Psychedelic Patents; Psychedelic Infrastructure; Psychedelic Botanicals
There were several developments this week worth touching on:
The U.S. Patent Office’s Patent Trial and Appeal Board upheld a patent awarded to Compass Pathways after it had been challenged
The Board of Psychedelic Medicines and Therapies officially launched last week with a $900K matching grant from the Steven & Alexandra Cohen Foundation
An editorial published on the Journal of the American Medical Association’s website highlights the need to build the infrastructure for psychedelic-assisted therapy
The Oregon Health Authority has approved five facilitator training programs
A naturally-derived psilocybin product is heading for clinical trials
Let’s work through these developments and see if we can make some sense.
Psychedelic Patent Melee
Two decisions this week from the U.S. Patent office landed on the side of psychedelic drug developers.
MindMed was awarded a patent for the combination of MDMA and LSD:
“A method of enhancing positive therapeutic effects of a psychedelic, by inducing a positive psychological state in an individual with an empathogen/entactogen of MDMA administered in a dose of 20-200 mg, administering a psychedelic to the individual, and enhancing a positive response to the psychedelic. A composition including an entactogen/empathogen and a psychedelic in the same dosage form.”
“At the end of last year, the non-profit Freedom to Operate challenged two [Compass] patents on a synthetic form of psilocybin, the active ingredient in magic mushrooms…
Yesterday, the PTAB released its decision: There will not be a trial over Compass patents, and it agreed with Compass’ interpretation of its patents and its claims. There is no right to appeal this decision, unlike court decisions.”
The takeaway, as I understand it from available expert comments I have seen:
The MindMed patent is an example of an overly-broad patent. As it stands, any combination of an entactogen and a psychedelic in a single dose would be an infringement.
The Compass patent, on the other hand, is narrow enough so that, according to attorney Jack Griem of Freedom to Operate, quoted in VICE, “Manufacturers of psilocybin now have a clear pathway for making sure that psilocybin they manufacture or sell is not at risk of infringing Compass’s ‘Polymorph A’ patents.” (Just before sending this email, Freedom to Operate published this press release.)
Mason Marks published a good primer in the Harvard Law Review about the challenge of patents in the psychedelic domain. He succinctly captures the matter in the introduction:
“Because they were criminalized for decades, the U.S. Patent and Trademark Office (PTO) lacks personnel with expertise in the field, rendering more questionable the quality of its evaluation of psychedelic patents.
Prior art refers to evidence that an invention or technology existed before a patent application is filed.
A cardinal issue in the psychedelic space is that the prior art relevant to psychedelics is not in the common databases that patent examiners look at because of their illegality.
The non-profit Porta Sophia was created to address this issue. Porta Sophia collects prior art relevant to psychedelics from many sources (internet forums, old research, etc.) and catalogs it into a searchable database so that patent examiners can easily find it.
Candyflipping, the colloquial term for combining MDMA and LSD, is apparently not in the common databases that patent examiners use; however easily encountered if you know where to look.
What Does This Mean?
Here is a hypothetical that comes to mind.
Let’s say an academic researcher receives a grant for a head-to-head comparison of single-dose MDMA+LSD against psilocybin for the treatment of depression.
This hypothetical researcher has the option of using psilocybin manufactured by Compass, Usona, Mydecine, Psygen, and others.
But because the trial evaluates a combination of an empathogen/entactogen and a psychedelic in a single capsule, does this mean they need to procure MDMA+LSD from MindMed?
Does it mean that MindMed would automatically own any data generated by this trial?
According to Pechenik, it seems that it would:
Psychedelic Infrastructure Developments
There were three noteworthy developments related to the infrastructure necessary for rolling out psychedelic-assisted therapy:
Oregon Health Authority Approves the first Five Facilitator Training Programs
From Inner Trek’s LinkedIn:
“Two weeks ago, InnerTrek got the first-ever government stamp of approval to begin training Psilocybin Service Facilitators! Our training program and curriculum is officially approved by the Oregon Health Authority. It’s a new era in the struggle for legal access to psilocybin…
As of this writing, there are five approved training programs listed on the OHA website:
“BPMT was recently established to certify healthcare professionals in psychedelic-assisted psychotherapy in the United States, which will help standardize the clinical quality of psychedelic-assisted psychotherapy treatments, enhance patient safety, increase provider accountability, and facilitate reimbursement by insurance providers.”
CEO Scott Shannon was on the Psychedelics Today podcast to mark the occasion and give insight into the role it seeks to assume in this emerging landscape. It is worth the listen, especially if you’re a therapist or clinician.
