“Gene Patents” in Australia – Where do we stand?

The Australian Government has vehemently rejected an absolute ban on the patenting of genes and other biological materials.

The provision of a patent system with sufficient flexibility to reward innovators and researchers, whilst ensuring reasonable access to the emerging technologies and medical treatments these innovators are developing, are the key objectives of the Australian Government’s response to three important reports into Australia’s patent system and gene patents.

A brief review

In recent years, the protection of biological materials through the patent system has been the subject of considerable debate in both the community and at various levels of Government in Australia. The question being asked essentially boiled down to this: “Should genes be patentable?”.

The position in Australia regarding the patentability of genes is based largely on the 1995 decision Kiren-Amgen v Board of Regents of University of Washington (1995) 33 IPR 557. In this decision, it was held that an isolated DNA sequence essentially constitutes an ‘artificially created state of affairs’ and is therefore capable of being a ‘manner of manufacture’ so that it is suitable subject matter for the grant of a patent.

On appeal, the Australian Federal Court further supported the view that the isolation of a DNA sequence (i.e. a gene) is fundamentally akin to the discovery of a class of chemical compounds, and by analogy, entitles the patentee to broad protection for genes and the products related to those specifically isolated genes. Accordingly, isolated DNA sequences and any biological or genetic material derived therefrom were considered subject matter worthy of patent protection.

One of the issues that arose subsequent to the formation of this position related to the question of patent scope and whether the isolation of a gene satisfying a particular purpose was sufficient to warrant patent protection of the gene for its ”isolator”. This provided considerable debate and discussion amongst action groups and research organisations in Australia.

Australia is of course not the first country in which the question of whether genes (and their biological products) should be patentable subject matter has been considered. Most notably this issue has been addressed in both the United States and Europe. The concerns of the Australian community toward the patenting of biological materials were therefore not in isolation, and were indeed fuelled by the international debate concerning the same issues.

It was considered by many that any decision outlawing the patenting of genes or biological materials would be likely to have a detrimental impact on innovation and investment in medical research in Australia.  This would have a fundamental flow-on effect across a broad range of industries, including the biotechnology, healthcare, agriculture and food technology sectors.

In response to the groundswell of concern on both sides of the debate, the Australian Government authorised several inquiries to review the current position on intellectual property rights over biological materials (including human and microbial genes and non-coding sequences, proteins, and their derivatives, including those materials in isolated forms) and whether the Australian patent system should remain as it stands (and allow for the protection of biological materials), or whether such patent protection should be disallowed.

These inquiries included the Senate Gene Patents Report (24 November 2010), the 2011 ACIP Report on Patentable Subject Matter, and the 2004 Australian Law Reform Commission’s Report on Genes and Ingenuity: Gene Patenting and Human Health (ALRC 99 Report).

In order to provide certainty to those involved in industries with a strong interest in the patenting of biological materials, such as research communities, a decision on where the Government and Australia at large stood on this issue was desperately needed.

On 23 November 2011, the Government issued its combined response to these inquiries.