- Patents are not possible on the first generation of psychedelics which have all expired. Therefore, novel formulations of these compounds or second generation psychedelics will need to be made to create an intellectual property (IP) moat. The former being easier to create but considerably less innovative.
- Data exclusivity is an overlooked opportunity where one would be able to protect a specific compound for a specific mental health or substance use disorder combination. MAPS will use this data exclusivity period of five to ten years to build a network that serves 500,000 patients and positions them as the provider of choice for PAT with MDMA for PTSD.
- Producing psychedelics at scale, with good manufacturing practice (GMP) levels of purity, is another frontier where more than a dozen companies are competing to offer both natural psilocybin, extracted from mushrooms, and synthetic versions to be produced at large scale.
Author: Floris Wolswijk is the founder of Blossom. He started Blossom in 2019 to help translate psychedelic research to a wider audience. Since then he has grown the database to encompass over 1500 papers and hundreds of other valuable resources. Floris has an MSc in Psychology though don’t hold it against him.
Many of the traditional psychedelics were synthesised many decades ago and the patents governing their use have long since expired. MDMA was first patented in 1914, LSD in 1957 and psilocybin in 1963. As a result, companies are creating novel psychedelic compounds based on classic tryptamines that can be patented.
In the UK, US and Canada, new drugs are patented upon discovery, rather than regulation, with a patent term of 20 years. Patenting medications provides drug manufacturers with a period of market exclusivity in order to incentivise the development of new treatments by enabling the company to monopolise sales.
Johnson & Johnson successfully secured a patent, and regulatory approval, for its esketamine nasal spray to treat treatment-resistant depression. Although Spravato was approved by the FDA, it fell short of regulation in the UK due to its prohibitive cost and a failure to significantly improve patient outcomes, above and beyond existing medications. Health Canada did approve Spravato as a treatment, but has recently rejected its patent claim. This signalled muted success for Johnson & Johnson, as it restricted Spravato’s use to a specific jurisdiction and a limited patient population, despite the company heavily investing in the drug’s development.
While the FDA’s approval of Spravato was an important milestone for the psychedelic industry, the failure to gain accreditation in other countries is a warning lesson for other manufacturers. It is not enough to develop new treatments with better patient outcomes, the treatments need to provide far greater efficacy than medications currently available and also be cost-effective for healthcare providers.
Novel psychedelics under patent
This is one of the main challenges facing the psychedelic industry, as the majority need to be applied in controlled settings and followed up with sessions with a trained therapist. This significantly adds to the cost of treatments, with companies exploring how compounds can be modulated for shorter durations and to mitigate the reliance on healthcare professionals.
One way this could possibly be achieved is reducing the hallucinatory experience, with non-hallucinogenic analog tabernanthalog engineered as a non-toxic ibogaine derivative. In an attempt to dominate the emerging industry, drug developers are filing dozens of patents on psychedelic-compounds, long before they are thoroughly researched or subjected to clinical trials. Some stakeholders see the application of over broad patents as strangling industry innovation, whereas others believe it is crucial to protect and futureproof a business model.
To prevent patents being applied that will stifle research and using information that has been known to the public, which is called ‘prior art’; two different organisations are challenging overreaching patents and collating earlier work. Freedom to Operate, a non-profit led by Carey Turnbull, the founder of the Heffter Research Institute, and Porta Sophia, supported in part by Usona Institute, are fulfilling these respective roles. This work should help patent reviewers to better judge if the work detailed on a patent is not already in the public domain.
Data exclusivity for MAPS
In addition to a patent to secure market exclusivity, organisations can also apply for data exclusivity to secure ownership and confidentiality of data provided to regulators. This typically includes the data generated through clinical trials, so it cannot be used to obtain regulatory approval for a similar medication. In the US data exclusivity lasts five years, eight in Canada, and ten in Europe and the UK.
MAPS will get data exclusivity for its clinical trials to treat PTSD with MDMA, as MDMA was originally patented in 1914 and its patent has long expired. Consequently, MAPS required data exclusivity to achieve returns on its investment, when the treatment is expected to be regulated by the FDA in 2023. This will give them five to ten years, depending on the continent, to scale up treatments and build a moat before others will also be able to offer MDMA-assisted psychotherapy for PTSD. In that time MAPS will scale up to over 1 million sessions in 2029, which means that they will be able to serve at least 500,000 patients between 2023 and 2029.
In the meantime, other organisations will still be able to generate their own data to get a treatment with MDMA approved. This can even be for MDMA-assisted psychotherapy for PTSD, but that would entail them generating the same level of data and efficacy as MAPS has done so far.
Making psychedelics at scale
Another area where patents are playing a role is in the production or extraction of psychedelics. Whereas natural production costs US$10-US$15 per effective dose, a novel yeast-based production method may, if scaled up, provide psilocybin at a much lower cost. Already in the year 2000, without wanting to be involved in psychedelics as medicines, the Royal Dutch DSM, applied for a patent, that was granted in 2007, for the improvement of the yield of psilocybin.
To prevent others from patenting known ways of producing psilocybin, and to advance Open Science, Usona Institute has published all their psilocybin production methods without patenting them. In August 2021, Filament Health became the first company to be issued a patent for the extraction of natural psilocybin.
Still, in the last few years, many companies have filed patents on different proprietary manufacturing processes for making psilocybin, DMT, MDMA, and many novel psychedelics. The same can be said about the different delivery methods which range from soft gels to small films that sometimes extend the period over which a psychedelic is released. It will be up to the patent reviewers to judge the innovative nature of each of these applications