Determination of Regulatory Review Period for Purposes of Patent Extension; VETMEDIN, 6639-6640 [E9-2684]
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erowe on PROD1PC63 with NOTICES
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
eligibility for patent term restoration. In
a letter dated April 22, 2008, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of SELZENTRY
represented the first permitted
commercial marketing or use of the
product. Shortly 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
SELZENTRY is 1,524 days. Of this time,
1,294 days occurred during the testing
phase of the regulatory review period,
while 230 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: June 6, 2003.
The applicant claims June 10, 2003, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 6, 2003,
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: December 20, 2006.
The applicant claims December 19,
2006, as the date the new drug
application (NDA) for SELZENTRY
(NDA 22–128) was initially submitted.
However, FDA records indicate that
NDA 22–128 was submitted on
December 20, 2006.
3. The date the application was
approved: August 6, 2007. FDA has
verified the applicant’s claim that NDA
22–128 was approved on August 6,
2007.
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 73 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) written or
electronic comments and ask for a
redetermination by April 13, 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
August 10, 2009. To meet its burden, the
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
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: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–2813 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0112]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VETMEDIN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
VETMEDIN 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
animal 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
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
6639
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 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 (the 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 recently approved for marketing
the animal drug product VETMEDIN
(pimobendan). VETMEDIN is indicated
for the management of the signs of mild,
moderate, or severe (modified NYHA
Class II, III, or IV) congestive heart
failure in dogs due to atrioventricular
valvular insufficiency or dilated
cardiomyopathy. VETMEDIN is
indicated for use with concurrent
therapy for congestive heart failure (e.g.,
furosemide, etc.) as appropriate on a
case-by-case basis. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for VETMEDIN (U.S. Patent
No. 5,364,646) from Dr. Karl Thomae
GmbH, 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 6, 2008, FDA advised the Patent
and Trademark Office that this animal
drug product had undergone a
regulatory review period and that the
approval of VETMEDIN represented the
first permitted commercial marketing or
use of the product. Shortly thereafter,
E:\FR\FM\10FEN1.SGM
10FEN1
erowe on PROD1PC63 with NOTICES
6640
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
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
VETMEDIN is 2,751 days. Of this time,
2,715 days occurred during the testing
phase of the regulatory review period,
while 36 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 act (21 U.S.C.
360b(j)) became effective: October 20,
1999. The applicant claims April 8,
1999, as the date the investigational new
animal drug application (INAD) 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 for a
new animal drug, whichever is earlier,
is the effective date for the INAD.
According to FDA records, October 20,
1999, is the effective date for the INAD.
2. The date the application was
initially submitted with respect to the
animal drug product under section 512
of the act: March 26, 2007. FDA has
verified the applicant’s claim that the
new animal drug application (NADA)
for VETMEDIN (NADA 141–273) was
initially submitted on March 26, 2007.
3. The date the application was
approved: April 30, 2007. FDA has
verified the applicant’s claim that
NADA 141–273 was approved on April
30, 2007.
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 1,492 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) written or
electronic comments and ask for a
redetermination by April 13, 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
August 10, 2009. 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
VerDate Nov<24>2008
18:25 Feb 09, 2009
Jkt 217001
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: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–2684 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0626]
Draft Guidance for Industry on
Bioequivalence Recommendation for
Vancomycin HCl; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; extension of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is extending to
March 19, 2009, the comment period for
the draft guidance for industry entitled
‘‘Bioequivalence Recommendation for
Vancomycin HCl’’ that published in the
Federal Register of December 16, 2008
(73 FR 76362). The draft guidance
provides specific guidance on the
design of bioequivalence (BE) studies to
support abbreviated new drug
applications (ANDAs) for vancomycin
HCl capsules. FDA is taking this action
in response to requests for an extension
of the comment period to allow
interested persons additional time to
submit comments.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by March 19, 2009.
