Determination of Regulatory Review Period for Purposes of Patent Extension; ARGUS II VISUAL STIMULATION SYSTEM, 76697-76699 [2015-31095]
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Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. 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 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 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:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
19:33 Dec 09, 2015
Jkt 238001
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 ELIQUIS
(apixaban). ELIQUIS is indicated to
reduce the risk of stroke and systemic
embolism in patients with nonvalvular
atrial fibrillation. Subsequent to this
approval, the USPTO received a patent
term restoration application for
ELIQUIS (U.S. Patent No. 6,967,208)
from Bristol-Myers Squibb Company,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated March 27, 2014, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of ELIQUIS 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
ELIQUIS is 3,685 days. Of this time,
3,227 days occurred during the testing
phase of the regulatory review period,
while 458 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:
November 28, 2002. FDA has verified
the applicant’s claim that the date the
investigational new drug application
became effective was on November 28,
2002.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: September 28,
2011. FDA has verified the applicant’s
claim that the new drug application
(NDA) for ELIQUIS (NDA 202155) was
initially submitted on September 28,
2011.
3. The date the application was
approved: December 28, 2012. FDA has
verified the applicant’s claim that NDA
202155 was approved on December 28,
2012.
This determination of the regulatory
review period establishes the maximum
PO 00000
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76697
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 1,424 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 ask for a redetermination
(see DATES). 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. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (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
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Petitions that have not been
made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31096 Filed 12–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–0271]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ARGUS II VISUAL
STIMULATION SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for ARGUS
II VISUAL STIMULATION SYSTEM
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
SUMMARY:
E:\FR\FM\10DEN1.SGM
10DEN1
76698
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
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 8, 2016.
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 7, 2016. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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.’’
VerDate Sep<11>2014
19:33 Dec 09, 2015
Jkt 238001
Instructions: All submissions received
must include the Docket No. FDA–
2014–E–0271 for Determination of
Regulatory Review Period for Purposes
of Patent Extension; ARGUS II VISUAL
STIMULATION SYSTEM. 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 Division of 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 Division of Dockets
Management. 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 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.fda.gov/
regulatoryinformation/dockets/
default.htm.: 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 Division of Dockets
Management, 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:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 ARGUS II VISUAL
STIMULATION SYSTEM. ARGUS II
VISUAL STIMULATION SYSTEM is
indicated for patients aged 25 years and
older with bare or no light perception
vision caused by advanced retinitis
pigmentosa. Subsequent to this
approval, the USPTO received a patent
term restoration application for ARGUS
II VISUAL STIMULATION SYSTEM
(U.S. Patent No. 7,668,599) from Second
Sight Medical Products, Inc., and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
May 22, 2014, FDA advised the USPTO
that this medical device had undergone
a regulatory review period and that the
approval of ARGUS II VISUAL
STIMULATION SYSTEM represented
the first permitted commercial
marketing or use of the product.
Thereafter, the USPTO requested that
FDA determine the product’s regulatory
review period.
E:\FR\FM\10DEN1.SGM
10DEN1
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
ARGUS II VISUAL STIMULATION
SYSTEM is 2,282 days. Of this time,
1,630 days occurred during the testing
phase of the regulatory review period,
while 652 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 (the FD&C Act) (21
U.S.C. 360j(g)) involving this device
became effective: November 17, 2006.
The applicant claims that the
investigational device exemption (IDE)
required under section 520(g) of the
FD&C act for human tests to begin
became effective on December 31, 2004.
However, FDA records indicate that the
IDE was determined substantially
complete for clinical studies to have
begun on November 17, 2006, which
represents the IDE effective date.
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): May 4, 2011. The
applicant claims May 3, 2011, as the
date the humanitarian device exemption
(HDE) for Argus II Visual Stimulation
System (HDE H110002) was initially
submitted. However, FDA records
indicate that HDE H110002 was
submitted on May 4, 2011.
