The Supreme Court finally ruled that the Prometheus Labs patents in Mayo v Prometheus are invalid. I personally tip my hat to the court on this decision. I’ve written about this case before, and I’ve done some general Pharamaceutically Speaking analysis on how 101 applies to pharma and personalized medicine. Because Prometheus was originally a 101 issue, we’ll start there.
As I said before in my Invention vs Observation article, some inventive step MUST be included. Simply observing a law of nature isn’t patentable. In this case, testing apparatus and SPECIFIC tests might be patentable. If, for example, you invent a blood draw vial that gives a test result on receiving at least X amount of blood, THAT is patentable. If you invent a diagnostic machine learning algorithm that can determine the presence of a disease (a very specific test, which a human could otherwise not reasonably perform), then of course that would be patentable. But, in such a case, that necessarily means that “if the blood level of the drug (or protein produced in response to it) is outside of the range Y to Z, then we need to adjust” is NOT patentable… that is an observation.
The court then went on to see if other parts of the methods were patentable. My 103 analysis kicks in here: testing blood levels for the efficacy of immunosuppressant therapy drugs has been around for a VERY LONG TIME (known since 1988 at the very latest). The parts that weren’t simple observation really were well known in the art. I’m no pharmacist or doctor, but if you ask anyone with an autoimmune disorder how often they have to go get their blood levels checked for whatever immunosuppressant they are on, you’re going to get an answer in the range of every week to every few months.
Perhaps, if the process were more involved than checking the level of the drug itself, such as checking levels of proteins or metabolites that could be produced by the presence of the drug, as well as taking into account other factors that might influence those levels, you might have a patentable, inventive process. Simply administering a drug and seeing how much is maintained in the body, however, isn’t particularly inventive.
Don’t believe me? Let’s go through Claim 1.
A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
Okay, we’ve established this is for treatment of an immune disorder.
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
Administer a drug.
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
Check to see how much of the drug is in the person’s system.
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
We’re clarifying that we are checking the blood for a specific minimum level of the drug.
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
…and checking the blood for a specific maximum level of the drug.
That’s Claim 1. It’s…shockingly basic. And, while it can be considered personalized medicine, the field of personalized medicine shouldn’t be too horribly affected. After all, drugs and tools are still patentable… simple correlations, or correlation observations, on the other hand, are (and rightly should be) out of the question.