[Federal Register Volume 76, Number 48 (Friday, March 11, 2011)]
[Notices]
[Pages 13404-13410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5609]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Cancer Therapy Evaluation Program Intellectual Property Option to
Collaborator
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Cancer Institute, Division of Cancer Treatment
and Diagnosis, is announcing the final revision of the NCI Cancer
Therapy Evaluation Program's Intellectual Property Option to
Collaborator.
[[Page 13405]]
SUPPLEMENTARY INFORMATION: In the Federal Register of April 6, 2010 (FR
Vol. 65, No. 65), the National Cancer Institute, Division of Cancer
Treatment and Diagnosis (DCT) issued a proposed revision to the Cancer
Therapy Evaluation Program (CTEP)'s Intellectual Property Option to
Collaborator. The proposed revision represents a major effort on the
part of NCI CTEP to address the disposition of intellectual property
(IP) related to data and Agent-treated specimens in studies where CTEP
provides agents, as well as to harmonize the IP terms with standards
currently used by the cancer research community. The background and
description of the rationale can be found in the Background Section of
the proposed revision issued April 6, 2010. The proposal called for
submission of comments by May 6th, 2010. NCI CTEP received numerous
comments in response to the proposed revision, many of which asserted
that the proposed change would not meet its stated goals and requested
NCI CTEP to reevaluate specific aspects of the proposal. CTEP agreed
with some of these comments and has revised selected aspects of the
proposed CTEP Intellectual Property Option to Collaborator to better
reflect our stated goals.
I. Rationale for the Changes to the IP Option
The Cancer Therapy Evaluation Program (CTEP) of the National Cancer
Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD)
obtains proprietary ``Agents'' from biotechnology and pharmaceutical
companies (hereinafter ``Collaborators'') for use in NCI-supported
clinical trials under funding agreements. As part of the arrangement
with these Collaborators to use their proprietary Agents and to make
conducting such clinical research possible, Collaborators will often
require, as a condition of collaboration, that the NCI funded
recipients receiving the Agent (``Institutions'') agree to certain
conditions, including the willingness to provide notice of and grant
options to certain intellectual property rights arising from research
involving the Agent under the scope of an NCI funding agreement. The IP
Option will apply to inventions generated from clinical studies for
which CTEP provided Agent(s) and for inventions generated under any
other NCI CTEP-approved studies that use CTEP- provided Agent(s), non-
publicly released clinical data or Agent(s)-treated specimens from
those clinical studies.
The previous IP option language was silent as to the disposition of
intellectual property developed from data and Agent-treated samples. As
a result, both Collaborators and Institutions claimed an ownership
interest in inventions generated from these data and materials. This
lack of clarity has become a major impediment in NCI CTEP's ability to
obtain proprietary Agents from collaborators for use in NCI CTEP-
sponsored clinical studies. This has resulted in delays and threatens
the continuing ability of CTEP to provide proprietary Agents to NCI-
funded investigators for important clinical studies to advance the
treatment of cancer. The lack of Agents for these clinical studies
jeopardizes NCI CTEP's ability to support these research activities.
The revised CTEP IP Option and Institution Notification is intended to
offer appropriate incentives and assurance for both Collaborators and
Institutions to participate in CTEP-sponsored clinical studies.
II. The Proposed Revision to the CTEP Intellectual Property Option to
the Collaborator
The following is the proposed revision to the CTEP IP Option that
was published in the Federal Register on April 6th:
The Cancer Therapy Evaluation Program (CTEP) of the National Cancer
Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD)
obtains ``Agents'' from biotechnology and pharmaceutical companies
(hereinafter ``Collaborators'') through Cooperative Research and
Development Agreements (``CRADAs'') and other means, for use in NCI-
funded research conducted via extramural funding agreements. As part of
the arrangement with these Collaborators to use their Agents and to
make the collaborative research possible, NCI CTEP would agree not to
provide Agents to Institutions unless they provide Collaborators with
the IP Options and Institution Notifications described below. The
specific terms of the IP Options depend on the types of inventions that
arise out of the NCI CTEP funded research (Section A Inventions,
Section B Inventions, or Unauthorized Inventions). NCI CTEP is
requesting applicants include assurances of agreement with the terms of
the IP Options and Institutional Notification described below in their
funding applications to NCI CTEP.
