Mounting clinical research is demonstrating that psychedelic therapies are a game-changer when it comes to mental health treatment. And recent decriminalization and legalization efforts by cities and states across the country have helped bolster those efforts while raising awareness of the therapeutic potential of psychedelic compounds.
The psychedelic industry is now faced with a huge opportunity to create novel, more targeted medications. But before psychedelic products can reach the market, they must travel down the long, winding, and expensive drug development pipeline. This is where intellectual property and patentability comes into play.
Patents are a form of intellectual property granted by the U.S. Patent and Trademark Office that give the owner of the patent the legal right to exclude others from making, using, or selling an invention for a limited number of years. Currently, the term of a new patent in the pharmaceutical industry is 20 years beginning on the date the application is filed.
Patents are especially important to pharmaceutical companies because they guarantee profit which enables the patent owner to cover the time and cost put into the development of their new medication.
The drug development process is long and arduous, and can take as long as 10-15 years for some medications to clear clinical trials and receive federal approval before the finished product reaches the market. And there are no guarantees that the medication will actually clear all the hurdles of safety and efficacy.
But having a patent in hand is a necessary step pharmaceutical companies and psychedelic treatment developers alike must take in order to progress through the drug pipeline. Many psychedelic companies have already started the patent process.
So how do companies patent a natural psychedelic? They don’t. They change it instead. Things found in nature, like so-called magic mushrooms, cannot be patented, nor can the psychoactive ingredient psilocybin it contains. In order to claim a compound as intellectual property and be able to profit from it exclusively, the product must be altered to create a new molecule, which researchers to better target these medicines to specific neurological or psychological conditions. Or they can create a novel form of delivery technology, such as oral dissolvable films, soft gel tablets, and controlled released formulations.
Dozens of psychedelic companies have recently filed for patents. Psilocybin Alpha runs a Psilocybin Patent Filings Tracker. Here’s a look at some of their most recently announced patents:
1. 2021-03-11, Aion Therapeutic, US Provisional Applications Filed (4)
“The patent applications include use of medicinal mushrooms for the treatment of human cancers including breast cancer, use of combination medical cannabis and medicinal mushroom preparations for the treatment of interstitial cystitis and other bladder diseases, and methods for producing emulsions and nano-emulsions for increasing bioavailability in these formulations.”
2. 2021-03-02, NeonMind, US Provisional Applications Filed (4)
“The provisional patent applications include data derived from NeonMind's initial preclinical trial that began in November 2020, which examined the potential use of psilocybin as a treatment for weight loss. NeonMind's proprietary preclinical data shows promise that both low and high dose psilocybin may reduce weight gain and that the reduction in weight gain can occur in a short period of time.”
3. 2021-02-05, Mindset Pharma, US Non-Provisional & PCT Applications Filed (3)
“applications cover a comprehensive range of novel diverse proprietary compounds designed to deliver similar therapeutic benefits to psilocybin with a lower overall metabolic liability and predictable duration of action, along with their related processing methods, potential compositions, and therapeutic uses”; “claim priority dates of the Company’s previously filed USPTO provisional applications, which were filed on February 4, 2020”
4. 2021-01-06, Mydecine, US Provisional Applications Filed (7)
“the developing patent portfolio from Mydecine is targeted at addressing the known shortcomings of psilocybin for medical uses and includes novel drug design and delivery mechanisms, precise doseable formulations and new technologies for improved use of psilocybin in a medical context”
5. 2020-12-15, Revive Therapeutics (acquired from PharmaTher), US Provisional Application Filed
“Psilocybin Pharmaceutical Combination Therapies” for “novel combinations of certain FDA approved drugs with psilocybin as a potential therapeutic option to reduce the side effects and improve the effectiveness of psilocybin to treat neurological disorders”
6. 2020-12-04, Lophora, US Provisional Application
“new chemical entity which has a different molecular scaffold from psilocybin but has the same ability to trigger biological responses via the serotonin 2A receptor with the difference being that [it] is selective… whereas psilocybin is a broad agonist that affects multiple receptors, this molecule … primarily activates the serotonin 2A receptor… theoretically we’ve got a molecule which is safer because we can specifically target 2A without touching 2B”
7. 2020-11-16, Revive Therapeutics (acquired from PharmaTher), US Provisional Application Filed
