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Patenting Lives Conference
Medicine and Public Health Panel
The Role of Intellectual Property in the South African Biopharmaceutical Innovation System
Marion Motari
This paper applies the Innovation Systems (IS) conceptual framework in order to move beyond studies that narrowly focus on the extent to which Intellectual Property Rights (IPRs) stimulate the creation of new knowledge and the application of this knowledge in production (innovation) in the biopharmaceutical sector in developing countries. It does so with reference to the South African case because this offers an opportunity to examine the emerging biopharmaceutical innovation systems in the context of a developing country with a relatively strong science base and research output. The hypothesis of this study is that IPRs are not necessarily the most essential tool for the creation and strengthening of innovation systems in South Africa and indeed in other Sub Saharan African (SSA) countries. Other factors as elucidated by the IS framework are likely to play a more important role than that played by IPRs.
This paper identifies and analyzes the factors that encourage learning and innovation in South Africa 's biopharmaceutical innovation system. These factors include the presence of the necessary actors in the system and the nature and intensity of linkages between these actors that necessitate learning. Institutions (in the sense of habits and practices) are also identified as influencing the way actors relate and share knowledge. Other factors include the presence of policy triggers to innovate and the pressures placed on the system by healthcare demands. This study draws on 2 bodies of literature namely, clusters literature and innovation systems (IS) literature and relies on both qualitative and quantitative research methods. The study hopes to contribute to the existing body of knowledge on the creation of and strengthening of innovation systems in developing countries by identifying the relevant stimuli for innovation and learning.
The Genetic Sequence Right
Luigi Palombi
In 1998 European Biotechnology Directive enabled an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, to be a patentable invention, even if the structure of that element was identical to a natural element. Despite the fact that in 2004 the Danish Council of Bioethics concluded that "it cannot be said with any reasonableness that a sequence or partial sequence of a gene ceases to be part of the human body merely because an identical copy of the sequence is isolated from or produced outside of the human body" the Directive is today a part of European Patent Convention. The problem is that art. 27.1 of TRIPS runs counter to the Directive and consequently patents so granted are most likely invalid.
The Genetic Sequence Right, a sui generis right is being proposed. This right (together with a ban on the patenting of Directive technologies) would replace all patents granted over Directive technologies and would see the establishment of a register of genetic and protein sequences that would record the first to file the disclosure of a new and useful sequence. The holder of the GSR (limited to ten years) would not have any exclusive rights regarding its use provided that the registered user first registered such use and second paid the prescribed fee or royalty. Any downstream innovation would not be subject of a claim by the GSR holder and could be the subject of a patent, assuming the conditions of patentability were first met. If the registered GSR holder was aided by information derived from indigenous, tribal or local knowledge, the holder would make full attribution in the register and the relevant peoples would be entitled to receive due compensation, whether monetary or otherwise, from the GSR holder. This paper considers the issues and makes recommendations as to the validity and relevance of this development in the law.Forfeited Consent: Body Parts in Eminent Domain
Angela Stanton
This paper considers the fundamental litigation in the controversial area of life patents, Moore v Regents of the University of California . Mr. Moore had a rare cancer of the spleen; his cells had an even rarer quality: immortality. Dr Golde, a UCLA physician and researcher, without Moore 's consent, used Moore 's cells and bodily fluids for his research, patented the cell line that he named Mo, and partnered with pharmaceutical companies to pocket the gains. When Moore found out about it by accident, he filed a lawsuit with 13 causes, from which three were of most importance: breach of fiduciary duty, lack of informed consent, and conversion. The Court gave inconsistent reasoning. It threw the cause of conversion out because Moore did not own his body parts—although it seems the researcher did. All other charges were ignored and the defendants dismissed. The Court reasoned that cells were of the same molecular structure in every human being; if so, why didn't the researcher use his own cells for research? Cells cannot be both so unique that it is important for them to come from Moore and so common that they exhibit the same molecular structure in every human being. Further, if not unique, it cannot be patented; if unique, it is not useful and should not be patentable. The court set up false premises and manipulated the means to reach a predetermined end: benefit the researchers. Our rights over our own bodies are not defined well and it appears that while we do not have rights, the researchers do. According to the judgment of Moore, we live in borrowed cells that we do not have the right to claim ours but the researchers may take any part to use for their own gain and for the greater good of the society - Moore's body cells became eminent domain. But the cell line was claimed to be worth about US$3 Billion for the pharmaceutical industry and several million for the researcher. This paper critiques the "eminent domain" whereby privatisation of life through patent delimitation is somehow prioritised over the public interest in the innovation and research.
