Notice2025-11858
Request for Comments: Division of Cancer Prevention Intellectual Property Option to Collaborators
Primary source
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Published
June 27, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Cancer Institute, an Institute of the National Institutes of Health, Department of Health and Human Services, Division of Cancer Prevention (DCP) is seeking comments on instituting a standard policy on Intellectual Property (IP) developed by certain funding recipients under NCI DCP funding agreements. This standard policy is entitled "The DIVISION OF CANCER PREVENTION INTELLECTUAL PROPERTY OPTION TO COLLABORATORS (IP Option)." The proposed policy, if finalized, shall apply to entities that conduct DCP-funded clinical studies under funding agreements which involve an NCI collaborator that provides its proprietary agent or technology for the DCP-supported studies where this IP Option is included as a term of applicable existing and future funding agreements.
Full Text
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<title>Federal Register, Volume 90 Issue 122 (Friday, June 27, 2025)</title>
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[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27648-27650]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11858]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Comments: Division of Cancer Prevention Intellectual
Property Option to Collaborators
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Cancer Institute, an Institute of the National
Institutes of Health, Department of Health and Human Services, Division
of Cancer Prevention (DCP) is seeking comments on instituting a
standard policy on Intellectual Property (IP) developed by certain
funding recipients under NCI DCP funding agreements. This standard
policy is entitled ``The DIVISION OF CANCER PREVENTION INTELLECTUAL
PROPERTY OPTION TO COLLABORATORS (IP Option).'' The proposed policy, if
finalized, shall apply to entities that conduct DCP-funded clinical
studies under funding agreements which involve an NCI collaborator that
provides its proprietary agent or technology for the DCP-supported
studies where this IP Option is included as a term of applicable
existing and future funding agreements.
DATES: Only written comments which are received by the National Cancer
Institute's Technology Transfer Center on or before July 28, 2025 will
be considered.
ADDRESSES: NCI welcomes public comment on the full text of the DCP IP
option, as set forth below. Comments should be addressed to: Sidra
Ahsan, Ph.D., Patent Agent, Senior Technology Transfer Manager, NCI
Technology Transfer Center, Telephone: (240) 276-6468; Email:
<a href="/cdn-cgi/l/email-protection#99eaf0fdebf8b7f8f1eaf8f7d9f7f0f1b7fef6ef"><span class="__cf_email__" data-cfemail="92e1fbf6e0f3bcf3fae1f3fcd2fcfbfabcf5fde4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The NCI's DCP is a division of NCI that supports cancer prevention
and early detection research by providing funding and support to
clinical and laboratory researchers, community and multidisciplinary
teams, and collaborative scientific networks. DCP supports clinical
research under funding agreements to funding recipients which conduct
the clinical studies. DCP obtains Agents and Technologies from
pharmaceutical, biotechnology and nutraceutical companies (hereinafter
``Collaborators'') under technology transfer agreements and provides
these Agents or Technologies to funding recipients that conduct the
clinical research. In exchange for providing their proprietary Agents
or Technologies under technology transfer agreements with NCI,
Collaborators will often require that the funding recipients conducting
the clinical research agree to certain conditions regarding the Agents
and Technologies. These conditions include granting options to IP
rights arising from the clinical studies using the Collaborator's Agent
or Technology.
Currently, there is no standard IP option in the DCP funding
agreements that covers the Collaborator's Agent or Technology when used
in the multitude of studies supported by DCP. These research studies
may involve pharmaceutical agents, nutraceuticals, or diagnostic assays
for timely prevention and early detection of cancers, and these
materials are often obtained by NCI from Collaborators. The lack of
clarity regarding IP rights language across the multi-disciplinary
clinical programs of DCP that utilize a Collaborator's Agent or
Technology has
[[Page 27649]]
become an impediment in NCI DCP's ability to obtain Collaborators'
proprietary Agents or Technologies for use in DCP-supported clinical
trials. This has led to uncertainty and delays in initiating important
clinical studies for the prevention and early detection of cancer. It
is imperative for DCP's programs and networks to institute a uniform IP
option that covers the many different types of clinical studies using a
Collaborator's Agent or Technology. The ``Division of Cancer Prevention
Intellectual Property Option to Collaborators'' is intended to cover
the clinical programs and networks of DCP that utilize Collaborator's
Agents or Technologies used in DCP-supported clinical trials and that
are obtained from Collaborators under technology transfer agreements
with DCP. It is also intended to offer appropriate incentives and
assurances for both Collaborators and funding recipients to participate
in DCP-funded clinical studies.
II. Division of Cancer Prevention Intellectual Property Option to
Collaborators
NCI DCP obtains Agents and Technologies from Collaborators under
technology transfer agreements, for use in NCI DCP-funded research
conducted at Institutions, under funding agreements. As part of the
arrangement with Collaborators to use their Agents or Technologies and
to make the collaborative research possible, NCI DCP would agree not to
provide Agents or Technologies to Institutions unless the Institutions
agree to the Division of Cancer Prevention Intellectual Property Option
and Institution Notification described below. This IP Option shall be
included as a term of applicable existing and future funding
agreements.
Definitions:
1. ``Affiliate'' means any corporation or other business entity
controlled by, controlling, or under common control with the
Collaborator. For this purpose, ``control'' means direct or indirect
beneficial ownership of at least fifty percent (50%) of the voting
stock or at least fifty percent (50%) interest in the income of the
corporation or other business entity.
2. ``Agent'' or ``Technology'' is Collaborator's property and
defined in the technology transfer agreement between NCI DCP and
Collaborator.
3. ``Collaborator'' means a biotechnology, pharmaceutical, or
nutraceutical company that provides a proprietary Agent or Technology
for use in the NCI DCP-supported Study.
