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The Continuing Chronicles of the Gene Patent Wars

Bloggers are still talking about the Myriad gene patent decision, and the Wall Street Journal Health Blog's Katherine Hobson thinks the "controversy ... is not going away anytime soon." A recent Journal article reported on a Duke University study , which found that "exclusive licensing of gene-based diagnostic tests can keep patients from benefiting from genetic discoveries and often leads to legal wrangling," Hobson says — meaning that Myriad was only the tip of the iceberg. And what's the future of full gene sequencing? If patents are already issued and exclusively licensed gene by gene, Duke Institute for Genome Sciences & Policy's Robert Cook-Deegan asks, then how can anyone offer full-genome sequencing without getting sued? The article also discusses chromosomal microarrays that can find chromosomal abnormalities. Hobson adds: "What's a doctor to do if that kind of analysis encompasses a gene that's already patented — tell the patient or stick to the letter of the law?"

But the Wall Street Journal isn't the only publication paying attention to Cook-Deegan's work. Genomics Law Report's Dan Vorhaus reports that Genetics in Medicine recently released an online-only supplement "analyzing the relationship between gene patents and genetic testing," with the majority of the issue devoted to a series of eight case studies undertaken by Cook-Deegan and his team. The journal's editor-in-chief, James Evans, also published an editorial, asking, "When rights to the human genome are fragmented to the point that thousands of genes are 'owned' by myriad parties (pun intended), how will we hack our way through the resultant thicket to facilitate the application of multiple genotyping, multiplex sequencing, and whole genome sequencing?" Evans also says that gene patents aren't needed for the development and availability of genetic diagnostic tests, and that universities are also contributing to the problem as they also apply for gene patents. The question now is if policy-makers will try to shape gene patent policy, Vorhaus adds. If not, "any revisions to the patent landscape will be ... conducted against the uncertain backdrop of ongoing patent litigation."

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