Hi, I'm Ethan Nadelman and this is psychoactive, a production of I heart radio and protozoa pictures. psychoactive is the show where we talk about all things drugs, but any views expressed here do not represent those of I heart media, protozoa pictures or their executives and employees. Indeed, as an inveterate contrarian, I can tell you they may not even represent my own, and nothing contained in this show should be used as medical advice or encouragement to use any type of drugs. Hello, psychoactive listeners. So today's subject is the issue of psychedelics and the law, specifically psychedelics and Intellectual Property Law, the issue of patents. His name is Graham Patch Nick. He's an attorney in San Francisco. We founded a law firm about six years ago called Kalix Law, C A L Y X, but he's been working in the area of patent law now for a couple of decades and a whole range of industries, the marijuana industry. Uh So, Graham, thanks so much for joining me on psychoactive. Thank you so much, Ethan, for the honor of being here. It's it's really enjoyed to be able to participate in your podcast, which I've enjoyed for so long. Grandma. Want to start off by sort of placing the issue of psychedelic patents law at the intersection of two things. One the broader issue of patent law, which will get into broadly because obviously in many respects the issues that are emerging in psychedelics patent law are just emblematic of the broader issues and challenges and problems in broader patent law. But it's also at the intersection of Patent Law and of PSYCHEDELIC law, and there's now a psychedelic law association. I think they just recently had one of their first meetings in September. And so, apart from patent law, what are the other issues in psychedelics law? I mean, I go back to thinking about those initial religious freedom cases involving the churches that we're using Ayahuasca, the UDV and the Siento dime. But apart from that religious peace and the area you're working on especially now, what else lies in that field of psychedelics law? Well, that's a good question, and so I say there is the Psychedelic Bar Association, which did just have its first psychedelic laws summit, which had over three dozen lawyers who have an interest or some bit of a practice in psychedelics. And there is also actually, where I am a California psychedelics Bar Association founded by two psychedelics General Council of two companies. In terms of the amount of work actually that people can do in terms of a focus, I think you're right to call out the religious freedom restoration act and work around there, because for many years that, I think, was the predominant area. Or if somebody was interested in psychedelics, law could work in and I think up until really I've had the great fortune of having this niche and psychedelics patents there haven't been all that many and certainly not ones where one could make an entire practice or the entire focus of a career on psychedelics. And actually there's an article that just came out recently by Matt Zorne, who I worked together with on a challenge against the D a. The challenge against the D A was one way we could get involved as lawyers who are interested in psychedelics. So the DA had proposed to schedule five psychedelic trip to means and because Matt is a really good d a lawyer and I had an interest in psychedelics. We joined horses, along with some others, to challenge that. I actually was reading that article that you mentioned, Graham, by Matt just last night and prepping for our discussion where he talks about the case, about the D E A. I mean we've so long seen the D e a as the bad guys, you know, trying to throw things into schedule one without any proper, you know, do process as her hearings. But this more recent case where the D A targeted these five trip to mean is a certain class of psychedelics and say they want to write the schedule one. I remember Hamilton's Morris, you know, who's one of my guests on psychoactives, sounding the alarm he emailed made lots of other people, got a lot of people mobilized and then I think Matt played a key role, with assistance from you, in challenging this, hopefuly beating back the d e a uh and forcing them not to throw these things into schedule one. So wonder if you could just tell our listeners to things. One, what was special about that fight and secondly, do you think it's going to have broader implications in terms of how the D e a views other psychedelic substances in the future. Sure. And so your first question, what do I think perhaps was special about that? I think what was special really was the just artillery, so to Speaker, the you know, the amount of work that Matt in particular brought to bear to this challenge. And so Hamilton Morris, as you mentioned, was involved. There was another company, Pantasy of plant sciences, and their CEO was very interested in this and it's spent a lot of effort even before this had filed against the DA. And then we had declarations from uh for many experts on the really everything from the fact that these particular compounds, we're not ones that had any evidence of abuse and didn't pose any threat of safety issues or any risks, and the D A's evidence that dad was over a decade old, from a report from around Um long before this the current wave of psychedelic research and the PSYCHEDELIC grandis songs. But Graham, why, why were they even bothering to try to throw these five substances, and I mean was there was there any evidence that they were being misused in the broader public. Yeah, that's a really good question and it's not really something that we were able to very easily figure out. I mean, the reason they had this ten year old report was because back in the ats there was something called Operation Red trip where the d a went after the vendors of research chemicals of different trip to means, and it looked like although they had went back then to go after some of the ones that had broader use, these sort of were left out because I didn't really have that many reports of use and the only deaths that were on record were poly drug abuse and involving other things. But that, I think, still kind of remains a mystery. What actually uh initiated this at the beginning of the year. So in terms of you were able to beat them back. Do you think it's going to impact how the D e a operates in the future on other novel compounds, especially psychonoloic compounds? Yeah, I mean I think that's really a big open question and so this sort of first way we thought about trying to see if there would be any evidence of an answer was with the second challenge there was to the d a. So just after the d a proposed schedule these five psychedelic trip to means. The D A also proposed to schedule too psychedelic finela means, D O I and D c. both, similarly to the five trip to means, had had very little evidence of abuse, almost none. D O I, however, is something that's in hundreds, if not thousands, of publications as a standard in research because it's such a good serotonin receptor agonists and because it is unscheduled, it's it's very easy to work with, and so we were looking out to see if the D A's proposal there would would go forward, and actually they withdrew that one as well. So it looks like maybe with psychedelics there might be some leniency, but I think with both they basically didn't say they're they're done entirely, but just that they're going back to the drawing board. So just briefly explained to the audience the difference between the two categories of substance. Yeah, so the difference between the two categories is based on the chemical structure, the chemical backbone, or scoff hold is some as some call it, and TRIPP to means have a chemical backbone that's the same as Serotonin. So serotonin actually is for hydroxy, tripp to mean. And so you know, we think of a lot of psychedelics we know with perhaps tripped to mean in the name. So die methyl trip to mean or five methoxy trip to mean Um, and so these are all tripp to means. LSD, for instance, is generally classed, or can be as a trip to mean. It has a more complex structure. Um. Even Ibagaine has a trip to mean or Indole core as part of it Bein ethyl means. Are Compounds that are like mescaline or or M D M A, or have a scaffold that's like an amphetamine Um, and amphenamine actually stands for an Alpha