State Policy Updates; Terran Sues Compass; Canadians Sue Government
Programming Note: we’ll be off next week, preparing a new website and some other offerings we’re excited to share!
Here’s a peak at what’s inside today:
State Level Updates from California, Colorado, and Oregon
Terran Biosciences sues Compass Pathways
Canadian’s Sue Canadian Government for Psilocybin Access
State Level Updates from California, Colorado, and Oregon
Colorado: Initiative 61 falls short
In Colorado, Initiative 61, the Decriminalize Nature effort, failed to collect the 125,000 signature requirement to appear on the November ballot.
The Secretary of State's office confirmed backers submitted 5,001 signatures, far short of the minimum number needed to qualify for the ballot.
Initiative 61 would have been the second psychedelic ballot initiative in Colorado this Fall—the Natural Medicine Health Act, Initiative 58, secured enough signatures just a few weeks ago.
Initiative 58, if passed, will establish a legalization framework for supported use, similar to Oregon, as well as the decriminalization of possession, cultivation, and non-monetary exchange of several psychedelic plant species.
Oregon: Opt-Out Update & Training Program
The deadline for Oregon localities to include opt-out measures on November’s ballot is next week, august 19th.
Marijuana Moment Reports:
As of early August, 24 counties—including four in which voters in 2020 approved Measure 109, which allowed the use of psilocybin in clinical settings—have placed opt-out measures on the ballot or are doing so.
Eight counties have chosen not to refer an opt-out measure to the ballot. In those counties, Measure 109 will go into effect in 2023, although cities and counties can regulate the service centers.
Four counties are undecided. The deadline to place a measure on the general election ballot is August 19.
Yesterday, Sam Chapman, former campaign manager for measure 109, tweeted that Yamhill County decided not to include an opt-out in the November ballot:
California: Senate Bill 519
As we noted last week, all eyes are on California’s Bill 519, a measure to decriminalize the possession, consumption, cultivation, and non-monetary exchange of several natural—and synthetic—psychedelics, as it moves through the state legislative process.
Yesterday the Assembly Appropriations Committee approved the bill, setting up a “do-or-die” vote on the Assembly floor, the San Joaquin Valley Sun reported:
“Amid last-minute votes in a powerful committee, a bill seeking to legalize possession of certain psychedelic drugs is headed to the floor of the California State Assembly…
Thursday, the Assembly Appropriations Committee – the final committee needing to weigh-in in the lower chamber – ushered the measure forward…
The vote sets up a do-or-die passage vote in the Assembly before returning to the Senate for a possible concurrence vote to clarify amendments included or removed during debate in the Assembly.”
Last night, the bill’s author, state senator Scott Wiener, tweeted:
Psychedelic Patent Wars Heat Up
Terran Biosciences is suing Compass Pathways.
According to the suit, University of Maryland researcher Scott Thompson disclosed trade secrets related to the “co-administration of psilocybin with a 5-HT2A antagonist” to Compass under NDA during conversations, presumably about Compass licensing his work, which never came to pass.
Terran Biosciences, who ultimately licensed trade secrets from Thompson, is now claiming that Compass included these trade secrets in their own patent filings.
Psychedelic Alpha had early coverage of the development on Twitter:
Stagnation and Legal Plasticity
This is a good opportunity to touch on two ideas about patents and intellectual property in psychedelics:
Psychedelics a plastogenic agents
While intended to protect and incentivize novel, useful, and non-obvious inventions, the patent system has ironically become the source of innovation stagnation.
As psychedelic attorneys Graham Pechenik and Chris Byrnes layout in a recent MAPS Bulletin:
“The current controversy over patenting psychedelics is therefore nothing new. “Attempts to patent therapeutic methods invented by others” may be “capitalism gone rogue” (Doblin, 2021), but they’re from the same rogues’ gallery we’ve had since the start—what are euphemistically called “low quality” patents, overbroad and claiming ownership of what is properly in the public domain. The dangers are proven. Conferring market power without public benefit, such patents chill healthy competition and can increase prices and reduce access, lead to rent-seeking infringement disputes, and deter further research and development.”
The article goes on to cite the shadow side of revolutionary inventions:
“For instance, James Watt, a key inventor of the steam engine, famously used his 1769 patent to fight all attempts at competition, suppressing advancement in the field for 31 years—as his engine improved little, and its use remained limited to pumping water out of mines (Boldrin et al., 2008)….
The Wright Brothers, similarly, turned their 1906 patent on a “flying machine” into eight years of litigation against competitors (Trainor, 2015). Distracted by expensive litigation, innovation languished, and the industry developed outside their patent’s range in Europe. By World War I, U.S. aviation lagged so far behind that American pilots initially flew European planes (Nocera, 2014).
Time and again, scorched-earth battles consumed entire emerging industries.”
Unfortunately, it seems clear that pharmaceutical psychedelics are on track for such stagnation.
