Freedom to Operate Publishes Open Letter to Compass Pathways Challenging Validity of Psilocybin Patent
The letter, which marks the fifth 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 asked Compass to disclaim this patent or issue a provided draft Covenant Not to Sue that would allow for the resolution of this matter. 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. One of FTO’s missions is to ensure that publicly available research and developments concerning psilocybin, and its use as a treatment for a range of conditions for which conventional medical treatments have not been effective, remain in the public domain for use in research and the development of treatments for patients. Psilocybin, a classic psychedelic, was first isolated by Swiss chemist Albert Hoffmann in 1958, and is currently the subject of extensive research into its use to treat a variety of mental health and neurological disorders, including treatment resistant depression, major depressive disorder, end-life-psychological distress, alcohol use disorder, cluster headache and obsessive-compulsive disorder. 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.”
Founded by Carey Turnbull in 2020, Freedom to Operate is a registered Section 501(c)(3) non-profit organization dedicated to advancing science and education, specifically research, in the public interest and for the public benefit.
“Freedom to operate” is a term of art in the field of intellectual property law, and refers to the ability to develop, manufacture, and market products without legal liabilities to third parties who claim intellectual property rights in those products. There is an important public policy interest in invalidating bad patents and promoting free competition that does not infringe on validly granted patents and other intellectual property rights. Issued patents are presumed valid and so operate to discourage investment by others into the same or similar subject matter. The public is benefited when potentially incorrectly issued patents are challenged or obviated.
In furtherance of its mission, FTO has previously filed two Petitions for Post-Grant Review (PGR) before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office seeking review of recently issued patents to Compass Pathways for certain medical uses of a particular polymorph of psilocybin, a well-known naturally occurring substance. FTO is challenging these patents that would have 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. Letter Serves to Put Compass on Notice Regarding Invalidity of U.S. Patent No. 11,149,044The letter, which marks the fifth 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 asked Compass to disclaim this patent or issue a provided draft Covenant Not to Sue that would allow for the resolution of this matter.
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. One of FTO’s missions is to ensure that publicly available research and developments concerning psilocybin, and its use as a treatment for a range of conditions for which conventional medical treatments have not been effective, remain in the public domain for use in research and the development of treatments for patients.
Psilocybin, a classic psychedelic, was first isolated by Swiss chemist Albert Hoffmann in 1958, and is currently the subject of extensive research into its use to treat a variety of mental health and neurological disorders, including treatment resistant depression, major depressive disorder, end-life-psychological distress, alcohol use disorder, cluster headache and obsessive-compulsive disorder. 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.”Founded by Carey Turnbull in 2020, Freedom to Operate is a registered Section 501(c)(3) non-profit organization dedicated to advancing science and education, specifically research, in the public interest and for the public benefit.
“Freedom to operate” is a term of art in the field of intellectual property law, and refers to the ability to develop, manufacture, and market products without legal liabilities to third parties who claim intellectual property rights in those products. There is an important public policy interest in invalidating bad patents and promoting free competition that does not infringe on validly granted patents and other intellectual property rights. Issued patents are presumed valid and so operate to discourage investment by others into the same or similar subject matter. The public is benefited when potentially incorrectly issued patents are challenged or obviated. In furtherance of its mission, FTO has previously filed two Petitions for Post-Grant Review (PGR) before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office seeking review of recently issued patents to Compass Pathways for certain medical uses of a particular polymorph of psilocybin, a well-known naturally occurring substance. FTO is challenging these patents that would have 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.
