A lawsuit filed by attorneys on behalf of psychedelic drug developer Reunion Neuroscience alleges that Mindset Pharma “knowingly copied” Reunion’s RE104 (FKA FT-104, when Reunion was part of Field Trip), “and presented that exact composition to the [U.S. Patent and Trademark Office] as its invention.”
The dispute, filed on March 13th in the U.S. District Court for the District of New Jersey, revolves around Reunion’s lead candidate isoprocin glutarate, a hemiglutarate prodrug of 4-HO-DiPT—one of Sasha Shulgin’s TiHKAL compounds. Shulgin described the drug as such: “I 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 orally”. 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. Reunion’s 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 Mindset’s 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 Reunion’s lawsuit, as well as the broader context of the company’s 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 “a desperation move”, 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 ‘765 patent). The application is titled Tryptamine Prodrugs (though there’s a typo in Reunion’s lawsuit, where it’s written “Tryptamin” 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.
Reunion’s patent received a Notice of Allowance on January 20, 2022. “Shortly thereafter”, the lawsuit alleges, Mindset “provided Reunion with copies of certain published Mindset patent applications.” Accordingly, Reunion petitioned the PTO to pull its application from issue, re-submitting it with Mindset’s applications referenced, to ensure the examiner had reviewed Mindset’s applications when deciding whether to issue Reunion’s tryptamine prodrugs patent. The ‘765 patent application then received a renewed Notice of Allowance on March 16, 2022. On April 5, 2022, Reunion’s ‘765 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 structure—indeed, 4-HO-DiPT hemiglutarate was the only specific compound claimed individually.
The lawsuit alleges that on January 20, 2023, Mindset’s outside counsel wrote a Demand Letter to Reunion founder Joseph del Moral, in which the company informs Reunion that its patent publications “contain claims that cover Reunion’s RE104 compound” (note that this letter was disclosed in Reunion’s MD&A filing dated February 10, 2023, when the company explained that it was investigating Mindset’s patent application “including potential offensive strategies”). 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, “rather than becoming involved in legal proceedings.”
According to the suit, “Mindset made clear that it “fully intends” to publicly announce “its patent rights around RE104 and to enforce its patent rights.” Reunion’s suit further alleges that Mindset’s counsel cautioned Reunion that “it would appear that Reunion must divulge that Mindset has patent rights covering RE104 during due diligence investigations and fund-raising discussions.”
Reunion’s response came in the form of a February 2023 letter. While Reunion expressed that it “strongly disagreed” with the assertions made in Mindset’s Demand Letter, it “agreed to meet with Mindset to explore a business resolution.”
According to the lawsuit, the companies engaged in a meeting at Mindset’s counsel’s 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: Mindset’s James Lanthier and Reunion’s Greg Mayes. According to the suit, the discussions were “successful”, with an agreement allegedly reached and confirmed by a handshake.
Within five days of this meeting, Mindset’s counsel purportedly circulated a draft licence agreement that reflected the terms supposedly agreed upon at the meeting. According to the lawsuit, however, Mindset “attempted to renege on this agreement, opting instead to pursue “strategic alternatives” in a communication on March 2, 2023. On this matter, Reunion insists that, “Mindset also should be held to its promises at the parties’ settlement meeting.” It’s worth noting that Mindset’s ‘353 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 what’s important is that Mindset’s 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 “Markush group”) only anticipates a specific compound (that is, renders it no longer novel) if “one of ordinary skill in the art is able to ‘at once envisage’ the specific compound within the generic chemical formula.” “When 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.” (MPEP § 2131.02(III).)
Here, the examiner reviewed Mindset’s application (indeed, after having been directed to it by Reunion itself), and found that Mindset’s generic disclosure was not anticipatory—even in view of Mindset’s disclosure, RE104 was still novel. Thus, Reunion’s claims to RE104 were allowed.
At the same time, Mindset still had the earlier priority date. Hence, Reunion’s application—and its specific disclosure of RE104—could not be used as prior art to Mindset’s claims. And to receive allowance of its own claims, Mindset did not need to meet the “at once envisage” standard for anticipation. Instead, Mindset only needed to meet the disclosure requirements of 35 U.S.C. § 112: “written description” and “enablement.”
Unlike the higher bar to show anticipation by a genus, the bars for disclosure are in effect lower: “possession of the invention” for written description, and the ability to “make and use” the invention without “undue experimentation” for enablement. (MPEP § 2163 (“In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass.”); § 2164 (“The 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.”).)
The examiner did not challenge Mindset’s “possession” of RE104, nor that Mindset’s application failed to teach how to “make and use” it. Thus, Mindset’s 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.)
Having presented the above timeline of events, the suit alleges that Mindset “committed inequitable conduct in the PTO”, and argues that “under settled law, Reunion co-owns the ‘353 patent in its entirety.”
The lawsuit seeks a number of remedies, most notably “correction of inventorship” of the ‘353 to substitute Reunion CSO Nathan Bryson as the sole inventor of the claim to RE104 (with Mindset’s Dr. Abdelmalik Slassi and Joseph Araujo as the inventors of the remaining claims); a declaration that Reunion is a co-owner of the ‘353 patent; and, a decision that Mindset be barred from enforcing the ‘353 patent against Reunion.
A further count described in the lawsuit seeks to frame Mindset’s actions as Promissory Estoppel, whereby Reunion relied on Mindset’s alleged promises related to entering into a non-exclusive licensing agreement to resolve the dispute.