3. The date the application was
approved: February 13, 2013. The
applicant claims that HDE H110002 was
approved on February 14, 2013.
However, FDA records indicate that
ARGUS II VISUAL STIMULATION
SYSTEM was approved on February 13,
2013.
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 1,735 days of patent
term extension.
mstockstill on DSK4VPTVN1PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). 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. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
VerDate Sep<11>2014
19:33 Dec 09, 2015
Jkt 238001
investigation. (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
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Petitions that have not been
made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31095 Filed 12–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0093]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Evaluation of the
Program for Enhanced Review
Transparency and Communication for
New Molecular Entity New Drug
Applications and Original Biologics
License Applications in Prescription
Drug User Fee Acts
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection involving
interviews of pharmaceutical
manufacturers who submit new
molecular entity (NME) new drug
applications (NDAs) and original
biologics license applications (BLAs) to
FDA under the Program for Enhanced
Review Transparency and
Communication (the Program) during
fiscal years (FYs) 2013–2017. The
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
76699
Program is part of the FDA performance
commitments under the fifth
authorization of the Prescription Drug
User Fee Act (PDUFA), which allows
FDA to collect user fees for the review
of human drug and biologics
applications for FYs 2013–2017.
DATES: Submit either electronic or
written comments on the collection of
information by February 8, 2016.
ADDRESSES: You may submit comments
as follows:
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. [FDA–
2013–N–0093] for ‘‘Agency Information
Collection Activities: Proposed
Collection; Comment Request;
Evaluation of the Program for Enhanced
Review Transparency and
E:\FR\FM\10DEN1.SGM
10DEN1
]]>Agencies
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76697-76699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31095]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-E-0271]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ARGUS II VISUAL STIMULATION SYSTEM
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ARGUS II VISUAL STIMULATION SYSTEM 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
[[Page 76698]]
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 8, 2016. 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 7, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-E-0271 for Determination of Regulatory Review Period for
Purposes of Patent Extension; ARGUS II VISUAL STIMULATION SYSTEM.
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 Division of 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
Division of Dockets Management. 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 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.fda.gov/regulatoryinformation/dockets/default.htm.: 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
Division of Dockets Management, 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 ARGUS II VISUAL
STIMULATION SYSTEM. ARGUS II VISUAL STIMULATION SYSTEM is indicated for
patients aged 25 years and older with bare or no light perception
vision caused by advanced retinitis pigmentosa. Subsequent to this
approval, the USPTO received a patent term restoration application for
ARGUS II VISUAL STIMULATION SYSTEM (U.S. Patent No. 7,668,599) from
Second Sight Medical Products, Inc., and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated May 22, 2014, FDA advised the USPTO that
this medical device had undergone a regulatory review period and that
the approval of ARGUS II VISUAL STIMULATION SYSTEM represented the
first permitted commercial marketing or use of the product. Thereafter,
the USPTO requested that FDA determine the product's regulatory review
period.
[[Page 76699]]
II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for
ARGUS II VISUAL STIMULATION SYSTEM is 2,282 days. Of this time, 1,630
days occurred during the testing phase of the regulatory review period,
while 652 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 (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: November 17, 2006. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C act for human tests to begin became effective on
December 31, 2004. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
November 17, 2006, which represents the IDE effective date.
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): May 4,
2011. The applicant claims May 3, 2011, as the date the humanitarian
device exemption (HDE) for Argus II Visual Stimulation System (HDE
H110002) was initially submitted. However, FDA records indicate that
HDE H110002 was submitted on May 4, 2011.
3. The date the application was approved: February 13, 2013. The
applicant claims that HDE H110002 was approved on February 14, 2013.
However, FDA records indicate that ARGUS II VISUAL STIMULATION SYSTEM
was approved on February 13, 2013.
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 1,735 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 ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (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 Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31095 Filed 12-9-15; 8:45 am]
BILLING CODE 4164-01-P
