Australia: The Future of Gene Patents in Australia?

Should genes be patentable? Few issues in biotechnology evoke as much debate and polarise opinions to the extent of this question. However despite fierce public debate and significant opposition, largely on moral grounds, patent applications for genes and gene sequences continue to be filed and granted.

The current position in Australia with respect to the patentability of genes is based on the 1995 Patent Office decision in Kiren-Amgen v Board of Regents of University of Washington, wherein it was held that an isolated DNA sequence constitutes an "artificially created state of affairs" and is therefore patentable. On appeal, the Federal Court further held that the isolation of a DNA sequence is akin to the discovery of a class of chemical compounds, thereby entitling the patentee to broad protection for sequences related to those specifically isolated. The difficulty with this position is one of defining the scope – where does the "class" begin and end?

The Federal Government has now called on the Australian Law Reform Commission (ALRC) to review the current position in Australia regarding intellectual property rights over genetic materials. The ALRC review will focus on the impact of gene patenting on research and its commercialisation, the biotechnology industry in Australia and healthcare issues.

Australia is not the first country to consider the question of whether genes should be patentable. Most notably, this issue has been addressed in both Europe and the United States.

Considering the issue from a predominantly policy perspective, in 1998 the European Union issued the Directive on the Legal Protection of Biotechnological Inventions. With specific reference to human genes, Article 5 of this Directive states that whereas the "simple discovery" of an element of the human body, including "the sequence or partial sequence of a gene" does not constitute a patentable invention, "an element isolated from the human body... including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element".

Despite causing much controversy, and being the subject of attempts to have it annulled, the Directive forms the basis of the approach currently adopted by the European Patent Office in considering patent applications for genes and gene sequences. All EU member states are obliged to implement laws in accordance with the Directive, however to date only a handful have done so.

In contrast to the EU approach, in the United States it was left to the USPTO to set the ground rules. Appearing to largely ignore the broader policy issues, the USPTO issued new utility examination guidelines in 2001 which contain specific reference to gene patents. Under these guidelines, genes and DNA sequences are considered patentable once isolated from their "natural environment" and are regarded as equivalent to any other chemical compound. The 2001 guidelines established a three-pronged utility test stating that at least one "specific, substantial and credible" utility must be provided. Exactly what this means continues to cause some confusion.

In Australia, the ALRC inquiry will undoubtedly consider gene patenting from a more policy-oriented perspective, similar to the EU. While it is difficult to predict the outcome of this review, it is hard to envisage Australia moving significantly away from the positions adopted by our major trading partners, in particular Europe and the United States. Furthermore, as a signatory of TRIPS – the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights – Australia has an obligation to provide patent protection in all technology areas.

The ALRC recommendations are due to be handed down by 30 June 2004. Although they are not expected to resolve public debate on the issue, it is hoped that a definitive statement and position on the boundaries of IP rights will provide an increased level of certainty for the biotech industry, for which the provision of effective patent protection for genes and gene-related inventions is critical in the post-genomics era.

It is likely we will have to await further court decisions before clear guidance is received on the more practical issues such as the appropriate claim scope for inventions relating to gene sequences.