And perhaps it will be even worse because of the vast amount of prior art created under prohibitionist drug policies and documented on websites and forums unfamiliar to drug developers or patent examiners.
However, the unique feature of the psychedelic ‘industry’ is that while high-profile pharmaceutical developers slug it out over patents, the black and gray markets, where anticompetitive legal battles cannot be levied, are flourishing.
I am fully aware of the risks of overextending metaphors and am myself leery (and weary) of narratives of psychedelics as agents of societal salvation.
However, consider the following circumstances:
the complete failure of the War on Drugs
the growing mental health crisis
the dearth of innovation in treatments for mental illness
Is it conceivable that if patent squabbles hold up psychedelic pharmaceutical development and hinder healthcare system access, it could lay the groundwork for patent reform?
Recent evidence suggests that barriers to access for veterans and the terminally ill was sufficient to galvanize bipartisan support for The Right to Try Clarification Act—is there an analogous feature of the patent system that lends itself to similar targeting?
In other words, just as psychedelics potentiate structural and functional changes in the brain, does their introduction to the mainstream lend itself to structural and functional changes in mainstream institutions?
This metaphor can’t be this scalable, can it?
Canadian’s Sue Canadian Government
From Bloomberg’s The Dose:
“A Canadian lawsuit over magic mushrooms could help spur the wave of liberalization the nascent industry has been pushing for. So just who is behind it, and what are its prospects?
Filed in late July, the lawsuit challenges the Canadian federal government to make it easier for medical patients to get access to psilocybin, arguing that current regulations violate their constitutional rights. Brought on behalf of eight individuals with conditions such as depression, cancer and chronic pain, the lawsuit came together with the help of TheraPsil, a Victoria-based nonprofit that helps patients access psychedelic drugs through Canada's current bureaucratic process of applying, one patient at a time, for government approval.
The case isn’t expected to see trial for another year or so, but if it succeeds, it could force Canada to set up a legal framework for medical psilocybin, similar to the one it established for medical marijuana in 2001. And, just as with Canada’s early adoption of medical marijuana, it could be a harbinger of more open access in the US and beyond.”
Legal access to psychedelics for the terminally ill is a frontline strategy to change current drug policy. This is how cannabis reform started since it is such a convincing cause.
In the U.S., this issue is playing out in the courts and the senate and has a broad coalition of support and an area of rare bipartisan agreement.
As we noted in Right to Try: A No-brainer, the culture is embracing psychedelics whether laws change or not, therefore:
“…legal access to psychedelics through Right To Try could be the perfect, gradual onramp for creating the clinical infrastructure for Psychedelic Assisted Therapies in a small, specific patient population in anticipation of FDA approval and the deluge of expected demand.”
UK Petition to Reschedule Psilocybin
A petition to reschedule psilocybin in the UK has gained over 5,000 signatures in its quest for 100,000.
The petition seeks to:
“Move psilocybin (the psychoactive compound found in “magic mushrooms”) to Schedule 2 of the Misuse of Drugs Regulations 2001, reducing unnecessary barriers to scientific research which slow the development of new and vital treatments for a range of physical and mental health conditions in the UK.”
Lucid News: What Happens when Psychedelics Meet Video Games?
“The trick is to Trojan Horse something into their world that’s comfortable, accessible, and appealing. Hide it within something that is a mirror, allowing them to cultivate more bravery instead of diving deeper into the fantasy. Create something that looks like what they’re drawn to, something visually or narratively stimulating enough for them to continue engaging in the number behavior. However, there’s also a core feedback loop there that engages them in a way that naturally gives them strength.”
Microdose: Pay-For-Success Contracts: An Open Source Alternative to Psychedelic Patents
“The potential for PFS contracts to address the market failure for developing off-patent therapies, including psychedelics as discussed above, is enormous. Under the PFS model, an impact investor that successfully repurposes an off-patent molecule or treatment protocol to obtain regulatory approval will receive an outcome payment or subsidized price. This payment is drawn from a Pay-For-Success fund in accordance with a pre-determined formula that calculates the payment based on the level of clinical impact or Quality-Adjusted-Life-Years (QALYs) generated.”
Stat News: Psychedelics researchers and investors should focus on delivering therapy, not drugs
“To be sure, these substances facilitate profound phenomenological experiences. But the difference between a profound drug experience and profound therapy experience has everything to do with context and container — everything surrounding the psychedelic experience to make sure it is beneficial, safe, and integrated into one’s life — not the chemicals themselves.”
Marijuana Moment: GOP Congressman Is ‘Hopeful’ His Psychedelic Research Amendment Can Pass The Senate
“In the podcast interview, Crenshaw acknowledged that both Ocasio-Cortez and Gaetz have introduced similar psychedelics amendments to his own…
“A lot of our base doesn’t want to see us work together,” he said. “I hate that. It’s stupid that that’s the case, but it is.”
Thanks for reading, and see you in two weeks!
This too, is being corralled and documented by Porta Sophia, a psychedelic prior art repository.