The patenting of genetic materials has become a matter of public concern and controversy in recent years, stemming particularly from the patent claims and practices of one company in relation to BRCA1 and BRAC2, the most common mutations for breast cancer. These concerns relate to the potential: (a) increased cost of testing—and the access and equity issues that flow from this; (b) restriction of testing to labs directly associated with the patent-holder; and (c) restrictions on further research and development. As a consequence, on 17 December 2002, the Australian Government asked the Australian Law Reform Commission (ALRC) to conduct an inquiry into the relevant laws, international obligations and practices relating to ‘Gene Patenting and Human Health’. After extensive professional and community consultation, the ALRC’s 700 page report, Genes and Ingenuity (ALRC 99, 2004) was completed in June 2004, and tabled in Parliament in August 2004. The ALRC made 50 recommendations for reform, including amendments to the Patents Act (Cth) to upgrade the burden of proving ‘usefulness’ (utility)—and thus to sharpen the distinction between mere ‘discoveries’ and patentable ‘inventions’—and to provide an express ‘experimental use’ exemption for researchers. The ALRC also recommended a significant upgrading of the skills and resources available to the Patent Office and patent examiners, and called for a far more active and strategic approach by federal and state Governments and Health Departments, in monitoring and challenging patents where appropriate, seeking to preserve the benefits of publicly-funded research, and using their existing legal powers more effectively (e.g., ‘Crown use’ rights and compulsory licences). The ALRC’s findings and recommendations in Genes and Ingenuity have been validated and adopted (expressly or coincidentally) by virtually all of the major international reports that have followed in the last five years, including the OECD’s 2006 Guidelines for the Licensing of Genetic Inventions, and the US Government’s Gene Patenting Task Force in 2009. Remarkably—and despite the topicality, media coverage and continuing public disquiet—the Australian Government has still not responded to the Genes and Ingenuity report. Besides the international reports mentioned above, several other significant developments have occurred in the years following ALRC 99, including the Senate Community Affairs Committee report on’the granting of patent monopolies in Australia over human and microbial genes and non-coding sequences, proteins and their derivatives’ in 2010; a major test of gene patents in the American courts; and a shift in the traditional approach by the US Government under President Obama from its support for the primacy of intellectual property rights towards a more access and equity-based policy.