Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL, 28979-28980 [E7-9950]
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pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices
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:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), 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
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 ORENCIA
(abatacept). ORENCIA is indicated for
reducing signs and symptoms, inducing
major clinical response, slowing the
progression of structural damage, and
improving physical function in adult
patients with moderately to severely
active rheumatoid arthritis who have
had an inadequate response to one or
VerDate Aug<31>2005
18:32 May 22, 2007
Jkt 211001
more disease modifying anti-rheumatic
drugs, such as methotrexate or TNF
antagonists. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for ORENCIA (U.S. Patent
No. 5,851,795) from Bristol-Myers
Squibb Company, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated September 5, 2006, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
ORENCIA 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
ORENCIA is 3,803 days. Of this time,
3,536 days occurred during the testing
phase of the regulatory review period,
while 267 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: July 28, 1995. FDA has
verified the applicant’s claim that the
date the investigational new drug
application became effective was on
July 28, 1995.
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): April 1, 2005. The
applicant claims March 31, 2005, as the
date the biologics license application
(BLA) for ORENCIA (BLA 125118) was
submitted. However, FDA records
indicate that BLA 125118 was received
on April 1, 2005.
3. The date the application was
approved: December 23, 2005. FDA has
verified the applicant’s claim that BLA
125118 was approved on December 23,
2005.
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 1,414 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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
28979
redetermination by July 23, 2007.
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 19, 2007. 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 2, 2007
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–9945 Filed 5–22–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0501]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; GARDASIL
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
GARDASIL 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
E:\FR\FM\23MYN1.SGM
23MYN1
pwalker on PROD1PC71 with NOTICES
28980
Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices
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
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
GARDASIL (Quadrivalent Human
Papillomavirus Recombinant Vaccine).
GARDASIL is indicated for vaccination
in females 9 to 26 years of age for
prevention of the following diseases
caused by Human Papillomavirus (HPV)
Types 6, 11, 16, and 18: Cervical cancer,
genital warts (condyloma acuminata),
and the following precancerous or
dysplastic lesions: Cervical
adenocarcinoma in situ (AIS); cervical
intraepithelial neoplasia (CIN) grade 1,
grade 2, and grade 3; vulvar
intraepithelial neoplasia (VIN) grade 2
and grade 3; and vaginal intraepithelial
neoplasia (VaIN) grade 2 and grade 3.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
GARDASIL (U.S. Patent No. 5,820,870)
VerDate Aug<31>2005
18:32 May 22, 2007
Jkt 211001
from Merck & Co., 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 February 6, 2007, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
GARDASIL 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
GARDASIL is 2,215 days. Of this time,
2,031 days occurred during the testing
phase of the regulatory review period,
while 184 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: May 17, 2000. The
applicant claims May 14, 2000, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was May 17, 2000,
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): December 7, 2005. FDA has
verified the applicant’s claim that the
product license application (BLA) for
GARDASIL (BLA 125126/0) was
initially submitted on December 7,
2005.
3. The date the application was
approved: June 8, 2006. FDA has
verified the applicant’s claim that BLA
125126/0 was approved on June 8, 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
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,200 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 23, 2007.
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
November 19, 2007. 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 7, 2007.
Jane A. Axelrad
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–9950 Filed 5–22–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007E–0002]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ELAPRASE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ELAPRASE 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), 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
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Notices]
[Pages 28979-28980]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9950]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E-0501]
Determination of Regulatory Review Period for Purposes of Patent
Extension; GARDASIL
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for GARDASIL 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy (HFD-007), Food and Drug
[[Page 28980]]
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 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
GARDASIL (Quadrivalent Human Papillomavirus Recombinant Vaccine).
GARDASIL is indicated for vaccination in females 9 to 26 years of age
for prevention of the following diseases caused by Human Papillomavirus
(HPV) Types 6, 11, 16, and 18: Cervical cancer, genital warts
(condyloma acuminata), and the following precancerous or dysplastic
lesions: Cervical adenocarcinoma in situ (AIS); cervical
intraepithelial neoplasia (CIN) grade 1, grade 2, and grade 3; vulvar
intraepithelial neoplasia (VIN) grade 2 and grade 3; and vaginal
intraepithelial neoplasia (VaIN) grade 2 and grade 3. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for GARDASIL (U.S. Patent No. 5,820,870) from
Merck & Co., 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 February 6, 2007, FDA advised the Patent
and Trademark Office that this human biological product had undergone a
regulatory review period and that the approval of GARDASIL 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
GARDASIL is 2,215 days. Of this time, 2,031 days occurred during the
testing phase of the regulatory review period, while 184 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: May 17,
2000. The applicant claims May 14, 2000, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was May 17, 2000,
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): December 7, 2005. FDA has verified the
applicant's claim that the product license application (BLA) for
GARDASIL (BLA 125126/0) was initially submitted on December 7, 2005.
3. The date the application was approved: June 8, 2006. FDA has
verified the applicant's claim that BLA 125126/0 was approved on June
8, 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 of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,200 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 23, 2007. 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 19,
2007. 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 7, 2007.
Jane A. Axelrad
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-9950 Filed 5-22-07; 8:45 am]
BILLING CODE 4160-01-S
