Magic Mushrooms Time is Coming

Investors, philanthropists, and researchers hope psychedelics will change the treatment of depression, substance misuse, post-traumatic stress disorder, and other mental health disorders.
People have consumed psilocybin, or "magic," mushrooms for thousands of years, and most synthetic hallucinogens have been around for much longer. However, there is a growing scrum of psychedelic companies looking to gain a competitive edge through a blizzard of patent claims, or at the very least to scare off potential competitors, as excited about the promise of psychedelic medicine reaches a fever pitch and attracts hundreds of millions in investment.
The controversy surrounding intellectual property rights in relation to psychedelics serves as a reminder of the high hopes that investors, philanthropists, and researchers have for a new field that many believe has the potential to revolutionize the treatment of mental health conditions such as depression, substance abuse, post-traumatic stress disorder, and other conditions.
According to Robin Feldman, an expert on pharmaceutical intellectual property who teaches at the University of California Hastings College of Law, the battle over psychedelics highlights broader issues with a patent system that causes Americans to pay some of the highest prescription drug prices in the world. When you look under the hood, it's not very appealing, she added. "What we're witnessing with psychedelics is a collision of cultures between the generosity of individuals who want to use old substances in new and creative ways slamming up against the realities of the patent system."
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Although the Food and Drug Administration has been more open to new applications for psychedelic medicines, the majority of them are still prohibited by federal law. The government is debating whether to approve MDMA, sometimes known as Ecstasy, and psilocybin, which is undergoing an expedited evaluation, for therapeutic purposes. Esketamine, a nasal spray made from the anesthetic ketamine, was granted F.D.A. approval three years ago to treat depression that has not responded to conventional forms of therapy.
The National Institutes of Health have started supporting psychedelic research for the first time in decades, and many of the top colleges in the nation are vying to establish psychedelic research centers. Several of them have partnered with pharmaceutical companies, attempting to innovative patent treatments and share any future profits.
Psilocybin mushrooms are no longer considered illegal in a number of municipalities, including Seattle, Denver, Oakland, California, and Washington, D.C. Oregon will be the first state to provide psilocybin therapy in a therapeutic setting starting in January.
The thirty-two publicly listed companies, the majority of which didn't exist four years ago, have been receiving an influx of investment. Market research company InsightAce Analytic estimates that the market for psychedelic therapeutics was worth $3.6 billion in 2021 and will grow to $8.3 billion by 2028, even though many businesses, like their biotech start-up cousins and the market as a whole, have recently been affected by falling stock prices.
Veteran psychedelic researchers, who kept the torch alive during the nation's determined war on drugs, when funding vanished, are finding the altering terrain to be both challenging and bracing. On the one hand, they are ecstatic about the avalanche of promising new research, the positive media attention, and the unexpected support from conservative legislators who have been moved by the stories of traumatized combat veterans who have been healed by psychedelic-assisted therapy. On the other hand, they are skeptical about the efficacy of psychedelic-assisted therapy.
In December of 2017, one of the godfathers of the present psychedelic revival, Bob Jesse, authored a manifesto for the commercial era of hallucinogens. This manifesto had an effect that rang as far and wide as when Timothy Leary famously evangelized, "Turn on, tune in, drop out," in 1966. Jesse spoke on a very different topic and conveyed the following message: "Open science for all!"
Jesse took a stand against would-be monopolists in the manifesto, accusing them of flagrantly exploiting patent rules. He advocated, instead, for a shared creative commons for psychedelic research, with limited rights to intellectual property.
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However, Robert Jesse, established at Johns Hopkins University more than twenty years ago, recognizes that there are possible hazards. According to him, psychedelics are religious implements that are the property of all people, not only the wealthy individuals who are able to pay $5,000 for a psychedelic retreat.
According to Mr. Jesse, the phenomenon of corporatization poses a risk of leading the psychedelic sector in potentially problematic directions. The sudden influx of money is pulling excellent scientists away from their research positions at academic institutions. In recent years, psychedelic research has been kept alive by the generous contributions of philanthropists. However, as he and other experts have pointed out, the prospect of substantial profits for investors has contributed to a drop in the number of such donations.
