This is of interest to me as I know an FDA regulatory lawyer. You’re not wrong that that big pharma is interested in patents, but that’s not all. They’re interested in things they can control. Patents were particularly valuable when the difficulty in drugs was in their formulation, but with the advent of biolgics, this isn’t entirely true. Biologics are drugs produced by genetic engineered bacteria, etc. Even after the patent expires, the ability to produce the drug depends on certain trade secrets (which are secrets that aren’t patented so the ability to produce remains a secret). That means that even after the patent expires, the drug can only be produced by the originator. If someone else does come up with it, the likelihood that it can be produced cheaply is very slight.
There’s already a brouhaha over how expensive patent-expired biologics. The generic discount is only about 15%. You can complain, but it costs what it costs because we have high standards for our drugs and we expect them produced and, even more importantly, sold without contamination.
I don’t see all the doom and gloom in big pharma companies investing in canna. They’re hedging their bets and getting enough vertical and horizontal integration so that they don’t get locked out of future markets. Canna is easily grown (relatively?) and would be impossible to strangle. So long as there’s growers like us, there’s hope.
My big concern is with the business model for big farming with companies like Monsanto where they produce seeds that can’t be crossed. It’s already hard enough producing feminized auto seeds. If those a-holes do the same thing to canna they did to corn, then it’s time to panic.
Well I agree with your big concern.
but of course the difficulty in designing drugs goes far far far beyond just the formulation. Formulations a small part of it. Sure sometimes something can be formulated in such a way to overcome since obstacle but reast assured there's a ton of hurdles in drug design.
It's the discovery of
1 a viable target so that activation or inhibition of said target actually achieved the desired result
2 synthetically designing a target molecule that actually hits that target as in it has sufficient potency cause let's be honest as you need to administer more and more drug to hit the desired level of activation/inhibition your also hitting all those off target pathways with more drug too.
3 having a target molecule that is bioavailable
4 having a target molecule that has decent ADME properties (adsorption, distribution, metabolism, excretion)
5 have reasonable animal models to prove that this should have desirable properties no off target effects IE it could be a perfect drugs in humans but if you can't prove it with a mouse rat model first your dead in the water end of story
6 designing a molecue that doesn't hit other targets or one that hits your target in such a way doesn't cause off target effects
Like Cyps issues or QT prolongation
7 desiegning a molecule that as your body metabolites it it doesn't create something that is in turn toxic even though the patent molecule was not toxic
8. Often times designing a molecule that can cross the blood brain barrier
9 on top of all that it has to be a novel molecule that has free IP space because if they can't patent it I can assure you they aren't interested in chasing it.
10 then it has to make it through the whole FDA approval process which I believe approx 10% of all candidates do on average.
My only point being it's not easy and they won't drop money chasing stuff they can't own cause they want to make money.
In the vast majority of cases at least with a medicinal chemistry department that means they want a patent if they can't patent it it's drop dead a done deal they won't touch it .
Once something's off patent and another company can produce it your big pharma companies are really not interested in competing they can't and wont. At that point Thier market share goes from block buster to diddly squat
I agree I don't see any gloom and doom regarding big pharma regarding cannabis honestly.
Now other big Business will no doubt .
Yes I agree biologics are tough and with that your looking at a different case.
I'm way way way more concerned with Big Business interfering cannabis. They're already into the industry up to thier eyeballs.
They can turn a profit especially in a market they can manipulate and control.
Wouldnt be the first time politics and big business went hand in hand.
I honestly truly believe if there's a threat to us being able to grow it's big business.
Epidiolex which I think started this subject (the drug approved to treat epilepsy) I think was given FDA approval in like 2018 and there is a patent which is right now being fought. They're fighting cause they want to keep that patent. They want that patent cause if it goes off patent they just lost Thier cash cow.
But they didn't patent THC or even CBD they flat out can't honest. I only say this so people don't worry. At least not about that .
Just my opinion but I really really agree that it's like your saying it's big business I'm worried about. Buying out senators or congressmen to get their way. Using local govt to over rule statewide efforts to legalize it (even ballot questions we won) until they're ready to profit big time off it.
Trying to roll back our hard fought rights to grow it. Cause if we're growing it they are losing market share.