For the purpose of this report, proprietary science means any process or product derived from scientific and research and development (R&D) activities that is legally owned or protected by intellectual property rights.
There are various established forms of intellectual property applied to scientific and research developments, and these may include patents, plant breeder's rights, trademarks, copyrights and trade secrets. There are also developing alternative rights regimes, including Farmers' Rights, traditional resource rights, sui generis property regimes at national and local levels, collective property rights, and systems for managing resource use and access that are not based on property rights. Some of these are not fully implemented, so that it is uncertain how they will work in practice: for example, the implications of the rights of the States to regulate access to their genetic resources and information are still being discussed by parties to the Convention on Biological Diversity. Others are not yet well defined: these include rights which are under negotiation in the process of the revision of the FAO International Undertaking on Plant Genetic Resources for Food and Agriculture (Farmers' Rights 1). Both intellectual property rights and alternative rights regimes can potentially impact the way IARCs co-operate with national programmes and other partners in developing countries, and must be taken into account by the CGIAR system in developing policies and guidelines on this subject.
1
The concept of Farmers' Rights, as it is stated by FAO resolution 4/89, means "rights arising from the past, present and future contribution of farmers in conserving, improving, and making available plant genetic resources". There are many views on the true meaning of Farmers' Rights, and how to implement them.
The increased utilization of biotechnology and the strengthening and enforcement of intellectual property rights throughout the world have dramatically influenced the collaboration among research institutes in both nature and intensity. A recent survey among university scientists conducting projects funded by the private sector reveals that 12% of them reported that industry support generated a trade secret from their university research; 24% said that their results could not be published without the previous consent of the sponsor; 44% said that, at least to some extent, industry support undermines intellectual exchange; 70% said that, at least to some extent, such support shifts towards too much emphasis on applied research; and 30% admitted that the future commercial application had influenced the choice of research topics 2.
2
Editorial. The Lancet 342 (8885), December 11, 1993
Research and development in biotechnology are now seen by some in the international scientific community to be important for the integration of both conventional and biotechnological breeding activities for food production. Data compiled by the International Service for the Acquisition of Agri-Biotech Applications (ISAAA)3 show that during 1986 to 1997, approximately 25,000 transgenic crop field trials were conducted by 45 countries on more than 60 crops and 10 traits. Of this total, 15,000 field trials were conducted during the first 10 year period, and 10,000 in the last two years. The global acreage planted with transgenic crops has changed from 7.0 million in 1996 to 31.5 million in 1997. Main transgenic crops in terms of the 1997 acreage are soybean (40%), corn (25%), tobacco (13%), cotton (10%), canola (10%), tomato (1%) and potato (<1%). The most frequent traits being incorporated into plant varieties in the US are herbicide tolerance (30%), insect resistance (24%), product quality (21%), viral resistance (10%) and fungal resistance (4%). Traits such as marker genes, selectable markers, bacterial resistance and nematode resistance accounted for the other 4% of applications. The significance of these trials is disputed: for some, they suggest that the technology is useful and safe, while others doubt their utility and are concerned that safety cannot be guaranteed and that environmental impacts are not fully understood.
3
James, C..1997. Global Status of Transgenic Crops in 1997. ISAAA Briefs N° 5. ISAAA: Ithaca, NY. 31 p.
Due to the changing intellectual property environment, the issue of Farmers' Rights, and the advancement of biotechnologies, the CGIAR at its ICW96 adopted a set of guiding principles on intellectual property and genetic resources for its Centres, for their use on an interim basis (see Appendix D-1). Among other principles, it is stated that "The Centres will not claim legal ownership nor apply intellectual property protection to the germplasm they hold in trust, and will require recipients of the germplasm to observe the same conditions, in accordance with the agreements signed with FAO" 4. It is understood that, based on this principle, genetic resources accessions delivered by the Centres from their 'in trust' collections are to be sent to users under Material Transfer Agreements (MTAs) imposing such obligations: this practice appears to be followed in most, but not all, cases.
4
Hawtin, G and Reeves, T. 1997 Intellectual Property Rights and the Access to Genetic Resources in the Consultative Group on International Agricultural Research (CGIAR). Paper presented to the workshop on Intellectual Property Rights III - Global Genetic Resources: Access and Property Rights. 4-6 June, 1997, Washington, D.C., USA.
