Unpatented Cancer Cure: FUD!
Posted by Ray @ 12:11 amRecently, news of a new, simple and effective way of fighting cancer was released [link].
The chemical dichloroacetate (DCA), works by re-activating the mitochondria in cancerous cells. This sets off a cell’s self-destruct sequence (I don’t exactly know how the biology of this works, I’m accepting the reported explanation for now).
Unfortunately, many websites are proclaiming that DCA will not be developed by pharmaceutical companies because DCA is unpatentable. Since no pharmaceutical companies can patent it, they are therefore not likely to want to spend the money to develop it. A smattering of websites spreading this FUD are (is?) here, here and here.
It has sparked the usual lively discussion in the slashdot thread (Patents are bad! Patents are good! Governments are bad! Pharmaceutical companies are bad! etc).
But I sincerely doubt there is reason to worry. A brief search through the US Patent Office’s records turns up US Patent 4,558,050: Treatment of metabolic disorders with dichloroacetate-thiamine preparations. This is probably the previous use the New Scientist article refers to. It’s limited to the treatment of said metabolic disorders. The claim also doesn’t appear to use DCA directly: it uses the DCA to produce something else, which is what they’re claiming.
There is, apparently, nothing preventing a pharmaceutical company or the University of Alberta filing a patent to use DCA to treat cancer.
As for the manufacture of DCA itself, I didn’t find it (probably because it’s pre-1930s), but that patent has probably expired a long time ago. So what? It has no bearing on the use the DCA can be put to.
To summarize:
1) The method of producing DCA is unpatentable.
2) But the uses to which DCA may be put have not been explored.
3) If someone finds a novel, non-obvious use for DCA through diligent research and work, it should be patentable.
Ergo, there is nothing to worry about. We have a possible breakthrough in cancer cures coming soon to a hospital near you.
(If any of my readers think I’m writing nonsense, please tell me!)
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hmmmm…. then by your patent process, there could be 2 companies holding 2 different patents to the same drug (same chemical structure etc etc), but both fulfilling a different purpose (assuming both are novel and blah blah blah).
Do you still think that could be it?
by your reasoning patents are grants for the use applied for, not for the means in which it is created by.
If someone discovers that panadol can now cure cancer/aids, does that mean all of a sudden there can be no more generic paracetamol, if the company that discovers it files a patent for panadol? Or does it mean there will be panadol (fever only), panadol (aids/cancer only).
hmmmm…..
Comment by ivan — Wednesday, January 24 2007 @ 8:11 am
Ivan:
The case I had in mind when I wrote this was National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252. A chemical was discovered to have weed-killing properties, and the patent examiner rejected the application on the basis that the chemical was already known.
The discussion there was, I admit, more nuanced than my hasty blurb. Previous case law had decided that where a chemical and its known uses were enumerated, you could not patent a new use of it. The assumption was that the new use would be similar to the old, hence running afoul of “inventiveness”.
But where the new use was sufficiently different from the old that its utility in that arena was hithero unsuspected, then there may be inventiveness in that new use.
Of course it doesn’t stop there; the inventor has to produce a new, functional result. What is the method of treatment with the DCA? Oral ingestion (seems likely, the molecule is very small which means it can go almost anywhere blood can go)? Injection? What is the best treatment plan? Etc. I’m sure the researchers are slaving over that now.
The problem then becomes: is the new use of DCA sufficiently inventive? DCA was known to fix mitochondria in cells. But until recently, science had thought that the mitochondria in cancerous cells were permanently damaged by the cancer - unfixable. Dr. Michelakis went against conventional wisdom (that itself is an indicator of inventiveness - PLG Research v Ardon International, though that case is more useful as a critique of the Catnic questions; but I digress) and tested it, with fantastic results.
If he subsequently works to make a novel chemotherapy treatment, why should he not get a patent?
I get the paracetamol issue you raised. It does seem a bit off - why should a company get a “new” monopoly on panadol? But I believe that is the wrong characterization. I vote for the latter alternative (panadol for fever and panadol for cancer). They will most likely have different dosages, delivery methods, treatment stages, etc. They will be different enough that you wouldn’t want to take one for the other. Of course it’s a very different matter if the same 500mg oral dosage works for both cancer and fever; then the pharmaco is well and truly screwed.
I’m pretty sure an ingenious patent attorney can get that DCA patented. I’m pretty sure a pharmaceutical company with its massive deep pockets can fight out the whole thing so it keeps the patent.
