- 📜 Patents: COMPASS Survives Challenges; MindMed Secures Candyflipping IP
- 🏥 Will Psychedelics Companies Step Up to Protect Access to Abortions?
- ⚖️ Colorado’s Initiative 58 Could Represent Most Progressive Psychedelic Drug Policy Reform in U.S.
- 🎖️ Psychedelic Therapy Returns to the VA
Join us at ICPR’s Psychedelic Science, Ethics & Business Event in Amsterdam
As part of the 5th Interdisciplinary Conference on Psychedelic Research (ICPR) organisers are convening a whole day dedicated to exploring the intersection of psychedelic science, ethics and business.
Our Editor Josh Hardman will be attending the event and giving a talk, and we would love to see you there.
Use the code PA100 for €100 off your tickets. Head here for more info and to purchase.
Psychedelic Sector News
Patents: COMPASS Survives Challenge; MindMed Secures Candyflipping IP
Psychedelic patents never fail to generate debate, and last week was no exception. Two developments—the successful defence of a granted patent and the granting of a new patent—are worthy of discussion here.
In both cases, some folks argue that the drug developers have secured patents covering formulations that are well-characterised in the prior art (i.e., they already existed in the public domain). The USPTO thought otherwise…
COMPASS Pathways Survives Challenges to Patents
Two post-grant review (PGR) petitions against COMPASS Pathways’ patents from Freedom to Operate (FTO), a non-profit group dedicated to “protecting psychedelic science and medical development for public benefit,” have been thrown out.
The PGRs sought to challenge COMPASS Pathways’ patents on Polymorph A, which are understood to cover its crystalline forms of psilocybin including COMP360 (the investigational new drug the company hopes to advance to Phase 3 this quarter).
This is an unreserved win for COMPASS, with the Patent Trial and Appeal Board (PTAB) siding with COMPASS on both of the claim constructions, and finding each of FTO’s invalidity arguments unsupported and unpersuasive. As such, PTAB refuses to institute a trial, and as such COMPASS’ patents survive on all counts.
As part of the decision, the Board determined that Polymorph A is characterised by X-ray powder diffraction (XRPD) peaks at 11.5, 12.0, 14.5, 17.5 and 19.7, within the recited variance of “±0.10°2θ” according to the claims’ “plain and ordinary meaning without additional experimental error.” In a statement released after the decision, FTO asserted that this “extremely narrow interpretation of Compass’s patent claims will provide generic manufacturers of psilocybin with wide latitude to produce and commercialise psilocybin without risk of violating the Compass patents.” (Although we note that broader peaks could have invalidated COMPASS’ patents based on the prior art, as the Folen 1975 reference relied on by FTO teaches peaks at 17.7 and 19.5°2θ—within ±0.2°2θ of 17.5 and 19.7°2θ, but outside the variance of ±0.10°2θ.)
Note: A separate point of uncertainty regarding how certain COMPASS’ patent claims may be enforced is whether only pure Polymorph A formulations will be deemed to infringe, or whether mere trace amounts of Polymorph A found in any formulation of synthetic psilocybin may also infringe. We discussed this late last year:
🧾 COMPASS’ 5th U.S. Patent | Our editor-at-large Graham Pechenik broke the news that COMPASS Pathways has received notice that its fifth U.S. patent now has a patent number and issuance date, November 23. Certain claims cover administering psilocybin that “compromises a crystalline Polymorph A,” but the crucial question now will be: “how much?” Might trace amounts of crystalline Polymorph A constitute an infringement, Pechenik asks?
For further coverage of this development see Shayla Love’s reporting in VICE.
Community Flips Out at MindMed’s Candyflipping Patent
Last week, our Editor-at-Large Graham Pechenik broke the news that MindMed (via its agreement with Matthias Liechti’s lab at University of Basel) has been granted a US patent that covers, among others, the combination of MDMA and LSD. Specifically, the patent has claims to:
“A composition comprising an empathogen/entactogen and a psychedelic in the same single oral dosage form.”
According to Pechenik, given the grant of this patent MindMed now has the exclusive right to make, sell and use:
any “single oral dosage form” of
an “empathogen/entactogen,” e.g., MDMA, MDA, MDEA, MDAI, 3-MMC
a “psychedelic,” e.g., LSD, mescaline, DMT, DOI, DOB, and “phenethylamine or tryptamine psychedelics”
The practice of ingesting MDMA and LSD concurrently is colloquially known as candyflipping, and is certainly not a new invention.
