Is this the work of man or nature?

Tomorrow, a band of technocrats will assess the 'morality' of granting the first European patent on a genetically engineered animal. Charles Arthur and Tom Wilkie report
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Tomorrow, the Book of Genesis will be rewritten. In the unlikely setting of the European Patent Office in Munich, a group of international civil servants will decide whether living animals are part of the natural world or whether they can be artefacts - "inventions" created by human ingenuity.

At issue is a mouse. Not an ordinary mouse, though. This mouse is perhaps the first animal to have been "invented" not by God, but by humans. In 1984, genetic engineers at Harvard University manipulated the biological instructions encoded in the genes of a laboratory mouse. The engineers, Timothy Stewart, Paul Pattengale and Philip Leder, unzipped the double helix of the mouse's DNA and stitched in a gene that fatally dooms the animal to the development of cancer.

Now the president and fellows of Harvard want to patent the animal as their "invention" because it has, in the language of the patent law, "utility" in research into how tumours form. The university has even coined a trademark for its "product" - the Harvard Oncomouse (from oncology) - and wants to profit from the exclusive right to sell these animals as if they were jars of laboratory reagents.

And it is unlikely to stop there. "Oncodogs" or "Oncorabbits" or "Oncomonkeys" are likely to follow, designed to be used in different types of cancer research. It's not just an "Oncomouse" but an "Onco" species.

When the EPO announced in 1992 that it intended to accept the patent application, which is wide-ranging enough to cover a variety of "Onco- animals", it provoked protests from across Europe. More than 200 organisations, including animal welfare groups, environmentalists, and representatives of the Christian churches in Germany, have combined to support 17 objections. At 8.30am tomorrow, the EPO (which is independent of the European Commission) will convene an open tribunal to hear their arguments. If the objectors lose, Europe will have started to patent life itself.

Patents are immensely important to the global biotechnology industry that has developed over the past 20 years. The industry spends more than $100m a year just to protect its intellectual property (which, of course, ranges far more widely than just patents on living animals). Harvard obtained patent protection for the Oncomouse in the United States as long ago as 1988. It sold a licence for exploiting the "invention" to the Du Pont Chemical company, which started marketing the mice for around $100 each, compared with around $1 for an ordinary laboratory mouse. Harvard has publicised its Oncomouse by, among other things, freeze-drying a couple of the animals and presenting the corpses to the Science Museum in London as artefacts to be kept in the museum's permanent collection.

Living organisms have been excluded from patent protection for hundreds of years. Life was considered a "product of nature" rather than a human invention and therefore inherently unpatentable. That all changed in 1980 when the US Supreme Court ruled in the case of Diamond v Chakrabarty.

In 1972, Ananada Chakrabarty genetically engineered bacteria by stitching in genes that gave them the ability to break down multiple components of crude oil. He believed the bacteria could be used to treat oil spills. At first, the US Patent Office dismissed his application on the grounds that the micro-organisms were living things. But the Supreme Court decided that the genetically engineered bacteria were patentable because they were not naturally occurring.

According to a review of the case published recently by Graeme Laurie, a law lecturer at Edinburgh University, the Supreme Court refused to address the morality of patenting living entities and confined itself to a strict examination of the letter of the law. It concluded that "anything under the sun that is made by man" is patentable.

In 1987, the US Patent Office announced that higher life forms than bacteria were also patentable, and granted the Oncomouse patent the following year. Once again, the American courts refused to hear moral objections to the Oncomouse patent by animal welfare groups, which were troubled by the implications of making an animal into a biochemical "invention". The groups had no legal standing to bring a case, the courts ruled.

But that may not be the case in Europe, thanks to clause 53a in the European Patent Convention. This clause forbids patents the "publication or exploitation of which would be contrary to 'ordre publique' or morality". It is this clause that has opened the way to the objections in Europe.

According to Peter Stevenson, legal director of Compassion in World Farming (CIWF), "This is the first European patent on a living animal and is a vital test case." If the Oncomouse patent goes through, he argues, "You'll see lots of applications for patents on farm animals for increased productivity."

He cites one application, since withdrawn, for a genetically engineered chicken. This had genes that produce cow's growth hormone stitched into its DNA to promote faster growth. The problem is that, while the muscles (which we eat as meat) grow more quickly, the legs and supporting skeletal structure do not.

"Through traditional selective breeding alone, chickens now grow twice as fast as they did 30 years ago," Mr Stevenson says. He estimates that 180 million chickens each year in Britain suffer intensely painful and crippling damage to their legs as a result. Many of today's farm animals are stretched to the limits of their physiological capacity. "Why push it even further with genetic engineering? You don't need a transgenic superchick."

CIWF objects to the Oncomouse patent on the moral grounds of the animal's suffering. It argues that the benefit to cancer research is at best marginal and that the EPO did not consider the welfare of the animals in reaching its decision that the patent could extend to all non-human oncomammals. Sue Croshaw, the founder of the group Disabled Against Animal Research and Exploitation (Daare), echoes this point in a letter sent to the EPO last week, which stresses: "Awarding a patent so that profits can be made out of these animals is immoral and unacceptable."

