DCT
0:24-cv-60246
Psycheceutical Inc v. Fleming
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Psycheceutical, Inc. (Florida)
- Defendant: Shawn Fleming (Florida) and Def, LLC (Colorado)
- Plaintiff’s Counsel: ArentFox Schiff LLP
- Case Identification: 0:24-cv-60246, S.D. Fla., 02/13/2024
- Venue Allegations: Venue is alleged to be proper in the Southern District of Florida based on Defendant Fleming’s residence within the district and a contractual clause in which the parties consented to jurisdiction in the district.
- Core Dispute: Plaintiff alleges that Defendants’ "Kanavive Products" infringe a patent related to therapeutic compositions, which Plaintiff claims to own following a disputed business venture and a subsequent assignment from the patent's original inventor.
- Technical Context: The technology at issue involves pharmaceutical compositions containing specific fish oil derivatives and cannabidiolic acid, intended to improve mitochondrial function to address age-related health decline.
- Key Procedural History: The complaint details a complex dispute over patent ownership. Plaintiff alleges that an initial assignment of the "NeuroDirect Patents" (which purportedly include the patent-in-suit) to Defendant DEF was invalid due to a failure of consideration. Plaintiff further alleges that the inventor subsequently assigned the patents directly to Plaintiff, who now claims to be the rightful owner with standing to sue for infringement. The complaint also notes a discrepancy regarding the patent-in-suit's inventorship and title as compared to the patent's official record.
Case Timeline
| Date | Event |
|---|---|
| 2018-02-07 | ’766 Patent Priority Date |
| 2020-07-21 | ’766 Patent Issue Date |
| 2020-09-22 | Letter of Intent executed between inventor and Defendant Fleming |
| 2020-12-09 | Defendants record assignment of NeuroDirect Patents at USPTO |
| 2021-03-30 | Licensing Agreement executed between Plaintiff and Defendant DEF |
| 2024-01-26 | Plaintiff records its own assignment of NeuroDirect Patents at USPTO |
| 2024-02-13 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,716,776 - "POLYUNSATURATED FATTY ACID MONOGLYCERIDES, COMPOSITIONS, METHODS AND USES THEREOF," issued July 21, 2020
The complaint identifies the patent-in-suit as the ’766 Patent but describes it as being titled "Topical Regional Neuro-Affective Therapy with Cannabinoids" and listing Dr. Aung-Din as the sole inventor (Compl. ¶12). However, the official record for U.S. Patent No. 10,716,776, which bears the same issue date cited in the complaint, lists Samuel C. Fortin as the inventor and SCF PHARMA INC. as the assignee, with the title noted above. This analysis is based on the official patent document.
The Invention Explained
- Problem Addressed: The patent addresses the gradual decline of an organism's normal functions associated with aging, identifying mitochondrial dysfunction as a key factor in this process ('766 Patent, col. 1:28-33).
- The Patented Solution: The invention provides compositions of polyunsaturated fatty acid (PUFA) monoglycerides, derived from sources like fish oil, combined with other compounds such as cannabinoids. These compositions are designed to enhance mitochondrial function by "decreasing the mitochondrial proton LEAK" and/or "increasing the mitochondrial OXPHOS" (oxidative phosphorylation), thereby improving cellular energy production and potentially slowing the aging process ('766 Patent, Abstract; col. 1:22-26).
- Technical Importance: The technology targets the fundamental biological process of mitochondrial health, which is a significant area of research for treating age-related diseases and improving longevity ('766 Patent, col. 1:28-33).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the ’766 Patent (Compl. ¶72). The patent contains only one claim.
- Independent Claim 1 recites a composition with the following essential elements:
- A composition "consisting essentially of"
- synthetic SN1 monoglyceride of fish oil,
- a synthetic diglyceride of fish oil (selected from SN 1,2 or SN 1,3 synthetic diglyceride),
- isolated cannabidiolic acid,
- synthetic ethyl ester of fish oil, and
- glycerol.
III. The Accused Instrumentality
- Product Identification: The accused instrumentalities are the "Kanavive Products" sold by Defendant Fleming (Compl. ¶24, ¶72).
- Functionality and Market Context: The complaint alleges that the Kanavive Products are sold using technology covered by the NeuroDirect Patents, including the ’766 Patent (Compl. ¶24). It further alleges that the defendants' website for Kanavive Products advertises that they "utilize the patented NeuroDirect technology" (Compl. ¶24). A screenshot from the "kanavive.com" website is referenced in the complaint, which allegedly shows this advertising claim (Compl. ¶24, Ex. D at 2). The complaint does not provide further technical details about the composition or operation of the Kanavive Products.
