Myriad Genetics Inc. of Salt Lake City and other biotechnology companies can’t monopolize disease treatment by patenting human genetic material, an Australian trial was told this week in the country’s first challenge to ownership of DNA molecules.
Cancer Voices Australia, a national organization representing cancer patients, and Yvonne D’Arcy, a Brisbane resident diagnosed with breast cancer, sued Myriad Genetics and Genetic Technologies Ltd. in 2010 over a patent the companies have on a gene mutation associated with an increased risk of breast and ovarian cancers.
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"Patents protect inventions, not discoveries," Rebecca Silsenan, a partner at Maurice Blackburn Lawyers, who represents the plaintiffs, said before the trial. "No Australian court has considered the question of whether isolated human genes are patentable."
Gene-sequencing breakthroughs are spawning a multibillion-dollar market for drugs and medical tests. In the United States, health regulators are developing rules for bolstering oversight of laboratory-developed tests and the U.S. Supreme Court may decide soon whether to hear two cases involving patents over genetic material, including a review of an appeals court decision that upheld Myriad Genetics’ patents.
Myriad Genetics contends in the Australian case that its screening process that includes an artificially made gene mutation mimicking the one that makes people more susceptible to breast and ovarian cancers should be eligible for a patent.
"You can’t use this to build another human being," David Shavin, Myriad Genetics’ lawyer, told Federal Court Justice John Nicholas this week in his opening statement at the start of the trial in Sydney, referring to the process and mutation. "All you can use it for is to compare" normal and mutated genes.
Australian law allows for patents on artificially created products with economic benefits, including computer programs and business methods, Shavin said.
"The position in the United States is similar to, but not the same as, in Australia," he said.
The Myriad Genetics process copies gene codes from people, the plaintiffs’ lawyer David Catterns told the judge in his opening statement.
If the plaintiffs isolated a mutation in a gene from a person’s blood, they would infringe the patent, Catterns said.
"The patent involves precisely the code that occurs in nature," he said. "This is not patentable on traditional principles."
The trial is scheduled to take as along as eight days.
"There is a philosophical and ethical issue about the commercialization of the human body," Gilsenan said. "The patent owner has a right to prevent people from studying and testing for the same gene mutation, so gene patents can stifle research."
The case is: Cancer Voices of Australia v. Myriad Genetics, NSD6743/2010. Federal Court of Australia, Sydney.
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