Prospective Grant of Evaluation Option Exclusive License: Development of Granulysin Immunotherapy, 40118-40119 [2014-16267]
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tkelley on DSK3SPTVN1PROD with NOTICES
40118
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
Arrangements in lieu of other,
potentially clinically superior,
laboratories. OIG recognizes that
whether any particular Registry
Arrangement violates the anti-kickback
statute depends on the intent of the
parties to the arrangement. Payments
from a laboratory to a physician to
compensate the physician for services
related to data collection and reporting
may be reasonable in certain limited
circumstances. However, the antikickback statute prohibits the knowing
and willful payment of such
compensation if even one purpose of the
payments is to induce or reward
referrals of Federal health care program
business.
Characteristics of a Registry
Arrangement that may be evidence of
such unlawful purpose include, but are
not limited to, the following:
• The laboratory requires,
encourages, or recommends that
physicians who enter into Registry
Arrangements perform the tests with a
stated frequency (e.g., four times per
year) to be eligible to receive, or to not
receive a reduction in, compensation.
• The laboratory collects comparative
data for the Registry from, and bills for,
multiple tests that may be duplicative
(e.g., two or more tests performed using
different methodologies that are
intended to provide the same clinical
information) or that otherwise are not
reasonable and necessary.
• Compensation paid to physicians
pursuant to Registry Arrangements is on
a per-patient or other basis that takes
into account the value or volume of
referrals.
• Compensation paid to physicians
pursuant to Registry Arrangements is
not fair market value for the physicians’
efforts in collecting and reporting
patient data.
• Compensation paid to physicians
pursuant to Registry Arrangements is
not supported by documentation,
submitted by the physicians in a timely
manner, memorializing the physicians’
efforts.
• The laboratory offers Registry
Arrangements only for tests (or disease
states associated with tests) for which it
has obtained patents or that it
exclusively performs.
• When a test is performed by
multiple laboratories, the laboratory
collects data only from the tests it
performs.
• The tests associated with the
Registry Arrangement are presented on
the offering laboratory’s requisition in a
manner that makes it more difficult for
the ordering physician to make an
independent medical necessity decision
with regard to each test for which the
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laboratory will bill (e.g., disease-related
panels).
Other characteristics not listed above
may increase the risk of fraud and abuse
associated with a Registry Arrangement
or provide evidence of unlawful intent.
For example, the risk of fraud and abuse
would be particularly high if a
laboratory were to pay, and collect data
for its Registry from, only a subset of
physicians who were selected on the
basis of their prior or anticipated
referral volume, rather than their
specialty, sub-specialty, or other
relevant attribute.
The anti-kickback statute does not
prohibit laboratories from engaging in,
or paying compensation for, legitimate
research activities. However, claims that
Registries are intended to promote and
support clinical research and treatment
are not sufficient to disprove unlawful
intent. Even legitimate actions taken to
substantiate such claims, including, for
example, retaining an independent
Institutional Review Board to develop
study protocols and participation
guidelines, will not protect a Registry
Arrangement if one purpose of the
arrangement is to induce or reward
referrals. Furthermore, for the reasons
set forth in section II.A above, OIG’s
concerns regarding Registry
Arrangements are not abated when
those arrangements apply only to data
collected from tests performed on nonFederal health care program patients’
specimens.
Finally, because the anti-kickback
statute ascribes criminal liability to
parties on both sides of an
impermissible ‘‘kickback’’ arrangement,
physicians who enter into Registry
Arrangements with laboratories also
may be at risk under the statute.
III. Conclusion
OIG is concerned about the risks that
Specimen Processing Arrangements and
Registry Arrangements pose under the
anti-kickback statute. This Special
Fraud Alert reiterates our longstanding
concerns about payments from
laboratories to physicians in excess of
the fair market value of the physicians’
services and payments that reflect the
volume or value of referrals of Federal
health care program business. Should
interested parties continue to have
questions about the structure of a
particular Specimen Processing
Arrangement or Registry Arrangement,
the OIG Advisory Opinion process
remains available. Information about the
process may be found at: https://
oig.hhs.gov/faqs/advisory-opinionsfaq.asp.
To report suspected fraud involving
Registry Arrangements, Specimen
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Processing Arrangements, or similar
arrangements, contact the OIG Hotline
at https://forms.oig.hhs.gov/
hotlineoperations/or by phone at 1–
800–447–8477 (1–800–HHS–TIPS).
Dated: June 7, 2014.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2014–16219 Filed 7–10–14; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Evaluation Option
Exclusive License: Development of
Granulysin Immunotherapy
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive evaluation option license
to practice the inventions embodied in
U.S. Provisional Patent Application. No.
