Part of the concern about patents in the growing psychedelic industry, is that once a patent is granted, it is costly and laborious to challenge it—with no guarantee of success. At the end of last year, the non-profit Freedom to Operate challenged two patents on a synthetic form of psilocybin, the active ingredient in magic mushrooms.
As Motherboard previously reported, it filed what are called petitions for post-grant review (PGR) against two of mental health company Compass Pathways’ patents, arguing that according to research conducted by Freedom to Operate and published in the journal Acta Crystallographica Section C, Compass’ synthetic psilocybin wasn’t actually new, and should not be patentable.
These petitions were sent to the Patent Trial and Appeal Board (PTAB), a group of administrative judges within the United States Patent and Trademark Office with backgrounds in science and patent law. Yesterday, the PTAB released its decision: There will not be a trial over Compass patents, and it agreed with Compass’ interpretation of its patents and its claims. There is no right to appeal this decision, unlike court decisions.
In its decision, the PTAB wrote that Freedom to Operate didn’t present convincing enough evidence that the claims in Compass’ patents were unpatentable. Part of its reasoning was that Compass’ form of psilocybin, called a polymorph, has a unique shape as determined by an x-ray powder diffraction (XRPD) diffractogram, a measurement of a solid form of a molecule that captures how X-rays bounce off of it. The PTAB wrote that the research Freedom to Operate submitted didn’t line up with Compass’ exact measurements of its synthetic psilocybin, called Polymorph A.
A lawyer for Freedom to Operate, Jack Griem, said that since the PTAB defined Polymorph A so narrowly, it means that Compass only has ownership over the exact shape of their form of psilocybin, and not others. “Compass is now on notice that its ‘Polymorph A’ patents cannot be asserted recklessly against any commercial-scale manufacturer or distributor of a psilocybin-based medicine,” Griem said. “Manufacturers of psilocybin now have a clear pathway for making sure that psilocybin they manufacture or sell is not at risk of infringing Compass’s ‘Polymorph A’ patents.”
Carey Turnbull, founder and director of Freedom to Operate, said that while the organization disagrees with the decision to deny the petition, “we are confident that the PTAB’s 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.”
Compass did not provide comment by the time of publication; we’ll update the story if they do. In December 2021, Compass’ chief communication officer told Motherboard, “We remain highly confident in the strength of our patents and our polymorph A is the subject of numerous granted patents from several different Patent Offices, confirming that it is novel and inventive.”
Graham Pechenik, a patent attorney at Calyx Law, said that if he was the petitioner however, “I would be very disappointed in these decisions. These are both complete wins for Compass, on every issue raised.”
The PTAB found that Freedom to Operate’s arguments were “unsupported and unpersuasive,” Pechenik said. “The Board thus determined that Petitioner failed to show that it is more likely than not that any of Compass' claims are unpatentable, and no trial was instituted. Compass' patents survived on all counts.” Further, Pechenik said he didn’t see how avoiding infringing on Compass’ patents is easier now than before, or how Compass’ position is weakened.
Compass is far from the only for-profit psychedelic company with patents, and several other recently granted patents or applications have raised alarm, because they included aspects of psychedelics that are well-known, and not novel. Earlier this week, the company MindMed received a patent for its combination of MDMA and LSD, despite this being well known as “candy flipping.”
The psychedelic database, Porta Sophia, filed third-party submissions to challenge MindMed’s patent application, with 20 references to prior art, or evidence that an invention has been known about, made, or used in the past. But MindMed filed another application with accelerated examination, and it was granted. In February, a patent was granted for a DMT vape pen, despite there being countless examples of prior art on this. A search revealed that the patent examiner only looked for prior art for seven minutes before he granted the patent.
Overly broad and evergreen patents in the pharmaceutical space have led to high drug prices and monopolies, a pattern that advocates worry about repeating in the psychedelic medicine industry.
Freedom to Operate’s petitions were one of the first high-profile challenges to psychedelic patents. The denial highlights how these kinds of actions can be risky. Those petitions took around a million dollars and months of work from a team of hired scientists and lawyers. Later efforts from Freedom to Operate have included strategies like defensive publishing, the creation of prior art, and asking for patent pledges from Compass executives not to enforce their IP—these have, so far, not resulted in any agreements.
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