References to ``Institution'' mean the funding recipient conducting
the research described herein. The Intellectual Property Options (IP
Options) and Institution Notification described below will apply to
inventions arising from research involving the Agent(s) under the scope
of an NCI CTEP funding agreement.
A. The IP Option described in this Section A would apply to
inventions that use or incorporate the Agent(s) and that are conceived
or first actually reduced to practice pursuant to NCI CTEP-funded
clinical or non-clinical studies utilizing the Agent(s) (``Section A
Inventions''):
Institution agrees to grant Collaborator(s): (i) A royalty-free,
worldwide, non-exclusive license for commercial 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 sub licenses, 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 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(s) will notify Institution, in writing, if it is
interested in obtaining a commercial license to any Section A 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 Section A Invention. In the event Collaborator
fails to so notify Institution, or elects not to obtain an exclusive
license, then Collaborator's option expires with respect to that
Section A 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 Invention,
then for a period of three (3) months thereafter Institution agrees not
to offer to license the Section A 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 Invention, then Institution agrees to file
[[Page 13406]]
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 Invention.
For all Section A 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 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 would apply to
inventions that do not use or incorporate the Agent(s) but that are
conceived or first actually reduced to practice pursuant to NCI CTEP
clinical or non-clinical studies utilizing the Agent(s). It also
applies to inventions that are conceived or first actually reduced to
practice pursuant to NCI CTEP studies utilizing clinical data or
specimens from patients treated with the Agent (including specimens
obtained from NCI CTEP-funded tissue banks) (``Section B Inventions''):
Institution agrees to grant to Collaborator(s): (i) A paid-up
nonexclusive, nontransferable, royalty-free, world-wide license to all
Section B Inventions for research purposes only; (ii) a time-limited
first option to negotiate a non-exclusive, exclusive, or co-exclusive,
if applicable, world-wide royalty-bearing license for commercial
purposes, including the right to grant sub-licenses, 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; and
(iii) a nonexclusive, royalty-free, world-wide license either to (a)
disclose Section B Inventions to a regulatory authority when seeking
marketing authorization of the Agent, or (b) disclose Section B
Inventions on a product insert or other promotional material regarding
the Agent after having obtained marketing authorization from a
regulatory authority. Collaborator will notify Institution, in writing,
of its interest in obtaining an exclusive commercial license to any
Section B Invention within one year of Collaborator's receipt of a
patent application or eighteen months of receipt of an invention report
notifying Collaborator of such Section B Invention(s). In the event
that Collaborator fails to so notify Institution, or elects not to
obtain an exclusive license, then Collaborator's option expires with
respect to that Section B Invention, and Institution will be free to
dispose of its interests in such Section B Invention in accordance with
Institution's 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 Subject B Invention, then for a period of six
(6) months thereafter Institution agrees not to offer to license the
Section B 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. Institution retains
the right to make and use any Section B Inventions for all non-profit
research, including for educational purposes and to permit other
educational and non-profit institutions to do so. If Collaborator
elects to negotiate an exclusive commercial license to a Section B
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 B Invention.
Inventions arising more than five years after the release of data
on the primary end point of the NCI CTEP clinical trial that generated
the clinical data and/or specimens will not be subject to the Section
B(ii) IP Option.
C. The IP Option described in this Section C would apply to
inventions made by Institution's investigator(s) or any other employees
or agents of Institution, which are or may be patentable or otherwise
protectable, as a result of research utilizing the Agent(s) outside the
scope of the NCI CTEP funding agreement (Unauthorized Inventions):
Institution agrees, at Collaborator's request and expense, to grant
to Collaborator a royalty-free exclusive or co-exclusive license to
Unauthorized Inventions.
D. Institution Notification
Institution agrees to promptly notify NCI CTEP
([email protected]) and Collaborator(s) in writing of any
Section A Inventions, Section B Inventions, and Unauthorized Inventions
upon the earlier of: (i) Any submission of any invention disclosure to
Institution of a Section A, Section B, or Unauthorized Invention, or
(ii) the filing of any patent applications of a Section A, Section B,
or Unauthorized Invention. Institution agrees to provide a copy of
either the invention disclosure or the patent application to the
Collaborator and to NCI CTEP 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.
