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As such it must be important, and we'll test for it.” Claims amounted to little more than saying, “This is a gene. In the 1990s the US office was inundated with applications for genes or gene fragments for which the demonstration of utility was, to say the least, vague.

The same is true for another core patenting criterion: usefulness or utility. Applications that would not satisfy the European Patent Office have found favour in its US counterpart. What would have justified the issue of a patent in the 1990s might not in the 2000s.Ī further complication is the relatively relaxed stance of the US Patent Office. When identifying and laying claim to a new gene may be little more arduous than using a suitably programmed computer to search a public database, claims of novelty and inventiveness begin to look rather feeble. But DNA technology has moved on and circumstances have changed: most notably the publication of the human genome sequence. That, at any rate, was the position until a few year ago. A review published by the Nuffield Council on Bioethics succinctly summarised the position on novelty and inventiveness: “Patent offices take the view that extracting genetic information encoded by a DNA sequence is not just a matter of gaining scientific knowledge about a natural phenomenon it involves the use of cloning techniques to create an artificial molecule.” 5 In this sense the process can be described as both novel and inventive. When patent offices examine new applications, they use several criteria including novelty, inventiveness, and usefulness. The further you delve into gene patenting, the more technical the issues become. may obtain a patent.” Although the wording does muddy the waters somewhat, patents have not in practice been granted to applicants who have put no inventive effort into whatever they're laying claim to-you never could have patented water simply by bottling it. Patents are intended to cover only the former-although, surprisingly, the relevant US statute does use the word discovery: “Whoever invents or discovers any new or useful process, machine, manufacture or composition of matter. This raises the issue of invention as opposed to discovery. However, bodies ranging from the courts to the European Union 4 have decided that a natural product which has been isolated, purified, or otherwise altered in some way is patentable. As products of nature-a term that obviously encompasses any molecule of human DNA-genes are not supposed to be subject to patent law. So how best to unpick this helically twisted mess?Īt first sight, the conventions governing patentability seem to rule out genes. But this is the climate in which dialogue on the many real and multilayered concerns raised by gene patenting is too often conducted.

“Yet by now one fifth of the genes in your body are privately owned.” The implication-that Genentec or some other biotechnology company will soon be knocking at the door demanding payback-is of course nonsense. 3 “You can't patent snow, eagles or gravity, and you shouldn't be able to patent genes either,” he insisted. One notable example is an opinion piece by Michael Crichton, the author of Jurassic Park, that appeared earlier this year in the New York Times. The problem with conferring a special status on DNA is that the underpinning emotions can swamp any attempt at reasoned discussion. Hence we have declarations of the kind issued by Unesco, which talks of the genome as our “common human heritage.” 2 The information encoded within our genes has helped to make us what we are, influences our health and longevity, and may even offer insights into our close relatives. Given that the patent system is long established and generally agreed to be socially desirable, why should its application to genes have proved so contentious?įor many reasons-not the least of which is a widespread reluctance to view DNA as just another chemical. The bill ran out of time, gene patenting remains legal, and the argument goes on. Had the bill been passed it would have resolved a long running dispute over the legitimacy of patenting genes. The bill ran thus: “Notwithstanding any other provision of law, no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies.” 1 That was it. Congressmen Xavier Becerra and Dave Weldon's proposed Genomic Research and Diagnostic Accessibility Act would have added a new section to the US legal code. A bill introduced earlier this year in the US House of Representatives had one indisputable virtue: brevity.

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