Determination of Regulatory Review Period for Purposes of Patent Extension; BELSOMRA, 6034-6036 [2018-02763]
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6034
Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
U.S.C. 360b(j)) became effective and
runs until the approval phase begins.
The approval phase starts with the
initial submission of an application to
market the animal 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 an animal
drug product will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(4)(B).
FDA has approved for marketing the
animal drug product BRAVECTO
(fluralaner). BRAVECTO is indicated for
treatment and control of flea infestations
(Ctenocephalides felis), and the
treatment and control of tick
infestations (Ixodes scapularis (black
legged tick), Dermacentor variabilis
(American dog tick), and Rhipicephalus
sanguineus (brown dog tick)) for 12
weeks in dogs and puppies 6 months of
age and older, and weighing 4.4 pounds
or greater. It is also indicated for the
treatment and control of Amblyomma
americanum (lone star tick) infestations
for 8 weeks in dogs and puppies 6
months of age and older and weighing
4.4 pounds or greater. Subsequent to
this approval, the USPTO received a
patent term restoration application for
BRAVECTO (U.S. Patent No. 7,662,972)
from Nissan Chemical Industries, Ltd.,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated October 19, 2015, FDA
advised the USPTO that this animal
drug product had undergone a
regulatory review period and that the
approval of BRAVECTO 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
BRAVECTO is 1,017 days. Of this time,
979 days occurred during the testing
phase of the regulatory review period,
while 38 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 FD&C Act (21
U.S.C. 355(i)) became effective: August
4, 2011. The applicant claims February
19, 2010, as the date the investigational
VerDate Sep<11>2014
19:23 Feb 09, 2018
Jkt 244001
new animal drug application (INAD)
became effective. However, FDA records
indicate that the INAD effective date
was August 4, 2011, which was the date
a major health or environmental effects
test was begun or the date on which the
Agency acknowledged the filing of a
notice of claimed investigational
exemption for a new animal drug,
whichever was earlier.
2. The date the application was
initially submitted with respect to the
animal drug product under section 512
of the FD&C Act: April 8, 2014. FDA has
verified the applicant’s claim that the
new animal drug application (NADA)
for BRAVECTO (NADA 141–426) was
submitted on April 8, 2014.
3. The date the application was
approved: May 15, 2014. FDA has
verified the applicant’s claim that
NADA 141–426 was approved on May
15, 2014.
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 792 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.
PO 00000
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Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02761 Filed 2–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–E–2725]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BELSOMRA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BELSOMRA 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 human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 13, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 13, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 13,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 13, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
E:\FR\FM\12FEN1.SGM
12FEN1
Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
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–
2015–E–2725 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; BELSOMRA.’’
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
VerDate Sep<11>2014
19:23 Feb 09, 2018
Jkt 244001
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
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
PO 00000
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Fmt 4703
Sfmt 4703
6035
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 BELSOMRA
(suvorexant). BELSOMRA is indicated
for treatment of insomnia, characterized
by difficulties with sleep onset and/or
sleep maintenance. Subsequent to this
approval, the USPTO received a patent
term restoration application for
BELSOMRA (U.S. Patent No. 7,951,797)
from Merck Sharp & Dohme Corp., and
the USPTO requested FDA’s assistance
in determining this patent’s eligibility
for patent term restoration. In a letter
dated October 15, 2015, FDA advised
the USPTO that this human drug
product had undergone a regulatory
review period and that the approval of
BELSOMRA 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
BELSOMRA is 2,291 days. Of this time,
1,577 days occurred during the testing
phase of the regulatory review period,
while 714 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: May 7, 2008.
The applicant claims May 10, 2008, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was May 7, 2008,
which was the date FDA notified the
applicant that the IND studies may
proceed.
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 30,
2012. FDA has verified the applicant’s
claim that the new drug application
(NDA) for BELSOMRA (NDA 204569)
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6036
Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
was initially submitted on August 30,
2012.
3. The date the application was
approved: August 13, 2014. FDA has
verified the applicant’s claim that NDA
204569 was approved on August 13,
2014.
