The Hoodia plant is a relatively unspectacular succulent of the genus Hoodia, of which a number of species are indigenous to
In 1997, the South African Council for Scientific and Industrial Research (CSIR) filed a patent application relating to the Hoodia plant at the South African Patent Office. The application was entitled “Pharmaceutical compositions having appetite suppressant activity”. This application was later completed and a number of corresponding foreign patent applications were filed. On the face of it, the CSIR appears to have acted in an exemplary manner. It is reported that the CSIR awarded a licence to the UK-based company, Phytopharm plc, to exploit the CSIR intellectual property. Phytopharm has proceeded on a program for the development of an appetite suppressant drug. For their part, the CSIR are reported to have signed a benefit-sharing agreement with the San Council and the San people have apparently already received substantial benefits arising out of the agreement with the CSIR. Why is it then that issues surrounding the exploitation of Hoodia resurface from time to time in the news media and in academic debate?
In compliance with its obligations under the CBD,
Some insight into the arguments in issue may be obtained by looking at the actual patent applications relating to the Hoodia plant filed by the CSIR. The specification of the US patent (US 6,376,657) reveals that the claims of the patent (ie the section of the patent that determines the scope of protection) are directed to an extract from a plant of the genus Trichocaulon or of the genus Hoodia which comprises an appetite suppressant agent having a complex chemical formula, which is specified in the claim. Various other independent claims all include complicated chemical formulae or processes. The claims of the corresponding South African patent specification are somewhat different and, in addition to claims directed to complex chemical compositions and processes, include, for example, claims directed to simple processes for the extraction of a an appetite suppressing agent from the Hoodia plant. However, what should be borne in mind is that if such claims are anticipated by the agents or processes used by the San, then they are invalid in terms of the ordinary patent law. To the extent that the CSIR attempted to claim a monopoly in the Hoodia plant or the traditional knowledge used in practice by the San, their patents are invalid. To the extent that these patents protect inventions that relate to the Hoodia plant, but are not simply regurgitations of information that was commonly known and used by the San, these inventions may be patentable and one would want them to qualify for patent protection, since this is the only way in which the San can obtain any commercial benefit from their traditional knowledge.
In developing drugs, the pharmaceutical industry must comply with rigorous standards set down by various agencies throughout the world. In order to do so the drugs must be tested and shown to be safe for human or animal use. This process is extremely time consuming and very expensive. Further, in order to commercialise a pharmaceutical product, it is necessary to be able to identify and extract the active ingredient and, preferably, to synthesise that ingredient. This is the process that is currently under way in respect of the Hoodia appetite suppressant composition and, at least in this example, what is clear is that idea that the large pharmaceutical companies are simply stealing inventions from indigenous peoples is a misrepresentation of the facts. In all probability, the lead given to the CSIR researchers by the information provided by the San people to the effect that they had used the Hoodia plant for many years and was of considerable value, but the process of developing a safe, commercially reproducible and effective drug based on that information probably required considerable inventive skill and effort, not to speak of funding.
In any event, one may well ask whether the whole project for the protection of genetic resources and traditional knowledge is not misguided. Two aims seem to be detectable in the arguments put forward by the developing nations. Firstly, there is an attempt to establish repositories of knowledge containing information about traditional knowledge and indigenous biological resources. The aim is to prevent monopolisation of this knowledge by way of patents filed by non-indigenous persons (particularly by bio-pirates in the developed world). There is nothing obviously wrong in this. However, the fact that an invention has been known and used is sufficient to invalidate any attempt to monopolise the invention by way of patent protection in most countries of the world, whether or not such knowledge or use is documented in the manner proposed. The accumulation of this knowledge and its provision in a readily accessible format merely makes access to information easier. Secondly, there is an attempt to obtain compensation for the use of indigenous biological resources and traditional knowledge in the development of new inventions, particularly pharmaceuticals. Again, in principle there is nothing wrong with this. However, the devil is in the detail. Who, for example, is the San Council? Do they represent all of the San people and does the money derived from the benefit-sharing agreement with the CSIR reach all of the San people. The San people are distributed quite widely over
Many other similar questions arise in relation to attempts to protect indigenous biological resources or traditional knowledge. However, perhaps the most important question is one which is not asked, namely: Why is it that developing nations such as
Frank Joffe is a director at Bowman Gilfillan.