Landmark High Court ruling on BRCA1 gene patent as pensioner wins legal case

Yvonne D’Arcy, who fought to have the breast cancer gene patent overturned, outside the Federal Court after it first ruled that mutations in the BRCA1 gene could be patented. Photo: Peter RaeA 69 year-old pensioner from Queensland has succeeded in a David-and-Goliath battle against a multinational corporation that claimed a patent over the “breast cancer” gene.

‘s highest court has unanimously ruled that a mutated gene that causes cancer cannot be subject to a patent, or the right to control use of the gene.

The decision has been hailed as a “revolution in intellectual property” and a victory for public health and medical research.

The case is a massive win for cancer survivor and grandmother Yvonne D’Arcy and the law firm that represented her, Maurice Blackburn, which took the case all the way to the High Court after repeated losses in the Federal Court. It argued that mutations in the so-called “breast cancer gene” BRCA1 were naturally occurring component of the human body that had been discovered, rather than an invention that could be patented.

But Medicines and some intellectual property lawyers say the decision could slow access to new drugs.

Ms D’Arcy said she was extremely excited and relieved.

“I have had breast cancer twice, and although mine’s not genetic, I’ve always been of the view that you can’t own a part of me, or anyone else,” she said.

BRCA1 mutations put a woman at far higher risk of breast and ovarian cancer. Many carriers, such as actress Angelina Jolie, choose to test for it so they can have preventative surgery if they are a carrier. The patent was held by US company Myriad Genetics, which had licensed it for use in by a company called Genetic Technologies.

Maurice Blackburn principal Rebecca Gilsenan said the case would end years of uncertainty for people with BRCA1 mutations.

“The High Court has found that a company cannot lay claim to ownership to our genetic information,” she said. “[It] recognised that genetic information is not something that is ‘made’ or ‘artificially created’.  Myriad did not ‘create, make or alter’ the genetic code. This is what we have argued since the outset,” she said.

“Justice Gordon stated that the specific mutations and polymorphisms are indicative of a predisposition to breast cancer and ovarian cancer is a fact. That fact existed before Myriad worked it out.”

“This judgment invalidates the patent on the BRCA1 gene. It provides certainty that testing and research on the BRCA1 gene cannot be monopolised in and can be carried out widely and cost-effectively.”

Director of Public Policy at Cancer Council Paul Grogan said the decision would hopefully also give certainty to other people who needed genetic testing.

“It has been a very emotional and difficult journey, and I really want to acknowledge the courage of Yvonne D’Arcy in this case, as it really was a David and Goliath battle,” he said.

Mr Grogan said cancer patients had been in limbo since 2008, when Genetic Technologies had written to providers of public testing programs to tell them that they could no longer test for BRCA mutations as it was enforcing its patent. It eventually withdrew the claim after public outcry.

“They only did it because it was a PR disaster,” Mr Grogan said, noting that other cancers that attracted less advocacy and support may not have been able to win a public relations battle.

“[It] was always our biggest concern, that because of the out-dated nature of patent law, that we were going to see [it impact on the] rapid acceleration in the development of genetic testing and the importance of biomarkers for the risk of future diseases.”

Matthew Rimmer, a professor of Intellectual Property and Innovation Law and the Queensland University of Technology, said the victory would be a boon for research and innovation.

“There was concern in the scientific community about the threat of patent litigation,” he said. “The ruling will also be an important precedent for public health administration. It will mean that the provision of genetic testing will be for public good, rather than private profit.”

He said the ruling was also likely to be important in regards to other international cases, including one underway in Canada challenging a patent on the mutation causing Long QT Syndrome, a rare heart problem.

“The pharmaceutical and biotechnology industry will be upset about the decision,” he said. “The biotechnology industry will perhaps consider an action under investor-state dispute settlement – like big tobacco did after losing the plain packaging case.”

But Grant Shoebridge, a partner at Shelston IP who has a PhD in immunology, said he believed the judgment may still leave room for patents on genetic material that had been isolated from nature.

Maurice Blackburn had previously suffered two crushing victories, with the Federal Court first finding that genes are the same inside and outside the body, but the act of removing them means they can then be subject to a patent.

On appeal, the full bench of the Federal Court found in February last year overturned the first decision, but decided that the very act of isolating a gene from the body means that it is no longer in its natural state and so is subject to a patent.

Dr Shoebridge said naturally occurring materials other genes that could be isolated could still be patented, and it may if that genetic material isolated was then used as a product rather than a test it would still qualify.

“I think there would be a strong argument that would probably still be eligible,” he said.

He said patents on genetic material did not stifle innovation, but researchers needed the money that came from patents to ensure that they could develop new treatments.

Krystal Barter, a BRCA mutation carrier and founder of Pink Hope, said the decision was a win for the people, while Sally Crossing from the group Cancer Voices said she was thrilled.

“After all these years of being involved and thinking this was the commonsense ethical thing to do, it really gives you faith in the judicial system,” she said.

The Consumers Health Forum said gene patents were an “indefensible barrier” to both research and ultimately patient treatment, as medicine became more personalised it was more important than ever the patents were overturned.

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