Genes are a fundamental cornerstone of biology. They determine the shape of our bodies, the colour of our eyes and skin, and to a large extent, our behaviour and personality. They are a unique molecular identifier of who we are. They are completely our own. Or are they?
The Federal Court of Australia recently ruled in favour of a US-based biotechnology company, Myriad Genetics, finding that it had rights to patent two genes that have been linked to breast and ovarian cancer; BRCA1 and BRCA2.
The argument for Myriad Genetics rested on the precedent of the National Research Development Corporation v Commissioner of Patents (1969) case. A binding High Court decision, this case decided that an item could be patentable if it existed in an ‘artificially created state of affairs’ The Federal Court agreed with the precedent put forward by Myriad Genetics, determining that a significant distinction exists between the ‘isolated’ genetic material in the laboratory and naturally occurring genetic material in the human body, and that a patent could extend to the genes in question due to their ‘isolated’ or ‘artificial’ state.
Rebecca Gilsenan, a lawyer from Maurice Blackburn, is leading the case against Myriad Genetics. She and her team argued broadly, and attacked the case by distinguishing the purpose of the legislation from its potential application under the case made by Myriad Genetics. They contested that patent law is intended to protect inventions, not discoveries, and thus the discovery made by Myriad Genetics cannot be deemed patentable. Likewise, it was debated that the discovery of a new gene cannot be a proper subject for patent law, as DNA is something that exists naturally in the human body and is completely distinct from the realm of invention.
Further, a proposal from Maurice Blackburn was that it would be more democratic if Myriad Genetics retained intellectual property rights without patenting, which would allow others limited rights to use the genes.
The court disagreed. They found that since Myriad Genetics had identified the two genes, they had invented them solely through discovery, rejecting most of the argument made by the company. Following this, it was decided that under Australian patent law these genes could be patented, hence Myriad Genetics could reserve their rights.
What does this mean for cancer sufferers, or people who want to get tested for a mutation in these genes? That is unclear.
Genetic tests will become more restricted, as Myriad Genetics would be the only entity with the right to dispense testing. Due to this, Myriad Genetics would have the prerogative to increase the cost of the procedures and disallow access to a second opinion on the findings of their tests. They could also have the right to retain, and potentially disclose, any medical information that was granted for the purposes of testing.
Furthermore, scientific research on these genes would decrease as less scientists have the right to research them, making cures and preventative medicines more elusive.
Lastly, and more frighteningly, it begs the question that if someone else can take our genetic rights, what other fundamental physical attributes can be patented? The exact curvature of our eyes? Our fingerprints? It seems an ominous precedent.
Numerous public groups, including the Breast Cancer Network Australia, have spoken out against the ruling in a show of solidarity with Yvonne D’Arcy, a breast cancer survivor, who along with Cancer Voices Australia brought the case. “I won’t give up the fight, because this is too important for future generations of people [who] may need testing and treatment for cancers and other diseases.” she said.
And the fight isn’t over. In a press release, Ms Gilsenan stated that, “Our opposition to gene patents remains,” with Oscar McLaren, a colleague at Maurice Blackburn, declaring during a recent conference that an appeal to overturn the judgment was underway.
Mr McLaren also stated that the principle arguments, particularly those that dealt with the public policy ramifications of a decision in favour of gene patenting, were rejected in the Federal Court case. He said that he felt optimistic that these arguments might be more persuasive in the High Court appeal, especially given the ability of the court to reject its 1969 decision. Mr McLaren finished by expressing gratitude to the public for the significant amount of support in their case against Myriad Genetics.