Sir

Biotechnology offers great potential for improving health and food production in the developing world, and achieving both will require significant cooperation between the public and the private sectors.

Such cooperation is being made more difficult by the accumulation of intellectual property rights (IPRs). These include in particular patents on genomic information, and on the basic tools of agricultural biotechnology such as important genes, promoters, and transformation methods. Patent considerations have already had to be taken into account in arranging dissemination of the new vitamin A-enriched rice (see discussions at http://www.agbioworld.org; archive message 503 gives the details). Not surprisingly, IPRs in biotechnology are highly controversial. Yet there is a dearth of knowledge about their impact, and about appropriate responses.

A concerned group of scientific, legal and economic experts in both agriculture and medicine, from the developed and developing worlds, met at the Rockefeller Foundation's centre at Bellagio in Italy earlier this year to discuss this matter. A number of priorities emerged: the first is to discover whether there really is a problem. Systematic study is needed, for example, of the 'platform' and enabling technologies that are most likely to be valuable to developing nations, to find out whether current IP practices present a barrier to access.

Allegations of direct infringement, such as those made in recent claims lodged by the University of Rochester against pharmaceutical firms marketing Cox-2 inhibitor drugs1, are not the only concern. We need to know whether the increasing emphasis on IPRs has led researchers to focus on areas likely to maximize royalty income, rather than address developing-world needs.

Information is also needed on whether research institutions, concerned about their relations with donors, are avoiding technologies that they are legally free to use in a limited context. Will international agricultural research institutes, for example, distribute crop varieties containing a Bt gene that is unpatented in developing countries, but patented in donor countries?

If there is a problem, the second need is to explore the potential to fine-tune IPR systems. Adjusting standards for granting patents might limit the scope for restricting access to basic or enabling technologies. We need to examine concepts such as ‘experimental use’ and ‘dependency licences’, which permit use for certain experimental purposes and for develop follow-on inventions. These could avert problems such as those faced by the US National Institutes of Health in gaining access to Cre-lox technology2. The evaluation will include an economic analysis and the implications for health care and agriculture. Important lessons may be learnt from examining past changes in national IP systems.

Other changes also deserve attention. There is an urgent need to examine the legal remedies available to developing countries that find their access to important technologies and products restricted by IPRs — highlighted, for example, by the recent debate over HIV/AIDS drugs in South Africa. Compulsory licences are frequently mentioned in this context. But other approaches exist, such as the public funding of licences, technology exchanges, anti-monopoly mechanisms, and creative use of the leverage available to major donors.

Better understanding of how to manage and license intellectual property in the public sector is also required. When should inventions be licensed exclusively and when non-exclusively? When should inventions originating in the public sector be put in the public domain without legal protection? Some major research organizations such as the International Maize and Wheat Improvement Centre are trying to keep their resources freely available by patenting them before private companies can seize the chance to do so3.

The adoption of the Trade-Related Aspects of Intellectual Property agreement (TRIPs) means the roles of international institutions in area of trade and intellectual property are changing significantly.

The development of international policy needs to be closely studied. This research is likely to lead to proposals for strengthening the participation of developing nations, and modifying procedures for negotiation and resolving disputes.