So, how on earth was this patent granted?
Well, according to MindMed the patentable invention is the combination of the entactogen and psychedelic (MDMA and LSD, for example) in “the same single oral dosage form”. This sought to differentiate from “recreational users”, who the patent says “use MDMA and MDMA in separate dosage forms” (which remains in the public domain).
The application used the example of a clinical trial that saw the co-administration of MDMA and LSD (which we reported on in January 2021). But, as Pechenik points out, the coadministration was not achieved via a single oral dosage form: rather, LSD was administered in pre-prepared vials, and MDMA via capsules.
Regardless, one might hope that the enormous amount of prior art on the coadministration of LSD and MDMA (candyflipping) would preclude a patent like this. Moreover, as neuroscientist and researcher Matt Baggott points out, there are also “tons of examples of people putting LSD and MDMA in the same oral preparation.”
The self-styled “psychedelic prior art library” Porta Sophia sought to thwart this patent (which is assigned to MindMed’s collaborator, University of Basel) by filing a third-party preissuance submission earlier this year. According to the group, the submission included “21 prior art documents that are material to the patentability of the application’s 28 claims”.
However, MindMed in effect side-stepped this submission, because it had already split off a sister application for which it sought accelerated examination. The accelerated application was allowed a week later. It’s unclear whether Porta Sophia’s challenge will make any impact whatsoever, given that it pertains to the still-pending original application: MindMed may simply abandon it.
But, one may ask, why was the Porta Sophia challenge not cited in the allowed application? Surely that information could be deemed relevant to the examiner?
Aside from claims to the combination itself, the granted patent also covers methods of use that include the treatment of psychiatric disorders such as depression, anxiety, OCD and addiction.
Aside from the obvious concerns (both ethical and in terms of USPTO’s apparent incompetence) regarding patenting something that is readily found in the prior art (see our February 2022 piece on a patent covering DMT vapes), the commercial value of this patent is also unclear.
As Matt Baggott also points out, there’s an obvious workaround here: “just using two pills”. This might even be more desirable, given that one is able to “control doses and timing” more precisely than with a single pill.
This granted patent also raises questions about the patentability of others’ pending patents, such as CaaMTech which has a pending application with claims including compositions of MDMA and LSD.
Will Psychedelics Companies Step Up to Protect Access to Abortions for U.S. Employees?
Following the reversion of Roe v Wade in the U.S. Supreme Court on Friday, some abortion clinics are already closing their doors. Many more will follow as trigger laws in thirteen states will see abortion banned within thirty days.
Given that many Americans will now be unable to access abortion services in their home state, some are looking to charities and employers to cover the expenses of travelling to access such care.
We’re keeping an eye on whether psychedelics companies choose to offer such support for their employees.
The first psychedelics company to prominently respond to the news was Thiel-backed atai Life Sciences, which issued a short statement on its corporate LinkedIn profile, writing:
“We at atai are committed to ensuring that everyone, everywhere has access to the care they need. Please be kind to each other today.”
In a similar vein, the company’s CEO, Florian Brand, wrote on his personal LinkedIn:
“We at atai Life Sciences will do everything we can to support and protect our team members’ rights to fundamental healthcare. Let’s all commit to working together to right a wrong and make sure #healthcare remains a right – not a privilege – for everyone, everywhere.”
COMPASS Pathways co-founder Ekaterina Malievskaia, meanwhile, wrote on her personal LinkedIn:
We haven’t learned from decades of the War on Drugs. Now, we’re waging a War on Women’s Health.
Loss of access to reproductive health care will disproportionately affect marginalized communities and women in abusive relationships. The consequences of this decision for individual women, healthcare providers, and American society are simply unimaginable.
COMPASS told Psychedelic Alpha that the company “will cover the costs of travel for those seeking an abortion who cannot access the procedure legally in their home state.”
While both atai and COMPASS are headquartered in Europe (UK and Germany, respectively), both have a substantial presence in the U.S. They’re also two of the largest psychedelics companies.
Also speaking to Psychedelic Alpha, Field Trip‘s Ronan Levy explained that the company is in the process of evaluating options to support its employees in states that may subsequently deny abortion access.