Furthermore, given that Mindset was allegedly aware that Reunion’s success in securing funding would depend on the resolution of the present dispute, Reunion alleges that Mindset “committed these acts knowing they would impair Reunion’s opportunity to obtain funding,” and seeks “an award of damages of more than $25 million” for Mindset’s tortious interference with Reunion’s prospective business.
The Crux of the Case
At the heart of Reunion’s dispute is the fact that Mindset’s initial patent application did not explicitly disclose or claim the structure of Reunion’s 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:
“Mindset only included that compound after RE104’s chemical structure became public following the publications of Reunion’s patent application and subsequently issued patent.”
For this, Reunion hopes to have Mindset’s patent found unenforceable for inequitable conduct before the PTO. This requires a finding that the patent applicant had the “specific intent” 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 competitor’s 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):
“[T]here is nothing improper, illegal or inequitable in filing a patent application for the purpose of obtaining a right to exclude a known competitor’s 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.”
Assuming this decision is applicable and still ‘good law’, there is little reason to believe that the new claims described in Mindset’s continuation patent application to the ‘353 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, it’s a pretty standard patent strategy. Perhaps it strikes as gamesmanship (and perhaps it is), but not filing such “targeted claims” might in fact have seemed like a lapse on the part of the patent attorneys. It’s a strategy familiar to many, as an internet search quickly confirms (“Careful monitoring of competitors’ products…will identify opportunities for…targeted claims”); (“it is good practice to present claims that would cover your competitor’s products”); (“If competitors attempt to design around your first patent, a continuation will give you the opportunity to pursue different claims to stop them.”); (“a continuation application gives you the opportunity to seek patent protection that will cover a competitor’s product”); (“Continuation applications can also be used offensively to file claims which cover a competitor’s product.”).
And, why wouldn’t 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 it’s not based on the original application, it would fail under the requirements of written description and enablement (i.e., fail to “comply with all statutes and regulations”), and be invalid—in essence, the court in Kingsdown seems to say that later claims shouldn’t be separately policed for where the subject matter comes from, as long as they’re adequately supported.
Here, as Pechenik noted to Psychedelic Alpha, there’s no allegation that Mindset’s original disclosure was invented by Dr. Bryson. Nor is there any allegation that Mindset learned of RE104 through anything but “legal and ethical means.” As Reunion asserts, “Mindset only included [RE104] in its patent application after the publication of Reunion’s application” (Complaint at 14, emphasis in original). But after Reunion’s application published, RE104 was public. While the “Federal Circuit’s holding in Kingsdown does not permit individuals to disregard firewalls and confidentiality agreements” (Gilead Sciences, at 57)—for instance, by claiming another company’s confidential information learned under NDA—claiming public information appears tantamount to claiming information with “its genesis in the marketplace,” and thus, per Kingsdown, “simply irrelevant” and not “evidence deceitful intent.”
As such, it’s difficult to see how Mindset’s addition of claims that explicitly cover 4-HO-DiPT hemiglutarate in its continuation patent application is anything other than ordinary patent strategy and practice. It’s 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 it’s spun out from Field Trip, is perhaps more accurately described as a ‘RE104 development company’. The company’s 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. Reunion’s lawsuit further explained that it needed to resolve “any intellectual property issues by the end of February 2023 to secure third-party funding it was negotiating.” And, Reunion has had to make investors—both present and future—aware of Mindset’s allegations, including the fact that Mindset has allegedly reneged on its “oral agreement”.
As such, it’s 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 “looks like a desperation move.” “The 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 law”, he continued.
Zorn also wondered why the District of New Jersey was chosen as the legal venue for the lawsuit, noting that “it is entirely unclear to me how New Jersey has personal jurisdiction over Mindset.” This is especially odd given the fact that Reunion alleges an oral agreement took place in Washington D.C., which would mean that jurisdiction “would be a place where Mindset could be sued.”
A Reunion with Karma?
Committed Psychedelic Alpha readers will recall the case of the DEA’s 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 Reunion’s 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 company’s development efforts (emphasis ours):
“Field Trip Discovery appreciates DEA’s ongoing efforts to prevent the diversion and abuse of controlled substances and concurs with the DEA’s proposal to place into Schedule I of the CSA the latter four (4) compounds.”
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 Bryson’s 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 “vociferously object” to any effort to exclude the submissions, and would “quash any subpoena.”
Bryson’s 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 Reunion’s 4-HO-DiPT IP.
Hence (to borrow the idea Matthew Baggott originally invoked), karma—might 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 “assess strategic options for the Company”.
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 “ongoing fixed costs associated with the Company’s 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.” 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 company’s latest investor presentation, this represents the majority of its locations.)
In January, Reunion’s incoming Chief Medical Officer Robert Alexander commented on what “separates Reunion from other CNS-focused biotech companies working with psychedelic medicine”. The company’s special sauce is two-fold, he explained: “first, its truly innovative asset, RE104, is the only 4-OH-DiPT drug in development”, and second, “the Company’s strong intellectual property position gives Reunion a significant competitive advantage over others in the space.”
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 Mindset’s 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, didn’t pull any punches when talking to Psychedelic Alpha about the lawsuit. “My best guess is Reunion used too much of Mindset’s 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 ‘its potential funding’ and ‘fundraising’”, he commented. “Either way, REUN to zero.”
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 “intends to vigorously protect its intellectual property position to the fullest extent.”
In a press release issued on March 14th, Mindset stated that it “disagrees with and denies the allegations set forth from Reunion”, adding that the company “plans to vigorously defend itself against this lawsuit.”