Geneva, 26 March 2002
Council for Trade-Related Aspects of Intellectual Property Rights. Technology transfer practices of the US National Cancer Institute's departmental therapeutics programme. Communication from the United States. Document IP/C/W/341 25 March 2002 (02-1523). Full text [WTO links may need to be tried twice before a document is displayed]
The following communication has been received from the Permanent Mission of the United States on 6 March 2002, with the request that it be circulated as an unrestricted Council document.
During the meeting of the TRIPS Council in April of 2001, the United States introduced a paper, IP/C/W/257 , discussing the relationship between the Convention on Biological Diversity and the TRIPS Agreement. In that paper, the United States noted that the most effective means for providing access to genetic resources, and for ensuring that any benefits that arise from their use are shared fairly and equitably, would be through contracts between those granting access to the resources and those to whom access is granted. This document describes the practices of the US National Cancer Institute's Departmental Therapeutics Programme (NCI-DTP) in collecting genetic materials for screening for potential therapeutic uses related to cancer.
Background
The DTP is the drug discovery programme of the NCI. The NCI-DTP is currently screening synthetic compounds and natural product materials derived from plants, marine macro-organisms and microbes as potential sources of novel anti-cancer drugs. Since 1986, the Natural Products Branch of the NCI-DTP has acquired 53,000 plant and 13,000 marine invertebrate samples, in addition to 3,000 marine plants and 25,000 fungal extracts from more than 30 tropical or sub-tropical source countries or their source country organizations. Aqueous and organic extracts (methylene chloride/methanol) of each of these materials have been prepared and are now available for high throughput screening in 1,650 microtiter plate maps (88 extracts per plate). In addition, taxonomy is available for each specimen. The chief use for screening such a unique resource is to isolate, identify and characterize a lead compound whose activity can be further developed through combination with other compounds or other synthesizing methodologies. The extracts, however, are available (under a Natural Products Repository-Material Transfer Agreement, NPR/MTA) to other scientific laboratories for screening against all diseases.
As it investigates the potential of natural products in drug discovery and development, NCI-DTP seeks to promote the conservation of biological diversity, and recognizes the need to collaborate with source country organizations in the development of any drug from an organism collected within a source country's borders from source country organizations and peoples and, in the event of commercialization of any drug so developed, to provide compensation or other benefits resulting from that commercialization. Most of the sample materials screened by NCI-DTP have been obtained under Letters of Collection (LOC) or Memoranda of Understanding (MOU) negotiated with or involving the source countries. Copies of the basic Natural Products Repository-Material Transfer Agreement, the Letters of Collection, and the Memorandum of Understanding are included as annexes to this paper....
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