III. Comments on the Proposed Revision and NCI CTEP's Response and
Modifications to the Proposed Option Based on Feedback
The NCI CTEP received 24 responses to the proposed revision to the
CTEP Intellectual Property Option. Comments were received from
pharmaceutical and biotechnology companies, diagnostic companies,
industry groups, the cooperative groups, universities, hospitals and
the Council on Government Relations.
To make it easier to identify comments and our responses, the word
``Comment'' in parentheses, appears before the comment's description
and the word ``Response,'' in parentheses, appears before our response.
Similar comments are grouped together under the same number. Due to the
detail of some responses as well as space and time limitations, we will
not address every point brought up by every Commenter, but will focus
on major concerns expressed by a variety of Commenter's and the issues
that were addressed in the final version of the CTEP IP Option. We have
condensed some responses into topic areas, especially areas where there
were a wide range of conflicting suggestions. The number assigned to
each comment is purely for organizational purposes and does not signify
the comment's value or importance or the order in which it was
received. For ease of use comments will be divided by Section and
follow a generalized order of the proposed Option itself:
1. Overall Scope of the IP Option and Situations in Which the IP Option
Would Be Applied
(Comment) A recurring issue among many respondents was that the
document itself was unclear as to the scope of the IP Option,
specifically to which studies the IP Option must be applied.
(Response) NCI has endeavored to properly clarify the scope in the
final revision. The NCI CTEP IP option will
[[Page 13407]]
apply to inventions generated from: (a) Clinical studies for which CTEP
provided Agent(s), (b) other NCI CTEP-approved studies that use CTEP-
Provided Agent(s), and (c) non-publicly released clinical data or
Agent(s)-treated specimens from those clinical studies.
2. The Definition of Inventions, Was too Vague and Ambiguous in Both
Sections A and B
(Comment) Many respondents from all groups commented that the
definition of inventions as those that ``use or incorporate'' Agent was
too vague. Several respondents offered suggestions as to language that
would clarify the intended meaning and narrow the scope.
(Response) NCI concurs that this language was vague, and in the
final Option has modified the language to more appropriately clarify
the scope. The final Option replaces ``use or incorporates'' with the
statement that the Option will apply to ``inventions that would be
described in patent disclosures that claim the use and/or the
composition of the Agent(s).''
3. Invention Language Should State That the Scope Should Cover
Inventions That Are ``Conceived AND Reduced to Practice'' Under the
Clinical Studies as Opposed to ``Conceived OR Reduced to Practice''
(Comment) Several respondents suggested altering this language
based on the following reasoning: While this language is consistent
with the Bayh-Dole Act scope of ``subject inventions'' for Federal
funding purposes, Bayh-Dole only speaks to the rights to inventions
provided to funding recipients and the government. The IP option,
however applies to rights that funding recipients grant to third party
Collaborators, therefore the Bayh-Dole scope does not apply to theses
inventions. Since the Bayh-Dole scope does not apply this language
should not be considered. Use of ``OR'' language was purported to have
substantial risk to create conflicting obligations, as the Collaborator
would have rights to prior conceptions (that are reduced to practice
under the clinical study) and future reductions to practice (of
conceptions made under this clinical study). This would require
institutions to carefully monitor and possibly restrict other
agreements and funding related to follow on research.
(Response) NCI CTEP finds this argument unpersuasive. While it may
not be necessary to apply the Bayh-Dole scope to the inventions covered
under this Option, NCI CTEP feels that there is value in maintaining a
consistent standard that reflects the intent of Bayh-Dole. This
language is also consistent with the terms offered to collaborators
under Federal Cooperative Research and Development Agreements. More
importantly this change would be inconsistent with programmatic policy
and the manner in which clinical studies are reviewed and approved.
Many of the clinical study proposals are in response to an NCI CTEP-
solicitation that has been formulated with the Collaborator so it would
be difficult for the investigator to have ``conceived'' the invention.
However, the investigator could be the first to ``reduce it to
practice.'' ``Conceived or reduced to practice'' benefits the
investigators submitting unsolicited proposals since, even if the
Collaborator disapproved a proposal, the investigator would still have
``conceived'' the invention.
In regards to future reductions to practice, NCI CTEP wants to
reinforce that the Section A is only applicable to studies wherein CTEP
provides Agent, which limits the application of this clause
sufficiently that future reductions are not a concern. If an
Institution is utilizing NCI CTEP provided agent, any invention
generated is by definition not a future reduction to practice, but
rather part of an ongoing study.
