A legal battle is already brewing between an American company, Biocyte, and a number of European government-funded bodies. The issue is complex, but boils down to this: Biocyte has the rights to use the blood cells from the umbilical cord of any baby born in the European Union. European doctors and blood specialists strongly oppose the granting of that right, made earlier this year by the European Patent Office.
The Japanese work transplanted a number of human genes which produce antibodies for the human immune system into embryo cells of mice, which then grew into healthy adults. Crucially, their blood contained human antibody proteins, confirming the success of the gene's movement.
Previous gene work has managed to create "transgenic" animals containing one or two genes from another organism - a plant, animal or human - but never before has an entire chromosome been successfully incorporated into another animal's DNA.
Steve Jones, professor of genetics at University College London (UCL), called the work, reported today in the science journal Nature Genetics, "a remarkable technical breakthrough".
The future applications could include the creation of transgenic animals which would make antibodies to all sorts of human illnesses. Biotechnology using transgenic animals is forecast to be a multi-billion dollar business. Imagine, for example, if cows could produce human antibodies: their milk could replace both breastfeeding and powdered milk. And that is only one of a myriad of possibilities.
A trade war could follow if regional patent offices began turning down patents from abroad for "local" reasons: on that basis, the challenges to the Biocyte patent could be the first step to a gene trade dispute.
But in the short term the most certain result of the latest work is that patent offices around the world will soon receive copies of applications from the Japanese group, "patenting" the mice's DNA and the techniques used to produce it. To many people, the idea of patenting genes and DNA - the blueprint for all living things - is repellent. But Professor Jones insists that the only way forward is to be pragmatic about the commercial aspects of biotechnology, and exploit them to our advantage.
"There's no field of human endeavour in which we don't have intellectual property rights," he said yesterday. "If you can patent plant varieties, as already happens, you can patent genes and DNA. You can't then say human DNA is a special chemical. You have already swallowed the camel."
This is where Biocyte has stepped in and identified the umbilical blood cells - known as "stem cells" - as biologically unique. Such cells are "mother cells" which, when introduced into diseased parts of the body, can generate healthy blood cells. More than 500 people have already benefited from that, as an alternative to replacing diseased bone marrow (which normally produces new blood cells), in cases of inherited blood disorders and cancers. Stem cells exist only in the foetus, and can normally only be collected from the umbilicus.
But a consortium of national blood transfusion services from the UK, France, Germany, Spain and the Netherlands, with the European Bone Marrow Association, and challenging the Biocyte patent on the basis that it is too broad. Their appeal will not be heard until some time next year.
Meanwhile, a parent could only prevent the umbilical blood cells from becoming Biocyte's intellectual property by altering the hospital consent form to exclude the cells' collection - but that would prevent their use in potentially lifesaving medical treatments.
Professor Jones suggests that the only way forward will be for everybody to become more aware of the value of their genetic material, and hanging on to it - possibly by altering consent forms. In 1984 in the US a man whose extracted spleen cells were used by the drugs company Sandoz to create new products sued the company for a share of the benefits - but lost because the consent form abrogated his rights once the tissues were removed from his body.
"Companies will try to make consent forms ambiguous and wide ranging, and play on peoples' fears," Professor Jones said. "I certainly wouldn't sign a consent form willy-nilly. People have got to become aware of what they're signing."
Biotechnology companies insist that the enormous investments they have made justify the breadth of their patents. Sometimes, though, the companies make the gamble and lose - badly. In 1989 the chemicals giant DuPont began offering for sale its patented "Oncomouse" - a mouse with a genetic predisposition to develop cancer. It spent more than $10 million on the controversial research and licensing. But almost ten years later, DuPont has seen barely any revenues from it.Reuse content