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Battle over genes goes to court

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In the United States a legal battle is raging over the patent rights for genes. The financial and ethical implications are huge. The growing number of patents is increasingly getting in the way of pioneering research.

In practice, this means research into specific forms of cancer could be blocked because the gene required for the research is owned by a particular company. A large sum of money has to be paid for the rights to use it. Gene patents are the new obstacle to science.

Companies are requesting patents for a gene or a DNA sequence in order to recover the money they have already spent on research. In doing so, they can prevent competitors from conducting research in the same field, says Robert Cook-Deegan of the Centre for Genome Ethics at the American Duke University.

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Patent law
Since the 1990s, Robert Cook-Deegan has done research into genes and the vested interests in them. His book The Gene Wars: Science, Politics and the Human Genome was published in 1994. In recent years, the matter has become even more complicated. So many patents have been issued now that, if all companies press claims, genetic research will become practically impossible.

“Every time we’ve checked when we do our research and if we would want to test for all of the people that are at risk of hemochromatosis, breast cancer, colon cancer, prostate cancer or Alzheimer’s disease, we will find at least a few patents. And sometimes many patents.”

Mr Cook-Deegan says finding out whether there is a gene patent and what that entails costs a lot of time.

Two camps
Genetic research is carried out preventatively, for instance to determine if someone is at risk of getting a hereditary disease or to find out whether someone may have an increased chance of getting a serious illness during their lifetime. Gene research is expensive so there is a lot at stake.

Companies which apply for patents, say they want to guarantee that genetic tests are carried out properly. At the same time it enables them to recover their investment in the development of a reliable test.

Opponents say it is not right that commercial companies claim ownership of something that they have done nothing to create. The human gene belongs in the human body and can therefore not become someone else’s property.

Second opinion
The United States is by far the front runner with an estimated 4000 to 5000 gene patents. The consequences are far-reaching. In theory, a new patent can prevent independent research, or remove a patient’s right to a second opinion. US labs are already refusing to carry out some research into patented genes out of fear they could be taken to court. Doctors are forced to find other ways around the problem.

“The doctors usually know that, you know, if we send it to this person who does research on breast cancer at this university they will do that test for us anyway. But you would actually get a second opinion that technically is infringing the patent but nobody’s doing anything about it.”

In the US, there is a controversial case about the BRCA1 and BRCA2 genes. Mutations in these genes have been linked to breast and ovarian cancer. They have been patented by the US company Myriad Genetics. Myriad has demanded sole rights to this genetic test in the US. It has even gone as far as to take the University of Pennsylvania to court over the issue.

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Unconstitutional
In May 2009, the American Civil Liberties Union (ACLU) took the US patent agency and Myriad Genetics to court, on behalf of patient organisations and medical organisations. It argued the patenting genes was unconstitutional and prevented medical research. A federal judge in New York ruled in favour of the ACLU in March. Last month, Myriad announced it would appeal the decision. “It’ll be very interesting to see what the outcome is,” says Robert Cook-Deegan.

“It’s only now that the courts are actually going to have to decide. We have this intuition that it makes no sense to patent something that you actually discovered, that is in nature. And at the same time you want to preserve the incentives for the value of the patent system if you are doing stuff that is hard and expensive. The patent system is going to have to figure it out. They can’t both be right.”

Legal experts expect the case to be fought over right up until the US Supreme Court. Mr Cook-Deegan hopes in any case that it will provide clarity. Because at the moment, no doctor in genetic research knows when he is breaking patent laws.

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Read more:
Duke Institute for Genome Sciences and Policy: Profile Robert Cook-Deegan

ACLU: Patents on breast cancer genes

Myriad Genetics: BRCA testing

Human Genome Project Information: Patents
 

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