Determination of Regulatory Review Period for Purposes of Patent Extension; RESTYLANE, 34138-34139 [E6-9213]
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34138
Federal Register / Vol. 71, No. 113 / Tuesday, June 13, 2006 / Notices
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by August 14, 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 11, 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 A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–9201 Filed 6–12–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0308]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RESTYLANE
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
RESTYLANE 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
medical device.
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.
VerDate Aug<31>2005
16:40 Jun 12, 2006
Jkt 208001
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 medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. 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 (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 medical device will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA recently approved for marketing
the medical device RESTYLANE.
RESTYLANE is indicated for mid-todeep dermal implantation for the
correction of moderate to severe facial
wrinkles and folds, such as nasolabial
folds. Subsequent to this approval, the
Patent and Trademark Office received a
patent term restoration application for
RESTYLANE (U.S. Patent No.
5,827,937) from Q-Med AB, 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 medical
device had undergone a regulatory
review period and that the approval of
RESTYLANE represented the first
permitted commercial marketing or use
of the product. Thereafter, the Patent
and Trademark Office requested that
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
RESTYLANE is 1,491 days. Of this time,
949 days occurred during the testing
phase of the regulatory review period,
while 542 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360j(g)) involving this device became
effective: November 14, 1999. The
applicant claims that the investigational
device exemption (IDE) required under
section 520(g) of the act for human tests
to begin became effective on August 4,
2000. However, FDA records indicate
that the IDE was determined
substantially complete for clinical
studies to have begun on November 14,
1999, which represents the IDE effective
date.
2. The date the application was
initially submitted with respect to the
device under section 515 of the act (21
U.S.C. 360e): June 19, 2002. FDA has
verified the applicant’s claim that the
premarket approval application (PMA)
for RESTYLANE (PMA P020023) was
initially submitted June 19, 2002.
3. The date the application was
approved: December 12, 2003. FDA has
verified the applicant’s claim that PMA
P020023 was approved on December 12,
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 879 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 14, 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 11, 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,
E:\FR\FM\13JNN1.SGM
13JNN1
Federal Register / Vol. 71, No. 113 / Tuesday, June 13, 2006 / Notices
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 A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–9213 Filed 6–12–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0043]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TYGACIL
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
TYGACIL 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 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–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
VerDate Aug<31>2005
16:40 Jun 12, 2006
Jkt 208001
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 TYGACIL
(tigecycline). TYGACIL is indicated for
the treatment of infections caused by
susceptible strains of the designated
microorganisms in the conditions listed
in this paragraph for patients 18 years
of age and older: (1) Complicated skin
and skin structure infections caused by
Escherichia coli (E. coli), Enterococcus
(Entero.) faecalis (vancomycinsusceptible isolates only),
Staphlococcus (Staph.) aureus
(methicillin-susceptible and -resistant
isolates), Streptococcus (Strept.)
agalactiae, Strept. anginosus group
(includes S. anginosus, S. intermedius,
and S. constellatus), Strept. Pyogenes,
and Bacteroides (B.) fragilis, and (2)
Complicated intra-abdominal infections
caused by Citrobacter freundii,
Enterobacter cloacae, E. coli, Klebsiella
(K.) oxytoca, K. pneumoniae, Entero.
faecalis (vancomycin-suspectible
isolates only), Staph. aureus
(methicillin-susceptible isolates only),
Strept. anginosus group (includes S.
anginosus, S. intermedius, and S.
constellatus), B. fragilis, B.
thetaiotaomicron, B. uniformis, B.
vulgatus, Clostridium perfringens, and
Peptostreptococcus micros. Subsequent
to this approval, the Patent and
Trademark Office received a patent term
restoration application for TYGACIL
(U.S. Patent No. 5,529,990) from Wyeth
Holdings Corp., 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
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
34139
Office that this human drug product had
undergone a regulatory review period
and that the approval of TYGACIL
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
TYGACIL is 2,487 days. Of this time,
2,304 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 (the act) (21 U.S.C.
355(i)) became effective: August 26,
1998. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on August 26, 1998.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 15, 2004.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Tygacil (NDA 21–821) was initially
submitted on December 15, 2004.
3. The date the application was
approved: June 15, 2005. FDA has
verified the applicant’s claim that NDA
21–821 was approved on June 15, 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 1,335 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 14, 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 11, 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
E:\FR\FM\13JNN1.SGM
13JNN1
]]>Agencies
[Federal Register Volume 71, Number 113 (Tuesday, June 13, 2006)]
[Notices]
[Pages 34138-34139]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9213]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E-0308]
Determination of Regulatory Review Period for Purposes of Patent
Extension; RESTYLANE
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for RESTYLANE 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 medical device.
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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. 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 (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 medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA recently approved for marketing the medical device RESTYLANE.
RESTYLANE is indicated for mid-to-deep dermal implantation for the
correction of moderate to severe facial wrinkles and folds, such as
nasolabial folds. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for RESTYLANE
(U.S. Patent No. 5,827,937) from Q-Med AB, 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 medical
device had undergone a regulatory review period and that the approval
of RESTYLANE 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
RESTYLANE is 1,491 days. Of this time, 949 days occurred during the
testing phase of the regulatory review period, while 542 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this
device became effective: November 14, 1999. The applicant claims that
the investigational device exemption (IDE) required under section
520(g) of the act for human tests to begin became effective on August
4, 2000. However, FDA records indicate that the IDE was determined
substantially complete for clinical studies to have begun on November
14, 1999, which represents the IDE effective date.
2. The date the application was initially submitted with respect to
the device under section 515 of the act (21 U.S.C. 360e): June 19,
2002. FDA has verified the applicant's claim that the premarket
approval application (PMA) for RESTYLANE (PMA P020023) was initially
submitted June 19, 2002.
3. The date the application was approved: December 12, 2003. FDA
has verified the applicant's claim that PMA P020023 was approved on
December 12, 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 879 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 14, 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 11,
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,
[[Page 34139]]
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 A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-9213 Filed 6-12-06; 8:45 am]
BILLING CODE 4160-01-S