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 zero 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: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02763 Filed 2–9–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5624]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Content and
Format of Labeling for Human
Prescription Drugs and Biological
Products; Requirements for Pregnancy
and Lactation Labeling
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 14,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0624. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Content and Format of Labeling for
Human Prescription Drugs and
Biological Products; Requirements for
Pregnancy and Lactation Labeling
OMB Control Number 0910–0624—
Extension
This information collection supports
Agency regulations regarding the
content and format requirements for
pregnancy and lactation labeling. In the
Federal Register of December 4, 2014
(79 FR 72064), FDA published a final
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19:23 Feb 09, 2018
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rule entitled ‘‘Content and Format of
Labeling for Human Prescription Drug
and Biological Products; Requirements
for Pregnancy and Lactation Labeling.’’
The final rule amended FDA regulations
concerning the content and format of
the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’
and ‘‘Nursing mothers’’ subsections of
the ‘‘Use in Specific Populations’’
section of the labeling for human
prescription drugs. The regulations now
require, among other things, a summary
of the risks of using a drug during
pregnancy and lactation and a
discussion of the data supporting that
summary. The labeling must also
include relevant information to help
health care providers make prescribing
decisions and counsel women about the
use of drugs during pregnancy and
lactation. The final rule eliminated the
pregnancy categories A, B, C, D, and X.
In addition, FDA eliminated the ‘‘Labor
and delivery’’ subsection because the
‘‘Pregnancy’’ subsection includes
information on labor and delivery. The
final rule also required that the labeling
include relevant information about
pregnancy testing, contraception, and
infertility for health care providers
prescribing for females and males of
reproductive potential. In addition, the
final rule provided for a 10-year
implementation schedule for
compliance with the relevant
regulations. As the implementation
schedule is realized, FDA plans to
discontinue this separate information
collection and incorporate the
provisions into existing collections as
appropriate.
The content and format requirements
apply to:
• Applications submitted on or after
June 30, 2015 (§§ 314.50 (21 CFR
314.50), 314.70(b) (21 CFR 314.70(b)),
601.2 (21 CFR 601.2), and 601.12(f)(1))
(21 CFR 601.12(f)(1));
• amendments to applications
pending on June 30, 2015 (§§ 314.60 (21
CFR 314.60), 601.2, and 601.12(f)(1));
• supplements to applications
approved from June 30, 2001, to June
30, 2015 (§§ 314.70(b) and 601.12(f)(1));
and
• annual reports for applications
approved before June 30, 2001, that
contain a pregnancy category, to report
removal of the pregnancy category letter
in their labeling (§§ 314.70(d) and
601.12(f)(3)).
Under § 201.57(c)(9)(i) and (ii) (21
CFR 201.57(c)(9)(i) and (ii)), holders of
approved applications must provide
new labeling content in a new format—
that is, to rewrite the pregnancy and
lactation portions of each drug’s
labeling. Section 201.57(c)(9)(iii)
requires that labeling must include the
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]]>Agencies
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6034-6036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02763]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-E-2725]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BELSOMRA
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 BELSOMRA 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 human drug
product.
DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
13, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 13, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 13, 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
[[Page 6035]]
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-2015-E-2725 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; BELSOMRA.'' 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 BELSOMRA
(suvorexant). BELSOMRA is indicated for treatment of insomnia,
characterized by difficulties with sleep onset and/or sleep
maintenance. Subsequent to this approval, the USPTO received a patent
term restoration application for BELSOMRA (U.S. Patent No. 7,951,797)
from Merck Sharp & Dohme Corp., and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated October 15, 2015, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of BELSOMRA 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
BELSOMRA is 2,291 days. Of this time, 1,577 days occurred during the
testing phase of the regulatory review period, while 714 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:
May 7, 2008. The applicant claims May 10, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was May 7, 2008, which
was the date FDA notified the applicant that the IND studies may
proceed.
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 30,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for BELSOMRA (NDA 204569)
[[Page 6036]]
was initially submitted on August 30, 2012.
3. The date the application was approved: August 13, 2014. FDA has
verified the applicant's claim that NDA 204569 was approved on August
13, 2014.
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 zero days of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02763 Filed 2-9-18; 8:45 am]
BILLING CODE 4164-01-P