methylamine. So these all have this finethylamine core which is more like the dopamine neurotransmitter. So now let's just put this into a kind of a little bit of historical context with a with a couple of the most famous names and psychedelics creation. Right. The first one is Albert Hoffman, who was working at Sandaz and sort of discovered or devised, however you want to put an LSD during World War Two years. So Hoffman and Sandas did patent those things back then. Right, those who were among the few patents in this area for many decades. Is that right? That's right. Yes, so after Albert Hoffman received samples of Psilocybin Mushrooms, actually from Gordon Watson, from the same area where Gordon Watson went and had his the first time, Um, Albert Hoffman and sandals filed patent applications on the the isolation of PSILOCYBIN and also its use as a tranquilizer action. But were there many, many more psychedelic patents back then, or were these really sort of standing alone? For some decades these were standing alone, and many people, of course, will know, and with Pikel and Tiko, that there were, how underds just in those books that were developed by by Sasha. Well, I mean you're jumping to my next question here, which is, did Sasha Shilgan ever seek or get a patent for any of his creations, or do you know, did he deliberately choose not to, because those two books, pe call and tea call, which are essentially recipe books for hundreds of these substances, put it out into the public domain and I guess that presumably means they can't be patented in the future, at least with the ways that he used to synthesize them. But what do you know about Sasha's history visa the patent? was He ever ever seeking in that area or did he deliberately abstain from seeking that? That's a good question actually. Interestingly, part of the reason, I think Sasha was even able to do the amount of chemistry that he did relating to psychedelics was due to the fact that he had some very successful patents that he filed when he was working at down and those patents earned so much money for the company that they gave him a little bit more free reigin with his laboratory and allowed him to pursue some other interests. In terms of his interest, though, filing patent applications on his own. I think it's a little bit unsettled, but there's a great article by by Matt Baggett about this and from what we know, he did actually file a patent application on one trip to mean, I think it's off a methyl trip to mean, because he saw a commercial market for it actually as a stimulant, I think, for older people. So I don't know that he was constitutionally or philosophically against patent applications or filing patents to protect work. I think perhaps he just didn't see that there was a commercial market for a PSYCHEDELIC. Well, what about something like two C B? I mean that's, you know, while bigard is one of his major, you know, concoctions. Um. But I presume there is no patent and presumably can be no patent on two C B, since it's been in the public record now correct. So I mean anything published in Pikel and Tekel, anything at all. It's the chemical structure itself disclosed to the public. That's something that can't be patented itself, the structure at least. So perhaps we'll get into but but of course, and not to jump ahead, but you know there are patent applications filed on Psychedelics, even known psychedelics. So the fact that just the chemical compound can't receive protection for it alone doesn't mean that it can't make part of a claim on something else that involves it. So a different method of synthesizing it might be able to get patent protection. Sure, a method of synthesizing it, maybe even a different form of it. So maybe now to jump ahead. But so there are some applications that are perhaps the most well known in the space that covers psilocybin, some of the first to be published, some of the ones that have probably received the most conversation around them in controversy, and they cover psilocybin in a particular crystalline form. So it's not psilocybin, just a chemical structure, but it's the way it is when it's part of a for instance, you know, a drug dark when it's mixed with an excipient at a certain purity and in a particular crystal instructure, as somebody would receive it if they got it as a prescription medication. So, Graham, why don't we just go directly there then? So, I mean the case that most people have heard of who follow this even tangentially is the case involving compass right, and compass is, you know, one of the biggest and most prominent the cycle of companies, was founded by the Goldsmith's, George Goldsmith, and his wife, and he's taken, you know, a fair bit of Flak Um Really, I guess, for two things. One is in seeking successfully getting a patent for a particular formulation of Psilocybin and then secondly, for you know, being highly ambitious aggressive in trying to get patents for all sorts of things associated with the administration Um of Psilocybin to treat h chronic depression and things like that. So maybe just explain to our listeners more about that controversy and it's significant. Yeah, and so the controversy on the patents, I think, is difficult to view outside of all the ways that it is impacted by the broader controversies around compass and compasses investors like Peter Thio and their long history. So I do think to some degree the controversies on the patents are inflected with these broader controversies around how they moved from being a nonprofit to a for profit, how they obtained information under the guise of what people say saying they were at first a nonprofit and speaking with Mak any academics who gave them information on on friendly terms and then perhaps were tried to be held to nondisclosure agreements, and how the company itself at one point allegedly try to make it more difficult for its competitors to get access to synthetic Solcibin to do research and a number of other things. I think that in pact the patent controversies, the patent controversies themselves, there's really two types of patents that they've pursued. One have been primarily on this psilocybin crystal inform, this polymore for polymore of a as it's described in their applications, and the other has been an application they've filed that published as a pct application that did contain all these aspects of the type of psychological support a patient would receive and even qualities of the room, the soft furniture, the high definition sound system, um. But it did cover these interactions with a therapist, like hand holding or the therapists putting their hand on the shoulder of the patient and things. That seems clearly to be part of what would expect perhaps in psilocybin therapy and part of what one would expect perhaps not to be things like be protected by a patent. In any event, I mean it sounds like total huts, but I mean the hand holding, our soft furniture or their sound stuff. I mean that's so inherent to the experience that why would they even think to include that stuff in the first place? Is it just a broader notion that we're getting a patent. You sort of throw everything against the wall and see what sticks or or isn't there an element of embarrassment about going that far? Yeah, yeah, I mean I am actually surprised of anything and I don't know what was encompasses minds when they filed this. So I can only sort of assume, based on my presumption of how most Patent Attorneys Act, I would be surprised that they didn't spend the effort to call through their patent a little bit or that that claims to see what might raise these controversies. But it is fairly standard practice when filing a PCT application to include often several hundred claims and there's no additional charges for those claims. Like there is a national examination and there's there's no real downside to shooting them and so oftentimes everything that's described in an application to some degree will make its way into a claim and there may not be in the end any real desire to pursue those things. Perhaps the company wants to get an opinion. So actually, as part of the PCT process, the applicant will get a preliminary opinion from a PCT examiner. You're using an acronym. There was it pct. So pct is a acronym that stands for the Patent Cooperation Treaty. So it's a treaty that has now a