Determination of Regulatory Review Period for Purposes of Patent Extension; NPLATE, 40205-40206 [E9-19233]
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Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
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[FR Doc. E9–19170 Filed 8–10–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0053]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NPLATE
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NPLATE 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 written or electronic
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.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological 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 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 recently approved for marketing
the human biologic product NPLATE
(romiplostim). NPLATE is indicated for
the treatment of thrombocytopenia in
patients with chronic immune
(idiopathic) thrombocytopenic purpura
(ITP) who have had an insufficient
response to corticosteroids,
immunoglobulins, or splenectomy.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
NPLATE (U.S. Patent No. 6,835,809)
from Amgen 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 26, 2009, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
NPLATE 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.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
40205
FDA has determined that the
applicable regulatory review period for
NPLATE is 2,319 days. Of this time,
2,014 days occurred during the testing
phase of the regulatory review period,
while 305 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: April 19, 2002. The
applicant claims April 23, 2002, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was April 19, 2002,
the date of the FDA correspondence
removing the clinical hold on the
application.
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): October 23, 2007. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
NPLATE (BLA 125268/0) was initially
submitted on October 23, 2007.
3. The date the application was
approved: August 22, 2008. FDA has
verified the applicant’s claim that BLA
125268/0 was approved on August 22,
2008.
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 818 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 October 13, 2009.
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
February 8, 2010. 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\11AUN1.SGM
11AUN1
40206
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
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: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–19233 Filed 8–10–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Research
Resources; Notice of Meeting
sroberts on DSKD5P82C1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Research Resources
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Research Resources Council.
Date: September 15, 2009.
Open: 8 a.m. to 12 p.m.
Agenda: Report from the NCRR Director
and other Council business.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6, Bethesda, MD 20892.
Closed: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6, Bethesda, MD 20892.
Contact Person: Louise E. Ramm, PhD,
Deputy Director, National Center for
Research Resources, National Institutes of
Health, Building 31, Room 3B11, Bethesda,
MD 20892. 301–496–6023.
louiser@ncrr.nih.gov.
Any interested person may file written
comments with the committee by forwarding
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.ncrr.nih.gov/newspub/minutes.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure,
93.306, 93.333; 93.702, ARRA Related
Construction Awards, National Institutes of
Health, HHS).
Dated: July 31, 2009.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19215 Filed 8–10–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; P01 and P01
Supplement Reviews.
Date: August 24–25, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Eduardo A. Montalvo,
PhD, Scientific Review Officer, Center for
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5212,
MSC 7852, Bethesda, MD 20892, (301) 435–
1168, montalve@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Radiation Therapeutics and Biology
Study Section.
Date: September 21–22, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Chicago, 151 East
Wacker Drive, Chicago, IL 60601.
Contact Person: Bo Hong, PhD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 6194, MSC 7804, Bethesda, MD
20892, 301–435–5879, hongb@csr.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Developmental Therapeutics Study
Section.
Date: September 24–25, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Alexandria Old Town, 1767
King Street, Alexandria, VA 22314.
Contact Person: Sharon K. Gubanich, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, (301) 435–
1767, gubanics@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; LCMI
Member Conflicts.
Date: September 24–25, 2009.
Time: 9 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Everett E. Sinnett, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2178,
MSC 7818, Bethesda, MD 20892, 301–435–
1016, sinnett@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 5, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19216 Filed 8–10–09; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\11AUN1.SGM
11AUN1
Agencies
[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Pages 40205-40206]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19233]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0053]
Determination of Regulatory Review Period for Purposes of Patent
Extension; NPLATE
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NPLATE 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 written or electronic 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.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.
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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological 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 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 recently approved for marketing the human biologic product
NPLATE (romiplostim). NPLATE is indicated for the treatment of
thrombocytopenia in patients with chronic immune (idiopathic)
thrombocytopenic purpura (ITP) who have had an insufficient response to
corticosteroids, immunoglobulins, or splenectomy. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for NPLATE (U.S. Patent No. 6,835,809) from
Amgen 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 26, 2009, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of NPLATE
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
NPLATE is 2,319 days. Of this time, 2,014 days occurred during the
testing phase of the regulatory review period, while 305 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: April 19,
2002. The applicant claims April 23, 2002, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was April 19, 2002,
the date of the FDA correspondence removing the clinical hold on the
application.
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): October 23, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
NPLATE (BLA 125268/0) was initially submitted on October 23, 2007.
3. The date the application was approved: August 22, 2008. FDA has
verified the applicant's claim that BLA 125268/0 was approved on August
22, 2008.
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 818 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 October 13, 2009. 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
February 8, 2010. 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
[[Page 40206]]
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: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-19233 Filed 8-10-09; 8:45 am]
BILLING CODE 4160-01-S