Navigating the Psilocybin Legal and Patent Landscape
Psilocybin, a compound found in "magic mushrooms," has a rich history in entheogenic rituals and cultural traditions. Despite being classified as a Schedule I substance, recent legal changes and FDA breakthrough therapy designations have propelled psilocybin into clinical trials. States like Oregon and Colorado have pioneered regulatory frameworks, while other states explore legislation. Internationally, countries like Jamaica, Brazil, and the Bahamas have distinct approaches. The surge in psilocybin patents, exceeding 330, reflects growing interest, covering areas from extraction techniques to treatment protocols. This evolving landscape indicates an exciting era for psychedelic research and legal reform. Our guest blog authors are Rachel Mount and Graham Pechenik and they wrote a comprehensive overview of Psilocybin legal status and patent landscape.
Graham Pechenik, founder of Calyx Law, is a registered patent attorney specializing in cannabis and psychedelics intellectual property. With a background in Cognitive Neuroscience and Biochemistry, his interest in consciousness changes fueled his career. After a decade at large law firms and contributing to landmark patent cases, Graham established Calyx Law in 2016 to guide ventures in designing IP strategies. As editor-at-large of Psychedelic Alpha, founding steward of the Psychedelic Bar Association's IP Committee, and a member of Chacruna’s Council for the Protection of Sacred Plants, Graham actively contributes to the field's legal and intellectual discussions. Graham was raised in Oakland, CA, and currently lives in San Francisco.
Rachel Mount, a current law student at the University of Wisconsin, holds a bachelor's degree in neuroscience from the University of Michigan, sparking her interest in the brain. During her undergraduate years, Rachel conducted research on psychedelics for emotional regulation, shaping her into a vocal advocate for psychedelic reform and responsible use. Motivated by personal experiences with family members facing autism, chronic depression, anxiety, alcoholism, and terminal illnesses, Rachel recognizes the potential of psychedelic medicine. At 23, while battling Hodgkin’s lymphoma, she founded Carefree Capping, a nonprofit subsidizing cold cap therapy for patients in Michigan and advocating for increased accessibility at cancer facilities.
Psilocybin is a compound that is produced naturally in a variety of species of fungi that are often referred to as “magic mushrooms.” Upon ingestion of such mushrooms, psilocybin is broken down into its active metabolite psilocin, which is a serotonergic hallucinogen that is the main psychoactive substance that is capable of providing psychedelic effects.
There is evidence that ancient civilizations all over the world incorporated psilocybin-producing mushrooms into entheogenic rituals, and that some are deeply rooted in cultural and spiritual traditions. Many people alive today have seen the rise, fall, and resurgence of psychedelics since the 1950s. Following the 1971 United Nations Convention on Psychotropic Substances, psilocybin joined a long list of other substances effectively banned. On a federal level, the United States classifies psilocybin as a schedule I substance, meaning the compound has “no currently accepted medical use” and “a high potential for abuse.”
However, psilocybin is now a compound of interest in numerous clinical trials, having been granted “breakthrough therapy” designation twice by the FDA. While therefore solidly on the path to approval as a prescribable medicine, to be provided along with psychological or psychosocial support, psilocybin is also becoming increasingly provided by underground (and in Oregon and soon Colorado, aboveground), facilitators. All the while, it has remained in wide use for so-called “recreational” purposes. Evidence demonstrates its low likelihood of addiction (indeed, among the very lowest for any drug substance), and past and emerging data support both short and long-term benefits from its consumption.
Public perceptions of psilocybin are changing in the United States as well as other countries, exemplified by a surge of legal changes and intellectual property filings in recent years. We cover some highlights of that surge here.
