Determination of Regulatory Review Period for Purposes of Patent Extension; ZACTRAN, 30854-30855 [2014-12350]
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30854
Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Notices
ongoing training of FDA staff, and
periodic audits of compliance with the
guidance.
The contractor’s Phase 1 final
comprehensive findings and
recommendations along with FDA’s
implementation plan based on the
contractor’s high-priority
recommendations issued December 11,
2013, are available at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MDUFAIII/ucm314036.htm.
Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12403 Filed 5–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–E–0595]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ZACTRAN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ZACTRAN 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 Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that animal 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, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
Silver Spring, MD 20993–0002, 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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:19 May 28, 2014
Jkt 232001
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 animal drug
products, the testing phase begins on
the earlier date when either a major
environmental effects test was initiated
for the drug or when an exemption
under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 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
Patents and Trademarks 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 ZACTRAN
(gamithromycin). ZACTRAN, an animal
drug product, is indicated for the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni in beef and nonlactating dairy cattle. ZACTRAN is also
indicated for the control of respiratory
disease in beef and non-lactating dairy
cattle at high risk of developing BRD
associated with M. haemolytica and P.
multocida. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for ZACTRAN (U.S. Patent
No. 5,985,844) from Merck Sharp &
Dohme Corp., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated February 1, 2013, FDA
advised the Patent and Trademark
Office that this animal drug product had
undergone a regulatory review period
and that the approval of ZACTRAN
represented the first permitted
commercial marketing or use of the
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
ZACTRAN is 2,990 days. Of this time,
2,930 days occurred during the testing
phase of the regulatory review period,
while 60 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: April
11, 2003. The applicant claims
September 11, 1997, as the date the
investigational new animal drug
application (INAD) became effective.
However, FDA records indicate that the
INAD effective date was April 11, 2003,
which was the date a major health or
environmental effects test is begun or
the date on which the Agency
acknowledges the filing of a notice of
claimed investigational exemption for a
new animal drug, whichever is earlier.
2. The date the application was
initially submitted with respect to the
animal drug product under section 512
of the FD&C Act (21 U.S.C. 360b): April
18, 2011. The applicant claims April 15,
2011, as the date the new animal drug
application (NADA) for ZACTRAN
(NADA 141–328) was initially
submitted. However, FDA records
indicate that NADA 141–328 was
submitted on April 18, 2011.
3. The date the application was
approved: June 16, 2011. FDA has
verified the applicant’s claim that
NADA 141–328 was approved on June
16, 2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the Patent and Trademark
Office applies several statutory
limitations in its calculations of the
actual period for patent extension. In its
application for patent extension, this
applicant seeks 1,826 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 28, 2014.
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 25, 2014. 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.,
E:\FR\FM\29MYN1.SGM
29MYN1
Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Notices
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 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12350 Filed 5–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–E–0035]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XARELTO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
XARELTO 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 Patents
and Trademarks, 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, Center for Drug
Evaluation and Research, Food and
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:19 May 28, 2014
Jkt 232001
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
Silver Spring, MD 20993–0002, 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 Patents and Trademarks 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 XARELTO
(rivaroxaban). XARELTO is indicated
for the prophylaxis of deep vein
thrombosis, which may lead to
pulmonary embolism in patients
undergoing knee or hip replacement
surgery. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for XARELTO (U.S. Patent
No. 7,157,456) from Bayer Pharma
Aktiengesellschaft, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated July 9, 2012, FDA advised
the Patent and Trademark Office that
this human drug product had undergone
a regulatory review period and that the
approval of XARELTO represented the
first permitted commercial marketing or
use of the product. Thereafter, the
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
30855
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
XARELTO is 3,291 days. Of this time,
2,222 days occurred during the testing
phase of the regulatory review period,
while 1,069 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: June 29,
2002. The applicant claims June 30,
2002, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 29, 2002,
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: July 28, 2008.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
XARELTO (NDA 22–406) was submitted
on July 28, 2008.
3. The date the application was
approved: July 1, 2011. FDA has verified
the applicant’s claim that NDA 22–406
was approved on July 1, 2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the Patent and Trademark
Office applies several statutory
limitations in its calculations of the
actual period for patent extension. In its
application for patent extension, this
applicant seeks 1,354 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 28, 2014.
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 25, 2014. 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
E:\FR\FM\29MYN1.SGM
29MYN1
]]>Agencies
[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30854-30855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12350]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-E-0595]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ZACTRAN
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ZACTRAN 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that animal 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, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002, 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 animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 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 Patents and
Trademarks 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 ZACTRAN
(gamithromycin). ZACTRAN, an animal drug product, is indicated for the
treatment of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in
beef and non-lactating dairy cattle. ZACTRAN is also indicated for the
control of respiratory disease in beef and non-lactating dairy cattle
at high risk of developing BRD associated with M. haemolytica and P.
multocida. Subsequent to this approval, the Patent and Trademark Office
received a patent term restoration application for ZACTRAN (U.S. Patent
No. 5,985,844) from Merck Sharp & Dohme Corp., and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
February 1, 2013, FDA advised the Patent and Trademark Office that this
animal drug product had undergone a regulatory review period and that
the approval of ZACTRAN represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
FDA has determined that the applicable regulatory review period for
ZACTRAN is 2,990 days. Of this time, 2,930 days occurred during the
testing phase of the regulatory review period, while 60 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: April 11, 2003. The applicant claims
September 11, 1997, as the date the investigational new animal drug
application (INAD) became effective. However, FDA records indicate that
the INAD effective date was April 11, 2003, which was the date a major
health or environmental effects test is begun or the date on which the
Agency acknowledges the filing of a notice of claimed investigational
exemption for a new animal drug, whichever is earlier.
2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the FD&C Act (21 U.S.C.
360b): April 18, 2011. The applicant claims April 15, 2011, as the date
the new animal drug application (NADA) for ZACTRAN (NADA 141-328) was
initially submitted. However, FDA records indicate that NADA 141-328
was submitted on April 18, 2011.
3. The date the application was approved: June 16, 2011. FDA has
verified the applicant's claim that NADA 141-328 was approved on June
16, 2011.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,826 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 28, 2014. 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 25, 2014. 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.,
[[Page 30855]]
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 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12350 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P
