The big boys' blood money

An American company is selling the right to use stem cells - vital components in the fight against blood disorders. What's wrong with that? Plenty, say scientists who plan to block the enterprise. By Charles Arthur
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The Independent Online
Should we be able to patent life? It's a question that, despite the growing number of patents granted on things such as genetically engineered vegetables and gene discoveries, has bubbled away within the world of science. Some say yes, definitely; others say no just as definitely. Later this summer, that argument is likely to boil over and become a lot more visible. Doctors and scientists across Europe are uniting to challenge a patent awarded to an American company, Biocyte, because they say it commercialises human life and could prevent lives being saved.

The row is over a patent granted by the European Patent Office to Biocyte, based in Pennsylvania. According to the patent, Biocyte has the rights to the use of any "stem cells" from umbilical blood. Anyone who wanted to use stem cells for a medical procedure - and that includes the process of collecting and storing them - would have to apply for a licence and possibly pay a royalty to the company, under the terms of the patent.

It might seem surprising in the first place that a commercial entity could patent something so ubiquitous as the blood cells found in the umbilical cord between mother and child. But don't forget that other companies, and research organisations, have patented human genes: for example, the breast cancer genes BRCA1 and BRCA2 are in effect "owned" by their discoverers on both sides of the Atlantic.

What has infuriated doctors about the Biocyte patent is that, unlike possible diagnoses and cures for BRCA-induced cancers, the use of stem cells is very immediate. In effect, they are "mother cells" of blood - when introduced into diseased parts of the body, they can repopulate it with new, healthy blood cells. The method has already been used in more than 500 cases as an alternative to replacing diseased bone marrow. Stem cells only exist in the foetus; after birth, it is the bone marrow which produces new blood cells.

Biocyte says that it should be allowed to patent the cells because it did much of the original work which discovered their function and ability to effect a cure. Chris Moller, the company president, says: "We spent more than $8 million [pounds 5 million] on this. We want to be appropriately rewarded. Who else thought of doing this and creating a commercial enterprise around it?"

Who indeed? The fact is that in Europe, the second sentence rarely enters the equation. Dr Marcela Contreras, executive director of the Blood Transfusion Service (BTS) in London, says: "Biocyte say they wanted the patent because speculators in the US have been freezing babies' stem cells for future use. But nobody's doing that in Europe, so why patent it over here?

"The patent is too broad. Life should not be patented. I'm all for patenting drugs, but not things that aren't real inventions. I don't see how you can patent life."

That's why Eurocord, a consortium of national blood transfusion services from the UK, France, Germany, Spain and the Netherlands, and the European Bone Marrow Association, are challenging the award of the patent to Biocyte. Their appeal should be heard within three months.

Part of the BTS's anger is derived from the fact that it has been expanding its collection of "cord blood", gathered with the consent of mothers (otherwise, its collection would legally count as assault). "We have 680 units, but by the end of the year we should have 2,000, and in three years' time 10,000 units," Dr Contreras says. The most important part of that growth in stocks is among people in ethnic minorities, who have been under-represented both in blood stocks and in potential bone marrow donors.

"Cord blood is useful for treating both inherited haemolytic disorders such as thalassaemia, and malignancies," says Dr Contreras. "It can also be used for children and young adults who can't find a matching bone-marrow donor."

Stem cells also have a significant advantage for blood disease treatment over bone marrow. Immunologists have identified that we have six categories of HLA (human leukocyte antibody) in our cells. A bone marrow donation must match in all six categories, which is why identical siblings are the ideal donor, as they come from the same embryo. But stem cells need only match in five of the six categories, greatly extending the chances of a match. Otherwise, your chances of finding a matching donor are fewer than one in 10,000.

Biocyte has told doctors that it will not levy a charge for non-commercial use of stem cells, though nobody is quite sure how that would apply in a health service where money ostensibly changes hands, even if only in the internal market. "Biocyte were challenged to confirm that by the New York Blood Centre, which is a non-profit organisation," says Dr Contreras. "The reply was, 'We won't charge you for a year.' We said that we would like this no-charge promise confirmed in writing, to tell us that we won't be charged for collecting and storing cord blood. We haven't heard anything."

The Biocyte patent cuts to the heart of the row over patenting of biological entities, though the issue itself is not new. Scientists are increasingly worried that the idea of researchers sharing useful information is being eroded by the fear that any information they let slip will somehow prove vital to a rival's efforts, and that consequently they will miss out not only on the glory, but also the riches. One eminent British scientist suggested recently that this has happened over the BRCA searches. Similarly, researchers investigating cystic fibrosis - the most common inherited genetic disorder - have received bills from the University of Michigan and the Toronto hospital which had patented the gene after they discovered it.

The idea of patents as a lawful means of protecting new inventions and techniques is far more easy to understand in the case even of the oncomouse, developed at Harvard University with the intention that it would develop cancer (because of a genetic alteration). The ethical position was always doubtful, but there was no gainsaying the fact that the oncomouse species had never existed before. It was not a discovery; it was an invention. Scientists in Britain are increasingly worried about the breadth of the European patent law, especially the new drafts that have been emerging from Brussels and the European Parliament. The Department of Trade and Industry said, before the election, that it was doing its best to defend Britain's interests. It will be interesting to see what happens now.

There is one image that will surely turn the public against the patenting law - that of a dying child whose parents and doctors are having to pay money to an American company because of a bizarre European law n