Psilocybin Legal Status in the US
The Trailblazing States for Legalization
Oregon
In 2020, Oregon voters approved Measure 109, making the Oregon Psilocybin Services Act the first law in the United States that established a regulatory framework for “psilocybin services.” The Act created 4 types of licenses: manufacturer, service center, laboratory, and facilitator, and the state began accepting applications for all four licenses in January 2023. Unlike state-legal cannabis, this is not a dispensary model. Rather, clients must be at least 21 years of age to consume a psilocybin product while on the grounds of a licensed ‘service center.’ Nor should it be considered a medical model. Facilitators are not required to be a licensed healthcare professional, doctor, or nurse; indeed, psilocybin facilitators are expressly not providing “therapy.” Clients do not receive a medical recommendation, and need not have a diagnosis; however, they must complete a preparation session with a facilitator before consuming the psilocybin product.
Colorado
Colorado voted to legalize psilocybin for users 21 years and older through Proposition 122 (Natural Medicine Health Act, “NMHA”) in 2022. The state-wide change first seen was decriminalization, which began at the start of 2023. NMHA removed criminal penalties for the possession, consumption, and cultivation of psilocybin-containing mushrooms (as well as consideration of three other psychedelic substances: mescaline, ibogaine, and DMT) for “personal” and “communal” use. Cultivation may take place within a 12-foot by 12-foot radius on private property. It is still illegal to “openly and publicly” consume psilocybin, with an administration fine of up to $100 and 24 hours of community service.
Although they remain illegal to sell, it is legal to “transfer without remuneration” (e.g., gift or share) psilocybin products. The new regulation also makes it legal for unregulated practitioners to sell ‘bona fide’ psilocybin services for support and/or harm reduction. The practitioners have the option to share the drug (e.g., free of charge) with clients, but the practitioner may not advertise their services.
Eventually, the state will permit “healing centers” to open, where consumers pay for psilocybin experiences that take place in the facility under supervision. Colorado appointed a Natural Medicine Advisory Board to help draw up rules and regulations for the healing center businesses, trip facilitators, and other employees. The board is composed of health experts, law enforcement, and researchers. As it stands, there are aspects of the Act that go further than Oregon’s, such as permitting at-home psilocybin treatment. This may be viewed as improving on one of the limitations of Oregon’s legislation, as some people who would benefit greatly from treatment are not physically able to travel to a service center (or would be much more comfortable receiving it in their home).
State and Local Legislation and Initiatives
There are over 20 other states spanning from east to west coast that have introduced legislation or initiatives that include psilocybin. There is a mixed bag of psilocybin and general psychedelic bills that fall on a spectrum of progressiveness, but they can generally be described as incremental steps towards models like Oregon and Colorado. There are research bills that establish research advisory councils and some bills establish working groups to study the medical use of psilocybin. The most progressive efforts include steps toward decriminalization, such as Colorado’s National Medicine Health Act.
Among the states, Washington (Seattle, Port Townsend), California (Arcata, San Francisco, Berkeley, Oakland, Santa Cruz), Michigan (Washtenaw County, Detroit, Ferndale, Hazel Park), D.C. Illinois (Evanston), and Massachusetts (Sommerville, Cambridge, Northampton, and Easthampton) also have local government initiatives that make personal use and possession of entheogenic plants, commonly referred to as “grow, gather, gift,” the lowest law enforcement priority and/or defund police resources for prosecuting entheogenic-related activities in the area. If you are interested in learning more about state and local policy and legal changes (or keeping up with new changes as they happen), continuously updated information is hosted at https://psychedelicalpha.com/data/psychedelic-laws. These changes within the U.S. have been accompanied by other changes around the world, some of which we note below (and a more complete map tracking international changes can be found at https://psychedelicalpha.com/data/worldwide-psychedelic-laws).
Progressive Psilocybin Status in Other Countries
Jamaica
Jamaica stood apart from many of its neighboring countries because the government never made psilocybin mushrooms illegal during the height of the War on Drugs, and psilocybin is not listed as a controlled substance in Jamaica’s Dangerous Drugs Act. Traditionally, the cultivation and sale of the mushrooms took place in an informal market. Today, the landscape of psilocybin mushroom cultivation and sales is changing. 2021 marked the first legal psilocybin mushroom retail shop, and since then, more “shroom shops” continue to pop up. Psilocybin healing centers found across the island attract locals and also draw international tourists.
