Psilocybin:
A Promising Treatment for
Mood, Behavior, and Neurological Disorders

 

Through science and medicine research, psilocybin has shown to be efficacious in the treatment of major mood disorders.

 

How We are Defending and Employing
Psychedelics Research and Development

Clinical Depression

Headache Disorders

Substance Use Disorders

FTO has taken the first step in seeking to invalidate Compass’s bad patents on so-called “Polymorph A”, but the dispute is not over. FTO’s invalidity Petitions are just the first action in a dispute that likely will continue through this year and into the next. The resolution of that dispute will shape the course of psilocybin research and therapy for decades to come.

We’ve challenged Compass’ patents because we believe they will likely impede individuals with treatable disorders from receiving affordable and widely available psilocybin medicines.

FTO needs your help in paying the cost of expert witnesses and patent lawyers. We anticipate expenses directly related to our Petitions challenging Compass’s bad patents to be at least $500,000 or more this coming year.

FTO has also invested in research on the polymorphic form of LSD D-tartrate, a common salt form of LSD. This published research can be used by researchers, patent examiners and others to reject unfounded claims and to fight back against anyone attempting to patent a polymorphic form of LSD and its salts. In doing so, FTO has taken a critical step to help protect and advance research and the development of LSD-based therapies that may eventually benefit millions of currently underserved patients.

If you share FTO’s values, we encourage you to donate to help fund our mission for the benefit of all.

FTO Files Requests for Reconsideration of U.S. Patent Trial and Appeal Board’s Decisions Concerning Petitions for Post Grant Review of Compass Patents

Update July 25, 2022

Today, Freedom To Operate (FTO) announced it has filed requests for reconsideration [PRG2022-00012 & PRG2022-00018] with the U.S. Patent Trial and Appeal Board (PTAB) in regard to its denials of FTO’s petitions for Post Grant Review of Compass Pathways’s Patents No. 10,947,257 and 10,954,259 directed to compositions and oral dosage forms containing its “Polymorph A” of psilocybin.  

“We believe the PTAB has committed  major errors in its decisions not to institute our petitions for Post Grant Review of Compass’s patents on its “Polymorph A” of psilocybin”, said Carey Turnbull, founder and director of Freedom to Operate.  “We maintain our belief that the specifics of PTAB’s decisions have rendered the Compass patents of little practical value as a tool to stifle competition. At the same time, an important policy function is advanced when bad patents are challenged and invalidated.  On this basis, we are asking the PTAB to reconsider its decisions as is provided for under U.S. patent law.”

In its requests for reconsideration of the decisions not to institute Post Grant Review of the Compass patents, FTO has identified two errors central to the PTAB’s rulings.   First, the PTAB has incorrectly construed the Compass patents claims as permitting a mixture of crystalline polymorphic forms of psilocybin having x-ray powder diffraction peaks as identified in the patent claim.  In doing so, the PTAB has ignored the inventor’s clear intention and acted contrary to how patents claiming polymorphs are interpreted by courts, which require that a form of a crystalline material be a single polymorphic phase of that material.  Second, the PTAB has exceeded its statutory mandate by erroneously discounting the unrebutted testimony of FTO’s experts, the veracity of which should be subject to consideration at trial rather than the institution phase of the proceedings. Given the criticality of these two issues to the PTAB’s rulings, FTO is submitting that a review and reversal of the decisions not to institute the post grant reviews is required by U.S. patent law.

 Irrespective of the outcome of these requests for reconsideration, FTO remains confident that the work undertaken to date in challenging the Compass patents will ensure that manufacturers and sellers of psilocybin will be able to bring treatments to market without risk of infringement.

FTO Issues Statement Regarding U.S. Patent Trial and Appeal Board’s Response to Petition for Post Grant Review of Compass Psilocybin Patents

Update June 24, 2022

Today, Freedom to Operate (FTO), issued the following statement regarding the U.S. Patent Trial and Appeal Board’s (PTAB) response to its petition for Post Grant Review of Compass Pathways’s Patents No. 10,947,257 and 10,954,259 directed to compositions and oral dosage forms containing its “Polymorph A” of psilocybin.

“While we disagree with the decision to disallow our petitions for Post Grant Review, we are confident that the PTAB’s extremely narrow interpretation of Compass’s patent claims will provide generic manufacturers of psilocybin with wide latitude to produce and commercialize psilocybin without risk of violating the Compass patents”, said Carey Turnbull, founder and director of Freedom to Operate.

In its decisions, the PTAB construed Compass’s “Polymorph A” claims narrowly, holding that they only cover psilocybin that has all of the x-ray powder diffraction (XRPD) peaks exactly as claimed. Most patent owners in cases involving claims with XRPD peaks try to give their claims some range outside the exact peaks stated in their claims, because often a product that the patent owner wants to allege infringes doesn’t have those exact peaks. As a result of the Board’s decision, Compass can’t reasonably take that position. Instead, the PTAB has now given manufacturers of psilocybin a clear pathway for making sure that the psilocybin they manufacture or sell is not at risk of infringing Compass’s “Polymorph A” patents.

