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Pα+ Psychedelic Patent Analysis (October 2023)

Written by Psychedelic Alpha’s Noah Smith with support from Editor-at-Large and patent attorney Graham Pechenik of Calyx Law.

Our monthly Psychedelic Patent Analysis provides headline figures regarding published psychedelic patent applications and grants, before diving into commentary on a select handful of patent-related actions.

Note: the monthly Psychedelic Patent Analysis is a Pα+ subscriber benefit (join today). Given that this is a new format, we’re making this first issue available without a paywall.

This Month:
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    General Overview

    • We added 59 PCTs and US patent applications focused on psychedelics to our tracker in the month of October.
      • Applications come from companies like GH Research, CaaMTech, Gilgamesh, Cybin, Compass, atai, and MindMed
    • 16 granted US patents were added to or updated in the tracker.
      • Companies that received grants include Beckley Psytech, Small Pharma, CaaMTech, and MindMed

    Note: Future issues of the Psychedelic Patent Analysis will include a more detailed summary of publications, allowances, grants and rejections. Subscribe to Pα+ to receive next month’s issue, along with other subscriber-only content.

    Key Terms

    Patent applications are generally published 18 months after filing, meaning they’re something of a lagging indicator.

    PCT stands for ‘Patent Cooperation Treaty’, and refers to a process by which patents ultimately can be sought in a broad swathe of 157 countries (beyond the country in which the original priority application was filed, often a U.S. provisional application) with one ‘international’ PCT patent application.

    ‘Claims’ are a central part of a patent (application); by establishing the ‘metes and bounds’ of the invention, they define the exclusive right.

    ‘The tracker’ refers to Psychedelic Alpha’s in-house database of psychedelics-related patents, curated by Calyx Law. At present, this tracker can be accessed through molecule-themed views.

    Allowance and grants: If the U.S. Patent and Trademark Office (USPTO) intends to grant a patent, it will issue a Notice of Allowance. As such, an allowance foreshadows a grant (when the patent is ultimately published, and becomes enforceable).

    MindMed Scores Psilocybin-Antidepressant Co-Treatment Patent

    Among the 16 U.S. psychedelic patents granted, one in particular stood out to us:

    Antidepressant-Psilocybin Co-Treatment to Assist Psychotherapy 
    US 17/692,105

    MindMed, through its agreement with Universitätsspital Basel (UHB), saw its intellectual property portfolio bolstered by the issuance of this U.S. patent.

    The newly granted patent, titled Antidepressant-Psilocybin Co-Treatment to Assist Psychotherapy, covers the combined use of an antidepressant followed by the administration of a psychedelic in order to induce, “a more positive psychological state in the individual with the antidepressant-psychedelic combination compared with the psychedelic alone.”

    Twenty claims were originally presented, which included methods and compositions, and covered a broad range of over 10 classes of antidepressants, and a broad range of psychedelics including psilocybin, psilocin, LSD, mescaline, DMT, DOI, DOB “phenethylamine or tryptamine psychedelics” as well as “analogs”, “prodrugs”, and “homologues” thereof. From these, UHB elected to prosecute method claims covering escitalopram and psilocybin specifically. After UHB incorporated these limitations into their claims, their amended claims were allowed. UHB’s amended independent claim 1 (below) focuses on, amongst other things, “enhancing the positive effects of a psychedelic” through the pretreatment of an individual with an antidepressant, with several limitations listed.

    MindMed Scores Psilocybin-Antidepressant Co-Treatment Patent

    The enhancement of positive effects, in this case, is purportedly achieved through the attenuation of “bad drug effects, anxiety, autonomic effects, and adverse effects of the psychedelic”, not explicitly through the direct amelioration of psychiatric symptoms.  

    UHB therefore appears to frame its invention as a method to achieve a more tolerable, effective, and thus beneficial psychedelic treatment. In this way, the psychedelic may be understood to be the primary therapeutic agent in the combination, while the antidepressant is merely a means to support the therapeutic effect of the psychedelic, and not as a means to elicit additional direct therapeutic benefit.

    UHB’s invention, and the framing thereof, seems to have been compelling enough—at least to the examiner charged with its evaluation—to warrant its issuance. Indeed, after receiving UHB’s election of claims to examine, the Examiner initiated an interview with the prosecuting attorney and the “Examiner suggested amendments to place the claims in condition for allowance” (according to the Examiner’s own summary). Adoption of those amendments indeed then led to allowance. In the Notice of Allowance, the examiner explained their rationale for allowing the company’s claims. Crucially, a considerable part of that justification was based upon the notion that UHB’s invention addressed an “unmet medical need.”

    The examiner, in support of this conclusion, offered two quotes from a July 2022 article authored by Mattha Busby:

    “As twin mental health and drug misuse crises kill thousands of people per week, the potential of psychedelic-assisted therapies “must be explored,” urges a federal letter on behalf of the U.S. health secretary and shared with The Intercept”

    “More than 17 former U.S. service members are estimated to kill themselves per day as traumas from futile and damaging wars abroad over the past 20 years find scant respite through traditional avenues. But hundreds of veterans have traveled to Mexico, Costa Rica, and elsewhere in recent years for successful treatments with psychedelics to address war traumas.”

    The urgent need for effective psychiatric treatments is undeniable. However, it is unclear, at least to this writer, how a method of using a classical psychedelic alongside a pre-existing standard of psychiatric care amounts to a novel invention that can meaningfully address that need. Especially given the fact that psychedelic medicines will likely—at least in the near future—be offered as third-line (and beyond) treatments, meaning almost all patients suffering from depression would have tried (and, often will be continued on a course of) conventional antidepressants.

    Nevertheless, MindMed, and its partners at UHB, are not the first to attempt to patent methods of this nature. In fact, Compass Pathways has previously introduced similar claims focused on the concomitant use of psilocybin with antidepressants, including related claims covering temporal limitations, such as those featured in UHB’s now-granted patent. However, unlike UHB, Compass’s claims appear to frame the concomitant use of an antidepressant as a means to achieve further direct therapeutic benefit in addition to that elicited by psilocybin.


    • Claim 1: A method of treating treatment-resistant depression in a subject in need thereof, the method comprising administering an effective amount of psilocybin or an active metabolite thereof to the subject as an adjunctive to Selective Serotonin Reuptake Inhibitor (SSRI) therapy.
      • Claim 2: The method of claim 1, wherein the SSRI is selected from the group consisting of escitalopram, sertraline, fluoxetine, vilazodone, vortioxetine, paroxetine or citalopram.
      • Claim 3: The method of any one of claims 1-2, wherein the SSRI is administered prior to administration of psilocybin.
      • Claim 4: The method any one of claims 1-2, wherein the SSRI is administered after administration of psilocybin.
      • Claim 5: The method any one of claims 1-4, wherein the SSRI is administered on the same day as the psilocybin.



    • Claim 21: The method of any one of claims 1 -19, wherein the method further comprises administering to the subject at least one additional therapeutic to reduce the sign or symptom of depression.
      • Claim 22: The method of claim 21 , wherein the at least one additional therapeutic is a selective serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, a tricyclic antidepressant, a tetracyclic antidepressant, a dopamine reuptake inhibitor, a 5-HT|| receptor antagonist, a 5-HT| receptor antagonist, a 5-HT1 receptor antagonist, a monoamine oxidase inhibitor, or a noradrenergic antagonist.

    While national phase entries for Compass’s WO2023114097 PCT are not due until June 2024 (30 months from the priority date), all claims relating to co-use of psilocybin and an antidepressant were canceled in the company’s US entry for its earlier WO2020212952 PCT.

    Nevertheless, many of Compass’s provisional applications, filed as early as April 17, 2019, make explicit reference to the administration of psilocybin “in combination with one or more treatments”, including “anti-depressant or anti-anxiety drugs, such as SSRIs, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), or serotonin norepinephrine reuptake inhibitors (SNRIs).”

    Compass’s provisional applications are evidently not the only prior art potentially relevant to UHB’s claims. In March 2023, Porta Sophia filed a third-party submission with the USPTO in response to UHB’s application. Porta Sophia’s submission included a collection of prior art documents the organization described as “material to the patentability of all 20” of UHB’s originally-filed claims.

    As noted above, UHB elected to prosecute claims directed specifically to the use of escitalopram and psilocybin. However, even with this restricted claim set, Porta Sophia’s submission points to the existence of a body of prior art that brings into question the novelty and non-obviousness of UHB’s now-patented methods. In spite of the submission, none of UHB’s claims were disallowed; nor, in fact, did UHB even receive a single prior art rejection.

    In their evaluation of UHB’s application, the assigned examiner cited a 2022 publication from Becker, et al. as the ‘closest art’. The publication, which was (perhaps not so coincidentally) the culmination of a UHB, Matthias Liechti-led, trial investigating how antidepressants interact with psilocybin, described how escitalopram pretreatment “reduced bad drug effects” of psilocybin.

    Interestingly, however, the publication also described how pretreatment “had no relevant effect on positive mood effects of psilocybin”. Such a finding would appear to contradict one goal of UHB’s claimed method, wherein the combined use of psilocybin and an antidepressant induces “a more positive psychological state in the individual … compared with the psychedelic alone.” (Perhaps, had they needed to overcome it as prior art, they could have even asserted that it ‘taught away’?)

