A lawsuit filed by attorneys on behalf of psychedelic drug developer Reunion Neuroscience alleges that Mindset Pharma âknowingly copiedâ Reunionâs RE104 (FKA FT-104, when Reunion was part of Field Trip), âand presented that exact composition to the [U.S. Patent and Trademark Office] as its invention.â
The dispute, filed on March 13th in the U.S. District Court for the District of New Jersey, revolves around Reunionâs lead candidate isoprocin glutarate, a hemiglutarate prodrug of 4-HO-DiPTâone of Sasha Shulginâs TiHKAL compounds. Shulgin described the drug as such: âI truly doubt that there is another psychedelic drug, anywhere, that can match this one for speed, for intensity, for brevity, and sensitive to dose, at least one that is active orallyâ. At 2-3 hours, the drug has a much shorter trip than that of psilocybin, for example, which might make it a more scalable product. Reunionâs initial indication for the candidate is postpartum depression. (We covered the compound back in a December 2021 Bulletin.)
Psychedelic Alpha Editor-at-large Graham Pechenik had expected an action for some time, explaining in January that Reunion might try to invalidate Mindsetâs claim via a post-grant challenge or via district court litigation.
Here, we provide an abridged timeline of events, a look at the potential strength of Reunionâs lawsuit, as well as the broader context of the companyâs present predicament. 4-HO-DiPT hemiglutarate, isoprocin glutarate and RE104 are used interchangeably throughout this piece.
Will this lawsuit, viewed by lawyer Matt Zorn as âa desperation moveâ, lead to a reunion with karma?

An Abridged Timeline
On February 4th, 2020, Mindset filed a U.S. provisional patent application, Psilocin Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders (62/969,934). As the title suggests, the application claims psilocin derivatives, processes for their preparation, compositions, and methods of their use in treating certain conditions. The application did not explicitly mention 4-HO-DiPT prodrugs or 4-HO-DiPT hemiglutarate specifically.
On June 30, 2020, Reunion filed a U.S. provisional disclosing and claiming 4-HO-DiPT hemiglutarate (63/045,901), which serves as the priority date for its granted U.S. Patent No. 11,292,765 (the â765 patent). The application is titled Tryptamine Prodrugs (though thereâs a typo in Reunionâs lawsuit, where itâs written âTryptaminâ on page 9). Subsequently filed as a U.S. non-provisional patent application claiming RE104, and with a number of working and prophetic examples on RE104 specifically, it published on December 30, 2021.
Reunionâs patent received a Notice of Allowance on January 20, 2022. âShortly thereafterâ, the lawsuit alleges, Mindset âprovided Reunion with copies of certain published Mindset patent applications.â Accordingly, Reunion petitioned the PTO to pull its application from issue, re-submitting it with Mindsetâs applications referenced, to ensure the examiner had reviewed Mindsetâs applications when deciding whether to issue Reunionâs tryptamine prodrugs patent. The â765 patent application then received a renewed Notice of Allowance on March 16, 2022. On April 5, 2022, Reunionâs â765 patent issued.
Two months later, on June 6, 2022, Mindset filed a continuation application (17/833,341) that for the first time explicitly claimed 4-HO-DiPT hemiglutarate by structureâindeed, 4-HO-DiPT hemiglutarate was the only specific compound claimed individually.
The lawsuit alleges that on January 20, 2023, Mindsetâs outside counsel wrote a Demand Letter to Reunion founder Joseph del Moral, in which the company informs Reunion that its patent publications âcontain claims that cover Reunionâs RE104 compoundâ (note that this letter was disclosed in Reunionâs MD&A filing dated February 10, 2023, when the company explained that it was investigating Mindsetâs patent application âincluding potential offensive strategiesâ). Mindset allegedly informed Reunion that the PTO had issued a Notice of Allowance for its patent application, and suggested that the companies meet to negotiate a commercial resolution, ârather than becoming involved in legal proceedings.â
According to the suit, âMindset made clear that it âfully intendsâ to publicly announce âits patent rights around RE104 and to enforce its patent rights.â Reunionâs suit further alleges that Mindsetâs counsel cautioned Reunion that âit would appear that Reunion must divulge that Mindset has patent rights covering RE104 during due diligence investigations and fund-raising discussions.â
Reunionâs response came in the form of a February 2023 letter. While Reunion expressed that it âstrongly disagreedâ with the assertions made in Mindsetâs Demand Letter, it âagreed to meet with Mindset to explore a business resolution.â
According to the lawsuit, the companies engaged in a meeting at Mindsetâs counselâs offices in Washington, D.C. on February 15, 2023. The meeting, which purportedly took place for around three hours, included a private meeting between the CEOs: Mindsetâs James Lanthier and Reunionâs Greg Mayes. According to the suit, the discussions were âsuccessfulâ, with an agreement allegedly reached and confirmed by a handshake.