hundred and fifties seven, I think, members. It's basically a treaty that allows anybody to file a single application, that's the PCT application, and then have up to thirty months from the earliest filing date to decide whether to enter any of those a hundred and fifty seven member states individually. And so the benefit of doing that is if you want to file and multiple applications, you know that's going to take a lot of expense to to translate your documents, you'll have to pay lawyers to be your agent and each those different jurisdictions, and so if you had to do that all at once, but how it would be a lot of upfront costs which in the end you may decide you don't even want to pursue it, depending on how your drug development and your research is going. So this sort of provides an ability to file a single application, get that preliminary opinion and hold off on some of those costs to see if, down the road and in thirty months. However, it takes whether it's even worth filing in those different jurisdictions. So are most patent applications in the US simultaneously PCT applications, or do people make a judgment and it's only apply in a few cases? Sometimes people, if they want to accelerate their patent grant, they might file both in the US and the PCT simultaneously, or sometimes will enter us or another country early and not wait the full thirty months. It really depends on the technology. So you can imagine in a fast moving technology like the invention that has to do with your smartphone, somebody might want to get the patent granted as quickly as possible because the value that application and the value of that invention might not even exist five years from now. With something like drug discovery, you might not have a drug on the market for seven years or eight years or longer, and so you don't really need to worry about having something that you can hold against a potentially infringing competitor for for much longer. Now. If if a company that did not have some of those negative associations you describe about compass in terms of their investors, in terms of, you know, having first been a nonprofit and taking advantage of that to give them an edge up as they became a for profit company. Would there have been as much controversy you think about them seeking and getting a patent for this other way of Synthesizing Psilocybin? I think there are probably some other reasons besides just those you mentioned about the other ethics perhaps of the company. I think one of them may just have to do that they were really the first company that had a published psychedelics related application, so most of the attention when it came was just directed to them, as people were surprised to see something filed on a psychedelic. I think another ask to do with the fact that it's on Psilocybin and so many of the patent applications on new chemical quantities, on on different types of psychedelics. Perhaps had Sasha Shulgun filed them on to Seeb when he first invented it, or another psychedelic that had never been before known, those might have less, less controversy. With psilocybin in particular, we know, of course, not only was it discovered, I suppose, by the West with with Albert Hoffman, and then patented, but it's been used in traditional and indigenous ceremonies and uses for centuries or millennium even, and so those aspects also caused another layer of controversy. We'll be talking more after we hear this ad when people talk about what are the first substances that are going to be approved for treating uh, you know, different types of mental illness, people topically typically talk about m d m a and the process that the organization maps is pursuing to get approved by the FD A, hopefully later this year next year. And the other one is the process being pursued by compass to get psilocybin approved for treating, I think, uh, intractable depression, and the argument by the Goldsmiths and others is that if we did not have a chance to patent this synthetics Um Psilocybin, then we, quite frankly, could not raise the money to go through the entire approval process required to get psilocybin approved for treatment in the first place. So what's the response to their argument? Well, that is definitely the argument that is always used by pharmaceutical companies and a big part of the controversy around compass also is the fact that there were other companies also pursuing psilocybin, like you SONA or clinical development around the same time, and there are concerns that by filing these patent applications, compass may preclude others from even continuing to do the work that they may have started the forehand, and precluding other companies from their work and bringing psilocybin also to patients. And so I think we can also perhaps look at maps, as you mentioned, as alternative models to being able to bring a drug through the FDA approval process without patents, although maps is also relying on something called data exclusivity. So data exclusivity is a regulatory benefit that when a company is first to obtain regulatory approval for a compound before anyone else on that compound, as maps would be with M D M A, that company has given five years or perhaps longer, to be the exclusive company to sell that compound before others can rely on its regulatory data to also seek approval. And so that does give maps a period of time which will be at least five years. Two gain back the type of profits that are argued to be necessary to bring the drug through drug discovery, although of course maps also relies on philanthropic funding to have gotten the drug to that point, to be able to get that data exclusivity. I've had Rick Doublin on and so you know, obviously we look at with the maps model where they set up to nonprofits that sets up what's called a public benefit corporation in order to market M D M A and M D m a treatment once it's approved by the F D A, with all the profits going back into maps, and then maps pouring all those profits into further, you know, good cluset right, psychedelics, uh research and even into broader drug policy reform. I don't know if it's an optimal model, but we see it as one of the best models out there. Conversely, we look at a thing like compass, which is essentially a for profit company, you know, with obligations to its shareholders and produce your obligations there. Um See, you know that that, even though it's going to be producing something that's valuable for humankind in terms of Psilocybin being used to treat intractable depression, ultimately there's a bottom line profit. Saying. Now there's another entity, activists in all of this. There's an or of nonprofit called freedom to operate, which was started by one of the major philanthropists in the psychelics area, carry turnbull, and freedom to operate was really set up to kind of prevent for profit companies from taking advantage and using their finance and power to block others from getting involved. And ultimately they spent a million dollars or more to challenge compasses effort and ultimately they failed. Compass prevailed and I'm sure is did you think that freedom to operate was going to succeed, Um, and therefore surprised if they were not successful? Or why do you think compass did prevail in the end? Well, so I wasn't terribly surprised. It's, I think, a result more of just the nature of patent law. The compass has quite narrow claims, even though they've been often described as really blocking the field. Quite narrow claims on this specific polymorph and there they are drafted in such a way that it's quite difficult to have evidence to show that anything before there application was filed would be the same as what they're covering Um, and so that's, you know, sort of just a trick of their patent drafting and a trick of the way that the patent system itself operates, and so I don't think I was surprised at the outcome of the case. But, you know, I certainly do see the you know, the concerns around the fact that there, of course, we're forms of synthetic Paul cybin before and there may be other forms of synthetic pulcybin that, even if they had been produced before and in use before, they may now infringe compasses claims and so to the degree they would be able to keep a competitor from being able to market their own sulcybin products. I do see that that's a concern. So Great. Let