Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZ, 6826-6827 [2013-02086]
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Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–E–0037]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XALKORI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
XALKORI 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 along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 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. 6284, Silver Spring, MD 20993–
0002, 301–796–3602.
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
srobinson on DSK4SPTVN1PROD with
SUMMARY:
VerDate Mar<15>2010
17:38 Jan 30, 2013
Jkt 229001
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 recently approved for marketing
the human drug product XALKORI
(crizotinib). XALKORI is a kinase
inhibitor indicated for the treatment of
patients with locally advanced or
metastatic non-small cell lung cancer
that is anaplastic lymphoma kinasepositive as detected by an FDAapproved test. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for XALKORI (U.S. Patent
No. 7,230,098) from Pfizer Inc., 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
XALKORI 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
XALKORI is 2,054 days. Of this time,
1,904 days occurred during the testing
phase of the regulatory review period,
while 150 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: January
12, 2006. The applicant claims January
21, 2006, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
January 12, 2006, 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: March 30, 2011.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
XALKORI (NDA 202–570) was
submitted on March 30, 2011.
3. The date the application was
approved: August 26, 2011. FDA has
verified the applicant’s claim that NDA
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
202–570 was approved on August 26,
2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. 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 178 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 April 1, 2013.
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
July 30, 2013. 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 petitions. It is
only necessary to send one set of
comments. However, if you submit a
written petition, you must submit three
copies of the petition. Identify
comments with the docket number
found in brackets in the heading of this
document. 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: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–02085 Filed 1–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–E–0277]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BEYAZ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
SUMMARY:
E:\FR\FM\31JAN1.SGM
31JAN1
srobinson on DSK4SPTVN1PROD with
Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Notices
the regulatory review period for BEYAZ
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 along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 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. 6284, Silver Spring, MD 20993–
0002, 301–796–3602.
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 recently approved for marketing
the human drug product BEYAZ
(drospirenone, ethinyl estradiol, and
levomefolate calcium). BEYAZ is
VerDate Mar<15>2010
17:38 Jan 30, 2013
Jkt 229001
indicated for use in women to: Prevent
pregnancy; treat symptoms of
premenstrual dysphoric disorder for
women who choose to use an oral
contraceptive for contraception; treat
moderate acne for women at least 14
years old only if the patient desires an
oral contraceptive for birth control; and
raise folate levels in women who choose
to use an oral contraceptive for
contraception. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for BEYAZ (U.S. Patent No.
6,441,168) from Eprova AG, and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated March 28,
2012, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
BEYAZ 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
BEYAZ is 1,271 days. Of this time, 874
days occurred during the testing phase
of the regulatory review period, while
397 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: April 4,
2007. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on April 4, 2007.
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 24,
2009. The applicant claims August 21,
2009, as the date the new drug
application (NDA) for BEYAZ (NDA 22–
532) was initially submitted. However,
FDA records indicate that NDA 22–532
was submitted on August 24, 2009.
3. The date the application was
approved: September 24, 2010. FDA has
verified the applicant’s claim that NDA
22–532 was approved on September 24,
2010.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
6827
this applicant seeks 834 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 April 1, 2013.
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
July 30, 2013. 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 petitions. It is
only necessary to send one set of
comments. However, if you submit a
written petition, you must submit three
copies of the petition. Identify
comments with the docket number
found in brackets in the heading of this
document. 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: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–02086 Filed 1–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Public Availability of DHS Fiscal Year
2012 Service Contract Inventory
Office of the Chief Procurement
Officer, DHS.
ACTION: Notice of availability.
AGENCY:
In accordance with Section
743 of Division C of the Consolidated
Appropriations Act of 2010 (Pub. L.
111–117), the Department of Homeland
Security (DHS) is publishing this notice
to advise the public of the availability
of the FY 2012 Service Contract
inventory. This inventory provides
information on service contract actions
over $25,000 that were made in FY
2012. The information is organized by
function to show how contracted
resources are distributed throughout the
agency. The inventory has been
developed in accordance with guidance
issued on November 5, 2010 and
SUMMARY:
E:\FR\FM\31JAN1.SGM
31JAN1
]]>Agencies
[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Pages 6826-6827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02086]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-E-0277]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BEYAZ
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined
[[Page 6827]]
the regulatory review period for BEYAZ 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 along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 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. 6284, Silver Spring, MD 20993-0002, 301-796-3602.
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 recently approved for marketing the human drug product BEYAZ
(drospirenone, ethinyl estradiol, and levomefolate calcium). BEYAZ is
indicated for use in women to: Prevent pregnancy; treat symptoms of
premenstrual dysphoric disorder for women who choose to use an oral
contraceptive for contraception; treat moderate acne for women at least
14 years old only if the patient desires an oral contraceptive for
birth control; and raise folate levels in women who choose to use an
oral contraceptive for contraception. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for BEYAZ (U.S. Patent No. 6,441,168) from Eprova AG, and
the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated March 28, 2012, FDA advised the Patent and Trademark
Office that this human drug product had undergone a regulatory review
period and that the approval of BEYAZ 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
BEYAZ is 1,271 days. Of this time, 874 days occurred during the testing
phase of the regulatory review period, while 397 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: April 4, 2007. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on April 4, 2007.
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 24,
2009. The applicant claims August 21, 2009, as the date the new drug
application (NDA) for BEYAZ (NDA 22-532) was initially submitted.
However, FDA records indicate that NDA 22-532 was submitted on August
24, 2009.
3. The date the application was approved: September 24, 2010. FDA
has verified the applicant's claim that NDA 22-532 was approved on
September 24, 2010.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
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 834 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 April 1, 2013. 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 July 30, 2013. 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 petitions.
It is only necessary to send one set of comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document. 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: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02086 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P
