Patents are a contentious subject in the psychedelic medicine space. They are a crucial part of a company’s intellectual property portfolio, giving firms protection for their development work and the opportunity to commercialize innovative products. But what constitutes an original discovery? Should there be limits to what a company can claim ownership of? Should certain things remain free of commercial restraints?
These questions are particularly relevant in psychedelics, with many of these medicines being naturally grown and having been used throughout history. Which is why the issue of patents is being closely scrutinized as the industry tries to find a balance between profitability and ethics.
Last year, two of Compass Pathways’ patents were challenged by the nonprofit group Freedom to Operate. The patents covered the company’s synthetic form of psilocybin, and the challenge argued that Compass’ synthetic psilocybin wasn’t a new innovation and thus should not be patentable.
This week the Patent Trial and Appeal Board (PTAB) announced its decision on the case, agreeing with Compass’ patent claims. This was a win for Compass Pathways as it bolsters its IP and gives investors added confidence in the company’s prospects.
Freedom to Operate put out a statement about the decision, mentioning that despite the loss there could be a silver lining for future access to psilocybin manufacturing. See the full press release below.
“While we disagree with the decision to disallow our petitions for Post Grant Review, we are confident that the PTAB’s extremely 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”, said Carey Turnbull, founder and director of Freedom to Operate.
In other patent news, MindMed was granted a patent for the combination of MDMA and LSD. Known recreationally as “candy flipping” the patent is causing some controversy as there are already many prior uses of this combination. Ethical considerations aside, if the patent withstands challenges it will definitely add to MindMed’s IP portfolio.
See the Twitter thread by patent lawyer Graham Pechenik for more details on this news.
MDMA + LSD = a patentable invention?
According to the USPTO, yes
Today—MindMed $MNMD granted a US patent, with claims to:
“A composition comprising an empathogen/entactogen and a psychedelic in the same single oral dosage form.”
Along with methods of using it
🍬🤸🏻
— Graham Pechenik (@calyxlaw) June 22, 2022
Freedom to Operate Issues Statement Regarding U.S. Patent Trial and Appeal Board’s Response to Petition for Post Grant Review of Compass Psilocybin Patents
Greenwich, Connecticut, June 24, 2022 – The non-profit Freedom to Operate (FTO) today issued the following statement regarding the U.S. Patent Trial and Appeal Board’s (PTAB) response to its petition for Post Grant Review of Compass Pathways’s Patents No. 10,947,257 and 10,954,259 directed to compositions and oral dosage forms containing its “Polymorph A” of psilocybin.
“While we disagree with the decision to disallow our petitions for Post Grant Review, we are confident that the PTAB’s extremely 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”, said Carey Turnbull, founder and director of Freedom to Operate.
In its decisions, the PTAB construed Compass’s “Polymorph A” claims narrowly, holding that they only cover psilocybin that has all of the x-ray powder diffraction (XRPD) peaks exactly as claimed. Most patent owners in cases involving claims with XRPD peaks try to give their claims some range outside the exact peaks stated in their claims, because often a product that the patent owner wants to allege infringes doesn’t have those exact peaks. As a result of the Board’s decision, Compass can’t reasonably take that position. Instead, the PTAB has now given manufacturers of psilocybin a clear pathway for making sure that the psilocybin they manufacture or sell is not at risk of infringing Compass’s “Polymorph A” patents.
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. In furtherance of its mission, FTO has filed three petitions for Post-Grant Review before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office seeking review of patents issued to Compass Pathways for certain medical uses of a particular polymorph of psilocybin, a well-known naturally occurring substance. FTO has challenged these patents that may have, if left uncontested, had 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. FTO will continue to challenge bad patents and, where appropriate, will support scientific research that contributes to the emergence of psychedelic science and the psychedelic renaissance.
About Freedom to Operate
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 invalidated.
For more information, please visit www.freedomtooperate.org
Contact: Christopher Koddermann
Tel.: +41 (79) 434 25 78
E-Mail: chris@nyprg.org
