Determination of Regulatory Review Period for Purposes of Patent Extension; KISQALI, 27128-27130 [2019-12305]
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27128
Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Notice.
Food and Drug Administration
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of six abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
[Docket No. FDA–2019–N–1740]
DATES:
[FR Doc. 2019–12298 Filed 6–10–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Novartis Pharmaceuticals Corp., et al.;
Withdrawal of Approval of Six
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Application No.
SUMMARY:
Approval is withdrawn as of July
11, 2019.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Applicant
ANDA 070185 .........
Fluor-Op (fluorometholone) Ophthalmic Suspension, 0.1%
ANDA 070858 .........
Trazodone Hydrochloride Tablets USP, 100 milligrams (mg)
ANDA 076023 .........
ANDA 078167 .........
ANDA 088726 .........
Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200
mg.
Paclitaxel Injection USP, 6 mg/milliliter .................................
Chlorpropamide Tablets USP, 250 mg .................................
ANDA 089852 .........
Chlorzoxazone Tablets USP, 250 mg ...................................
Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12287 Filed 6–10–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
Drug
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 11, 2019.
Approval of each entire application is
withdrawn, including any strengths or
products inadvertently missing from the
table. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on July 11, 2019
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
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ACTION:
17:36 Jun 10, 2019
Jkt 247001
Novartis Pharmaceuticals Corp., One Health Plaza, East
Hanover, NJ 07936.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy.,
Bldg. A, Parsippany, NJ 07054.
Sandoz, Inc., 100 College Rd. West, Princeton, NJ 08540.
Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East
Windsor, NJ 08520.
Do.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–E–0068; FDA–
2018–E–0069; FDA–2018–E–0070; FDA–
2018–E–0071; and FDA–2018–E–0072]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; KISQALI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for KISQALI and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of
patents which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 12, 2019.
Furthermore, any interested person may
SUMMARY:
PO 00000
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Sfmt 4703
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 9, 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 August 12,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 12, 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
E:\FR\FM\11JNN1.SGM
11JNN1
Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
khammond on DSKBBV9HB2PROD with NOTICES
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2018–E–0068; FDA–2018–E–0069;
FDA–2018–E–0070; FDA–2018–E–0071;
and FDA–2018–E–0072 for
‘‘Determination of Regulatory Review
Period for Purposes of Patent Extension;
KISQALI.’’ 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
VerDate Sep<11>2014
17:36 Jun 10, 2019
Jkt 247001
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
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27129
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 KISQALI
(ribociclib succinate). KISQALI, in
combination with an aromatase
inhibitor as initial endocrine-based
therapy, is indicated for the treatment of
postmenopausal women with hormone
receptor-positive, human epidermal
growth factor receptor 2-negative
advanced or metastatic breast cancer.
Subsequent to this approval, the USPTO
received patent term restoration
applications for KISQALI (U.S. Patent
Nos. 8,324,225; 8,415,355; 8,685,980;
8,962,630; and 9,416,136) from Novartis
AG and Astex Therapeutics Ltd., and
the USPTO requested FDA’s assistance
in determining the patents’ eligibility
for patent term restoration. In a letter
dated February 6, 2018, FDA advised
the USPTO that this human drug
product had undergone a regulatory
review period and that the approval of
KISQALI 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
KISQALI is 2,393 days. Of this time,
2,196 days occurred during the testing
phase of the regulatory review period,
while 197 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: August 26,
2010. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on August 26, 2010.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: August 29,
2016. FDA has verified the applicant’s
claim that the new drug application
(NDA) for KISQALI (NDA 209092) was
initially submitted on August 29, 2016.
3. The date the application was
approved: March 13, 2017. FDA has
verified the applicant’s claim that NDA
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Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
209092 was approved on March 13,
2017.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 879 days, 22 days,
292 days, 459 days, or 204 days of
patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
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: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12305 Filed 6–10–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKBBV9HB2PROD with NOTICES
[Docket No. FDA–2019–D–0298]
Quality Considerations for Continuous
Manufacturing; Draft Guidance for
Industry; Availability; Reopening of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; reopening
of comment period.
ACTION:
VerDate Sep<11>2014
17:36 Jun 10, 2019
Jkt 247001
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
notice entitled ‘‘Quality Considerations
for Continuous Manufacturing; Draft
Guidance for Industry; Availability’’
that appeared in the Federal Register of
February 27, 2019. The Agency is taking
this action to allow interested persons
additional time to submit comments.
DATES: FDA is reopening the comment
period for the notice published on
February 27, 2019 (84 FR 6403). Submit
either electronic or written comments
on the draft guidance by August 12,
2019 to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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.’’
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–0298 for ‘‘Quality
Considerations for Continuous
Manufacturing.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27128-27130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12305]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-E-0068; FDA-2018-E-0069; FDA-2018-E-0070; FDA-
2018-E-0071; and FDA-2018-E-0072]
Determination of Regulatory Review Period for Purposes of Patent
Extension; KISQALI
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 KISQALI and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of patents which claims that human drug
product.
DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
12, 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 December 9, 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 August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 12, 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
[[Page 27129]]
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2018-E-0068; FDA-2018-E-0069; FDA-2018-E-0070; FDA-2018-E-0071; and
FDA-2018-E-0072 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; KISQALI.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product KISQALI
(ribociclib succinate). KISQALI, in combination with an aromatase
inhibitor as initial endocrine-based therapy, is indicated for the
treatment of postmenopausal women with hormone receptor-positive, human
epidermal growth factor receptor 2-negative advanced or metastatic
breast cancer. Subsequent to this approval, the USPTO received patent
term restoration applications for KISQALI (U.S. Patent Nos. 8,324,225;
8,415,355; 8,685,980; 8,962,630; and 9,416,136) from Novartis AG and
Astex Therapeutics Ltd., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated February 6, 2018, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of KISQALI 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
KISQALI is 2,393 days. Of this time, 2,196 days occurred during the
testing phase of the regulatory review period, while 197 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:
August 26, 2010. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on August
26, 2010.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: August 29,
2016. FDA has verified the applicant's claim that the new drug
application (NDA) for KISQALI (NDA 209092) was initially submitted on
August 29, 2016.
3. The date the application was approved: March 13, 2017. FDA has
verified the applicant's claim that NDA
[[Page 27130]]
209092 was approved on March 13, 2017.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 879 days, 22 days, 292 days, 459 days, or 204 days
of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12305 Filed 6-10-19; 8:45 am]
BILLING CODE 4164-01-P