IV. Analysis of Infringement Allegations
The complaint does not provide a detailed, element-by-element claim chart mapping features of the accused products to the limitations of the asserted claim. The infringement allegations are made generally, stating that the Kanavive Products meet or embody all elements of the patent's claims (Compl. ¶72).
’766 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition consisting essentially of | The complaint alleges that the Kanavive Products are compositions that meet the claim limitations. | ¶72 | col. 10:22-23 |
| synthetic SN1 monoglyceride of fish oil, | The complaint alleges, on information and belief, that the Kanavive Products embody this element. | ¶72 | col. 10:23-24 |
| a synthetic diglyceride of fish oil selected from the group consisting of SN 1,2 synthetic diglyceride and SN 1,3 synthetic diglyceride, | The complaint alleges, on information and belief, that the Kanavive Products embody this element. | ¶72 | col. 10:24-27 |
| isolated cannabidiolic acid, | The complaint alleges, on information and belief, that the Kanavive Products embody this element. | ¶72 | col. 10:27 |
| synthetic ethyl ester of fish oil and | The complaint alleges, on information and belief, that the Kanavive Products embody this element. | ¶72 | col. 10:28 |
| glycerol. | The complaint alleges, on information and belief, that the Kanavive Products embody this element. | ¶72 | col. 10:28 |
- Identified Points of Contention:
- Evidentiary Question: A primary question will be evidentiary: what proof, such as chemical analysis or formulation data, does Plaintiff possess to demonstrate that the Kanavive Products contain all six components recited in Claim 1? The complaint does not present such evidence.
- Scope Question: The claim uses the transitional phrase "consisting essentially of." This raises the question of whether the Kanavive Products contain other unlisted ingredients and, if so, whether those ingredients "materially affect the basic and novel properties" of the claimed composition, which relate to improving mitochondrial function.
V. Key Claim Terms for Construction
- The Term: "consisting essentially of"
- Context and Importance: This term is critical because it defines the boundary of the composition claim. Unlike "comprising" (which is open-ended) or "consisting of" (which is closed), this term permits the presence of unlisted ingredients so long as they do not materially affect the invention's fundamental characteristics. Practitioners may focus on this term because infringement will depend on both what is in the Kanavive Products and the functional effect of any additional ingredients.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Parties arguing for a broader scope (i.e., that more unlisted ingredients are permissible) may point to the specification's general purpose of improving mitochondrial function, arguing that only ingredients that interfere with that function are "material."
- Evidence for a Narrower Interpretation: Parties arguing for a narrower scope may contend that the "basic and novel properties" are tied specifically to the interaction of the six listed components. They may argue that the addition of other active ingredients, even if beneficial for other purposes, would inherently alter the material character of the specific claimed combination. The patent's disclosure of other potential ingredients for different compositions, such as selenium or vitamin B, could be used to argue that the claimed combination is purposefully limited ('766 Patent, col. 4:28-30).
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement and contributory infringement (Compl. ¶73). However, it does not plead specific facts to support these claims, such as referencing user manuals, instructions, or advertising that would encourage an infringing use by a third party.
- Willful Infringement: Willfulness is alleged based on Defendant Fleming’s purported awareness of the ’766 Patent and his knowledge that the sale of Kanavive Products constituted infringement (Compl. ¶76).
VII. Analyst’s Conclusion: Key Questions for the Case
- A threshold issue will be one of standing and ownership: can Plaintiff establish that it is the rightful owner of the ’766 Patent and has standing to sue? This question is amplified by the significant discrepancy between the complaint's narrative, which centers on inventor Dr. Aung-Din, and the patent's official record, which names Samuel C. Fortin as the inventor and SCF PHARMA INC. as the assignee.
- A key evidentiary question will be one of compositional identity: assuming Plaintiff establishes ownership, can it prove through technical evidence that the accused Kanavive Products contain every one of the six specific components recited in Claim 1? The complaint's general allegations suggest this will be a central point of discovery and expert analysis.
- A central legal question will turn on claim scope: how will the court construe the term "consisting essentially of"? The outcome will depend on the court's definition of the patent's "basic and novel properties" and whether any additional ingredients in the Kanavive Products are found to materially affect those properties.