Determination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR-13, 18035-18036 [2014-07058]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
requested to make their presentation on
or before April 4, 2014. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 7, 2014.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Walter
Ellenberg at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 26, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–07112 Filed 3–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–E–0388]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PREVNAR–13
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
PREVNAR–13 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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:10 Mar 28, 2014
Jkt 232001
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–
796–3602.
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 PREVNAR–13
(Pneumococcal 13-valent conjugate
vaccine (diphtheria CRM–197 protein)).
PREVNAR–13 is indicated for (1) Active
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
18035
immunization for the prevention of
invasive disease caused by
Streptococcus pneumoniae serotypes 1,
3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,
19F, and 23F, in patients aged 6 weeks
through 17 years of age and in adults 50
years of age and older; and (2) active
immunization for the prevention of
otitis media caused by S. pneumoniae
serotypes 4, 6B, 9V, 14, 18C, 19F, and
23F in patients aged 6 weeks through 5
years. Subsequent to this approval, the
Patent and Trademark Office received a
patent term restoration application for
PREVNAR–13 (U.S. Patent No.
5,614,382) 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
July 9, 2012, FDA advised the Patent
and Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of PREVNAR–13 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
PREVNAR–13 is 2,102 days. Of this
time, 1,771 days occurred during the
testing phase of the regulatory review
period, while 331 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 26, 2004. The
applicant claims April 23, 2004, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was May 26, 2004,
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): March 31, 2009. The
applicant claims October 24, 2008, as
the date the biologics license
application (BLA) for PREVNAR–13
(BLA 125324) was initially submitted.
However, FDA records indicate that
BLA 125324 was a rolling submission
and the final module was received by
FDA on March 31, 2009.
3. The date the application was
approved: February 24, 2010. FDA has
verified the applicant’s claim that BLA
125324 was approved on February 24,
2010.
E:\FR\FM\31MRN1.SGM
31MRN1
18036
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
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 1,312 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 May 30, 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
September 29, 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: March 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07058 Filed 3–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
tkelley on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2012–E–0019]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NULOJIX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
SUMMARY:
VerDate Mar<15>2010
18:10 Mar 28, 2014
Jkt 232001
the regulatory review period for
NULOJIX 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 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–
796–3602.
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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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 NULOJIX
(belatacept). NULOJIX is indicated for
prophylaxis of organ rejection in adult
patients receiving a kidney transplant
and is used in combination with
basiliximab induction, mycophenolate
mofetil, and corticosteroids. Subsequent
to this approval, the Patent and
Trademark Office received a patent term
restoration application for NULOJIX
(U.S. Patent No. 7,094,874) from BristolMyers 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 July 10, 2012, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
NULOJIX 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
NULOJIX is 4,479 days. Of this time,
3,764 days occurred during the testing
phase of the regulatory review period,
while 715 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: March 13, 1999. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
March 13, 1999.
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): July 1, 2009. The applicant
claims June 30, 2009, as the date the
biologics license application (BLA) for
NULOJIX (BLA 125288) was initially
submitted. However, FDA records
indicate that BLA 125288 was submitted
on July 1, 2009.
3. The date the application was
approved: June 15, 2011. FDA has
verified the applicant’s claim that BLA
125288 was approved on June 15, 2011.
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,
E:\FR\FM\31MRN1.SGM
31MRN1
]]>Agencies
[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18035-18036]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07058]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-E-0388]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PREVNAR-13
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for PREVNAR-13 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 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, 301-796-3602.
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 PREVNAR-
13 (Pneumococcal 13-valent conjugate vaccine (diphtheria CRM-197
protein)). PREVNAR-13 is indicated for (1) Active immunization for the
prevention of invasive disease caused by Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, in
patients aged 6 weeks through 17 years of age and in adults 50 years of
age and older; and (2) active immunization for the prevention of otitis
media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and
23F in patients aged 6 weeks through 5 years. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for PREVNAR-13 (U.S. Patent No. 5,614,382) 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 July 9, 2012, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of PREVNAR-
13 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
PREVNAR-13 is 2,102 days. Of this time, 1,771 days occurred during the
testing phase of the regulatory review period, while 331 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 26,
2004. The applicant claims April 23, 2004, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was May 26, 2004,
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): March 31, 2009. The applicant claims
October 24, 2008, as the date the biologics license application (BLA)
for PREVNAR-13 (BLA 125324) was initially submitted. However, FDA
records indicate that BLA 125324 was a rolling submission and the final
module was received by FDA on March 31, 2009.
3. The date the application was approved: February 24, 2010. FDA
has verified the applicant's claim that BLA 125324 was approved on
February 24, 2010.
[[Page 18036]]
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 1,312 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 May 30, 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 September 29, 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: March 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07058 Filed 3-28-14; 8:45 am]
BILLING CODE 4160-01-P
