Determination of Regulatory Review Period for Purposes of Patent Extension; PERJETA, 28734-28735 [2014-11515]
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Federal Register / Vol. 79, No. 96 / Monday, May 19, 2014 / Notices
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 has approved for marketing the
human drug product ELELYSO
(taliglucerase alfa). ELELYSO is
indicated for long-term enzyme
replacement therapy for adults with a
confirmed diagnosis of Type 1 Gaucher
disease. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for ELELYSO (U.S. Patent
No. 7,951,557) from Protalix Ltd., 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 19, 2013, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of ELELYSO 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
ELELYSO is 2,483 days. Of this time,
1,746 days occurred during the testing
phase of the regulatory review period,
while 737 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: July 16,
2005. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on July 16, 2005.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: April 26, 2010.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
ELELYSO (NDA 22–458) was submitted
on April 26, 2010.
3. The date the application was
approved: May 1, 2012. FDA has
verified the applicant’s claim that NDA
22–458 was approved on May 1, 2012.
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
applicant seeks 336 days of patent term
extension.
VerDate Mar<15>2010
17:17 May 16, 2014
Jkt 232001
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 18, 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 17, 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 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11516 Filed 5–16–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–E–1235; FDA–
2012–E–1236; FDA–2012–E–1237]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PERJETA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
PERJETA 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
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
which claims that human biological
product.
ADDRESSES: Submit electronic
comments to https://
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 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 PERJETA
(pertuzumab). PERJETA is indicated in
combination with trastuzumab and
docetaxel for treatment of patients with
E:\FR\FM\19MYN1.SGM
19MYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 96 / Monday, May 19, 2014 / Notices
HER2-positive metastatic breast cancer
who have not received prior anti-HER2
therapy or chemotherapy for metastatic
disease. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for PERJETA (U.S. Patent
Nos. 6,949,245; 7,560,111; 7,862,817)
from Genentech, Inc., and the Patent
and Trademark Office requested FDA’s
assistance in determining these patents’
eligibility for patent term restoration. In
a letter dated February 4, 2013, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
PERJETA 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
PERJETA is 3,925 days. Of this time,
3,741 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: September 11, 2001.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on September 11, 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): December 8, 2011. The
applicant claims December 6, 2011, as
the date the biologics license
application (BLA) for PERJETA (BLA
125409) was initially submitted.
However, FDA records indicate that
BLA 125409 was submitted on
December 8, 2011.
3. The date the application was
approved: June 8, 2012. FDA has
verified the applicant’s claim that BLA
125409 was approved on June 8, 2012.
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 1,317 or 624 or 354 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
VerDate Mar<15>2010
17:17 May 16, 2014
Jkt 232001
electronic or written comments and ask
for a redetermination by July 18, 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 17, 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 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11515 Filed 5–16–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–E–0056]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ZIOPTAN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ZIOPTAN 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
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
28735
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
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 human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug 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 has approved for marketing the
human drug product ZIOPTAN
(tafluprost). ZIOPTAN is indicated for
reducing elevated intraocular pressure
in patients with open-angle glaucoma or
ocular hypertension. Subsequent to this
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 79, Number 96 (Monday, May 19, 2014)]
[Notices]
[Pages 28734-28735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11515]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-E-1235; FDA-2012-E-1236; FDA-2012-E-1237]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PERJETA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for PERJETA 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 electronic comments to https://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 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 PERJETA
(pertuzumab). PERJETA is indicated in combination with trastuzumab and
docetaxel for treatment of patients with
[[Page 28735]]
HER2-positive metastatic breast cancer who have not received prior
anti-HER2 therapy or chemotherapy for metastatic disease. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for PERJETA (U.S. Patent Nos. 6,949,245;
7,560,111; 7,862,817) from Genentech, Inc., and the Patent and
Trademark Office requested FDA's assistance in determining these
patents' eligibility for patent term restoration. In a letter dated
February 4, 2013, FDA advised the Patent and Trademark Office that this
human biological product had undergone a regulatory review period and
that the approval of PERJETA 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
PERJETA is 3,925 days. Of this time, 3,741 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: September
11, 2001. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on September
11, 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): December 8, 2011. The applicant claims
December 6, 2011, as the date the biologics license application (BLA)
for PERJETA (BLA 125409) was initially submitted. However, FDA records
indicate that BLA 125409 was submitted on December 8, 2011.
3. The date the application was approved: June 8, 2012. FDA has
verified the applicant's claim that BLA 125409 was approved on June 8,
2012.
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 1,317 or 624 or
354 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 18, 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 17, 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 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11515 Filed 5-16-14; 8:45 am]
BILLING CODE 4160-01-P
