Determination of Regulatory Review Period for Purposes of Patent Extension; XOLAIR, 4920-4921 [E6-1078]
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Federal Register / Vol. 71, No. 19 / Monday, January 30, 2006 / Notices
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 ENABLEX
(darifenacin hydrobromide). ENABLEX
is indicated for the treatment of
overactive bladder with symptoms of
urge urinary incontinence, urgency, and
frequency. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for ENABLEX (U.S. Patent
No. 5,096,890) from Novartis
International Phamaceutical Ltd., and
the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
July 8, 2005, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of ENABLEX 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
ENABLEX is 3,824 days. Of this time,
3,073 days occurred during the testing
phase of the regulatory review period,
while 751 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355) became effective: July 6, 1994. The
applicant claims June 13, 1994, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was July 6, 1994,
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
of the act: December 3, 2002. The
applicant claims December 30, 2002, as
the date the new drug application
(NDA) for ENABLEX (NDA 21–513) was
initially submitted. However, FDA
records indicate that NDA 21–513 was
submitted on December 3, 2002.
3. The date the application was
approved: December 22, 2004. FDA has
verified the applicant’s claim that NDA
VerDate Aug<31>2005
14:07 Jan 27, 2006
Jkt 208001
21–513 was approved on December 22,
2004.
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 2,298 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 March 31, 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
July 31, 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: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–1072 Filed 1–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0021]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XOLAIR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
XOLAIR and is publishing this notice of
that determination as required by law.
FDA has made the determination
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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 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:
Claudia V. Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6681.
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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product 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 biological product XOLAIR
(omalizumab). XOLAIR is indicated for
adults and adolescents (12 years of age
and above) with moderate to severe
persistent asthma who have a positive
E:\FR\FM\30JAN1.SGM
30JAN1
cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 71, No. 19 / Monday, January 30, 2006 / Notices
skin test or in vitro reactivity to a
perennial aeroallergen and whose
symptoms are inadequately controlled
by inhaled corticosteroids. Subsequent
to this approval, the Patent and
Trademark Office received a patent term
restoration application for XOLAIR
(U.S. Patent No. 6,267,958) from
Genentech, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated April 8, 2005, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
XOLAIR 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
XOLAIR is 3,440 days. Of this time,
2,329 days occurred during the testing
phase of the regulatory review period,
while 1,111 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: January 20, 1994. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
January 20, 1994.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act:
June 5, 2000. The applicant claims June
2, 2000, as the date the product license
application (BLA) for XOLAIR (BLA
103976/0) was initially submitted.
However, FDA records indicate that
BLA 103976/0 was submitted on June 5,
2000.
3. The date the application was
approved: June 20, 2003. FDA has
verified the applicant’s claim that BLA
103976/0 was approved on June 20,
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 463 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
VerDate Aug<31>2005
14:07 Jan 27, 2006
Jkt 208001
electronic comments and ask for a
redetermination by March 31, 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
July 31, 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: January 6, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–1078 Filed 1–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Anti-Infective Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anti-Infective
Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 6, 2006, from 8:30 a.m.
to 5 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research, Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Cathy A. Groupe,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
4921
1093) Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
GroupeC@cder.fda.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512530. Please call the information
line for up-to-date information on this
meeting.
Agenda: The committee will discuss
new drug application (NDA) 21–572/S–
008, CUBICIN (daptomycin for injection
500 mg/vial), Sponsor Cubist
Pharmaceuticals, for the proposed
indication of the treatment of
Staphylococcus aureus bacteremia,
including those with known or
suspected endocarditis caused by
methicillin-susceptible and methicillinresistant strains.
The background material will become
available no later than the day before
the meeting and will be posted on
FDA’s Web site at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm under
heading ‘‘Anti-Infective Drugs Advisory
Committee (AIDAC).’’ (Click on the year
2006 and scroll down to AIDAC
meetings.)
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by February 27, 2006. Oral
presentations from the public will be
scheduled between 1 p.m. and 2 p.m.
Time allotted for each presentation may
be limited. Those desiring to make
formal oral presentations should notify
the contact person before February 27,
2006, and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants and an indication of the
approximate time requested to make
their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Cathy A.
Groupe at least 7 days in advance of the
meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
E:\FR\FM\30JAN1.SGM
30JAN1
]]>Agencies
[Federal Register Volume 71, Number 19 (Monday, January 30, 2006)]
[Notices]
[Pages 4920-4921]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1078]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E-0021]
Determination of Regulatory Review Period for Purposes of Patent
Extension; XOLAIR
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for XOLAIR 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 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: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6681.
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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product 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 biological product
XOLAIR (omalizumab). XOLAIR is indicated for adults and adolescents (12
years of age and above) with moderate to severe persistent asthma who
have a positive
[[Page 4921]]
skin test or in vitro reactivity to a perennial aeroallergen and whose
symptoms are inadequately controlled by inhaled corticosteroids.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for XOLAIR (U.S. Patent No.
6,267,958) from Genentech, and the Patent and Trademark Office
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated April 8, 2005, FDA advised
the Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of XOLAIR
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
XOLAIR is 3,440 days. Of this time, 2,329 days occurred during the
testing phase of the regulatory review period, while 1,111 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: January 20,
1994. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on January
20, 1994.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act: June 5, 2000. The applicant claims June 2, 2000, as the
date the product license application (BLA) for XOLAIR (BLA 103976/0)
was initially submitted. However, FDA records indicate that BLA 103976/
0 was submitted on June 5, 2000.
3. The date the application was approved: June 20, 2003. FDA has
verified the applicant's claim that BLA 103976/0 was approved on June
20, 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 463 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 March 31, 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 July 31,
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: January 6, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-1078 Filed 1-27-06; 8:45 am]
BILLING CODE 4160-01-S
