Australian court says genes can be patented

Patents on breast-cancer gene challenged in US fare better in Australia.

by Joe Mullin

A major legal battle is underway over gene patents in the US and is now headed to the Supreme Court, with oral arguments scheduled for April. A similar battle is taking place in Australia, and proponents of gene patents have just won a major victory in that nation.

An Australian federal judge has ruled that because the BRCA1 cancer gene has been "isolated" from the human body, it's appropriate to grant a patent on it. "The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated," wrote the judge.

That's the exact opposite of the finding by the judge who heard the US case, who agreed with various doctors' groups and the ACLU that the whole idea of "isolating" genes really doesn't change the calculus. The patent holder was effectively demanding a monopoly on any doctors who viewed the gene, and that was unacceptable. The genetics company lost at district court, won at the patent-friendly US Court of Appeals for the Federal Circuit, and now has its case headed to the US Supreme Court.

The patent-holder in the case is the same one that claims to own the BRCA1 gene in the US, Utah-based Myriad Genetics. (Hat tip to Techdirt.) The case was brought by an Australian advocacy group, Cancer Voices Australia. Today's Australian ruling could be appealed to a three-judge panel, which would have the final say unless the case went to the High Court of Australia, the equivalent of the US Supreme Court.

The BRCA1 and BRCA2 genes are important because they can predict a woman's likelihood of contracting breast or ovarian cancer. In the US, the Myriad test can cost upwards of $3,000 and isn't always covered by insurance. In Canada, where Myriad has threatened but failed to enforce its patent, doctors have been able to offer test results for one-third of the US cost, and get results far quicker.

The politics of these gene patents in Australia differ from the US. One reason the ACLU targeted Myriad in the US was because of Myriad's vigorous enforcement efforts. The company sent cease-and-desist letters to researchers and threatened lawsuits. In Australia, Myriad outsourced its patent to a Melbourne company, which "gifted" the patent rights to many health care institutions and promised not to demand royalties for testing.