Now here is an awful, awful idea, and it's made it all the way to the Supreme Court. Oral arguments were heard last week in Mayo Collaborative Services v. Prometheus Laboratories, and this one really has the potential to screw things up.
Why am I so downbeat? Wait until you hear the basis of this case. Prometheus has a patent whose first claim is as follows:
(1) A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x10^8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
There, that sounds like a nice little chunk of medico-legal boilerplate. But look closely: what they're claiming is the process of using a blood test to decide whether or not to administer a drug. Prometheus Labs did not discovery any immune-mediated gastrointestinal diseases. They most certainly did not discover thioguanine, nor did they discover that giving thioguanine is beneficial to people who are deficient in it. No, they make a test kit, and they are claiming the process of checking a patient's blood levels (their test kit's function) in order to make a medical decision. The Mayo Clinic planned to offer a competing test kit, and Prometheus sued, and here we are.
Now, think about a world in which such processes are patentable (here's a column at Ars Technica that's done that already). Prometheus seems to be claiming that the awareness of needing to test for thiopurine levels in order to decide whether to dose a patient is enough to infringe their patent. Doesn't matter if the physician doses anyone or not - just the idea of testing their blood is enough. IP rights have been infringed. Money must change hands. Ka-ching. Imagine every new bit of medical practice broken down into the smallest patentable, monetizable steps. A physician reads about a new finding that might affect clinical practice - but not so fast! Better check to see what the patent rights are. Wouldn't want to get sued for applying the scientific literature without the proper licensing fees. As the AMA's amicus brief has it:
"If claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care"
If you follow intellectual property issues, you'll have noted the similarity of this case to software and business-method patents, which have been a gigantic tar pit of litigation for some years now. But the tide of tar is not finished rising. The IP lawyers are, as you'd expect, watching this case with great interest, some with thoughts of perpetual employment, and some in a sort of fascinated horror. This problem has been developing for a long time, since the main legal decisions on what constitutes patentable matter actually appear to contradict each other, and perhaps this will be the case that begins the ugly process of sorting all that out. (Or perhaps the Supreme Court will recoil from that task and decide this case on some narrower basis, kicking the issue a few years into the future).
Here's a more technical legal summary of the oral arguments at the Patently-O site. It appears that Justice Breyer will be a key player in the eventual opinion; he spent by far the most amount of time asking questions during the orals. And here (also from Patently-O) is a new law review paper from Case Western on the whole tangled subject of medical diagnostic patents. This post at Patent Baristas has links to the various briefs filed on both sides of the case.