From JAMA: Applying Lessons From Cannabis to the Psychedelic Highway: Buckle Up and Build Infrastructure
This article used the shortcomings of the cannabis legalization movement to suggest that psychedelics take a therapy-first approach:
“Drawing from the lessons of cannabis, we advocate that psychedelic policy move beyond the cannabis liberalization movement’s emphasis on drug access…Thus, pragmatic and safety-oriented policy should focus on minimizing harm and maximizing benefits by developing appropriate therapeutic infrastructure—the regulatory equivalents of seatbelts, traffic lights, and speed limits. We offer recommendations to address this goal.”
The authors make three core suggestions that any policy efforts should consider:
Focus on the training of guides/therapists/facilitators
“as with cannabis, few monitors are trained to skillfully manage psychedelics clinically, highlighting the need for expanded educational opportunities for interested monitors and students.”
Scientific study and policy should focus on expanding the patient-to-therapist ratio and group facilitation options.
“the extensive time commitments required for monitors to provide this intervention creates an accessibility problem. Creative policy could expand availability considerably.”
Leverage Real-World Data
“implementing systematic data collection on treatment outcomes and adverse events in locations where decriminalization has occurred, such as Oregon.”
In 1984 the FDA started getting so many botanical applications that they created guidelines for applicants developing Botanical Drugs.
Botanicals are naturally heterogeneous mixtures that often lack distinct active constituents, so more than one constituent may contribute to the therapeutic effect. Drug development is even more challenging if you can’t titrate the dosage of the active agent.
And this has proved to be a problem for botanical drug developers:
“The United States FDA has received over 800 botanical investigational new drug applications (IND) and pre-IND meeting requests (PIND) in the years preceding 2018… Despite increasing global interest in the investigation of botanical mixtures as drug products, only two botanical new drug applications (NDA) have been approved in the U.S.
However, a botanical made from psilocybin-containing mushrooms with a quantifiable active ingredient could change this trend.
This is what Filament and other naturally sourced developers of psilocybin are hoping to accomplish.
“This is the first study of any psychedelic botanical product; that alone is a big deal to me,” said Dr. Joshua Woolley, a UCSF professor who leads the university’s Translational Psychedelic Research Program (TrPR). “Because of the millions of people that have used this drug, the vast majority are taking mushrooms that have been grown. But the number of clinical trials using mushrooms is zero.”
Filament also announced a partnership with Jaguar Health to develop additional botanical drugs:
“Under this partnership, Jaguar will have responsibility for the identification of plants that may offer novel mechanisms of action, as well as for botanical drug development and the raw material supply chain. Filament will be responsible for developing the manufacturing techniques required to produce standardized, pharmaceutical-grade drug candidates. The two companies will then jointly seek partnership with a potential licensee for full development and commercialization of novel drug candidates, with proceeds from the relationship split equally between Jaguar and Filament.”
We covered Jaguar Health back in October 2020 in Botanical Pharmaceutical Co. Enters Psychedelic Space.
Notably, Jaguar Health developed one of two FDA-approved botanicals.
Atlas of Psychedelic Research
Our friends at Blossom developed a psychedelic research tracker. A helpful tool as the amount of research seems to be increasing at an increasing rate!
From PsyMed Ventures: 16 tech startups making psychedelic therapy more effective and affordable
“We also believe technology will be a key driver to bring down costs and improve outcomes. In the future, therapists will leverage technology to support patients outside of the clinic, incorporate biomarkers for diagnosis, and optimize patient outcomes. In this post, we highlight technology companies that will help deliver psychedelic therapy efficiently, safely and affordably. These companies fall into six categories: Patient management software, Telehealth, Virtual Reality (and Extended Reality), Digital biomarkers, Therapist training, and Neurotech. This is a non-exhaustive list that we’re sure will grow.”
From The New York Times: After Six-Decade Hiatus, Experimental Psychedelic Therapy Returns to the V.A.
“the F.D.A. said there are formidable challenges to establishing the safety and efficacy of medicinal psychedelics. For starters, there is no easy way to run studies with a placebo control because the sensory effects of the drugs are evident to participants and researchers. The F.D.A. has also cautioned that patients might walk away from psychedelic sessions in a “hyper-suggestible” state, which could lead to a merely short-lived sense of improvement.”
The Psychedelic Integration Scales: Tools for Measuring Psychedelic Integration Behaviors and Experiences
“We created the Integration Engagement Scale (IES) to capture positive behavioral engagement with integration and the Experienced Integration Scale (EIS) to capture internal aspects of feeling integrated. These scales were developed to measure post-acute psychedelic administration dynamics in order to inform the creation of enhanced integration support and to help refine a general conceptual understanding of the construct of psychedelic integration.”
That’s it for this week! Thanks for reading!