Dave Hodes, author of the Green Market Report

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

But the discovery sparked controversy within the psychedelic industry over patents on synthetic psilocybin being sought by Compass Pathways (NASDAQ: CMPS), one of the leading psychedelic product development companies, using what they said to be their original discovery of essentially the same polymorph as the Usona. the reported search already existed.

The new Usona Institute to study presented the experimental challenges for solving the crystallographic puzzle of synthetic psilocybin, bringing clarity to the polymorphic (unique crystal arrangements) that occur naturally from the production of synthetic psilocybin.

Usona says the study conclusively shows that three polymorphs of psilocybin occur repeatedly from the well-known crystallization process, and that they have appeared in many places throughout the history of psilocybin synthesis. 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 it invented the crystal form of psilocybin used in its synthesized psilocybin formulations, polymorph A, and wants to patent it. Not so fast, experts say.

The rise of the patent conundrum

Usona’s team of chemists and collaborating crystallographers claim to have already solved key crystal structures of psilocybin using X-ray powder diffraction (PXRD) data collected on psilocybin at the National Laboratory’s Advanced Photon Source synchrotron. ‘Argonne.

At the scale of the Usona process crystallographic research investigation, three crystal forms of psilocybin were repeatedly observed: hydrate A, polymorph A, and polymorph B. The crystal structure of hydrate A had previously been resolved by X-ray diffraction.

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

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

Then… the twist

This data, this new discovery information from a non-profit company that simply wants to advance the science of psilocybin, creates conflict between purists who say psilocybin shouldn’t be subject to patents and companies that seek to create capitalist enterprises based on the patenting of these new product discoveries. .

This is where Compass Pathways comes in. Compass Pathways has developed a synthesized formulation of psilocybin, COMP 360, which uses crystalline psilocybin, and in November 2021 obtained its fifth american patent by the United States Patent and Trademark Office (USPTO)—US Patent No. 11,180,517– which covers treatment methods for treatment-resistant depression (TRD) with crystal psilocybin.

A petition filed on December 15 will challenge the patent granted on March 16, 2021. Additional petitions challenging Compass’s patents from Freedom to operate (OTF), a non-profit organization seeking to advance science and education by combating erroneous and erroneously issued patents, are expected.

December 15 FTO Petition Cited expert statements filed with him Dr. Sven Lidin (Dean of Lund University in Sweden) and Dr. James Kaduk (Chemistry professor 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 because it claims a non-existent polymorph.

So, can Compass still claim to have identified a new crystal structure – a supposedly new variant as mentioned in their patent application – for their synthetic psilocybin? Or does this discovery by Usona and the statements in the filing challenging Compass now invalidate Compass Pathway’s synthetic psilocybin patents?

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

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

But the disagreement Usona Institute v. Compass Pathways serves to illustrate a deeper and growing problem between non-profit psychedelic 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 a business trying to control access and use of a natural product.

The questions for the psychedelic community are: Who can market and control psilocybin? Or.. should this happen?

“Nobody objects to Compass manufacturing and distributing psilocybin for medical purposes, and certainly not me,” Carey Turnbull, Founder and Director of FTO, in a letter from the founder. “On the other hand, Compass has used its resources to try to prevent anyone but themselves from manufacturing and distributing psilocybin. That’s the rub.

He continues, “(Compass) tries to patent things they should know they didn’t invent. Patents are not a systemic flaw in the system; bad patents that attempt to appropriate pre-existing knowledge of the commons and then return it to the human race are a misuse of this system.

Lola R. McClure