me circle around in it from a different angle on this in this case, you know, I had a while back Leonard Picard on psychoactive and as many of our listeners know, you know he is regarded as one of the great underground chemists UH and produces LSD. In the late twentieth century he spent a couple of decades in prison and fortunately got out. But when he speaks about the underground, the Brotherhood of underground chemists and he and others creating you know, they're unique types of LSD. You know, were these things that potentially could have been patented if these guys had wanted to go through that process, notwithstanding it's illegality, were they likely doing things that were sufficiently unique in terms of the way that they were synthesizing or making the lst that would have been patentable? Well, that's that's a really good question. I mean how unique they were. I guess I'd have to talk to Leonard to understand the, you know, the steps of the process that allegedly he was pursuing, and certainly I don't I don't know enough about the chemistry to understand if it was something that was patentable. Um, in terms of whether the patent office might grant a patent on it, I think because of the fact that many of these processes were not published and we're not included in any prior patents, the patent office generally, I think it's perhaps safe to say, could have granted patents on them, and so there is a bit of a disconnect there in terms of a patent to be granted has to be something that's novel and inventive, but the patent office to determine whether something is novel and inventive really just looks at higher literature and some of the peer of viewed literature and some of the places that are more obvious to do research, but it certainly doesn't look to see what people are doing in the underground and even today might not look at things that one might see as obvious, like looking on Uh errowit or blue light or a forum, UM, looking on Reddit, even doing a google search. M You know, actually there there's a case. I mean you used a term of art in the patent law field, prior art, and and I've oftentimes read about the infamous example of the D Mt Vate Pen uh and it sounds like that's a pretty good example of one of the major problems, not just in the psycholical area but the broader pattern area, that we now have a federal pattern office which has existed for two centuries. I mean pattern law is in the U S constitution, but where it's overstaffed and undertrained. So just tell our listeners a little bit more about that d m t U Vay pen and why it stands out there is an the apple and what's wrong with the system. Yeah, I mean that example I used generally just because it's it's very easy to see how the patent office in this case just completely missed the prior art and it's a really good example using it again. So the prior art is a term of art. I suppose. The prior just means anything that's public before the date that the patent application was filed. The main part of the patent examination process is just for the patent examiner to look at the application and in particular, the claims of the application. So the claims are what the applicant rights to say this is what I should own, and it compares those claims to what's in what's called the prior art, which just means everything that's public before the patent was filed, so everything that was basically in the public domain. So, for instance, was something like a vape pen. The patent applicant will draft a claim that will say a you know, a device for vaporization that contains a chamber with a liquid for vaporization, with a chemical compound like D mt, and then the patent examiner will take that claim and say, well, has anybody else ever done this or describe this before, and then it will do a search and then it will see if somebody has if somebody has and will project the claim and then the applicant will come back and say, well, but they didn't do it quite like this or the way I'm doing it is a little bit narrower, or they'll say no, you're you're misreading with the prior art says and actually it says something different. Um and the patent examination process might take four or five years or longer, with three or four or five different times going back and forth in writing or sometimes with phone interviews between the Examiner and the applicant to decide what's in the prior art and what's being claimed and to try to narrow the claim so nothing in the claim is covered or covers what's in the prior art with this d m t vapen. So the application covered basically D M T vapens. They're very broadest had figures which were pictures basically of, you know, what you would imagine a d m t vapen looks like, the same way you know a cannabis vape looks like the kind you can buy the dispensary. Um and the patent examiner did a search and it looked at prior patent applications and then it did a search in a particular database of chemical abstracts from the just scientific literature for less than seven minutes, because everything is on the record. So you can see the search terms they use, you can see how much time they spent, you can see the databases. They looked in Um and they searched for a few terms like dimethyl trip to mean, but they didn't search for d m t, the abbreviate just to letters. They didn't search for Vapen, they didn't search for Google and because of that they missed the fact that the few months prior to the application being filed there was a whole double blind article on d m D v Apens with many pictures. It looked just like the pictures in the path an application. UH, several years before that there was an article by somebody, Lester Black, who wrote all about D M T v APENS and actually wrote about how he receives some copies of D M T v APENS and describes him in the article Um. Coincidentally, D M T v APENS. That actually, I believe, came from David Heldre, who, David Heldreth, has talked about this. So I don't think I'm revealing anything offered controversial. Actually say tell our audience who David Heldreth. So David Heldreth is the CEO of Pantasy Plant Sciences who he mentioned, who was the sort of thorn in the d a side, who may have been part of the reason why the d a had been thinking about these particular trip to means when they decided to schedule them. Um, just a sort of small world coincidence in terms of getting back to the DM DV apens. But in any event, because the patent examiner didn't do a google search, didn't search for vapen or for D M T, they decided that this was a novel and Inventive Uh invention and they granted it patent on it, and the patent covers any d m t vapen that you would see and can that pattern that will be reversed. I mean now that there their mistakes are become so publicly known, it could be Um, the you know the the type of effort it might take, but it hasn't been. No. So somebody could do what for him to operate did as you mentioned? I don't think it. In this instance. It would costs a million dollars, but it is quite expensive so it's over fifty dollars just in filing fees to the patent office two challenge a patent after it's been granted, Um. And of course that's before you even pay for for lawyers and in many instances you probably have to pay for an expert to submit an affidavit Um and gather other factual information. So it's, you know, a bit prohibitive to be able to challenge patents after they've been been granted. And so you know, the D M T v APEN has, you know, it's not not necessarily the example of the most valuable patent that's out there, but it's a an easy example to see the way that the patent office can miss things and in this way of missing things because of, as you mentioned, that the Patent Examiners are typically overworked. Um. There's actually a bill pending right now by by two senators, Leahy and until us, to try to give pattent examiners more time. They don't always spend as little as seven minutes, but they don't generally spend all that much time and not enough time because of the way they're rewarded up for just moving quickly through applications, and so this means that many patents get granted and many of those granted patents can end up being asserted against companies who could have been doing the same thing they were doing even before the patent was filed, and so this is often kind of wasteful litigation that it's taking away