Determination of Regulatory Review Period for Purposes of Patent Extension; RAINDROP NEAR VISION INLAY, 54360-54362 [2018-23527]
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evaluate the potential benefits and risks
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Dated: October 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23577 Filed 10–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–4181]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RAINDROP NEAR VISION
INLAY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for RAINDROP NEAR VISION INLAY
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.
SUMMARY:
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 December 28, 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
DATES:
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April 29, 2019. See ‘‘Petitions’’ in the
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 December 28,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 28, 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.
SUPPLEMENTARY INFORMATION
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–
2017–E–4181 for ‘‘Determination of
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Regulatory Review Period for Purposes
of Patent Extension; RAINDROP NEAR
VISION INLAY.’’ 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 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
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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 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 RAINDROP NEAR
VISION INLAY. RAINDROP NEAR
VISION INLAY is indicated for
intrastromal implantation to improve
near vision in the non-dominant eye of
phakic, presbyopic patients, 41 to 65
years of age, who have manifest
refractive spherical equivalent of +1.00
diopters (D) to -0.50 D with less than or
equal to 0.75 D of refractive cylinder,
who do not require correction for clear
distance vision, but who do require near
correction of +1.50 D to +2.50 D of
reading add. Subsequent to this
approval, the USPTO received a patent
term restoration application for
RAINDROP NEAR VISION INLAY (U.S.
Patent No. 8,057,541) from ReVision
Optics, Inc., and the USPTO requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated September
20, 2017, FDA advised the USPTO that
this medical device had undergone a
regulatory review period and that the
approval of RAINDROP NEAR VISION
INLAY represented the first permitted
commercial marketing or use of the
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54361
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
RAINDROP NEAR VISION INLAY is
2,354 days. Of this time, 2,074 days
occurred during the testing phase of the
regulatory review period, while 280
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: January 20, 2010. FDA has
verified the applicant’s claim that the
date the investigational device
exemption required under section
520(g) of the FD&C Act for human tests
to begin became effective was January
20, 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): September 24,
2015. The applicant claims March 25,
2014, as the date the premarket approval
application (PMA) for RAINDROP
NEAR VISION INLAY (PMA P150034)
was initially submitted. However, FDA
records indicate that PMA P150034 was
completely submitted on September 24,
2015.
3. The date the application was
approved: June 29, 2016. FDA has
verified the applicant’s claim that PMA
P150034 was approved on June 29,
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 828 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
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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: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23527 Filed 10–26–18; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1051]
Modified Risk Tobacco Product
Applications for Snus Products
Submitted by Swedish Match North
America Inc.; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
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’’).
ACTION:
Written/Paper Submissions
The Food and Drug
Administration (FDA or the Agency) is
reopening the period for public
comment on modified risk tobacco
product applications (MRTPAs) for
specific General Snus products
submitted by Swedish Match North
America Inc. and announcing the
availability for public comment of a
recently received amendment to the
MRTPAs. The original notice of
availability for the applications
appeared in the Federal Register of
August 27, 2014. In that notice, FDA
requested comments on the originally
filed MRTPAs that are posted on https://
www.regulations.gov and FDA’s
website. In the Federal Register of July
31, 2015, FDA issued a notice to reopen
and extended the comment period for
comments on amendments to the
MRTPAs. That comment period closed
on August 31, 2015. FDA is now
reopening the comment period to seek
comment specifically on a recent
amendment to the MRTPAs.
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–N–1051 for ‘‘Modified Risk
Tobacco Product Applications for Snus
Products Submitted by Swedish Match
North America Inc.’’ 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.
SUMMARY:
amozie on DSK3GDR082PROD with NOTICES1
Electronic or written comments
on the application may be submitted
beginning October 29, 2018. FDA will
establish a closing date for the comment
period as described in section I.
ADDRESSES: You may submit comments
as follows:
DATES:
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• 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 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 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: Paul
Hart, Center for Tobacco Products, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993–0002, 1–877–
287–1373, email: AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 27,
2014 (79 FR 51183), FDA published a
notice of availability for MRTPAs
submitted by Swedish Match North
America Inc. and gave the public 180
days to comment on the applications.
FDA subsequently published a notice in
the Federal Register of July 31, 2015 (80
FR 45661), to reopen and extend the
comment period to allow for comment
on amendments to the applications. The
comment period closed on August 31,
2015. On December 14, 2016, FDA
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]]>Agencies
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54360-54362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-E-4181]
Determination of Regulatory Review Period for Purposes of Patent
Extension; RAINDROP NEAR VISION INLAY
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 RAINDROP NEAR VISION INLAY
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
December 28, 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 April 29,
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 December 28, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 28, 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 No.
FDA-2017-E-4181 for ``Determination of
[[Page 54361]]
Regulatory Review Period for Purposes of Patent Extension; RAINDROP
NEAR VISION INLAY.'' 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 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 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 RAINDROP NEAR
VISION INLAY. RAINDROP NEAR VISION INLAY is indicated for intrastromal
implantation to improve near vision in the non-dominant eye of phakic,
presbyopic patients, 41 to 65 years of age, who have manifest
refractive spherical equivalent of +1.00 diopters (D) to -0.50 D with
less than or equal to 0.75 D of refractive cylinder, who do not require
correction for clear distance vision, but who do require near
correction of +1.50 D to +2.50 D of reading add. Subsequent to this
approval, the USPTO received a patent term restoration application for
RAINDROP NEAR VISION INLAY (U.S. Patent No. 8,057,541) from ReVision
Optics, Inc., and the USPTO requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated September 20, 2017, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of RAINDROP NEAR VISION INLAY 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
RAINDROP NEAR VISION INLAY is 2,354 days. Of this time, 2,074 days
occurred during the testing phase of the regulatory review period,
while 280 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: January 20, 2010. FDA has verified the
applicant's claim that the date the investigational device exemption
required under section 520(g) of the FD&C Act for human tests to begin
became effective was January 20, 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):
September 24, 2015. The applicant claims March 25, 2014, as the date
the premarket approval application (PMA) for RAINDROP NEAR VISION INLAY
(PMA P150034) was initially submitted. However, FDA records indicate
that PMA P150034 was completely submitted on September 24, 2015.
3. The date the application was approved: June 29, 2016. FDA has
verified the applicant's claim that PMA P150034 was approved on June
29, 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 828 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
[[Page 54362]]
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: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23527 Filed 10-26-18; 8:45 am]
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