Some very interesting litigation has been going down this year, somewhat under the radar for most of us, regarding the patentability of biological products and processes that could have huge implications for both the biotech industry and academic research labs hoping to commercialize their findings.
Earlier this spring, what would look to most people (and even most scientists) as a very dry case made its way up to the Supreme Court. The case was brought by Mayo Clinic (via their laboratory group Mayo Collaborative Services) against Prometheus, a medical diagnostics company. Prometheus own(ed?)(s?) the patent on a certain test offered by the laboratory. This test involved detecting the levels of a certain drug metabolite in order to monitor dosage/predict side effects/etc., and correlate those levels to the health of the patient (i.e. efficacy). Basic pharmacokinetics/pharmacodynamics (PK/PD) type information--thousands upon thousands of people get a similar kind of testing for their coumadin/warfarin levels all the time, This is mainly because there are certain polymorphisms in a couple of enzymes (VKORC1 and CYP2C9) that affect the metabolism and thus blood levels of warfarin in some patients, and if the balance isn't right (and the effective dose ends up too high) the patient's blood won't be able to clot at all, which is a bad thing, obviously. If it's the other way around, the patient won't get enough of the thinning effect and will not get the intended benefit. So everyone who starts on warfarin has to get their prothrombin time and "international normalized ratio" (PT/INR i.e. measures of clotting) regularly checked to make sure the dose is having the intended effect; doctors adjust based on the outcomes of these tests as necessary.
So, Prometheus developed a test for a certain drug metabolite in a certain disease (unrelated to warfarin, that was just a handy example) that was a little more direct: it measured the actual level of the metabolite in the blood rather than a downstream effect of that level. (you could do this for warfarin too, but it's probably a lot cheaper to do the PT/INR test) They also established a correlation between those levels and the outcomes, and patented the whole system. They sold a kit, that made this test simple, to the Mayo labs, and Mayo Labs bought it and used it regularly. Then at some point, somebody at Mayo Labs said, "Hang on, if this is just measuring the level of this metabolite using a machine we already have, let's just put together our own reagents off the shelf and run it without paying all this money for this expensive kit." (something research labs may or may not do all the time... ahem...) As you might expect, Prometheus wasn't very happy about this and it all culminated in some intellectual property litigation. You know, just a little argument that ended up... before the Supreme Court.
Teh SCOTUS' decision ruled, in way-shortened summary, that because a drug metabolite is produced by the body, it is a "law of nature" and is thus unpatentable. This result sent waves through the intellectual property law community because if a diagnostic for drug levels is considered a "law of nature," WHAT ELSE is now going to be challenged as unpatentable?? The entire freaking biotech industry??!
Think, in particular, the ongoing fight about Myriad Genetics' test for BRCA1/BRCA2 mutations. Someone else certainly did. Last week, in an update to this law of nature drama, the U.S. Court of Appeals for the Federal Circuit ruled in favor of Myriad, that because the DNA constructs covered under their patents are cDNAs and other pieces of cloned out material, they are not "natural" and thus don't fall under the "law of nature" definition. This is a key result: it means that the issue isn't necessarily so sweeping and cut and dried as it looked from the opinion that came out of ye olde SCOTUS... and may ultimately end up back there via this Myriad case.
But overall, this whole discussion may end up having the effect that was speculated to be part of the SCOTUS' plan for their dramatic ruling: to better define what constitutes "natural" in the 21st century, where modern biotechnology can generate whole artificial genomes, and exome sequencing (heck, even the cheap kind of sequencing, or good old fashioned GC/MS metabolomics) can help predict who is at risk of a given disease and/or will benefit from a given drug; and to force the biotech world to figure out which and how molecular parts are owned by the individual who produced them (either in their body or from their mind). And us in academia, we better pay attention--because these are our discoveries out there, too, and if we want them to ever see the light of day, somebody is going to have to help us make products out of them. That's pretty hard to make happen without viable intellectual property in place.