Our genes determine how we look, how our bodies work, and we now know that they also play a major role in our susceptibility to disease. Consequently, there has been a huge increase in genetic research to find ways to battle disease more effectively.
Now the spotlight is on the patents covering the outcomes of this research – but what is a gene patent, and why do they appear controversial?
Since the 1970s, researchers have been able to artificially add new genetic information into genes to create modified genes though genetic engineering. These modified genes formed the basis of advancements such as the production of human insulin to treat diabetes, and pest resistant and drought resistant crops. Most of these new technologies, and the modified genes involved in them, are protected by patents.
More recently, research has focused on what information can be obtained from genes, and what it tells us about a person’s susceptibility to disease. Researchers can now isolate a single gene and use its genetic information to determine the likelihood of an individual developing a particular disease. As opposed to modified genes, these isolated genes contain the same information as genes that are found in ordinary cells; the only difference is that they have been separated from all of the other genes and DNA sequences.
The fact that this research is also often covered by patents has led to controversy in some countries, notably Australia and the United States. Recently, the issue has been highlighted by a case between Myriad Genetics and the Association for Molecular Pathology, which is currently before the US Supreme Court. The case considers the legality of a patent covering two isolated genes which, when decoded, can be used to determine the likelihood of an individual developing breast cancer or ovarian cancer.
Opposition arguments to the patent for isolated genes include that they restrict a person’s ability to know more about their genetic predispositions. Another argument is that the isolated genes protected by patents are no different to genes inside an ordinary human cell, and so are not “inventions” that should be able to be patented in this way.
Those in favour of gene patents say these new techniques provide a powerful tool in diagnosis and enable a more personalised approach to medical treatment, and that patents are necessary to recoup the costs of the development of the screening techniques and promote further innovation in this field.
A decision for this case is expected around June this year.