Saturday, 30 July 2011

Appeals Court overrules lower court, upholds breast cancer gene test

A bit over two years ago, a large collection of interested parties joined together with the ACLU to challenge a practice that had become business as usual: the patenting of human genes. The group filed a suit that targeted a specific set of patents: those used by Myriad Genetics to control the market for tests of the BRCA breast cancer genes. In a surprise result, the judge overseeing the case issued a sweeping ruling that not only voided Myriad's patents, but seemed to put all gene patents at risk. Now that decision has been reversed, as an Appeals Court has upheld the patents in question.

The initial ruling that voided Myriad's patents relied on a novel interpretation of what was being patented. Patents on natural substances are allowed if the process of obtaining them is transformative, meaning the end result differs significantly from the original, natural state. In order to do genetic testing, the judge reasoned, it didn't matter which particular DNA molecule was obtained or in what manner—what you needed was the information conveyed by the gene, in terms of its protein sequence, not a specific piece of DNA. And that information is a natural product, which can't be patented unless it was transformed in some way. Since the genetic test doesn't involve any transformations, then the patents were invalid. Since many other gene-focused patents relied on this sort of information, rather than the actual DNA, this decision seemed to place many of them at risk.

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