U.S.-based biotech Myriad Genetics ($MYGN) lost a closely watched court appeal case in Australia over a patent for a BRCA1 and BRCA2 cancer gene diagnostic that was brought by a grandmother who survived cancer twice.
The case pitted Myriad against Yvonne D'Arcy, 69, on whether the patent met a criteria that showed discovery over invention, the Australian Broadcasting Corp. (ABC) said.
Myriad has developed diagnostics that show specific mutations and alterations in the BRCA1 and BRCA2 genes increase the risk of breast and ovarian cancers in women. What's more, they account for about 20% to 25% of hereditary breast cancers and 15% of ovarian cancers.
The company succeeded twice in Australian Federal Court in claims that its work was inventive, ABC said, but the High Court overturned those decisions this week as it ruled unanimously for D'Arcy.
"The testing will be a lot cheaper and it will be more available … rather than using only Myriad's agents at a price that nobody really can afford," she was quoted as saying by ABC. "I'm just hoping that other countries will see sense and follow us and the Americans."
In January, Myriad settled legal actions pending over its BRCA technology patents that followed a complex legal ruling in the United States.
The U.S. Supreme Court ruled in 2013 that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," quashing Myriad's patents on the BRCA1 and BRCA2 genes.
At the same time, however, the Supreme Court said manipulating a gene to create something that doesn't occur in nature could still be eligible for patent protection.
Companies like Ambry Genetics, Gene by Gene and Quest Diagnostics ($DGX) that have rolled out their own BRCA tests for breast cancer have also fought Myriad in patent suits for a share of the market.
A similar issue was before the court in Australia, ABC said, adding that in this case what is known as "the manufacture test" applied.
In a summary of the case, the court found: "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."
- here's the story from the Australian Broadcasting Corp.