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Psychedelic Patents

Compass Pathways Discusses Psilocybin Patents

Ekaterina Malievskaia, co-founder of Compass Pathways recently published a statement about the company’s psilocybin research program, including a section about “MANUFACTURING AND PATENTING” psilocybin. See MAPS website.  The statement appears to respond to the Statement on Open Science signed by many leaders in psychedelic research.  Recently, the U.S. Patent and Trademark Office granted COMPASS Pathways U.S. Patent No. 10,519,175, which covers methods of treating treatment resistant depression with a specific crystalline form of psilocybin.

In the statement Ms. Malievskaia explains that making an Investigational Medicinal Product (an “IMP”) is difficult and expensive and that sharing the product of that work could only be accomplished through standard licensing agreements, which protect Compass’s ability to “recoup the expenses” and “ensure the integrity of the data collected” by controlling who has access to psilocybin made through Compass’s manufacturing patents. 

Ms. Malievskaia notes that Compass’s intellectual property does not prevent members of the community from inventing different psilocybin manufacturing procedures, using other sources of the psilocybin, or buying Compass’s product. In other words, others will be excluded from using Compass’s (arguably better) manufacturing process unless they enter into some form of licensing agreement with Compass. The good news is that Compass will not have a monopoly on magic mushrooms as some journalists have contended.  

Below, the “MANUFACTURING AND PATENTING” section of Compass’s statement is reproduced with emphasis on several relevant portions used to synthesize the above summary.  

Statement from Compass

While psilocybin is a naturally occurring molecule, psilocybin as an Investigational Medicinal Product or IMP is a regulatory entity that includes a detailed description of a GMP-compliant, scalable and reproducible manufacturing process; associated preclinical data; and ongoing safety data collected in clinical trials. The IMP can be thought of as a product’s fingerprint, so that regulators can recognize the safety and efficacy evidence gathered in the clinical trials as it relates to this unique product. The creation of an IMP is an extremely complex and expensive* process that requires sustainable funding and a serious multi-disciplinary team effort. Based on our experience and the regulatory input from EMA, we now estimate that the development process will continue through marketing authorization and cost over £3 million (nearly $4 million).

In the process of synthesis, formulation and creation of preclinical data, we reached out to the researchers at Heffter and Usona with offers to share experience and ever rising cost, the last conversation being at PS17 in Oakland. Shortly after, the initial phases of the synthesis and formulation were completed, and psilocybin became the Investigational Medicinal Product. From that point on, for the reasons of data consistency, there was no regulatory acceptable mechanism of “sharing” it other than through standard licensing agreements for the use of IMP. This is the way clinical research regulation works around the world.

As the previously published synthesis processes did not scale to meet regulatory standards, we had to invent our own process. As he would have done for anyone who would have asked for his help, David Nichols advised our manufacturing team. With his support our team has solved over 60 distinct technical problems in the synthesis and formulation process. Some of these inventions became the basis for our manufacturing patents. In general, patents provide an opportunity for an organization willing not only to take a significant financial risk to recoup the expenses, but more importantly, to ensure integrity of the data collected before and after the approval.

Our patents do not preclude others from creating a range of different solutions for the synthesis and formulation of psilocybin; nor do they preclude the use of naturally occurring mushrooms, extracts, or any other products created by alternative synthesis and formulation routes. Equally, our patents do not prevent other clinicians from using our product or any psilocybin-containing products in conjunction with the types of therapy or psychological support they judge to be helpful, as long as it does not jeopardize patient safety. Lastly, neither our patents, regulatory strategy, nor pricing strategy have an impact on the practices of the underground community of practitioners in nonclinical settings.

Our exclusive contract with the drug manufacturer does not prevent others from choosing among many different competing manufacturers through the standard Request for Proposal (RFP) process. The advances of science may now offer new creative solutions for the synthesis and formulation of psilocybin with new partners for those who are willing and able to spend the time, effort, and funds to create an alternative psilocybin-based IMP.

While we have created the supply of psilocybin for our own research, we have made the unusual decision to share it with qualified independent researchers free of charge in exchange for being able to use their safety data. [Is something really “free” if the receiving party must provide valuable date “in exchange” for it?] This is not a commercial decision, but yet another way to accelerate the generation of clinically relevant evidence that may ultimately improve patient outcomes.

