Those claims related to isolated nucleic acid sequences of the BRAC1 gene, mutations of which have been implicated as a risk factor for breast cancer and ovarian cancer.
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Following the ruling in the D’Arcy v Myriad Genetics High Court appeal, Davies Collison Cave partner Bill Pickering said the ruling has “muddied” the definition of patentable material.
Ms D’Arcy argued the genes existed in nature so were discovered rather than invented.
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.
Experts said the Australian decision could affect access to genetic testing, medical research and treatments in the country.
“While the invention claimed might be, in a formal sense, 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”, the High Court said in a statement.
Her legal battle finally ended in success on Wednesday, when those earlier judgements were dramatically reversed in a unanimous High Court verdict against Myriad Genetics’ patent. 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 69-year-old cancer survivor has spent years fighting Myriad Genetics – the U.S. company that had a patent over the isolated BRCA-1 gene.
“I am only a little person – but it is not the size of the dog in the fight, it is the size of the fight in the dog”. We are basically challenging the validity of gene patents, much like you are in Australia.
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.
The structure of the protein produced by the so-called “breast cancer gene”, BRCA1.
Holding [judgment summary, PDF] that allowing the gene to be patented would “involve an extension of the concept of a manner of manufacture”, the court said that this question was not “appropriate for judicial determination”.
However, the free rein given by the High Court to the inclusion of wide-ranging policy considerations in the assessment of patentable subject matter introduces a few uncertainty into the law – at least until we see how the Patents Office, and the Federal Court, respond to the Myriad decision.
“Myriad did not “create, make or alter” the genetic code”.
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In NRDC, the Court upheld the validity of a patent for the use of previously unknown properties of a known chemical to effect a new objective.
