Report underlines researchers' fears on gene patents

Public sector researchers and healthcare experts are concerned that gene patents will stifle research and cause problems affecting cost and access to genetic tests, according to a new discussion paper on gene patents released by the Australian Law Reform Commission. But biotech companies are equally worried that changes to patent laws could affect the viability of the industry.

According to ALRC president Prof David Weisbrot, there is widespread confusion and anxiety about gene patents, not helped by a lack of understanding of the system. Some people, he said, claimed it was wrong to patent life or naturally occurring entities such as genes or proteins. Researchers and companies involved in patenting genes, however, point out that the patent has to show novel utility.

And Weisbrot said it would also be impossible to dismantle a system that has granted thousands of genetic patents around the world. He noted that with the exception of a few high-profile patents, the system seemed to be working fairly well, but needed to be updated to cope with the challenges posed by gene patents and related intellectual property issues.

The ALRC has come up with more than 40 proposals for reforms of intellectual property law, and will seek feedback on the discussion paper over the next couple of months. The final report is due to be delivered to the Attorney-General at the end of June this year, and will be made public about a month later.

"The major concerns that led to the inquiry being established was whether patenting in the biotechnology area would prevent researchers from doing further research in those areas, and would it drive up the cost of clinical genetic testing," Weisbrot said. "But we were also keen to maintain the basic intellectual property system, which provides rewards for investment and innovation."

Weisbrot said studies performed in Australia and in the US had found that researchers in companies and the public sector alike had a lot of anxiety about patents, particularly since the US Supreme Court decision on Madey v Duke ruled that there was no research exemption for patents.

"One idea that has come up is that we should entrench a research exemption into the patent legislation," Weisbrot said.

Companies have expressed concern that cuts to the period of exclusivity that a patent offers might stifle the industry. "We accepted the argument that patent law has a very big role to play [in the biotech industry] because of the high level of investment and long time to market," Weisbrot said. "We didn't want to stifle that."

The final ALRC recommendations will not just be directed at the federal government either. Weisbrot said it was time that state and territory governments became more proactive and strategic in the way they dealt with patents, for example those affecting public sector genetic testing capabilities.

He said that the state and territory governments would be advised to set up specialist offices to monitor and manage IP issues. The development of policies for 'Crown use' of patents for public health purposes would also be recommended, in addition to policies covering public benefit uses of patents.

Universities and research institutions have also been targeted with recommendations that researchers be made aware of patenting and commercialisation issues.

The report will also consider issues surrounding the patenting of stem cells and stem cell derived products.

The discussion paper Gene Patenting and Human Health (DP 68) is available for download from the ALRC's web site, www.alrc.gov.au