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16-12-2012 | Article

Experts speculate on Supreme Court’s future gene patent ruling


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medwireNews: The Supreme Court will likely rule that complementary (c)DNA is patentable while isolated DNA is not, health law experts recently posed in a blog in Health Affairs.

John Golden, from Harvard Law School, and William Sage, from the University of Texas at Austin, provided insight on what to expect from the Supreme Court's recent announcement on whether genes can be patented.

"Given [the] high stakes and the differences in views on the intermediate appellate court," they wrote, "the Supreme Court's decision… is unsurprising."

By inferring that cDNA will maintain patentability, the professors predict that the Supreme Court judges will consider that this form of DNA, which has had non-coding nucleotides removed, differs enough from what is "natural" to fall within the definitions of what is patentable.

The specific case that the court will review concerns a challenge to patents of genes that were awarded to Myriad Genetics Inc. The two genes in question, BRCA1 and BRCA2, are strongly linked to a heightened risk for hereditary breast and ovarian cancer when mutated - up to an 85% and 50% cumulative risk, respectively.

Myriad has argued that it is within legal boundaries to patent and have exclusive rights to these genes when they are isolated from their natural form, after being removed from the body and its associated cellular material.

"Myriad poses the classic dilemma of patent law: how to balance exclusive rights that can help investors recoup the expense of initial innovation against the free use of such innovation once developed," Golden and Sage wrote.

But the plaintiffs, led by the Association of Molecular Pathology and including national organizations of physicians, geneticists, researchers, and clinicians, argue that the patent cannot apply in this scenario as it involves laws of nature and abstract ideas.

Additionally, the plaintiffs point out that the patents prohibit "scientific inquiry and medical care to the detriment of patient's health and to scientific advancement," explains a document released by the Supreme Court.

Speculating on factors that might impinge on the Supreme Court's decision, Golden and Sage are wary of the final arbiters' lack of scientific training and experience.

"Without fact-finding hearings and after an oral argument likely to last no more than one hour," they wrote, "they will rule on the means for developing and commercializing some of our most advanced biomedical technologies."

By Peter Sergo, medwireNews Reporter