We’ve just come through the 2012 retrospectives season. Rather than try to recount the top bioethics stories of 2012—a worthy task, to be sure—allow me to nominate one prospectively for 2013: the Supreme Court decision on the Myriad Genetics case. Reports in the general press say that the Court will hear the case this coming spring (with a decision sometime after that). I am not a patent attorney, so any discussion I can offer here will be ignorant about the legal nuances, and I must therefore be reserved. But as I understand the case, at issue is whether a gene sequence that is found in nature—in this case, the BRCA1/BRCA2 genes—can be patented. Now, methods to target those genes, or their products, can be patented in the course of, for example, drug discovery and development. And a specific method of assaying the gene can be patented. But can the sequence itself be patented, and what does that say for any intellectual property rights around the interpretation of the results?
I am in the camp that is suspicious of patenting actual gene sequences—normal or mutant—as opposed to methods to assess them or to interdict the consequences of their biologic activity. Of course, a decision in that direction would invalidate the Myriad Genetics patent, breaking their monopoly on the BRCA1/BRCA2 test—and lowering the price of testing in the process. Some entrepreneurial opportunities would be hindered as a result, but my overall impression is that not only academic research, but the possibility for competing tests and for lower costs for personalized medicine in the process, would be enhanced.
Either way, it will be of keen interest to see the breadth of whatever decision the Court reaches, and its implications for other patents in biotech. Rather than speculate here, I will wait for the decision.