Genes are No Longer Patentable In Australia

Gene Patents struck down by Australia’s High Court saying that allowing patents of genes were wrong, and they do not constitute a patentable invention.

The judges unanimously agreed on the outcome 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 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.

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.

It is very similar to the US Supreme Court’s reasoning for not allowing gene patents from last year. However, the Australian ruling is stronger, in which it says that even complementary DNA or cDNA is also not patentable.

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 $3000 USD.

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.

But the present decision by the Australian High Court is a win for 69-year-old Queensland breast cancer survivor Yvonne D’Arcy.

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