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Psychedelic drugs: recent breakthroughs and patent protection

Posted: August 18, 2022

Psychedelics are a class of psychoactive substances that cause changes in perception, mood, and cognitive processes. Examples include LSD, MDMA (ecstasy), and psilocybin (the main active ingredient of the fungi colloquially referred to as ‘magic mushrooms’).   Recently, they have become the focus of research for mental health therapy.

Psychedelics: past

Historically, psychedelics were regarded to have a high potential for abuse and, as such, had no accepted medical use. This resulted in manufacturing and possession of psychedelics being criminalised and limited use of psychedelics in clinical research.

Due to rising rates of mental health illnesses, research into the therapeutic uses of psychedelics has increased. In 2018, the European Medicines Agency (EMA) identified psilocybin as a breakthrough therapy for treatment-resistant depression and major depressive disorders. Similarly, in the US, several states are considering the legalisation of psilocybin for medical use and, in 2020, Oregon became the first state to legalise the compound for therapeutic use.

Other compounds include MDMA and esketamine, a substance derived from anaesthetic ketamine. In 2019, ketamine was approved by the FDA and the EMA for the treatment of depression. This led to the approval of Sparvato®, Johnsons and Johnsons’ esketamine drug equivalent, for use in treatment, but only under special prescription and direct supervision of a healthcare professional. The EMA stated that with these restrictions in place the benefits of Spravato® would be greater than its risks. MDMA as an adjunct to therapy for PTSD in The UK is currently under an accelerated programme to authorise this drug for The UK market.

Psychedelics: present and future

Investment in psychedelic research and commercialisation of psychedelics is on the rise.

There are already 138 marketed psychedelic drugs worldwide, with four in the late stages of development (Phase III and pre-registration) for treating a range of disorders, such as ADHD, narcolepsy, and major depressive disorder. Flowing from this, there have been patent filings to cover new psychedelic drugs, new variations of known psychedelics and associated medical uses.

Below, we highlight some patent portfolios in this rising field:

• COMPASS Pathways (UK Pharmaceutical company):
  • Patent family concerning new forms of psilocybin and associated medical uses.
  • Granted patents include: GB2571696B and several US patents. Several European patent applications are currently pending before the EPO.

 Small Pharma (UK-based drug development firm – focus on mental health):

• • Patent protection for SPL801B – a preclinical stage ketamine-based drug.
  • EP3463323B1 – granted patent for oral administration of SPL801B in treating depression. US application is currently pending along with a pending European divisional.
  • Pending PCT for SPL026 – DMT-based compound. Phase 1 and 2a clinical trials for SPL026 treatment in major depression disorder.

Psychedelics have been used for centuries, and their methods of administration are commonly known – which can pose a problem for the novelty and inventive step of psychedelic patent applications.

However, Forresters specialises in navigating the complex issues to secure patent protection for these types of inventions.  We explore product claims for synthetic compounds based on natural psychedelics, modified natural compounds and derivatives, combination therapies and new medical uses.  Please contact us if you have any questions.