Determination of Regulatory Review Period for Purposes of Patent Extension; VECTIBIX, 27000-27001 [E8-10512]
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Federal Register / Vol. 73, No. 92 / Monday, May 12, 2008 / Notices
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 July 11, 2008.
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
November 10, 2008. 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–10466 Filed 5–9–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–E–0047] (formerly
Docket No. 2007E–0139)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VECTIBIX
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
VECTIBIX 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
VerDate Aug<31>2005
17:54 May 09, 2008
Jkt 214001
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human biological
product.
ADDRESSES: Submit written or electronic
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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological 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 biologic product VECTIBIX
(panitumumab). VECTIBIX is indicated
for the treatment of EGFR-expressing,
metastatic colorectal carcinoma with
disease progression on or following
fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
regimens. Subsequent to this approval,
the Patent and
Trademark Office received a patent
term restoration application for
VECTIBIX (U.S. Patent No. 6,235,883)
from Amgen Fremont 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 May 16,
2007, FDA advised the Patent and
Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of VECTIBIX 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
VECTIBIX is 2,662 days. Of this time,
2,479 days occurred during the testing
phase of the regulatory review period,
while 183 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: June 16, 1999. The
applicant claims June 19, 1999, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 16, 1999,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): March 29, 2006. The
applicant claims December 15, 2005, as
the date the original biologics license
application (BLA) for VECTIBIX (BLA
125147/0) was initially submitted.
However, FDA records indicate that
BLA 125147/0 was submitted in several
modules under the continuous
marketing application pilot program. It
is FDA’s position that the approval
phase begins when the marketing
application is complete for review. The
final module of the BLA making it
complete for review was submitted on
March 29, 2006.
3. The date the application was
approved: September 27, 2006. FDA has
verified the applicant’s claim that BLA
125147/0 was approved on September
27, 2006.
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
E:\FR\FM\12MYN1.SGM
12MYN1
Federal Register / Vol. 73, No. 92 / Monday, May 12, 2008 / Notices
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,122 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 July 11, 2008.
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
November 10, 2008. 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.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–10512 Filed 5–9–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0281]
Pilot Program to Evaluate Proposed
Name Submissions; Concept Paper;
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
rwilkins on PROD1PC63 with NOTICES
ACTION:
SUMMARY: The Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER) of the Food and Drug
Administration (FDA) are announcing a
public technical meeting in preparation
VerDate Aug<31>2005
17:54 May 09, 2008
Jkt 214001
for a pilot program to enable
pharmaceutical firms to evaluate
proposed propriety names and submit
the data generated from those
evaluations to FDA for review. The
purpose of the public technical meeting
is to discuss a concept paper that
describes the logistics of the pilot
program, proposed recommendations
for carrying out a proprietary name
review, and the way FDA intends to
review submissions made under the
pilot program. FDA plans to formally
issue the concept paper by the end of
fiscal year (FY) 2008 and expects to
begin enrollment in the pilot program in
FY 2009.
DATES: The public meeting will be held
on June 5 and 6, 2008, from 8:30 a.m.
to 5 p.m. each day. Register to make a
presentation at the meeting by May 23,
2008. See section III of this document
for information on how to attend or
present at the meeting. Submit any
written or electronic comments
regarding the concept paper and pilot
program by July 7, 2008.
ADDRESSES: The public meeting will be
held at the Crowne Plaza Hotel, 877
Georgia Ave., Silver Spring, MD 20910
(Metro: Silver Spring Station on the Red
Line). Submit written or electronic
requests to make a presentation at the
meeting to Lana Pauls (see FOR FURTHER
INFORMATION CONTACT). A draft concept
paper will be available soon.
Comment Submissions: 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.
