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Cancer patient appeals gene patenting decision

22 June 2015
Appeared in BioNews 807

Australia's highest court will decide whether isolated molecules of DNA linked to a gene mutation associated with an increased risk of hereditary breast and ovarian cancers are patentable under Australian law.

The hearing at the High Court, which started on 16 June, is the final appeal against a decision made by the Federal Court of Australia in December 2013, which ruled that patents held by the US biotechnology firm Myriad Genetics over the BRCA1 gene were valid (see BioNews 693).

The federal court upheld this ruling in September 2014 (see BioNews 770), saying that the patents were valid because isolating the gene in question requires human intervention.

The patents have been held in Australia by Myriad Genetics since the late 1990s and relate to mutations in the BRCA1 gene. People with a mutation in one of the BRCA1 or BRCA2 genes have a risk of developing breast cancer of between 50 and 85 percent.

The patents mean that genetic tests to look for BRCA1 mutations can only be carried out in Australia by Myriad Genetics and its licensee, Genetic Technologies, which advocacy group Cancer Council Australia argues increases their price and affects research. Supporters of the patents maintain, however, they are needed to attract funds so a product can reach the market.

Yvonne D'Arcy, who has twice been treated for breast cancer, brought the case with campaign group, Cancer Voices Australia. Her lawyer, Rebecca Gilsenan of law firm Maurice Blackburn, told ABC News: 'The crux of the argument that we'll be putting to the High Court in Australia is that a human gene, merely by the fact that it's isolated from the human body, is not an invention.

'We say that it's a discovery... discoveries are not patentable subject matter; inventions are.'

Lisa Taliadoros, a lawyer acting for Myriad Genetics, which has not to date enforced its BRCA patent rights in Australia, told Sky News after the last ruling: 'The claims relate not to a "gene" but rather to an isolated nucleic acid sequence that is chemically, structurally and functionally different from that which is found in the human body.'

The previous decisions of the Australian courts contrast with the US Supreme Court's ruling in 2013 that human genes in their natural form cannot be patented, since they are a 'product of nature'. The Supreme Court rejected a number of patents held by Myriad Genetics (see BioNews 709), but upheld others relating to synthetically created DNA sequences.

Dr Luigi Palombi, a patent lawyer and an academic at Murdoch University, Western Australia, told The Guardian that he hopes for a decision similar to that made by the Supreme Court in the USA.

'The fact that scientists and companies interested in developing new diagnostics and treatments in the US can do that without negotiating through a maze of gene patents gives them a distinct advantage', he said.

A decision from Australia's High Court is expected within days.

10 June 2019 - by Kulraj Singh Bhangra 
A bill that would nullify the US Supreme Court decision that banned the patenting of human genes is being debated by the US Congress...
14 March 2016 - by Ryan Ross 
Tania Simoncelli's narrates the story of the successful legal challenge against Myriad Genetics' BRCA patents, but may have missed an opportunity to consider the broader impact of gene patenting...
12 October 2015 - by Cait McDonagh 
An isolated gene sequence cannot be patented, Australia's highest court has unanimously ruled. It is the latest and final decision in litigation that has lasted over five years...
2 February 2015 - by Cait McDonagh 
Myriad Genetics has settled litigation with competitors who had been using genetic testing for breast cancer genes...
30 June 2014 - by James Brooks 
Does the pharmaceutical and biotech industry's profit motive actually pervert rather than inspire innovation and the hunt for new therapies? Is the patent system well suited to a new life sciences landscape including stem cell and gene therapies?...
9 June 2014 - by Simon Hazelwood-Smith 
The backdrop to the third event in the Progress Educational Trust's 'Breast Cancer: Chances, Choices and Genetics' series was the Myriad Genetics gene patenting legal saga, which came to a conclusion last year with Myriad being denied a patent on the isolated forms of the BRCA genes...
17 March 2014 - by Patricia Cassidy 
Myriad Genetics has failed to obtain a preliminary injunction to prevent a competitor, Ambry Genetics, from offering BRCA-related genetic testing products...
15 July 2013 - by Ruth Retassie 
Myriad Genetics is suing two other companies who are offering genetic tests for BRCA1 and BRAC2 gene mutations for patent infringement...
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