This process has proven to be challenging at times. As we have learned, university legal departments and technology transfer offices are vigilant about the potential Intellectual Property (IP) that might be created in the process of investigator-initiated studies. This IP, despite the best intentions of the researchers, does not belong to the scientists, who have limited say in how it is used by their institutions. In the event of IP creation, Technology Transfer Offices have a legal obligation to license it out to the ‘highest bidder’ with the most aggressive and scalable business model that will generate the most return for the academic institution. Even though such IP would be created by independent researchers with our IMP, in order to use the invention, we still have to compete with other commercial entities who might have different ethics or commercial goals.

This is an important consideration for the signatories of the Statement on Open Science and Open Praxis who work for academic institutions, as they need to align with their institutions on terms of IP licensing. The core principle of the statement is that knowledge created by signatories is open to all – that is, the knowledge is to be given away unconditionally by relinquishing researchers’ rights to protect it and to control who gets to use it after it becomes public.

We believe our patent strategy offers some protection against uses that may not be fully aligned with our mission to create access to innovative treatments for as many people as possible at an affordable cost to patients and health care systems.

*Our emphasis added above in bold.

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Psychedelic Patents

Has Flourish Mushroom Labs Revolutionized the Field of Psychedelics?

Yield Growth (now Better Plant Sciences Inc., CSE:PLNT) subsidiary Flourish Mushroom Labs appears to have discovered a fundamentally new use for the active compounds in magic mushrooms, i.e. psilocin and its prodrug psilocybin.

On December 10, 2019, Yield Growth Corporation announced that its subsidiary Flourish Mushroom Labs filed a U.S. provisional patent application relating to “methods of using serotonin antagonists, in particular, psychedelic mushroom actives, for weight loss.

This development is exciting for at least two reasons:

  1. Using active compounds from magic mushrooms as serotonin-2a (i.e., 5HT-2a antagonists) represents an entire new area in psychedelic research.
  2. This departure from the accepted knowledge about psilocybin/psilocin suggests that Flourish Mushroom’s new use of these compounds as 5HT-2a antagonists will likely result in patentable subject matter.  (Inventions that represent a major departure from accepted knowledge are usually considered “non-obvious” during examination at the patent office.)

According to the press release, the Flourish Mushroom Labs patent application pertains to administering psilocin and/or psilocybin to provide an overall weight loss in individuals.  The weight loss is achieved by reducing food cravings, counteracting compulsive overeating, and aiding in improving quality of diet by altering food choices. The application also attempts to claim methods of administering “microdoses” of psilocin/psilocybin to provide weight loss by “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.” Yield Growth also claims that “the Flourish Mushroom Labs pending patent also covers the use of psilocin/psilocybin in treatment or regulation of diabetes, and regulation of blood glucose and to reduce susceptibility to cardiovascular disease, high blood pressure, diabetes mellitus and other illnesses associated with obesity.”

Yield Growth’s New Approach to Psychedelics as Serotonin Receptor Antagonists.

According to Yield Growth’s press release about Flourish Mushroom Labs Provisional Patent Application, “Psilocin/psilocybin is known as 5-HT2A agonists or partial agonists.”

Psilocin is a known 5HT-2A agonist.  Psilocybin is recognized as an inactive prodrug of psilocin, i.e., neither an agonist or an antagonist.

Yield Growth’s description of Flourish Mushroom’s patent application is as follows: “U.S. PATENT TO USE SEROTONIN ANTAGONISTS FROM PSYCHEDELIC MUSHROOMS FOR WEIGHT LOSS.”

Although neither Yield Growth’s website nor the press release provides detailed information about the technology, the use fo psilocybin/psilocin as a 5HT-2A antagonist represents a significant departure from previous approaches.  To date, all other research has focused on using psilocybin as a prodrug of psilocin, thereby providing psilocin as a 5HT-2A agonist with an increasing number of applications.

This development highlights the tremendous opportunities for making new fundamental breakthroughs in the space.  It will be fascinating to follow Yield Growth and Flourish Mushrooms as they develop this new technology, which seems to defy accepted wisdom about psilocin’s method of action.