But even if it doesn’t happen, there’re always non-profit ways. If DCA really is all that, no way it’s going to be “suppressed” for want of funding. And if it is not, well, it will just drop by the sidelines never to be heard of again.
Comment by Ray — Wednesday, January 24 2007 @ 12:20 pm
hmmm.. i’m not doubting that that the DCA will indeed be patented if filed. However, i do think it’d be granted by a sleight of hand.
“is the new use of DCA sufficiently inventive? DCA was known to fix mitochondria in cells. But until recently, science had thought that the mitochondria in cancerous cells were permanently damaged by the cancer - unfixable. Dr. Michelakis went against conventional wisdom (that itself is an indicator of inventiveness - PLG Research v Ardon International, though that case is more useful as a critique of the Catnic questions; but I digress) and tested it, with fantastic results.”
I believe you’re conflating inventiveness of step/process and current knowledge. For a patent to succeed, it must show an inventive step. ie. it uses some mechanism that no on has thought of before. Arguably, i would concur with you that in terms of pharmacological products, this inventive step would share borders with an inventive use. However DCA has all along been used to reactivate inactive mitochondria. It’s current use as a cure of cancer, is based on this known use. What is new however is the knowledge that cancer cell do not have damaged mitochondria, and thus can be reactivated. The new/inventiveness here does not relate to a use of the drug, but better use of a old drug due to new revelations in cancer cell study. Or to put thing clearer and more blunt, what’s new here is not the use of the drug (thought it might seem so, but note the way the drug works is exactly the same), but knowledge of cancer cells.
“But where the new use was sufficiently different from the old that its utility in that arena was hithero unsuspected, then there may be inventiveness in that new use.”
I totally agree with this statement, however i feel it does not apply here. I would think a new inventive use, would only pass the test, if it was sufficiently different from the old use. Note this does not mean if one is for cancer and the other for metabolic disorders, then that itself is sufficiently different. What sufficiently different implies in the way the drug works must be sufficiently different. ie. if DCA works by reactivating mitochondria (in metabolic disorder cases), but irt to cancer, it works totally differently (ie. not by reactivating mitochondria); then it’d be a new use.
“Of course it’s a very different matter if the same 500mg oral dosage works for both cancer and fever; then the pharmaco is well and truly screwed.”
That is what i’m trying to say with the panadol example. Which seems to me to be the case in DCA. Clearly treatment is slightly different, but would it be sufficiently different for another doctor not to be able to get cheap generic DCA and administer it to a cancer patient. By throwing in doses and administration process, the patent of DCA has turned into an application for the process of administering DCA. The drug itself will have remained unchanged.
“If he subsequently works to make a novel chemotherapy treatment, why should he not get a patent?”
I agree once again. and with this para, i perhaps understand where our differences lie. However i would note that even if a patent for a new chemotherapy process was granted. It would still not affect the production of generic DCA. DCA itself would not be under patent.
“I get the paracetamol issue you raised. It does seem a bit off - why should a company get a “new” monopoly on panadol? But I believe that is the wrong characterization.”
Why shouldn’t the company get a new monopoly? After all, it has found a new use for the drug. If it works in exactly the same way (ie. akin to the DCA issue), you seems to favor a new patent if a new process can be found. If it works in different ways, then clearly a patent can be granted, assuming the PO cares nothing about public policy.
Comment by ivan — Wednesday, January 24 2007 @ 8:54 pm
“However DCA has all along been used to reactivate inactive mitochondria. It’s current use as a cure of cancer, is based on this known use. What is new however is the knowledge that cancer cell do not have damaged mitochondria, and thus can be reactivated.”
Ah, yeah you hit the nail on the head with that one. I did indeed mush the two together. I still believe inventiveness can be fulfilled, since it does not matter where exactly inventiveness comes from. But I am unsure if what the good doctor did will suffice, so the case for patentability looks much weaker now.
I also agree that the ramifications of the drug being patentable would be rather odd, especially considering the treatment method appears - for now - to be simple oral ingestion.
As a solution, then, the researchers would probably have to find a treatment solution that would be different from oral ingestion, and also much more effective (than oral ingestion).
Comment by Ray — Thursday, January 25 2007 @ 12:57 am
fingers crossed they would be able to patent it. we all know how likely and generous gov and non profit funding is. if it cures cancer i’d put up with 40 (? rough figure from the top of my mind lol ?) years of crazy prices.
Comment by ivan — Tuesday, January 30 2007 @ 11:18 pm