genomeboy.com

The defense takes the field:

Sequencing the genome yields information that is fantastically important, but it does not tell you the exact location of the gene and most importantly what function is specified by the gene or by a mutated disease causing gene. I can understand why one should not be allowed to patent DNA without having any knowledge about its function, but an isolated DNA where the function of its products has been determined is a different story - here, an invention has been made. Moreover, if you figure out a direct link or an association between a gene sequence and a cause for or if you figure out the correlations or associations between a gene sequence and an increased risk for a specific disease, this discovery can be used to develop diagnostics and drugs that help people. I do not see any reason why a patent should not be awarded for such inventions.

 

- From the Declaration of Joseph Schlessinger, PhD, 21 December 2009

 

…without the promise of a period of market exclusivity provided by patents and the infusion of  venture and risk capital derived therefrom, companies that capitalize on innovation simply would not be created. Their products would not be brought to market, to the clinic, and most importantly, to patients. This of course, holds true for companies such as Myriad and its BRCA1/2 diagnostic tests.

 

- From the Declaration of Philip R. Reilly, MD, JD, 21 December 2009

 

Association For Molecular Pathology et al v. United States Patent and Trademark Office et al UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK, Robert W. Sweet, presiding

They all want to know

How can you patent a gene

Maybe soon you can’t

 

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.