Sometimes when corporations hold patents on human genes, the only winner is big business. Now, a High Court has agreed with a unanimous ruling that BRCA1 is a naturally occurring gene and not an invention that can be patented.
Yvonne D’Arcy, a 69 year-old pensioner and two-time cancer survivor, has won her High Court challenge against Myriad Genetics — a United States-based biotech company — from owning human genes. The BRCA1 gene has been linked to an increased risk of hereditary breast and ovarian cancers.
What is BRCA1 and BRCA2?:
After losing in a Federal Court challenge, D’Arcy went to the High Court where her lawyers argued the genetic material is a product of nature — even if it was isolated from the body, and, therefore, is not patentable.
They had also contended that:
Allowing corporations to own patents over human genes would slow cancer research.
It would also also allow them to charge exorbitant rates to patients wishing to be tested for the BRCA1 mutation.
In the unanimous decision, the High Court found the 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.”
Ms D’Arcy told The Sydney Morning Herald (SMH): “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.”
Watch the following announcement on intellectual property:
The judges said: “While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed.
“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 monopolized in Australia and can be carried out widely and cost-effectively.”
Rebecca Gilsenan from Maurice Blackburn, who acted for D’Arcy, told SMH that this case would end the 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.
Gilsenan said: “[It] recognized 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.”
The ruling is in line with the U.S. Supreme Court ruling that genes are not inventions, but discoveries. Myriad Genetics had argued that patents ensured innovation could be commercialized for everyone’s benefit, wrote the ABC.
See why the Supreme Court says human genes cannot be patented:
Before the Australian case, in 2013, the United States Supreme Court also ruled against the patent. Specifically, the U.S. Court ruled that naturally occurring DNA was a product of nature and not patentable, the ABC added.
Myriad Genetics’ lawyers had claimed that the law in the U.S. did not reflect the law in Australia, and that the legal test in the U.S. is different in that it asked only if the material “is a product of nature.”
The High Court has ordered the Australian patent to be revoked, which was licensed to Genetic Technologies.
The research industry used to be about the discovery of “the new and the unknown,” but now — unfortunately — it’s more about the money.