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Bio Technology : October 2009
44 Australasian BioTechnology Volume 19 • Number 3 • October 2009 AusBioFEATURE By The Hon Richard Marles, Parliamentary Secretary for Innovation and Industry. Gene patents: a very 21st Century dilemma Gene patents are at the intersection of cutting edge technology, modern commerce and human ethics. And recently the Senate's Community Affairs Committee has taken evidence as part of their inquiry into gene patents. Who owns your genes? Over the last two decades around the world patents have been granted over isolated gene sequences for which a practical and useful application has been identified. More often than not the practical application is a test for diagnosing a condition that the inventor has shown is associated with the gene. A patent gives intellectual property rights over isolated gene sequences and its uses if the chemical structure of the isolated sequence was not previously known. How the law responds to the regulation of gene patents represents the kind of thorny challenge which is uniquely facing public policy makers in the 21st Century. Yet patents are not new. Originating in the 15th Century patents are a response to the dilemma of trail blazing. The first person to make the trail expends enormous effort in the journey, while every person following completes the same journey with ease. So why would any person blaze a trail? Yet as a society we need trails blazed. Patents are our answer to this dilemma. In exchange for developing an invention and making it public, the inventor is provided with a monopoly over the commercial exploita- tion of the invention for a period of up to 20 years. Patents provide an incentive to invent. They have been integral to the most extraordinary period of human innova- tion in history. Where the rubber has hit the road in relation to gene patents has been the patent for the BRCA breast cancer susceptibility. In 1994 American researchers isolated the BRCA1 gene sequence, determined its chemical structure and its association with familial breast cancer. The resulting test enables women to be tested for the presence of mutations in the BRCA1 gene and take action to reduce their risk. It is an invention that is saving lives. In Australia, Genetic Technologies Limited (GTL) is the licensee of the BRCA diagnostic test and provides an accredited testing service. Initially GTL permitted public hospitals to undertake BRCA testing, but later sought to enforce their patent. It was this enforcement of the patent, and the fear that GTL's testing service might be more expensive, which has fuelled the debate about human gene patenting. While issues around the human genome are unique, the role of patents in the affordable provision of medicine is far from unique. For example the availability of generic drugs for HIV sup- pression in the developing world in the face of patents held by drug companies is a debate that has raged for twenty years. Yet without the availability of patents, research may never