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?”