Human gene patent update

The battle over whether human genes can be patented is heading to the US Supreme Court.

The Court of Appeals for the Federal Circuit decided in July last year that DNA isolated from the body was patentable because it was ‘markedly different’ in its chemical structure from DNA that exists in chromosomes in the human body. This had overturned a controversial lower court decision that had found that Myriad’s patents on the breast cancer genes, BRCA1 and BRCA2, were invalid because the genes were unpatentable products of nature.

Two public interest groups, the American Civil Liberties Union and the Public Patent Foundation, have filed an appeal, asserting that genes are products of nature and cannot be patented.

The patents cover genetic tests that can be used to determine a person’s susceptibility to breast and ovarian cancer and these groups are concerned that the patents might restrict patient access to the tests.

However, industry groups argue that the inability to patent such technologies will mean that companies are less likely to put money into developing them.

In Australia, there is a corresponding case before the Federal Court (Cancer Voices Australia & Anor v Myriad Genetics Inc & Ors), which is set down for hearing in February and March of this year.

The Australian government issued a report in November last year, rejecting a legislative ban on the patenting of genes and other biological materials, and instead supporting a clarification of the existing compulsory licence and Crown use provisions to ensure that Australians have reasonable access to essential healthcare treatments, including those which draw on gene-based technologies.

We will now wait with great interest to see what the Australian and US courts decide.

Contact: If you have any specific enquiries about this decision, or gene patents generally, please contact Debra Tulloch.