In a joint submission by India, Brazil, Cuba, Bolivia, Colombia, Dominican Republic, Ecuador, Peru and Thailand to the council for Trade Related Aspects of Intellectual Property Rights (Trips) at the World Trade Organisation, the countries have stated that it should also be seen that the shares of benefits that accrued to the source and country of origin or local and indigenous community, was equitable and fair in the circumstances. The submission underlined a number of factors that could be used to make this determination.
It stated that assuming that there was sufficient prior informed consent, the sharing of benefits should be promised upon mutually agreed terms in the context of the provisions in the convention on bio-diversity (CBD). Mutually agreed terms generally cover elements relating to the conditions, obligations, procedures, types, timing, distribution and mechanisms of the benefits shared.
The submission added that there should be a reporting obligation on issues relating to patenting or commercialisation especially where future benefit-sharing is contemplated.
In this regard, given that CBD recognises the rights of states to prescribe the conditions of access to the genetic resources that are under their sovereign jurisdiction, it is expected that the prevalent laws and practices of the countries of origin of the genetic resources and associated traditional knowledge should provide the framework within which to determine the terms of fair and equitable benefit-sharing.
The submission clarified that a requirement for patent applicants to disclose evidence of benefit-sharing and prior informed consent would not be intended as a replacement for or alternative to national access and benefit-sharing regimes. On the contrary, it is intended that a requirement of disclosure of evidence of benefit-sharing would operate, in effect, as a vital supplementary measure and a necessary incentive for patent applicants to comply with the prevalent laws and practices of the countries of origin of the genetic resources and associated traditional knowledge, in accordance with the objectives and norms of CBD.
Where the failure to provide evidence of benefit-sharing is discovered after the grant of a patent, the legal effect could include revocation of the patent where it is determined that there is fraudulent intention or as an alternative to revocation, criminal or administrative sanctions may also be imposed.