from real innovation. One thing also, I mean I know you worked in, Uh did a fair bit of work in the area of marijuana law and patents before you jump more fully into the psychedelics area. And I saw that one of the CO founder of Compass, George Goldsmith, was quoted as saying that when he it started, one of his models, his role models, was GW pharmaceutical, you know, the UK firm which I think was the first to get approval and get a patent for its Um you know, it's it's version of medical marijuana. So can you say a little something? Why would why would George Goldsmith, ahead of compass, have looked to g double pharmaceutical and what was the significance in the marijuana field? Um, well, it's a good question and actually I should say I think even my start to a large degree was because of what G W Farma was doing in that a lot of my early clients in the cannabis days before I started working in Psychedelics, was because there are many companies that were looking at what Gw was doing and and seeing that was a way of raising money to to try to bring other canabinoid based medicines to to market through the FDA approval process. But what Gw Farma did was file many patent applications. I think they have several hundred on purified forms of CBD and and all the ways that CBD can be used in different types of treatment. GW has patents covering CBD for just about everything you can think. So in terms of this industry now, I mean look, obviously when when the companies are engaged in trying to come up with truly novel products, right, new psychedelic substances in the way that Sasha was creating in his backyard lab UM, or if they're trying to create a new version of U, say AAHUASCA D Mt Without the nausea or a shorter acting thing. I mean there are some people who are out there just saying hey, leave nature alone, we got what we need. We don't need new synthetic creations but I think most people would say no, you know, uh, individuals, the companies should be free to try to create other novel psychelic substances that may be enhanced the benefits of what nature has already produced or reduced the downsides, or that can be more efficacious in various ways or more naturally tailored to treat certain conditions. Right. But what we also know is that, whether we're talking about the psychedelics are almost any other here, that the vast majority are not really about that. So I was reading recently, I don't know when exactly this piece was written, but it said that if you look at the top five public psychedelics companies by market CAP, so a Thaie life sciences, which invest in a range of other companies, compass, which we've talked about, mind mead, which you've mentioned, and also G H research in Cybin, they've already submitted or owned the rights to at least a hundred fifty seven patents, with undoubtedly hundreds more in the pipeline. So what I'm curious there is that, I mean, is this all sort of, you know, ultimately going to turn out? I mean, whatever value added it happens here. I assume that most of these are not novel products. A lot of them are all forms of administration or you know synthesis that are not all that crucial to the advances. I assume that many of them their market cap value is based upon how likely they are to get a patent and that's primarily what's drawing, you know, driving them. So I'm wondering, are we all headed in the wrong direction on this thing, or is there any collaborative effort among the leaders, the for profit leaders um together was say, Rick Dolbin's maps or or carry Turnbull's Um Freedom to operate? So two part question. Is it all heading the wrong direction and is there any collaborative effort to try to write this? Well, yeah, those are really food questions. I mean I maybe I'll start with the second because it's the easiest one, because it's just the answer at least, is I don't know, and perhaps I don't think so. I mean I certainly think that there could be ways of collaborating, but just in terms of the way the system is set up and that this is not something about just perhaps psychedelics, but just about the you know, the way are are just corporate ecosystem and broader capitalist system is structured. You know, I don't. I don't think these companies are necessarily going to pair with AH nonprofits and and and try to work together. I know that their investors would want that. Um, maybe to answer one thing just that you didn't ask, which was just about the number of patents. I mean you're right to call the very large number of them, but I think part of this is just because with any even individual drug there are dozens, if not hundreds, of patents filed on just like a single drug. So I don't think all of these will reflect necessarily novel compounds or novel ways of really doing things. In terms of our we all pointed in the wrong direction. You know, I often go back, um to something I heard at horizons, which was Joe Green at the Business Day saying that in Oregon it costs five and a half million dollars to bring measure one o nine through, and I don't know what it costs to get measure one tent through, but I know I would imagine it's something on that same order. Now, if we think of all these companies, and by the way, for our listeners, one oh nine, Um was was the initiative in Oregon to legalized psycholic therapy. And the one ten is the one that was D by Drug Policy Alliance under my successors, together with allies in Oregon, which is essentially a Portugal model, the all drug decrim and a siphoning money over to treatment for addiction. So yeah, right now and that you're good to describe those. So yeah, so obviously one to measure to get drug or PSILOCYBIN therapy legalizing and one for decriminalization, and both just in one state, in Oregon. But let's say even together it was, you know, it's something on the order of ten million dollars. And so calling this out to say at Horizons Um that you know the amount of money that's raised by all of these companies, so g h Pharma, Atie, compass, mind met the others, many, many orders of magnitude more than ten millions of ten million dollars. So are we pointing the wrong direction? Maybe the question is, is putting all this money in drug development, in patent filings? Is that going the wrong direction? Mean what would all this money do if it was put into drug policy or form into a to decriminalize drugs at the state level? And to attempts to provide other legally legalized, regulated Um ways to access psychedelics, like what measure one on nine is going to do an Oregon Um. And so, you know, it's a question, I suppose, of just kind of priorities, um, but but it is something that I think, uh, depending on, you know, what what you see as being the sort of ideal orientation for a future psychedelics market, that perhaps we could be pointing away from it. Because what I worry about old say is I look, you know, another issue that I was involved in deeply was the one around overdose and making the locks zone more available. And that, you know, the lock zone was patented, uh, I don't know, sixty years or so by Jack Fishman and a few others. It was not a big profit thing that patent ran out. But then you have one company that comes along and produces a nasal spray version and another one that produces an auto injective version. So they're making a little easier for people to administer and then they do everything possible to try to block others from coming into that. And the face of a massive over those fatality crisis, you know, we have these products of Deloson, which has cost pennies or maybe dollars to make, but the products are being sold for, you know, you know, tens of dollars, if not hundreds of dollars. And so is that a risk in this psychedelics area, in the psychedelic Strap Ay area, are we going to see an issue where, in fact, some of the first companies to succeed in getting patents land up blocking significant innovations and reductions and cost in the way that we saw happen, for example, in the the loxone area? I mean, I definitely do see that that's a concern and that really just is the way the patent system plays itself out. The benefit of the patent to the patent holder is that they can set prices however they want. That's the monopoly power that the patent gives them and I think in just about every instance with pharmaceutical drugs, they tend to go up in price as the