Determination of Regulatory Review Period for Purposes of Patent Extension; REPEL-CV, 54887-54888 [2010-22496]
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Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices
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[FR Doc. 2010–22472 Filed 9–8–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0414]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; REPEL–CV
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for REPEL–
CV 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
medical device.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:24 Sep 08, 2010
Jkt 220001
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 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 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 medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. 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 (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 medical device will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA recently approved for marketing
the medical device, REPEL–CV. REPEL–
CV, a bioresorbable adhesion barrier, is
indicated for reducing the severity of
post-operative cardiac adhesions in
pediatric patients who are likely to
require reoperation via sternotomy.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for REPEL–
CV (U.S. Patent No. 5,711,958) from
SyntheMed, 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 medical device had
undergone a regulatory review period
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
54887
and that the approval of REPEL–CV
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that the
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
REPEL–CV is 4,023 days. Of this time,
3,256 days occurred during the testing
phase of the regulatory review period,
while 767 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360j(g)) involving this device became
effective: March 3, 1998. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) required under section
520(g) of the act for human tests to begin
became effective March 3, 1998.
2. The date an application was
initially submitted with respect to the
device under section 515 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360e): January 30, 2007. FDA has
verified the applicant’s claim that the
premarket approval application (PMA)
for REPEL–CV (PMA P070005) was
initially submitted January 30, 2007.
3. The date the application was
approved: March 6, 2009. FDA has
verified the applicant’s claim that PMA
P070005 was approved on March 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 1,742 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 November 8,
2010. 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 March 8, 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
E:\FR\FM\09SEN1.SGM
09SEN1
54888
Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices
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
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–22496 Filed 9–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0416]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; IXIARO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for IXIARO
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 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:24 Sep 08, 2010
Jkt 220001
Law 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 IXIARO
(Japanese Encephalitis Virus, Vaccine
Inactivated, Adsorbed). IXIARO is
indicated for active immunization for
the prevention of disease caused by
Japanese encephalitis virus in persons
17 years of age and older. Subsequent to
this approval, the Patent and Trademark
Office received a patent term restoration
application for IXIARO (U.S. Patent No.
6,309,650) from Chiel Jedang Corp. and
Walter Reed Army Institute of Research,
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 IXIARO
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
IXIARO is 3,461 days. Of this time,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
2,994 days occurred during the testing
phase of the regulatory review period,
while 467 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: October 10, 1999. The
applicant claims October 9, 1999, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was October 10, 1999,
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): December 20, 2007. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for IXIARO (BLA B125280/0) was
initially submitted on December 20,
2007.
3. The date the application was
approved: March 30, 2009. FDA has
verified the applicant’s claim that BLA
B125280/0 was approved on March 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 1,588 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 November 8,
2010. 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 March 8, 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\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 75, Number 174 (Thursday, September 9, 2010)]
[Notices]
[Pages 54887-54888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22496]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0414]
Determination of Regulatory Review Period for Purposes of Patent
Extension; REPEL-CV
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for REPEL-CV 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 medical device.
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 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. 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 (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 medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA recently approved for marketing the medical device, REPEL-CV.
REPEL-CV, a bioresorbable adhesion barrier, is indicated for reducing
the severity of post-operative cardiac adhesions in pediatric patients
who are likely to require reoperation via sternotomy. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for REPEL-CV (U.S. Patent No. 5,711,958) from
SyntheMed, 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 medical device had undergone a
regulatory review period and that the approval of REPEL-CV represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that the FDA
determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
REPEL-CV is 4,023 days. Of this time, 3,256 days occurred during the
testing phase of the regulatory review period, while 767 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this
device became effective: March 3, 1998. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the act for human tests to begin
became effective March 3, 1998.
2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): January 30, 2007. FDA has verified the
applicant's claim that the premarket approval application (PMA) for
REPEL-CV (PMA P070005) was initially submitted January 30, 2007.
3. The date the application was approved: March 6, 2009. FDA has
verified the applicant's claim that PMA P070005 was approved on March
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 1,742 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 November 8, 2010. 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 March 8, 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
[[Page 54888]]
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 regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-22496 Filed 9-8-10; 8:45 am]
BILLING CODE 4160-01-S
