Last Updated: November 17, 2011

PRINCIPLES

• PRINCIPLES FOR ACCESSING GENETIC RESOURCES, THE TREATMENT OF INTELLECTUAL PROPERTY AND THE SHARING OF BENEFITS ASSOCIATED WITH ICBG-SPONSORED RESEARCH

In developing both research plans and appropriate intellectual property agreements, it is important that all involved understand the differences between patent coverage and benefit-sharing agreements. While legal protection of the right to commercialize an invention is generally accomplished through the patent system, agreements among collaborators are generally required to designate the terms of partnerships including, among other things, the licensing of an invention and the sharing of any financial benefits that accrue from it.

The conduct of ICBG-sponsored research and the agreements among the collaborators must address the following principles to be eligible for funding.

1. Disclosure and consent of indigenous or other local stewards.
   a) Plans to collect samples for drug discovery or for other potentially commercializable agents should be vetted with the national government authorities of the host country and with any other organizations they, you or your partners deem appropriate at the earliest stage of planning and once again, formally, before any collections take place.
   
   b) Where national governments do not have clear regulations to guide informed consent procedures, activities should follow a two phase approach to distinguish basic and commercial research. Basic research intended primarily for publication, including collecting and analyzing biodiversity, including bioassay and chemistry work, may be considered "basic" research for the purposes of this program. If, at any time, researchers intend to file a patent application based on this work or to send a sample for testing to an industrial partner, the research immediately enters the commercial realm for the purposes of this program and must follow all the requisite permit and contract standards of the host country.
   
   c) Arrangements for the use of traditional knowledge or the collection of samples from the lands of local peoples should be based upon full disclosure and informed consent of those peoples. Under best practices such arrangements develop as a partnership with early and ongoing full participation of community representatives in project design.
   
   d) Indigenous concepts of intellectual property should be respected. If, for instance, cooperating indigenous groups, on the basis of religious or other concerns, object to specific uses, widespread dissemination or other treatments of the knowledge or resources they provide, these concerns should be respected in the conduct of ICBG projects.
   
   e) The process of disclosure and informed consent should be as inclusive and formal as is possible and culturally appropriate. The best practice is the development of written agreements with a community following complete and formal mutual agreement and understanding of the Group’s goals and methods. Presentations by scientists to host country stakeholders should provide realistic descriptions of the type, amounts and probabilities of benefits, as well as any costs or risks that may accrue to cooperating communities or organizations. Arrangements with individuals who cooperate or provide information should be based upon prior community-level agreements whenever possible or appropriate.
   
   
2. Clear designation of the rights and responsibilities of all partners.
   a) This is principally done through the design of adequate contractual agreements. Agreements should be among all collaborating organizations, whether or not they are recipients of government funds. These may include commercial drug developers, source country and U.S. research institutions, and indigenous and local peoples whose resources, biological or intellectual, are utilized in the research process.
   
   b) It is strongly recommended that all parties to agreements have separate, competent legal counsel to represent their interests.
   
   c) Useful contractual tools for the designation of rights and responsibilities include material transfer agreements, research and development agreements, license options agreements, know-how licenses, benefit-sharing agreements, and structured trust funds.
   
   d) Unless stipulated otherwise in agreements among source country institutions and their collaborators, biological samples and associated information collected under ICBG-sponsored research is the property of the source country institutions. The US Government retains "march-in" rights to require licensing if the inventing organization(s) fail to pursue development of the process or invention or discovery (e.g. process), as described in the "Terms and Conditions of Award."
   
   e) The ownership and compensation terms of first generation and subsequent inventions based upon a lead discovered in ICBG work should be clearly stipulated in agreements.
   
   f) Agreements should specify that the basic goals of the collaboration include biodiscovery for therapeutic, agricultural and/or energy-related agents, economic development, and the conservation and sustainable use of biological diversity.
   
   g) Agreements should also indicate how a sustainable source of materials for follow-up analysis of a lead compound will be developed, and should preferentially use the participating country and/or communities as the first source of raw or processed materials.
   
