The cost of developing psilocybin therapy, with clinical trials in multiple countries, is significant, and involves considerable risk and resource. We think it’s an investment worth making. We are also committed to investing in other innovative treatments to address the rapidly growing problem of mental health conditions.
Intellectual property (IP) protection is granted to enable companies to protect the investment they make – and offer a return to investors – when inventing new products or processes. Without IP, there would be little incentive to take the risk to fund the research and development of new products, given the large number of drug candidates that fail during the development process. Patents drive innovation and bring new therapies to patients.
We use synthesised psilocybin in our psilocybin therapy, because it’s necessary to have GMP (Good Manufacturing Practice) product, manufactured to a consistently high standard and guaranteed to be the same for every patient everywhere in the world. We have applied for patents to cover the particular form of psilocybin we have synthesised, and the manufacturing process we use. As the previously published synthesis processes did not scale to meet regulatory standards, we had to invent our own process.
The patent protection we are seeking does not cover naturally occurring mushrooms, it would not prevent others from creating different solutions for their own psilocybin synthesis, nor would it restrict others researching in this field.