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Court Rules in Australian Gene Patenting Case

The Australian High Court has ruled that an isolated gene sequence cannot be patented, as GenomeWeb has reported.

The case, D'Arcy v Myriad Genetics, was brought by a 69-year-old two-time breast cancer survivor against Myriad, which held a patent on mutations and polymorphisms in BRCA1 and BRCA2 that it licensed to Melbourne-based Genetic Technologies. But the court found that a gene cannot be patented.

"An isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture," the court says. "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."

ScienceInsider notes that this ruling brings Australia in line with rulings made in the US, South America, and much of Asia. Gene patenting is allowed, it adds, in Canada and the European Union.

Cancer patient advocates in Australia tell the Sydney Morning Herald that they are thrilled with the outcome of the case.

The Herald adds that the decision would likely open up lower-cost public genetic testing programs in Australia and enable researchers to use such mutations in their research without fear of infringing a patent.

However, Tim James, CEO of the industry group Medicines Australia, tells ScienceInsider that the decision could led to a "significant negative impact" on access to new biological medicines.

In a statement, Myriad also expresses its disappointment with the ruling. "The High Court's decision comes at a critical time when we're entering the golden era of personalized medicine," it says, as GenomeWeb reports. "In order for personalized 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."