patent life goes along because the company has the ability to set those prices on their own. And so I mean to myself, this is something I'm very sensitive too because as a type one diabetic, I use insulin and insulin I think like a Oxon very famously was was patented many, many years ago, and actually that the pattern was sold to a university for a dollar because the inventor wanted insulin to be broadly available. And people now, a hundred years later, still might pay over a thousand dollars a month for it Um and so similarly, I think in the pharmaceutical space companies know how to play these games with their their patents, to extend patent life and patent protection, to find ways to patent tweaks to a molecule or delivery device or a way that it's being offered, to continue to be able to raise prices and exclude competition. So I do see that once the psychedelics enter the pharmaceutical system is at large, those suffer from all the same structural failures of the broader patent system within the pharmaceutical industry. Let's take a break here and go to an ad. So when it comes to solutions, right, so there's the big picture one, right, which is about the overall patent system being broken. Right. So The New York Times earlier this year had a huge editorial called Save America's patent system. You know about how, fundamentally broken it is and what needs to be done. And then there was a very good article, I think you've quoted various places, by one of the smartest young journalists covering the psychedelics field, Shalah love, and the title of her piece was psychedelic patents are broken because the patent system is broken. So we're talking about patent reform in the US. Is Anything on the horizon thin or are we just kind of doomed to keep living with this for years the way it is? Well, I hope you don't have to end here, because how do to some degree think that we in a sense are doomed, at least with the patent system we have, especially when it comes to the pharmaceutical space, because the pharmaceutical lobby is really one of the strongest and the pharmaceutical lobby has been doing all it can to keep the patent system working in its favor. And so I think there certainly are efforts, and I will keep my fingers crossed that these efforts can be successful, both in terms of sort of at the individual level, like with what the hey utilius are doing, making sure individual patents are are are granted fairly, and in view of all the proper prior art Um. I think, for broadly that the patent system itself. There are things that are being worked out through other reform bills that have been introduced in I think there's still a chance there can be something that might raise the standards so that pharmaceutical innovation actually occurs. I mean, despite the fact that hundreds of pharmaceutical patents are granted every year, it's a or on every drug, even it's a very small number of them that actually provide any real innovation in terms of patient outcomes and in terms of clinical benefits. Um. But I mean I think even Perdue Pharma right effectively extended the patent or got a new one on its oxy content just by a slight reformulation and effective interactions with FDA. And I think what they were doing was fairly typical. Right, you have a kind of medication which maybe a breakthrough or semi breakthrough, but then just by tinkering it with it, they just keep extending their protections, patent protections, keeping the cost up, blocking generics and uh, and and yet you know, for all the politicians saying we need to fix this Um, not much is happening. I think that's right, and I mean it's it's wrapped up inside, you know, broader reform to to just the healthcare system and the way insurance covers drugs and health care more broadly. And so it is in terms of a structure to look out at from within the the PSYCHEDELIC space. It's something that is pretty daunting to think that the ethos of the psychedelic space somehow can be used as a as a model to reimagine the pharmaceutical patent system at large. But I think there are ways to that. Companies within the PSYCHEDELIC space can choose to interact with the patent system a little bit differently and there have been some examples of some companies who have made some attempts to do that and I think it certainly is something that's on people's minds in the PSYCHEDELIC space. And so I think just the fact that so many people are talking about psychedelics patterns and see them as a as a problem, means that companies will, to the extent they have uh, you know, consumers of their of their products, concerned with what they're doing, perhaps can be held to higher standard. Well, you know, I see. I mean if you look at the proactive efforts. I mean we've discussed free to operate, right carry Turnbull's operation, which try to block compass. But you know, there's also this thing called Porta Sophia, right, which tries to address the issue with prior art and to try to make sort of create a database of all the prior art, you know, the pre existing you know, types of uses of these drugs so that people can't falsely make claims for patents. And there's, I think you're, you're you're, a thing called Psychedelic Alpha Dot COM um, which provides, you know, a pretty good listing of all this. Just tell tell us a little more about what's going on with your thing and and port to Sophia, their significance and are those sorts of ideas that come that are all settening in other areas of non, you know, psychoactive drug areas? Maybe to the place to start with the Psychedelic Alpha is actually to sort of go back to the origin stories of it. Um, I actually was volunteering at a at a maps INFO table at a at a conference that just coincidentally happened to be the weekend after an article by Olivia Gold Hill published on compasses first patent. It hadn't yet published but they had Um told people about its filing and that it was on Psilocybin, and this article was really the first to kind of raise the outrage and because I mentioned everyone there that I was a patent lawyer, I spent basically the weekend talking about uh Psilocybin patents and how it could be even possible to file a patent on PSILOCYBIN. And after I left the conference that weekend and went home, I started keeping track of a table of patents on Psilocybin in particular, at which point there were maybe a dozen and probably not very many more, including the ones at Albert Hoffman had filed that Sandos. Since then, of course, now there are are many hundreds and because patent applications aren't published until eighteen months after they're filed, there there's probably even twice or three times as many now, but most of them still just secret. That is not only something that's in the in the PSYCHEDELIC space. I mean part of the reason I decided it would be worthwhile publishing it on Psychedelic Alpha was because it was, you know, a good way of making people aware of the types of applications that were out there and and sort of starting a conversation around them. But there's an organization called IMAC, the initiative for medicines access and knowledge, which I use their statistics a lot. I Am A K right, a k dit org, which I think was an important source for that New York Times editorial and it's been taking on some of these issues in a broader way. So yeah, very much so, yes, and they've been sort of counting and cataloging that the number of applications that have been filed on of other pharmaceuticals, just in terms of seeing the impact that they have on particular pharmaceutical drugs. And so to some degree that was, I'd say, somewhat of an inspiration, just seeing that a conversation can be started around individual compounds through looking at the types of applications that are filed on them and what that might mean for the price of somebody using that that compound as part of a medicine. Um. I see, and I think even with Imac died or I MAAC, are they engaging in some ways in the psychological area or they are familiar with it? Are you in contact with them? Well, yeah, so they're co founder, Prett Crystal has um actually been on a panel with me with Shakruna, Um, speaking of Sheila love. I think Um really is, uh, the best writer on on pharmaceutical or on psychedelic patents in this space and and certainly everyone should read but she's written about this. Um, she and Um