Usona Archives - Green Market Report

Dave HodesJanuary 13, 2022
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10min13610

On December 20, 2021, breakthrough research at the Usona Institute, a 501(c)(3) non-profit medical research organization based in Madison, Wisconsin, revealed the true crystal forms of pharmaceutical psilocybin. It’s a new discovery of characteristics of the polymorphs of the plant that have always existed but were not detected until now.

But that discovery has ignited controversy within the psychedelics industry about synthetic psilocybin patents being sought by Compass Pathways (NASDAQ: CMPS), one of the leading psychedelics product development companies, using what they said is their original discovery of essentially the same polymorph that the Usona research reported already existed.

The new Usona Institute study laid out the experimental challenges to solve the crystallographic puzzle of synthetic psilocybin, bringing clarity to the polymorphs (unique crystalline arrangements) that naturally occur from the production of synthetic psilocybin. 

Usona claims that the study conclusively shows that three psilocybin polymorphs repeatedly occur from the well-known crystallization process, and that they have appeared in numerous places throughout the history of synthesizing psilocybin since 1959. 

In short, the study finds that there is nothing new to see here.

But Compass Pathways sees it differently. The company said they invented the crystalline form of psilocybin used in their synthesized psilocybin formulations, polymorph A, and want to patent it. Not so fast, the experts says.

The rise of the patent conundrum

The team of Usona chemists and collaborating crystallographers say that they already solved key psilocybin crystal structures using powder X-ray diffraction (PXRD) data collected on psilocybin at the Advanced Photon Source synchrotron at Argonne National Laboratory. 

In the Usona process-scale crystallographic research investigation, three crystalline forms of psilocybin were repeatedly observed: hydrate A, polymorph A, and polymorph B. The crystal structure for hydrate A had already been solved using X-ray diffraction. 

Usona’s study presents key new crystal structure solutions for the two anhydrates, polymorphs A and B, previously unidentified but part of the crystal structure dating back to when the crystalline structure was first reported in the 1970’s. 

Dr. Alexander Sherwood, lead author of the study and medicinal chemist at Usona, said they were just following clues available to any researcher to put together a full, clear picture of the three psilocybin polymorphs. “The process for isolating and crystallizing pure psilocybin has been consistently reproduced since first reported in 1959, and many different clues throughout history pointed to three psilocybin polymorphs resulting from that process,” he said. “The crystal structure solutions unified all the old evidence and data with precision and elegance. Once we put it all into one place, the full picture came together to tell a complete and compelling story about psilocybin crystallization.”

Then.. the twist

That data, that new discovery information from a non-profit company just wanting to advance the science of psilocybin, is creating conflicts between purists who say psilocybin should not be subject to patents and companies looking to build capitalist enterprises based on patenting such new product discoveries.

That’s where Compass Pathways comes in. Compass Pathways has developed a synthesized formulation of psilocybin, COMP 360, which uses crystalline psilocybin, and, in November, 2021, was granted its fifth U.S. patent by the U.S. Patent and Trademark Office (USPTO)—U.S. Patent No. 11,180,517—which covers methods of treating treatment-resistant depression (TRD) with crystalline psilocybin. 

A petition filed December 15 will challenge the patent granted on March 16, 2021. Additional petitions challenging Compass’ patents from the Freedom to Operate (FTO), a non-profit seeking to advance science and education by fighting bad and mistakenly issued patents, are expected.

The December 15 FTO petition quoted expert declarations filed with it from Dr. Sven Lidin (dean at the Lund University in Sweden) and Dr. James Kaduk (professor of chemistry at Illinois Tech and contributor to the Usona study) who explained that “’Polymorph A’ is a mixture of known psilocybin polymorphs, not a new polymorph as claimed. Compass’s patent is therefore invalid as claiming a nonexistent polymorph..”

So can Compass still claim to have identified a new crystalline structure—a so-called novel variant as mentioned in their patent application—for their synthetic psilocybin? Or does this finding by Usona and statements in the filing challenging Compass now negate the Compass Pathway’s synthetic psilocybin patents?

 Usona reseachers also addressed this in their study: “Revision is recommended on characterizations in recently granted patents that include descriptions of crystalline psilocybin inappropriately reported as a single-phase ‘isostructural variant.’”

In other words, the Compass patents using crystalline psilocybin are at best controversial—and at worst, null and void. 

