Will the Supreme Court kill the gene-patent business?

Posted: May 29, 2013 at 5:46 pm

4 hours ago May. 29, 2013 - 10:58 AM PDT

For $99, the company 23andMe can generate all of your basic DNA testing information: ancestral origins, disease predisposition and even if you are more likely to sneeze under a bright light. But it is the only company in the U.S. that can tell you if you carry a gene variant that makes you more likely to develop Parkinsons Disease.

Like many other companies in Silicon Valleys thriving biotechnology scene, 23andMe holds a patent for a human gene. Anyone who wishes to find if they carry the Parkinsons-related gene must use 23andMes testing kit. In fact, thats how Googles Sergey Brin, who also happens to be married to 23andMe co-founder AnneWojcicki, found out he has the gene.

It is a scenario that is common across the industry; companies pour money into research and then rely on patents to protect their discoveries and diagnostic tools, and to generate revenue. More than 40,000 patents cover 41 percent of the human genome, according to a Cornell University study released in March.

That could change this year. A case currently before the Supreme Court asks the justices to consider if a human gene should be patentable. At the center of the case is Myriad, a Utah company that holds two patents for genes linked to breast and ovarian cancer. Supporters say intellectual property protection makes it possible for companies to confidently sink millions into research. They also say the patents are issued for the minute segment of DNA that makes up a gene, which researchers must extract from a much larger strand. Once it is removed from the body and chemically altered, it becomes distinct.

They were never available to the world until Myriads scientists applied their inventive faculties to a previously undistinguished mass of genetic matter and created a new chemical entity, Myriad says in a Supreme Court brief.

Opponents say it is still the same gene, and isolating it does not constitute a patentable invention. They also say being able to patent genes makes genes inaccessible to research and raises testing costs for patients.I see Myriads claim that a gene should be patentable because they isolated and purified it away from its natural context to have no more validity than claiming that if you cut a leaf off a tree you have now created a new thing and should be able to patent it, said Robert Nussbaum, head of genomic medicine at University of California-San Francisco and founder of an open-access gene database. I see a gene that is isolated or patented as being a discovery of something in nature, not an invention.

The justices are expected to rule before the end of their term in June.

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Will the Supreme Court kill the gene-patent business?

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