Actually Josh Hardman and myself, and pretty crystal proposed a panel itself. By southwest is coming here, so we hope we can all speak together. So we have, of course also been speaking a little bit together in general and see that we're aligned in terms of what we hope to see. For you know, the psychedelic spaces is very similar to the types of reforms that Imac for for decades now, has argued are necessary in the broader medicine space. And and and preachy had done really great work arguing around access to AIDS, medications and and other drugs for for many years, even before she started Imac, and has has long been an advocate for more equitable access to pharmaceuticals, and so definitely saw both that as a resource but also as an inspiration for sort of the ways that would be useful to sort of Orient Um ethics in the in the psychedolic space itself. So Graham normally asked this the beginning. But how did you get intold, I mean I've I've heard you talk about growing up in the west coast with Hippie parents and getting involved at a young age on UH. You know, I think you said you've been involved with the prop two fifteen in the Middle Ca Marojuina initiative twenty five years ago. But just teleraudience a little more about your evel Lucian uh into becoming one of the leading patent lawyers working in this area. Yeah, yeah, I think maybe going back to that Um property fifteen is but sort of how I draw my origin story, although I suppose maybe the fortune of growing up in Oakland too. I mean so I do mention, you know, my my mom went to Berkeley in the Sixties and Um my dad did have his share of long hair, although I don't think they were either, the two of them, that much into psychedelics. And so I grew up with be here now sort of as a coffee table book and you know, Carlos Castaneda and other books on the the bookshelves. That sort of piqued my interest. And so I was kind of a stoner in high school and when proper to fifteen was on the ballot. Actually one of the first things I did was, when I had my driver's license, go collect signatures for the ballot on in front, in front of a couple of grocery stores. And in college, fairly early I had my first psychedelic experiences and I had so much inspiration from those that I changed my major to, you neuroscience, to try to both learn a little bit more about how it had those impacts on my on my consciousness, how chemicals like that could have such a profound role in, uh, shifting the way that I saw myself and saw the world. Um and actually, for a time in college thought that perhaps I could study a some sort of psychopharmacology or I speaking of peakle and Tacl and I bought bought those books Um and sort of saw Sasha. I suppose it's something of a Um inspiration. And you know, I received some encouragement from others that law school might be a good way if I was interested in drug policy, and so somewhat naively, I suppose, in retrospect, because thinking I could work in cognitive liberty or something like drug policy with law school loans. Um, it did end up in law school but realized that the Science degree to to pay off my loans was best used in the the patent space, which was, you know, hiring it good salaries and paying bonuses. And even though I had written my law school term paper actually on the way that generics are kept off the market by aggressive patent policies and, Um, how drugs are are kept expensive by the sort of abuse of the patent laws, it spent the first sort of half decade of my career at a law firm in New York working with branded drug companies to actually keep generic drugs off the market for longer, Um, and so to some degree I think I'm paying off that Karma a little bit now. Well, I'm curious how you balance that now, right and because obviously you know many of your clients are going to be for profit companies and are when you're talking with them or they want to hire you, retain you or if you're already working for them, are are there lines where you say look, this is something I cannot make that argument here, or do you turn down client who wants you to do things that you don't feel or ethically right. I mean because you're obviously out there as a forceful voice in terms of it trying to advocate for good policies in this area. You serve, you as an advisor to Chakruna, you know, be able about these organizations doing a lot of good work, but you're also, you know, a for profit. I mean you were an attorney with clients. So how do you balance that in your in your professional life? Yeah, that I think is really the best, the best kind of like the best question, and I think that is the attention that I find myself trying to navigate and spend a lot of my own time really thinking about. I'm fortunately, I think that when I started my own firm, to sort of go back a little bit before maybe answering the question, when I started Calix Law in actually that tension was sort of part of the reason for even starting it. I had worked for a long time on a case against Monsanto with their genetically modified crops Um and I had obviously been very interested in cannabis and that was part of the reason for wanting to enter the cannabis space as a patent lawyer and because of my interest in it. I had a number of friends who are trying to go from the legacy market into the sort of adult use market at the turn of and sort of my thesis for starting my firm was that there were ways for smaller inventors to get involved with the patent system and two also used the patent system to keep off a company like a Monsanto or a Philip Morris from entering the cannabis space and sort of taking it over and dominating it. And so that sort of tension between seeing patents as ways of giving a leg up to smaller, independent inventors, but also as a way of keeping a market from being dominated by aggressive monopolists. Um is sort of the kind of premise that I even started my firm with, and so taking that kind of thinking through to the psychedelic space, I think that was part of the kind of fortune that let me see that there were these issues around pcybian patenting, for instance, Um, perhaps a bit earlier than you know, maybe some others did, and so I think I'm I'm fortunate for having spent some time talking about those controversies that I actually do get presented with opportunities to to try to find ways to to navigate them. Um, from clients who who see patents as being necessary to raise money. I have some clients who tried to go without patents and just pursue their their work, uh, sort of in the open, put things in the public domain, and and sometimes found that they either couldn't raise money or, in one instance, another company took an article that they had published and filed patterns covering exactly what it was that they had described. Um, and so I saw a concern that like, well, if we don't file a pattern for like, what if somebody else does? And so, Um, I don't know that I've perhaps had to turn down clients for wanting to unethically use the patent system, and maybe I've just had the fortune of because I've been to some degree of kind of a voice for for balance in the patent system. Okay, so last questions here. One of the issues that's been out there more and more, and I know that Cody Swiss River Stix Foundation is making this issue and others have, is what is owed to indigenous peoples when the psychedelic products that, you know, emerged from their indigenous uses start becoming commercialized, and so you know I mean when we look at Mescaline and Peyote, when we look at Eboga coming from cabone and the surrounding areas in West Africa, I mean he's came so much out of indigenous use, is mescal in Um. And so it's a question what is owed and exactly to whom. And then there's the broadening of the issues. So, for example, when it comes to Psilocybin, mushrooms are growing, you know, they grow all around the world and on the one hand you hear the claim. Well, but for Maria Sabina Educating Gordon Wasson, you know, sixty, seventy years ago. You know, we want to have all these people aware of Psilocybin uh, you know, in other parts of the world. But then I think it's Paul stamens will say, well, hold on a second. PSILOCYBIN has been actually used around the world of different ways for a long time. So let's not extend this indigenous obligation issue to PSILOCYBIN. And then, of course, as m D M A, which is