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Psychedelic Patents

Compass Pathways’ Patents

In late April of 2019, both the United States Patent and Trademark Office (“USPTO”) and the World Intellectual Property Office (“WIPO”) published Compass Pathways’s Patent Applications directed to psilocybin technology.  These applications were previously unavailable for public inspection, which led some journalists to speculate that Compass Pathways was creating a “magic mushroom monopoly.”

Now that Compass’s patent applications have published, it seems clear that they have no intentions of creating an expansive patent portfolio or stifling R&D by other entities.  To the contrary, their patent claims are extremely narrow, bordering on insignificant. Thus, fears that Compass Pathways has been creating a “magic mushroom monopoly” have been drastically overstated.  By way of analogy, Compass Pathways has claimed a few grains of sand in the middle of a vast desert– not the entire desert.

Despite widespread concern that Compass’s patent portfolio would impede psilocybin science, their patent portfolio probably won’t affect psilocybin research or commerce in any meaningful way.  Again referring to the analogy of a few grains of sand in the desert:

  • There are over 180 known species of psilocybin containing “magic” mushrooms
  • Those magic mushrooms contain many active ingredients — psilocybin is just one of them.
  • Psilocybin can exist in many forms, including mushrooms, mushroom preparations, crude mushroom extracts, separated/isolated psilocybin, or synthetic psilocybin.
  • Synthetic psilocybin can exist in many forms, including crystalline material.
  • Pure crystalline psilocybin can exist in a variety of different crystalline forms, aka “polymorphs.”
  • Compass has claimed (but not yet received a patent for) two specific crystalline forms.

The figure below shows how magic mushrooms can be extracted and separated into individual active molecules.  Instead of extracting those molecules (e.g., psilocybin) from a mushroom each of them could be made synthetically in a chemical laboratory.

Naturally occurring psychoactive mushrooms contain many active ingredients. Those ingredients can be extracted with a solvent to eliminate the insoluble structural material of the mushroom. That extract can be further processed to separate out the molecules present in the extract — resulting in a collection of isolated individual molecules that are much easier to study scientifically.
Psilocybin is just one of those molecules. Psilocybin can also be produced synthetically. Synthetic psilocybin can exist as a number of different salts and crystalline forms. Compass Pathways is only claiming one new crystalline form of synthetic psilocybin.

Concerns about Compass Pathways Monopolizing Psilocybin

Over the past year, Compass Pathways has received considerable attention for its commercial interests in psilocybin technology.  Compass Pathways is presently conducting clinical trials for administering pure synthetic psilocybin to patients with Treatment Resistant Depression.  Compass Pathways is poised to become the first legal provider of pure synthetic psilocybin.

Because of a somewhat anti-capitalist reaction towards commercializing psilocybin, Compass has been the subject of considerable criticism.  Much of this criticism has focused on Compass’s filing of several patent applications related to psilocybin. Robert Jesse of John’s Hopkins University fears that corporate influence could create a landscape “clogged by proprietary methods, restrictive licensing, exclusive contracts, patents, and the like.”

In November of 2018, Olivia Goldhill wrote an article in Quartz, stating that “A millionaire couple is threatening to create a magic mushroom monopoly,” referring to Compass’s founders George Goldsmith and Katya Malievskaia.

In her article, Ms. Goldhill explained that Compass was “well ahead of other institutions working in this field—and a recently filed patent application could help the company stay ahead.”

“Compass Pathways has relied on conventional pharmaceutical-industry tactics that could help them dominate the field, including blocking potential rivals’ ability to purchase drugs, filing an application for a manufacturing patent, and requiring contracts that give Compass power over academics’ research and are restrictive even by pharmaceutical-industry standards.

Responding to concerns about the implication of their patent portfolio, Compass Pathways told Quartz “our patents will not restrict research in the field, or preclude others from creating different solutions for the synthesis and formulation of psilocybin.”

In her article, Ms. Goldhill conceded “It’s not clear what exactly would be covered by the patent.”  Now that Compass’s patent application has published, it appears that Compass was telling the truth.  Their patents will not restrict research in the field, or preclude others from creating different solutions for the synthesis and formulation of psilocybin.

Compass’s patent application is extremely narrow. It does not create a threat of any sort of “magic mushroom monopoly.”

Compass Pathways’ Published Patent Applications

Compass Pathways United States Patent Application Number 16/155,386 published on April 25, 2019 as U.S. Patent Application Publication Number 2019/0119310.  International Patent Application Number PCT/IB2018/057811 published on April 18, 2018 as WO2019073379A1.  Both of these applications claim priority dating back to the British Application Number GB1716505.1, filed on October 9, 2017. Both applications claim extremely narrow subject matter.