61/250,601, filed October 12, 2009, HHS
Ref. No.: E–158–2009/0–US–01, Titled:
‘‘Granulysin Immunotherapy’’;
International Application No. PCT/
US2010/052036, filed October 8, 2010,
HHS Ref. No.: E–158–2009/0–PCT–02,
Titled: ‘‘Granulysin Immunotherapy’’;
U.S. Patent Application No. 13/501,726,
filed April 12, 2012, HHS Ref. No.: E–
158–2009/0–US–06, Titled: ‘‘Granulysin
Immunotherapy’’, and foreign
equivalents thereof to Orpheden
Therapeutics, Inc. (‘‘Orpheden’’), a
Delaware corporation doing business
principally in the state of Illinois. The
patent rights in these inventions have
been assigned to the United States of
America.
The prospective exclusive evaluation
option license territory may be
worldwide and the field of use may be
limited to the development of 15kD
granulysin as set forth in the Licensed
Patent Rights for the treatment of human
cancers.
Upon the expiration or termination of
the exclusive evaluation option license,
Orpheden will have the exclusive right
to execute an exclusive
commercialization license which will
supersede and replace the exclusive
evaluation option license with no
greater field of use and territory than
granted in the exclusive evaluation
option license.
SUMMARY:
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Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
28, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 451–
7337; Facsimile: (301) 402–0220; Email:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
Granulysin is a cytolytic and
proinflammatory molecule expressed by
activated human cytotoxic T
lymphocytes (CTLs) and natural killer
(NK) cells when they are attached to
disease cells including infection, cancer,
transplantation, autoimmunity, skin and
reproductive maladies. Granulysin is
made in a 15-kDa form that is cleaved
into a 9-kDa form at both the amino and
the carboxy termini. Granulysin is
broadly cytolytic against tumors and
microbes. It has been implicated in
many of diseases and studies suggest
that granulysin may be a useful
therapeutic directly contributing to
immunity against foreign molecules for
a wide variety of diseases.
This technology describes the use of
15 kD granulysin for enhancing immune
responses.
Investigators at the NIH have
discovered that 15 kD granulysin
activates monocytes and induces them
to differentiate into mature dendritic
cells and activates allospecific T cells.
The proof of this principle was
demonstrated by mice expressing
granulysin in vivo showing markedly
improved anti-tumor responses, with
increased numbers of activated
dendritic cells and cytokine-producing
T cells. Furthermore, current data
suggest that dendritic cells matured
with 15 kD granulysin are superior to
the well-established GM–CSF induction.
There appears to be a significant market
opportunity for use of the 15 kD
granulysin for the ex vivo dendritic cell
maturation and adoptive
immunotherapy.
The prospective exclusive evaluation
option license, and a subsequent
exclusive commercialization license,
may be granted unless the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
tkelley on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
20:23 Jul 10, 2014
Jkt 232001
CFR part 404 within fifteen (15) days
from the date of this published notice.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
evaluation option license. Comments
and objections submitted to this notice
will not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: July 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–16267 Filed 7–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Evaluation Option
Exclusive License: Development of a
Diagnostic and Prognostic for Breast
and Prostate Cancer Using Spatial
Genome Organization
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive evaluation option license
to practice the inventions embodied in
U.S. Provisional Application 61/094,318
filed September 4, 2008 entitled
‘‘Method for detection of cancer based
on spatial genome organization’’ (HHS
Ref No. E–283–2008/0–US–01);
International Application PCT/US2009/
055857 filed September 3, 2009 entitled
‘‘Method for detection of cancer based
on spatial genome organization’’ (HHS
Ref No. E–283–2008/0–PCT–02); U.S.
Patent Application 13/062,247 filed
March 4, 2011 entitled ‘‘Method for
detection of cancer based on spatial
genome organization’’ (HHS Ref No. E–
283–2008/0–US–0; and foreign
equivalents thereof to Radial Genomics,
Ltd. (‘‘RG’’), a company located in
Cambridge, U.K. The patent rights in
these inventions have been assigned to
the United States of America.
The prospective exclusive evaluation
option license territory may be
worldwide and the field of use may be
limited to the use of the Licensed Patent
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
40119
Rights for the diagnosis, prognosis, and
prediction of cancer.
