Determination of Regulatory Review Period for Purposes of Patent Extension; LEXISCAN, 42678 [E9-20307]
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42678
Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2009–E–0048 and FDA
2009–E–0047]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LEXISCAN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LEXISCAN 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 patents
which claim that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
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 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.
VerDate Nov<24>2008
15:04 Aug 21, 2009
Jkt 217001
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 LEXISCAN
(regadenoson monohydrate). LEXISCAN
is indicated for radionuclide myocardial
perfusion imaging in patients unable to
undergo adequate exercise stress.
Subsequent to this approval, the Patent
and Trademark Office received patent
term restoration applications for
LEXISCAN (U.S. Patent Nos. 6,403,567
and 6,642,210) from CV Therapeutics,
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining the patents’ eligibilities for
patent term restoration. In a letter dated
February 26, 2009, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of LEXISCAN 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
LEXISCAN is 2,446 days. Of this time,
2,113 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 act) (21 U.S.C.
355(i)) became effective: August 1, 2001.
The applicant claims August 2, 2001, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was August 1, 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 act: May 14, 2007. FDA has
verified the applicant’s claim that the
new drug application (NDA) 22–161
was submitted on May 14, 2007.
3. The date the application was
approved: April 10, 2008. FDA has
verified the applicant’s claim that NDA
22–161 was approved on April 10, 2008.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 1,024 days and 977
days of patent term extension,
respectively.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by October 23, 2009.
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
February 22, 2010. 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.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: July 31, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–20307 Filed 8–21–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 74, Number 162 (Monday, August 24, 2009)]
[Notices]
[Page 42678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20307]
[[Page 42678]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2009-E-0048 and FDA 2009-E-0047]
Determination of Regulatory Review Period for Purposes of Patent
Extension; LEXISCAN
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for LEXISCAN 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 patents
which claim that human drug product.
ADDRESSES: Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov.
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 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 LEXISCAN
(regadenoson monohydrate). LEXISCAN is indicated for radionuclide
myocardial perfusion imaging in patients unable to undergo adequate
exercise stress. Subsequent to this approval, the Patent and Trademark
Office received patent term restoration applications for LEXISCAN (U.S.
Patent Nos. 6,403,567 and 6,642,210) from CV Therapeutics, Inc., and
the Patent and Trademark Office requested FDA's assistance in
determining the patents' eligibilities for patent term restoration. In
a letter dated February 26, 2009, FDA advised the Patent and Trademark
Office that this human drug product had undergone a regulatory review
period and that the approval of LEXISCAN 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
LEXISCAN is 2,446 days. Of this time, 2,113 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 act) (21 U.S.C. 355(i)) became effective:
August 1, 2001. The applicant claims August 2, 2001, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 1, 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 act: May 14, 2007.
FDA has verified the applicant's claim that the new drug application
(NDA) 22-161 was submitted on May 14, 2007.
3. The date the application was approved: April 10, 2008. FDA has
verified the applicant's claim that NDA 22-161 was approved on April
10, 2008.
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 1,024 days and
977 days of patent term extension, respectively.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by October 23, 2009. 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
February 22, 2010. 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.
Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 31, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-20307 Filed 8-21-09; 8:45 am]
BILLING CODE 4160-01-S
