[Federal Register Volume 75, Number 65 (Tuesday, April 6, 2010)]
[Notices]
[Pages 17412-17414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Cancer Therapy Evaluation Program Intellectual Property Option to 
Collaborator

AGENCY: National Cancer Institute (NCI), National Institutes of Health 
(NIH), DHHS.

ACTION: Notice; request for comments.

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SUMMARY: The National Cancer Institute, Division of Cancer Treatment 
and Diagnosis, is seeking comments on a proposed revision to its policy 
on intellectual property agreements with certain funding recipients, 
entitled the Cancer Therapy Evaluation Program (CTEP) INTELLECTUAL 
PROPERTY OPTION. The proposed policy, if finalized, would establish 
that potential applicants for CTEP funding should include an assurance 
of agreement with the recommended Intellectual Property Option and 
Institution Notification if they wish to be considered for funding 
support to carry out any CTEP-sponsored clinical trial for which CTEP 
holds the investigational new drug (IND) application.

DATES: Comments must be received by NIH on or before May 6, 2010.

ADDRESSES: The NIH welcomes public comment on the full text of the CTEP 
IP option, set forth below. Comments should be addressed to: CTEP IP 
Option Project, [email protected].

FOR FURTHER INFORMATION CONTACT: Jason Vittorio Cristofaro, J.D., PhD, 
Intellectual Property Advisor, National Cancer Institute/NIH/DHHS, 
Division of Cancer Treatment and Diagnosis, 31 Center Drive, Room 3A44, 
Bethesda, MD 20892-2580, telephone 301-594-5318, fax 301-496-0826, e-
mail [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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 CTEP-supported 
clinical trials under funding agreements. As part of the arrangement 
with these Collaborators to use their proprietary Agents and to make 
funding clinical research possible, Collaborators will often require, 
as a condition of collaboration, that the NCI CTEP funding 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 CTEP funding agreement.
    The current IP option language is silent as to the disposition of 
intellectual property developed from data and Agent-treated samples. As 
a result, both Collaborators and Institutions have 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 CTEP-sponsored 
clinical studies, which has resulted in delays

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and threatens the continuing ability of CTEP to provide proprietary 
Agents to CTEP-funded investigators. The lack of Agents for these 
clinical studies would jeopardize NCI CTEP's ability to support these 
research activities. The proposed 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.
    This proposed policy was developed with input from a variety of 
sources including the CTEP-sponsored cooperative groups, other CTEP-
sponsored investigators performing early clinical trials, industry 
representatives who partner with CTEP and the Council on Government 
Relations (COGR).

II. Proposed Revision to CTEP Intellectual Property Option

    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 that 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 to Collaborator(s): (i) A royalty-free, 
worldwide, nonexclusive license for commercial purposes; and (ii) a 
time limited first option to negotiate an exclusive, or co-exclusive, 
if applicable, worldwide, 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 nonexclusive 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 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 
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 nonexclusive, 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

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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. Request for Comments

    NCI CTEP is seeking comment not only from NCI CTEP funding 
recipients, but from the full range of academic, not-for-profit, 
government, and private sector participants in biomedical research and 
development. Widespread comment and participation by varied 
stakeholders in the biomedical research and development enterprise is 
critical if this language is to be effective in guiding the 
interactions of NIH funding recipients with external Collaborators in 
CTEP-funded studies.

    Dated: March 30, 2010.
Jeffrey Abrams,
Associate Director, Cancer Therapy Evaluation Program, Division of 
Cancer Treatment and Diagnosis, NCI, National Institutes of Health.
[FR Doc. 2010-7743 Filed 4-5-10; 8:45 am]
BILLING CODE 4140-01-P