Gene patenting not allowed rules High Court

The High Court of Australia Wednesday ruled in favor of a cancer survivor in a landmark judgment against an American biotech firm.

The case was brought by 69-year-old pensioner from Queensland, Yvonne D’Arcy, who had taken the United States 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.

While Ryerson skipped the common step of genetic testing and had a preventative double mastectomy without knowing if she carried the genetic mutation associated with breast cancer, the testing is becoming common practice for women who have a family history of breast and ovarian cancers.

Breast cancer is the leading cancer killer of women aged 20-59 worldwide, and supporters of the case had argued that patenting a gene could stymie medical research and testing.

In 2008, Myriad Genetics threatened to have the tests withdrawn from public laboratories in Australia.

The High Court found that while isolating the gene required human activity, that was not enough to classify it as a manufactured product and so make it patentable. “Rather, what is important is (the ruling’s) effect on the availability of patents in new areas of technology more generally”, she said.

However, synthetic DNA created in a laboratory setting is eligible, the USA supreme court ruled.

I’m only a little person, but it’s not the size of the dog in the fight, it’s the size of the fight in the dog.

Myriad’s patent covered various aspects of this finding, including the isolated nucleic acid itself, probes, vectors, methods of producing mutant BRCA1 polypeptides, preparations and uses of polypeptides, and various methods of diagnosis.

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.

Ultimately, the High Court overturned the previous decision of the Full Federal Court in 2013 by holding that the invention claimed was not a “manner of manufacture” as described in the Patents Act 1990.

Myriad’s other patent claims concerning its diagnostic tests for the BRCA 1 and BRCA 2 genes were never challenged.

“In order for personalised medicine to become a reality, strong patent protection is essential because it provides the research-based companies like Myriad with an incentive to continue to invest in R&D”.

“We have been waiting nearly 30 years for a decision of this nature, on the issue of whether isolated DNA sequences are patentable subject matter”, said Ms Dianne Nicol, director of the Centre for Law and Genetics at the University of Tasmania. However, he notes the new Australian Prime Minister Malcolm Turnbull “has expressed his concern about gene patents, previously”.