Patent on breast cancer risk genes: right or wrong?

The BRCA1 (breast cancer 1) gene is a gene closely associated with breast cancer. Mutations in the gene increased an individual’s risk to have breast cancer as well as ovarian cancer. Nowadays, it is very common for women to be tested for mutations in the BRCA1 gene as well as in another gene, the BRCA2 gene for breast cancer risk assessment.

What you probably don’t know is that for every BRCA1 testing in the US, a certain amount is probably paid to somebody. You see, the BRCA1 gene is one of the genes whose sequence has been patented. And not only one patent but many.

The original holder of the BRCA1 gene sequence in question was Myriad Genetics but it was transferred to the University of Utah in 2004.

In Europe, resistance to the patent was strong and it took 7 years to finally resolve the issue. And the patent owners won their case in the European Patent Office last November. “Between 10% and 15% of all heritable breast and ovarian cancers have a mutation in BRCA1 or BRCA2, another gene linked to breast cancer, leading to as many as 5,000 new cases of both cancers in the European Union every year…The ruling means that the patent owners now have the right to collect royalties on tests carried out on tens of thousands of women across Europe every year”, according to this Nature report.

European scientists are dismayed about the ruling.

“Clinical geneticists do not agree with monopolies on diagnostic testing of genes for such diseases because they believe they block the competition that could lead to the development of better, cheaper products.”

Paying royalties would mean increased cost for the tests. Currently, it costs more than $US 3000 to test for each BRCA gene in the US. In the EU, it costs much less when testing for both. With the patent in place, it is expected that the price of the test will skyrocket, adding to the burden of the European health care system.

In addition, it might hinder further research since using the gene in the lab might mean infringement of the patent owner’s rights. There have been many cases of gene and biological patents hindering scientific research, including patents on hepatitis C, haemophilus influenza, and SARS.

Some claims the ruling on BRCA1 is confusing and doesn’t clearly define what constitute infringement of the patent.

Granting gene patents have been severely criticized but this didn’t stop the process. In this article in the New York Times, the late Michael Crichton, doctor, science fiction writer, film maker and cancer victim brought up the following food for thought regarding biological patents: