DCT
5:24-cv-00371
Nutramax Laboratories Inc v. Gosuppscom LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nutramax Laboratories, Inc. (South Carolina)
- Defendant: GoSupps.com LLC (Delaware) and Digital Incorporations LLC (Connecticut)
- Plaintiff’s Counsel: Dickinson Wright PLLC
- Case Identification: 5:24-cv-00371, E.D. Ky., 12/18/2024
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Kentucky because Defendants committed acts of infringement within the district, including offering to sell and selling the accused product to Kentucky residents. The complaint further notes a purchase was shipped to a customer in Kentucky and that the product packaging lists a manufacturing address in Glasgow, Kentucky.
- Core Dispute: Plaintiff alleges that Defendants’ liposomal sulforaphane nutritional supplement infringes three patents related to synergistic compositions of sulforaphane and glucans.
- Technical Context: The technology involves nutritional supplement formulations that combine sulforaphane, a compound derived from cruciferous vegetables like broccoli, with glucans, polysaccharides often sourced from mushrooms, to achieve enhanced health benefits.
- Key Procedural History: The complaint alleges that Plaintiff sent a notice letter to Defendant Digital Incorporations LLC on October 31, 2024, identifying U.S. Patent No. 10,583,178 and asserting infringement. This pre-suit notice is presented as the basis for a claim of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2012-07-05 | Earliest Priority Date for '178, '057, '186 Patents |
| 2020-03-10 | U.S. Patent No. 10,583,178 Issues |
| 2021-03-30 | U.S. Patent No. 10,960,057 Issues |
| 2023-05-23 | U.S. Patent No. 11,654,186 Issues |
| 2024-10-31 | Plaintiff sends notice letter to Defendant |
| 2024-12-18 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,583,178 - "Compositions comprising sulforaphane or a sulforaphane precursor and a mushroom extract or powder" (Issued: March 10, 2020)
The Invention Explained
- Problem Addressed: The patent's background section describes a need for effective, natural chemoprotective and antioxidant agents. It notes that while sulforaphane (found in vegetables like broccoli) has beneficial properties, achieving effective levels through diet alone is difficult, and its conversion in the body can be inconsistent and inefficient, particularly in acidic environments like the stomach ('178 Patent, col. 1:41-48, col. 2:49-56).
- The Patented Solution: The invention is a composition that combines sulforaphane (or its precursor) with a glucan, a type of polysaccharide. The patent teaches that this combination produces a synergistic effect, meaning the combined benefit is greater than the sum of the individual components' effects ('178 Patent, Abstract; col. 15:15-22). This synergy is intended to provide a more potent and reliable chemoprotective or therapeutic result.
- Technical Importance: This approach seeks to enhance the known benefits of sulforaphane by combining it with a second active ingredient (glucan) to create a more powerful formulation, potentially overcoming the bioavailability and efficacy challenges associated with sulforaphane alone ('178 Patent, col. 15:11-19).
Key Claims at a Glance
- The complaint asserts independent claim 14 (Compl. ¶25, ¶39).
- Essential elements of Claim 14:
- An orally administrable composition
- comprising a synergistic combination of:
- a sulforaphane or sulforaphane derivative; and
- a glucan.
U.S. Patent No. 10,960,057 - "Compositions comprising sulforaphane or a sulforaphane precursor and a mushroom extract or powder" (Issued: March 30, 2021)
The Invention Explained
- Problem Addressed: Similar to its parent, the '057 Patent addresses the need for effective natural chemoprotective agents and the challenges of delivering sulforaphane effectively ('057 Patent, col. 1:41-48).
- The Patented Solution: This patent claims a more specific composition than the ’178 Patent. It requires a composition comprising a broccoli extract and specific mushroom extracts (maitake and/or shiitake) that is formulated to synergistically deliver sulforaphane and glucans in amounts effective to increase the levels or gene expression of a key detoxification enzyme, NQO-1 ('057 Patent, Abstract; col. 6:8-23). The patent's examples include data showing this synergistic effect on NQO-1 expression ('057 Patent, Figs. 5-6).
- Technical Importance: The invention refines the broader concept by identifying specific sources for the active ingredients and tying their synergistic effect to a measurable biological marker (NQO-1), suggesting a more targeted and verifiable mechanism of action ('057 Patent, col. 21:30-46).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶31, ¶39).