Within five days of this meeting, Mindsetâs counsel purportedly circulated a draft licence agreement that reflected the terms supposedly agreed upon at the meeting. According to the lawsuit, however, Mindset âattempted to renege on this agreement, opting instead to pursue âstrategic alternativesâ in a communication on March 2, 2023. On this matter, Reunion insists that, âMindset also should be held to its promises at the partiesâ settlement meeting.â Itâs worth noting that Mindsetâs â353 patent issued on February 28, 2023.
How Can Two Patents Cover the Same Compound?
Many are likely thinking, how is it that both Mindset and Reunion were entitled to patent claims on the very same compound? Or, perhaps asking more narrowly, if Mindset had filed an earlier application, why was Reunion able to get claims at all?
To answer that, we spoke with Psychedelic Alpha Editor-at-large and patent attorney Graham Pechenik. From Pechenik, we learned that whatâs important is that Mindsetâs earlier application disclosed a broad generic class of chemical compounds that encompassed RE104, but did not specify it directly. Under the patent law, the generic disclosure of a class of compounds (a âMarkush groupâ) only anticipates a specific compound (that is, renders it no longer novel) if âone of ordinary skill in the art is able to âat once envisageâ the specific compound within the generic chemical formula.â âWhen a claimed compound is not specifically named in a reference, but instead it is necessary to select portions of teachings within the reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated.â (MPEP § 2131.02(III).)
Here, the examiner reviewed Mindsetâs application (indeed, after having been directed to it by Reunion itself), and found that Mindsetâs generic disclosure was not anticipatoryâeven in view of Mindsetâs disclosure, RE104 was still novel. Thus, Reunionâs claims to RE104 were allowed.
At the same time, Mindset still had the earlier priority date. Hence, Reunionâs applicationâand its specific disclosure of RE104âcould not be used as prior art to Mindsetâs claims. And to receive allowance of its own claims, Mindset did not need to meet the âat once envisageâ standard for anticipation. Instead, Mindset only needed to meet the disclosure requirements of 35 U.S.C. § 112: âwritten descriptionâ and âenablement.â
Unlike the higher bar to show anticipation by a genus, the bars for disclosure are in effect lower: âpossession of the inventionâ for written description, and the ability to âmake and useâ the invention without âundue experimentationâ for enablement. (MPEP § 2163 (âIn claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass.â); § 2164 (âââThe scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required.â).)
The examiner did not challenge Mindsetâs âpossessionâ of RE104, nor that Mindsetâs application failed to teach how to âmake and useâ it. Thus, Mindsetâs claim to RE104 was also allowed. (Interestingly, the ease of meeting the disclosure requirements is currently being challenged in a blockbuster case before the Supreme Court, Amgen v. Sanofi, that has attracted the attention and amicus briefs of dozens of companies, groups, and academics, with potentially far-reaching implications for genus claiming in pharmaceutical and chemical applications.)
Reunionâs Remedies
Having presented the above timeline of events, the suit alleges that Mindset âcommitted inequitable conduct in the PTOâ, and argues that âunder settled law, Reunion co-owns the â353 patent in its entirety.â
The lawsuit seeks a number of remedies, most notably âcorrection of inventorshipâ of the â353 to substitute Reunion CSO Nathan Bryson as the sole inventor of the claim to RE104 (with Mindsetâs Dr. Abdelmalik Slassi and Joseph Araujo as the inventors of the remaining claims); a declaration that Reunion is a co-owner of the â353 patent; and, a decision that Mindset be barred from enforcing the â353 patent against Reunion.
A further count described in the lawsuit seeks to frame Mindsetâs actions as Promissory Estoppel, whereby Reunion relied on Mindsetâs alleged promises related to entering into a non-exclusive licensing agreement to resolve the dispute.
Furthermore, given that Mindset was allegedly aware that Reunionâs success in securing funding would depend on the resolution of the present dispute, Reunion alleges that Mindset âcommitted these acts knowing they would impair Reunionâs opportunity to obtain funding,â and seeks âan award of damages of more than $25 millionâ for Mindsetâs tortious interference with Reunionâs prospective business.
The Crux of the Case
At the heart of Reunionâs dispute is the fact that Mindsetâs initial patent application did not explicitly disclose or claim the structure of Reunionâs 4-OH-DiPT prodrug (RE104) until after the point at which it became clear that Reunion was pursuing the compound. As written in the suit:
âMindset only included that compound after RE104âs chemical structure became public following the publications of Reunionâs patent application and subsequently issued patent.â
For this, Reunion hopes to have Mindsetâs patent found unenforceable for inequitable conduct before the PTO. This requires a finding that the patent applicant had the âspecific intentâ of deceiving the PTO: a very high bar to clear.
