Myriad Genetics Inc. (MYGN:US), owner of patents for genes linked to cancer risks, won an Australian court ruling allowing it to patent isolated DNA, a first in the country, with the U.S. Supreme Court set to hear a similar case.
Federal Court Justice John Nicholas today in Sydney dismissed a 2010 lawsuit aimed at stopping Myriad and Genetic Technologies Ltd. (GENE:US) from patenting a gene mutation associated with an increased risk of breast and ovarian cancers.
The issue has divided the global medical community with groups including the Association for Molecular Pathology and the American College of Medical Genetics arguing that Myriad is attempting to get legal ownership of parts of the human body. The conflict returns to the U.S. Supreme Court this year after the U.S. Court of Appeals for the Federal Circuit twice ruled that genes can be patented. The U.S. high court agreed on Nov. 30 to hear the Association for Molecular Pathology’s appeal.
Rebecca Gilsenan, a lawyer at Melbourne-based Maurice Blackburn, the firm representing the opponents, said after the Australian decision that they will have to review the 41-page judgment before determining whether to appeal.
“We’re really interested in the U.S. Supreme Court hearing,” Gilsenan said. “We’ll be watching it very closely.”
The Australian ruling will allow patents on anything that is artificial, without consideration of the biological material from which it derived, Luigi Palombi, a patent lawyer and author of “Gene Cartels: Biotech Patents in the Age of Free Trade,” said in an e-mailed statement.
“No matter how important it is to identify a gene linked to a disease, it’s still not something that Myriad or anyone else has invented,” Palombi said. Politicians must now change the law to prevent patenting of genetic materials, he said.
Some scientists argue they have been stymied in researching new medicines and treatments because they may come up against demands for royalties or letters demanding they stop using patented inventions. Companies such as Genomic Health Inc. have argued they can’t attract investment dollars if they can’t protect their research from competitors.
Cancer Voices Australia, a national organization representing cancer patients, and Yvonne D’Arcy, a Brisbane resident diagnosed with breast cancer, sued Myriad Genetics (MYGN:US) and Genetic Technologies (GENE:US) to block the patenting of genes in the country.
Gene-sequencing breakthroughs are spawning a multibillion- dollar market for drugs and medical tests.
DNA, as deoxyribonucleic acid is commonly known, contains genetic information that determines differences in living organisms. RNA, or ribonucleic acid, is a molecule that carries instructions from genes to cells’ protein-making machinery.
“There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent,” Nicholas wrote.
Myriad Genetics (MYGN:US), based in Salt Lake City, and Genetic Technologies extract the gene from cells that have been purged of other biological material, which is a manufacturing process that can be patented, Nicholas said.
“You can’t use this to build another human being,” David Shavin, Myriad Genetics’ lawyer, said at the start of the trial in Sydney last year, 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, a position with which Nicholas agreed.
U.S. rulings didn’t help either side in the Australian case, Nicholas said.
“The constitutional setting in which patent legislation operates in the U.S. is quite different to that in which patent legislation operates in this country,” the judge wrote.
The Myriad Genetics process copies gene codes from people, the plaintiffs’ lawyer David Catterns said at the start of the trial.
If the plaintiffs isolated a mutation in a gene from a person’s blood, they would infringe the patent, Catterns said.
D’Arcy said after the ruling that she’s worried about the impact the decision will have on future research.
“I’m extremely disappointed,” she said.
The case is: Cancer Voices Australia v. Myriad Genetics. NSD643/2010. Federal Court of Australia (Sydney).
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