- Essential elements of Claim 1:
- An orally administrable composition comprising a broccoli extract or powder and one or both of a maitake and a shiitake mushroom extract or powder,
- the orally administrable composition being formulated to provide synergistically effective amounts of one or both of a sulforaphane and a sulforaphane precursor and one or more glucans,
- wherein the one or both of the sulforphane and the sulforaphane precursor and one or more glucans are provided to a subject in need thereof in amounts synergistically effective to at least increase levels and/or gene expression of NAD(P)H:quinone oxidoreductase 1 (NQO-1).
U.S. Patent No. 11,654,186 - "Compositions comprising sulforaphane or a sulforaphane precursor and a mushroom extract or powder" (Issued: May 23, 2023)
- Technology Synopsis: The '186 Patent continues the theme of the asserted patent family, addressing the need for effective chemoprotective agents through compositions that synergistically combine sulforaphane or its derivative with a glucan ('186 Patent, Abstract). This patent specifically claims the combination within a defined ratio of sulforaphane-to-glucan (from about 50:1 to about 1:50), suggesting a focus on an optimized formulation for achieving the desired synergistic effect ('186 Patent, col. 24:14-19).
- Asserted Claims: The complaint asserts independent claim 16 (Compl. ¶37, ¶39).
- Accused Features: The complaint alleges that the Accused Product, as an orally administrable composition containing both a sulforaphane derivative and a glucan, infringes this patent (Compl. ¶39, ¶44).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is a Liposomal Sulforaphane supplement sold under the Osasuna® brand (Compl. ¶4).
Functionality and Market Context
- The Accused Product is an oral softgel supplement sold through the GoSupps.com online storefront (Compl. ¶4, ¶44). The complaint provides an image of the product's "Supplement Facts" panel, which lists the ingredients as including "Liposomal Sulforaphane (from Broccoli Seed Extract)," its precursor "Glucoraphanin (from Broccoli Seed Extract)," and a "Proprietary Sulforaphane Boost Blend" containing "Maitake Mushroom Extract (Grifola frondosa)" (Compl. ¶44, Ex. 8). The complaint alleges that this Maitake Mushroom Extract is a source of glucan and cites the Defendant's website for the statement that this extract "works synergistically with sulforaphane" (Compl. ¶44, ¶45). The image of the "Supplement Facts" panel provided in the complaint shows the product is a softgel supplement with 60 servings per container (Compl. ¶44).
IV. Analysis of Infringement Allegations
10,583,178 Patent Infringement Allegations
| Claim Element (from Independent Claim 14) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An orally administrable composition | The Accused Product is a softgel supplement intended for oral ingestion. | ¶44 | col. 13:34-39 |
| comprising a synergistic combination of: | The product contains both a sulforaphane source and a glucan source. The complaint alleges synergy based on Defendants' website, which states the ingredients work "synergistically." | ¶45 | col. 15:15-22 |
| a sulforaphane or sulforaphane derivative; and | The "Supplement Facts" panel on the product packaging lists "Liposomal Sulforaphane" and its precursor, "Glucoraphanin." | ¶44 | col. 7:12-24 |
| a glucan. | The "Supplement Facts" panel lists "Maitake Mushroom Extract," which the complaint alleges is a glucan. The patent specification identifies mushroom extracts as a source of glucans. | ¶44, ¶45 | col. 10:48-50 |
10,960,057 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An orally administrable composition comprising a broccoli extract or powder and one or both of a maitake and a shiitake mushroom extract or powder, | The Accused Product is an oral softgel containing "Broccoli Seed Extract" and "Maitake Mushroom Extract," as shown on its packaging. | ¶44 | col. 9:22-26 |
| the orally administrable composition being formulated to provide synergistically effective amounts of one or both of a sulforaphane and a sulforaphane precursor and one or more glucans, | The product contains sulforaphane and its precursor from the broccoli extract and a glucan source from the maitake extract. The complaint alleges synergy based on Defendants' website. | ¶44, ¶45 | col. 5:46-51 |
| wherein the one or both of the sulforphane and the sulforaphane precursor and one or more glucans are provided to a subject in need thereof in amounts synergistically effective to at least increase levels and/or gene expression of NAD(P)H:quinone oxidoreductase 1 (NQO-1). | This is a functional limitation. The complaint alleges infringement based on the composition of the product but does not provide direct evidence that the Accused Product has been shown to increase NQO-1 levels or gene expression. | ¶31, ¶44-45 | col. 6:8-14 |
Identified Points of Contention
- Technical Questions: A primary issue for all asserted patents will be proving the "synergistic" nature of the combination in the Accused Product. The complaint relies on a marketing statement from the defendant's website (Compl. ¶45), which may not be sufficient to establish technical synergy. The court may require empirical evidence demonstrating that the combined effect of the ingredients is greater than their individual effects.
