How can a biotech company own a cancer gene? Myriad Genetics and the BRCA1 Patent Ruling
You have almost certainly heard the news by now: in October 2015 Queensland cancer survivor Yvonne D’Arcy 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 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, a 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 occuring 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.
Myriad fought many battles in the US over their patents. In 2013 the US Supreme Court ruled that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” referring to Myriad’s work in isolating BRCA1 and BRCA2 however the work they had done in synthetically reproducing the mutation, or production of c-DNA was still eligible for patent protection.
The 2015 Australian High Court decision was similar, ruling that an isolated nucleic acid, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer was not a “patentable invention”.
Where to from here? More work needs to be done in challenging the legal industry, particularly in the field of intellectual property law. While originally the US patent law was created to seek a balance between creative “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention,” there is obviously a commercial aspect that is being exploited for monetary gains.
What happened to advances in science being motivated for the betterment of mankind? Admittedly, investment equals innovation for these companies, but rather than life-saving tests costing in the range of $40,000 these tests need to be affordable and accessible in order for progress to occur.
This originally appeared on Australian Hospital and Healthcare Bulletin.