Protecting Psychedelic Science
& Medical Development
for Public Benefit
Freedom to Operate funders and supporters,
At the end of the year Freedom to Operate wants to take a few moments to thank our funders and supporters, principally Bill Linton, the Steve and Alexandra Cohen Foundation, Evolve Foundation, and Turnbull Family Foundation (Claudia Turnbull), and to provide a brief synopsis of 2022, and a description of our ongoing activities.
Our psilocybin patent filings were impactful and fulfilling. Patents depend on matters of fact. Matters of fact do not depend on patents. Hence our confidence that the crystallography paper authored by Alex S., Poncho M., and Robert K., Nick C., and reviewed by Sven Liden, Chair of the Nobel Prize chemistry committee, and Bob Jesse, left a trail of breadcrumbs for anyone coming behind us. “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” said Carey Turnbull, founder and director of Freedom to Operate. An important policy function is advanced when bad patents are challenged and invalidated.
In a stark example of its disregard for prior art and knowledge already in the public domain, Compass Pathways obtained issuance of a patent which contains claims for things it should recognize as prior art. This action continues Compass’s pattern of claiming and being awarded patents it should now know are likely invalid and unlikely to be enforceable. In addressing this example of questionable patenting practices, FTO underwrote ground-breaking research that enabled the quantification of particular polymorphic forms of crystalline psilocybin present in historical samples. The results of that research are reported in Psilocybin: crystal structure solutions enable phase analysis of prior art and recently patented examples, Acta Cryst. (2022). The paper demonstrates that U.S. Patent No. 11,149,044’s claimed “Hydrate A” was available as early as 1963 and was used in human clinical trials as early as 2017. Likewise, the use of psilocybin for the treatment of depression was well known before 2017, as shown in peer-reviewed articles published by Dr. David Nichols and Dr. Roland Griffiths. If Compass was unaware of the prior art at the time they filed for this patent, they should now review the peer reviewed published science on the matter and disclaim their patents directed to polymorphic forms of psilocybin.
To head off any similar attempt to claim composition of matter on LSD, FTO performed and published new research on the polymorphic form of LSD D-tartrate, a common salt form of LSD. This new FTO sponsored study 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 is taking 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. FTO submitted this study to Porta Sophia which placed it in its data base for patent examiners to easily locate.
In a related matter Ceruvia Lifesciences has offered to supply GMP LSD to academic research sites, and has created an Investigators Brochure that NYU and JHU will use as the first recipients of this material.
FTO wants again to thank its donors and supporters for their vision in being part of this important facet of the psychedelic renaissance.
Carey Turnbull for Freedom to Operate
Freedom to Operate is a non-profit seeking to advance science and education, specifically research, in the public interest and for the public benefit.
If you share FTO’s values, we encourage you to donate to help fund our mission for the benefit of all.
CHALLENGE INAPPROPRIATE PATENTS
IMPROVE MEDICINE & RESEARCH
Patents that attempt to appropriate pre-existing knowledge from the public commons then sell it back as a novel invention is a misuse of the patent system.
- Fighting bad patents is important public policy.
- Mistakenly issued patents can prevent research and innovation by other organizations.
- Inappropriate patent rights create excess burden or loss of economic efficiency.
We know that there can be no patents on Psilocybin or LSD as substances,
nor on the known methods for making them or using them medically.
Freedom to Operate is a Non-Profit Corporation Organized Exclusively for
Charitable, Religious, Educational and Scientific Purposes
Challenge Improperly Claimed Patent Rights
Patent rights that are inappropriately claimed can prevent other individuals and organizations from engaging in research and innovation that would benefit the public.
Facilitate Science & Medical Research
Primarily by challenging improper patent claims, Freedom to Operate supports and facilitates scientific research for the benefit of all.
Providing Advocacy & Other Assistance
We provide advocacy around intellectual property and other business issues and we help support the conduct of medical and scientific research.
Who is Freedom to Operate?
Freedom to Operate (FTO) is a non-profit corporation organized exclusively for charitable, religious, educational, and scientific purposes. FTO was formed primarily to advance science and education and specifically to support and facilitate scientific research in the public interest and public benefit.
FTO allocates its time to challenging inappropriate patent claims and conducting related medical and scientific research.
Carey Turnbull, CEO, manages these activities without compensation and with the assistance of legal, medical, and technical experts.
How We are Defending and Employing Psychedelics Research and Development
We intend to challenge patents that would have the effect of deterring, and potentially preventing, other individuals and organizations from engaging in research and innovation in the public interest.
We undertake further research in order to establish what I know to be true: there can be no patent on psilocybin or LSD as substances, nor on the known methods for making them or using them medically.
By challenging mistakenly awarded patents and inappropriate patent rights, we enable research and development of medicines that will benefit the public.
The Case for Psychedelics Research and Development
Psilocybin and LSD are two of a number of psychedelic compounds that can be useful in treating depression, substance abuse disorders, and other serious and painful health issues.
According to the National Institute of Mental Health, more than 17 million people in the United States suffer from or have experienced major depression while millions of others struggle daily with other metal health issues.
Psilocybin was first isolated in 1958 by a Swiss chemist, Dr. Albert Hofmann. Separate studies by Charles Grob, Stephen Ross, and Roland Griffiths show promising results with participants who received psilocybin in a controlled setting with support. In fact, the research has shown a long duration of clinically significant reduction of major depression.
LSD was first synthesized by Dr. Albert Hofmann in 1938 and was for several decades prior to 1980 the subject of extensive research for the treatment of alcohol use disorder and other mental health conditions. Following its prohibition in the late 1960s research efforts largely came to a halt but now, several decades later, LSD is once again being studied for its potential therapeutic usefulness in treating a range of mental health issues and neurological disorders.
These are just a few examples of why substances such as psilocybin and LSD should not, and cannot, be patented.