Crucial genes monopoly case goes to court

GeneA court case starting in the US Supreme Court this week could help decide whether Australian women have open and relatively inexpensive access to tests to inform them about breast cancer, or whether one company will retain a monopoly over such vital human health information. CLA’s CEO, Bill Rowlings, reports.

Crucial genes case goes to court

By Bill Rowlings, CEO of Civil Liberties Australia, with NYT reporting

A crucial case in the US Supreme Court may soon change how much – and how expensively – women in Australia can find out whether they are likely to suffer from breast cancer.

The hearing in the US Supreme Court, starting this week, is about patent rights over particular gene codes related to breast cancer, but the US court’s decision will have major international impact.

Here in Australia, courts have recently ruled in favour of companies being allowed to patent human gene information. Critics of the decision – like Civil Liberties Australia, cancer researchers and the Cancer Council – are hoping the US decision will turn the situation on its head, and require a re-think here.

But, even if the US Supreme Court hands the company, Myriad Genetics,  patents rights (which US observers say is unlikely, the company will still own the largest database that tells patients what various mutations mean. That dominance of public health for women is a direct result of being granted a patent over human genome information that should never have been given, in the USA or in Australia, CLA says.

With 17 years of experience, millions of tests (at a charge to a female patient of around $3000 each) looking for thousands of mutations in the genes, and a $500 million investment, the company was able to amass a huge database that tells which DNA changes increase cancer risk and by how much, and which are inconsequential blips in DNA. And it is keeping that data to itself.

Having one company control the data for genes is contrary to the way medicine is developing, said Heidi Rehm, a Harvard geneticist, in a New York Times report. And many other genetics researchers, who are furious, have now figured out a way to get the data anyway.

Every time Myriad sends out a report on a gene test, it specifies not just the mutations it found but also what they mean. As a result, Myriad’s data on each of the mutations is scattered in millions of reports in the hands of doctors and patients. If the geneticists could just gather those reports, they say, they can recreate Myriad’s database.

So they started a grass-roots project, Sharing Clinical Reports, and are asking cancer clinics and doctors to provide them with all the Myriad data they have from patients who have been tested. The project’s leader, Dr Robert L. Nussbaum, chief of the division of genomic medicine at the University of California, estimates that with about 1,000 mutations collected so far, he has only about 1.5% of what Myriad has. None of the data have names of patients or other identifiers, so confidentiality is not an issue, advocates say.

 Clinics that sent in at least 200 unique genetic variants would get an iPad mini.

The funds for these inducements were supplied by Peter Kolchinsky, managing director of RA Capital Management in Boston. Dr Kolchinsky, a scientist by training, said he would like to see many gene testing labs compete on the basis of cost, speed and customer service. But they would all share data on interpreting alterations in genes rather than creating what he called “gene- or disease-specific trade secret monopolies.”

“That works for Coke, not for cancer,” Dr. Kolchinsky said.


 Bill Rowlings is part of a CLA team, led by Director Tim Vines, mounting a campaign to pass a new Australian law to protect Australians’ rights to our genes. Others working with us include federal MPs, the Cancer Council, research academics and people interested in health rights.

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