But the Usona Institute v. Compass Pathways disagreement serves to illustrate a deeper and growing issue between non-profit psychedelics companies like Usona who just want to create and advance better therapies to treat human conditions, and for-profit companies like Compass who want to build an enterprise trying to control access and use of a natural product. 

The questions for the psychedelics community are: Who can commercialize, and control, psilocybin? Or.. should that ever happen?

“No one objects to Compass manufacturing and distributing psilocybin for medical uses, and certainly not me,” Carey Turnbull, founder and director of FTO, in a letter from the founder. “On the other hand, Compass has used their resources to try to prevent anyone but themselves from manufacturing and distributing psilocybin. That’s the rub.”

He continues: “(Compass) is attempting to patent things they should know they did not invent. Patents are not a systemic fault of the system; bad patents that attempt to appropriate pre-existing knowledge from the public commons and then ransom it back to the human race are a misuse of that system.”


StaffNovember 30, 2021
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7min13211

This week, Horizons – Perspectives On Psychedelics the largest and longest-running psychedelic conference will take place in New York City. It is a five-day conference that includes credit coursework for professionals as well as sessions on medical research. The event has grown from its original one-day conference with the addition of classes and business talks. The initial three days are held at the prestigious New York Academy of Medicine.

The days generally break down as follows:

  • (Wed/Thurs) Classes: in-depth intros to psychedelic therapy from researchers and practitioners in small class environments.
  • (Thurs) Business Forum: first-of-its-kind gathering about creating purpose-driven and value-centered organizations that are also pro-business and profitable.
  • (Fri) Focus on Clinical Research: a briefing on psychedelic-assisted therapy research and practice.
  • (Sat) Psychedelics in Medicine: insights, big ideas on moving the market, and visions for the future.
  • (Sun) Psychedelics in the World: a survey of psychedelics in society.

One of the reasons, people are drawn to this conference is that it targets its panels to just one to two people. The sessions end up delivering more information as speakers aren’t limited to just a few sentences. 

If you are considering attending this conference, here are the five things you don’t want to miss. 

Classes

The classes will be held on Wednesday and Thursday and they are specifically for people who want to learn about Psychedelic therapy. There are introductions to MDMA, psilocybin, and ketamine therapy, plus attendees can get CME credit. The classes are introductions on how to work with these types of therapy. 

Business Forum

Thursday is the business forum, which is mostly talks geared toward people in the space already. The sessions will be targeted to shaping the ecosystem, focusing on integrity, and including sessions on ethics. There will also be a focus on a values-oriented approach, specifically on how to operate with integrity. There will also be discussions on how to get funding. This day will be great for networking.

Clinical Research

Friday’s sessions will focus on clinical research and specifically taking psychedelics from the lab to the clinic. One speaker that attendees shouldn’t miss is Dr. Charles Raison, an author at the Usona Institute. He will be talking about psilocybin for treating depression. Another speaker that shouldn’t be missed is Gul DolenAssociate Professor Johns Hopkins University, School of Medicine, who is also speaking on Friday. Her topic is The pharmacology and neuroscience of psychedelics. 

Medical Research

Saturday is the most medical day of the conference and the conference moves its location to Cooper Union and the landmarked Great Hall, built in 1859 and is one of the most prestigious auditoriums in the nation, having been graced by such eminences Abraham Lincoln, Mark Twain, Frederick Douglass, Susan B. Anthony, and Barack Obama. Dr. Raison will lead another discussion on this day. It is expected that Saturday will lean into the issue of patents over the various compounds in the psychedelic world. It is a heavily debated subject with the leader of the industry MAPS against patents, while the Usona Institute is open to the idea. 

Culture

Like the cannabis industry, there is a bifurcation in the psychedelics industry concerning medical versus culture. Many within the industry see psychedelics as a spiritual experience, while some see it as recreational and others as purely medical. Sunday will focus more on the cultural aspects of the psychedelic world with sessions on history and indigenous communities. 

In Closing

Dr. Julie Holland, MD, a psychiatrist, psychopharmacologist, and medical advisor to the psychedelic investment fund Palo Santo said, “I come away learning things I didn’t know, whereas most conferences I feel they are already preaching to the choir. Horizons is my favorite conference.” She also noted that what makes this conference unique is that it isn’t afraid to talk about the failures in therapy. “It addresses the shortcomings and where we’re having problems. There is a lot of attention paid to ethics,” she added.


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