The trouble is, courts may be unlikely to find the addition of claims to a competitorâs product as inequitable conduct. In fact, all signs point to the contrary.
As Pechenik points out, the case of Kingsdown Medical Consultants, Ltd. v. Hollister, Inc. is likely instructive here. The relevant portion of the decision is as follows (emphasis added):
â[T]here is nothing improper, illegal or inequitable in filing a patent application for the purpose of obtaining a right to exclude a known competitorâs product from the market; nor is it in any manner improper to amend or insert claims intended to cover a competitor’s product the applicant’s attorney has learned about during the prosecution of a patent application. Any such amendment or insertion must comply with all statutes and regulations, of course, but, if it does, its genesis in the marketplace is simply irrelevant and cannot of itself evidence deceitful intent.â
Assuming this decision is applicable and still âgood lawâ, there is little reason to believe that the new claims described in Mindsetâs continuation patent application to the â353 patent filed in June 2022 (17/833,341)—which explicitly identify isoprocin glutarate (aka 4-OH-DiPT hemiglutarate, RE104)—were foul play, or anything approaching inequitable conduct.
Instead, itâs a pretty standard patent strategy. Perhaps it strikes as gamesmanship (and perhaps it is), but not filing such âtargeted claimsâ might in fact have seemed like a lapse on the part of the patent attorneys. Itâs a strategy familiar to many, as an internet search quickly confirms (âCareful monitoring of competitorsâ productsâŠwill identify opportunities forâŠtargeted claimsâ); (âit is good practice to present claims that would cover your competitorâs productsâ); (âIf competitors attempt to design around your first patent, a continuation will give you the opportunity to pursue different claims to stop them.â); (âa continuation application gives you the opportunity to seek patent protection that will cover a competitorâs productâ); (âContinuation applications can also be used offensively to file claims which cover a competitorâs product.â).
And, why wouldnât it be an acceptable strategy? So long as the invention being claimed in a continuation application is supported by the original application, is it not a part of the original invention? If itâs not based on the original application, it would fail under the requirements of written description and enablement (i.e., fail to âcomply with all statutes and regulationsâ), and be invalidâin essence, the court in Kingsdown seems to say that later claims shouldnât be separately policed for where the subject matter comes from, as long as theyâre adequately supported.
Here, as Pechenik noted to Psychedelic Alpha, thereâs no allegation that Mindsetâs original disclosure was invented by Dr. Bryson. Nor is there any allegation that Mindset learned of RE104 through anything but âlegal and ethical means.â As Reunion asserts, âMindset only included [RE104] in its patent application after the publication of Reunionâs applicationâ (Complaint at 14, emphasis in original). But after Reunionâs application published, RE104 was public. While the âFederal Circuit’s holding in Kingsdown does not permit individuals to disregard firewalls and confidentiality agreementsâ (Gilead Sciences, at 57)âfor instance, by claiming another companyâs confidential information learned under NDAâclaiming public information appears tantamount to claiming information with âits genesis in the marketplace,â and thus, per Kingsdown, âsimply irrelevantâ and not âevidence deceitful intent.â
As such, itâs difficult to see how Mindsetâs addition of claims that explicitly cover 4-HO-DiPT hemiglutarate in its continuation patent application is anything other than ordinary patent strategy and practice. Itâs even more difficult to see how these actions might be proven to be inequitable conduct.
A Hail Mary?
Given what appears to be poor legal grounds, why is Reunion bringing this suit against Mindset? The answer likely lies in the fact that psychedelic drug developer Reunion, now that itâs spun out from Field Trip, is perhaps more accurately described as a âRE104 development companyâ. The companyâs only drug development candidate is at an apparent stand-still until this dispute is resolved.
As aforementioned, Reunion has stated that its ability to raise further financing, and commence its Phase 2 trials of RE104, is dependent on resolving this dispute. Reunionâs lawsuit further explained that it needed to resolve âany intellectual property issues by the end of February 2023 to secure third-party funding it was negotiating.â And, Reunion has had to make investorsâboth present and futureâaware of Mindsetâs allegations, including the fact that Mindset has allegedly reneged on its âoral agreementâ.
As such, itâs difficult to see a way out of this bind for Reunion. This lawsuit is likely a hail mary, and perhaps a performative one at that.
Lawyer and co-author of On Drugs Matt Zorn agrees, telling Psychedelic Alpha that this âlooks like a desperation move.â âThe claims and legal contentions appear neither to have a basis in existing law nor are justified by a nonfrivolous argument to extend, modify, or reverse existing lawâ, he continued.
