The story of Prometheus proves that bringing good things to mankind may not always have a good payback. In case you forgot, the Greek Titan Prometheus stole fire from Zeus and gave it to us mere mortals. Zeus punished him for his crime by having him bound to a rock while a great eagle ate his liver every day only to have it grow back to be eaten again the next day. While Prometheus the Titan’s crime might have been clear, not so with Prometheus Laboratories, whose patent on certain diagnostic blood tests might or might not have been patentable.
Prometheus Labs has had its patent eaten and regrown at least twice. However, with a Supreme Court ruling it seems the cycle is finally over (at least for Prometheus). For the rest of us, the Supreme Court’s invalidity ruling for Prometheus raises significant questions about the value of investing in certain types of research activities.
To put the case in a nutshell, Prometheus discovered/observed/researched that the lowest effective dose of a particular class of drug could be determined by the level of its metabolite (the product that remains after the drug is broken down by the body) measured in the blood. Their patent claim(s) essentially said “administer the drug to a patient and determine from a blood test if the metabolite is within the desired range”. From the perspective of the Supreme Court, these claims were nothing more than a statement of a law of nature (that the body produces the metabolite in proportion to how effectively it uses the administered drug) along with the instruction to observe nature in action. And, since laws of nature are not patentable, Prometheus lost the right to keep others from selling competing test kits. Note that the test kits were not patented, just the use of the kits to guide doctors in determining the proper dosage.
This ruling is important to the rest of us because the basis for invalidity was that the invention was ruled “not patentable subject matter”. To the Supreme Court the patent was the equivalent of saying “put more wood on the fire if you’re cold, break the fire apart if you are too hot.” Basic law of nature; more fuel equals hotter fire, less fuel equals cooler fire.
But this perspective is flawed, since it presumes that coming up with the acceptable range of the measurement has no inventive, patentable value. But saying that the acceptable range has no patentable value is really an issue of obviousness – just like knowing when to throw wood on Prometheus’s gift to man is obvious. The Supreme Court said “we don’t care how hard it is to come up with the right limits to make this a medically valid test. The Constitutional directive to reward inventors and discoverers of advances to the useful arts will not be applied to tests like this“.
We all may suffer from this ruling. How many research dollars will flow into medical tests that are simple to perform but whose diagnostic value comes from knowing how to interpret the results?
The validity of Prometheus’s patent should have been determined by obviousness, not by subject matter. If measuring the single metabolite in a hundred patients was all that was needed, then maybe it’s obvious. If figuring out which metabolite to measure, out of a hundred in the blood stream, was required, well, maybe not so obvious.
How about your company – how much of your value comes from a key bit of hard won knowledge? Are you the next company to have your liver eaten?