FOR FURTHER INFORMATION CONTACT:
Lana Pauls, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6196, Silver Spring,
MD 20993, 301–796–0518, FAX: 301–
847–8753, e-mail:
lana.pauls@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Institute of Medicine (IOM) in its
2006 report ‘‘Preventing Medication
Errors’’ noted that ‘‘[i]n particular, drug
names that look or sound alike increase
the risk of medication errors.’’ FDA also
has determined that many of the
medication errors reported to the agency
result from proprietary names that look
or sound like the names of other
medical products. Reducing the
potential for medication errors due to
proprietary name confusion is part of
FDA’s ongoing medical product risk
management effort. In 2003, FDA held
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
27001
two public meetings that explored many
of the issues involved in proprietary
name review:
• The June 26, 2003, public meeting
on ‘‘Minimizing Medication Errors—
Methods for Evaluating Proprietary
Names for Their Confusion Potential,’’
Docket No. 2002N–0201 (68 FR 32529,
May 30, 2003). Information about the
meeting is available at https://
www.fda.gov/cder/meeting/
drugNaming.htm.
• The December 4, 2003, meeting of
the Drug Safety and Risk Management
Advisory Committee (68 FR 65075,
November 18, 2003). Transcripts,
presentations, and materials from the
meeting are available at https://
www.fda.gov/ohrms/dockets/ac/
cder03.html#DrugSafetyRisk
Management.
FDA reviews proprietary names from
both promotional and safety
perspectives. The promotional review of
proposed names considers whether the
name functions to overstate the efficacy,
minimize the risk, broaden the
indication, make unsubstantiated
superiority claims for the product, or is
overly fanciful. The safety review of a
proposed name is based on the findings
of a Failure Modes and Effects Analysis
of the proprietary name, and is focused
on the avoidance of medical errors. FDA
not only considers the potential for a
name to be spelled similarly and/or
sound similar to a currently marketed
product or one that is in the approval
pipeline, but also considers the
potential for the proposed name to
inadvertently function as a source of
error for reasons other than look and
sound-alike name confusion, for
instance whether the abbreviation for
the drug would be similar to the
abbreviation of another drug product.
Consideration also is given to the
proposed product’s characteristics
including its intended use, dosage form
and strength, and route of
administration, because the product
characteristics provide a context for
communication of the product name
and ultimately determine the use of the
product in the usual clinical practice
setting. In addition, because productname confusion can occur at any point
in the medication use process, FDA
considers the potential for confusion
throughout the process, including
product procurement, prescribing and
ordering, dispensing, administration,
and monitoring the impact of the
medication.
Currently, the data generated to access
this information is internal to FDA.
However, there have been a number of
calls for industry to become involved in
the name testing process including
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 73, Number 92 (Monday, May 12, 2008)]
[Notices]
[Pages 27000-27001]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-E-0047] (formerly Docket No. 2007E-0139)
Determination of Regulatory Review Period for Purposes of Patent
Extension; VECTIBIX
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for VECTIBIX 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 or electronic 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological 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 biologic product
VECTIBIX (panitumumab). VECTIBIX is indicated for the treatment of
EGFR-expressing, metastatic colorectal carcinoma with disease
progression on or following fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy regimens. Subsequent to this
approval, the Patent and
Trademark Office received a patent term restoration application for
VECTIBIX (U.S. Patent No. 6,235,883) from Amgen Fremont 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 May 16, 2007, FDA advised the Patent and Trademark Office that
this human biological product had undergone a regulatory review period
and that the approval of VECTIBIX 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
VECTIBIX is 2,662 days. Of this time, 2,479 days occurred during the
testing phase of the regulatory review period, while 183 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: June 16,
1999. The applicant claims June 19, 1999, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was June 16, 1999,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): March 29, 2006. The applicant claims
December 15, 2005, as the date the original biologics license
application (BLA) for VECTIBIX (BLA 125147/0) was initially submitted.
However, FDA records indicate that BLA 125147/0 was submitted in
several modules under the continuous marketing application pilot
program. It is FDA's position that the approval phase begins when the
marketing application is complete for review. The final module of the
BLA making it complete for review was submitted on March 29, 2006.
3. The date the application was approved: September 27, 2006. FDA
has verified the applicant's claim that BLA 125147/0 was approved on
September 27, 2006.
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
[[Page 27001]]
of the actual period for patent extension. In its application for
patent extension, this applicant seeks 1,122 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 July 11, 2008. 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 November 10,
2008. 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.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-10512 Filed 5-9-08; 8:45 am]
BILLING CODE 4160-01-S
