GUIDANCE FOR SHARING OF DATA AND RESOURCES GENERATED BY THE MOLECULAR LIBRARIES 
SCREENING CENTERS NETWORK (MLSCN) - ADDENDUM TO RFA RM-04-017
 
RELEASE DATE: July 22, 2004
  
NOTICE:  NOT-RM-04-014 
 
National Institutes of Health (NIH) 
 (http://www.nih.gov/)
 
This Notice is for a roadmap initiative.  All NIH Institutes and Centers 
participate in roadmap initiatives. 
 
This addendum to RFA-RM-04-017, "Molecular Libraries Screening Centers Network 
(MLSCN)" (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-017.html), which 
was released in the NIH Guide for Grants and Contracts on April 21, 2004, provides 
further information about the NIH guidance relevant to sharing of data from, and 
the management of intellectual property (IP) related to resources generated by the 
pilot MLSCN centers.  The MLSCN was described in detail in RFA-RM-04-017, including 
NIH's programmatic interest in having assay protocols, screening data, and 
optimization chemistry for probe development within the MLSCN centers publicly 
available as rapidly and freely as possible, e.g., minimizing restrictive 
enforcement of IP. Specifically, the RFA provided preliminary information on NIH's 
proposed plans for sharing data and research resources generated by the MLSCN 
centers as well as IP rights and accessibility of research resources.  However, the 
RFA also indicated that the NIH would convene meetings to further discuss IP issues 
associated with the Molecular Libraries Roadmap, and would issue updated guidance 
in the NIH Guide prior to the receipt date for RFA-RM-04-017.  Since the issuance 
of the RFA, the Molecular Libraries Roadmap Implementation Group has convened two 
meetings, received opinions, and discussed these issues with a broad range of 
chemists, technology transfer experts, and legal advisors from the academic, non-
profit, government, biotechnology, pharmaceutical, and disease foundation sectors 
of the scientific community.  Taking these discussions into consideration, NIH has 
developed this notice to provide the updated guidance for the subject RFA. 
 
Background 
 
The MLSCN is intended to be a national resource that is capable of providing:  (a) 
innovative high throughput molecular screening (HTS) approaches for the 
identification of small organic molecules (compounds) that are active in biological 
assays; and (b) synthetic chemistry capabilities to improve the utility of these 
molecules as bioactive probes for in vitro, and potentially in vivo, studies of 
normal and abnormal physiology of cells, organs, model systems, and/or organisms.  
The MLSCN will include the intramural NIH Chemical Genetics Center and the pilot 
centers that will be funded as a result of RFA-RM-04-017. 
 
NIH's primary objective for this new public sector screening effort are:  (a) to 
identify bioactive compounds that will constitute a new set of research tools to be 
used by scientists in both the public and private sectors; (b) to facilitate 
studies of biology and pathophysiology; (c) to catalyze the identification of novel 
targets for therapeutic intervention.  Furthermore, in some cases, the compounds 
identified by the MLSCN will ultimately serve as starting points for drug discovery 
programs by the private and public sectors; however, such drug discovery activities 
are outside the scope of the MLSCN initiative.  
 
The MLSCN will collaborate and interact with several other components of the 
Molecular Libraries Roadmap Initiative.  The first such component is the NIH Small 
Molecule Repository, which will be a repository of 100,000-500,000 publicly 
available, chemically diverse, small organic molecules of both known and unknown 
activities.  The compounds in this repository will constitute a National Screening 
Set and, with one exception, will have no IP restrictions.  The exception is that 
of certain FDA-approved drugs, which may be included in the collection because of 
their potential for immediate usefulness and benefit to public health.  The other 
Molecular Libraries Roadmap components are PubChem, a public sector database that 
will archive the chemical structures and biological data generated by the MLSCN, 
and a program to develop related technologies.  See  
http://nihroadmap.nih.gov/molecularlibraries/index.asp for a more complete 
description.
 
Since the inception of the Molecular Libraries Roadmap, NIH has emphasized that, in 
order to reap the maximum benefit from the MLSCN, the HTS data, assay protocols, 
and chemical structures of compounds tested in the centers should be publicly 
available.  There are very strong scientific arguments supporting this position. 
 
