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April 5, 2010
Should Genes Be Patentable?
In response to my posting a couple weeks back on more IP that kills, a reader suggested I cover the recent decision invalidating a patent on two genes linked to breast cancer.
I was undecided then and I remain undecided. The situation gets unpleasantly complex. First off, there's a question as to whether one ought to allow patenting of so-called natural sequences (genes, typically) or other things that come about without deliberate action or intervention. I'm not a patent lawyer, but even here I'm of two minds. I'd like to think that for-profit enterprises ought not to be rewarded simply for being first to file a sequence isolated from a creature or compound that has existed for hundreds of years - what's the invention here anyway?
But there are situations where the sequence is unknown and most essentially the relationship of the sequence to causation and effect in the macroscopic world is unknown. The science of discovering that is largely driven by profit motives - you find things like mutations or genetic markers in order to develop diagnostic tests or curative agents. Unless we give sufficient protection to the people and companies engaged in this research they may not be motivated to invest the millions the research requires. So what's the alternative to permitting patents on (gene) sequences?
Second, is there a threshold case here? Breast cancer is unpleasant at best and if untreated can lead to other cancers, major side effects, and even death. That said, a predictive genetic test for it is definitely a First World concern. The predictive test may be better than other methods, but does it pass the threshold that I feel anti-retroviral medicines for AIDS pass? I'm not sure.
Third, the ethical consequences of patents on genes are poorly understood (at best). We really don't know what it's going to mean for society to give monopoly powers over creatures and bits of our own bodies to commercial entities. The fact that this case has arisen over a situation as personal and deeply affecting as breast cancer is probably not a coincidence.
Finally, is the practice of gene isolation an important and necessary part of the process? Is that sufficient to create a patentable product or is it, as the NY Times story notes, merely a "lawyer's trick." The root problem here is that the patent system is increasingly divorced from our growing understanding of science (h/t to Greg Aharonian of PATNEWS who has been hammering on this issue for years). If patent examiners could be properly trained in the science of the area in which they're issuing patents, and if the patent law supported clear statements of the scientific principles underlying patents, then we'd be in a better position to judge this - or at least a competent scientist would be.
As with most of these big thoughts I have far more questions than answers. I do expect this case to be appealed and probably overturned on appeal, but that won't make the fundamental issues go away.
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