In a series of informal interviews conducted for the Panel, private companies responded that the CGIAR should be a forum for discussion about IPR and public use issues on a world-wide basis, and it should bring the interests of the private sector into the discussions. The CGIAR Centres should continue to adapt technologies to regional needs and act as a technology conduit to access proprietary technologies. These private sector interviewees also believe that the role of the CGIAR will diminish unless ways are found to access proprietary technologies. However, they believe that as the Centres get involved in IPR and their enforcement, they should not try to become businesses but, rather, continue to serve the public interest. Another set of questions responded to by technology transfer officers at selected US land grant universities revealed that they are not aware of ever having received a request for proprietary materials from any CGIAR Centre. However, all acknowledged that it is likely that there are direct scientist-to-scientist exchange of materials that occur informally. All these universities would be willing to make proprietary materials available to the centres under standard MTAs (i.e., limited to research use, no transfer to third parties, new inventions must be reported, and ownership is based on inventorship).
The use of biotechnology at selected CGIAR Centres was investigated by ISNAR in a study commissioned by this Panel 5 The purpose of this study was three-fold: 1) to provide an assessment of the extent to which proprietary applications of biotechnology (technologies and materials) are being used at the IARCs; 2) to identify the potential legal implications regarding use of these proprietary technologies and materials, and 3) to provide a synthesis of findings and recommendations which stimulates further discussions. These technologies and materials were grouped according to their crop applications in cereals, non-cereals and other, and in eight categories as follows: transformation systems; promoter genes, insect-resistance genes, disease-resistance genes, selectable markers genes, genetic markers, diagnostic probes, and others.
5
Appendix C-1. ISNAR - The Use of Proprietary Biotechnology Research Inputs at Selected CGIAR Centres. Report of an ISNAR Study Commissioned by the CGIAR Panel on Proprietary Science and Technology.
The results, based on responses from seven IARCs 6, show that some Centres are using "state-of-the-art" proprietary technology. A total of 166 applications of proprietary technologies being used were identified, according to the following: 45 selected markers (17 cereals, 26 non-cereals and 2 others), 35 promoters (18, 14 and 3), 29 transformation systems (12, 14 and 3), 19 insect-resistance genes (8, 11 and 0), 11 disease-resistance genes (6, 5 and 0), 10 genetic markers (4, 4 and 2), 3 diagnostic probes (0, 0 and 3), and 14 other applications (6, 6 and 2).
6
An essential condition for conducting the survey in a timely manner was the explicit guarantee of confidentiality. For that reason, IARCs are not identified in this report.
The majority of the categories of proprietary technology used by IARCs are protected by patents, though may be not in the countries where the CGIAR's clients operate. Concerning the permission for use, authorizations were mainly formalized by means of MTAs, licenses and sublicenses. It is worth mentioning that for nearly 40 research applications, the type of permissions were not known or lacking in the questionnaires. The survey also showed the need for immediate action by the IARCs to determine whether, and if so how, they need to revise or renegotiate licenses on the use of patents and other categories of protection. Also, where results are derived from proprietary science, some IARCs anticipate difficulties in dissemination, especially in the case of improved varieties or germplasm of mandate crops. Some Centres are also expecting to file for protection of new products. Examples are the potential patenting of an improved crop line with virus resistance; apomixis; and one vaccine. In addition, licensing is being considered for 11 different types of diagnostic probes.
A preliminary analysis of trade flows (imports and exports) for CGIAR research crops showed relatively minor proportions of such crops being exported from developing to developed country markets. This indicates that, while there will be specific difficulties in particular cases, problems of intellectual property infringement (by crops protected in developed but not in developing countries) may generally not be too serious (and for some crops, non-existent). This could of course change in the future. 7
7
Eran Binenbaum and Brian D. Wright. On the significance of South-North trade in IARC crops. Study commissioned by the Panel on Proprietary Science and Technology, CGIAR, 1998.
In conclusion, some Centres may be operating in a risky situation due to limited information and knowledge of IPR management and are in need of immediate IPR consultation for at least half of the technologies and materials identified. Also, Centres are relying primarily on MTAs generally issued for research purposes and not for development activities. Also, Centres are often unfamiliar with the implications of proprietary technologies regarding possibility for liability and implications for collaborative research.