4. The Section A and B Licenses Should be an Assignment of all
Intellectual Property (Including Copyright and Trademarks) to the
Collaborator, With an Offer to Provide an Automatic Non-Exclusive
Research Use License Back to the Inventing Institution
(Comment) Several respondents felt that an outright assignment of
all intellectual property to collaborators would provide a better
incentive for participation in NCI CTEP clinical studies.
(Response) NCI believes that while this would provide greater
incentives for participation on the part of Industry, such assignment
would have a chilling effect on the participation of academic
researchers and on the business model of downstream diagnostic
companies. In addition, NCI CTEP feels that the rights offered in the
CTEP IP Option should pertain solely to patents.
5. The Section A Non-Exclusive Royalty Free Commercialization License
Should be Sub-Licensable
(Comment) Several respondents felt that the Section A non-exclusive
license needed to be sub-licensable in order to have any real value. In
today's market place, collaborators often partner with several other
entities when undertaking development efforts, so the non-exclusive
license is effectively worthless without the ability to sub-license.
(Response) NCI believes that there is merit to this position;
however we are cognizant that an unfettered right to sub-license would
destroy all value for inventing institutions. NCI CTEP has included new
language indicating that the Section A license is sublicensable,
however it may only be sub-licensed to affiliates or Collaborators for
the purposes of development.
6. Patent Expenses Related to all Licensing Options
(Comment) There were several distinct and competing views in the
comments related to the disposition of patent expenses. Some
respondents felt that it was inappropriate for the Institutions to
receive reimbursement of any patent expenses for non exclusive
licenses. Conversely, other respondents felt that the Option should
clearly state that the Collaborator is responsible for all patent
expenses, including expenses associated with the exclusive licensing
option.
(Response) NCI believes that the proposed IP option strikes an
appropriate balance in regards to patent expenses. Since the proposed
option represents an expansion of rights relative to the current
option, NCI believes it is entirely appropriate for Collaborators to
shoulder patent expenses (in a pro-rated manner) if they wish to
exercise their option to the NERF or the Exclusive licensing option in
Section A. If Collaborator is not interested in shouldering patent
expenses related to Section A inventions, they are in no way obligated
to and will still receive a research use license.
In regard to Section B inventions, NCI CTEP feels that the granted
licenses are sufficiently narrow in scope and consistent with the free
research use license of Section A. NCI CTEP will remain silent in
regard to any exclusive or non-exclusive licenses that parties may wish
to negotiate in addition to the licenses described in this section. The
Institution and the Collaborator are in the best position to determine
the most appropriate terms for an exclusive or a non exclusive license
on any Section B invention, should they decide to negotiate such a
license. While it is a standard convention in exclusive licensing
negotiations for the licensee to cover the cost of patents, there may
be instances, particularly with regard to smaller companies
participating in the program, where it would be to the benefit of both
the Institution and the Collaborator to have the flexibility to
negotiate other licensing terms.
[[Page 13408]]
7. Time Frames On Negotiation of Section A Exclusive Licensing Options
as Well as Most-Favored Nation Period
(Comment) This was an area of broad discussion where comments
varied substantially based on the position of the commenter. In general
Industry responders felt the time period for negotiation and most
favored nation status was too short, and asked for a time frame double
what the proposed Option provided. Arguments focused on the difficulty
of properly valuating the IP in such a short time frame. Conversely,
Institutions and diagnostic company respondents felt the time frame for
negotiation was too long, and that the most favored nation provisions
should be removed entirely. Arguments focused on the delay that these
terms engender and the ability of a Collaborator to use them to
``halt'' development of associated technologies.
(Response) NCI believes that the current time frame for negotiation
of Section A inventions appropriately balances the concerns expressed
by both Collaborators and Institutions. While neither side is
completely satisfied with the time frames, they are consistent with
previous policy, and our experience indicates they are at the very
least functional.
8. Section B Inventions: Clarity Regarding the Scope of Data to Which
the Option Will Apply
(Comment) Several respondents felt that the description of data in
Section B was ambiguous and overly broad, and that it could be
interpreted to apply to data that had been published or had otherwise
entered the public domain.
