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One of the hottest controversies raised by genetic engineering is over commercial rights. Now we can manipulate nature like this, should be able to patent genes and genetically modified organisms as if they were human inventions?
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What's the Problem?
According to an EU Directive passed in 1998 almost anything biological must now be patentable, to ensure future medical discoveries and a competitive biotechnology industry. For many religious and environmental groups, this is a misleading exaggeration at best. At worst, it reduces nature to a commodity, imposing the agenda of industry over the ethical values of ordinary people. Who's right?
What's the Church doing here?
Church of Scotland has been prominent in voicing concern on this issue through its Society, Religion and Technology Project (SRT). SRT's 5 year working group on the ethics of genetic engineering in animals and plants culminating in our new book "Engineering Genesis", published by Earthscan in November 1998. We examined patenting in depth, and found deep differences of view. The SRT Director has also been spokesman for a European church working group on bioethics, addressing members of the European Parliament and Commission. This information sheet lays out the main issues and outlines the Church of Scotland's official position from its General Assembly in May 1997.
What is a Patent and Why is it Important?
A patent is granted to someone who invents something novel which has an industrial use. Its purpose is to prevent other people from marketing it without paying royalties to the inventor. It lasts 20 years to allow a fair return on the inventor's investment, on condition that the full details are published. It does not give the inventor the right to make the invention (that is subject to other regulations) but it stops others doing so. It must be something novel, not an obvious extension of present knowledge, and you cannot patent a mere discovery. It has to have a practical use. The patent system has evolved over centuries around products of industry like mechanical inventions or chemical processes.
Up to about 1980, products of nature were normally excluded. You couldn't patent a plant, say. But once biotechnology began to discover ways of modifying living organisms, first bacteria and then plants and animals, pressure mounted to allow patents on these. Genetic research is expensive and it often takes years from discovery to market. In a competitive world, companies say they have a legitimate need to know they have a chance to protect their large research investment with a patent. The question is how far should this be taken? The EU Directive has aroused widespread criticism that it has bowed to the demands of industry to the point that basic public values were simply overridden.
Should we allow patents on living organisms?
To get a patent you have to have invented something. Can humans claim to have invented a genetically modifed animal or plant, just because they have added one or two genes to it? For the church this would make an unwarranted claim to have invented something which is part of God's creation, or a product of nature. What have we really invented is not the animal but the new sequence. Underlying this is an important insight. To extend patenting from industrial artefacts to living things in themselves is to violate a normal ethical distinction between what is alive and what is not. They are not just another industrial commodity. Christian moral principles stress the idea of relationship and care for nature as more important than a purely functional view of industrial utility. The relationship with life takes precedence. So we may patent a mouse trap, or a novel gene sequence used in a mouse, but not a genetically modifed mouse itself, and so also for other animals and plants.
Should we allow patents on human genes?
One of the hottest issues is whether we might patent the knowledge of a human genetic sequence. In normal understanding this is a discovery, and so should be unpatentable. Patents are not allowed on human body parts, so why patent genes, which are just as much part of our human make up? But according to the EU patent directive, even a human gene becomes a patentable invention because you have to copy it millions of times in order to analyse it, so the resulting "copy genes" are inventions. Quite apart from the ethical objections, many scientists dispute the logic of this, because the key thing is the information encoded in the gene. By definition that is a discovery. Also the act of gene copying is not novel but a standard technique. The EU has turned a deaf ear to these and other arguments, but the Directive is now being challenged in the European Court by the Dutch Government.
An added concern is that patenting genetic discoveries implies an attitude of "winner takes all" over knowledge which could address areas of acute human suffering. It has led to undignified scrambles to claim commercial priority over discovering genes, and has not always encouraged the spread of medical research or investment. It may even add to the cost of therapies. The church considers it unacceptable to claim invention over genes as part of our human make up. Investment in medical research will be adequately ensured by allowing patents on the application of a human gene to make a specified range of pharmaceutical products, without needing to patent the gene itself or all its uses.
When does a discovery become a human invention?
One company has claimed that human DNA is patentable because the intellectual effort to discover it raises it from a discovery to an invention. To many, this is a case of special pleading which would abuse the very idea of patenting, since all discoveries require intellectual effort. Logically, this would bring an end to the notion of discovery and mean that anything could become a commodity.
How do we decide what is ethical in biotechnology?
Some say ethics has no place in patenting. Yet every activity involving law also involves ethics, and the EC official advisors on bioethics have said that once animate matter is involved, ethics becomes a prominent issue in patenting. But this raises a serious question about how our society should assess the progress of biotechnology. Often the first time the public hear about a biotechnological invention is when the patent is published. Up to this point it is secret. Objections can then be raised, but the patent process is not the best place to debate and decide about bioethics. Patent lawyers are not trained in ethics and cannot speak for society. And because a patent gives no right to market the invention, it isn't (at least in theory) a judgement about ethics, either way. The problem is that no proper system exists, either in Europe or the UK, which allows for an ethical assessment to be made of a biotechnological invention, while its patent is being assessed, to enable society to decide whether it wants it to be marketed or not. This serious deficiency urgently needs to be addressed, if this vital area of science is to remain accountable to the public and not driven by commercial interests alone.
From 1993 to 1998 we ran a multi-disciplinary expert working group study, leading to the book Engineering Genesis, acclaimed as one of the most balanced studies available on these issues.
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Ref.no. PATDISPL Revised 16/11/99, retitled 25/11/03
