This is all clear, but my question was about the legal status of GDF11. And I'm asking what is the ability for multiple firms to manufacture it and compete on price.
In the end, if GDF11 by itself doubles lifespan and increases healthspan by 30% for people over 40, then we won't need to understand any other issue for it to be beneficial. If we evaluate safety and cannot measure any increase in cancer or other diseases, understanding that bottom line is sufficient. It would be nice to understand the mechanism, but understanding the mechanism isn't required to realize a benefit.
The legal status of GDF11 . . . No one here can give legal advice just so we are clear.
I suppose as you pointed out it's a naturally produced protein. There are now legal limitations on what you can control if it's a natural substance. I'm pretty sure it can't be patented for exclusive production. You could likely make and sell the stuff if you don't infringe on any one's production patents. I say this barring any liability you may encounter from its end use from potential customers, which is also a concern. I find prior art dating back to Nov 1, 1978 but most of the original patents cluster around 1994-1996. More recent patents are trying to corner its medical applications.
Is there a market? Sure, I already see one developing.
Is it safe? That has yet to be determined and safe at what dosage? It's likely safe, but what kinds of health problems could cascade from its use if a realistic dosage is found?
There are no clinical studies yet to determine the pharmacokinetics. Not knowing the related clinical factors who would invest in large scale production of the substance at this time, especially if they couldn't control and license its production and didn't know all its health liabilities. Today we are just starting to see the possible benefits, everything else is speculative. These are the factors that control commercialization and later the competition you mention. Determine these variables, the size of the geriatric market who might buy and all hell could break loose, if there isn't a health down side.
I think what will happen as more data is accumulated and the buzz increases is someone will create a black market in this substance. Someone may be already doing this. However, you could be buying expensive saline solution or something worse? You can buy it for yourself today, but at expensive micro lab quantities.
That price is coming down slightly, when you see things like this on a retail website like Amazon, you know there is a real consumer market for the stuff. RayBiotech is likely capitalizing on the buzz but I don't think the dosage is high enough to likely produce beneficial health results.
Then there is the flip side. If you have the money, for all I know you might, why take a risk. Just pay college students or unemployed 19-25 year olds for their blood plasma. Sounds gruesome, but I can almost guarantee someones doing it, doesn't take much imagination to see that. It's already happening in a clinical setting "The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study"
Its likely Pharmaceutical companies will research a modified molecular substitute they can control and patent. Or they will devise other drugs to stimulate the production of the protein.
Those are the basic talking points considering the realities.
Personally, I'd like to see its availability increase and at first blush it looks relatively safe. I think other medical approaches may need to be combined or you may find yourself on a capsizing ship. niner mentioned Systemic Amyloidosis as one example and if this was my only concern I might roll the dice on that one. Still misfolded proteins are nothing to laugh at and they lie at the root of other illnesses. As I mentioned before cellular maintenance, NAD levels and as researchers are suggesting mitochondrial health may help correct these problems at the root. Plus you'll need a heathy immune system to reach those later years.
Edited by Bryan_S, 14 January 2015 - 07:14 AM.