Transgenic crops from another perspective

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Meeting report

Transgenic crops from another perspective he significance of transgenic T plants for developing countries was the theme of a recent conference* that brought together speakers and participants from India, Africa, Asia, Europe and the USA. The wider aspects of technology transfer from developed to developing countries were discussed, including regulations, biosafety and societal implications. The meeting was open to the public, and the organizers obtained authorization from the Swiss Agency for Environment, Forests and Landscape to display virus-resistant papayas that were freshly shipped from Hawaii. (Switzerland has authorized four transgenic crops for food and feed use; three cultivars of corn and one of soybean.) This was an opportunity to familiarize the European public with a transgenic product that is rarely mentioned in the European debate surrounding transgenic crops but has had a significant impact on the Hawaiian economy. Over a two-year period in the early 1990s, the spread of the papaya ringspot virus (PRSV) in the Puna district of the Big Island had devastated papaya plantations there. Dennis and Carol Gonsalves (Cornell University, Geneva, NY, USA), and Michael Goldman (Nixon, Hargrave, Devans & Doyle, Rochester, NY, USA) presented a compelling and comprehensive case study of the PRSV-resistant papaya, and its rapid evolution from the subject of a research project to a possible solution for saving the endangered livelihoods of papaya growers in Hawaii. The progression from laboratory to the commercial planting of transgenic papaya in the USA required a full orchestration of science, and this experience gained can serve as a model for the transfer of papaya and other products to developing countries. *The Significance of Transgenic Plants for Developing Countries was organized by UNIDO and the Agencies BATS and BICS of the Swiss Priority Programme Biotechnology of the Swiss National Science Foundation, and was held at Basel, Switzerland, 30 November – 2 December 1999.

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National markets for transgene crops Crops such as papaya can satisfy the national niche markets that the major transnational companies do not emphasize. In developing countries there are other sets of criteria and expectations for the use of genetic engineering in plant breeding. The presence of a sound regulatory review process is necessary for the promotion of ‘biotechnology for the public good’ (Ajay Parida, Swaminathan Foundation, Chennai, India). In India, the promulgation of the rules for dealing with genetically modified organisms (GMOs) took place in 1989, and committees were established to review and monitor research, movement and commercial release (such as the Review Committee on Genetic Manipulation, RCGM, and the Genetic Engineering Approval Committee, GEAC)1. Over the past ten years, the Department of Biotechnology (Ministry of Science and Technology) has established seven Centres of Plant Molecular Biology, which focus on major national crops, such as wheat, rice, brassica, cotton, chickpea and other important pulses. Although there are no commercial plantings of transgenic crops in India to date, field trials are either under way, such as for eggplants that express the gene encoding CryIAb (India Agricultural Research Institute), or under preparation, such as for rice that expresses the gene encoding synthetic CryIAc (K. Veluthambi, Madurai Kamaraj University, Madurai, India) (CryIAb and CryIAc belong to the family of bacterial endotoxins produced by Bacillus thuringiensis). John Wafula (Kenya Agricultural Research Institute, Nairobi, Kenya) reminded the conference participants of the reality of hunger in Africa and urged them all to forego the narrow view of plant genetic engineering that is propagated by the anti-GM movement in Europe. Although the debate in Europe is taken seriously in Africa, Africa still needs to improve its crop production. In 1997 and 1998 the overall maize yield in subSaharan Africa was only 15% of

that achieved in the USA (Ref. 2). Reasons for massive crop failure include the lack of frequent rainfall, and crop destruction by disease and pests. The flowering witchweed, Striga spp., parasitizes the roots of all major grain and legume crops in subSaharan Africa, threatening the lives of resource-poor farmers when complete yield losses occur3 (Jonathan Gressel, Weizmann Institute of Science, Rehovot, Israel). As the weed proliferates, the ‘bewitched’ crop is sapped of its energy and the soil depleted of nutrients. Biotechnology solutions, such as transforming herbicide tolerance genes into the crop, could help to control Striga. However, as Michael Goldman (Nixon, Hargrave, Devans & Doyle) pointed out, there are patents covering many commonly used genetic components and plant transformation procedures in the field of transgenic biotechnology. ‘The technology is there’ said Dennis Gonsalves, ‘It’s the people who make the transfer happen.’

International guidelines and safety Other key elements in the transfer of technology from developed to developing countries, include international guidelines and safety considerations regarding the environmental use of transgenic organisms. Since the workshop, the Cartagena Protocol has been concluded to ensure ‘an adequate level of protection in the safe transfer, handling and use of living modified organisms resulting from modern technology’. (See the Report of the Fifth Meeting of the Conference of Parties to the Convention on Biological Diversity, May 2000; www.biodiv.org). The Cartagena Protocol is not meant to act as a substitute for a national framework, but its adoption might help to stress the importance of national legislation and capacity building in biotechnology. Because the capacity and resources to exercise regulatory oversight are, in most cases, severely limited for developing countries, a tool such as the computerized decision support system for risk assessment of transgenic crops could help to assemble, organize and deliver the scientific information needed to assess the potential risks arising from the use of transgenic crops in the environment

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(George Tzotzos, UNIDO, Vienna, Austria). Examining the impact of gene flow between crops and wild plants is a fundamental part of the risk assessment. Associating the word ‘risk’ with a natural process of pollen movement detracts attention from the important issues that are related to the impact of gene movement in the environment. The extent of gene movement between crops and weeds should be examined on a case-bycase basis in different geographic regions, and examples from conven-

tional agriculture show that crop genes can persist for many generations in wild populations (Allison Snow, Ohio State University, Columbus, OH, USA). The creation of efficient information-sharing channels for scientific knowledge would support the scientific aspect of regulatory decisions. Because each country also possesses a unique set of regional and cultural determinants surrounding the use of transgenic plants, this part of technology application can only be carried out through conversation with society.

References 1 Ghosh, P.K. and Ramanaiah, T.V. (2000) Indian rules, regulations and procedures for handling transgenic plants. J. Sci. Ind. Res. 59, 114–120 2 Chetsanga, C.J. (1999) Exploitation of Biotechnology in Zimbabwe. Conference on Ensuring Food Security, Protecting the Environment, Reducing Poverty in Developing Countries. Can Biotechnology Help? 21–22 October 1999, World Bank, Washington, DC, USA 3 Berner, D.K. et al. (1995) Striga Research and control: a perspective from Africa. Plant Dis. 79, 652–666

the entire meeting – these debates will run for some time yet. Judith Pritchard (Zeneca Agrochemicals, UK) dealt with similar themes and with high-throughput screening techniques for chemical compounds with medical or agrochemical applications. The problematic topic of claiming compounds by function, rather than by chemical formula definition, was also covered. Strategic timing of patent applications and the black art of deciding who is legally the correct person to be named as inventor in this sort of investigation were raised. Alison Blakey (SmithKline Beecham, UK) explained combinatorial chemistry and the various types of combinatorial library that can exist, an unusual topic for a patent audience. The subject of how such a library could be patented, and whether it might pre-empt the subsequent patenting of individual compounds within the library when they are proven active, stretched the imagination of the audience, although examples were provided to show that this is not an entirely fictional activity. Gordon Wright (now Elkington and Fife, Sevenoaks, UK) concentrated on pharmaceutical chemical topics in light of the on-going European patent controversy surrounding broad claims. In a mind-expanding contribution, he put forward for consideration the idea of claiming compounds by functional definition based on their interaction with drug receptors. This idea was exemplified by the Vertex patent application on inhibitors of the interleukin 1-b converting enzyme (ICE) which claims the compounds with reference to their fit in the ICE-binding

Meeting report

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Genomics, proteomics and patents iven that patent law inevitably G lags behind the technologies it has to cope with, there is a danger that conferences about patenting* will seldom live up to their titles and promises. However, this criticism does not apply to the initiative of the Euroforum group. In coming years, patent offices and courts will have to deal with the expanding disciplines of genomics and proteomics, but even now they are gearing up for this challenge by gaining experience of dealing with patent issues that relate to biomolecules of various types, such as full length genes, receptors, expressed sequence tags (ESTs), and single nucleotide polymorphisms (SNPs). The international team of patent attorneys, chosen by Euroforum to guide us in the evolving art of patent knowledge and to provide skills in these fields, addressed many aspects of this issue. David Forman (Finnegan Henderson, Washington, DC, USA) summarized the issues that arise for the US Patent Office (Box 1) when patent applications on ESTs are examined. After some years of uncertainty, a framework is now emerging on which to apply the official utility and enabling disclosure requirements of US patent law to ESTs [The use of an invention is required and the patent must enable a skilled person to reproduce the invention (enabling disclosure)]. This framework will suffice until the important questions *The Patenting in the Age of Genomics conference was sponsored by Euroforum and held in London, UK, 5–6 July 2000.

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Lillian Auberson Agency BATS, Clarastrasse 13, CH-4058 Basel, Switzerland (E-mail: [email protected])

are decided by the courts. This framework will attempt to deal with the difficult question of claim scope (i.e. claims that include the use of words such as ‘comprising’ or ‘consisting of’) in relation to subsequent discovery of full length genes. Keith Percy (BTG International, London, UK) used many examples to expose some of the proteomic techniques, at the root of patents and applications, that are now surfacing and placing demands on comprehension. Attorneys were given clear and impressive instructions on how they must expand their technical knowledge if they are to do their job effectively in these fields. How to define proteins for the purposes of patent claiming was also covered. Patenting the uses of proteins for drug screening and the policing of such patents raised many problems for this speaker, a view shared by most of the audience. The patenting of biological targets, including receptors, enzymes and assay methods, was dealt with by Leo Polz (Hoffmann Eitle, Munich, Germany). He exemplified these topics, first with a patent claiming the binding pocket geometry of the graft rejection enzyme calcineurin; second with a patent on the ‘threehybrid system’ of Licitra and Liu; and, finally with the field of G-protein-coupled receptors, illustrated by Rhodopsin. The issue of claiming compounds discovered using screening methods was also addressed by Polz; this is the notorious topic of ‘reach-through’ claims that provoked lively debate throughout