[Ip-health] Australian challenge to validity of BRCA1&2 patents:
Judit Rius Sanjuan
judit.rius at keionline.org
Mon Jun 7 18:28:05 PDT 2010
Bid to halt patenting of genes
June 8, 2010
A LANDMARK court case is set to challenge the legality of an Australian-issued patent for a breast and ovarian cancer gene.
If successful, the case could set a precedent leading to other gene patents being overturned.
The case could also strengthen calls by researchers, doctors and healthcare advocates to stop the practice of gene patenting altogether.
There are about 16,000 gene patents worldwide, covering the breadth of human affliction from breast cancer, epilepsy and hepatitis C to cystic fibrosis and hemochromatosis.
The fact that monopoly rights over gene patents can be bought has raised concerns over impediments to genetic research, as well as the higher cost for patients forced to use the gene test offered by the patent owner. Researchers are also often forced to pay large licence fees.
Law firm Maurice Blackburn will file the patent challenge in the Federal Court today. The move comes after a New York court recently invalidated the US patent for the same breast and ovarian cancer gene, and as an Australian Senate inquiry into the impact of gene patents prepares to release its report.
Maurice Blackburn principal Rebecca Gilsenan said the legality of gene patents had never been challenged in Australia.
She said the patents agency, IP Australia, was ''giving these [patents] out - they're privatising [genes] … and it's never been clarified by anybody''.
The court challenge will seek to overturn the Australian patent to the genetic mutations BRCA 1 and BRCA, which is owned by a US biotech company and two international research organisations.
She said the main legal argument against the patent was one of discovery over invention, but there were also big ethical and philosophical questions about whether the body could be privatised. ''It's a healthcare rights issue and an issue of freedom of research into the fundamental building blocks of our being,'' Ms Gilsenan said.
She said Maurice Blackburn's interest in gene patents had been galvanised in 2008 when Australian-based Genetic Technologies tried to enforce its licensee patent rights to BRCA 1 and BRCA 2.
The company backed down after a public outcry and government intervention.
Genetic Technologies, along with the patent co-owners Myriad Genetics, Centre de Recherce de Chul in Canada and The Cancer Institute (Japan), are respondents in this case.
About 400 gene patents have been granted in Australia. Access to the genes, whether for research or diagnostics, is at the behest of the company, which holds the patent for 20 years.
But with genetic medicine and development of targeted treatment to be the next leap forward in healthcare, it was imperative that all gene information remained in the public domain, said John Stubbs, chief executive of Cancer Voices, one of two applicants in the court case.
''If researchers can isolate a part of a gene that can have an impact on a cancer, we believe that the information should stay in the public domain,'' Mr Stubbs said. ''As a cancer patient you want to feel that you retain ownership, that you retain control over your treatment.''
Yvonne D'Arcy, 64, a cervical and breast cancer sufferer and the second case applicant, agrees. ''It's morally and ethically corrupt [to own the rights to a gene],'' Ms D'Arcy said.
A spokesman for Genetic Technologies, Greg McPherson, said public institutions had previously taken months, and sometimes years, to provide BRCA 1 and 2 results. His company could determine a woman's risk in as little as two weeks.
''Genetic Technologies has always operated within the existing legal and patent framework. Should the rules change, the company will operate within the new rules,'' he said.
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