4. ``Institution'' means an NCI DCP funding recipient that utilizes
a Collaborator's Agent or Technology under the scope of a funding
agreement.
5. ``Invention'' means any invention or discovery which is or may
be patentable or otherwise protectable under Title 35 of the United
States Code, or any novel variety of plant which is or may be
protectable under the Plant Variety Protection Act (7 U.S.C. 2321 et
seq.).
6. ``Study'' means DCP-supported clinical and associated non-
clinical studies conducted by the Institution under the scope of a
funding agreement with NCI DCP.
7. ``Subject Invention'' means an Invention that is conceived or
first actually reduced to practice in the performance of the Study
conducted by the Institution using Collaborator's Agent or Technology.
A. The IP Option described in this Section A applies to Subject
Inventions that claim the use and/or composition of the Collaborator's
Agent or Technology in patent disclosures (``Section A Subject
Inventions''). Collaborator's Agent or Technology will be provided to
the Institution by NCI DCP, as applicable:
Institution agrees to grant to Collaborator(s): (i) a royalty-free,
worldwide, non-exclusive license for commercial purposes with the right
to sublicense to Affiliates or collaborators working on behalf of
Collaborator for Collaborator's development purposes; and (ii) a time-
limited first option to negotiate an exclusive, or co-exclusive, if
applicable, world-wide, royalty-bearing license for commercial
purposes, including the right to grant sublicenses, subject to any
rights of the Government of the United States of America, on terms to
be negotiated in good faith by the Collaborator(s) and Institution. If
Collaborator accepts the royalty-free, worldwide, non-exclusive
commercial license, the Collaborator agrees to pay all out-of-pocket
patent prosecution and maintenance costs which will be pro-rated and
divided equally among all licensees. If Collaborator obtains an
exclusive commercial license, in addition to any other agreed upon
licensing arrangements such as royalties and due diligence
requirements, the Collaborator agrees to pay all out-of-pocket patent
prosecution and maintenance costs. Collaborator will notify
Institution, in writing, if it is interested in obtaining a commercial
license to any Section A Subject Invention within three (3) months of
Collaborator's receipt of a patent application or six (6) months of
receipt of an Invention report notification of such a Section A Subject
Invention; the timing is based on whichever event comes first. In the
event that Collaborator fails to notify Institution, or elects not to
obtain an exclusive license, then Collaborator's option expires with
respect to that Section A Subject Invention, and Institution will be
free to dispose of its interests in accordance with its policies. If
Institution and Collaborator fail to reach agreement within ninety (90)
days, (or such additional period as Collaborator and Institution may
agree) on the terms for an exclusive license for a particular Section A
Subject Invention, then for a period of three (3) months thereafter
Institution agrees not to offer to license the Section A Subject
Invention to any third party on materially better terms than those last
offered to Collaborator without first offering such terms to
Collaborator, in which case Collaborator will have a period of thirty
(30) days in which to accept or reject the offer. If Collaborator
elects to negotiate an exclusive commercial license to a Section A
Subject Invention, then Institution agrees to file and prosecute patent
application(s) diligently and in a timely manner and to give
Collaborator an opportunity to comment on the preparation and filing of
any such patent application(s). Notwithstanding the above, Institution
is under no obligation to file or maintain patent prosecution for any
Section A Subject Invention.
For all Section A Subject Inventions, regardless of Collaborator's
decision to seek a commercial license, Institution agrees to grant
Collaborator a paid-up, nonexclusive, royalty-free, world-wide license
for research purposes only. Institution retains the right to make and
use any Section A Subject Invention for all non-profit research,
including for educational purposes and to permit other educational and
non-profit institutions to do so.
B. The IP Option described in this Section B applies to Subject
Inventions not covered by Section A, but are nevertheless conceived or
first actually reduced to practice by the Institution during the
conduct of the Study. It also applies to Inventions that are conceived
or first actually reduced to practice pursuant to NCI DCP-funded
studies that use non-publicly available clinical data or specimens from
patients treated with Collaborator's Agent or Technology (including
specimens obtained from NCI DCP-funded tissue banks) (``Section B
Subject Inventions''):
Institution agrees to grant to Collaborator a paid-up nonexclusive,
nontransferable, royalty-free, world-wide license to all Section B
Subject Inventions for research purposes only.
[[Page 27650]]
Institution retains the right to make and use any Section B Subject
Invention for all non-profit research, including for educational
purposes and to permit other educational and non-profit institutions to
do so. Notwithstanding the above, Institution is under no obligation to
file or maintain patent prosecution for any Section B Subject
Invention.
Institution Notification
Institution agrees to promptly and confidentially notify NCI DCP
(<a href="/cdn-cgi/l/email-protection#f49a979d909784849d9bc6b499959d98da9a9d9cda939b82"><span class="__cf_email__" data-cfemail="bed0ddd7daddceced7d18cfed3dfd7d290d0d7d690d9d1c8">[email protected]</span></a>) and Collaborator(s) in writing of any
Inventions upon the earlier of: (i) any submission of any Invention
disclosure to Institution of an Invention, or (ii) the filing of any
patent applications on an Invention. Institution agrees to provide a
copy of either the Invention disclosure or the patent application to
the Collaborator and to NCI DCP which will treat it in accordance with
37 CFR part 401. These requirements do not replace any applicable
reporting requirements under the Bayh-Dole Act, 35 U.S.C. 200-212, and
implementing regulations at 37 CFR part 401.
Dated: June 24, 2025.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2025-11858 Filed 6-26-25; 8:45 am]
BILLING CODE 4140-01-P
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