Other objectors point out that the 1973 European Patent Convention forbids the patenting of plant and animal varieties. Earlier this year, the EPO ruled against the Plant Genetic Systems company of Belgium, which had applied for a patent on genetically engineered rapeseed plants. The patent office said that only the plant cells, not the plant itself nor its seeds, were patentable.

The debate in Munich tomorrow will turn on fine points of law. But the significance of the case is the way it highlights the questions of whether there are any limits to what people can, and should, do to animals to further human ends and, if so, who is to set these limits. The Oncomouse patent application comes at a particularly sensitive time.

The issues have special resonance to Britain, where the outbreak of mad cow disease in the mid-Eighties revealed to an appalled population that for years British farmers had been feeding cattle and sheep on the ground- down remains of other cattle and sheep. Not only were "natural" herbivores turned into carnivores, but into cannibals as well.

This year, animal welfare - in the shape of the live export of calves for veal - became a grassroots political issue that brought even the middle classes out on to the streets of places such as Brightlingsea in protest.

A couple of weeks ago, the limits of the acceptable were probed again when a Tomorrow's World special report broadcast images of a genetically engineered hairless mouse with a human ear apparently growing from its back. An American researcher, Dr Charles Vacanti, at the University of Massachusetts medical centre in Worcester, had used the mouse as part of a project to grow human ears in the laboratory for transplantation on to patients who lack them. The process is called "tissue engineering".

He took cartilage cells from a child and seeded them on to an ear-shaped mould made from biocompatible plastic. Subsequently, Dr Vacanti's team surgically inserted the combination of plastic and cells under the back of a mouse that had been genetically engineered to have no immune system. (Otherwise it would reject the graft of human cells.) The mouse's visually disturbing hairlessness is a by-product of that genetic engineering - there is no suggestion that anyone has genetically engineered mice to sprout human ears.

"The immediate impact of that image was very deep: it reminds people of Frankenstein's monster, constructing human things from bits and pieces," says Michael Thick, a consultant surgeon and director of the liver and kidney transplantation units at the Freeman Hospital, Newcastle. "The way that they chose to put this work forward was unnecessarily shocking. It disturbed a lot of people."

Dr Robert Brown, of the plastic surgery and tissue repair unit at University College Hospital, says: "It was a display, not an experiment. If you were designing an experiment to see whether the cartilage cells were really growing effectively, you wouldn't put in something like this. It was bizarre."

Bizarre. Disturbing. Shocking. If that is how the professionals react, then what of the public? Politicians will soon have to take the issue seriously. In scientific laboratories here the welfare of living animals lies in the hands of the Home Secretary, Michael Howard. Under the terms of the Animals (Scientific Procedures) Act 1986, no one can carry out any experiment on a living animal without a licence from the Home Secretary.

Mr Howard is a generous man. Last month, the Home Office quietly released statistics showing that 2,842,400 animal experiments were carried out in 1994, an increase of about 15,000 over the previous year. The overall trend, however, is downwards: 1993 and 1994 represented the lowest figures since 1956.

But the power of genetic engineering developed over the past 25 years is evident from the figures. The number of "transgenic" animals used in scientific work has more than doubled since 1990, to more than 100,000 in 1993, according to the Home Office. At the same time, the number of transgenic animals which either had "harmful" genetic defects, or were bred but not used, rose to 200,000 in 1993.

To acquire a licence, a researcher has to justify the experiment and show that the scientific results obtained cannot be acquired by any other route. The overall justification for animal experiments is simple and utilitarian: they help to save human lives and alleviate human suffering.

There are many examples of this. A classic in medical history, for instance, is the work by Frederick Banting and Charles Best on diabetes. Working in Toronto in the Twenties, they turned normal dogs into diabetics by removing the pancreas - in stages, over a period of several weeks. Seventy years on, it sounds grisly and must have caused the dogs great distress before their inevitable deaths. But the result was the identification of insulin and, today, hundreds of thousands of people have lived fulfilled, healthy lives who would otherwise have died in pain and misery.

Yet while the case for animal experimentation can be made in general, there are still questions about the specifics. Medical research is expensive nowadays, but it can yield immense commercial benefit to pharmaceutical companies. In the US, a picture of a weird mouse with an ear growing out of its back can serve as a magnet for venture capital funding, from investors eager to get in as near to the ground floor as possible on any biotechnology that might pay off in the future.

Tomorrow, at the EPO in Munich, the commercial exploitation of animals and animal rights meet head on. The EPO is unhappy that its anonymous international technocrats have to be the arbiters in a moral dispute about the relationship between humanity and the natural world. For many people, it is almost a religious issue: Genesis may have given us dominion over the animals, but God is clearly credited as the author of creation.

And if the EPO decides in Harvard's favour, it may have a string of weird and wonderful cases coming before it. If Frankenstein were alive today, he might be thinking of penning a letter to Munich.

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