The NY Times has some excellent coverage on this ruling. The article notes that the ruling was in many ways a surprise to some observers. The patent holder, Myriad Genetics, in particular felt that the 1980 Supreme Court ruling allowing the patenting of a genetic modification to bacteria to allow it to break down crude oil was a strong enough precedent to protect its patent claim.
Judge Sweet disagreed, not seeing an adequate transformation in Myriad’s work. Rather he disallowed it under the reasoning that their patent on a couple of human genes relating to breast and ovarian cancer involved a law of nature. Based on the article, the links it provides and a cursory glance at the massive ruling, the key difference seems to have more to do with the fact that the earlier case resulted in a directly useful artificial organism, rather than genetic tests based on some specific knowledge or research.
I tend to think Sweet’s reading of the machine-or-transformation test is accurate. Patenting diagnostic tests based on genetic research has always seemed rather borderline to me in terms of it just not representing much of an invention beyond the mere discovery of biological facts. I’d be curious, too, to see what the actual break down is on new tests developed based on potential patent royalties vs. grants for basic research.
I also don’t buy the doom and gloom portents from those on the losing side of this case. I don’t think invalidating the patent on a $3000 dollar genetic test is going to seriously erode the state of the art in medicine. It might temporarily weaken the funding outlook for new, private biotech ventures, but I think that is likely only to apply to those pursuing testing to the exclusion of all else and only until they adjust to the consequences of the ruling.
The ruling occurred in a district court, so Myriad will no doubt appeal. It will be interesting to see if higher courts validate Sweet or choose a different interpretation.