Landmark US court ruling reignites debate on gene patenting

Written on the 20th of May 2010 by Kerrin Anderson

A landmark US court ruling against gene patents has reignited debate on the issue in Australia just as the senate announced an extension to the reporting time for the gene patents inquiry.

Myriad case

At the end of last month, in Association for Molecular Pathology et al v US Patent and Trademark Office (Myriad Case) the New York district court ruled that biotechnology company Myriad Genetics’ gene patents issued in relation to human breast cancer genes (BRCA1 and BRCA2) were invalid as the genes were ‘products of nature’.

Myriad asserted that the patent claims related to genes that have been isolated and purified and although they are ‘naturally occurring’ compounds, they ‘do not exist in nature in pure form’, rendering those compounds patentable. The plaintiffs argued that a gene, even in its isolated form, is a ‘product of nature’ and therefore not patentable subject matter.

Judge Sweet considered that the isolation and purification of a product of nature is insufficient to enable the product to be patentable subject matter. Instead, the purified product must have ‘markedly different characteristics’ from the original. On this basis, the court held that the isolation of the BRCA1 and BRCA2 genes, ‘does not alter its essential characteristic – its nucleotide sequence – that is defined by nature and central to both its biological function within the cell and its utility as a research tool in the lab’. The court therefore held that the patent claims are directed to unpatentable products of nature.

While Myriad Genetics intends to challenge the ruling in a case that seems destined for the US Supreme Court, for the moment the ruling only has effect in the district of New York.

Impact on gene patent inquiry

The US court ruling is likely to impact on the gene patent inquiry. Generally, the inquiry is to report on whether the existing patent laws covering genes should be revised either to prohibit the patenting of genes or to provide more clarity in relation to the exemptions for the purposes of research.

Submissions made to date by the scientific community and biotechnology industry have been divided on whether genes should be patented and how the issue should be handled.
Scientific research institutions are against granting patents for genes, claiming they are restricting research and access to genetic testing. However, the biotechnology industry argues that such patents are needed to encourage investments in genetic research.

Some organisations favour a compromise as recommended by the 2004 Australian Law Reform Commission report, which would, among other things, formalise an exemption for non-commercial research.

Inquiry reporting extension

The senate announced an extension of the reporting time for the gene patents inquiry to 17 June 2010 to allow more time for the committee to consider in detail the complex issues involved and to assess the range of opinions.