COMPASS Pathways’ United Kingdom psilocybin patent, GB2572023B, is under scrutiny in a new opinion, which was released by UK Intellectual Property Office patent examiner Jason Bellia on July 28, 2021. 

The UK patent in question lays out the preparation and use of psilocybin Polymorph A — a crystalline form of psilocybin defined by its X-ray powder diffraction (XRPD) diffractogram peaks and differential scanning calorimetry (DSC) thermogram measurements. 

The novelty of COMPASS Pathways’ patents for Polymorph A have been previously called into question by Freedom to Operate Inc. (FTO), a nonprofit founded by Carey Turnbull — a board member of Usona Institute, President of the Heffter Research Institute, and CEO of Ceruvia Lifesciences. 

COMPASS Pathways’ international patent applications have also been criticized for attempting to patent psilocybin therapy for an overly-broad range of conditions. 

Bellia’s recent opinion concluded that he does not think that certain claims in the UK patent are inventive or novel, based on prior art. 

“In summary I consider that claims 1, 3 and 10-20 are not inventive, based on Folen and Nichols [relevant prior art presented by Freedom to Operate Inc.],” Bellia wrote. 

Claims 1, 3, and 10-20 — which Bellia deemed “not inventive” — define aspects and uses of Polymorph A based on XRPD and DSC thermogram measurements; color; purity; batch size; dosage forms and sizes; and uses such as treatment of a central nervous system disorder or treatment-resistant depression. 

According to Graham Pechenik, a patent attorney with Calyx Law and Editor-at-Large for Psilocybin Alpha, “not inventive” in this context means “to lack an ‘inventive step’ or that any purported ‘inventive concept’ over the state of the art ‘would have been obvious to the person skilled in the art.’ In simpler terms, it just means the supposed invention is obvious.” 

Pechenik said that in layman’s terms, Bellia’s conclusion “means that the UK patent examiner believes that those claims are not inventive, and should be invalid, but the opinion is not binding and does not have any immediate effect on Compass’ patent, although it could subsequently be revoked.”

Of interest to those following Compass Pathways' patents on psilocybin: On July 28 an examiner at the UK IP Office issued an opinion on Compass' UK patent: "I consider that claims 1, 3 and 10-20 are not inventive, based on Folen and Nichols." 1/ https://t.co/lLyB7WcS8w pic.twitter.com/xj1oZP1k4P

— Shayla Love (@shayla__love) August 2, 2021

Regarding Bellia’s opinion, COMPASS Pathways wrote to Psilocybin Alpha: “We have received a non-binding opinion from the UK IP Office, questioning aspects of some of the claims in our granted UK patents. The opinion came in response to a ‘Request for opinion’ from a third party [Kohn & Associates PLLC, on behalf of FTO] and is just that: a non-binding opinion. The opinion does not invalidate our patent or any of its claims. We remain confident in the strength and defensibility of our patents.”

However, Dr. David Nichols, a co-inventor of COMPASS Pathways’ GB2572023B patent, told Psymposia that he believes Bellia’s opinion could be accurate.

“The opinion is very comprehensive,” Nichols said. “I am not a patent attorney, so I cannot opine on whether it is precisely correct. I assume that examiner Bellia is well versed on patents and that his opinion is a valid one.”

Pechenik noted that COMPASS Pathways and its patent attorneys in the United States have a “duty of candor and good faith in dealing with the [Patent] Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability.”

This duty of disclosure means that COMPASS Pathways and its patent attorneys “may need to alert its US patent examiners about the opinion, in its pending US prosecutions. Failure to do so could be inequitable conduct that renders any subsequently issued US patents unenforceable, but it would be up to a US patent examiner to determine if the Opinion is reason to reject any currently pending claims,” Pechenik said. 

According to Pechenik, only a small number of these UK opinions have ever been issued. And he is not aware of any being notably dispositive or significant in any US litigations or proceedings in the past.