The claimed subject matter is extremely narrow because all of the claims are limited to one specific crystalline form of psilocybin.  Currently pending claim 1 recites:

1 . Crystalline psilocybin in the form Polymorph A or

Polymorph A ‘ , characterised by one or more of :

a . peaks in an XRPD diffractogram at 11 . 5 , 12 . 0 and

14 . 5°20 + 0 . 1°20 ;

b . peaks in an XRPD diffractogram at 11 . 5 , 12 . 0 and

14 . 5°20 + 0 . 1°20 , further characterised by at least one

further peak at 19 . 7 , 20 . 4 , 22 . 2 , 24 . 3 or 25 . 7°20 + 0 .

1°20 ;

c . an XRPD diffractogram as substantially illustrated in

FIG . 7a or 7b ; or

d . an endothermic event in a DSC thermogram having an

onset temperature of between 205 and 220° C . substantially as illustrated in FIG . 8a or 8b .

Compass’s claims do not read on previously known forms of psilocybin.  Compass’s claims have nothing to do with “magic mushrooms.” Compass’s claims have nothing to do with the other active ingredients found in magic mushrooms.  In short, Compass’s claims are only relevant the particular crystalline form of psilocybin created and used by Compass.

Unless they use Compass’s specific process and crystalline form(s), other entities would be unaffected in their ability to make, use, or sell psilocybin or the other active ingredients in magic mushrooms.

Similarly, other entities would be unaffected in their ability to make, use, or sell other prodrugs of psilocin, such as psilacetin. They would also be unaffected in their ability to make, use, or sell any varieties of magic mushrooms.

The only monopoly sought by Compass Pathways is for the right to make, use, or sell their extremely narrow and specific form(s) of synthetic psilocybin.  Compass claims ownership of new crystalline forms of psilocybin on account of their intellectual contribution to the crystallization of psilocybin.  Compass’s new/inventive crystallization step is described in detail within Example 1 at paragraph 285 of the published application. In short, the crystallization method involves dissolving crude psilocybin in hot water and then gradually cooling the water. The process is similar to making rock candy from sugar.

Compass’s method of making psilocybin is also disclosed in the application.  Their method is best described as an optimized version of a procedure that was published in the Journal of Natural Products 2003, volume 66, pages 885-887.  Compass claims to have optimized this method for making larger batches of psilocybin: “In contrast to the prior art, the present invention sought to produce psilocybin at a commercial large scale.”  Para. 276.

Conclusions

Concerns about Compass Pathways monopolizing magic mushrooms or psilocybin have been drastically overstated. Based on their recently published patent applications, Compass is only claiming a new crystalline form of psilocybin. The patentability of that “new” form has yet to be determined. During examination of the claims, a patent examiner will determine whether crystallizing psilocybin from water to afford Compass’s “new” forms represents a patentable advance beyond the prior art.  Either way, Compass is highly unlikely to impede scientific progress with its patent portfolio.

Categories
Psychedelic Patents

New Psilocybin Patent Application by Paul Stamets

The increasing interest in psychedelic investment opportunities, including some recent developments in China, has led some analysts to begin studying the psychedelic patent landscape. Given the relatively small amount of research in the psychedelic space, very little IP has been generated to date.  Two exceptions to this rule include world-renowned mycologist Paul Stamets and CaaMTech, LLC. The UK based pharmaceutical company, COMPASS Pathways has also filed some psilocybin related patent applications, but they appear to be relatively narrow in terms of both the subject matter and geographical relevance.

Paul Stamets is one of the leading authorities on psychedelic mushrooms. See, e.g., Psilocybin Mushrooms of the World, by Paul Stamets, which is arguably the leading book on magic mushrooms. He is also an inventor of several patents, including some in the psychedelic space. On April 11, 2019, the United States Patent and Trademark Office (the “USPTO”) published a new patent application by  Mr. Stamets.

This article focuses on Mr. Stamets’s new application, US Patent Application serial number 16/211,281 (filed Dec. 6, 2018; herein “the ‘281 Application”). The ‘281 Application is a continuation of Mr. Stamets’s earlier filed U.S. Patent Application serial number 15/494,503, (filed Apr. 23, 2017), which claims priority to U.S. Provisional Patent Application No. 62/365,982, (filed Jul. 23, 2016).  Juxtaposing these two applications raising some interesting questions about the direction of psilocybin research and technology. Or, at least they may signal a change in Paul Stamets’s research focus, which may be significant to the industry in its own right.

Changing Focus of Stamets Patent Applications

Mr. Stamets’s new application (the ‘281 Application) claims a broader subject matter than the earlier filed application.  The (earlier) ‘503 Application was titled “Compositions and methods for enhancing neuroregeneration and cognition by combining mushroom extracts containing active ingredients psilocin or psilocybin with erinacines or hericenones enhanced with niacin.” The new ‘281 Application is simply titled “Psilocybin compositions.”

