After the Justice Department weighed in late last week with an opinion that genes should not be patented, experts on both sides of the issue have been arguing heatedly over the potential impact. On one side are the biotech groups and patent attorneys who see this as a direct threat to the kind of intellectual property laws needed to build up the diagnostic side of the industry. And on the other are experts who see the feds' move as a necessary step toward a new age in which complex genetic analysis will be cheap and widely available for use to spot diseases and direct care.
Not surprisingly, the Biotechnology Industry Organization sees it as a lethal threat undermining the country's lead role as a drug developer, scuttling any kind of significant investment in the field. And BIO was joined by the Association of University Technology Managers.
"Patentability of isolated DNA molecules is critical to the translation of university research discoveries for the public good. Without this, many promising discoveries would not make their way from the university research lab and into the hands of companies for development of products which improve the public health," stated AUTM President Ashley Stevens.
Then there's Steve Salzberg, a computer scientist at the University of Maryland who developed a computer program that could define mutations in the BRCA1 and BRCA2 genes by analyzing a person's genome. Those two genes have been recognized as the pioneers in the pursuit of markers that highlight disease risk and potential drug benefits. In the not too distant future, full genome sequencing should be available for $1,000 or even less. And Salzberg tells the New York Times that he believes that "if you want to look at your own genome and see if you have a mutation, you should be able to do that without paying a license fee to someone else."
For now, it appears that the Patent Office itself hasn't adopted the same attitude as the DoJ, although it's officially staying mum as the debate rages on.
- see the BIO release
- and here's the NYT article