BY MICHAEL SLEZAK
Your genes are no longer patentable in Australia. The country’s highest court found unanimously that two previous Australian judgments allowing patents of genes were wrong, and they do not constitute a patentable invention.
The judges unanimously agreed on the outcome, but had different reasons. The majority of judges ruled that the key part of a gene is not its physical structure, but rather the information stored in it, which is not an invention. They wrote: “[Its] substance is information embodied in arrangements of nucleotides. The information is not ‘made’ by human action. It is discerned.”
They also said that if the patent was allowed, then it could be infringed by someone regardless of how they tested for it. And a pathologist wouldn’t know they had infringed it, until they actually found the gene. They noted that this could have a “chilling effect” on healthcare and research. “Such a result would be at odds with the purposes of the patent system,” they wrote.
Another group of judges said the subject of the patent was the isolated piece of DNA, but that it occurs naturally, so can’t be patented. They said a method of using the gene could potentially have been patented, but not the gene itself. The final judge gave similar reasons.
Dianne Nicol from the University of Tasmania in Hobart says the majority decision is the one that will have the most weight in future cases, and is very similar to the US Supreme Court’s reasoning for not allowing gene patents from last year.
However, the Australian ruling is stronger, and perhaps more coherent, than the US ruling, says Nicol. The unanimous ruling in the US Supreme Court allowed that complementary DNA, or cDNA, could be patentable, attracting a lot of criticism. cDNA is produced by a lab from RNA, but lacks the “introns” that are found in the full sequence of the gene.
“The US supreme court says that’s patentable because it’s different from isolated, naturally occurring DNA, even though the information it provides – in terms of making proteins and so on – is exactly the same,” says Nicol. “There’s been a lot of criticism of that as to whether the logic is coherent. But the court here is saying neither would be patentable.”
In several countries around the world, the test case has been the same: Myriad Genetic’s patent for BRCA1 mutations, which are associated with a heightened risk of cancers, particularly breast and ovarian cancer.
In Australia, it all started 21 years ago when Myriad Genetics filed patents for mutations in the BRCA1 genes. That meant any test that found the mutations in a patient would infringe on Myriad’s patent. Licences to test for the genes in other jurisdictions cost up to US$3000.
Public pressure forced the licensee of the patent to allow labs to test for the genes for free in Australia. But despite that, Myriad vigorously defended the patents against a legal challenge from Cancer Voices Australia and breast cancer survivor, Yvonne D’Arcy.
In 2013, Justice John Nichols of the Federal Court handed down the first ruling on the matter in Australia. He ruled that genes are no different outside of the body than they are inside the body. But despite that, he said isolating them from the body created an “artificial state of affairs” and therefore were an invention and patentable.
The ruling was appealed, but in 2014, five judges on the Federal Court ruled in Myriad’s favour again, and strengthened the decision further.
“We are thrilled that after this long and hard fought case, the High Court has found that a company cannot lay claim to ownership of our genetic information,” says Rebecca Gilsenan, principal at social justice law firm Maurice Blackburn which has fought the case since 2010. “It provides certainty that testing and research on the BRCA1 gene cannot be monopolised in Australia and can be carried out widely and cost-effectively.”