Brazil
In 2006 Brazil reshaped its drug laws to become one of the more tolerant countries regarding psilocybin mushrooms. This is due largely to some of its Indigenous population who have used psychedelics for generations (even following the UN Convention in 1971 that banned psychedelics, Brazil made an exemption for its Indigenous population). Brazil does not deem the mushroom itself to be illegal, and there have been no known charges in recent years made in relation to the sale, distribution, or use of psilocybin mushrooms. There are an abundance of psilocybin mushroom and spore websites, and these sellers generally live without fear of prosecution by local authorities. Vacationers may come across some resorts that offer a spiritual therapy with psychedelics.
Bahamas
The Bahamas signed the 1971 UN Convention on Drugs, effectively banning all psychedelics. Today, psilocybin mushrooms are no longer illegal under the Bahama legal framework. Individuals are free to grow and sell psilocybin mushrooms, although psilocybin itself is a controlled substance. The Dangerous Drugs Act is the main legislation that governs drug policy, and psilocybin mushrooms are absent from the list. Psilocybin therapy and psychedelic tourism (“psychotourism”) with psilocybin continue to grow in popularity, and providers face relatively no legal risk. Like Jamaica and Brazil, there are psilocybin health and wellness retreats opening across the island for tourists.
Notable Psilocybin Patents
The modern resurrection of psilocybin research, funding, and general societal acceptance has gone hand-in-hand with a dramatic increase in the number of organizations racing to get various protections on their investments through intellectual property. From roughly one dozen published psilocybin patents five years ago, there are now over 330, with many more on the horizon likely, as applications are unpublished and otherwise largely kept secret for at least 18 months after filing.
Patents in short provide a government-granted monopoly, entitling the patent owner to exclude others from all aspects of the patented invention for around 20 years from the filing date. To obtain a patent on a psychedelic compound like psilocybin, applicants must convince a patent examiner (such as in the U.S. Patent and Trademark Office) that the claimed invention is novel, nonobvious, useful, and patent-eligible subject matter, and that the application enables one to practice the invention without “undue experimentation.” Certain inventions are ineligible for patent protection, including most importantly in the field of psilocybin, as mere “products of nature.” Nonetheless, as long as they are also novel and non-obvious, many psilocybin-related inventions are still patentable (as the growing number of published applications suggests): these include, for example, forms of psilocybin, formulations comprising psilocybin, methods of extracting or producing psilocybin, methods of using psilocybin such as in the treatment of conditions, and others, such as the examples that follow.
Examples and up-to-date tracking of more psilocybin, LSD, MDMA, ibogaine, ketamine, 5-MeO-DMT, and DMT patents available at https://psychedelicalpha.com/data)
First, some rather famous psilocybin-related patents:
The Stamets Stack: Compositions and methods for enhancing neuroregeneration and cognition by combining mushroom extracts containing active ingredients psilocin or psilocybin with erinacines or hericenones enhanced with niacin (US20180021326, Paul Stamets, first filed in 2016)
Paul Stamets is credited with introducing the concept of ‘stacking,’ e.g., the practice of combining non-psychoactive substances with a microdose of a psychoactive substance in an effort to enhance its effects. The Stamets Stack includes Lion’s Mane, Niacin, and psilocybin. Stamets claims that the combination has the ability to support neural growth and repair neurological damage. Stamet’s patent also dives into the optimal psilocybin microdosing protocols.
Psilocybin Extraction: Extraction of psychoactive compounds from psilocybin fungus (US11382942, Filament Health, first filed in 2020)
This application explains techniques that can be used to extract psychoactive compounds (e.g., psychoactive alkaloids) from psilocybin fungus for use in medicine. The inventors state that various methods of extraction existed prior to their invention, but the known methods resulted in difficulties with large crop-to-crop variation as well as large concentration variability within a single plant or fungus. The result of inefficient extraction is a high cost for consumers. This invention therefore claims what it says is a high efficiency, standardized preparation of target compounds while using acceptable solvent systems to create a more consistent supply chain.
