Right: genetic research is claimed by many to be too expensive to undertake without the possibility of a commercial reward at the end of it. Others say that naturally-occuring genes cannot be patented.'
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Arguments against private companies being able to patent human genes
1. The monopoly on diagnostic tests held by gene-patent holding companies can restrict access to medical treatment
Myriad Genetics Inc currently charges US$3,340 for its genetic test for breast cancer.
In this test Myriad sequences the two patented genes, known as BRCA1 and BRCA2, checking for mutations that raise the risk of a woman getting breast and ovarian cancer. It is Myriad's patent on the two genes which allows it control of the testing process. The sequencing process itself can and is employed by other institutions.
The breast cancer test accounted for $353 million, or 88 percent, of Myriad's $402 million in revenue in the fiscal year that ended in June 2011. It has been claimed that Myriad Genetics is hampering treatment and research because of the increased costs its charges create and because the gene sequencing process it uses has now been superseded.
In an article published in The New York Times, Andrew Pollack claimed, 'Newer DNA-sequencing techniques are far faster and only a fraction of the cost of the 1990s technology that Myriad uses. Indeed, it will soon be possible to sequence a person's entire genome, all 22,000 or so genes, for less than Myriad charges for just two genes.'
Mary-Claire King, a professor of genome sciences and medicine at the University of Washington, has stated, 'Science has moved beyond what these folks do. It's not good for the science and it's not good for the patients and their clinicians if they cannot have the most complete, up-to-date, cost-efficient information.'
In 2006, Professor King of the University of Washington published a paper showing that Myriad's test, known as the Comprehensive BRAC Analysis, failed to detect a significant number of genetic alterations in the two genes.
Myriad then developed a test for these alterations. But instead of incorporating it into its main product, it offered it as a supplemental test at a price of $700. Many insurers do not pay for it, and therefore many women do not get this test.
2. Gene patents can discourage further research on the patented genes
It has been claimed that gene patents can discourage further research using the patented genes.
Steven Salzberg, a Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins School of Medicine has noted that by 2005, 4,382 human genes had either been patented or had related intellectual property claims files on them by more than 1,100 different claimants.
Professor Salzberg has claimed, 'This presents a bewildering "patent thicket" to any investigator wishing to pursue a new medical application of a gene. Working on a patented gene can involve endless hours talking with lawyers, negotiating licenses, and paying for those licenses. No scientist wants to spend time on such extraneous activities, and, when given a choice, most will simply avoid patented genes entirely, preferring instead to work on other genes.'
It has further been noted that legal disputes over access to patented genes are a further source of lost scientific effort. Professor Salzberg has stated, 'Patent lawyers have no business in the laboratory. But scientists have invited them in, and now we are finding that they are hard to chase out. Once a gene is patented, court cases drag on for years, taking up countless hours of scientists' time.'
3. Patents should be granted on processes and inventions, not discoveries
It is claimed that under Australian law a patent can be applied to an invention but not to a discovery. Patents, it is argued, are a means of protecting intellectual property, that is, the holder of the patent must have made or developed the product or process he or she has patented. It is claimed, therefore, that naturally occurring substances cannot be patented.
On September 13, 2010, On Line Opinion published a comment titled 'Who owns you?' arguing against the patenting of human genes. The piece includes the following comment 'No one is seeking to stop [companies] patenting and protecting their research product - in other words any "tests" or products derived from their work around the genes or other biological material.
If they've invented a treatment or an identification test, or whatever, then they deserve the benefits from that; and they also deserve the commercial protection a patent provides so they can maintain a good portion of the market before others who haven't done the early leg work can cash in, riding on their coat tails.'
The comment goes on to argue 'But patenting a gene is wrong. Patenting biological material that already exists in a particular form in nature is wrong. Patents recognise invention - not discovery of something which already exists.
A genuine invention should get all the protections it can, and if a large corporation happens to be that inventor then good on it and may it protect its interests with all its might...
But a patent should not apply to a discovery. Imagine the world if all the past discoveries in the natural world were owned by a company rather than just being part of the human knowledge bank.'
On May 10, 2010, On Line Opinion published a comment by Leslie Cannold titled 'Patently absurd'. The comment included the observation, '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.'
In an editorial published in Incite, in September, 2010, it was stated, 'Patents are designed to protect the commercial interests arising from an invention, not a discovery. Discoveries are part of the natural world and are there for all to explore and utilise. In claiming a patent over a gene, the patent holder is making a claim over something that he did not synthesise or create... As a matter of principle, patents on naturally-occurring genes should not have been approved.'
Incite is the online magazine of the Cancer Institute of New South Wales.
4. The processes involved in isolating and sequencing genes are not sufficiently complex or costly to warrant patenting the resulting product
Those who argue that genes should be able to be patented, stress the complexity of the process which results in the isolation of genes. They argue that this constitutes a form of manufacture and that the resulting product should be able to be patented. Critics claim that the complexity of these processes has been exaggerated and do not warrant the granting of patents for genes that are discovered using these techniques.
In June 2012, The Journal of Clinical Pharmacology & Therapeutics published an article by Steven Salzberg, a Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins School of Medicine.
Professor Salzberg argued, 'Today we can sequence an individual human genome in just a few days, for less than $5,000. Once we have a person's genome, we can easily and rapidly discover all known mutations in that genome, and with ever-increasing accuracy we can link these mutations to risk factors for disease.'
Professor Salzberg has gone on to argue that the granting of gene patents has exaggerated the complexity and thus the intellectual property rights of those many companies which have now been granted gene patents. The Professor has stated, 'In 1982, DNA-sequencing technology was a very new idea and the patent examiners probably had little, if any, idea of where the technology was heading. Once they allowed the first patent, the floodgates opened and patent applications poured in. As genome-sequencing technology improved, scientists using highly automated procedures discovered thousands and later millions of genes, and the flood of gene patents became unmanageable.'
5. Myriad Genetics Inc is monopolising information in a way which damages research and treatment options
It has been claimed that Myriad Genetics Inc is monopolising information in a way which undermines effective research and treatment.
In the United States, Myriad Genetics Inc requires all BRCA testing to be done in its own laboratories. The biotech company has been particularly vigilant in enforcing its patent rights in America.
When Myriad Genetics Inc carries out its BRCA Analysis (on behalf of a research or testing facility which it has charged for the process) it can sequence the test material and retain information on the different variants in its database.
Myriad Genetics Inc used to share such information with a public database maintained by the National Institutes of Health, and it also cooperated with academic scientists trying to analyse the mutations. However, Myriad Genetics Inc is currently stockpiling huge amounts of data on the gene, which it has not shared with an international community of cancer researchers since 2004.
Daniel B. Vorhaus, a New York lawyer and editor of the Genomics Law Report, has claimed there are ethical questions about whether Myriad should be withholding the mutation information, important for public health, to extend its monopoly beyond the life of the patents.
Commenting on the impact of gene patents, Steven Salzberg, a Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins School of Medicine, has stated, 'Much of the scientific progress during the past two centuries has occurred because we share our scientific discoveries. The faster our work is disseminated, the more rapidly we move forward. The entire system of scientific journals was created to serve this purpose. Science that remains secret cannot contribute to scientific progress and is for all intents worthless.'