(Response) NCI CTEP agrees that the language in this Section B
pertaining to data required more clarity. We have added language
specifying that it only applies to confidential data from clinical
studies that used NCI CTEP-provided Agent or data from such studies
that has not yet been published. The Option is not intended to read on
publicly available or published data.
9. Section B(ii) Inventions (ii): Exclusive Licensing Option
(Comment) In general the inclusion of the Section B(ii) exclusive
licensing option was the source of greatest controversy within the
proposed Option. Institutions and diagnostic company respondents felt
strongly that the proposed B(ii) exclusive licensing option:
a. Was overly broad and included reach-through that would stifle
the development of Inventions that are critical to the treatment of
cancer patients. In particular the Option would make it difficult, if
not impossible, for diagnostic companies to develop companion
diagnostics to a particular treatment in a timely manner.
b. Had time frames for negotiation of these licenses that were
overly generous and needed to be reduced.
c. Should not have a 5 year time limitation as this was both overly
long and logistically impractical to implement.
d. Was fundamentally unfair, would constrain the ability of
Institutions to collaborate on diagnostics, and thus, it would have a
chilling effect on participation in CTEP studies.
(Response) NCI believes that Institution, and particularly
Diagnostic company respondents made a compelling argument for the
removal of this clause from the proposed option. The NCI's goal in
promulgating the revision was to encourage participation in CTEP
studies by ensuring that Collaborators receive enough rights to protect
their ability to successfully manufacture and commercially market any
therapeutic they supply to the CTEP program (freedom to operate).
The NCI believes that freedom to operate is protected by the more
narrowly tailored Section B(iii) option, and that the B(ii) option as
presented in the proposed option is overbroad and unnecessary to
achieve NCI's goals. In response, the NCI has removed the Section B(ii)
option in its entirety from the final Option.
10. Section B(iii) Inventions Use of ``and'' Instead of ``or''
(Comment) Several respondents felt that it was unclear whether
Collaborators would receive both the right to use Invention data for
regulatory purposes and the right to include Invention data on product
insert information.
(Response) NCI agrees that this language was unnecessarily vague.
The intent was for Collaborator to have both rights and as such the
wording has been amended to replace ``or'' with ``and.''
11. Section C Inventions: Recommendations That the NCI Remain Silent on
Unauthorized Inventions
(Comment) Several respondents felt that that section was unduly
harsh and should be removed altogether, with any action regarding
unauthorized use to be left for the parties to resolve. Respondents
also felt that this language may be in conflict with the Bayh-Dole Act.
(Response) The NCI finds this argument unpersuasive. The removal of
this section would effectively make it more attractive to develop an
invention outside the scope of approved studies than under the scope
and would provide a strong incentive for participants to breach the
agreement. The NCI feels that there must be some form of penalty for
breaching the agreement in order to maintain our ability to obtain
proprietary Agents for clinical studies.
In regards to Bayh-Dole, NCI has discussed this with our legal
counsel at OGC. These unauthorized studies are, by definition, not done
under the scope of a government funding agreement (the party is in fact
in breach of a government funding agreement) therefore Bayh-Dole does
not apply to these inventions. This language provides consequences in
the event that a party steps outside of the agreed upon scope of work.
12. Section C Inventions: Recommendation That the NCI include a Non-
Exclusive Research Use License Back to the Inventing Institution
(Comment) Several respondents felt that while the unauthorized use
language was appropriate, the institution should retain a license to
use any inventions generated, including those through unauthorized use,
for internal research purposes.
(Response) The NCI believes that this argument has merit and has
included this language in the final Option. While we do not believe it
is appropriate for Institutions to benefit from misuse of Agent, data
or Agent-treated samples, we feel that we also have an obligation to
support the scientific endeavor and avoid blocking important research
in the case of inadvertent breach.
IV. The Final Revision to the CTEP IP Option
The following is the revision in its final form, with alterations
made based on comments received to the April 6th Federal Register
notice:
The Cancer Therapy Evaluation Program (CTEP) of the National Cancer
Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD)
obtains ``Agents'' from biotechnology and pharmaceutical companies
(hereinafter ``Collaborators'') through Cooperative Research and
Development Agreements (``CRADAs'') and other means, for use in NCI-
funded research conducted via extramural funding agreements. As part of
the arrangement with these Collaborators to use their Agents and to
make the collaborative research possible, NCI CTEP would agree not to
provide Agents to Institutions unless they provide Collaborators with
the IP Options and
[[Page 13409]]
Institution Notifications described below. The specific terms of the IP
Option depend on the types of inventions that arise out of the studies
wherein Agent is supplied by NCI CTEP pursuant to an agreement with a
Collaborator (Section A Inventions, Section B Inventions, or
Unauthorized Inventions). NCI CTEP is requesting that applicants
include assurances of agreement with the terms of the IP Options and
Institutional Notification described below in applicable funding
applications to NCI.
