Determination of Regulatory Review Period for Purposes of Patent Extension; FERAHEME, 26557-26558 [2012-10849]
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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Notices
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 (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 approved for marketing the
animal drug product EQUIDONE GEL
(domperidone). EQUIDONE GEL is
indicated for prevention of fescue
toxicosis in periparturient mares.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
EQUIDONE GEL (U.S. Patent No.
5,372,818) from Dechra, Ltd., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated April 26,
2011, FDA advised the Patent and
Trademark Office that this animal drug
product had undergone a regulatory
review period and that the approval of
EQUIDONE GEL 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
EQUIDONE GEL is 6,378 days. Of this
time, 6,336 days occurred during the
testing phase of the regulatory review
period, while 42 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption under
section 512(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b(j))
became effective: March 26, 1993. The
VerDate Mar<15>2010
15:20 May 03, 2012
Jkt 226001
applicant claims February 24, 1992, as
the date the investigational new animal
drug application (IND) became effective.
However, the date that 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
(NCIE) for a new animal drug,
whichever is earlier, is the effective date
for the IND. According to FDA records,
the applicant’s first submission of an
NCIE was March 26, 1993, which is the
effective date for the IND.
2. The date the application was
initially submitted with respect to the
animal drug product under section 512
of the Federal Food, Drug, and Cosmetic
Act: July 30, 2010. The applicant claims
July 27, 2010, as the date the new
animal drug application (NADA) for
EQUIDONE GEL (NADA 141–314) was
initially submitted. However, a review
of FDA records reveals that the date of
FDA’s official acknowledgement letter
assigning a number to NADA 141–314
was July 30, 2010, which is considered
to be the initially submitted date for
NADA 141–314.
3. The date the application was
approved: September 9, 2010. FDA has
verified the applicant’s claim that
NADA 141–314 was approved on
September 9, 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 5 years 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
written or electronic comments and ask
for a redetermination by July 3, 2012.
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
October 31, 2012. 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
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
26557
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: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2012–10853 Filed 5–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0049]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; FERAHEME
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
FERAHEME 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
SUMMARY:
E:\FR\FM\04MYN1.SGM
04MYN1
erowe on DSK2VPTVN1PROD with NOTICES
26558
Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Notices
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 FERAHEME
(ferumoxytol). FERAHEME is indicated
for the treatment of iron deficiency
anemia in adult patients with chronic
kidney disease. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for FERAHEME (U.S. Patent
No. 6,599,498) from AMAG
Pharmaceuticals, 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 May 2, 2011, FDA advised
the Patent and Trademark Office that
this human drug product had undergone
a regulatory review period and that the
approval of FERAHEME 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
FERAHEME is 3,680 days. Of this time,
3,120 days occurred during the testing
phase of the regulatory review period,
while 560 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 5,
1999. The applicant claims June 4, 1999,
as the date the investigational new drug
application (IND) became effective.
VerDate Mar<15>2010
15:20 May 03, 2012
Jkt 226001
However, FDA records indicate that the
IND effective date was June 5, 1999,
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: December 19,
2007. The applicant claims December
18, 2007, as the date the new drug
application (NDA) for FERAHEME
(NDA 22–180) was initially submitted.
However, FDA records indicate that
NDA 22–180 was submitted on
December 19, 2007.
3. The date the application was
approved: June 30, 2009. FDA has
verified the applicant’s claim that NDA
22–180 was approved on June 30, 2009.
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 1,209 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 3, 2012.
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
October 31, 2012. 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.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Dated: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2012–10849 Filed 5–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–E–0661 and FDA–
2010–E–0662]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; JEVTANA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
JEVTANA 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 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
SUMMARY:
E:\FR\FM\04MYN1.SGM
04MYN1
]]>Agencies
[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Notices]
[Pages 26557-26558]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10849]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-E-0049]
Determination of Regulatory Review Period for Purposes of Patent
Extension; FERAHEME
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for FERAHEME 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
[[Page 26558]]
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 FERAHEME
(ferumoxytol). FERAHEME is indicated for the treatment of iron
deficiency anemia in adult patients with chronic kidney disease.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for FERAHEME (U.S. Patent No.
6,599,498) from AMAG Pharmaceuticals, 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 May
2, 2011, FDA advised the Patent and Trademark Office that this human
drug product had undergone a regulatory review period and that the
approval of FERAHEME 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
FERAHEME is 3,680 days. Of this time, 3,120 days occurred during the
testing phase of the regulatory review period, while 560 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 5, 1999. The applicant claims June 4, 1999, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was June 5,
1999, 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: December
19, 2007. The applicant claims December 18, 2007, as the date the new
drug application (NDA) for FERAHEME (NDA 22-180) was initially
submitted. However, FDA records indicate that NDA 22-180 was submitted
on December 19, 2007.
3. The date the application was approved: June 30, 2009. FDA has
verified the applicant's claim that NDA 22-180 was approved on June 30,
2009.
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 1,209 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 3, 2012. 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 October 31, 2012. 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: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-10849 Filed 5-3-12; 8:45 am]
BILLING CODE 4160-01-P
