An increasing number of clinical studies show promising results for the use of psychedelic therapies in the treatment of various mental health conditions. Research on psychedelics will continue to advance say partner, Jennifer Harris, and trainee patent attorney, Johanna Viluma, at patent and trade mark attorneys Kilburn & Strode. They consider the key role patents will play in navigating the challenges of obtaining protection in this rapidly growing field
With the awareness and recognition of mental health issues growing over the last few decades, there is an increasing need for effective treatments of mental health conditions.
Current treatments typically involve a combination of psychotherapy and medication. Since the introduction of selective serotonin reuptake inhibitors (SSRIs) in the 1980s, progress in the psychopharmaceutical space has been relatively slow, and commonly used medications still tend to show limited effects compared to placebo. Psychedelics represent a potential breakthrough in this field.
What are psychedelics?
Put simply, psychedelics are substances that profoundly alter one’s sense of reality. Classic psychedelics include lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), psilocybin (the active ingredient in magic mushrooms) and mescaline, all of which work by binding to serotonin 5-HT2A receptors.
The term ‘psychedelics’ is also often used more broadly to refer to compounds that provide similar effects, such as distorted perception, hallucinations and synaesthesia. This broader definition of psychedelics includes ketamine and 3,4-methylenedioxy-methamphetamine (MDMA).
The current landscape
Psychedelics have been prohibited substances in most countries for decades, significantly stalling research in this field.
However, in recent years, there is a revived interest in the therapeutic potential of these compounds, with several clinical trials underway.
Phase 3 trials have recently produced positive results for MDMA-assisted psychotherapy as a potential treatment of PTSD. These trials may lead to an application for the US Federal Drug Administration’s (FDA) approval of MDMA as a legal treatment of PTSD later this year.
In addition, a psilocybin formulation, COMP360, is about to enter phase 3 trials for potential use in treatment-resistant depression (TRD).
Several phase 2 trials are also currently underway, investigating the use of various psychedelics in disorders such as PTSD, TRD, generalised anxiety disorder (GAD), and major depressive disorder (MDD).
Overall, while the legal landscape remains uncertain, the psychedelics industry appears to be poised for exponential growth.
One indicator of this is the growing number of patent filings in this field.
What can be patented?
Indigenous communities have been using psychedelic plant medicines for thousands of years, and the classic psychedelics have been known for decades. This provides challenges for obtaining patent protection, as it is necessary to show that an invention is novel (new) and inventive (not obvious).
However, scope still remains for innovation in the psychedelics field, as developments are sought to achieve effective therapies.
For example, psilocybin treatments need to take place in a clinical setting, typically in the presence of two therapists. This presents a practical challenge and expense, particularly due to psilocybin’s long duration of action. Potential improvements in this field could be directed to optimising the length of the psychedelic experience.
Other research is directed to removing the hallucinogenic properties of psychedelics altogether, which could potentially make psychedelic treatment available to patients who are excluded from treatment, for example, due to psychotic disorders. There is also potential for improvement in terms of bioavailability and side effects.
One approach to addressing the challenges associated with psychedelics involves the optimisation of compounds that are already known. An example of this is SPRAVATO®, an esketamine nasal spray developed by Janssen Pharmaceuticals and used to treat TRD. Esketamine is present in ketamine in equal parts with arketamine, whose chemical structure is the mirror image of esketamine, and which is believed to be less potent than esketamine. This means that the use of esketamine could potentially allow for lower doses compared to ketamine and has led to a number of patent applications and granted patents with claims directed to specific compositions, salts, methods of manufacture, medical uses in specific patient populations, and the like.
In principle, developments such as new derivatives, polymorphs, formulations, combinations and dosage regimens can all be patented.
However, the novelty and inventiveness criteria mean that patents should only be granted for developments that provide an improvement and hence represent a genuine advance from what has been done before.
An alternative approach taken by some companies involves developing entirely new psychedelic compounds. This could provide improved therapeutic properties compared to the known psychedelics and also avoid the challenging psychedelic patent landscape.
While the above patenting considerations apply similarly to other pharmaceutical compounds, psychedelics come with their own unique challenges due to their legal status.
In patent offices around the world, patent applications are examined by examiners with technical expertise in the field of the invention who are generally well placed to understand the invention and assess its patentability over previously published information.
However, because psychedelics have been criminalised for decades, uses that have been occurring for decades are not well documented – meaning that there is little written prior art available.
For the same reason, patent examiners have limited expertise in the field. This combination of factors could lead to invalid patents being granted for inventions that are not truly novel and inventive.
Invalid patents can be challenged by third parties and eventually revoked, but this process is lengthy and expensive, and existence of invalid patents risks deterring further research.
Non-profit organisation Porta Sophia has identified the unique patenting challenges in the psychedelics field and is working to help prevent the grant of invalid patents. To do this, it has created a non-profit library compiling prior art on psychedelics, including documents from little-known archives. This library is available online to patent examiners, researchers and the general public alike, forming a useful tool to stimulate and support development of psychedelic therapies.
Tools like this, alongside examiners’ increasing familiarity with psychedelic subject matter as the number of patent filings in this field continues to rise, should hopefully improve the process, ensuring that true innovation can be supported and protected.