3.1 This chapter begins by describing the subject matter of gene patents, which comprises genetic technologies, natural and isolated genetic materials, and genetic products (such as proteins). Genetic materials and technologies are important in medical research and in the provision of healthcare. They are likely to become increasingly significant as more becomes known about the biological function of genes and the proteins they produce.[1]

3.2 The patent system must constantly accommodate new technologies. In the past 20 years, inventions in the field of biotechnology have become a new focus of the patent system, particularly in relation to genetic materials and technologies. This chapter provides a brief chronology of the patenting of genetic materials and technologies, as a background to the issues examined throughout this Report.

3.3 Gene patenting raises many social and ethical concerns. These include concerns about the social impact of gene patents on the conduct of research and the provision of healthcare; and ethical concerns about sharing the benefits of genetic research, consent to the use of genetic material in research that leads to commercial outcomes, and indigenous issues. This chapter summarises these concerns and explains the approach taken by the Inquiry in assessing possible problems with the patenting of genetic materials and technologies and in recommending reforms.

[1] An introductory ‘primer’ on the relevant genetic science was included in Australian Law Reform Commission, Gene Patenting and Human Health, IP 27 (2003), Ch 2.