However, Mr. Jesse is most concerned about the avalanche of patent applications. It can take years and millions of dollars to defend oneself against a patent claim, even if the claim is eventually ruled without merit by a judge.
The notion that patent filings were nothing more than dishonest attempts to obtain a monopoly on already existing pharmaceuticals was refuted by other executives working for pharmaceutical companies. According to Doug Drysdale, chief executive officer of Cybin, a Canadian company specializing in psychedelics that has been in business for three years, patents safeguard the work of scientists attempting to improve the therapeutic value of existing medications.
He referred to dimethyltryptamine, also known as D.M.T., a naturally occurring hallucinogen known for its capacity to generate profound experiences. According to him, the issue is that they are unusually short, often lasting only five to ten minutes — possibly not long enough to disturb engrained ways of thinking and assist people with severe depression in finding new ways to understand their illness.
Mr. Drysdale reported that the company had recently been granted a patent for an improved formulation of D.M.T., which made it possible for sessions to last between 30 and 40 minutes. He explained that they were not simply changing the molecule to change it. If you are going to approach investors for hundreds of millions of dollars, then you absolutely need to have the intellectual property; otherwise, there is no way to achieve a return on investment.
Psilocybin analogs that cause experiences lasting two to three hours are something that a number of companies, including Cybin, have been attempting to develop. This is about half the time required for the treatment that is now in use. As a result of the fact that many psychedelic sessions require the participation of two certified experts as a precaution against the possibility of patient abuse, the objective of this project is to bring down the cost of therapy.
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Dr. Stephen Ross, a founding member of the Psychedelic Research Group at New York University, expressed concern that attempts to create much shorter psychedelic episodes without the need for psychotherapy could result in negative experiences for patients and negative media attention, potentially sparking the type of backlash that strangled the fledgling field during the nation's war on drugs four decades ago.
According to analysts, the economic model for psychedelics presents a number of significant challenges in certain respects. Most psychedelic therapies are based on only a few sessions, which is a possible barrier to making large revenues. In contrast, many of the most lucrative prescriptions on the market are those that are taken for an extended period of time, such as those that treat diabetes, hypertension, or kidney failure. These medications are typically consumed over the course of an individual's whole life.
Another factor contributing to the complexity of psychedelic medicine is that most researchers are not pursuing F.D.A. approval for the compounds on their own; rather, they are seeking permission for a combination treatment that includes both drugs and talk therapy.
Researchers believe that therapy, which typically entails preparing patients for taking the medications and assisting them with processing the experience, is the most important component of effective treatment. When a person already has a psychiatric condition, such as schizophrenia or bipolar disorder, it is especially important not to give it short shrift or ignore the patient's mindset and the environment in which the sessions take place. This can lead to unpleasant experiences during the sessions.
For the time being, the initiative to reign in excessive patent claims is being spearheaded by a group of about forty intellectual property wonks and archivists doing their work for free to examine long-lost research papers and scour university libraries. Their database, known as Porta Sophia, means "Doorway to Wisdom," is designed to assist U.S. patent officials in compiling what is known as "prior art."
Because we value valid patents, we established Porta Sophia. A patent is awarded when it is found that an invention is both practical and original enough to warrant protection from imitation. This is accomplished by checking that no records exist that reveal the innovation was already in the public domain before filing the patent application. This proof, known as prior art, might come in the form of anything that is already in the public domain, such as a thread or post on a blog forum, a thread or post from a blog, a conference abstract, a document from an archive, or an artifact from a culture.
The risk of erroneous patents increases when protection is awarded for innovations for which useful prior art exists but cannot be located. These patents prevent people from using information that is already in the public domain, even though the inventions in question are not genuinely new. Given the historical and cultural aspects that obfuscate previous art relating to psychedelics, there is a greater danger of defective patents in the psychedelic domain.