150038 was
submitted on October 21, 2015.
3. The date the application was approved: July 11, 2016. FDA has
verified the applicant's claim that PMA P150038 was approved on July
11, 2016.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,158 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
[[Page 62595]]
regarding whether the applicant for extension acted with due diligence
during the regulatory review period. To meet its burden, the petition
must comply with all the requirements of Sec. 60.30, including but not
limited to: must be timely (see DATES), must be filed in accordance
with Sec. 10.20, must contain sufficient facts to merit an FDA
investigation, and must certify that a true and complete copy of the
petition has been served upon the patent applicant. (See H. Rept. 857,
part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26282 Filed 12-3-18; 8:45 am]
BILLING CODE 4164-01-P
