Determination of Regulatory Review Period for Purposes of Patent Extension; BYETTA, 57977-57978 [E6-16086]
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Federal Register / Vol. 71, No. 190 / Monday, October 2, 2006 / Notices
IV. Nomination Procedures
All nominations must include a cover
letter, a curriculum vitae or resume (that
includes the nominee’s office address,
telephone number, and e-mail address),
and a list of consumer or communitybased organizations for which the
candidate can demonstrate active
participation. Nominations will specify
the advisory panel(s) or committee(s) for
which the nominee is recommended.
Nominations will include confirmation
that the nominee is aware of the
nomination, is willing to serve as a
member of the advisory committee if
selected, and appears to have no conflict
of interest that would preclude
membership.
Any interested person or organization
may nominate one or more qualified
persons for membership as consumer
representatives on one or more of the
advisory committees/panels. Selfnominations are also accepted. Potential
candidates will be required to provide
detailed information concerning such
matters as financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of a conflict of interest.
The nomination should specify the
committee(s)/panel(s) of interest. The
term of office is up to 4 years,
depending on the appointment date.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: September 25, 2006.
Randall Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–16216 Filed 9–29–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0050]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BYETTA
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC67 with NOTICES1
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BYETTA 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
15:07 Sep 29, 2006
Jkt 211001
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
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 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 BYETTA
(exenatide injection). BYETTA is
indicated as adjunctive therapy to
improve glycemic control in patients
with type 2 diabetes mellitus who are
taking metformin, a sulfonylurea, or a
combination of metformin and a
sulfonylurea but have not achieved
adequate glycemic control. Subsequent
to this approval, the Patent and
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
57977
Trademark Office received a patent term
restoration application for BYETTA
(U.S. Patent No. 5,424,286) from Amylin
Pharmaceuticals, 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 24, 2006, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of BYETTA
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
BYETTA is 2,271 days. Of this time,
1,968 days occurred during the testing
phase of the regulatory review period,
while 303 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: February 10,
1999. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on February 10, 1999.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: June 30, 2004. The
applicant claims June 29, 2004, as the
date the new drug application (NDA) for
BYETTA (NDA 21–773) was initially
submitted. However, FDA records
indicate that NDA 21–773 was
submitted on June 30, 2004.
3. The date the application was
approved: April 28, 2005. FDA has
verified the applicant’s claim that NDA
21–773 was approved on April 28, 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 1,286 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 December 1, 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
E:\FR\FM\02OCN1.SGM
02OCN1
57978
Federal Register / Vol. 71, No. 190 / Monday, October 2, 2006 / Notices
April 2, 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: September 1, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–16086 Filed 9–29–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0008]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; DRAXXIN
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC67 with NOTICES1
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
DRAXXIN 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.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
VerDate Aug<31>2005
15:07 Sep 29, 2006
Jkt 211001
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 (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
a 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 DRAXXIN
(tulathromycin). DRAXXIN is indicated
for control of respiratory disease in
cattle at high risk of developing bovine
respiratory disease (BRD) and for
treatment of BRD associated with
Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni. It is
also indicated for the treatment of swine
respiratory disease associated with
Actinobacillus pleuropneumoniae, P.
multocida, Bordetella bronchiseptica,
and Haemophilus parasuis. Subsequent
to this approval, the Patent and
Trademark Office received a patent term
restoration application for DRAXXIN
(U.S. Patent No. 6,420,536) from Pfizer,
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 24, 2006, FDA advised the
Patent and Trademark Office that this
animal drug product had undergone a
regulatory review period and that the
approval of DRAXXIN represented the
first permitted commercial marketing or
use of the product. Shortly thereafter,
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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
DRAXXIN is 2,451 days. Of this time,
2,414 days occurred during the testing
phase of the regulatory review period,
while 37 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 Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b(j))
became effective: September 9, 1998.
FDA has verified the applicant’s claim
that the date the investigational new
animal drug application (INADA)
became effective was on September 9,
1998.
2. The date the application was
initially submitted with respect to the
animal drug product under section
512(b) of the Federal Food, Drug, and
Cosmetic Act: April 18, 2005. FDA has
verified the applicant’s claim that the
new animal drug application (NADA)
for DRAXXIN (NADA 141–244) was
initially submitted on April 18, 2005.
3. The date the application was
approved: May 24, 2005. FDA has
verified the applicant’s claim that
NADA 141–244 was approved on May
24, 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 360 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 December 1, 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
April 2, 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
E:\FR\FM\02OCN1.SGM
02OCN1
]]>Agencies
[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Notices]
[Pages 57977-57978]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16086]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E-0050]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BYETTA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BYETTA 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 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 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 BYETTA
(exenatide injection). BYETTA is indicated as adjunctive therapy to
improve glycemic control in patients with type 2 diabetes mellitus who
are taking metformin, a sulfonylurea, or a combination of metformin and
a sulfonylurea but have not achieved adequate glycemic control.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for BYETTA (U.S. Patent No.
5,424,286) from Amylin Pharmaceuticals, 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 24, 2006, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of BYETTA 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
BYETTA is 2,271 days. Of this time, 1,968 days occurred during the
testing phase of the regulatory review period, while 303 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:
February 10, 1999. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
February 10, 1999.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: June 30, 2004.
The applicant claims June 29, 2004, as the date the new drug
application (NDA) for BYETTA (NDA 21-773) was initially submitted.
However, FDA records indicate that NDA 21-773 was submitted on June 30,
2004.
3. The date the application was approved: April 28, 2005. FDA has
verified the applicant's claim that NDA 21-773 was approved on April
28, 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 1,286 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 December 1, 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
[[Page 57978]]
April 2, 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: September 1, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-16086 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S