Upon the expiration or termination of
the exclusive evaluation option license,
RG will have the exclusive right to
execute an exclusive commercialization
license which will supersede and
replace the exclusive evaluation option
license with no greater field of use and
territory than granted in the exclusive
evaluation option license.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
28, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 451–
7337; Facsimile: (301) 402–0220; Email:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
successful treatment of cancer is
correlated with the early detection of
the cancerous cells. Conventional
cancer diagnosis is largely based on
qualitative morphological criteria, but
more accurate quantitative tests could
greatly increase early detection of
malignant cells. It has been observed
that the spatial arrangement of DNA in
the nucleus is altered in cancer cells in
comparison to normal cells. Therefore,
it is possible to distinguish malignant
cells by mapping the position of labeled
marker genes in the nucleus. This NIH
invention provides methods of detecting
abnormal cells in a sample using the
spatial position of one or more genes
within the nucleus of a cell, as well as
a kit for detecting abnormal cells using
such methods. It also provides methods
of identifying gene markers for
abnormal cells using the spatial position
of one or more genes within the nucleus
of a cell. Therefore, this invention could
be used as a very effective cancer
diagnostic from tumor biopsies after
non-invasive techniques such as a
mammogram or PSA assay have
suggested cancer.
The primary product arising from this
technology would be a diagnostic for
cancer using tumor biopsies after noninvasive techniques such as a
mammogram or PSA assay have
suggested the presence of cancer. This
novel in vitro diagnostic test for cancer
has use in oncology laboratories of
hospitals and commercial clinical
laboratories. It has several advantages
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40118-40119]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16267]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Evaluation Option Exclusive License:
Development of Granulysin Immunotherapy
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
404, that the National Institutes of Health, Department of Health and
Human Services, is contemplating the grant of an exclusive evaluation
option license to practice the inventions embodied in U.S. Provisional
Patent Application. No. 61/250,601, filed October 12, 2009, HHS Ref.
No.: E-158-2009/0-US-01, Titled: ``Granulysin Immunotherapy'';
International Application No. PCT/US2010/052036, filed October 8, 2010,
HHS Ref. No.: E-158-2009/0-PCT-02, Titled: ``Granulysin
Immunotherapy''; U.S. Patent Application No. 13/501,726, filed April
12, 2012, HHS Ref. No.: E-158-2009/0-US-06, Titled: ``Granulysin
Immunotherapy'', and foreign equivalents thereof to Orpheden
Therapeutics, Inc. (``Orpheden''), a Delaware corporation doing
business principally in the state of Illinois. The patent rights in
these inventions have been assigned to the United States of America.
The prospective exclusive evaluation option license territory may
be worldwide and the field of use may be limited to the development of
15kD granulysin as set forth in the Licensed Patent Rights for the
treatment of human cancers.
Upon the expiration or termination of the exclusive evaluation
option license, Orpheden will have the exclusive right to execute an
exclusive commercialization license which will supersede and replace
the exclusive evaluation option license with no greater field of use
and territory than granted in the exclusive evaluation option license.
[[Page 40119]]
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before July
28, 2014 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Whitney A. Hastings, Ph.D., Licensing
and Patenting Manager, Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301) 402-0220;
Email: hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: Granulysin is a cytolytic and
proinflammatory molecule expressed by activated human cytotoxic T
lymphocytes (CTLs) and natural killer (NK) cells when they are attached
to disease cells including infection, cancer, transplantation,
autoimmunity, skin and reproductive maladies. Granulysin is made in a
15-kDa form that is cleaved into a 9-kDa form at both the amino and the
carboxy termini. Granulysin is broadly cytolytic against tumors and
microbes. It has been implicated in many of diseases and studies
suggest that granulysin may be a useful therapeutic directly
contributing to immunity against foreign molecules for a wide variety
of diseases.
This technology describes the use of 15 kD granulysin for enhancing
immune responses.
Investigators at the NIH have discovered that 15 kD granulysin
activates monocytes and induces them to differentiate into mature
dendritic cells and activates allospecific T cells.
The proof of this principle was demonstrated by mice expressing
granulysin in vivo showing markedly improved anti-tumor responses, with
increased numbers of activated dendritic cells and cytokine-producing T
cells. Furthermore, current data suggest that dendritic cells matured
with 15 kD granulysin are superior to the well-established GM-CSF
induction. There appears to be a significant market opportunity for use
of the 15 kD granulysin for the ex vivo dendritic cell maturation and
adoptive immunotherapy.
The prospective exclusive evaluation option license, and a
subsequent exclusive commercialization license, may be granted unless
the NIH receives written evidence and argument that establishes that
the grant of the license would not be consistent with the requirements
of 35 U.S.C. 209 and 37 CFR part 404 within fifteen (15) days from the
date of this published notice.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive evaluation option license. Comments and
objections submitted to this notice will not be made available for
public inspection and, to the extent permitted by law, will not be
released under the Freedom of Information Act, 5 U.S.C. 552.
Dated: July 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16267 Filed 7-10-14; 8:45 am]
BILLING CODE 4140-01-P
