The medicinal psychedelics space is continuing to grow as interest from the public increases and more research on these substances is conducted. Additionally, issued psychedelic patents portfolios are getting larger, with challenges to these patents being filed with the U.S. Patent and Trademark Office. These patents may shape the trajectory of this burgeoning space, especially in the short term.
The need for psychedelic compounds to be treated as common pharmaceutical medications is one of the primary reasons why some patents in this infant industry have been challenged. In the past, patents helped encourage innovation in biopharmaceutical companies by protecting the interests of those developing a new medication by ensuring that no other party could manufacture the same drug for a period of time. This reduced imitations through exclusion, which made the costly and risky process for companies that dared develop new drugs, worth it.
However, with more organizations arguing that patenting may stifle innovation especially in the psychedelics field, an open approach that will prevent one company from monopolizing the flourishing industry may soon be adopted. Until then, the current rigid patent system will continue to stand.
Below is a patent dispute currently being resolved by the patent and trademark office.
Freedom to Operate Inc. vs. Compass Pathways PLC
Compass Pathways PLC (NASDAQ: CMPS) is a for-profit mental healthcare company focused on developing alternative therapies for the treatment of a range of mental health conditions. The psychedelic company recently patented its synthetic psilocybin manufacturing process, which was used to create its Polymorph A compound.
Freedom to Operate filed petitions to review this and related patents, arguing that Compass Pathways’ claims weren’t new because mixtures of other crystalline forms of psilocybin had already been made before, which made it unpatentable. However, Compass refuted this, arguing that while psilocybin was first synthesized in 1958, older processes that had been published before its research couldn’t meet present regulatory standards, so the company had to create its own process which involved solving various technical problems in the formulation and synthesis process.
Freedom’s post-grant review petitions to the Patent Trial and Appeal Board were ultimately denied earlier this year. The decision was based on the fact that Freedom’s arguments were unconvincing as the measurements that reflected previous processes didn’t correspond exactly to Compass’ process.
Compass Pathways used its Polymorph A process in the formulation of its COMP360 psilocybin formulation. This formulation was recently awarded breakthrough designation by the U.S. Food and Drug Administration (FDA) for its use in managing treatment-resistant depression.
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