Ekaterina Malievskaia, co-founder of Compass Pathways recently published a statement about the company’s psilocybin research program, including a section about “MANUFACTURING AND PATENTING” psilocybin. See MAPS website. The statement appears to respond to the Statement on Open Science signed by many leaders in psychedelic research. Recently, the U.S. Patent and Trademark Office granted COMPASS Pathways U.S. Patent No. 10,519,175, which covers methods of treating treatment resistant depression with a specific crystalline form of psilocybin.
In the statement Ms. Malievskaia explains that making an Investigational Medicinal Product (an “IMP”) is difficult and expensive and that sharing the product of that work could only be accomplished through standard licensing agreements, which protect Compass’s ability to “recoup the expenses” and “ensure the integrity of the data collected” by controlling who has access to psilocybin made through Compass’s manufacturing patents.
Ms. Malievskaia notes that Compass’s intellectual property does not prevent members of the community from inventing different psilocybin manufacturing procedures, using other sources of the psilocybin, or buying Compass’s product. In other words, others will be excluded from using Compass’s (arguably better) manufacturing process unless they enter into some form of licensing agreement with Compass. The good news is that Compass will not have a monopoly on magic mushrooms as some journalists have contended.
Below, the “MANUFACTURING AND PATENTING” section of Compass’s statement is reproduced with emphasis on several relevant portions used to synthesize the above summary.
Statement from Compass (boldface added):
While psilocybin is a naturally occurring molecule, psilocybin as an Investigational Medicinal Product or IMP is a regulatory entity that includes a detailed description of a GMP-compliant, scalable and reproducible manufacturing process; associated preclinical data; and ongoing safety data collected in clinical trials. The IMP can be thought of as a product’s fingerprint, so that regulators can recognize the safety and efficacy evidence gathered in the clinical trials as it relates to this unique product. The creation of an IMP is an extremely complex and expensive process that requires sustainable funding and a serious multi-disciplinary team effort. Based on our experience and the regulatory input from EMA, we now estimate that the development process will continue through marketing authorization and cost over £3 million (nearly $4 million).
In the process of synthesis, formulation and creation of preclinical data, we reached out to the researchers at Heffter and Usona with offers to share experience and ever rising cost, the last conversation being at PS17 in Oakland. Shortly after, the initial phases of the synthesis and formulation were completed, and psilocybin became the Investigational Medicinal Product. From that point on, for the reasons of data consistency, there was no regulatory acceptable mechanism of “sharing” it other than through standard licensing agreements for the use of IMP. This is the way clinical research regulation works around the world.
As the previously published synthesis processes did not scale to meet regulatory standards, we had to invent our own process. As he would have done for anyone who would have asked for his help, David Nichols advised our manufacturing team. With his support our team has solved over 60 distinct technical problems in the synthesis and formulation process. Some of these inventions became the basis for our manufacturing patents. In general, patents provide an opportunity for an organization willing not only to take a significant financial risk to recoup the expenses, but more importantly, to ensure integrity of the data collected before and after the approval.
Our patents do not preclude others from creating a range of different solutions for the synthesis and formulation of psilocybin; nor do they preclude the use of naturally occurring mushrooms, extracts, or any other products created by alternative synthesis and formulation routes. Equally, our patents do not prevent other clinicians from using our product or any psilocybin-containing products in conjunction with the types of therapy or psychological support they judge to be helpful, as long as it does not jeopardize patient safety. Lastly, neither our patents, regulatory strategy, nor pricing strategy have an impact on the practices of the underground community of practitioners in nonclinical settings.
Our exclusive contract with the drug manufacturer does not prevent others from choosing among many different competing manufacturers through the standard Request for Proposal (RFP) process. The advances of science may now offer new creative solutions for the synthesis and formulation of psilocybin with new partners for those who are willing and able to spend the time, effort, and funds to create an alternative psilocybin-based IMP.
While we have created the supply of psilocybin for our own research, we have made the unusual decision to share it with qualified independent researchers free of charge in exchange for being able to use their safety data. [Is something really “free” if the receiving party must provide valuable date “in exchange” for it?] This is not a commercial decision, but yet another way to accelerate the generation of clinically relevant evidence that may ultimately improve patient outcomes.
This process has proven to be challenging at times. As we have learned, university legal departments and technology transfer offices are vigilant about the potential Intellectual Property (IP) that might be created in the process of investigator-initiated studies. This IP, despite the best intentions of the researchers, does not belong to the scientists, who have limited say in how it is used by their institutions. In the event of IP creation, Technology Transfer Offices have a legal obligation to license it out to the ‘highest bidder’ with the most aggressive and scalable business model that will generate the most return for the academic institution. Even though such IP would be created by independent researchers with our IMP, in order to use the invention, we still have to compete with other commercial entities who might have different ethics or commercial goals.
This is an important consideration for the signatories of the Statement on Open Science and Open Praxis who work for academic institutions, as they need to align with their institutions on terms of IP licensing. The core principle of the statement is that knowledge created by signatories is open to all – that is, the knowledge is to be given away unconditionally by relinquishing researchers’ rights to protect it and to control who gets to use it after it becomes public.
We believe our patent strategy offers some protection against uses that may not be fully aligned with our mission to create access to innovative treatments for as many people as possible at an affordable cost to patients and health care systems.