Gene patent genie back in the bottle —

Gene patents probably dead worldwide following Australian court decision

Other countries likely to follow the lead of top courts in US and Australia.

Gene patents probably dead worldwide following Australian court decision

Australia's highest court has ruled unanimously that a version of a gene that is linked to an increased risk for breast cancer cannot be patented. The case was brought by 69-year-old pensioner from Queensland, Yvonne D'Arcy, who had taken the US company Myriad Genetics to court over its patent for mutations in the BRCA1 gene that increase the probability of breast and ovarian cancer developing, as The Sydney Morning Herald reports. Although she lost twice in the lower courts, the High Court of Australia allowed her appeal, ruling that a gene was not a "patentable invention."

The court based its reasoning (PDF) on the fact that, although an isolated gene such as BRCA1 was "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." Since the information stored in the DNA as a sequence of nucleotides was a product of nature, it did not require human action to bring it into existence, and therefore could not be patented.

Although that seems a sensible ruling, the pharmaceutical and biotechnology industry has been fighting against this self-evident logic for years. The view that genes could be patented suffered a major defeat in 2013, when the US Supreme Court struck down Myriad Genetics' patents on the genes BRCA1 and the similar BRCA2. The industry was hoping that a win in Australia could keep alive the idea that genes could be owned by a company in the form of a patent monopoly. The victory by D'Arcy now makes it highly likely that other judges around the world will take the view that genes cannot be patented.

This is a result that will have major practical consequences, and is likely to save thousands of lives. In the past, holders of gene patents were able to stop other companies from offering tests based on them, for example to detect the presence of the BRCA1 and BRCA2 genes that were linked with a greater risk of breast and ovarian cancers. This patent monopoly allowed companies like Myriad to charge $3,000 (£2,000) or more for their own tests, potentially placing them out of the reach of those unable to afford this cost, some of whom might then go on to develop cancer because they were not aware of their higher susceptibility, and thus unable to take action to minimise their risks.

Striking down gene patents in Australia, as in the US, clears the path for new entrants to the gene testing market, which is likely to drive down prices. It could also spur more biomedical innovation by allowing researchers freedom to investigate previously patented genes and develop new therapies, without fearing potential lawsuits.

If the judgement is followed by courts in other jurisdictions, and the whole idea of gene patents is rejected, the number of people whose lives could be saved will be correspondingly greater.

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Channel Ars Technica