Fuente: Prohibición Partners Lugar: General Report Contents
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Introduction →
Definitions And Scope →
Executive Summary →
Key Trends →

Market Value →
Legislation and Regulation →
Consumer Attitudes →
Healthcare Providers’ Attitudes →

Spotlight On Health →
Psychedelics – Timeline of Key Developments →
Countries to Watch →
Psychedelic Profiles →

Key Psychedelics Deep Dive →
Other Psychedelics of Note →
Psychedelics as Medicine: Potential Therapies →
Psychedelics and Technology →

Psychedelics Per Country →
Psychedelics and The Law →
Patents and Intellectual Property →
Therapy Practitioners →

Psychedelic Research →
Glossary →


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Key Takeaways



Patents cannot be applied to first-generation psychedelic compounds, as the original intellectual property protections expired decades ago. As a result, companies seeking to build defensible intellectual property (IP) positions must focus on novel formulations, delivery methods, manufacturing processes, or second-generation psychedelic compounds. While reformulations are easier to develop, they are generally less innovative than new molecular entities.



Data exclusivity represents a significant but often overlooked opportunity. By securing regulatory protection for clinical trial data tied to a specific compound and indication, organisations can achieve temporary market exclusivity without owning the underlying molecule. MAPS plans to leverage this exclusivity window—ranging from five to ten years depending on jurisdiction—to scale MDMA-assisted psychotherapy for PTSD and position itself as the dominant provider.



Another competitive frontier is large-scale psychedelic manufacturing under Good Manufacturing Practice (GMP) standards. More than a dozen companies are now competing to supply both natural and synthetic forms of compounds such as psilocybin at pharmaceutical grade and commercial scale.



Why Classic Psychedelics Cannot Be Patented



Many of the most prominent psychedelic compounds were synthesised in the early to mid-20th century, and the patents governing their use have long expired. MDMA was first patented in 1914, LSD in 1957, and psilocybin in 1963. As a result, these substances exist in the public domain and cannot be patented in their original form.



In jurisdictions such as the United States, United Kingdom, and Canada, pharmaceutical patents are granted at the point of discovery rather than regulatory approval, typically lasting 20 years. Patent protection provides a temporary monopoly to incentivise innovation by allowing companies to recoup development costs through exclusive sales.



With first-generation psychedelics off-patent, companies are instead pursuing new psychedelic analogues derived from classic tryptamines, along with novel formulations and therapeutic protocols that can still qualify for protection.



Lessons from Patenting Ketamine: The Spravato Case



Johnson & Johnson successfully secured both patent protection and regulatory approval for esketamine, a ketamine-derived nasal spray marketed as Spravato, for treatment-resistant depression. While Spravato was approved by the US Food and Drug Administration, it failed to receive approval in the United Kingdom due to concerns around cost-effectiveness and limited incremental benefit over existing treatments.



Health Canada approved Spravato as a treatment but later rejected the company’s patent claim. This restricted its commercial reach and limited patient access, despite significant investment in development.



The Spravato case marked an important milestone for psychedelic-adjacent medicines, but it also served as a cautionary example. Regulatory approval alone is not sufficient; new treatments must demonstrate clear superiority in outcomes and offer value for healthcare systems to justify reimbursement and widespread adoption.



Novel Psychedelics and the Patent Race



One of the core challenges in psychedelic medicine is the high cost of delivery. Many psychedelic therapies require administration in controlled clinical environments, combined with extensive psychological support before and after dosing. This makes treatments resource-intensive and limits scalability.



To address this, companies are exploring second-generation psychedelics designed to shorten session duration, reduce hallucinatory effects, or minimise reliance on therapists. One example is tabernanthalog, a non-hallucinogenic and non-toxic analogue of ibogaine engineered to retain therapeutic potential.



In anticipation of future market growth, drug developers have filed dozens of patents covering psychedelic compounds well before extensive clinical validation. Some stakeholders argue that overly broad patents risk stifling innovation, while others believe strong IP protection is essential for attracting investment and ensuring long-term commercial viability.



Protecting the Public Domain: Prior Art and Patent Challenges



To prevent patents from being granted on discoveries that already exist in the public domain—known as “prior art”—several organisations are actively challenging overreaching applications.



Freedom to Operate, a non-profit led by Carey Turnbull, founder of the Heffter Research Institute, and Porta Sophia, supported in part by the Usona Institute, are cataloguing historical research and traditional knowledge. Their work aims to support patent examiners by ensuring that applications do not appropriate existing science or indigenous knowledge.



This effort is designed to strike a balance between encouraging innovation and preserving open access to foundational psychedelic research.



Data Exclusivity: MAPS and MDMA-Assisted Psychotherapy



Beyond patents, organisations can secure market protection through data exclusivity, which prevents competitors from relying on proprietary clinical trial data to obtain regulatory approval for similar products.



In the United States, data exclusivity lasts five years; in Canada, eight years; and in Europe and the UK, up to ten years. MAPS will rely on this mechanism to protect its MDMA-assisted psychotherapy protocol for PTSD, as MDMA’s original patent expired long ago.



With FDA approval anticipated in 2023, MAPS is expected to receive data exclusivity that will allow it to scale treatment delivery while competitors would need to independently generate equivalent clinical data. MAPS plans to deliver over one million treatment sessions by 2029, serving at least 500,000 patients during the exclusivity period.



While other organisations may pursue approval for MDMA-assisted psychotherapy during this time, they would need to replicate the extensive clinical evidence already produced by MAPS, representing a substantial barrier to entry.



Manufacturing Psychedelics at Scale



Patents also play a critical role in the production and extraction of psychedelic compounds. Traditional natural production of psilocybin costs approximately US$10–US$15 per effective dose, but novel manufacturing approaches—such as yeast-based biosynthesis—may significantly reduce costs at scale.



As early as 2000, Royal Dutch DSM filed a patent, granted in 2007, to improve psilocybin yield, despite not being directly involved in psychedelic medicine. To counter restrictive patenting and promote open science, the Usona Institute published its psilocybin production methods without seeking patent protection.



In August 2021, Filament Health became the first company to receive a patent specifically for the extraction of natural psilocybin. Since then, numerous companies have filed patents covering proprietary manufacturing processes for psilocybin, DMT, MDMA, and a range of novel psychedelic compounds.



Innovation also extends to delivery mechanisms, including soft gels, oral films, and extended-release formulations designed to control dosing profiles. Determining whether these developments represent genuine innovation ultimately rests with patent examiners assessing novelty and inventiveness.








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The post Patents and Intellectual Property in Psychedelic Medicine – PSYCH: The Psychedelics As Medicine Report 3rd Edition appeared first on Prohibition Partners.