   
3. Protection of inventions using patents or other legal mechanisms.
   a) Non-profit organizations (including universities) and small business firms retain the rights to any inventions resulting from U.S. Government contracts, grants, or Cooperative Agreements consistent with the Bayh-Dole Act and its implementing regulations (35 USC 200-212; 37 CFR 401). PL 96-517, through regulation, extends to businesses of any size the first option to the ownership of rights to inventions made in the performance of a federally-funded contract, grant, or Cooperative Agreement. All group members, therefore, including businesses of any size, might be full partners in the research of the Group and in rights to file patents for any inventions resulting therefrom as specified in the Group's research agreement. This includes communities organized into or represented by an appropriate legal entity.
   
   b) The specific intellectual property arrangements among the institutions may vary and could include joint patent ownership, exclusive licensing arrangements, etc., ., consistent with the Bayh-Dole Act. Valuable intellectual resources that cannot or will not be patented, such as novel assays or traditional medicinal techniques, may require alternative protection methods, such as trade secrets. You are encouraged to develop an arrangement that best suits the particular circumstances of your Group.
   
   
4. Sharing of benefits with the appropriate source country parties.
   a) Benefits that emerge from an ICBG should be considered thoughtfully by the Group, and may include financial benefits from a commercial relationship or product, as well as training, targeted research to address local priorities, and the establishment of long-term partnerships, among other types.
   
   b) Equitable distribution of financial or other benefits that flow from a commercial relationship or product should accrue to all those who contribute to the relationship or product, whether they are members of the consortium or not, including research institutions and local or indigenous people who provide useful traditional knowledge.
   
   c) Benefits should flow back to the area in which the source plant, animal or microorganism was found, in such a way that they at least indirectly promote conservation of biological diversity.
   
   d) The selection of beneficiaries must be justified in terms of program goals, as well as local and international laws and customs.
   
   e) Benefits should be structured such that they are appropriate to the needs of the communities and the resources of the other collaborators. For example, trust funds managed by a community or community-project board may be more effective in support of conservation and health or education services than cash payments to a single individual or authority.
   f) Ideally, compensation begins flowing early in the collaboration through initial payments, training, equipment or services, to provide near-term conservation incentives.
   
   
5. Information flow that balances proprietary, collaborative and public needs.
   a) Agreements and research plans should anticipate the tension between the traditional scientific ethic of public access to information, including publication of results, and the understandable desire of indigenous or commercial partners for confidentiality of information with potential commercial value, pending protection through patenting or other means. While proprietary needs often require at least temporary confidentiality, you are strongly encouraged not to withhold research results beyond those which are likely to be commercialized or would harm the interests of project stakeholders in identifiable ways.
   
   b) Sharing of information among collaborating organizations should be an ongoing and regular process and should be as complete as possible to maximize efficiency of research and equity in partnerships while recognizing the proprietary concerns of those partners. Reporting back to collaborating communities, where relevant, on significant project developments should be a regular and expected component of the project.
   
   
6. Respect for and compliance with relevant national and international laws, conventions and other standards.
   a) Relevant international conventions, such as the U.N. Convention on Biological Diversity and national laws regarding study, use and commercialization of chemical, genetic, biological and cultural resources, should be observed rigorously in the development of agreements and the conduct of research.
   
   b) An essential goal of this program is to develop models for sustainable and equitable commercial use of biodiversity-rich ecosystems. As such, ICBG research agreements and activities should, wherever possible, go beyond the minimum legal standards regarding international research collaborations, looking to codes of conduct and other standards for guidance. In this regard you are encouraged to review the U.N. Biodiversity Convention’s Bonn Guidelines on Access and Benefit-sharing: http://www.cbd.int/doc/publications/cbd-bonn-gdls-en.pdf.
   
   

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm) .