FTO is a non-profit founded to advance science and education, specifically to support and facilitate scientific research, in the public interest and for the public benefit. In furtherance of its mission, FTO has filed three petitions for Post-Grant Review before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office seeking review of patents issued to Compass Pathways for certain medical uses of a particular polymorph of psilocybin, a well-known naturally occurring substance. FTO has challenged these patents that may have, if left uncontested, had the effect of chilling, and potentially preventing other individuals and organizations from engaging in research and innovation in the public interest relating to known medical uses of psilocybin, such as the treatment of depression. FTO will continue to challenge bad patents and, where appropriate, will support scientific research that contributes to the emergence of psychedelic science and the psychedelic renaissance.

 

FTO Publishes Open to Letter to Compass Pathways Challenging
Validity of Psilocybin Patent

Update April 13, 2022

Freedom to Operate (FTO), has published an open letter to Compass Pathways CEO, George Goldsmith, regarding the invalidity of a U.S. patent on psilocybin. The letter, which marks the third occasion on which FTO has disputed the validity of a Compass patent on psilocybin, serves to put Compass on notice that FTO believes U.S. Patent No. 11,149,044 to be invalid as relating to a known form of crystalline psilocybin that was publicly used prior to the date on which the patent for the claimed invention was first filed. In communicating this, FTO has also proposed to Compass a draft Covenant Not to Sue, that would allow for the resolution of this and other ongoing patent disputes.

Compass’ U.S. Patent No. 11,149,044 is for a crystalline “Hydrate A” of psilocybin, as well as a pharmaceutical composition containing “Hydrate A” and a method of treating major depressive disorder by administering “Hydrate A.” Patent grants may be revoked when evidence exists that the invention claimed was publicly known or obtainable prior to the date on which the patent for the claimed invention was first filed. In the case of the Compass patent in question, previously published research, funded by FTO, demonstrates that the patent’s claimed Hydrate A was present in historical samples manufactured in 1963, 1976 and in a sample used in human clinical trials in 2017.

According to Carey Turnbull, Founder and Director of Freedom to Operate, “This is a clear case of a patent being mistakenly awarded for a claimed invention that was in the public domain prior to the filing and awarding of the patent.”

In communicating this information to Compass’s CEO, George Goldsmith, FTO is providing an opportunity to Compass to disclaim its patent or, at minimum, to publicly covenant that it will not attempt to enforce any claim based on it.

“We believe it is in the interest of both Compass and FTO to resolve this issue without our having to resort to expensive and time-consuming litigation”, said Turnbull. “We hope that Compass’ leadership shares this view. Should that not be the case, we are of course prepared to pursue the legal remedies available to seek a revocation of Compass’ patent.”

Compass Pathways Files Preliminary Response to FTO Petition for Post Grant Review of Psilocybin Patent No. 10,947,257

Update April 13, 2022

On December 15, 2021, Freedom to Operate filed a petition for Post Grant Review of Compass patent number 10,947,257 at the USPTO. The petition details the legal and evidentiary case for the invalidity of Compass’s patent directed to an oral dosage form containing its “Polymorph A” psilocybin and an excipient called silicified microcrystalline cellulose.

Compass has now filed its preliminary response to FTO’s PGR.  The content of Compass’s response is not surprising as FTO had anticipated all of the arguments put forward. The legal arguments were addressed in detail in our petition, and we remain confident in our position that the challenged claims of the Compass Polymorph A patents are invalid for multiple reasons.

Compass’s argument that other parties like Usona should be considered “real parties in interest” is without basis.  FTO alone controlled the filing of the Petition and decided which arguments and evidence to include.  The fact that Usona, like other companies researching psilocybin as a promising treatment for a range of conditions, would benefit from the invalidation of Compass’ Polymorph A patents does not make it a “real party in interest.”

FTO Files PGR Petition on a Second Compass Patent

Update December 22, 2021

Dear Friends,

A comprehensive, peer-reviewed study was just published on the crystal structures of psilocybin. The work entailed intensive computational modeling as well as the use of a synchrotron at Argonne National Laboratory to get high-resolution diffractograms of several samples of crystalline psilocybin. Historical samples analyzed included Sandoz material almost six decades old.

Vice.com ran an article about a USPTO petition recently filed for a post-grant review of a Compass patent, based on the new scientific findings: “The non-profit Freedom to Operate used research from chemists and crystallographers to argue in a legal filing that Compass’ form of synthetic psilocybin is not a new invention.”

FTO filed another such PGR, Wednesday, Dec. 22, challenging a second Compass patent.

From the paper’s press release:

  • Over the last 57 years, each of the historical samples quantitively reflect one or more of the three repeatedly observed crystalline forms of psilocybin.
  • Modern analysis of crystallographic research with psilocybin published in the 1970’s reveals the three predominant crystalline forms were described and publicly available for decades.
  • Unusual characterization data originally reported to be unique were exposed instead as a simple mixture of the known polymorphs.
    Revisions are recommended on characterizations in recently granted patents that include descriptions of crystalline psilocybin mixtures inappropriately reported as a novel variant.
  • Crystallization experiments show how to precisely control and obtain each polymorph individually and how to avoid undesirable mixtures in large-scale manufacturing.