- Scope Questions: The infringement theory for the '057 Patent raises a significant question of scope and proof. Claim 1 requires that the composition be effective to produce a specific biological result: an increase in NQO-1 levels or expression. The complaint does not allege facts showing this result has been tested or observed for the Accused Product. The dispute may turn on whether the mere presence of the claimed ingredients is sufficient to meet this functional limitation, or if Plaintiff must provide evidence that the Accused Product actually achieves this specified outcome in a subject.
V. Key Claim Terms for Construction
The Term: "synergistic combination" ('178 Patent) / "synergistically effective" ('057 Patent)
Context and Importance: This term is the crux of the infringement allegations for all asserted patents. Infringement requires not just the presence of the ingredients but that they work together in a synergistic manner. Practitioners may focus on this term because its definition will determine the level of proof required to show infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides a standard definition: "Synergy refers to the effect wherein a combination of two or more components provides a result which is greater than the sum of the effects produced by the agents when used alone" ('178 Patent, col. 15:17-20). Plaintiff may argue this broad definition applies and can be met by evidence such as the defendant's own marketing claims.
- Evidence for a Narrower Interpretation: Defendants may point to the patent's own examples, which use quantitative in vitro cell assays measuring NQO-1 gene expression to demonstrate synergy ('178 Patent, Figs. 5-6). They may argue that this sets a high bar for what constitutes "synergy" in the context of the patent, requiring similar scientific proof rather than just marketing language.
The Term: "glucan" ('178 Patent)
Context and Importance: The infringement case hinges on the "Maitake Mushroom Extract" in the Accused Product qualifying as a "glucan" under the patent.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides very strong support for the Plaintiff's position, stating explicitly that the "glucan may be provided in a mushroom extract or powder selected from one or more of a maitake, a shiitake, or a reishi mushroom" ('178 Patent, Abstract). It further clarifies that mushroom extracts "comprise one or more glucans" ('178 Patent, col. 11:13-14).
- Evidence for a Narrower Interpretation: A defendant might argue that the term implies a certain quality or quantity of glucan. The patent discusses standardizing mushroom extracts to contain specific percentages of glucans (e.g., "about 1% to about 75%... of one or more glucans") ('178 Patent, col. 11:34-40). This could be used to argue that the plaintiff must prove the specific maitake extract in the accused product meets such criteria.
VI. Other Allegations
- Indirect Infringement: The complaint does not plead specific facts to support claims for either induced or contributory infringement, such as allegations of specific intent to encourage infringing acts or knowledge that a component is especially made or adapted for infringement with no substantial non-infringing use. The allegations focus on direct infringement by Defendants (Compl. ¶44).
- Willful Infringement: The complaint alleges willful infringement based on Defendants' continued infringing conduct after receiving an "Asserted Patents Notice Letter" on October 31, 2024 (Compl. ¶42). This letter allegedly provided notice of the '178 Patent and its infringement by the Accused Product. The allegations of willfulness extend to all three related patents, suggesting a theory of objective recklessness in continuing sales after being put on notice of the patent family (Compl. ¶48-49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A key evidentiary question will be one of functional proof: Can the Plaintiff provide sufficient evidence that the Accused Product meets the functional limitations of the asserted claims? This is particularly acute for U.S. Patent No. 10,960,057, which requires the composition to be "synergistically effective to at least increase levels and/or gene expression of... NQO-1," a specific biological outcome for which the complaint offers no direct testing or results.
- The case will also turn on a question of definitional scope: How will the court construe the term "synergistic"? Will the analysis require rigorous, quantitative scientific evidence akin to the patent's own examples, or will the combination of the claimed ingredients and the Defendant's own marketing claims be sufficient to establish that the product is a "synergistic combination"?