genomeboy.com

If you’re like me and you go to way too many scientific and professional meetings, it’s easy to get jaded. I am trying to limit my travel to stuff that 1) I can afford; and 2) actually interests me. One meeting I am totally geeked up for is the Open Science Summit in Berkeley, California from July 29-31, and organized by Joseph Jackson and his merry band of paradigm-shifting partners in crime:

The well known “10/90” gap references the fact that only 10% of biomedical spending goes toward conditions that affect 90% of the world’s population.  Under this regime, “diseases of the poor,” such as malaria, are neglected, while companies focus on “blockbuster” drugs for conditions that affect citizens of the wealthiest nations.  This situation, appalling though it is, actually grossly understates the systemic flaws of the prevailing biomedical innovation paradigm.  Framing this as a tradeoff between Market vs Social Values or the need for balancing commercial interests with public health, implies that the bio-pharma industrial complex works for what it purports to do.  If only we could find some way to engage or tweak existing mechanisms, we’ll make it through.  Wrong! 

There will be sessions on synthetic biology, gene patents, open data/open access, biodefense, microfinance, entrepreneurship, drug discovery, tech transfer, and more. There will be smart, talented and good-looking presenters (and, uh, me). And it’s cheap!

Why am I pimping this so hard? I am supportive of the cause. These are ideas and approaches that are less likely to be embraced by funding agencies and academia (as you will learn in my forthcoming book). I like and respect the organizers and want to see them succeed.

See you in Berzerkeley!

I am always astonished by how much one can learn for free on the interwebs and how quickly. The Genomics Law Report has not one, but two terrific analyses of the ruling striking down gene patents. Here, arguably, is the nut graf from the second:

With the decision only hours old, the headlines are already starting to roll in. “The End of Gene Patenting?” “Judge Rejects Patents on Genes.” “Judge Nullifies Gene Patents.” While it is clear that this decision is headline news, it is equally important not to overstate either its legal significance or its likely practical effect. The limited legal reach of the opinion—unless and until it is upheld by a higher court—has been discussed above. Less certain is its practical effect, including how businesses, clinicians and patients may change their behavior in response to the ruling.

My own thoughts:

1)  The ACLU and its allies, to clumsily mix sports metaphors, threw a Hail Mary and put on a full-court press.  They assaulted gene patents not on technicalities, but essentially on what is patentable and on First Amendment grounds (although the latter did not really figure in the decision). They won big and they got a summary judgment.  I am not a lawyer nor do I play one on TV, but I was surprised this did not go to trial. Both sides appealed to emotion and hyperbole during oral arguments, but I thought the plaintiffs were over-reaching unnecessarily and history was certainly not on their side. And I thought they were probably ten years too late. Good thing for them they didn’t ask my opinion…

2) Near-term business may not change much for anyone involved, but I imagine this will be appealed all the way to the SCOTUS, because both sides perceive there to be too much at stake to accept losing.

3) But even without appeals, this is hardly an “all clear” from a practical standpoint. If you had $50 million bucks lying around, would you enter the breast cancer genetic testing market in the US? I wouldn’t. Myriad’s been at this for well over a decade and it’s had the market all to itself. The legal hurdles may have been dealt with and barriers to entry may be pretty low at this point, but so what? Even if you could undercut its price by more than half, would you want to compete with the iPod?

4) The initial patents on BRCA1 and BRCA2 were awarded in 1997 and 1998 (pdf). I suspect that by the time this gets definitively sorted out, many if not most of those patents will have expired. Both sides will have spent a lot of money on something whose ultimate outcome was inevitable from the beginning. And with whole-genome screening around the corner and 23andMe already returning a small subset of BRCA mutation results, I’d argue that to continue fighting the last war is both myopic and a disservice to one’s shareholders. Myriad Genetics has made a boatload of money on BRCA testing and continues to do so–fine, bully for it. It was and is simply playing by the rules that were in place. And the company does a fine job screening these two genes and has for many years (I’ve been tested myself via DNA Direct). But was an exclusive license necessary to grow the BRCA testing market? Case studies prepared by my colleagues and me strongly suggest that it was not. And so to start singing apocalyptic refrains seems to me to be way, way off base. Monopolies are not necessary incentives for innovation in DNA diagnostics. Check out CF testing in the SACGHS report.

5) Judge Sweet chose to release his ruling on the eve of Passover. So what’s the message? “Dayeinu?” “Why is this product of nature different from all other products of nature?” “Next year in Salt Lake City?” “Let My Patents Go?”

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.