Determination of Regulatory Review Period for Purposes of Patent Extension; SYNRIBO, 26271-26272 [2015-11004]
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26271
Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices
file a petition to participate in a formal
evidentiary hearing, either personally or
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requires that any person filing a notice
of participation state their specific
interest in the proceedings, including
the specific issues of fact about which
the person desires to be heard. This
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include a statement that the person will
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hearing before a Public Board of Inquiry,
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13.25). In accordance with § 12.45(e) the
presiding officer may omit a
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information in a hearing to identify
specific interests to be presented. This
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expedite the prehearing conference and
commits participation.
The respondents are individuals or
households, State or local governments,
not-for-profit institutions and
businesses, or other for-profit groups
and institutions.
In the Federal Register of December
10, 2014 (79 FR 73320), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Total
annual
responses
Average
burden per
response
Total
hours
10.30—Citizen Petition ........................................................
10.33—Administrative reconsideration of action .................
10.35—Administrative Stay of Action ..................................
10.85—Advisory Opinions ...................................................
12.22—Filing Objections and Requests for a Hearing on a
Regulation or Order ..........................................................
12.45—Notice of Participation .............................................
207
4
5
4
1
1
1
1
207
4
5
4
24
10
10
16
4,968
40
50
64
3
4
1
1
3
4
20
3
60
12
Total ..............................................................................
........................
........................
........................
........................
5,194
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
Agency records and experience over the
past 3 years.
Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–10996 Filed 5–6–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–E–1690]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SYNRIBO
AGENCY:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SYNRIBO 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:07 May 06, 2015
Jkt 235001
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
SUPPLEMENTARY INFORMATION:
HHS.
ACTION:
Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Campus, Rm. 3180,
Silver Spring, MD 20993, 301–796–
7900.
ADDRESSES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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 SYNRIBO
(omacetaxine mepesuccinate). SYNRIBO
is indicated for treatment of adult
patients with chronic or accelerated
phase chronic myeloid leukemia with
resistance and/or intolerance to two or
more tyrosine kinase inhibitors.
Subsequent to this approval, the USPTO
received a patent term restoration
application for SYNRIBO (U.S. Patent
No. 6,987,103) from Robin, Mahon,
Maisonneuve, Maloisel, and Blanchard,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated January 30, 2014, FDA
E:\FR\FM\07MYN1.SGM
07MYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
26272
Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of SYNRIBO represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
SYNRIBO is 4,182 days. Of this time,
3,037 days occurred during the testing
phase of the regulatory review period,
while 1,145 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: May 17,
2001. The applicant claims May 18,
2001, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was May 17, 2001,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: September 8,
2009. The applicant claims September
4, 2009, as the date the new drug
application (NDA) for SYNRIBO was
initially submitted. However, FDA
records indicate that the NDA was
submitted on September 8, 2009.
3. The date the application was
approved: October 26, 2012. FDA has
verified the applicant’s claim that the
NDA for SYNRIBO was approved on
October 26, 2012.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,217 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by July 6, 2015.
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
November 3, 2015. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
VerDate Sep<11>2014
18:07 May 06, 2015
Jkt 235001
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–11004 Filed 5–6–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–E–0070 and FDA–
2014–E–0071]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; GATTEX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
GATTEX 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 a patent which claims that
human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Food and Drug
Administration, 10001 New Hampshire
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Ave., Hillandale Campus, Rm. 3180,
Silver Spring, MD 20993, 301–796–
7900.
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 GATTEX
(teduglutide [rDNA origin]). GATTEX is
indicated for treatment of adult patients
with Short Bowel Syndrome who are
dependent on parenteral support.
Subsequent to this approval, the USPTO
received patent term restoration
applications for GATTEX (U.S. Patent
Nos. 5,789,379 and 7,056,886) from NPS
Pharmaceuticals, Inc., and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
March 26, 2014, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
GATTEX represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
SUPPLEMENTARY INFORMATION:
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26271-26272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11004]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-E-1690]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SYNRIBO
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SYNRIBO 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.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to https://www.regulations.gov at Docket
No. FDA-2013-S-0610.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
SUPPLEMENTARY INFORMATION: 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 SYNRIBO
(omacetaxine mepesuccinate). SYNRIBO is indicated for treatment of
adult patients with chronic or accelerated phase chronic myeloid
leukemia with resistance and/or intolerance to two or more tyrosine
kinase inhibitors. Subsequent to this approval, the USPTO received a
patent term restoration application for SYNRIBO (U.S. Patent No.
6,987,103) from Robin, Mahon, Maisonneuve, Maloisel, and Blanchard, and
the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated January 30,
2014, FDA
[[Page 26272]]
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of SYNRIBO represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.
FDA has determined that the applicable regulatory review period for
SYNRIBO is 4,182 days. Of this time, 3,037 days occurred during the
testing phase of the regulatory review period, while 1,145 days
occurred during the approval phase. These periods of time were derived
from the following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: May 17, 2001. The applicant claims May 18, 2001, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was May 17,
2001, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: September
8, 2009. The applicant claims September 4, 2009, as the date the new
drug application (NDA) for SYNRIBO was initially submitted. However,
FDA records indicate that the NDA was submitted on September 8, 2009.
3. The date the application was approved: October 26, 2012. FDA has
verified the applicant's claim that the NDA for SYNRIBO was approved on
October 26, 2012.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,217 days of patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 6, 2015. 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 November 3, 2015. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
https://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11004 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P
