Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV, 15322-15323 [2011-6514]
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Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices
documents in the docket at https://
www.regulations.gov.
References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20857, under
Docket No. FDA–2010–P–0176 and may
be seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday.
1. Letter from Christy Foreman, FDA,
CDRH, to Ken Charak, Ethicon EndoSurgery, Inc., containing the order
denying approval of the PMA for the
SEDASYS system, October 26, 2010.
2. Charter Medical Devices Advisory
Committee; Charter Amendment,
Medical Devices Advisory Committee;
FDA; July 15, 2008, https://www.fda.gov/
AdvisoryCommittees/Committees
MeetingMaterials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/
ucm124098.htm.
3. ‘‘Resolving Scientific Disputes
Concerning the Regulation of Medical
Devices, A Guide To Use of the Medical
Devices Dispute Resolution Panel; Final
Guidance for Industry and FDA’’ FDA,
CDRH; July 2, 2001, https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
default.htm.
Dated: March 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6520 Filed 3–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0400]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VPRIV
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for VPRIV
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://
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:50 Mar 18, 2011
Jkt 223001
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. 6222, 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 VPRIV
(velaglucerase alfa). VPRIV is indicated
for long-term enzyme replacement
therapy for pediatric and adult patients
with type 1 Gaucher Disease.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for VPRIV
(U.S. Patent No. 7,138,262) from Shire
Human Genetic Therapies, 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 September
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
30, 2010, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
VPRIV 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
VPRIV is 2,221 days. Of this time, 2,041
days occurred during the testing phase
of the regulatory review period, while
180 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
30, 2004. The applicant claims May 20,
2004, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was January 30, 2004,
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: August 31,
2009. FDA has verified the applicant’s
claim that the new drug application
(NDA) for VPRIV (NDA 22–575) was
initially submitted on August 31, 2009.
3. The date the application was
approved: February 26, 2010. FDA has
verified the applicant’s claim that NDA
22–575 was approved on February 26,
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 687 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 May 20, 2011.
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
September 19, 2011. 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.
E:\FR\FM\21MRN1.SGM
21MRN1
Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices
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. It is no longer necessary to
send three copies of mailed 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: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2011–6514 Filed 3–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0241]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ATRYN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for ATRYN
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 biological 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. 6222, 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)
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:50 Mar 18, 2011
Jkt 223001
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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological 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 biological 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 biologic product ATRYN
(antithrombin (recombinant)). ATRYN is
indicated for the prevention of perioperative and peri-partum
thromboembolic events in hereditary
antithrombin deficient patients.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for ATRYN
(U.S. Patent No. 6,441,145) from GTC
Biotherapeutics, 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 February 17, 2010, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
ATRYN represented the first permitted
commercial marketing or use of the
recombinant 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
ATRYN is 4,468 days. Of this time,
4,285 days occurred during the testing
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
15323
phase of the regulatory review period,
while 183 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 (21 U.S.C. 355(i))
became effective: November 15, 1996.
The applicant claims November 14,
1996, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was November 15,
1996, which was 30 days after FDA
receipt of the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): August 8, 2008. The
applicant claims January 31, 2008, as
the date the biologics license
application (BLA) for ATRYN (BLA
125284) was initially submitted.
However, FDA records indicate that
BLA 125284 was submitted on August
8, 2008.
3. The date the application was
approved: February 6, 2009. FDA has
verified the applicant’s claim that BLA
125284 was approved on February 6,
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 1,243 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 May 20, 2011.
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
September 19, 2011. 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. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
E:\FR\FM\21MRN1.SGM
21MRN1
]]>Agencies
[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Pages 15322-15323]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6514]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-E-0400]
Determination of Regulatory Review Period for Purposes of Patent
Extension; VPRIV
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for VPRIV 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. 6222, 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 VPRIV
(velaglucerase alfa). VPRIV is indicated for long-term enzyme
replacement therapy for pediatric and adult patients with type 1
Gaucher Disease. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for VPRIV (U.S.
Patent No. 7,138,262) from Shire Human Genetic Therapies, 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 September 30, 2010, FDA advised the Patent and Trademark Office
that this human drug product had undergone a regulatory review period
and that the approval of VPRIV 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
VPRIV is 2,221 days. Of this time, 2,041 days occurred during the
testing phase of the regulatory review period, while 180 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 30, 2004. The applicant claims May 20, 2004, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was January
30, 2004, 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: August 31,
2009. FDA has verified the applicant's claim that the new drug
application (NDA) for VPRIV (NDA 22-575) was initially submitted on
August 31, 2009.
3. The date the application was approved: February 26, 2010. FDA
has verified the applicant's claim that NDA 22-575 was approved on
February 26, 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 687 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 May 20, 2011. 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 September 19, 2011. 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.
[[Page 15323]]
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. It is no longer
necessary to send three copies of mailed 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: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-6514 Filed 3-18-11; 8:45 am]
BILLING CODE 4160-01-P
