DCT

2:23-cv-01416

Reunion Neuroscience Inc v. Mindset Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Reunion Neuroscience Inc. v. Mindset Pharma Inc., 2:23-cv-01416, D.N.J., 03/13/2023
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is not a resident of the United States and may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant copied its previously-invented and patented psychedelic compound, RE-104, and wrongfully obtained a patent on the same compound by misrepresenting inventorship to the U.S. Patent and Trademark Office.
  • Technical Context: The technology involves novel serotonergic psychedelic compounds, specifically prodrugs of tryptamine derivatives, designed for treating mental health conditions such as depression.
  • Key Procedural History: The complaint alleges that Plaintiff's inventor conceived of the compound RE-104 in mid-2020, leading to the issuance of U.S. Patent No. 11,292,765. Plaintiff alleges that after its patent application was publicly disclosed, Defendant amended its own pending application to claim the identical compound for the first time, which later issued as U.S. Patent No. 11,591,353. The suit follows a demand letter from Defendant and subsequent failed settlement negotiations.

Case Timeline

Date Event
2020-02-04 Mindset files provisional patent application, which allegedly did not include the RE-104 compound
2020-06-30 Earliest priority date for Reunion's '765 Patent
2020-07-31 Alleged latest date for conception of RE-104 by Reunion's inventor, Dr. Bryson
2020-11-03 Reunion files provisional patent application disclosing RE-104
2021-02-04 Mindset files PCT application, which allegedly did not include the RE-104 compound
2021-06-30 Reunion files non-provisional patent application disclosing RE-104
2021-07-28 Mindset files U.S. patent application, which allegedly did not include the RE-104 compound
2021-12-30 Reunion's patent application is published, publicly disclosing the RE-104 structure
2022-04-05 Reunion's U.S. Patent No. 11,292,765 issues
2022-06-06 Mindset files a continuation patent application that includes the RE-104 compound for the first time
2023-02-28 Mindset's U.S. Patent No. 11,591,353 issues, including a claim to the RE-104 compound
2023-03-13 Complaint filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,292,765 - "Tryptamine Prodrugs" (Issued April 5, 2022)

The Invention Explained

  • Problem Addressed: The patent addresses the need for improved psychedelic tryptamine compounds for treating mental disorders like depression (Compl. ¶39; ’765 Patent, col. 3:60-65). While psychedelic substances have shown therapeutic potential, existing forms can have undesirable characteristics, such as prolonged psychedelic states (6 to 15 hours) or unpredictable absorption and conversion rates for prodrugs, which complicate clinical use (’765 Patent, col. 3:42-51).
  • The Patented Solution: The invention is a novel class of tryptamine prodrugs created by forming diacid hemiesters of hydroxytryptamines, such as psilocin (’765 Patent, col. 5:5-12). This structure, specifically a zwitterion, is designed to be stable, highly soluble, and capable of rapid hydrolytic cleavage in the body to release the active psychedelic compound (’765 Patent, col. 12:30-45). The stated goal is to provide a medication that produces a psychedelic experience with a shorter, more convenient duration (e.g., less than 4-6 hours) suitable for clinical settings (’765 Patent, col. 12:56-60).
  • Technical Importance: This approach seeks to improve the clinical viability of psychedelic-assisted psychotherapy by creating a prodrug with more predictable and desirable pharmacokinetic properties than naturally occurring compounds or simpler synthetic variants (Compl. ¶41).

Key Claims at a Glance

  • The complaint identifies claim 2 as disclosing the compound at issue, RE-104 (Compl. ¶55). Claim 2 is dependent on independent claim 1.
  • Independent Claim 1 recites:
    • A compound of Formula (I), (II), (III), or (IV), or a pharmaceutically acceptable salt or zwitterion thereof,
    • Wherein for Formula (I), the key elements include a core tryptamine structure,
    • And a substituent R4 defined as –X–CO2H, where X is a carbon chain, forming a diacid hemiester.
  • The complaint does not explicitly reserve the right to assert other dependent claims.

U.S. Patent No. 11,591,353 - "Psilocin Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders" (Issued February 28, 2023)

The Invention Explained

  • Problem Addressed: The patent describes the need for new treatments for mental illnesses and neurological disorders, noting that psychedelics represent a promising class of agents (’353 Patent, col. 1:29-34). The background highlights the potential for next-generation neurotherapeutics that may have attenuated pharmacological risk profiles (’353 Patent, col. 2:45-51).
  • The Patented Solution: The invention provides a class of novel psilocin derivatives represented by a general Formula (I) (’353 Patent, col. 9:18-24). These compounds are designed to act as serotonergic agents for treating CNS disorders through the activation of serotonin receptors (’353 Patent, Abstract). The patent claims a broad genus of compounds as well as specific species.
  • Technical Importance: The invention purports to provide a new set of psilocin derivatives as potential therapeutic agents for a range of psychiatric and neurological conditions, expanding the chemical space for serotonergic drug development.

Key Claims at a Glance

  • The complaint identifies claim 13 as disclosing the RE-104 compound (Compl. ¶68). Claim 13 is dependent on independent claim 1.
  • Independent Claim 1 recites:
    • A compound of Formula (I) or a pharmaceutically acceptable salt, solvate and/or prodrug thereof,
    • Wherein Formula (I) includes a core indole structure,
    • And a substituent Y, which can be X-A, where X is a linking atom (e.g., oxygen) and A can be a variety of groups, including acyl groups like C(O)Q'.
  • The complaint does not explicitly reserve the right to assert other dependent claims.

