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BRCA gene cannot be patented, says Australia's High Court

12 October 2015
Appeared in BioNews 823

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.

Myriad Genetics was granted patents over isolated versions of the BRCA1 and BRCA2 genes in the 1990s. The patents effectively conferred a monopoly over the testing for certain gene sequences, which, if present in a patient, indicate an increased risk of developing ovarian and breast cancers.

Yvonne D'Arcy, who was twice treated for breast cancer, challenged the patents with the support of campaign group Cancer Voices Australia on the grounds that even it its isolated form, a human gene is not an invention.

Myriad contended, on the other hand, that isolated nucleic acid was chemically, structurally and functionally different from that found in a cell and was therefore patentable. Supporters argued that patent protection is necessary to encourage innovation in research and development for biological medicines.

Overturning two previous Federal Court decisions (see BioNews 693 and 770), the High Court ruled unanimously that an isolated nucleic acid coding for a BRCA1 protein was not a 'patentable invention' under Australian law.

The judges gave different reasons for their conclusion. The majority said that while the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element. Other judges said that variations indicating increased risk of cancer was a 'matter of chance', and not something 'made' or 'artificially created'.

A broadly similar approach has been taken in Europe and Asia, and there is a challenge to gene patents yet to be heard in Canada. The High Court's decision also brings Australia's position in line with that in the USA, where Myriad Genetics lost their BRCA1 patent in 2013 (see BioNews 709).

The ruling means that other researchers and clinicians can now test for the gene without risk of infringing the patent. D'Arcy hopes that the decision will result in more affordable testing for patients.

Speaking after the court case, D'Arcy said: 'For all those people who do have the genetic footprint, it's a win for them, because now they're forewarned and forearmed.'

Australia court rules against breast cancer gene patent
BBC News |  7 October 2015
Australian campaigners win gene patenting victory
Science (AAAS) |  8 October 2015
D'Arcy v Myriad Genetics Inc [2015] HCA 35
AustLii (judgment) |  7 October 2015
D'arcy v Myriad Genetics Inc & Anor [2015] HCA 35
High Court of Australia (press release) |  7 October 2015
Genes can't be patented, rules Australia’s High Court
New Scientist |  7 October 2015
Patient wins high court challenge against company's cancer gene patent
The Guardian |  7 October 2015
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...
27 June 2016 - by Dr Helen Robertson 
A drug currently used to treat osteoporosis in old age may help prevent breast cancer in women with a genetic predisposition for the disease...
23 May 2016 - by Antony Starza-Allen 
Myriad Genetics has been hit by a complaint filed by the American Civil Liberties Union (ACLU) on behalf of four patients who are seeking a right of access to all their genetic information held by the company...
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...
22 February 2016 - by Dr Helen Robertson 
More than 95 percent of younger women diagnosed with early-onset breast cancer are opting for genetic testing, a study has found...
22 June 2015 - by Paul Waldron 
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....
2 February 2015 - by Cait McDonagh 
Myriad Genetics has settled litigation with competitors who had been using genetic testing for breast cancer genes...
23 June 2014 - by Alice Plein 
Pathway Genomics, a biotech company based in San Diego, announced it will 'vigorously defend itself' against a patent infringement suit filed by Myriad Genetics and others...
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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