Doctors Fight Patent On Medical Knowledge 205
I Don't Believe in Imaginary Property writes "Doctor's groups, including the AMA and too many others to list, are supporting the Mayo Clinic in the case Prometheus v. Mayo. The Mayo Clinic alleges that the patents in question merely recite a natural phenomenon: the simple fact that the level of metabolites of a drug in a person's body can tell you how a patient is responding to that drug. The particular metabolites in this case are those of thiopurine drugs and the tests are covered by Prometheus Lab's 6,355,623 and 6,680,302 patents. But these aren't the only 'observational' patents in medicine — they're part of a trend where patents are sought to cover any test using the fact that gene XYZ is an indicator for some disease, or that certain chemicals in a blood sample indicate something about a patient's condition. There are even allegations that certain labs have gone so far as to send blood samples to a university lab, order testing for patented indicators, then sue that university for infringement. Naturally, Prometheus Labs sees this whole story differently, arguing that the Mayo Clinic will profit from treating patients with knowledge patented by them. They have their own supporters, too, such as the American Intellectual Property Law Association." Prometheus doesn't seem to be a classic patent troll; they actually perform the tests for which they have obtained patents.
Comment removed (Score:5, Informative)
Re:Chicken Little (Score:5, Informative)
That's a loophole to the medical practice exception that you could drive an ambulance through.
Re:Test for Money or No Test at All? (Score:5, Informative)
Although I appreciate the distaste of making money off sick people, I don't think that applies. Promethius should be tied to a rock for a giant eagle to eat their livers.
They merely patented something that a "common knowledge" thing in drugs. It's how urine drug screening has worked for 20 years, it's how tons of drug effectiveness tests work (mostly drug screenings). It's a false monopoly, troll or not.
If they invented some sort of new test for the metabolites... like a special litmus stick which would tell you the levels of metabolites, that would be completely different.
patent: new, useful, non-obvious, inventive step (Score:5, Informative)
I understand the need for patents, but I don't feel discoveries should be patented.
A discovery cannot be patented by itself. To be patentable, there is an explicit requirement under US law for an "inventive step" to be taken. A discovery might cover the requirement for non-obviousness, and perhaps the requirement for usefulness, but a discovery is not an invention.
In the case of the cited patents (6,355,623 and 6,680,302), I think the non-obviousness part is severely lacking. Rephrased, their independent claims are for the combination of (i) treating condition X with drug Y, in which (ii) the dose of drug Y is adjusted based on the inferred level of drug Y in the bloodstream. Given that treating condition X with drug Y was already known, the step of adjusting the dose would be obvious to one of ordinary skill in that art (gastro-intestinal medicine). The method of inference is the "discovery" in question.
Both patents suck, but for other reasons.
Re:O to CO2 conversion (Score:5, Informative)
"Does this mean I can patent the method the body uses to convert O2 to C02 and then sue everyone?"
No, and I don't see the connection. The patent doesn't cover a natural process of the body; it covers the procedure of looking at the results of that natural process.
It doesn't look to my (admittedly untrained) eyes like a valid patent, but that's because it appears obvious. It essentially seems to say, "Want to know if there's too much or too little of a drug in the patient's system? Then check!" My attitude would vary if there's some sophisticated, non-obvious mechanism behind taking the reading of how much drug is in the system, and they invented that method, and that method is spelled out in the patent...
That the patent "recites a natural phenomenon" is a non-issue to me. Every patent can be boiled down to observations about nature. Every patent is an observation about a useful application of natural laws of physics, chemistry, etc.
Comment removed (Score:3, Informative)
Re:Test for Money or No Test at All? (Score:3, Informative)
The idea of testing metabolite levels is not what the patents claim, though. The patents claim testing for specific levels of a specific metabolite produced by the administration of specific drugs given for a narrow class of conditions.
The immunosuppressant drugs in question (6-mercaptopurine, azathioprine, 6-thioguanine, and 6-methylmercaptopurine riboside) require very careful titration in order to be effective. Too little and they are not therapeutic, too much and they overwhelm the immune system. Thus, too little and the patient could have a potentially fatal disease flare up, too much and they could contract a fatal infection. Because of the way they work, a changed serum metabolite level takes week or months to have an effect on the disease or the immune system. Thus, it is vital that the doctor and patient be able to zero in on the correct dosage very quickly rather than through trial and error.
Figuring out which metabolite levels corresponded to the optimal dosage took a fair bit of expensive research (for starters, the drugs are not cheap, even as generics). The patent on the test is a valuable incentive for getting that research done. Mayo Clinic, which could have done the research itself, chose not to do so. Instead, it wants to free ride on the work done by Prometheus because it decided a patent infringement lawsuit is cheaper than paying for the test.
Re:This is the nature of medical science (Score:4, Informative)
The problem here is in trying to patent a trade secret rather than an invention. Patents are intended to cover inventions. Real, working gizmos that operate is a specific fashion. Trade secrets cover processes and information that is of a competitive advantage.
In this case, the two are getting mixed up. The company may have a device to detect certain attributes (which IS patentable) but the fact that the attributes can be measured in order to draw conclusions is inherently unpatentable. If someone else develops a machine for measuring the attributes that works different from your machine... well... tough noodles.
All that can be done is to keep the information a secret. By keeping it secret, it is legally viewed as a "trade secret" which can be contractually protected when sharing with interested parties.
Disclaimer: I am not a lawyer, but I did stay at a Holiday Inn Express once. ;-)
Re:Knowledge, or "Facts" should not be patentable. (Score:3, Informative)
>>such as TEST for a certain condition
That's exactly what Prometheus is patenting.
-b