Victory over patent for breast cancer gene

Issue 
Yvonne D'Arcy won in the High Court against gene patenting.

Queensland pensioner and grandmother, 69-year-old Yvonne D'Arcy, who has twice beaten breast cancer, won an important victory in the High Court on October 7.

D'Arcy brought a landmark legal challenge against US-based biotech company Myriad Genetics after it was granted a patent over the BRCA1 and BRCA2 genes. Mutations in the genes dramatically increase a woman's chance of developing breast and ovarian cancer.

The court, in ruling against Myriad Genetics, said a gene mutation linked to cancer cannot be patented. The court also ruled that the company does not have the right to control the use of the gene for research purposes.

If Myriad Genetics had won, it would have been able to charge a fee equivalent to US$4000, or more for any Australian woman who wanted to test for a mutation in the BRCA1 gene.

D'Arcy, a member of the advocacy group Cancer Voices, has said many times she did it on behalf of future generations.
It has been a long battle for D'Arcy in the Australian courts. She lost the case in the Federal Court in 2013 when Justice Nicholas ruled that the patent was valid because the method of isolating the gene was an invention. She lost again in the full Federal Court in 2014.

But she successfully applied for special leave to appeal to the High Court. Thanks to Maurice Blackburn lawyers, who took the case pro bono, and the persistence of D'Arcy, the decision was reversed in a unanimous decision of the full bench of the High Court.

D'Arcy said after the victory: “For all those people who do have the genetic footprint for breast cancer or any cancer basically, it's a win for them because now they're forewarned and forearmed.

“The testing will be a lot cheaper and it will be more available to more geneticists, rather than using only Myriad's agents at a price that nobody really can afford, except for Angelina Jolie.” She added that the motivation of Myriad Genetics was just greed.

The two genes, BRCA1 and BRCA2, code for two different tumour suppressor proteins that help repair DNA damaged by radiation or a transcription error. If either of these genes has a mutation, which has been inherited or from old age, then the remaining cell DNA is not repaired. The cell can then develop additional genetic mutations that can lead to breast, ovarian or colon cancer.

Breast cancer affects about one in 10 women at some time in their lives. The frequency of BRCA1 and BRCA2 gene mutations is approximately one in 500. Identifying carriers of an inherited BRCA gene mutation is an important step in helping women avoid breast cancer.

While a company cannot claim ownership of our genetic information, Myriad Genetics was granted a patent for the two genes in 1995. Australian company Genetic Technologies, which holds the patent in Australia on behalf of Myriad Genetics, told doctors in 2008 that all testing had to be done through them.

The US Supreme Court ruled last year that isolating a human gene is not an act of invention. However the decision was ambiguous as the court argued that synthetically-produced DNA sequences could be patented.

There are more than 4000 gene patents in the US. Patent monopolies provide the owner with a 20-year intellectual property right, which means they can prevent other researchers and doctors from making use of the genetic information for medical applications.

A patent also ignores the donation of thousands of women who have given permission for researchers to use their tumour DNA to search for the mutations.

The decision by the Australian courts will have significant international implications, tipping the balance towards genetic testing being for public good rather than private profit.

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