Congratulations and thanks to the scientists at Usona and the consulting scientists who were able to complete this very specialized work, and to those who supported the project financially through Freedom to Operate.

Bob Jesse
Advisor to FTO

Crystallographic Discoveries Bring New Clarity to Pharmaceutical Psilocybin Polymorph Characterization

Update December 21, 2021

“FTO was seminal in both the conception and the eventual creation of, this important paper and its conclusive peer-reviewed science. Everyone who will benefit from the clinical use of psilocybin owes a great debt to the credentialed scientists who did this work.” 

Carey Turnbull, Executive Director, Freedom to Operate, Inc.

Acta Crystallographica Section C

Crystallographic Discoveries Bring New Clarity to Pharmaceutical Psilocybin Polymorph Characterization

Peer-reviewed study out today shows three most pharmaceutically relevant crystalline forms of psilocybin have been consistently created and observed since 1959.

FTO’s PGR Petition Filing Milestone

Update December 16, 2021

Freedom to Operate filed yesterday a petition for Post Grant Review of Compass patent number 10,947,257 at the USPTO. The PGR Petition explains that Compass’s patent claims, directed to an oral dosage form containing its “Polymorph A” psilocybin and an excipient called silicified microcrystalline cellulose, are invalid for a number of reasons. The Petition and the expert declarations filed with it from Dr. Sven Lidin and Dr. James Kaduk explain 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, and also obvious in light of prior art samples of psilocybin and previous clinical studies teaching the use of psilocybin to treat depression. Compass’s patent is also invalid because it does not explain how to determine the claimed characteristics of the psilocybin and SMCC in the claimed oral dosage form.

Freedom to Operate, Inc. filed this petition to further its mission to challenge mistakenly issued patents, in particular in the widely researched psychedelic space. Gathering the evidence supporting the Petition and preparing and filing it required several years and close to a million dollars in funding on the part of FTO. In the course of its work, FTO and its research collaborators identified a dozen or so sources of psilocybin with sufficient forensic provenance, many predating the Compass patent, that was extensively analyzed and tested. The production of hard science by world-class chemists and crystallographers used state-of-the-art X-ray powder diffraction, including crystallography analysis done on the synchrotron at Argonne National Laboratory, a multidisciplinary science and engineering research center that works in concert with universities, industry, and other national laboratories on questions and experiments too large for any one institution to do by itself. A psilocybin sample was obtained from the US Government National Institute of Drug Abuse, which was determined to be original Sandoz material dating from 1963, and others were obtained from several Universities and research institutions well known for their work on psilocybin for decades. The sample most extensively used to document the preexistence of the well-known anhydrous polymorph was made by renowned psychopharmacologist and founder of Heffter Research Institute Dave Nichols, and had been supplied to the prolific Johns Hopkins University psilocybin research lab of Roland Griffiths.

FTO founder and Executive Director Carey Turnbull said “I want to thank the chemists and crystallographers who worked on this project and who are named in the filings and publications for their perseverance and hard work. In addition, we owe a debt to the vision, patience, and generosity of Bill Linton, The Steve and Alexandra Cohen Foundation, Evolve Foundation, Bronner’s Soaps, and others without whose gifts, in addition to those from Claudia Turnbull on behalf of my family foundation, this important work would not have been possible.”

Here are the links to FTO’s PGR Petition and associated exhibits and an article about the project by Shayla Love published in VICE. Soon to be added and published shortly, will be the print of an in-press, peer-reviewed paper in the high impact crystallography journal Acta Crystallographica Section C.

UK IP Office Opinion in Response to FTO Request

Update July 28, 2021

Just this week, the United Kingdom Intellectual Property Office issued an Opinion regarding a Compass patent directed to its so-called “Polymorph A”. That Opinion was issued in response to a request by Freedom to Operate asking the UK IP Office to consider the validity of the patent in light of prior scientific publications, particularly an article by Dr. Folen in the Journal of Forensic Science and by well-known psychedelic chemist Dr. David Nichols. The Opinion found that many of the claims of the Compass patent were not inventive, including the broadest claim directed to its “Polymorph A”, in light of these publications.

The new UK Opinion is from a knowledgeable UK patent examiner and supports FTO’s position that there can be no valid patent on the known forms of psilocybin. Patents in the psychedelic space should be carefully limited to only truly new inventions. The Opinion is publicly available and can be downloaded here. FTO is committed to defending the right of the public to use the various forms of synthetic psilocybin made for many years and used by researchers in human clinical trials well before Compass filed its patent applications. FTO’s research strongly suggests that Compass did not discover any new crystal forms of psilocybin in the course of conducting its scale-up research.”

Shayla Love, Vice News Journalist, via Twitter