On Patenting Genes and Their Correlations: It's a Chicken-Egg Problem

Last month, my colleague Shane Climie wrote a post inspired by an article in the New Yo

Last month, my colleague Shane Climie wrote a post inspired by an article in the New York Times (“How Bright Promise in Cancer Testing Fell Apart”), which exposed disturbing and cautionary insights into the application of genetic testing technology. Today, I’m responding to a recent New York Times article in which reporter Andrew Pollack wrote of challenges facing Myriad Genetics in spite of the company having received a victory when a federal appeals court upheld the company’s patents on two human genes – and the validity of gene patents.

It’s worth checking out Andy’s article for more context, but here are my two cents on some of the issues covered:

My hunch is that eventually courts will rule (and in so doing give clear guidance) that while products of nature cannot be patented, companies likely will be able to continue to patent the knowledge that a gene or other physiological marker (all of which are “products of nature”) correlates to a particular condition, disease, and/or drug response. This is a key point of clarity that is needed in order for the field of “personalized medicine” to reach its full potential.
As is clear from some of the expert and company representative quotes in the article, what we’re looking at here is a chicken-egg situation. In most cases, clinical validation that a gene correlates with a particular condition (or another type of correlation) is made possible by the investment of capital in a private company’s research, and the investors depend on the research entity having patent protection to help generate a return on their investment. On the other hand, society as a whole (i.e., public health) may be worse-off if use of the knowledge of the correlation is not allowed or made widely available.
And, as we’ve written about in previous blog posts, whole genome sequencing will soon be done at a relatively low cost but how the resulting data is interpreted and used will continue to present challenges and be subject to the competing forces described above.

As life science consults with deep experience in medical devices and in genomics research, this issue is fascinating to the Popper and Company team. How does it strike you? Do you agree that this boils down to a chicken vs. egg situation or do you see it differently? Do you have any specific insights on the Myriad situation or similar business examples? We welcome your thoughts on this important topic.