Patent laws were designed to protect actual inventions, not discoveries of natural phenomena. Patenting the human gene is challenging that rule. This is not in the public interestby John Maddox / March 20, 1996 / Leave a comment
Are there any circumstances in which a private citizen, a public institute or a corporation can legitimately hold a patent on a human gene? All patent laws refuse protection to discoveries about the natural world; Columbus could not have patented America. But genetics has become so competitive and potentially profitable that researchers (or, more often, their corporate sponsors) are nibbling away at the spirit, if not the letter, of the law. The distinction between discovery and invention is becoming blurred.
There was a spectacular illustration of this four years ago, when the US National Institutes of Health, on behalf of its employee Craig Venter, applied for patent protection for some hundreds of pieces of DNA that were almost certainly identical with authentic “ends” of human genes. Some were recognisable as the ends of genes already known. Others were the ends of genes of unknown function. There was a great outcry from the research community. People protested that it should not be possible to patent pieces of DNA whose useful purpose could be determined only by further research. Both the British and the French governments put out statements deploring this development, while the Medical Research Council in Britain sought to protect its position by applying for patents for data similar to Venter’s. Eventually the US patent applications were refused on the grounds that the invention’s utility had not been proved.
But the research community remains alarmed. Last year, the American Society of Cell Biologists called for a change in the patent laws to deal with what it saw as growing inequity between researchers. Patents in the field of genetics rest on a mass of research which has appeared in the scientific literature; but patents are awarded only to the handful of people who take the decisive-and first patentable-step. If patent law cannot easily be modified to meet the cell biologists’ wish that the rewards be more equitably shared, then the remedy must lie with academic institutions.
These issues have become prominent because the techniques for analysing genes (and pieces of them) have been made marvellously powerful in the past few years. Genes are lengths of DNA strung together in the human genome, and are exactly defined by the sequence in which chemical units called nucleotides (of which there are four) are linked with each other. The practical value of this information is, for the time being, mostly in the diagnosis…