WHO owns your genes? The argument has raged for decades. As long ago as 1991 there was an outcry when the US National Institutes of Health attempted to patent partial sequences emerging from the early stages of the human genome project.
At the time, many patent lawyers believed that such attempts would be futile: they argued that genes are discoveries, not inventions, and so cannot be patented. How wrong they were. The US Patent and Trademark Office (USPTO) has issued patents on genes and other DNA sequences covering up to 40 per cent of the human genome.
The argument justifying such patents maintains that isolating a gene upgrades it from a discovery to an invention. This tenuous claim has been accepted by the USPTO for the past 20 years. The European Patent Office also grants gene patents, though with stricter limitations.
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鈥淭he patents are defended on the tenuous grounds that isolating a gene makes it an invention鈥�
Now a US federal court has ruled that patents on two breast cancer genes are invalid (see 鈥淚s this the end of gene patenting?鈥�), accepting the argument that genes should not be patented. The patents are owned by Myriad Genetics and cover variants of two genes, BRCA1 and BRCA2, that make women highly susceptible to breast and ovarian cancer. Ownership of the patents has allowed Myriad to secure a near monopoly on diagnostic tests for these gene variants in the US.
This one ruling doesn鈥檛 invalidate other gene patents, and it may not in any case survive a legal challenge. Even so, opponents of gene patenting hope that it signals the beginning of the end of a practice that they have long argued stifles innovation.
They are right. Applied properly, patents protect inventors鈥� rights to be rewarded, while enabling others to improve on their innovations. Without such a system there would be little incentive to invest in research. In that context, patents are a good thing. Gene patents do not, however, achieve this goal. Numerous analyses, most recently in the journal PLoS Medicine (), have concluded that they actually inhibit biomedical innovation.
In another damning analysis, one of Myriad鈥檚 patents on BRCA1 was found to be so broad that it covers genetic sequences found in 80 per cent of all human genes (Genomics, ). Anybody working on any of these genes is technically in breach of the patent. Myriad has not enforced it, but it shows what can happen when you allow discoveries to be patented.
We need a global agreement that genes as such are not patentable. This should allow genuine inventions reliant on genes to be patented, while putting end to the situation we are in now, in which a system that is supposed to encourage innovation is doing exactly the opposite.