My mother’s family hails from Shepparton in the Goulburn Valley in Victoria. In 1873 the blacksmith, John Furphy, set up a forge in the town, and produced a range of farm machinery. He was awarded a Victorian colonial patent in respect of a “grain-stripping machine” in 1882. The invention won first prize at the Grand National Show in 1884, and enjoyed great popularity at agricultural fairs. Patent law has become unrecognisable since the time of John Furphy. Once the province of mechanical inventions and chemicals, patent law has expanded in its scope to cover all sorts of biological inventions.
Over the past few decades, the patent system has grown progressively until “anything under the Sun” that is made by man has been considered patentable. In the 1980 case of Diamond v Chakrabarty the Supreme Court of the United States held by a slim majority that a new strain of bacteria - useful in breaking down crude oil - was patentable.
Subsequently, patent protection was extended to traditionally bred plants, hybrid plants and genetically modified crops. Patent law also enveloped the animal kingdom. After it was recognised that polyploid oysters could constitute patentable subject matter, patents were sought in respect of the Harvard Oncomouse, model organisms, and methods to clone animals such as Dolly the sheep.
The prohibition against patenting methods of human treatment has been lifted in a number of western jurisdictions.
Patents have thus been sought for medical devices, surgical techniques and diagnostic tests, as well as research tools, pharmaceutical drugs and personalised medicine. More recently, patents have been granted in respect of human tissues, genes, stem cells and somatic nuclear cell transfer (so-called “therapeutic cloning”).
There remain few taboo inventions under patent law. Perhaps only human cloning and animal-human hybrids remain clearly outside the scope of patentable subject matter.
The limits of patentable subject matter have even been stretched to accommodate frontier technologies such as bioinformatics, proteomics, pharmacogenomics, nanotechnology and synthetic biology.
Recently the J. Craig Venter Institute filed a patent application in 2006 in respect of a “minimal bacterial genome”. He maintained that such research into synthetic biology could produce alternative energy solutions. However the ETC Group - a Canadian group opposed to biotechnology - has complained that such work poses ethical and environmental concerns about the use of biodiversity to build new life forms.
The Australian Law Reform Commission and The Advisory Council on Intellectual Property
Despite the passion of the public debate over patenting life, the Australian Parliament has taken little action in respect of intellectual property and biotechnology.
In December 2002, the Federal Attorney General, The Honourable Daryl Williams, commissioned the Australian Law Reform Commission to undertake a review of intellectual property rights over genes and genetic and related technologies, with a particular focus on human health issues. This inquiry was prompted in particular by concerns about the impact of patents held by biotechnology companies such as Myriad Genetics and Genetic Technologies Limited in respect of genetic testing and non-coding DNA.
The Australian Law Reform Commission released an issues paper in July 2003, a discussion paper in January 2004 and a final 678-page report in June 2004, which was tabled in Parliament in August 2004. The final report contained 50 recommendations. The key recommendation was that the Australian government should recognise a statutory defence under patent law for the experimental use of an invention. The Advisory Council on Intellectual Property conducted an independent inquiry into the desirability of this, and concluded that there should be a research exemption.
Unfortunately, four years later, the Australian Parliament has not paid much heed to the modest recommendations of the Australian Law Reform Commission and the Advisory Council in Intellectual Property. The Coalition government did not even implement the recommendation to enact a statutory defence for experimental use.
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