ADDRESSES: Submit written comments
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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–9314.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December
16, 2008 (73 FR 76362), FDA published
a notice announcing the availability of
a draft guidance for industry entitled
‘‘Bioequivalence Recommendation for
Vancomycin HCl.’’ As described in the
notice, the draft guidance further
clarifies FDA’s recommendations on the
design of BE studies to support ANDAs
for vancomycin HCl capsules. As also
described in the notice, FDA will
consider comments on the draft
guidance as it finalizes its BE
recommendations and addresses the
complicated issues raised in
ViroPharma Inc.’s (ViroPharma’s)
petitions for stay of action challenging
FDA’s revised BE recommendations
(Docket No. FDA–2006–P–0007).
By letter dated December 19, 2008,
ViroPharma requested that FDA extend
the comment period for the draft
guidance by 60 days. In support of its
request, ViroPharma provided several
reasons that explained why it believes
an extension is appropriate, including
that the issues involved with the draft
guidance are complex and that the
current 60-day comment period for the
notice includes the months of December
and early January when many interested
persons are on holiday vacation. While
ViroPharma acknowledges that the
Federal Register notice announcing the
availability of this draft guidance
indicates that comments to guidance
documents may be submitted at any
time, ViroPharma states that it is
essential that FDA be able to review and
consider comprehensive comments from
all stakeholders before finalizing the
guidance. In addition, by letter dated
January 23, 2009, the Biotechnology
Industry Organization (BIO) requested
that FDA extend the comment period for
the draft guidance to provide interested
persons additional time to submit
comments, and by letter dated February
2, 2009, Akorn Inc. objected to BIO’s
extension request.
FDA has considered ViroPharma’s
and BIO’s requests and Akorn’s
objection. FDA does not believe that a
60-day extension as requested by
ViroPharma is warranted, but in
response to ViroPharma’s and BIO’s
requests, FDA is extending the comment
period for the draft guidance for 30
days, until March 19, 2009. This
extension will provide interested
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6639-6640]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-E-0112]
Determination of Regulatory Review Period for Purposes of Patent
Extension; VETMEDIN
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for VETMEDIN 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 animal 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 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 (the 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 recently approved for marketing the animal drug product
VETMEDIN (pimobendan). VETMEDIN is indicated for the management of the
signs of mild, moderate, or severe (modified NYHA Class II, III, or IV)
congestive heart failure in dogs due to atrioventricular valvular
insufficiency or dilated cardiomyopathy. VETMEDIN is indicated for use
with concurrent therapy for congestive heart failure (e.g., furosemide,
etc.) as appropriate on a case-by-case basis. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for VETMEDIN (U.S. Patent No. 5,364,646) from
Dr. Karl Thomae GmbH, 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 6, 2008, FDA advised the Patent
and Trademark Office that this animal drug product had undergone a
regulatory review period and that the approval of VETMEDIN represented
the first permitted commercial marketing or use of the product. Shortly
thereafter,
[[Page 6640]]
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
VETMEDIN is 2,751 days. Of this time, 2,715 days occurred during the
testing phase of the regulatory review period, while 36 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 act (21 U.S.C.
360b(j)) became effective: October 20, 1999. The applicant claims April
8, 1999, as the date the investigational new animal drug application
(INAD) 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 for a new animal drug, whichever is earlier, is the effective
date for the INAD. According to FDA records, October 20, 1999, is the
effective date for the INAD.
2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the act: March 26, 2007.
FDA has verified the applicant's claim that the new animal drug
application (NADA) for VETMEDIN (NADA 141-273) was initially submitted
on March 26, 2007.
3. The date the application was approved: April 30, 2007. FDA has
verified the applicant's claim that NADA 141-273 was approved on April
30, 2007.
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 1,492 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) written or electronic comments and ask for a redetermination
by April 13, 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 August 10,
2009. 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: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-2684 Filed 2-9-09; 8:45 am]
BILLING CODE 4160-01-S
