The Battle for Psychedelic Patents

As biomedicine wakes to the potential of psychedelic medicine as a treatment for psychiatric disorders, patents have become a growing source of conflict and friction within the industry.

Mindset Pharma is one drug discovery company that has focused on filing patents on chemically novel psychedelics. It was one of the first companies to file a patent around a so-called “next-generation” psychedelic.

In this article, Technology Networks speaks with Mindset CEO James Lanthier about how patents work in the fast-changing psychedelics industry, what makes a patent effective and how newer compounds stack up against natural psychedelics.

Ruairi J Mackenzie: (RM) What patents does Mindset hold and what ones is it pursuing? 

James Lanthier (JL): Mindset has a portfolio of 12 different patent applications that we've filed. We recently announced that we've received a Notice of Allowance from the US Patent Office on one of those patents.; essentially, a notice that we expect to have that patent issued in the near future. The portfolio covers mainly designs of novel psychedelic drugs. Of the twelve, ten of them cover new drugs, one of them covers a manufacturing process to synthesize psilocybin and one of them covers a drug formulation.

RM: The issuing of patents is a fairly drawn-out process. How does that function in the context of a rapidly changing industry like psychedelics?

JL: There’s a lot of discussion in the space and a lot of commentary around patents. There’s a lot of different viewpoints. From the beginning, we've been focused on and believe that new psychedelic drugs really would be the biggest opportunity in the space. We really viewed what we call first generation drugs, like psilocybin, which is a psychoactive component of psilocybin mushrooms, as being really a great proof of concept for what psychedelic drugs are capable of from a therapeutic standpoint.

But in our view, there were some shortcomings with first generation drugs that we believed could be addressed through drug design. Our view is that, ultimately, psychedelic medicine requires the involvement of pharma and pharma investors, and that they would naturally be more interested in new drugs because of the opportunity to own stronger intellectual property rights around those drugs that could justify the investment. Obviously in North America or Europe, it takes an enormous amount of capital to bring a drug all the way through the regulatory process. That's why we've been focused from the very beginning on what we describe as second- or third-generation psychedelic drugs.

RM: Patenting in the biomedical sciences is a tricky business. What makes a patent “good” or “bad”?

JL: I’m not sure I can use the word “bad”. But I think where a lot of the controversy arises in the space is because if you take, say, psilocybin; the structure of psilocybin has been in the public domain for decades. It was discovered in the 20th century, it's been published on, there's no way that you can patent psilocybin itself.

But there's lots of great data around the potential of using psilocybin. So, there's been quite a bit of activity from different groups trying to trying to establish whatever IP protection they can around the use of psilocybin and formulations of psilocybin; a formulation being a new mixture, where psilocybin is still the active pharmaceutical ingredient, but you're structuring it as an enantiomer or a salt.

I think the patent applications that have rubbed people the wrong way have been ones trying to patent things that are really obvious: the setting for psilocybin therapy and background music and that kind of thing.

There’s also the fact that psilocybin comes from a natural product. I'm just not sure that patents targeting psilocybin are going to offer the patent holders much in the way of defensible protection.

Whereas our point of view was to come up with drugs that are chemically novel and haven't been described before and are differentiated – that’s the key. A patent on a new psychedelic drug has a pretty high bar to clear because the first-generation drugs are useful. If all you're doing is patenting something that's novel, but not differentiated, that's probably not going to be enough in the long run.

RM: Say you're a potential patient for a psychedelic therapy drug combined with a therapeutic session treatment. How good does the patented second-generation drug have to be versus the natural compound to make someone want to pay? You could find psilocybin mushrooms for free at the side of your local golf course!

JL: I think it's got to offer some potential advantages. I think as great as those mushrooms on the side of the golf course, or the airport runway are, with the natural product there's real limitations.

The psilocybin quantity from mushrooms can vary quite wildly and dosing a psychedelic drug is incredibly important. You want to ensure that the dose is consistent from patient to patient.

The mushroom itself is a miraculous thing that we should all be grateful for. But I don't think that the mushroom itself really fits within a regulated medical environment. You need to look to synthetic options, but even synthetic psilocybin has challenges. One of these challenges that I think will keep psilocybin from widespread adoption is the duration – six to eight hours. Psychiatrists who we talk to who are conversant in the clinical data view it as being almost settled that psilocybin has a therapeutic benefit. But they tend to view the duration as being likely an impediment to widespread adoption because it's just a long time to have to spend in clinic and it requires two therapists. It doesn’t fit in with their therapeutic model. If you can deal with the duration, I think that's one area of improvement.

I think the other area that is important but underappreciated is safety. Psilocybin is generally safe, and, based on what we know, not addictive. But when you're talking about patients suffering from treatment-resistant depression, they likely have more than more than one health problem; we are talking about a psychically compromised patient group. We think that safety is an important concern as well. And we think, based on what we've seen at least preclinically, that that's an area that can be improved on with second-generation drugs.

RM: Within the companies investing in preclinical and clinical psychedelic research, do you think there's a consistent move towards the second-generation compounds? Or do you think it's a more split seen with some focusing on natural compounds and others like yourselves, moving into synthetic compounds?

JL: I think it's varied. I think that the initial wave of startups in the space were focused on the easier kind of opportunities, which were around formulations of known drugs and trying to pursue data exclusivity through clinical research. But certainly now, I think that you see more and more companies focusing on second- and third-generation opportunity for the reasons we discussed. I think we were really fortunate that this was the opportunity that our scientific founders really identified from the beginning.

That allowed us to do a lot of scientific work early and file our patents early. I think that most groups are focused on formulations of all drugs, but I think there is some room for all of this. We just think that the bigger opportunity at the end in the future will be in newer drugs.

James Lanthier was speaking to Ruairi J Mackenzie, Senior Science Writer for Technology Networks