Bio-Prospecting within South Africa: Indigenous Biological Resources and Traditional Knowledge
Persons carrying out research on indigenous biological resources and bioprospecting projects in South Africa need to consider the effects and requirements of both the Biodiversity Act, which comes into effect from 1 April 2008, and recent amendments to the Patents Act.
The Biodiversity Act
The enormous economic benefit that may be obtained from the exploitation of biological resources has lead to international conventions and agreements being formulated, such as the Convention on Biological Diversity to which South Africa has acceded and is bound. As a result, South Africa promulgated the National Environmental Management: Biodiversity Act No. 10 of 2004 (the Biodiversity Act).
The main objectives of the Biodiversity Act are to manage and conserve the biological diversity in South Africa and to ensure that indigenous biological resources are used in a sustainable manner. It also seeks to combat biopiracy and to ensure that indigenous communities share equally and equitably in the benefits flowing from bioprospecting and indigenous knowledge in South Africa. While the Biodiversity Act was promulgated in 2004, the Regulations relating to Chapter 6 (Bioprospecting, Access and Benefit Sharing) and Chapter 7 (Permit System) will come into force as from 1 April 2008.
As already mentioned, one of the aims of the Act is to combat what has been termed "biopiracy". Biopiracy is essentially the appropriation of intellectual property rights gleaned from indigenous knowledge or biological resources for commercial gain without the indigenous communities who originally developed the indigenous knowledge, or the country or community from whom the biological resources are obtained, benefiting from the commercialisation. There are a number of examples around the world of what has been considered to be biopiracy, including the use of turmeric in wound healing, the Rosy Periwinkle, the Neem Tree and the Enola Bean cases.
Bioprospecting is defined as research on, or development or application of, indigenous biological resources for commercial or industrial exploitation.
Indigenous biological resources are defined very broadly, but the term "indigenous" is taken to mean "South African". Some resources are specifically excluded, such as:
- genetic material of human origin,
- other exotic plants, and
- indigenous biological resources listed in the International Treaty on Plant Genetic Resources for Food and Agriculture.
The Regulations requires that one of three different types of permits be issued for each bioprospecting project: bioprospecting permits; integrated export and bioprospecting permits; and export permits for research other than bioprospecting. Any person already involved in a bioprospecting project as of 1 April 2008 has six months within which to apply for a permit, i.e. until 1 October 2008. Permits will not be issued to foreign persons or entities unless a South African person or entity is also a co-applicant.
Bioprospecting and integrated export and bioprospecting permits will only be issued if the relevant stakeholders have been identified; all relevant information has been disclosed to the stakeholders; the prior consent of the stakeholders has been obtained; and a material transfer agreement and/or benefit-sharing agreement has been entered into with the stakeholders. Benefit-sharing agreements must be fair and equitable and the public may be invited to comment on a benefit-sharing agreement before it is approved. The Biodiversity Act prescribes the content of material transfer and benefit-sharing agreements, and prescribed formats of material transfer and benefit sharing agreements are provided as Annexures 7 and 8 to the Regulations.
Any money due to a stakeholder in terms of a benefit-sharing agreement is to be paid into a trust fund to be established and administered by the Government, and the Government will be responsible for distributing the money from the fund to the relevant stakeholders.
Penalties for contravening any of the provisions of the Biodiversity Act or Regulations are provided. These include a criminal conviction and a fine or imprisonment for a period not exceeding five years, or both such fine and imprisonment.
Certain exemptions from the Biodiversity Act have been published. These include:
- Research other than bioprospecting, provided that it is conducted within the borders of South Africa. Such research may not be conducted for the purposes of commercial or industrial exploitation (the filing of a complete patent application relating to the research will constitute commercial exploitation);
- The export of ex situ indigenous biological resources (indigenous biological resources that occur in collections outside their natural habitat) for the purposes of research other than bioprospecting, provided that the exporter has entered into an export agreement and notified the issuing authority thereof;
- The trade of commercial products purchased from a bioprospector, provided that the bioprospector has complied with the Regulations on Bioprospecting, Access and Benefit-sharing;
- The keeping, breeding, cultivation, moving, trading and use of wildlife (defined to include mammals, birds, reptiles, amphibians, arthropods, fish and plants) not directed at the development and production of: products such as drugs, industrial enzymes, food flavours, fragrance, cosmetics, emulsifiers, oleoresins, colours and extracts; or
- new plant varieties and products;
- the collection, use, propagation, cultivation or trade of indigenous biological resources for domestic use or subsistence purposes;
- the artificial propagation, multiplication or cultivation of flora species for the local and international cut flower and existing ornamental plant markets;
- aquaculture or mariculture activities involving fresh water and marine species producing specimens for consumption purposes.
Amendments to the South African Patents Act
The Patents Amendment Act No. 20 of 2005 is linked to the Biodiversity Act in that it requires that every applicant who lodges an application for a patent accompanied by a complete specification, must state whether or not the claimed invention is:
- based on or derived from an indigenous biological resource or an indigenous genetic resource; or
- based on or derived from an indigenous biological resource or an indigenous genetic resource and also based on or derived from traditional knowledge or use; and
- if the invention is based on or derived from traditional knowledge or use, whether it is co-owned by the owners of the traditional knowledge or use.
"Indigenous biological or genetic resource" means a South African biological or genetic resource. Similarly, "traditional knowledge or use" means the knowledge or way in which an indigenous community has used the indigenous biological or genetic resource.
These amendments to the Patents Act came into force on 14 December 2007 by proclamation and with the publication of Regulations for the Patents Amendment Act.
As a result, every applicant for a patent (with the exception of provisional patent applications) filed in South Africa on or after 14 December 2007 is required to lodge a declaration or statement on a Form P26, irrespective of the nature of the invention sought to be protected. It will not be possible to obtain a patent if the required statement is not lodged at the Patent Office. It is important to note that if the statement on the P26 contains a false statement or representation which is material and which the applicant knew, or ought reasonably to have known, to be false at the time when the statement or representation was made, the patent can be revoked. Furthermore, it is likely that in a case where a false statement is made, it will not be possible to take any corrective action, which could result in the patent being revoked.
The Form P26 should be filed within six months (extensions can be obtained) of filing the patent application in South Africa.
As mentioned above, it should be noted that the required statement relates only to indigenous (i.e. South African) biological or genetic resources and traditional knowledge. In other words, the required statement does not refer to biological or genetic resources or traditional knowledge from countries other than South Africa. It should also be noted that the genetic resources to which the amendments to the Patents Act relate are broader than the indigenous biological resources defined in the South African Biodiversity Act. More specifically, the amendments to the Patents Act do not have the exceptions and exemptions that are included in the Biodiversity Act.
If an applicant acknowledges that the invention is based on, or derived from, an indigenous biological or genetic resource or traditional knowledge, the applicant must submit proof of their title or authority to make use of the resource or traditional knowledge by lodging one of the following:
- if applicable, a copy of a permit issued in terms of Chapter 7 of the Biodiversity Act;
- if applicable, proof that prior consent has been obtained as contemplated in Chapter 6 of the Biodiversity Act;
- if applicable, proof of a material transfer agreement as contemplated in Chapter 6 of the Biodiversity Act;
- if applicable, proof of a benefit-sharing agreement as contemplated in Chapter 6 of the Biodiversity Act;
- if applicable, proof of co-ownership of the invention for which protection is claimed; or
- any other proof to the satisfaction of the Registrar.