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Myriad Genetics wins gene patent bid in landmark Australian ruling

18 February 2013
Appeared in BioNews 693

A patent over a gene linked to hereditary breast and ovarian cancers is valid, an Australian federal court has ruled in a landmark case.

Myriad Genetics, a US biotech firm, holds a patent on an isolated form of the gene, BRCA1. The patent allows the company exclusive rights to perform genetic tests that can detect an increased risk of developing breast and ovarian cancers.

Cancer patient Yvonne D'Arcy and advocacy group Cancer Voices Australia brought the case against Myriad Genetics and Genetic Technologies, the only company licensed to use these genetic tests in Australia and New Zealand. The plaintiffs argued that naturally occurring substances, such as genes, cannot be patented and that patents protect inventions, not discoveries.

Justice John Nicholas rejected the argument on the grounds that isolating the gene requires human intervention. This is the first time an Australian court has had to consider the validity of genetic patents.

'I won't give up the fight because this is too important for future generations of people who at some point in their lives may need testing and treatment for cancers and other diseases', said D'Arcy.

Myriad Genetics also holds a patent for the isolated form of the BRCA2 gene. Mutations in the either of the BRCA1/2 genes can increase a woman's risk of breast cancer. It is estimated that faults in these high-risk genes affect one in 500 people.

Among women with the faulty genes, 50 to 80 percent will develop breast cancer in their lifetime. Of those women without the mutations, 10 percent are at risk of developing breast cancer before they are 80 years old. The BRACAnalysis genetic test created by Myriad Genetics can detect the presence of risky mutations.

Myriad's patents over the BRCA1 and BRCA2 genes have generated much controversy, with the American College of Medical Genetics accusing the company of attempting to gain ownership over the human body.

'This is the beginning of personalised medicine', Sally Crossing, a spokesperson for Cancer Voices Australia, told CNN. 'Any testing or access to material for researchers needs to be made as free and as easy as possible for them just to speed it up'.

Rebecca Gilsenan of Maurice Blackburn Lawyers, who represented D'Arcy and Cancer Voices Australia, said: 'We think there may be grounds to appeal, and that there's a reasonable chance that we will make that decision in the next week or two'.

Myriad Genetics will have to defend its right to patent human genes in the US Supreme Court later this year. A lawsuit filed by the American Civil Liberties Union and the Public Patent Foundation argues that patents on the BRCA1/2 genes are unconstitutional and invalid.

Campaigners have been fighting to have Myriad Genetics' patents declared invalid since 2009. Since then, the right to patent genes has been an on-going battle in US courts, as previously reported in BioNews 675 and 669.

The Australian case is called Cancer Voices Australia v Myriad Genetics and was heard in the Federal Court of Australia in Sydney.

Australian court backs claim to own breast cancer gene
CNN International |  15 February 2013
Calls for law change after gene ruling
Sydney Morning Herald |  15 February 2013
Cancer group loses Federal Court bid against human gene patent
Australian |  15 February 2013
Challenge to cancer gene patent fails in Australia
AFP |  15 February 2013
Myriad Genetics wins bid to patent human genes
Sydney Morning Herald |  15 February 2013
8 September 2014 - by Matthew Thomas 
Gene sequences isolated from the human body are patentable, according to a ruling by the Australian federal court...
1 July 2013 - by Dr Michael Hopkins and Dr Stuart Hogarth 
Last week saw the conclusion of the long-running gene patent lawsuit known as AMP v. Myriad Genetics. At stake was the patentability of isolated DNA sequences...
24 June 2013 - by Dr Linda Briceno Moraia and Dr Jane Kaye 
The US Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics will have far-reaching implications, not just by lowering the costs of genetic tests, but also for the development of innovations in genetics and genomics and in other emerging fields such as stem cell research and synthetic biology....
17 June 2013 - by Dr Sarah Spain 
The US Supreme Court has unanimously rejected a number of patent claims made by Myriad Genetics on isolated forms of two genes, BRCA1 and BRCA2, associated with an increased risk of breast and ovarian cancer....
3 June 2013 - by BioNews 
A patent over a method for assessing cell-cycle data that can be used in IVF treatments to predict an embryo's future viability will make IVF treatments in the USA prohibitively expensive, a leading embryologist has said...
5 November 2012 - by Antony Starza-Allen 
A group of academics has accused Myriad Genetics, the US biotech company that holds patents over the BRCA1 and BRCA2 genetic tests for increased risk of breast cancer, of keeping secret clinical data obtained from the tests by saying the information is commercially sensitive...
1 October 2012 - by Ruth Saunders 
The American Civil Liberties Union has asked the US Supreme Court to reconsider its decision to uphold the patent held by Myriad Genetics on two human genes associated with hereditary breast and ovarian cancers...
20 August 2012 - by Dr Sarah Spain 
In the latest instalment of a highly contested case, the US Federal Circuit Court of Appeals in Washington DC upheld Myriad Genetics' right to patent two genes, BRCA1 and BRCA2,which are associated with the risk of breast and ovarian cancer....
2 April 2012 - by Dr Sarah Spain 
The US Supreme Court has ordered that the two gene patents held by Myriad Genetics be sent back to the US Court of Appeals for the Federal Circuit, to be re-examined...
27 February 2012 - by Luciana Strait 
A new genetic mutation linked to a greater risk of developing breast cancer has been shown to interact with the well-known breast cancer-causing gene BRCA1...
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