Small molecule probes that selectively interact with biological targets are 
extremely valuable research tools for understanding the functions of proteins and 
biological pathways.  A collection of such probes that would allow the 
comprehensive study of all of the proteins and other gene products encoded by the 
human genome would be an invaluable contribution to biomedical research.

It will take the combined resources of researchers in the public and private 
sectors many years to use small molecule probes to characterize the biology of 
genes and proteins of interest, cellular processes, and disease processes, and then 
to use that information to develop products and other approaches that will improve 
public health.

Potentially, the open sharing of data, research tools, and resources will lead more 
rapidly to the identification and validation of novel targets for drug discovery, 
and will facilitate the more rapid development of therapeutics by both the private 
and public sectors, with resulting benefits to public health, especially for rare 
or marginalized disorders. 
 
Guidance for Community Resources 
 
The following data and materials generated or developed by the MLSCN are expected 
to be community resources.  These include:  (1) primary data from high throughput 
screening (HTS); (2) data generated in secondary screens; (3) protocols for assays 
implemented in the MLSCN; (4) the chemical structure of compounds tested in the 
MLSCN; and (5) the synthesis protocols for optimization chemistry for probe 
development conducted within the MLSCN centers. 
 
Note:  Prior to the implementation of assays, the MLSCN will consider whether any 
existing IP rights restrictions are consistent with the objectives of this 
initiative. 
 
NIH is concerned that enforcement of patents on HTS hits or chemical probes, could 
have a chilling effect on the development of future substantive inventions.  Such 
actions could interfere with the broad utilization of early-stage biological and 
chemical information. In addition, developers might not pursue projects where there 
is prior patenting.  The intention of the MLSCN program is to facilitate subsequent 
innovations that are at a later stage of development.  Stimulation of such 
subsequent development is the ultimate goal of the MLSCN program. 
 
It is, therefore, NIH's understanding that the usefulness of the data and resources 
generated by the MLSCN would be of maximal benefit to public health if they are 
treated as a community resource and made publicly available.  While NIH recognizes 
that, under the Bayh-Dole Act, awardees have the right to elect title to subject 
inventions and seek appropriate IP protection, the data sharing and IP plans should 
take all of the above considerations into account.   Applicants should provide 
clear explanations and rationales for any proposed plan that involves principles 
differing from those described in this Notice.  
 
Guidances for IP and Accessibility of Technology Development Resources 
 
A separate component of the IP plan should address any other data and resources 
that are expected to be generated by the MLSCN centers.  These may include, but are 
not limited to, HTS methods or instrumentation, development of technology to 
automate or miniaturize assays for HTS, data analysis software, etc.  NIH 
encourages applicants to consider inclusion of "non-assert" language in IP plans 
for all potentially patentable inventions to ensure that, while an institution 
might apply for a patent on an invention, e.g., as a diagnostic or as a measurement 
tool, the institution would not attempt to enforce that patent against 
organizations utilizing the technology for research purposes. 
 
Review of Plans 
 
The data sharing and IP plans in the application will be evaluated by the 
Scientific Review Committee using the principles and expectations detailed in this 
Notice, but will not be considered in the priority score.  Following the review, 
program staff will negotiate a final version of plans for data sharing and IP to 
ensure accessibility of research resources.  Finalized plans will be made a term 
and condition of any cooperative agreement awarded under this RFA.
 
Applicants' plans for maximizing the public use of the data and resources generated 
by the MLSCN network will be a major evaluation criterion for the pilot centers, 
and for applicants to become fully operational MLSCN centers.  During the pilot 
MLSCN period, NIH will solicit opinions and collect additional data from the 
scientific and commercial sectors to allow an evaluation of whether the approaches 
described above are sufficient to ensure that screening data and resources 
generated by the MLSCN centers are broadly available. If the goals of the MLSCN are 
not being met using this approach, NIH will consider using a determination of 
exceptional circumstances (DEC) under future awards to restrict or eliminate the 
right of parties to elect title to subject inventions.

INQUIRIES:

Linda Brady, Ph.D.
Project Team Leader, MLSCN
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7185, MSC 9641
Bethesda, MD  20892-9641
Rockville, MD 20852-9641 (for express/courier service)
Telephone:  (301) 443-5288
FAX:  (301) 402-4740
Email: lbrady@mail.nih.gov


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