Patenting of human genetic material in Australia

Attempts to patent human genes by large biotechnology companies are viewed with intense suspicion within the wider community. Religious groups, indigenous peoples, scientists and even companies themselves are beginning to recognise that excessively broad patents on genes may be inappropriate. Research on human genes, on the other hand, is recognised as providing many benefits to society, particularly in the diagnosis and treatment of genetic diseases. Effective diagnosis and treatment will require considerable investment in research by biotechnology companies. Companies will not provide that investment without protection of the type usually afforded by the patent system. Tensions between the need for companies to patent their research and the perceived inappropriateness of patenting human genes have not yet been fully explored in Australia. My aim in this thesis is to explore these tensions and suggest means for reconciliation. The threads of the debate on patenting genes are difficult to unravel. Before a full assessment of the issues can be made, a description of the two highly technical areas of Australian patent law and genetics is required. I first provide those descriptive backgrounds, thereby establishing the framework around which the other issues can be assessed. 1. The ethics of human genetic research. Regimes already exist outside the patent system for ethical scrutiny of all biomedical research, including human genetic research. Human genetic research also raises questions involving invasion of privacy and genetic discrimination, for which the law may not yet provide adequate safeguards. 2. The role of commercialisation in human genetic research and its applications. Development of genetic products occurs within a competitive commercial environment. There is a need to moderate the excesses that might occur in a purely market-driven system. 3. Patenting of human genetic material. Australian patent law principally requires: ‚Äö an invention ‚Äö full disclosure ‚Äö commercial applicability ‚Äö novelty and ‚Äö an inventive step. Provided that these requirements are met human genetic material is patentable, apart from gene sequences of unknown function and naturally occurring sequences. Patent rights should not be confused with real property rights. Nor should human genes be confused with life and humanity. Patents merely provide a temporary right to exploit an invention, they do not imply ownership. Once this distinction is realised many of the ethical concerns are adequately addressed by the current system. I conclude by recommending that the tensions associated with patenting human genetic material can be resolved within the patent system, principally through limitations that already exist but are seldom used.