Saturday, May 23, 2009

Cancer Patients Challenge the Patenting of a Gene


Dr. Chung and others involved with the suit do not accuse Myriad Genetics of being a poor steward of the information concerning the two genes at issue in the suit, known as BRCA1 and BRCA2, but they argue that BRCA testing would improve if market forces were allowed to work.

Harry Ostrer, director of the human genetics program at the New York University School of Medicine and a plaintiff in the case, said that many laboratories could perform the BRCA tests faster than Myriad, and for less money than the more than $3,000 the company charged.

A patent was also granted to a single company for genetic testing on long QT syndrome, which can lead to heart arrhythmias and sudden death, and to the HFE gene, linked to hereditary hemochromatosis, a condition in which iron accumulates in the blood and can cause organ damage. Doctors and scientists have complained about both patents.

On the other hand, the company that owns the patent to the gene CFTR, which has been linked to cystic fibrosis, has licensed the testing to dozens of laboratories, drawing praise from the medical world.

The decision to allow gene patents was controversial from the start; patents are normally not granted for products of nature or laws of nature. The companies successfully argued that they had done something that made the genes more than nature’s work: they had isolated and purified the DNA, and thus had patented something they had created — even though it corresponded to the sequence of an actual gene.

So far, however, two panels of government experts who have looked at the issue have not found significant impediments to research or medical care caused by gene patents. A 2006 report from the National Research Council found that patented biomedical research "rarely imposes a significant burden for biomedical researchers."

That report and others, however, warn that the patent landscape "could become considerably more complex and burdensome over time."

In the future, genetic tests are likely to involve the analysis of many genes at once, or even of a person’s full set of genes. Some 20 percent of the human genome is already included in patent claims, amounting to thousands of individual genes, says a draft report from the National Institutes of Health. The report warns that "it may be difficult for any one developer to obtain all the needed licenses" to develop the next generations of tests.

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