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Ethics is a place east of London

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Comment Why does my suspicious mind instantly think that there's an extra letter "i" in disgraced Korean researcher Hwang Woo-suk's admission that he faked data on developing patient-specific embryonic stem cells? Was his mind more on patents, than patients, perhaps?

Intellectual property law, worldwide, makes IP lawyers very rich. That's because the rest of us don't understand it. It's bad enough trying to understand IP law in Britain, or IP law in America, or in Canada or Hong Kong or the rest of China. Trying to understand the international situation is really tough. But most type of patent laws do have one thing in common - you can't patent something someone else has already invented.

Until now, large companies have spent fortunes by hiring bright people to invent things so that if, one day, the invention turned out to be useful, the company owned the patent.

The world may, at last, be changing. What could be happening is that people are alert to the possibility that something useful may be patented. And a good way of pre-empting that is to publish something before it can actually be proven. "Prior art" means that if something is already published, whether or not the publisher filed a patent, then nobody else can patent it. Well, that's the theory.

American patent law, which can only be explained by the number of lawyers in Congress, allows people to patent ideas that have been published (but not patented) under some circumstances.

One theory I was given, when researching this, was that it was a defence against Cold War invention politics, when some obscure Russian or Ukrainian member of the Soviet empire would pop up and show prior art after an American corporation had published and patented an idea.

The suspicion, according to my expert, was that it was a lot easier to fake prior art in a totalitarian regime. But why would I suspect something like this in Korea? Rewind back to 1967 and in South Africa, the race to perform the first heart transplant was famously won by the late Dr Christiaan Barnard.

According to author Donald McRae (Every Second Counts) Barnard specifically requested a black patient. He was working in a country where "black citizen" meant you were automatically of a lower class, and where legislation to enforce ethical medical practices was significantly more relaxed than in Europe or America.

Other surgeons were certainly close to proving the technique, and were foiled by colleagues invoking those ethical standards. Looking back, it seems absurd that people felt so strongly about it, but one American surgeon has recalled that he was in the operating theatre, scapel poised, when his team refused to cooperate - because the donor heart was still beating.

The surgeon felt (correctly!) that to have the recipient lying on the operating table without a heart for any extended period was to extend the risk. No matter! His colleagues just couldn't get their heads around the idea of taking a beating heart out of a human being, no matter how brain dead that person might be. Puzzling to us, today, of course.

This week, it's the tenth anniversary of the creation of the first cloned sheep, Dolly. That has started a lot of people looking back, and re-assessing our ethical standards. In Europe, at the moment, stem cell research is being re-assessed. Because of fears by (mainly) religious groups such research is hedged about with many ethical restrictions which, maybe, we'll look back on in 25 years with equal puzzlement.

But the fact remains that in the Far East there are places where it is possible to perform research you can't do in Europe or America. The normal fear is, of course, that some Korean or Chinese medical team will achieve a breakthrough and come up with a patentable idea, and collect revenues from the rest of the world, later.

But Hwang Woo-suk's admission - that he faked the results - is one that seems odd. You can't claim a patent on the basis of faulty research - but if you can show prior art, then other people may have more trouble getting their own patent validated, later.

Are we going to see "proof of concept" experiments done in countries where ethical standards are relaxed, not in order to allow patents, but in order to prevent others from obtaining them? Or, now that Hwang Woo-suk has been exposed, is that avenue closing?

It's impossible to answer the question without reading the research chief's mind, but it may be significant that when he admitted faking data, he insisted that nonetheless, the research was valid. His team had not made "as many cell lines as claimed" but, he insisted, they had nonetheless succeeded with enough to make the process valid. ®

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