Should it be Legal to Patent DNA?

Are the genetic components of life more like cookies or baseball bats? The Supreme Court has been recently considering this question as they heard arguments over whether DNA can be patented, aided by some silly metaphor fencing. Here are a transcript of the arguments and a history of the case, Association for Molecular Pathology v Myriad Genetics.

The gist is that a biotech company called Myriad Genetics isolated two genes associated with a high risk for breast and ovarian cancer (BRCA1 and BRCA2) and patented the DNA, as well as diagnostic methods to find the genes, which involve cDNA. The original patents were obtained in 1997 and 1998. Since then, the Association for Molecular Pathology, the American Civil Liberties Union, and the Public Patent Foundation have challenged the right to patent DNA in various courts, claiming that a product of nature is not patent eligible. Myriad Genetics counters that, by isolating the DNA, their scientists have indeed invented something new and patentable.

Human Genome Project scientist Eric Lander put a damper on that argument in this "Friend of the Court" briefing. "It is well-accepted in the scientific community that isolated DNA fragments of the human genome—including many fragments covered by Myriad's patents—occur routinely in the human body and thus are products of nature," writes Lander.

Both sides of the argument appeal to the notion of scientific progress. The anti-patent petitioners claim that granting exclusive rights to genes will stymie future research, limiting what scientists unaffiliated with Myriad might be able to do. Team patent, on the other hand, insists that such exclusivity is a necessary condition for the investment that drives research. Randy Ribaudo, PhD, an accomplished veteran of both sides of the industry/academia divide, notes that this argument isn't so straightforward. "That research is inhibited because of patents is too general a statement," he says. "One can conduct basic research with patented entities as long as they are not used for commercial gain. It is not clear to me why investigators interested in understanding the biology, genetics, and/or causes of breast cancer in this case would be inhibited from conducting basic research. If on the other hand, there are motives to take their research discoveries and commercialize them, then obviously if this infringes on existing patents, it would inhibit that kind of work. But that strays from the argument that patents inhibit research."

Ultimately, the ruling depends on a clear understanding of what exactly is being patented, and the series of analogies flung around at the Supreme Court last Monday wasn’t particularly helpful in that regard. "It's overly simplistic, and not accurate," says Ribaudo. He elaborates, "If Myriad is patenting a derived product from the BRCA genes, such as cDNAs to be used for diagnostics purposes, that makes sense to me.  As to the actual cDNA itself, that gets dicier since it is a direct transcription of a naturally occurring element (the mRNA). This gets really complicated as one can also argue that since cDNA is not 'naturally occurring,' then it should be patentable."

Sandra Park, Senior Staff Attorney with the ACLU, disagrees. In a webinar on the case held on April 19th, she argued, "The scientist does not determine the sequence [of the cDNA]. It's all determined by nature."

The decision probably won't come until the end of the Supreme Court's term in June. It's looking like Lander's briefing was convincing regarding the isolated DNA. cDNA, however, is likely to remain patentable.

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