Categories
Psychedelic Patents

Silo Wellness Announces Patent Pending Psilocybin Formulation

Silo Wellness just announced the world’s first metered-dose magic mushroom nasal spray. The nasal spray formulation was designed to provide users with rapidly absorbed and predictable doses of “full spectrum” magic mushroom compositions.  According to Silo Wellness founder, Mike Arnold, the new formulations were made to address an unmet need for precision dosing: “This is a business problem in need of a solution.  I reached out to my long-time colleague from the marijuana space, brilliant inventor Michael Hartman, and we agreed that we need to be able to give patients predictable dosing so they can self-titrate into the desired levels of sub-psychedelic or psychedelic treatment.”  

The inherent chemical variability of naturally occurring magic mushrooms has been a longstanding unmet need for people wishing to consume precise and reliable amounts of full spectrum psilocybin composition.  See State of the Art for Microdosing Psychedelics. To date, the existing options have been either (a) consume mushroom fruiting bodies or (b) consume a single purified chemical. The former fails to provide precise or reliable doses of known ingredients; the latter fails to provide the synergistic benefits of full spectrum mushroom compositions.  See Entourage Effect.  We have previously pointed out that the future of the magic mushroom industry will be formulated tryptamines.  Paul Stamets recently expressed a similar view regarding the benefits of “standardized” doses on the Joe Rogan Podcast #1385.

Silo Wellness’s Patent Strategy

Silo Wellness is also clear about its aggressive intellectual property strategy, which has become in important consideration for investors in the psychedelic space.  Silo Wellness’s webpage emphasizes its “Provisional Application for a Patent for metered dosing formulations” and directs readers to an entire page dedicated to Intellectual Property.  On its intellectual property page, Silo Wellness explains: “We have filed [in July 2019] a provisional application for a patent to cover metered dosing formulations of plant and fungal compounds for oral, nasal, sublingual, and topical use. We are developing solutions for metered dosing for mushrooms, Ayahuasca/DMT, and peyote/mescaline.”  The intellectual property was apparently developed by Michael Hartman, who has developed extensive metered-dose inhaler IP for other pharmaceutical companies. Examples of Mr. Hartman’s metered dose technology can be found here and here.

Silo Wellness further highlights it’s IP-guided strategy by describing its dual focus on technology and IP:  “The problems we are attempting to address through protectible IP (patent and trade secrets) are as follows: 1. How to deliver a predictable and safe experience; and 2. How to make them palatable.

Foreshadowing a Patent Licensing Strategy?

According to their webpage, Silo Wellness “intend[s] to be directly involved through ownership interests, product licensing agreements, and management contracts in the cultivation, manufacturing, and therapy dosing in this emerging space.”  Silo Wellness’s description of their Nasal Spray formulation also includes a section about “Licensing the Technology for Manufacturing,” where the company invites discussions about licensing their IP.

“If you have a lab in Jamaica or are otherwise interested in licensing our technology in advance of legalization in your home jurisdiction, please contact our team for available territories.”

Although Silo Wellness frequently mentions its intellectual property and licensing strategy, there is no information about the scope or contents of its patent portfolio.  The webpage states that their provisional patent application was filed in July of 2019, suggesting that the content of that patent disclosure will not publish until about January of 2021 (18 months from the earliest priority). Presumably, the IP is centered around “metered dosing formulations,” leveraging Mr. Hartman’s expertise with metered dose inhalers.  However, it is not clear what chemical compositions will be used in the metered dose inhalers or whether those compositions are subject to patent protection by Silo Wellness or another entity, like Paul Stamets who holds multiple earlier-filed patent applications on magic mushroom compositions.

Conclusions – The Patent Race has Begun

On August 28, 2018, the Waking Times published an article explaining that “The Race to Patent Magic Mushrooms Heats Up.”  Since that time, there have been murmurings about different entities filing patent applications on magic mushroom formulations or related technology.  But, with their heavy emphasis on patent strategy, Silo Wellness has confirmed earlier suspicions that the patent race has begun in the psychedelics industry.  Here, Mike Arnold refers to the “Shroom Boom” as the “New Cannabis Green Rush,” adding that the peer-reviewed studies are even stronger.  However, Mr. Arnold further notes: “When everyone is running in one direction, that’s the last place an entrepreneur or investor wants to be. If you were on time for cannabis, you were already too late.”  Given that patents are awarded to the first inventor to file, do these signs of the psychedelic patent race indicate that it’s already too late to make a meaningful IP play in the space?