Determination of Regulatory Review Period for Purposes of Patent Extension; BENLYSTA, 27878-27879 [2014-11176]
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27878
Federal Register / Vol. 79, No. 94 / Thursday, May 15, 2014 / Notices
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by July 14, 2014.
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 12, 2014. 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11175 Filed 5–14–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–E–0711; FDA–
2011–E–0712; FDA–2011–E–0715]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BENLYSTA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BENLYSTA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of Patents and Trademarks,
Department of Commerce, for the
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:18 May 14, 2014
Jkt 232001
extension of a patent which claims that
human biological product.
ADDRESSES: Submit written petitions
(two copies are required) and written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Submit
petitions electronically to https://
www.regulations.gov at Docket No.
FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
Silver Spring, MD 20993–0002, 301–
796–7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 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 has approved for marketing the
human biologic product, BENLYSTA
(belimumab). BENLYSTA is indicated
for treatment of adult patients with
active, autoantibody-positive, systemic
lupus erythematosus who are receiving
standard therapy. Subsequent to this
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
approval, the Patent and Trademark
Office received patent term restoration
applications for BENLYSTA (U.S. Patent
Nos. 6,403,770; 7,138,501; and
7,879,328) from Human Genome
Sciences Inc., and the Patent and
Trademark Office requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated July 2, 2012, FDA advised
the Patent and Trademark Office that
this human biological product had
undergone a regulatory review period
and that the approval of BENLYSTA
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
BENLYSTA is 3,426 days. Of this time,
3,152 days occurred during the testing
phase of the regulatory review period,
while 274 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: October 23, 2001. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
October 23, 2001.
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): June 9, 2010. The applicant
claims June 10, 2010, as the date the
biologics license application (BLA) for
BENLYSTA (BLA 125370/0) was
initially submitted. However, FDA
records indicate that BLA 125370/0 was
submitted on June 9, 2010.
3. The date the application was
approved: March 9, 2011. FDA has
verified the applicant’s claim that BLA
125370/0 was approved on March 9,
2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the Patent and Trademark
Office applies several statutory
limitations in its calculations of the
actual period for patent extension. In its
applications for patent extension, this
applicant seeks 1,733 days or 610 days
or 37 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) either
electronic or written comments and ask
for a redetermination by July 14, 2014.
Furthermore, any interested person may
E:\FR\FM\15MYN1.SGM
15MYN1
Federal Register / Vol. 79, No. 94 / Thursday, May 15, 2014 / Notices
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 12, 2014. 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Comments and petitions that have not
been made publicly available on
https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11176 Filed 5–14–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0132]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PALLADIA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
PALLADIA 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 electronic
comments to https://
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:18 May 14, 2014
Jkt 232001
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to https://
www.regulations.gov at Docket No.
FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
Silver Spring, MD 20993–0002, 301–
796–7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 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 (the FD&C 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
an 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 has approved for marketing the
animal drug product PALLADIA
(toceranib phosphate). PALLADIA is
indicated for the treatment of Patnaik
grade II or III, recurrent, cutaneous mast
cell tumors with or without regional
lymph node involvement in dogs.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
27879
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
PALLADIA (U.S. Patent No. 6,573,293)
from Sugen, Inc., and Pharmacia &
Upjohn Company LLC, 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 3, 2011, FDA advised
the Patent and Trademark Office that
this animal drug product had undergone
a regulatory review period and that the
approval of PALLADIA represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that the FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
PALLADIA is 2,711 days. Of this time,
2,681 days occurred during the testing
phase of the regulatory review period,
while 30 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 FD&C Act) (21
U.S.C. 355(i)) became effective:
December 21, 2001. The applicant
claims November 23, 2001, as the date
the investigational new animal drug
application (INAD) became effective.
However, Food and Drug
Administration (FDA) records indicate
that the INAD effective date was
December 21, 2001, which was the
received date of the first submission that
includes a study with substantial data
(submission of a major health test) or
the first submission containing a Notice
of Claimed Investigational Exemption.
2. The date the application was
initially submitted with respect to the
animal drug product under section 512
of the FD&C Act (21 U.S.C. 360b): April
23, 2009. The applicant claims April 22,
2009, as the date the new animal drug
application (NADA) for Palladia (NADA
141–295) was initially submitted.
However, FDA records indicate that
NADA 141–295 was submitted on April
23, 2009.
3. The date the application was
approved: May 22, 2009. FDA has
verified the applicant’s claim that
NADA 141–295 was approved on May
22, 2009.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the 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
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27878-27879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11176]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-E-0711; FDA-2011-E-0712; FDA-2011-E-0715]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BENLYSTA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BENLYSTA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications 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 petitions (two copies are required) and
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002, 301-796-7900.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 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 has approved for marketing the human biologic product, BENLYSTA
(belimumab). BENLYSTA is indicated for treatment of adult patients with
active, autoantibody-positive, systemic lupus erythematosus who are
receiving standard therapy. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
BENLYSTA (U.S. Patent Nos. 6,403,770; 7,138,501; and 7,879,328) from
Human Genome Sciences Inc., and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated July 2, 2012, FDA advised
the Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of BENLYSTA
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
BENLYSTA is 3,426 days. Of this time, 3,152 days occurred during the
testing phase of the regulatory review period, while 274 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: October 23,
2001. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on October
23, 2001.
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): June 9, 2010. The applicant claims June
10, 2010, as the date the biologics license application (BLA) for
BENLYSTA (BLA 125370/0) was initially submitted. However, FDA records
indicate that BLA 125370/0 was submitted on June 9, 2010.
3. The date the application was approved: March 9, 2011. FDA has
verified the applicant's claim that BLA 125370/0 was approved on March
9, 2011.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,733 days or
610 days or 37 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) either electronic or written comments and ask for a
redetermination by July 14, 2014. Furthermore, any interested person
may
[[Page 27879]]
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by November 12, 2014. 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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
https://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Comments and petitions that have not been made publicly available
on https://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11176 Filed 5-14-14; 8:45 am]
BILLING CODE 4160-01-P
