genomeboy.com

In this week’s issue of Nature, Bob Cook-Deegan, Shubha Chandrasekharan and I have a commentary on gene patents in diagnostic testing in the US. There is also a second commentary by Sibylle Gaisser, Michael Hopkins and colleagues that addresses the state of gene patenting in European diagnostics.  Nature has weighed in with its own meta-editorial and the indefatigable Brendan Maher has taken up the issue on the Nature Network blog. I encourage you to read all of them if you’re interested in gene patenting for genetic diseases—they’re not too long, even for my feeble attention span.

What we did—and by “we” I mean mostly Bob and Shubha with endless help from the Secretary’s Advisory Committe on Genetics, Health and Society and its Task Force on Gene Patenting and Licensing Practices ably led by Jim Evans—was to try to reconstruct the patent histories of a number of human genetic diseases and assess patient, provider and physician views. SACGHS asked us  to help answer the question: How have gene patents affected patient access to genetic testing?

The short answer: insofar as we can tell, not all that much. Patents may have helped bring genetic tests to market more quickly and to build markets for them in some cases, but it’s not at all clear that they were absolutely necessary. And occasionally, they’ve had obnoxious consequences. On the other hand, exclusive providers have a strong incentive to get third parties to pay for their tests. If Myriad had to rely on out-of-pocket payment for its full-monty $3000 BRACAnalysis test, how much smaller would its market be? My guess: A helluva lot. Even Myriad’s critics—and I’ve been one—would have to concede that its testing regime and payer coverage circa 2009 are outstanding (I was tested for BRCA mutations via DNA Direct earlier this year). Does that mean all gene patents are a good idea? Hardly. In a future post and/or a dingy bar we can argue about why that may or may not be the case.

One of my favorite movies is It’s A Wonderful Life, probably because it appeals to both my misanthropic and sentimental sensibilities.  The beauty of the film’s premise is that it’s A Christmas Carol to the nth degree: George Bailey gets to see what the world would be like without him in it, i.e., a dark and harrowing place.

We have no such luxury with gene patents. We can’t know what hereditary breast cancer testing in the US would be like without Myriad’s exclusive license; nor can we know what Bedford Falls would have been like had a single company obtained an exclusive license to cystic fibrosis genetic testing. We are limited to the natural experiments provided by human disease gene cloning in the 1980s and 1990s, patents on those genes filed by the universities where the research was done, and the subsequent licensing of those patents. The outcomes of those experiments are inevitably going to be complex and their consequences for public health neither unequivocally good nor categorically bad. Law and public policy are often instruments too blunt to negotiate such complexities. But I suspect within a decade this debate will be mostly moot anyway–the relevant patents will have expired and we’ll all have our genomes in our wallets next to our drivers’ licenses.

UPDATE: Kevin Noonan at Patent Docs has a different view.