III. The Accused Instrumentality

Product Identification

  • The "instrumentality" at issue is not a commercial product but the act of filing, prosecuting, obtaining, and asserting U.S. Patent No. 11,591,353, specifically claim 13, which recites the chemical structure of compound RE-104 (Compl. ¶¶ 2, 68, 74).

Functionality and Market Context

  • The complaint alleges that the '353 Patent, and particularly claim 13, provides Defendant with patent rights covering the RE-104 compound (Compl. ¶74). Defendant allegedly asserted these rights against Plaintiff in a January 2023 demand letter, proposing a license and stating its intent to "enforce its patent rights" (Compl. ¶¶ 76, 78). Plaintiff alleges this conduct impairs its ability to pursue clinical trials, secure funding, and commercialize its own RE-104 product, which it claims to have invented first (Compl. ¶¶ 89-91).

IV. Analysis of Infringement Allegations

The central allegation is not one of product infringement but of improper inventorship, with Plaintiff claiming that the subject matter of claim 13 of the '353 Patent is an invention conceived solely by Plaintiff's employee, Dr. Bryson. The complaint presents a side-by-side comparison of the chemical structures from claim 2 of the ’765 Patent and claim 13 of the ’353 Patent to support its allegation of identity. This side-by-side visual is provided in the complaint and shows the alleged structural identity of the two compounds (Compl. ¶69).

'353 Patent Inventorship Allegations

Claim Element (from '353 Patent, Claim 13) Alleged Subject Matter is Identical to Plaintiff's Prior Invention Complaint Citation '765 Patent Citation
The compound of claim 1 that is: [Chemical structure of N,N diisopropyltryptamine-4-glutarate, also known as RE-104] The complaint alleges this compound is structurally identical to the compound invented by Dr. Bryson and disclosed in Plaintiff's '765 Patent. ¶¶ 69, 70 col. 29:32-48 (claim 2)
A glutaric acid derived side chain with five carbon atoms attached via an ester linkage The complaint alleges both patents disclose this feature, identifying it as a key structural component of the RE-104 compound. ¶70 col. 8:37-40
A diisopropyl substituted amine moiety The complaint alleges both patents disclose this feature as part of the identical tryptamine structure. ¶70 col. 8:23-26
  • Identified Points of Contention:
    • Originality and Derivation: The central factual dispute will be whether Mindset's named inventors conceived of the RE-104 compound independently of Dr. Bryson's work. The complaint alleges that Mindset only included the compound in its patent application after Reunion's application publicly disclosed the structure, suggesting derivation rather than independent invention (Compl. ¶¶ 61, 63). The complaint presents a timeline graphic to visually support this chronology of events (Compl. ¶64).
    • Evidentiary Questions: A key question for the court will be what evidence, such as lab notebooks or other contemporaneous documentation, Mindset can produce to establish a conception date for the compound in claim 13 that precedes Reunion's public disclosure on December 30, 2021.
    • Materiality and Intent: For the inequitable conduct claim, the court will examine whether the alleged failure to name Dr. Bryson as an inventor was material to patentability and was done with a specific intent to deceive the PTO (Compl. ¶¶ 71-72, 113).

V. Key Claim Terms for Construction

Because the core of this dispute is the alleged derivation of a specific chemical compound recited in dependent claims, traditional claim construction may be less central than the factual determination of inventorship. However, the scope of the respective independent claims that provide the basis for the specific compounds could be relevant.

  • The Term: "The compound of claim 1 that is:" (’353 Patent, claim 13) and the corresponding structure from claim 2 of the '765 Patent.
  • Context and Importance: This phrasing makes the dependent claim exceptionally narrow, covering only the specific chemical structure depicted. The dispute hinges on the allegation that this exact structure was first conceived by Reunion's inventor. Practitioners may focus on the identity of this structure, as its alleged copying forms the basis for all of Plaintiff's patent-related claims.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Not directly applicable to these narrow dependent claims. The scope is fixed by the depicted structure.
    • Evidence for a Narrower Interpretation: The patents themselves define the claimed compounds with precise chemical structures. For example, the '765 patent explicitly names the compound as "N,N diisopropyltryptamine-4-glutarate" ('765 Patent, col. 9:15-18). The complaint alleges the two-dimensional graphical representations in both patents describe the "same chemical structure" (Compl. ¶70).

VI. Other Allegations

  • Inequitable Conduct: The complaint alleges that Mindset and its named inventors committed inequitable conduct by failing to inform the PTO that Dr. Bryson was the true inventor of the compound in claim 13 (Compl. ¶¶ 65, 71, 111-119). The complaint alleges this omission was material, because the claim would not have been allowed had the examiner known the named inventors did not invent it, and was done with deceptive intent, inferred from the timing of events and Mindset's subsequent assertion of the patent against Reunion (Compl. ¶¶ 72, 113, 115).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of originality and derivation: Can Mindset provide sufficient evidence, such as dated lab notebooks or other contemporaneous records, to prove that its named inventors conceived of the specific chemical compound in Claim 13 of the '353 patent prior to, and independent of, Reunion's public disclosures?
  • A second key question will be one of deceptive intent: Does the timeline of events—specifically, Mindset adding the disputed compound to its application only after Reunion's publication and then asserting the resulting patent against Reunion—support a finding of specific intent to deceive the PTO regarding inventorship, as required to sustain a claim of inequitable conduct?