Beyond individual companies, psychedelic VC Brom Rector suggested that the industry writ large “can vote with our wallets and refuse to bring tourism dollars to states that restrict abortion access.” Presumably referring to Microdose’s forthcoming Wonderland conference in Miami, Rector went on to explain:
“Miami is an amazing place for a conference, and everyone that attended Wonderland last year had a blast, but it feels wrong to spend money in anti-abortion jurisdictions – especially when there are other locations available.”
Point of Clarification: Mydecine’s Smoking Cessation Trial Has Not Commenced
There’s been quite a bit of chatter in this past week around Mydecine’s planned trial of its MYCO-001 psilocybin for smoking cessation. To be clear: the Mydecine-sponsored trial has not commenced.
Rather, an academic-sponsored trial using Mydecine’s MYCO-001 has been cleared by the FDA. Even Bloomberg’s reporting misrepresented the facts, as we noted on Twitter (and had confirmed by Mydecine).
Featured Psychedelic Jobs
Colorado’s Initiative 58 Could Represent Most Progressive Psychedelic Drug Policy Reform in US
Two psychedelic-related initiatives could be on the ballot in Colorado this year, reports Jacob Curtis for the Denver Channel.
While Initiative 61 is cut from the Decriminalize Nature cloth, Initiative 58 – the Natural Medicine Health Act of 2022 – is deemed to be far more progressive than other psychedelic drug policy reform initiatives (see our Tracker).
The Initiative would see psilocybin, DMT, iboga and mescaline-producing cacti decriminalised for adults engaging in personal use, possession, cultivation (at home) and sharing. Beyond simple decrim., the Initiative would establish a regulated model for psilocybin access by 2024, with regulated access to DMT, iboga and mescaline readied for 2026. This regulated model would be Oregon-esque in the sense that people would use psychedelics on-site, as opposed to the take-home, dispensary model seen in cannabis.
Particularly progressive elements include provisions for the sealing of prior convictions records pertaining to these four psychedelics; mandatory representation of people of colour on the rules taskforce; sliding scale requirements for clinics with the aim to make such provisions accessible to those on low incomes; explicit acknowledgement that psychedelic use in-line with the Initiative does not constitute child abuse; and, protections for those on probation or parole.
Psychedelic Alpha understands Natural Medicine Colorado will submit the completed petition for Initiative 58 this week, meaning it will appear on the 2022 Colorado Ballot in November.
NY Times: “Experimental Psychedelic Therapy Returns to the V.A.
After a six-decade hiatus, a series of clinical trials employing psilocybin and MDMA “represent a resurrection of promising research abandoned in the 1960s,” writes Ernesto Londoño for the Times.
And, these trials aren’t just looking to tackle PTSD; they’re also targeting substance use disorder and other indications common among veterans. “This is a watershed moment […] a time for a lot of hope,” said Dr. Rachel Yehuda.
Stuck behind the paywall? Axios has a neat summary.
Note: Londoño is working on a book about psychedelics and mental health tentatively titled, “Trippy: Unearthing the Past, Peril and Promise of Medicinal Psychedelics”.
BBC Reel: “Can ‘magic mushrooms’ and MDMA cure depression?” (10 mins)
This short documentary from the BBC looks at how the combination of psychotherapy and psychedelics “has effectively treated depression, PTSD, and more.”
Viewers hear from researchers like Anthony Bossis, as well as patients undergoing these treatments.
Rolling Stone: “How an NHL Enforcer Broke His Body — and Turned to Psychedelics to Heal His Brain”
“Over eight years playing pro hockey, Riley Cote suffered countless blows to the head. Now he’s preaching the power of psilocybin to help treat the effects”
The story involves another NHL player that will be known to many readers: Daniel Carcillo, who currently heads up Wesana Health. In fact, Cote introduced Carcillo to psilocybin:
“Cote made arrangements for Carcillo to attend a mushroom ceremony in Colorado, a decriminalized state. That first experience, says Carcillo, included the spiritual sensations that psilocybin is known to induce — and something more. A few days later, Carcillo realized that he could start crossing off symptoms: light sensitivity, slurred speech, his suicidal feelings giving way to hope.”
Psychedelics as Narrative Accelerants?
An interesting piece in The Wall Street Journal explores the increasing presence of psychedelics in novels, with a psychedelic trip potentially representing a “transformative plot device” that provides a “new way to dramatize deep confrontations within the self”.
But, just as many warn that psychedelics are no panacea for mental health, William Brewer (a novelist interviewed for the article) argues that psychedelic therapies are no silver bullet for fiction writers, either: they’re no “deus ex machina plot device,” he notes.
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