Explainer: Myriad Genetics and BRCA1 Patent Ruling
First published on Australian Hospital + Healthcare Bulletin – September 5th, 2015
You have almost certainly heard the news by now: Queensland cancer survivor Yvonne D’Arcy has won an extensive battle against US biotech company Myriad Genetics. The Australian High Court ruled that the BRCA1 genetic mutation patent could not be owned by Myriad or any other company, allowing breast cancer sufferers access to diagnostic tests without exorbitant fees from private companies.
What you’re probably wondering is how this could happen in the first place, and why did it have to go all the way to the High Court?Let’s just put it down to good lawyers and complicated (or overly simplistic) laws.
Simply speaking, cancer is not the natural human state but rather a mutation in the gene. When the researchers at Myriad identified the BRCA1 and BRCA2 genes which caused cancer – and were able to replicate the mutation in them, this was viewed as an intervention and therefore legally, an invention.
Section 18(1)(a) of the Patents Act 1990 grants a patent to inventions that produce an “artificial state of affairs that has some discernible effect”.
Did Myriad’s work in identifying the BRCA1 and BRCA2 and replicating the mutation occurring as cancer fit this definition? Well, yes.
Myriad Genetics was granted patent for isolating hereditary mutations to the BRCA1 (in 1997) and BRCA2 (in 1995) genes, which increase the carrier’s risk of developing breast and ovarian cancer. The patent filed covered access to the genetic information in certain countries including Australia, and so clinicians requiring the information would need permission from their own country’s legal system. Enter the Australian courts.
Darcy had taken her case to the Australian Federal Court in 2013 – where the court had dismissed Darcy’s appeal against a judge’s finding that the invention fell within the concept of a “manner of manufacture”. The proceedings had focused on the structural nature of the gene, citing the differences in chemical structure between its ‘natural’ and mutated state were enough for a patent case…