Have Intellectual Property Problems Been a Major Hindrance to Diffusion of Agricultural Biotechnology in Other Countries until

In the international agricultural research community, the belief has been widespread that patents have been hindering access to important plant biotechnologies for developing countries. Talk by economists of international 'violation' of US patents indicates that their reach in the non-profit sector can extend well beyond the geographic bounds of their legal, if not their political, reality, and certainly beyond the scope of protection recognized by well-informed private firms.

Such confusion is encouraged by well-publicized news stories of donations of IPRs for technologies patented in Europe, the USA and other rich countries such as 'Golden Rice', virus-resistant potato, sweet potato and yam for use by poor farmers in developing countries.15 The reports often imply that IPRs would otherwise constrain such research and innovation in those developing countries.

Thus, the Nuffield Council on Bioethics (2004, p. xix) commented that 'the recent example of Golden Rice shows that patented technologies need not necessarily be a barrier'. In fact, few or no relevant IPRs existed in most of the developing countries among the top 15 importers or producers of rice (Kryder et al., 2000; Binenbaum et al., 2003).

Innovators generally do not file for patent protection in many developing countries, even where they could do so. (After all, it is quite expensive.) Moreover, the main staples for the poor in such countries are largely consumed domestically; the portions exported to rich countries where imports are subject to relevant domestic patents are typically small (Binenbaum et al., 2003). Finally, indigenously developed modern biotechnology has not been commercially applied in those countries yet. Patent-holders typically have little or no incentive to constrain upstream research. Prior to commercialization, little or no recoverable damages are generated. In fact, patent-holders are often happy to see their technology locked into an innovation, because the investment committed, in time as well as in resources, improves the patentee's bargaining position should the innovation proceed to commercialization.

Biosafety compliance, if at all achievable, can be very costly. Redenbaugh and McHughen (2004, p. 109) report these costs to be at least US$1 million per allele for both horticultural and field crops, if approval is sought solely for the USA. Cohen (2005, p. 30) reports estimates of compliance costs of US$700,000, US$4 million and US$2.25 million for transgenic papaya and soybeans in Brazil and rice in Costa Rica, respectively. He observes that '[p]aradoxically, because they are novel, locally developed products pose unique challenges for institutes seeking regulatory approval. . . . In contrast, GM crops pre-approved in Western markets are more successful in gaining approvals in developing countries' (Cohen, 2005, p. 33). Kent (2004), drawing on his experience with biotechnology transfer to Africa, notes that biosafety regulations '. . . risk stifling the emergence of locally adapted technologies by making it too expensive to take even the first step in moving them out of the lab and into field conditions. This problem affects public and nonprofit researchers even more seriously than companies.'

Regulation of large firms and non-profit organizations is often easier to implement than regulation of a multitude of domestic farmers. Recent experience with soybean in Brazil and cotton in India shows that regulations and laws that delay or prevent importation or domestic commercialization of transgenic germplasm by large, highly visible plant-breeding firms can be ineffectual in preventing smaller breeders or farmers from introducing and adopting transgenic cultivars without any formal approval or regulation. The latter occurred on such a massive scale in both the Brazilian and the Indian cases that there appeared to be a loss of effective public regulatory control.16 Both examples illustrate that dissemination of transgenic technologies, if sufficiently attractive, can rapidly occur without IPP and without sponsorship by public authorities or large firms.

Even under optimistic assumptions, appropriate biosafety regulations, IPP and some components of adaptive research will impose fixed minimum costs on applications of biotechnology such as genetic transformation. Public involvement in these innovations will not be justified in cases in which the added social value of the innovative effort is below the fixed costs incurred. Early hopes that genetic transformation would be cheaper than back-crossing for introduction of new traits have been killed by costs of biosafety regulation.

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