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obtaining copyright or a patent does not in itself yield any direct commercial benefit. Such commercial benefits, if any, may arise only many years later after a specific product has been developed and successfully placed on the market. By this stage the IPR in the original genetic resources subject to the ABS agreement may have passed through several stages (i.e. from copyright to patent) and from several different ‘users’ (i.e. from research laboratory to SME to large corporation) whether by way of assignment or transfer. Of course in theory a well-designed ABS agreement should be able to anticipate such scenarios and address what third parties should be subsequently allowed to do with the material and knowledge. However it may well be the case that a ‘come back’ clause will be necessary such that if there is a change in the use of the material the consent from the (authorised) organisation in the provider country is obtained. Obviously pending the entry into force of the Nagoya Protocol it is impossible to evaluate how the system envisaged will actually work. Nevertheless is seems reasonably clear that it will be a challenging process, not only in terms of concluding ABS agreements but more particularly in terms of sharing of economic benefits with the country from which genetic resources were obtained, country A in this scenario, given the potentially long chain of actors and actions between the genetic samples and the final product. The key point to note here is that in terms of marine biotechnology the party that concludes the ABS agreement will in most cases not be the person who is able to successfully exploit the economic benefits of the genetic material. In theory of course the mechanism foreseen in the ABS Regulation, that of a contractual link back to the original ABS agreement, should work. The challenge will be more practical in terms not only of managing the contractual chain but also in terms of locating the precise source of genetic material used in inventions that are subject to patent applications, which may be sourced from gene banks or from different physical locations (for example from ABNJ as well as areas under national jurisdiction). A further point to note in this respect is that while practice may vary from country to country patent legislation typically does not require the source of genetic materials to be identified in the course of a patent application. The adoption of the Nagoya Protocol has seen repeated calls from developing countries who have sought to argue for this point to be regulated through an instrument adopted within the auspices of the WIPO or TRIPs. Finally in terms of ABS relating to marine genetic resources acquired in ABNJ the current situation is one of potential uncertainty. In terms of future legal obligations as regards benefit sharing much may depend on the outcome of the negotiations currently under way at the UN in connection with the possible adoption of an impact assessment. However, if the example of the regime for seabed mining in the Area provided for in Part XI of UNCLOS is any indication (in so far as the rights of pioneer investors` were specifically recognised or `grandfathered` in UNCLOS and in Part XI Deep Sea Mining Agreement) it seems reasonable to assume that the rights and interests of those holding IPR relating to marine genetic resources sourced in ABNJ at the time of adoption of an IA would be respected. Use, manufacturing and marketing Before Blue Biotechnology products can be placed on the market they are typically subject to a range of regulatory approvals that depend on the type of product in question such as pharmaceuticals, cosmetics and food. However such regulatory approvals are of general application and as such are not focussed only on the marine biotechnology sector. For example, 208 Study in support of Impact Assessment work on Blue Biotechnology

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