Its incredibly interesting. Usually there is 180-day exclusivity for a specific “drug product”. And the patents only extend to the specific “usage”.
As the article says - this is a totally normal thing in pharma, I’ve had to deal with this a number of times.
Most generics start the process long before patents expire - because process itself can take YEARS. x.X So starting now, does make a lot of sense, especially for the tops generic producers that are listed here.
And I think there’s plenty of room to show that GWs patents are a bit strange, since almost all of what they say in their patents is about stuff that was publicly available information from lots of other sources. People had been using CBD to treat seizures for a long time - they just had not jumped through the FDAs loops.
Always nice to see what a patent battle between huge pharma companies will do. Their patents only go to 2035… which is AMAZING in itself - that just shows how much research they didn’t have to do on their own, because usually the patent would have started so much longer ago to get here. But they didn’t have to do that, they were able to get their product patented and too market in record time for US standards. -shrug-
Not that the Farm Bill will talk about this at all. GW Pharma was already approved to use this drug before the Farm Bill of 2014 or 2018. And their product will still exist with its special DEA limitations and FDA approvals regardless of any changes from the legislature. I suppose they could ban it outright, but since there aren’t any deaths or things related to it, I’m not sure that would happen (and that has only happened a handful of times in the history of the FDA…)
The problem with this argument is that hemp is excluded from the CSA and because it is you’re not able to use the Analogue Act as its part of the CSA and derives its power from the CSA
There’s a court case where a judge said this I’ll try and find it
Remember marijuana and synthetic thcs are scheduled any other form that falls within the definition of hemp wouldn’t be.
Another clause that would also invalidate this is in order for the Analogue Act to be used you have to be proven to know that the substance in question is in fact an Analogue. With the wording and definition of hemp in the farm bill you could easily argue you didn’t know something was an Analogue because it falls under the definition of hemp which is excluded from the CSA
Here’s one of them, good luck proving that a hemp derived product is a controlled substance when it falls into the definition of hemp and is excluded from the CSA
Which is why we hope that the Legislature in the Farm Bill of 2023 will be specific about the processing side of CBD manufacture. Because the USDA and DEA have not (although the USDA did all for expansion based on normal rules as created by States and Tribes).
But really that still doesn’t matter because the FDA has been very clear that there are no legal cannabis derived additives. And they have started enforcing those rules at this point. So that too would need to be changed - even if there THC free hemp available that could be concentrated down without going over the limit. What would you do with the materials? Nothing legally right now - not even animal feeds.
So that needs to change. And I suspect it will change. Whether it changes to allow more things or provide more limits, so we only have industrial hemp is up to the legislature.
So call them and write them and let them know what you think and how these changes impact your businesses!
FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward
How current FDA rules impact your business positive or negative.
If you are multi-state how different state rules impact your business
If you are plant-touching how rules on testing impact your business
If you are a processor how mishmashed rules impact you
Its awesome to have real life examples to bring up with these legislators and their staffers. If you really want to be pushing specific kinds of legislation or regulatory change, feel free to reach out and we can talk about those.
But honestly - just hearing that what you have is not currently working is HUGE. The more people who talk about the impacts to their farms, families, companies, the better. Especially if your congressperson or senator is on one of the Ag committees.
I had not expected negotiations over SNAP to be part of the debt ceiling debate, but they might be. Time will tell if they get that argument done before the farm bill debate or not.
He’s trying to claw back like +100 billion in spending. Like so much. Even to things that usually get fully funded (like our troops…)
Its kind of crazy I think. SNAP was discussed last year in the Farm Bill hearings, it had its only like multi-month panel.
The crazy part, to me, is that they all pass these bills. And then they decide not to fund them. Its like why pass the bill if you aren’t planning to fund it?
Still crazier to me is… how the fuck can anyone even think about not taking on more debt to pay back the debts? I mean… we all know what would happen to any citizen if they did that. Bankrupty, inability to take loans for almost a decade, loss of almost all assets except those to live.
And in cannabis even worse - you default on cannabis stuff and you lose EVERYTHING and get garnished wages and maybe go to jail (cause some states are fucking terrible about not paying “court fees”). Because you don’t have access to bankruptcy protections.
So for “the government” to be like - let us discuss if we will pay our bills or not. x.X just mind boggling.
You were willing to spend the money on war and tax breaks and all kinds of other things. You don’t get to decide not to pay for it now…
I mean I suppose they could - but what kind of stupid fuckers are they? Borrowing trillions of dollars, spending all of it, and then thinking about not paying it back even though they have the means.
Crazy shit. Even when they decided they would have the spending cuts for 10 years (which then they wiggled out of to give tax cuts…) it never really worked. What are they trying to accomplish? Even if we had a budget surplus - we’d still have all the debt accrued for the last 230 years… it doesn’t go away just cause you have more. And then people freak out and want you to give them more tax breaks (which they almost always do…) and then you are in a deficit again - even though, you already have the debt.
But maybe they just don’t have good skillz in the mathz. itz possible. i suppose. -shrug-
That’s pretty much what drove my mom to have a breakdown and retire from the state senate, the budget committee nonsense. I couldn’t imagine the fuckery going on at the federal level. And we can’t realistically do anything about it as citizens. Nobody’s going to try to overthrow/overhaul the US government.
the public dollars initially designed to protect farmers and keep supply managed to feed a hungry nation in the Great Depression are now reinforcing wealthy agribusiness corporations to grow commodities that are not even meant for human consumption
I think this is really a lost point here in people talking about the industry being “stifled”. What is the realistic CBD demand in the US? Even if it were universally allowed in food, beverage, and supplements, would people really consume all that much more of it? The amount of hemp grown in the early days was way too much. That level was never sustainable. I don’t think there’s any law anyone can pass that will make that much production make sense…
