Yesterday, NSW Liberal Senator Bill Heffernan, introduced the Patent Amendment (Human Genes and Biological Materials) Bill 2010 into Federal Parliament. The Bill has the potential for significant ramifications for the biotechnology industry in Australia. The Bill seeks to fundamentally amend the Patents Act 1990 by expressly excluding from patentability “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.”1 In the proposed amendment, biological materials are defined to “include[s] DNA, RNA, proteins, cells and fluids.”
This development is a tangible result of the so-called “gene patent debate” that has been simmering for some time now in Australia and elsewhere. In advance of the introduction of the Bill, Ausbiotech, Australia’s peak biotechnology industry association, recently expressed deep concern that some of the views being expressed in the debate were "founded on incomplete information". Ausbiotech called for more informed consideration of the critical issues at stake, noting that the social and economic benefits provided by patents, which act to drive and facilitate innovation, will be severely impacted in an unintended manner if the fundamental changes to the Patents Act are allowed to proceed.2
In a related development, the final report of a Senate Committee inquiry into the impact of patenting of human genes and genetic materials is set to be presented to parliament today. The Committee was directed to inquire into the impact that such patents have had on the provision of healthcare, the accreditation for healthcare professionals, the progress in medical research and the overall health and wellbeing of the Australian people.
Before it can be enacted into the Patents Act, the Bill will be the subject of parliamentary debate. We will keep you updated as any news breaks.
1Patent Amendment (Human Genes and Biological Materials) Bill 2010 (Cth)
2Ausbiotech, 'Call for calm in gene patent debate', 17 November 2010