a twentieth century synthetic creation Um, is anything owed from something like m d m a UH to indigenous people? So what's your view on on what is the proper obligations and and and, to the extent there are obligations, how those should be addressed? Yeah, yeah, I mean well, M D M A, even though Um, I think, comes from Sasha's tinkering, so to speak, with mescaline. So perhaps even there you could draw some degree through line back to try to find some way to provide reciprocity. I mean, if we speak in terms of legal obligations, legally there really are none in the sense that there are some treaties, there is something called the Nagoya Protocol, but it hasn't been adopted by the US ratified by the US, and so there's basically just the patent law, which prevents companies from patenting something that are that's done by somebody else. But there's certainly no mechanism for reciprocity. It's in the law, unfortunately. So it really is up to to us, I suppose, to decide what companies are owed and to hold companies to account for that. In terms of my own views, I mean I think this all really comes down to just the broader controversy to around patents, which is where the values derived from and how much of that value gets extracted towards the the owner of a patent or the the owner of a group of patents. And we can look at not just psilocybin but sort of any invention and I think any invention to some degree, I think even the UH that the saying goes. You know, we stand on the shoulders of giants like nothing comes sue generous and even though our patent system is served based on this ideal of this kind of loan inventor genius working alone is workbench, who sort has this Eureka moment where he comes up with something that's never been done before and gets a patent on it and is entitled to all the monopoly profits on that for the next two decades. Nothing is quite like that. And so how do we really find a way to give some calculation to, you know, what is Ode and you know, where does the value derive from, Um, in terms of reciprocity, for for psychedelics? I mean, I I certainly think that it's important to recognize that. You know, many psychedelics come from these lineages where, whether they're just from underground use like m D M A, dating back to the seventies and eighties, whether they're from further back than that, dating back to Maria Sabina or earlier, whether they're getting back to, you know, potentially millennial use. Um. I think having the conversation that that people are having, Um, you know the question you're asking me, Um, not to necessarily dodge it, but I think that's what's important and I think it's you know it's even though I know you asked my personal views. I mean, I think it's an important decision for Vole to be making as the PSYCHEDELIC space starts to mature more in terms of trying to understand what the companies who make all the profits, uh, should be responsible for. And I'm here again optimistic because I see that there are many. Already you have found ways to try to give some degree of reciprocity. Um. There are companies who have given some portion of their profits or said that they've dedicated some portion of their profits, have given some of their equity, have provided other means of reciprocity. At the same time, I've also spoken to some indigenous people who feel like reciprocity, even as a term, is perhaps not used correctly, in the sense that it's only reciprocity if somebody accepts what you're giving to them. And so just for a company to to say, well, I'M gonna give ten percent back to the indigenous like that, not only is perhaps not enough, but it's maybe even a form of I know some people have called it tied eye washing or greenwashing, but sort of, I guess, avoiding a greater responsibility, which is perhaps what like the Nagoya Protocol I mentioned requires, which is actually consulting with the groups from which you're taking the knowledge or the wisdom and before doing something that would give you the profits that you would just give back, actually consulting, getting informed consent and having a process at the beginning to really share those those benefits. So last question, Graham. Do you have a favorite psychedelic? And the part to that question is can you think of any moments where you're a psychedelic experience actually proved specifically helpful in addressing um professional issues or questions that you were thinking through? Um? Well, so my favorite PSYCHEDELIC is mushrooms. Um just just because I love the I guess the fact that they're just so tangible and they're very accessible and that you can grow them quite easily yourself. You can find them places, often when you're not even expecting to. Um. I love just mushrooms in general and my my Fians, I and I are I think our our favorite thing to do together is a mushroom foraging Um, not usually for for psychedelic mushrooms, but just generally Um. And so, you know, I love the fact that they're just, you know, a natural thing and they're they're also very well they're a little bit variable, but they're much easier to dose than than other things, since you can see exactly what it is you're you're getting. In terms of professional impacts, I don't know, that's a good question. I don't know that I actually in terms of like creativity or the sort of stories you hear about people like, Um, Carrie Molli's or, you know, or somebody who's had a sort of Eureka moment that's been perhaps influenced by the use of psychedelics. Um. I think maybe it's because the last thing I generally want to think about when I'm on psychedelics is anything to have to do with patents or work. So maybe I should try and see if I can have some creativity on them. I mean, I definitely credit them with a lot of change in sort of personal um attributes sort to my life. I mean, I I had a long time where I was Um, somebody who didn't really have a healthy relationship with alcohol, and I found that I um had an experience with pulcibin mushrooms. Actually that reframe the way I was viewing my relationship with alcohol. And actually that's sort of last time after that that I have had any kind of uh use of alcohol, Um, and other things that I've had really personal meaning. But no, I think I'm gonna have to find an opportunity maybe to Um think about some of these pattern issues, what sort of reciprocity we are or some of the things you asked me that I didn't have very good answers for, and uh, maybe I'll find them. Okay. Well, Graham, listen. Thank you ever so much both for the work you're doing and for the taking the time to speak with me and our psychoactive audience. Thank you, even though that the briggles was entirely mine, Um, and I'm so thankful for being asked to join you in the conversation. I hope I see you again in horizons or another conference. So I hope to sting. If you're enjoying psychoactive, please tell your friends about it, or you can write us a review at Apple podcasts or wherever you get your podcasts. We love to hear from our listeners. If you'd like to share your own stories, comments and ideas, then leave us a message at one, three, three, seven, seven nine. That's eight, three three psycho zero, or you can email us at psychoactive at protozoa dot com or find me on twitter at Ethan Natal Man. You can also find contact information in our show notes. PSYCHOACTIVE is a production of I heart radio and protozoa pictures. It's hosted by me Ethan Nadelman. It's produced by Noham Osband and Josh Stain. The executive producers are Dylan Golden, Ari Handel, Elizabeth geesus and Darren Aronofsky from protozoa pictures, Alex Williams and Matt Frederick From my heart radio and me Ethan Nadelman. Our Music is by Ari Blucien and a special thanks to a Brios F Bianca grimshaw and Robert Deep. Next week I'll be talking with Professor Edwards Ainger, author of the book drunk who argues that the consumption of alcohol has been essential to the evolution of human civilization? You know, I look at evidence from other parts of the world, that wherever you look, it seems like the first cultivated plants were chosen for their psychoactive properties, not for nutrition, and so that's a sense in which, quite literally, the desired to get intoxicated gave rise to civilization. It's would cause on our gatherers to settle down in the first place. Subscribe to psychoactive now see it, don't Miss It.