Determination of Regulatory Review Period for Purposes of Patent Extension; CYSVIEW (Previously HEXVIX), 34388-34389 [2012-14003]
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Federal Register / Vol. 77, No. 112 / Monday, June 11, 2012 / Notices
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comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
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The Department specifically requests
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–14059 Filed 6–8–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–E–0133; FDA–
2011–E–0136]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CYSVIEW (Previously
HEXVIX)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
CYSVIEW (previously HEXVIX) 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.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:21 Jun 08, 2012
Jkt 226001
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 the
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 CYSVIEW
(hexaminolevulinate hydrochloride).
CYSVIEW is an optical imaging agent
indicated for use in the cystoscopic
detection of non-muscle invasive
papillary cancer of the bladder among
patients suspected or known to have
lesion(s) on the basis of a prior
cystoscopy. Subsequent to this
approval, the Patent and Trademark
Office received patent term restoration
applications for CYSVIEW (U.S. Patent
ADDRESSES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Nos. 7,247,655 and 7,348,361) from
Photocure ASA, and the Patent and
Trademark Office requested FDA’s
assistance in determining the patents’
eligibilities for patent term restoration.
In a letter dated June 9, 2011, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of CYSVIEW
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
CYSVIEW is 3,103 days. Of this time,
2,770 days occurred during the testing
phase of the regulatory review period,
while 333 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:
November 30, 2001. The applicant
claims October 29, 2001, as the date the
investigational new drug application
(IND) became effective. However, FDA
records indicate that the IND effective
date was November 30, 2001, 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: June 30, 2009.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
CYSVIEW (NDA 22–555) was submitted
on June 30, 2009.
3. The date the application was
approved: May 28, 2010. FDA has
verified the applicant’s claim that NDA
22–555 was approved on May 28, 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 applications for patent extension,
this applicant seeks 686 days or 564
days, respectively, 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 August 10,
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
E:\FR\FM\11JNN1.SGM
11JNN1
Federal Register / Vol. 77, No. 112 / Monday, June 11, 2012 / Notices
period by December 10, 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: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2012–14003 Filed 6–8–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0399]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Progel Pleural Air Leak
Sealant
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for Progel
Pleural Air Leak Sealant 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.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:21 Jun 08, 2012
Jkt 226001
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 (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, Progel Pleural Air
Leak Sealant. Progel Pleural Air Leak
Sealant is indicated for application to
visceral pleura during an open
thoracotomy after standard visceral
pleural closure with, for example,
sutures or staples, of visible air leaks (≥2
mm) incurred during open resection of
lung parenchyma. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for Progel Pleural Air Leak
Sealant (U.S. Patent No. RE38158) from
Neomend, 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 June 8, 2011, FDA advised
the Patent and Trademark Office that
this medical device had undergone a
regulatory review period and that the
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
34389
approval of Progel Pleural Air Leak
Sealant 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
Progel Pleural Air Leak Sealant is 3,854
days. Of this time, 787 days occurred
during the testing phase of the
regulatory review period, while 3067
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 FD&C Act) (21
U.S.C. 360j(g)) involving this device
became effective: June 29, 1999. FDA
has verified the applicant’s claim that
the date the investigational device
exemption (IDE) required under section
520(g) of the FD&C Act for human tests
to begin became effective June 29, 1999.
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): August 23, 2001. FDA has
verified the applicant’s claim that the
premarket approval application (PMA)
for Progel Pleural Air Leak Sealant
(PMA P010047) was initially submitted
August 23, 2001.
3. The date the application was
approved: January 14, 2010. FDA has
verified the applicant’s claim that PMA
P010047 was approved on January 14,
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
electronic or written comments and ask
for a redetermination by August 10,
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 December 10, 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.
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34388-34389]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14003]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-E-0133; FDA-2011-E-0136]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CYSVIEW (Previously HEXVIX)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for CYSVIEW (previously HEXVIX) 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 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 the 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 CYSVIEW
(hexaminolevulinate hydrochloride). CYSVIEW is an optical imaging agent
indicated for use in the cystoscopic detection of non-muscle invasive
papillary cancer of the bladder among patients suspected or known to
have lesion(s) on the basis of a prior cystoscopy. Subsequent to this
approval, the Patent and Trademark Office received patent term
restoration applications for CYSVIEW (U.S. Patent Nos. 7,247,655 and
7,348,361) from Photocure ASA, and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibilities
for patent term restoration. In a letter dated June 9, 2011, FDA
advised the Patent and Trademark Office that this human drug product
had undergone a regulatory review period and that the approval of
CYSVIEW 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
CYSVIEW is 3,103 days. Of this time, 2,770 days occurred during the
testing phase of the regulatory review period, while 333 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: November 30, 2001. The applicant claims October 29, 2001, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was November 30, 2001, 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: June 30,
2009. FDA has verified the applicant's claim that the new drug
application (NDA) for CYSVIEW (NDA 22-555) was submitted on June 30,
2009.
3. The date the application was approved: May 28, 2010. FDA has
verified the applicant's claim that NDA 22-555 was approved on May 28,
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
applications for patent extension, this applicant seeks 686 days or 564
days, respectively, 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 August 10, 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
[[Page 34389]]
period by December 10, 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: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-14003 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P
