Gene sequences isolated from the human body are patentable, according to a ruling by the Australian federal court. The ruling upholds a decision last year to uphold a patent over an isolated version of the BRCA1 gene mutation, held by US-based biotech firm Myriad Genetics.
Mutations in BRCA1 are linked to an increased risk of hereditary breast and ovarian cancers. The patent in question is part of a portfolio that confers exclusive rights to perform the genetic tests that can identify these risky mutations, and Australian company Genetic Technologies is currently licensed to use the tests in Australia and New Zealand.
Cancer Voices Australia, an advocacy group, sought to oppose the patent, arguing that genes are naturally occurring substances and, as such, cannot be patented. Along with cancer patient Yvonne D'Arcy, the group took Myriad Genetics and Genetic Technologies to court, but in February 2013 a judge rejected their application, ruling that isolating the gene requires human intervention and so can be patented under Australian law (reported in BioNews 693).
Following an appeal heard by the full court, the latest decision affirmed the earlier ruling, explaining that the nucleic acid isolated was different in chemical composition from its state in the body. It held: 'In our view the products [in question] are different to the gene comprising the nucleic acid sequence as it exists in nature'.
'The isolation of the nucleic acid also leads to an economically useful result – in this case, the treatment of breast and ovarian cancers. This is surely what was contemplated by a manner of new manufacture [under Australian law]'.
The ruling may have significant implications for Australia's medical research. '[The decision] has long-term consequences for research and genetic testing, and the patent is preventing other companies doing research that might help save lives', Rebecca Gilsenan from Maurice Blackburn Lawyers, who represented D'Arcy and Cancer Voices Australia, told Yahoo! News.
Gilsenan said there are now two options available to the appellants: appeal to Australia's High Court or 'lobby the government to change the law'.
Patent lawyer Dr Luigi Palombi, who was not involved in the case, also told Yahoo! News: 'Only an invention can be the subject of a patent. The [Australian federal court's] decision ignores the scientific facts. It ignores good policy. And it ignores common sense'.
Myriad's patents over the BRCA1 and BRCA2 genes were declared invalid by the US Supreme Court in June 2013, which ruled that companies could not patent isolated forms of genes since they are 'products of nature' (see BioNews 709). However, the Australian federal court said the US court's emphasis on the similarity of the ordering and location of nucleotides was 'misplaced', stressing that the chemical changes in the isolated nucleic acid were of 'critical importance' in distinguishing the resulting product as 'artificial'.
The federal court also said that the policy or moral questions over the patentability of gene sequences were for Parliament to decide, noting that it had in fact decided not to exclude it from patentability.
Myriad holds patents relating to isolated forms of both BRCA1 and BRCA2 gene mutations, which carry a lifetime risk of contracting cancer of between 45 percent to 90 percent. Its BRCA1 patent is due to expire in August 2015 in Australia.