Polymorphic Forms: Preparation of psilocybin, different polymorphic forms, intermediates, formulations, and their use (US20230250115, Compass Pathways, first filed in 2017)
This application relates to the large-scale production of psilocybin for use in medicine, particularly in the form of Polymorph A. One claim of the invention is to provide psilocybin, of consistent crystalline or “polymorphic” form, for administration to humans. Another is to provide chemically pure psilocybin in large scale batch quantities that are suitable for commercial use. The invention also provides a method of crystallizing psilocybin in a desired polymorphic form. By obtaining a crystalline form, the typically unstable nature of the compound is said to be stable for at least 12 months.
Further examples of psilocybin-related patents in four different categories include:
Method of use: Treatment of Treatment Resistant Depression with Psilocybin (WO 2023086252, Compass Pathways, first filed in 2021).
This application claims a method of use for psilocybin treatment in patients with treatment resistant depression (“TRD”). In this application, Compass claims the use of psilocybin to treat patients “that did not respond to a first dose of psilocybin” by “administering a second dose of psilocybin about 3 weeks after administering the first dose of psilocybin.” Compass may be best known, in relation to its patent filings, by its numerous “Polymorph A” patents on crystalline psilocybin, such as the one above, and its notorious published claims on aspects of psychological support (such as holding hands) and room decor (such as “soft furniture”).Method of production: Alternative Biosynthesis Pathways for the Production of Psilocybin and Intermediates or Side Products (WO2023081842, Miami University, first filed in 2021).
Published studies to date all focused on the use of the psilocybin biosynthesis pathway, originally reported by the Hoffmeister group. This application discloses a method of production of psilocybin and its intermediate or side product, where there is a prokaryotic host cell (or a recombinant prokaryotic cell) with one or more expression vectors that contain certain selected genes. The host cell is cultured for production of psilocybin.Modified structure: Glycosylated Psilocybin Derivatives and Methods of Using (WO2022040802, Enveric Biosciences, first filed in 2020).
This application discloses glycosylated psilocybin derivatives that activate the 5-HT2A cell surface receptor and increase intracellular calcium concentration with a profile different from that of psilocin, and pharmaceutical and recreational drug formulations that contain the disclosed derivatives. The compounds may be produced by reacting a hydroxylated psilocybin derivative with a glycosyl compound.Formulation: Formulations of Psilocybin (WO2022243285, Cybin, first filed in 2021)
Psilocybin typically requires upwards of 7-8 hours of supervised clinical observation due to its slow onset of drug action (1.5-2 hours) and a fairly long duration of drug action. This application contains formulations of psilocybin and deuterated psilocybin that are said to have a faster therapeutic onset and a shorter duration of drug action, explaining for example that “buccal, lingual, and sublingual administration” have “increased bioavailability and faster onset compared to oral administration through the gastrointestinal tract.” These formulations still act on the 5-HT2A (serotonin 2A) receptors, as does naturally produced psilocybin.
A Quick Glimpse into the Future
All of this goes to say, we are living in a very exciting time in the psychedelic space. We expect there to be a steady influx of new patent applications for psilocybin, as well as for other psychedelic compounds that hold promise for treatment purposes. We will continue to see more local and state jurisdictions reform their drug policy laws – even traditionally conservative states like Texas have restructured regulations to allow medical research of certain psychedelics, and provided state funding for research. There also may be federal rescheduling of psilocybin on the horizon (one can always hope!). It is important to note that because of “bifurcated scheduling,” even if psilocybin is approved by the FDA for medicinal use, psilocybin other than the approved drug product (e.g., Compass’ “COMP360”) is likely to remain a Schedule I substance. We cannot get back the research and development time lost to the War on Drugs, but we can look forward to modern-day advances and movements that are happening at an unprecedented pace.
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