References to ``Institution'' mean the funding recipient conducting
the research described herein. The Intellectual Property Options (IP
Options) and Institution Notification described below will apply to
inventions arising from research involving the Agent(s) under the scope
of an NCI funding agreement.
A. The IP Option described in this Section A would apply to
inventions that would be described in patent disclosures that claim the
use and/or the composition of the Agent(s) and that are conceived or
first actually reduced to practice pursuant to clinical or non-clinical
studies utilizing the NCI CTEP provided Agent(s) (``Section A
Inventions''):
Institution agrees to grant to Collaborator(s): (i) a royalty-free,
worldwide, non-exclusive license for commercial purposes with the right
to sub license 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 sub licenses, 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 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(s) will notify Institution, in writing, if it is
interested in obtaining a commercial license to any Section A 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 invention. In the event that
Collaborator fails to so notify Institution, or elects not to obtain an
exclusive license, then Collaborator's option expires with respect to
that Section A 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 Invention,
then for a period of three (3) months thereafter Institution agrees not
to offer to license the Section A 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 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 Invention.
For all Section A 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 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 would apply to
inventions not covered by Section A, but are nevertheless conceived or
first actually reduced to practice pursuant to clinical or non-clinical
studies utilizing the CTEP-provided Agent(s). It also applies to
inventions that are conceived or first actually reduced to practice
pursuant to NCI CTEP-approved studies that use non-publicly available
clinical data or specimens from patients treated with the CTEP-provided
Agent (including specimens obtained from NCI CTEP-funded tissue banks)
(``Section B Inventions''):
Institution agrees to grant to Collaborator(s): (i) a paid-up
nonexclusive, nontransferable, royalty-free, world-wide license to all
Section B Inventions for research purposes only; and (ii) a
nonexclusive, royalty-free, world-wide license to (a.) disclose Section
B Inventions to a regulatory authority when seeking marketing
authorization of the Agent, and (b.) disclose Section B Inventions on a
product insert or other promotional material regarding the Agent after
having obtained marketing authorization from a regulatory authority.
Notwithstanding the above, Institution is under no obligation to file
or maintain patent prosecution for any Section B Invention.
C. The IP Option described in this Section C would apply to
inventions made by Institution's investigator(s) or any other employees
or agents of Institution, which are or may be patentable or otherwise
protectable, as a result of research utilizing the CTEP-provided
Agent(s), unreleased or non-publicly available clinical data or Agent
treated specimens outside the scope of approval granted by the NCI CTEP
(Unauthorized Inventions):
Institution agrees, at Collaborator's request and expense, to grant
to Collaborator a royalty-free exclusive or co-exclusive license to
Unauthorized Inventions. Institution will retain a non-exclusive, non-
sub-licensable royalty free license to practice the invention for
research use purposes.
D. Institution Notification
Institution agrees to promptly and confidentially notify NCI CTEP
([email protected]) and Collaborator(s) in writing of any
Section A Inventions, Section B Inventions, and Unauthorized Inventions
upon the earlier of: (i) Any submission of any invention disclosure to
Institution of a Section A, Section B, or Unauthorized Invention, or
(ii) the filing of any patent applications of a Section A, Section B,
or Unauthorized Invention. Institution agrees to provide a copy of
either the invention disclosure or the patent application to the
Collaborator and to NCI CTEP 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.
V. Conclusion
NCI and NIH would like to offer our thanks to all respondents for
their articulate and well thought out comments, and their willingness
to participate in this process.
[[Page 13410]]
Dated: March 8, 2011.
Jeffrey Abrams,
Associate Director, Cancer Therapy Evaluation Program, Division of
Cancer Treatment and Diagnosis, National Cancer Institute.
[FR Doc. 2011-5609 Filed 3-10-11; 8:45 am]
BILLING CODE 4140-01-P