Tuesday, March 30, 2010

I'm "Brand Me", But My Genes Belong to Someone Else?

It's too early to celebrate -- who knows what will happen on appeal, and I have not doubt that this decision will be appealed -- but US District Court Judge (Southern District of New York) Robert W. Sweet is my hero for the day.

In a 152-page ruling Judge Sweet struck down seven patents currently held by Myriad Genetics for genes associated with a greater risk for breast and ovarian cancer, as reported by John Schwartz and Andrew Pollack in today's New York Times, and by many other news channels. The suit had been filed last May by a group of women with breast cancer, several medical research organizations, the American Civil Liberties Union, and others.

I think that many of us, who are not genetic scientists, find it hard to understand (and more than a little ambiguous morally) that a corporate entity could own genes that come from our own bodies. And that was the crux of the suit.

The patents had been used in the development of a test that looks for mutations in the BRCA 1 and 2 genes. The only way to know whether you have the mutations is to pay up to $3000 for the Myriad Genetics test; Myriad has refused to license the test to other companies. The suit charged that by doing so, Myriad kept prices artificially high and prevented woman from getting a second opinion from another testing company.

Moreover, the suit asserted that the "patenting of human genes, the concept of looking at or comparing human genes, and correlations found in nature between certain genes and an increased risk of breast and/or ovarian cancer violates long established legal principles that prohibit the patenting of laws of nature, products of nature, and abstract ideas." (More background on the case can be found here, in a March 2010 E-Commerce Times article by C. Douglas Brown, and here, in Turna Ray's piece for Pharmacogenomics Reporter) The patenting of genes, the plaintiffs argued, "stifle[s] research that could lead to cures and limit women's options regarding their medical care."

Companies like Myriad have argued that without the potential for significant financial gain that the patents represent, there would be no incentive to invest in potentially life-saving research.

Some legal experts had expected that the case would be dismissed -- after all, as Schwartz and Pollack reported in the Times, "the Supreme Court upheld patents on living organisms in 1980."

But Judge Sweet agreed with the plaintiffs, ruling that the patents had been "improperly granted".

This is hardly the end of the story. As I said above, appeals can be expected. Moreover, Myriad holds 23 patents for its BRCA analysis, so there are still 15 not addressed by this suit.

Note that at present, about one-fifth of all human genes have been patented. Hello?!? Note also that this is a US problem; most other countries do not permit gene patenting.

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