Forget the piracy off the Somali Coast; South Africa has some piracy of its own – Biopiracy
18/08/2010

Earlier this year, the little Eastern Cape town of Alice successfully fought against a German pharmaceutical giant in order to protect its biological resources. Plants that were identified as having medicinal properties were harvested from South African farms and exported overseas to be used in the manufacture of pharmaceutical compositions which were used to treat various ailments. The locals received a small wage for stripping farm land of these plants and several patent applications were filed by the German pharmaceutical company in an attempt to create a monopoly over the right to these plants.

Biopiracy occurs when a corporation from the developed world claims ownership of, or otherwise takes unfair advantage of, the genetic resources and traditional knowledge and technologies of developing countries without the consent of that country.

The case related to a plant species that is indigenous to the Eastern Cape. Pelargonium Sidoides and Pelargonium Reniforme are both medicinal plants that have been used locally for hundreds of years. Pelargonium Sidoides in particular has been used by the Zulu, Basotho, Xhosa and Mfengi tribes to treat coughs and upper respiratory tract infections. Locally, this bulbous root plant is known as “umckaloabo”, meaning heavy cough. The issue arose because Schwabe Pharmaceuticals, the German company, had registered patents or applied for patents relating to the use of these plant extracts for the treatment of the very same ailments that they have been treating locally for centuries, and more importantly (from a biopiracy point of view) these plants had been taken from South Africa for use in the manufacture of these medicaments without compliance with the laws that regulate biological species.
The effect of the grant of these patents would have been to provide a 20 year monopoly to the pharmaceutical giant which would prevent any other party from making use of the plants to extract the medicinal compounds, something that traditional healers had been doing in South Africa already. The patents were successfully opposed in Munich by, amongst others, the African Centre for Biosafety and the Swiss NGO, the Berne Declaration, on several grounds including lack of novelty, lack of inventive step and non-patentable subject matter.

After losing the case in January, Schwabe Pharmaceuticals announced in April of this year that it would no longer be pursuing any of the five patents and/or patent applications that related to Pelargonium Sidoides and Pelargonium Reniforme which were opposed.

South Africa is considered the third most biologically diverse country in the world meaning that it has one of the richest genetic pools in the world. This is something which South Africans are rapidly becoming more aware of and they are also, at a slightly less rapid rate, becoming aware of the critical importance of protecting their inherent genetic wealth.

Advances in molecular science techniques allow for the doors to the genetic pool of this biologically diverse country to be opened. The economic value of biodiversity and its genetic pool has been one of the reasons for a number of agreements, conventions and laws that have arisen with a central goal of protecting these resources. The Convention on Biological Diversity (CBD) and the agreement on trade-related aspects of intellectual property rights (TRIPS) are two such agreements. TRIPS provides the minimum requirements to the protection of Biodiversity throughout the world, whist the CBD provides a more detailed set of requirements which each member state must comply with. The objective of the CBD is: “the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.”
The CBD recognizes the intrinsic value of biodiversity and the importance of conservation and sustainable use of plant genetic resources. South Africa has implemented national legislation to comply with the objectives of the CBD.

The South African National Environmental Management: Biodiversity Act 10 of 2004 is complemented by the South African Patents Amendment Act 20 of 2005 to regulate the use of biological resources and accompanying traditional knowledge in South Africa.

The Biodiversity Act regulates the bioprospecting of genetic material and provides for the fair and equitable sharing of benefits arising from the bioprospecting of genetic material derived from indigenous biological resources. In addition to this, it includes the steps that need to be taken when traditional knowledge accompanies the genetic resource.

Before a party may legally bioprospect in South Africa, in terms of the Biodiversity Act, that party must obtain a permit from the South African government, and this permit will only be granted if the community possessing the indigenous resource has consented to the terms of a benefit-sharing agreement. In addition to this agreement, a material transfer agreement must be entered into with the holders of the traditional knowledge, if such is associated with the genetic material.

The biodiversity Act is complemented by the Patents Amendment Act which provides that every applicant for a patent in South Africa must, within six months of filing a patent application, lodge a statement (on Form P26) disclosing whether or not the invention disclosed in the patent specification that accompanies the application Is based on or derived from an indigenous biological resource, genetic resource or traditional knowledge or use. Any failure to lodge this statement or any misrepresentation included in the statement may be grounds for the revocation of the patent to which the statement relates.

The South African Biodiversity Act and the Patent Amendments Act show South Africa’s commitment to its international obligations in terms of the CBD and also its commitment to the protection of its genetic heritage.
Alison Baker
Professional Assistant
alison-b@adamsadams.co.za