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Discovery Phase Researchers No Longer Require A Bioprospecting Permit




On 27 May 2009, the National Environmental Management: Biodiversity Act 2004 was amended to allow academic researchers to continue working with indigenous South African biological resources or traditional knowledge without obtaining a bioprospecting permit.

This amendment addresses the concerns of local researchers that have been the subject of vigorous debate since the Biodiversity Act came into law in 2004. However, although bioprospecting permits are no longer required for the discovery phase of bioprospecting, a bioprospecting permit must be obtained for the commercialisation phase of bioprospecting. Therefore, before any project involving a bioprospecting discovery phase is initiated, notice must be given to the Minister of Water and Environmental Affairs, together with a commitment to comply with the requirements of the Act should the project progress to a commercialisation phase.

The amendment specifies how to determine when a bioprospecting project crosses the line from the discovery phase to the commercialisation phase. A project is deemed to be in the discovery phase if the potential commercialisation or industrial exploitation in relation to the project is not sufficiently clear or known to begin the process of commercialisation. However, the filing of a complete patent application anywhere in the world, the commencing of clinical trials and product development, or the obtaining or transferring of any intellectual property rights will result in the bioprospecting project being regarded as having entered the commercialisation phase. Further activities that infer the start of the commercialisation phase include the multiplication of indigenous biological resources through cultivation, propagation or cloning, or other means to develop and produce products, such as drugs and industrial enzymes to name a few.

From a practical viewpoint it is now necessary for researchers intending to patent subject matter arising from a bioprospecting project to first apply for, and obtain, a bioprospecting permit before filing a complete patent application.


 

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