Confusion over gene patents

An Australian Law Reform Commission (ALRC) inquiry has found widespread anxiety and uncertainty about whether genetic patents will stifle research and development in the billion-dollar biotech industry and cause cost blowouts and access problems for the healthcare system.

ALRC President Professor David Weisbrot said allegations that individual patent holders were acting unreasonably - for example, by setting exorbitant licence fees or severely restricting the use of a patent material or technology - have set off alarm bells in Australia.

Prof Weisbrot's comments follow the release of a major ALRC Discussion Paper, Gene Patenting and Human Health (DP 68), which is part of a comprehensive review of whether Australia's intellectual property laws can cope with the rapid advances in genetic science and technology.

Prof Weisbrot said the issue of patents in the field of human genetics is a "hugely controversial and often completely misunderstood area". "In return for a 20-year monopoly on the right to exploit their invention, patent holders must publish their work in detail. This allows other researchers to test, improve and expand on the initial research.

"In such a dynamic area like genetic research, there's a generational change, in effect, every five years. And it is very important to keep in mind that the most important research efforts in this field - the Human Genome Project and its successor, the International Haplotype Mapping (HapMap) Project - were consciously established as community resource projects, committed to placing all of the data in the public domain, at no cost to users."

Prof Weisbrot said despite the general climate of apprehension, the ALRC review had so far found no real evidence that a radical overhaul of the patents system was warranted.

ALRC Commissioner Mr Brian Opeskin said the ALRC is suggesting that state and federal governments must take a more pro-active approach to monitoring genetic patents.

"At the moment, individual applications for patents can be challenged - but no one is monitoring how the system develops as a whole. We're suggesting that commonwealth, state and territory health departments establish specialist offices to monitor and manage intellectual property issues relating to genetic materials and technologies.

"As well, governments need to develop policies about when it may be necessary to step in and take control of a patented invention, for the purposes of promoting human health or medical research. The existing law already provides for 'Crown use' for the purpose of promoting human health, and for compulsory licensing in the public interest - but these provisions are rarely used.

"Government funding and purchasing power also could be used to control the cost of goods and services that are subject to gene patents, in much the same way as the Pharmaceutical Benefits Scheme has worked well to contain the costs of medicines in Australia," Mr Opeskin said.

ALRC Commissioner Professor Anne Finlay said other proposals made in the Discussion Paper encouraged the biotechnology industry to take more responsibility for ensuring small, cash-strapped university research teams were given help in commercialising and promoting their work.

Prof Finaly said the Discussion Paper also considers ways to:

• establish an express defence of 'experimental use' in the Patents Act, to make clear that researchers are entitled to study and experiment upon a patented invention;
• provide rules for the patentability of inventions involving stem cells and stem cell technologies;
• develop policy on the circumstances in which it may be appropriate for the Australian Government to acquire a patent for the purposes of promoting human health under the 'Crown use' provisions of the Patents Act;
• develop policy on the circumstances in which the public interest would require the compulsory licensing of a patented genetic invention;
• deal with intellectual property rights in genetic research databases;
• increase the capacity of patent examiners and the courts to scrutinise applications for gene patents;
• ensure patent applications are not overly broad - which can restrict other geneticists from pursuing particular lines of research;
• ensure that publicly funded research, where commercialised, results in appropriate benefits to the community;
• encourage universities and other publicly funded research institutions to raise the awareness of researchers about patenting issues and the commercialisation of research; and
• apply competition law more fully and effectively to business practices involving patented genetic inventions, including through prices surveillance by the ACCC.

The ALRC is calling for feedback on its proposals and will undertake another round of public consultations, before delivering its final report to the federal Parliament later this year. The Discussion Paper is available free from the ALRC, or can be downloaded from the ALRC's website at www.alrc.gov.au