Zorn also wondered why the District of New Jersey was chosen as the legal venue for the lawsuit, noting that âit is entirely unclear to me how New Jersey has personal jurisdiction over Mindset.â This is especially odd given the fact that Reunion alleges an oral agreement took place in Washington D.C., which would mean that jurisdiction âwould be a place where Mindset could be sued.â
A Reunion with Karma?
Committed Psychedelic Alpha readers will recall the case of the DEAâs proposed scheduling of five psychedelic tryptamines, which was ultimately abandoned following pushback (see our long read for more). Among the five tryptamines that the DEA intended to schedule was 4-HO-DiPT.
The most eagle-eyed reader will also remember that Reunionâs CSO, Nathan Bryson, made a submission to the DEA during the public comment period.
In that heavily-redacted letter, Bryson recommended that all of the tryptamines be added to Schedule I, except for 4-HO-DiPT: the subject of the companyâs development efforts (emphasis ours):
âField Trip Discovery appreciates DEAâs ongoing efforts to prevent the diversion and abuse of controlled substances and concurs with the DEAâs proposal to place into Schedule I of the CSA the latter four (4) compounds.â
Notably, this was after messages seen by Psychedelic Alpha had been circulated to several dozen different academic and company recipients (Bryson and Levy among them), discussing the drug policy and overall public benefit of keeping all five tryptamines off Schedule I, as well as the need for some to defend their ability to continue their ongoing research into each of the five, and seeking participation in a group effort.
In documents seen by Psychedelic Alpha, counsel for two psychedelic drug developers who opposed the scheduling of all five tryptamines argued that, given the level of redaction in Brysonâs letter, it would not be possible to adequately cross-examine or otherwise consider it in the course of the proceedings (necessary, as in effect Bryson had given evidence in support of the very scheduling they were fighting). Instead, they considered a subpoena of Bryson, or exclusion of the comment from evidence. Counsel for Reunion (then operating as Field Trip) struck back, stating that the company would âvociferously objectâ to any effort to exclude the submissions, and would âquash any subpoena.â
Brysonâs submission, which recommended the placement of four of the five psychedelic tryptamines into Schedule I of the Controlled Substances Act upset many in the psychedelics space. Some of these individuals have made comments that demonstrate a level of schadenfreude with respect to the present cloud over Reunionâs 4-HO-DiPT IP.
Hence (to borrow the idea Matthew Baggott originally invoked), karmaâmight one form of commercial gamesmanship deserve another?
Field Trip Health & Wellness (the care delivery portion of Field Trip that was spun out in an August 2022 corporate reorganisation), meanwhile, is also floundering. A February business update reported the formation of an independent committee of the board of directors that would âassess strategic options for the Companyâ.
The formation of this committee was in partial response to challenging market conditions that have led to the company struggling to raise additional financing, as well as âongoing fixed costs associated with the Companyâs brick and mortar locations and the pausing of its hybrid in-clinic/virtual Freedom Program due to regulatory changes potentially affecting the ability of the Company to operate the program.â Potential remedies could include cost reductions, restructuring, and the closing of clinics; among other options.
(Note: as this piece went to press, Field Trip announced that it will close five locations. According to the companyâs latest investor presentation, this represents the majority of its locations.)
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In January, Reunionâs incoming Chief Medical Officer Robert Alexander commented on what âseparates Reunion from other CNS-focused biotech companies working with psychedelic medicineâ. The companyâs special sauce is two-fold, he explained: âfirst, its truly innovative asset, RE104, is the only 4-OH-DiPT drug in developmentâ, and second, âthe Companyâs strong intellectual property position gives Reunion a significant competitive advantage over others in the space.â
These comments were made over ten months after Mindset provided Reunion with copies of certain published patent applications, and over three months after the publication of Mindsetâs continuation application containing a claim specifically on RE104 (as US2022/0324889A1). The very next day, Mindset received a Notice of Allowance; it sent its Demand Letter the day after that.
Zorn, meanwhile, didnât pull any punches when talking to Psychedelic Alpha about the lawsuit. âMy best guess is Reunion used too much of Mindsetâs patented product or, far more likely, realized that this patent presents an existential crisis for the company, the company is in the middle of a raise, and it had no choice but to file this lawsuit or risk âits potential fundingâ and âfundraisingââ, he commented. âEither way, REUN to zero.â
Both Greg Mayes and James Lanthier, CEOs of Reunion and Mindset, respectively, declined to comment.
In a press release issued on the day of the lawsuit filing, Reunion stated that it âintends to vigorously protect its intellectual property position to the fullest extent.â
In a press release issued on March 14th, Mindset stated that it âdisagrees with and denies the allegations set forth from Reunionâ, adding that the company âplans to vigorously defend itself against this lawsuit.â