We tend to think of patents as good, or at least necessary, legal tools. Patents provide legal protection for innovations on which inventors rely to recoup the investment of time and money they made to develop a new medication, or bring a new product to market.
But where wrongly applied, patents can stifle innovation, drive up costs and restrict access to medicines and diagnostic tests. They can literally put lives at risk. Patents on genes do just this, yet the Australian government continues to grant them every year. To date, around 15,000 patents on human genes have been granted around the world, including linked to cystic fibrosis, hearing loss, hereditary haemochromatosis, long QT syndrome Tay-Sachs and Alzheimer’s disease.
Among the most high-profile victims of inappropriate patents are women at risk, or suffering from, hereditary breast or ovarian cancer. Myriad Genetics has patents on two of the genes that predict such cancers. Their proprietary control means scientists must seek Myriad’s permission to use the genes in studies designed to understand the condition, and to develop effective cures. Myriad has also used its monopolistic control to prevent women getting tested to find out whether they carry the gene in non-Myriad laboratories. In America, this meant that sick women could either pay the company’s exorbitantly high fee for the test or go without.
In Australia, with our public health system, such extortionist tactics target the taxpayer. When Amgen had its 20-year patents on anemia treatment Erythropoietin or Epo extended by the Australian patent office few years back, $250 million was added to the public health bill. At least the treatment remains available. At the Westmead Children’s Hospital in Sydney, doctors are prohibited by a patent on the SCN1A gene from testing infants for epilepsy. This is despite the fact that those baby’s parents, and all other taxpayers, funded the research that identified the gene in the first place.
Americans have had enough. In a landmark decision last month, a New York court ruled that patents for the genes associated with hereditary breast and ovarian cancer should never have been granted. The judge ruled that genes are products of nature, not innovations that can or should be made corporate property. Genes are part of all our bodies, the court noted, containing fundamental information about human life and heath that should be available to everyone, not locked up by private companies for profit.
While Myriad intends to challenge the ruling in a case that seems destined for the US Supreme Court, for the moment the Federal Court judgment is the law of the land. Until further notice, the US patent office will not grant any further patents on human genes isolated from the body, while those granted to date are now in jeopardy.
Australian are not so lucky, or at least not yet. The Australian Senate recently concluded a public consultation about the appropriate role of patents in regulating gene technology, but has yet to make recommendations. The inquiry looked at the impact of patents on the provision and costs of healthcare, the training of healthcare providers, the progress of medical research and the “health and wellbeing of the Australian people.” Its findings have been delayed due to the “complex nature of many issues associated with this inquiry” (and, it is rumoured, the well-funded and vociferous lobbying efforts of bio-tech companies). Australian legislators must also now be attentive to the US court decision, as US and Australian patent laws are kissing cousins. This means that while the American decision is not binding on Australian courts, it should have persuasive effect.
Australian supporters of current legal arrangements say that without patents, medical innovation will grind to a halt. Why should companies invest in research from which they cannot profit? In a recent article in the Wall Street Journal, Noble Prize winning economist Joseph Stiglitz and John Sulston argue that for science to progress, and medical care to improve, the knowledge derived from genes must remain in the public domain, not locked up by patents. “As we move into an era where the sequencing of all of an individual's genes is common and necessary for personalized medicine, free sharing of information about genes will be vital … to translate this information into medical advancements.”
Genes are part of our bodies. The understandings derived from them - knowledge critical to understanding and curing disease - is the birthright of all humanity, not the private property of a corporation. If we want knowledge about human nature and human health to flourish, we must ensure it is available to and for us all.
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