AUSTRALIA’S BILLION dollar biotechnology industry risks being stunted by intellectual property laws that cannot withstand rapid advances in genetic science and technology and emerging scientific breakthroughs, the Australian Law Reform Commission (ALRC) said last week.
After 18 months of extensive research and community consultation, the ALRC has released a report, tabled last week by the Federal Government, which examines intellectual property rights over genes, genetics and related technologies, as well as their impact on human health.
According to ALRC president David Weisbrot, more flexibility is needed in the patent system to accommodate genetic technology, or the results could be catastrophic for research development. There would be a “chilling effect” on research and development as well as the commercialisation of that research, Weisbrot said, which would have adverse effects on healthcare advancement in this country.
The 700-page report, Genes and Ingenuity: Gene Patents and Human Health (ALRC 99), highlights the need for a review of Australian gene patenting laws and practices.
“While we found there’s no need for a radical transformation of the patents system, the ALRC has made 50 recommendations for significant reform to customise the current system to accommodate emerging scientific breakthroughs,” Weisbrot said.
Australia needs to promote investment in research and development, according to Weisbrot. “Biotechnology is hugely expensive and patent rights are the main way of rewarding innovation and investment.”
Australia is a party to a massive industry of biotechnology, Weisbrot said. It is a “highly globalised field” in which investment and expertise flows across borders. Already, thousands of gene patents have been granted around the world and there are a number of major international agreements in which Australia has taken part.
The report suggests there is a high level of anxiety among researchers that because gene patents can be broad and licensing practices can be aggressive, there is a chance they will stifle further research.
They could “create problems for governments in providing access to high quality and cost-effective healthcare”, said ALRC commissioner Brian Opeskin.
“However, we are confident that if the ALRC’s recommendations are adopted, there will be sufficient flexibility, monitoring and oversight of gene patents to ensure that won’t happen.”
Governments and health departments need to be more strategic in using the available mechanisms, including the courts where necessary, “to challenge dubious patents of questionable licensing practices,” Opeskin said.
According to ALRC Commissioner Anne Finlay, the Australian public could miss out on the maximum benefit of “our world class genetic research” unless scientists and universities develop a more sophisticated understanding of intellectual property rights and licensing practices.
The report also suggests there should be reform directed towards adding a competition test to the grounds under which a compulsory license over a patent can be ordered by the court.
As well, the Australian Competition and Consumer Commission (ACCC) should be encouraged to play a more active role by issuing guidelines indicating which licensing practices would not be unduly anti-competitive, the report states.
The ‘fair dealing’ exception in the Copyright Act 1968 should be clarified so that research with a commercial purpose may come within that exception, the report suggests. Amendments should also be made to ensure the fair dealing provisions for the purpose of research cannot be excluded or modified by contract in relation to databases protected by copyright.
Key international organisations such as UNESCO, the OECD, the Human Genome Organisation and the American Association for the Advancement of Science are “keen” to see what Australian policymakers will do in response to the report, Weisbrot said.