Life just got easier—and cheaper—for Australian medical researchers, clinicians, and patients needing genetic testing. On 6 October Australia’s highest court overturned a lower court decision by ruling that an isolated gene sequence is not a “patentable invention.” The decision brings to an end a long-running legal saga kick-started in 2010 by cancer survivor Yvonne D'Arcy, now age 69.
The ruling also aligns Australian legislation with that of the United States, South America, and most of Asia. Canada allows human gene patenting, as does the European Union if the biological material has been isolated by a technical process.
D'Arcy challenged patents over the BRCA1 and BRCA2 genes held by U.S. firm Myriad Genetics and its Melbourne-based licensee Genetic Technologies. Both genes significantly increase a woman’s chance of developing breast and ovarian cancer. Myriad had used the genetic information to develop diagnostic tests over which it or its international representatives held a potentially lucrative monopoly.
Although the full implications of the ruling are not yet clear, D'Arcy told The Sydney Morning Herald she was “thrilled” with the High Court decision. According to intellectual property experts like Luigi Palombi, the decision is “fantastic” for medical researchers, enabling them to work with genetic material without fear of encroaching on patents. “They have freedom to operate without having to employ expensive lawyers and patent attorneys to scour the landscape for patents,” says Palombi, with Murdoch University in Perth.
The decision also sets an important precedent for public health administration. Hospitals will be free to perform genetic testing—and develop their own tests—without fear of reprisals from biotechnology companies. That means the provision of genetic testing will be for “public good, rather than private profit,” adds Matthew Rimmer, an intellectual property expert at the Queensland University of Technology in Brisbane.
Big Pharma and the biotechnology community see things differently. They fear the ruling will have a chilling effect on research and be a “blow to innovation,” as claimed by the industry publication Pharma in Focus. Tim James, CEO of industry group Medicines Australia, predicts the decision could have “significant negative impact” on access to new and innovative biological medicines.
Myriad Genetics agrees. Although its BRCA1 and BRCA2 patents have expired, the company said in a statement that “strong patent protection” is essential because it provides research-based companies with an “incentive” to invest in research and development. The company said it had spent more than $1 billion over 25 years to develop its facilities and its tests have been used on 2 million patients to date.
There are a number of ways Myriad could contest the decision under Australian law, Rimmer says. A Myriad spokesperson, however, says that the company has no plans to fight the ruling.
The High Court case, run pro bono by Rebecca Gilsenan of the firm Maurice Blackburn in Sydney, will have an impact beyond Australia. Rimmer suggests the ruling may serve as a precedent in a Canadian test case brought against gene patents by the Children’s Hospital of Eastern Ontario.
Meanwhile, the next round of legal wrangling does not worry D'Arcy. “It’s been a long hard fight and it means so much, to so many people.”
*Update, 12 October, 8:00 a.m.: This story has been changed to reflect Myriad’s current position.