Determination of Regulatory Review Period for Purposes of Patent Extension; BONIVA, 35918-35919 [E6-9817]
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Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices
Sponsors must provide specific data
and information in a TEA to
demonstrate that the condition has been
marketed for a material time and to a
material extent to become eligible for
consideration in the OTC drug
monograph system. When the condition
is found eligible, FDA publishes a
notice of eligibility and request for
safety and effectiveness data for the
proposed OTC use. The TEA that FDA
reviewed (Ref. 1) and FDA’s evaluation
of the TEA (Ref. 2) have been placed on
public display in the Division of
Dockets Management (see ADDRESSES)
under the docket number found in
brackets in the heading of this
document. Information deemed
confidential under 18 U.S.C. 1905, 5
U.S.C. 552(b), or 21 U.S.C. 331(j) was
deleted from the TEA before it was
placed on public display.
wwhite on PROD1PC61 with NOTICES
II. Request for Data and Information
FDA determined that the information
submitted in this TEA satisfies the
criteria of § 330.14. FDA will evaluate
sodium picosulfate, up to 10 mg, as a
laxative single active ingredient for
inclusion in the monograph for OTC
laxative drug products (21 CFR part
334). Accordingly, FDA invites all
interested persons to submit data and
information, as described in § 330.14(f),
on the safety and effectiveness of this
active ingredient for this use so that
FDA can determine whether it can be
GRAS/E and not misbranded under
recommended conditions of OTC use.
The TEA does not include an official
or proposed United States
Pharmacopeia-National Formulary
(USP–NF) drug monograph. According
to § 330.14(i) sponsors must include, an
official or proposed USP–NF
monograph for this ingredient as part of
the safety and effectiveness data for this
ingredient.
III. Comments
Interested persons should submit
comments, data, and information to the
Division of Dockets Management (see
ADDRESSES). Submit three copies of all
comments, data, and information.
Individuals submitting written
information or anyone submitting
electronic comments may submit one
copy. Submissions are to be identified
with the docket number found in
brackets in the heading of this
document and may be accompanied by
supporting information. Received
submissions may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Information submitted after the closing
date will not be considered except by
petition under (21 CFR 10.30).
VerDate Aug<31>2005
19:08 Jun 21, 2006
Jkt 208001
IV. Marketing Policy
Under § 330.14(h), any product
containing the condition for which data
and information are requested may not
be marketed as an OTC drug in the
United States at this time unless it is the
subject of an approved new drug
application or abbreviated new drug
application.
V. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and may
be seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday.
1. TEA for sodium picosulfate submitted
by Ropes and Gray LLP on behalf of
Boehringer Ingelheim on June 24, 2005.
2. FDA’s evaluation and comments on the
TEA for sodium picosulfate.
Dated: June 16, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–9896 Filed 6–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0444]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BONIVA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BONIVA 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
that claims 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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 human drug
application 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 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 BONIVA
(ibandronate sodium). BONIVA is
indicated for treatment and prevention
of osteoporosis in postmenopausal
women. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for BONIVA (U.S. Patent
No. 4,927,814) from Hoffmann-La Roche
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
October 19, 2004, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of BONIVA 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
BONIVA is 2,559 days. Of this time,
2,254 days occurred during the testing
phase of the regulatory review period,
E:\FR\FM\22JNN1.SGM
22JNN1
wwhite on PROD1PC61 with NOTICES
Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices
while 305 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) became effective: May 15, 1996.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on May 15, 1996.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: July 16, 2002. The
applicant claims July 15, 2002, as the
date the new drug application (NDA) for
BONIVA (NDA 21–455) was initially
submitted. However, FDA records
indicate that NDA 21–455 was initially
submitted on July 16, 2002.
3. The date the application was
approved: May 16, 2003. FDA has
verified the applicant’s claim that NDA
21–455 was approved on May 16, 2003.
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 337 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 August 21, 2006.
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 19, 2006. 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.
VerDate Aug<31>2005
19:08 Jun 21, 2006
Jkt 208001
Dated: May 17, 2006.
Jane Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–9817 Filed 6–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0413]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CIALIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for CIALIS
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 that claims 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
35919
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 CIALIS
(tadalafil). CIALIS is indicated for
treatment of erectile dysfunction.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for CIALIS
(U.S. Patent No. 5,859,006) from ICOS
Corporation, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated October 19, 2004, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of CIALIS
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
CIALIS is 1,943 days. Of this time, 1,067
days occurred during the testing phase
of the regulatory review period, while
876 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) became effective: July 29, 1998.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 29, 1998.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: June 29, 2001. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
CIALIS (NDA 21–368) was initially
submitted on June 29, 2001.
3. The date the application was
approved: November 21, 2003. FDA has
verified the applicant’s claim that NDA
E:\FR\FM\22JNN1.SGM
22JNN1
]]>Agencies
[Federal Register Volume 71, Number 120 (Thursday, June 22, 2006)]
[Notices]
[Pages 35918-35919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9817]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E-0444]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BONIVA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BONIVA 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
that claims 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
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 human drug application 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 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 BONIVA
(ibandronate sodium). BONIVA is indicated for treatment and prevention
of osteoporosis in postmenopausal women. Subsequent to this approval,
the Patent and Trademark Office received a patent term restoration
application for BONIVA (U.S. Patent No. 4,927,814) from Hoffmann-La
Roche 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 October 19, 2004, FDA advised the Patent
and Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of BONIVA 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
BONIVA is 2,559 days. Of this time, 2,254 days occurred during the
testing phase of the regulatory review period,
[[Page 35919]]
while 305 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) became effective: May
15, 1996. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 15,
1996.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: July 16, 2002.
The applicant claims July 15, 2002, as the date the new drug
application (NDA) for BONIVA (NDA 21-455) was initially submitted.
However, FDA records indicate that NDA 21-455 was initially submitted
on July 16, 2002.
3. The date the application was approved: May 16, 2003. FDA has
verified the applicant's claim that NDA 21-455 was approved on May 16,
2003.
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 337 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 August 21, 2006. 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 19,
2006. 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: May 17, 2006.
Jane Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-9817 Filed 6-21-06; 8:45 am]
BILLING CODE 4160-01-S