Arguably, the differences between the application titles illustrate Mr. Stamets’s intentions to broaden the scope of his earlier disclosure– changing the focus from (A) methods comprising at least three ingredients (psilocin or psilocybin + erinacines or hericenones + niacin) to (B) compositions containing three ingredients (a psilocybin derivative + psilocybin mushrooms or extracts + niacin).  The later-described compositions do not require erinacines or hericenones, which were an essential aspect of the original disclosure.

The evolution of the claims in the ‘281 and ‘503 Applications follow a similar trend.

The claims of Mr. Stamets’s earlier filed application (the ‘503 Application) were directed entirely to methods (not compositions), and those methods included more limitations regarding the compositions.  Claim 1 of the ‘503 Application recites:

1. A method for improving neurological health of an animal comprising: administering a therapeutically effective amount of a composition to an animal, wherein the composition comprises one or more of psilocybin, psilocin, baeocystin, norbaeocystin, salts thereof, or combinations thereof, one or more of erinacines, hericenones or combinations thereof, and niacin.

By contrast, the most recent ‘281 Application focuses on compositions.  Claim 1 recites:

1. A composition comprising:
psilocybin, psilocin, baeocystin, norbaeocystin, or salts thereof, psilocybin mushrooms or extracts thereof, or combinations thereof; and
niacin.

Compositions Combining Psilocybin Derivatives + Cannabinoids

Another interesting difference between Mr. Stamets’s earlier disclosure (the ‘503 Application) and the latest published application (the ‘281 Application) is his increased focus on combinations of psilocybin derivatives with cannabinoids.

For example, Claim 6 of the new ‘281 Application recites:

6. A composition comprising:
psilocybin, psilocin, baeocystin, norbaeocystin, or salts thereof, psilocybin mushrooms or extracts thereof, or combinations thereof;
Cannabis extracts comprising cannabidiol, tetrahydrocannabinol, or combinations thereof; and
niacin.

By contrast, the earlier disclosure provided only a limited general disclosure of this idea.  For example, claim 11 of the (earlier) ‘503 Application disclosed the following within claim 11:

11. The method of claim 1, wherein the composition additionally comprises one or more of (Bacopa monnieri), Gotu kola (Centella asiatica), Gingko (Gingko biloba), Ginger (Zingiber officinale), Holy Basil (Ocimum sanctum), Hu Zhang (Polygonum cuspidatum), Oregano (Origanum vulgare, Origanum onites), Rosemary (Rosmarinus officinalis, Rosmarinus eriocalyx, Rosmarinus species), Turmeric (Curcuma longa), Green Tea (Camellia sinensis), lavender (Lavandula spica and Lavandula species), skullcap (Scutellaria lateriflora), oat straw (Avena sativa and Avena byzantine), Diviner’s Sage (Salvia divinorum), ayahuasca (Banisteriopsis caapi and Psychotria species), Tabernanthe iboga, Voacanga africana, Tabernaemontana undulate, peyote (Lophophora williamsii), morning glory (Ipomoea tricolor, Argyreia nervosa), Cannabis sativa, Cannabis indica or Cannabis ruderalis, or combinations thereof.

Accordingly, the newer application narrows the focus considerably from (A) methods including compositions that contain (any one of) an extensive list of plants, to (B) composition having several specific compounds from one specific plant.

Discussion and Remaining Questions

Although neither Mr. Stamets’s ‘281 Application nor his ‘502 Application have issued as patents, the evolution of the claims in these applications suggest that Mr. Stamets has substantially changed the focus of his invention.

  1. Mr. Stamets’s original focus on neuroregenerative methods has evolved into a focus on all-purpose compositions.  Does this signify a departure from neuroregeneration research and development?  If not, why change the focus from particular methods to all-purpose compositions?
  2. Mr. Stamets’s original focus on erinacines or hericenones or both has virtually disappeared in the latest application.  The original disclosure was clear that the disclosed compositions all included niacin combined with erinacines or hericenones.  But the latest published application (the ‘281 Application) appears to eliminate these once critical components from the compositions.  Why the change of heart regarding erinacines or hericenones?  Given that these ingredients were critical ingredients throughout the original disclosure, why aren’t they important now?
  3. One clear consistency between Mr. Stamets’s ‘281 Application and his ‘502 Application is the absolute requirement that all of the disclosed methods or compositions include niacin. Arguably the niacin component of the invention is more important than even the psilocybin derivative: The disclosure provides for some flexibility regarding the chemical compositions of the mushrooms/mushroom extracts; But, all methods and compositions must include niacin.  Arguably, Mr. Stamets’s applications are most appropriately categorized as “Niacin Compositions.”
  4. Why the new and specific focus on psilocybin derivatives and cannabinoids? These are all naturally occurring molecules with therapeutic potential.  But, the earlier application only listed the cannabis plant alongside dozens of other plants and fungi. In the most recent application, cannabis and specific cannabinoids have been elevated to a level of importance that is surprisingly inconsistent with the original filing.