    Despite some of the similarities between the effects described in the publication and the claims in the patent, in the Notice of Allowance, the examiner explained that the limitations included in the company’s amended independent claim were not taught by Becker, et al. (2022). These limitations include specific psilocybin and escitalopram dose ranges and pretreatment time periods.

    As a result, the claims were allowed and UHB was granted its patent. However, it is unclear if or how MindMed, as a beneficiary of the issuance, intends to leverage this newly granted patent, considering the company’s drug development pipeline does not include psilocybin. Further, it is also unclear how the administration of psilocybin to patients on escitalopram could constitute infringement of this patented method, and if so, whether MindMed intends to enforce its claims.

    For parties interested in employing the drug combination in clinical trials, patent infringement may not be a concern (at least, not right away). As Graham Pechenik explained in an earlier thread, 35 U.S.C. § 271(e)(1), also known as the Hatch-Waxman “Safe Harbor”, makes an exception for otherwise-infringing acts when they are “solely for uses reasonably related to the development & submission of information” for FDA approval.

    It is in medical practice, when psilocybin and escitalopram are both administered to a patient, where infringement could arguably be a greater risk (although clinicians themselves are rarely targets, and are shielded from some forms of infringement liability). And even where a single entity is not responsible for administering (or inducing the administration of) both the psilocybin and the escitalopram, the doctrine of divided patent infringement may apply in instances “where more than one party may have participated in a patent’s claimed steps.” (In the case of MindMed’s patent, for instance, there could be liability for divided infringement, if one party is  “directing or controlling” the actions of the other, or together acting as a “joint enterprise”.)

    In addition to eliciting concerns of infringement for anyone not participating in a clinical trial for FDA approval, the granting of UHB’s patent raises another question: did the patent examiner deviate from standard lines of reasoning in their reliance on “unmet medical need” as a partial rationale for its issuance? To date, our team has been unable to identify instances where equivalent lines of reasoning have been offered by a patent examiner in support of the issuance of other patents. (And are unaware of any legal relevance for such a rationale, outside of a special program like the COVID-19 “Patents for Humanity”.)

    A Spate of PCTs Published from GH Research

    Of the 59 patent applications published throughout October, 19 came from the Irish psychedelic drug developer GH Research.

    The 19 PCTs, all of which published on October 5th, focus largely on the use of 5-MeO-DMT for treating an exhaustive list of indications. These claimed clinical uses of 5-MeO-DMT include commonly referenced indications like anxiety, depressive, and bipolar disorders, along with less ‘conventional’ uses such as sleep disturbances and nervous system disorders. Examples include:

    • 5-Methoxy-N,N-Dimethyltryptamine For The Treatment Of Anxiety (WO2023186828)
    • 5-Methoxy-N,N-Dimethyltryptamine For The Treatment Of Psychomotor Retardation (WO2023186830)
    • 5-MeO-DMT For Use In The Treatment Of Postpartum Depression (WO2023186826)
    • 5-MeO-DMT For Use In The Treatment Of Sleep Disturbance (WO2023186798)
    • 5-MeO-DMT For Use In The Treatment Of Negative Thinking (WO2023186821)
    • 5-Methoxy-N,N-Dimethyltryptamine For The Treatment Of Cognitive Dysfunction (WO2023186824)
    • 5-Methoxy-N,N-Dimethyltryptamine For The Treatment Of Social/Emotional Withdrawal Or Detachment (WO2023186832)

    In addition to its methods-focused PCTs, an application focused on compositions of a crystalline hydrobromide salt of 5-MeO-DMT was also published. GH Research’s new PCT adds to a growing assortment of applications and granted patents focused on solid forms of 5-MeO-DMT filed by the likes of Beckley Psytech (WO2021250434), Terran (WO2023107931), Small Pharma (US 11,697,638) and others.

    Early Fruits of Cybin’s Small Pharma Acquisition

    At the end of August, Cybin announced that it would be acquiring industry competitor Small Pharma, and it didn’t take long for the fruits of the acquisition to emerge.

    The acquisition follows years of both companies concurrently pursuing the development of similar deuterated drug candidates. The unification of development pipelines has allowed Cybin to bolster the moat around its CYB004, deuterated DMT, candidate.

    This moat now includes two Small Pharma patents (US11,773,062 & US11,771,681) issued at the beginning of October, both of which include claims covering deuterated forms of DMT.

    Explore our Psychedelic Patent Trackers

    Curated by Calyx Law, our patent trackers catalogue published patents across a number of molecules, including psilocybin, DMT and MDMA.