“potential novel use of psilocybin to treat cancer, which was discovered by panaceAI™, the Company’s proprietary psychedelic drug repurposing artificial intelligence platform. The patent application, entitled “Use of Psilocybin in the Treatment of Cancers”, outlines psilocybin’s use of significant unmet medical needs for Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms and Acute Myeloid Leukemia”
8. 2020-11-12, Silo Pharma, US Provisional Applications Filed (3)
“central nervous system delivery of unique anti-inflammatory therapeutics coupled with psilocybin”
9. 2020-10-20, Allied Corp., US Provisional Application Filed
“novel combination of psilocybin and proprietary mushroom formulation, as well as a novel treatment regimen targeting Post Traumatic Stress (PTSD), Depression and General Anxiety”; “novel micro-dose ratios of several medical mushroom compounds combined with additional natural health molecules”
10. 2020-10-07, Mydecine/NeuroPharm, US Provisional Application Filed
“psychedelic therapy enhancer,” for treatment of psychiatric disorders, including enhancements for PTSD, “that reduces the enzymatic breakdown of psilocin, the active ingredient in psilocybin that causes psychedelic effects,” and “may result in an enhanced psychedelic experience in the treatment of PTSD, whether by extended in time, intensity, intensity per dose, or a combination thereof”
11. 2020-09-29, Field Trip, US Provisional Application
“a novel psychedelic molecule derived from the chemical structures of known psychedelic substances. FT-104 is designed to provide unique and useful pharmacological features to make a commercially viable alternative to naturally derived substances such as psilocybin, DMT and LSD”
12. 2020-09-21, Flourish Mushroom Labs, US Provisional Application Filed
“methods of using serotonin agonists, in particular, psychedelic mushroom actives, for weight loss”; ” use of microdose administration of psilocin/psilocybin to have the additional weight loss effect of increasing metabolism which, combined with a decrease in food cravings or compulsive overeating, or altering food choices to less calorie dense foods, could result in substantial and beneficial weight loss”
13. 2020-09-18, PsyBio, PCT Application Filed
“methods for the production of psilocybin and intermediates and side products”; modular biosynthetic production platform for in vivo production of psilocybin in E. coli
14. 2020-09-14, Lobe Sciences, US Provisional Applications (3)
administration to an individual a psilocybin-derived agent and/or N-acetylcysteine via nasal delivery system, in combination with programmed virtual and augmented reality (VR, AR) simulations; aims to alleviate unwanted and emotions linked with PTSD or mTBI with PTSD; multiple VR devices can be used for group therapy sessions; VR device can be controlled remotely
15. 2020-09-03, Aion Therapeutic, US Provisional Applications Filed (5)
“new treatments combining healing compounds in medical cannabis with healing compounds from mushrooms (edible and psychedelic), and other natural plants known for their medicinal properties”; “formulation claims directed to methods of treating numerous conditions including cancer, psychiatric disorders, addiction (opioid and alcohol), viral diseases, obesity, and inflammatory disorders”
16. 2020-08-20, Psilera Bioscience, US Provisional Application Filed
“new chemical entities and delivery methods relating to psychedelics”
17. 2020-07-27, Mindset Pharma, US Provisional Application Filed
“groundbreaking process to synthesize psilocybin and psilocin”
18. 2020-07-09, MagicMed Industries, US Provisional Application Filed
“composition of matter, drug formulation and process of preparation claims for novel psilocybin derivatives”; “anticipated to be the first in a series of applications that together will protect the Company’s broad portfolio of novel psilocybin molecular derivatives, the Psybrary™”
19. 2020-06-04, NeonMind, US Provisional Application Filed
“therapeutic administration of psilocybin or psilocin (or analogs thereof) combined with supportive therapeutic treatment for a patient to provide weight loss benefits and treatment for related health issues”
20. 2020-05-26, Frontier Neurochem, US Provisional Application Filed
“novel proprietary tryptamine compounds and methods of use thereof”
21. 2020-04-29, Revive Therapeutics, US Provisional Applications
“methods of production of psilocybin-based formulations, including sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens)”; “Psilocybin extraction and crystallization methodologies”
22. 2020-04-04, Orthogonal Thinker, US Provisional Application Filed
“improved version of psilocin” named “Psilly”; “proprietary formula that uses natural, rather than biosynthetic, alkaloids”
23. 2020-03-27, Champignon Brands, US Provisional Applications (4)
“combination of psilocybin and cannabidiol in treating mTBI with PTSD or standalone PTSD”; “novel delivery systems”; treatments for PTSD and OCD that are “enhanced by timely measured dosages of psilocybin and cannabidiol”
24. 2019-12-04, CB Therapeutics, US Provisional Application Filed
“biosynthesis of psilocybin, psilocin and related tryptamine-based compounds typically found in plants and fungi”
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