DCT
1:24-cv-00050
Nutramax Laboratories Inc v. PARAMI Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nutramax Laboratories, Inc. (South Carolina)
- Defendant: Parami Limited d/b/a Osasuna (United Kingdom); Serumlab S&C Int. LLC (Oregon); Optimum Supps Nutrition (California)
- Plaintiff’s Counsel: Dickinson Wright PLLC
- Case Identification: 1:24-cv-00050, W.D. Ky., 03/19/2024
- Venue Allegations: Plaintiff alleges venue is proper in the Western District of Kentucky because Defendant Parami Limited d/b/a Osasuna has a regular and established place of business in the district, and because all defendants allegedly committed acts of infringement by manufacturing, importing, and selling the accused product to residents within the district. For the foreign defendant, venue is also alleged to be proper in any judicial district.
- Core Dispute: Plaintiff alleges that Defendants’ "Liposomal Sulforaphane" nutritional supplement infringes three U.S. patents related to compositions combining sulforaphane or its precursors with glucans for synergistic health benefits.
- Technical Context: The lawsuit operates in the nutritional supplement market, where compositions are developed to provide specific, biochemically-active compounds like sulforaphane, known for its antioxidant and chemoprotective properties.
- Key Procedural History: The three patents-in-suit are part of the same patent family, originating from a 2013 international patent application and claiming priority to a series of provisional applications filed in 2012. This shared lineage suggests the patents cover related aspects of a core invention. No prior litigation or post-grant proceedings are mentioned in the complaint.
Case Timeline
| Date | Event |
|---|---|
| 2012-07-05 | Earliest Priority Date for ’178, ’057, and ’186 Patents |
| 2020-03-10 | ’178 Patent Issued |
| 2021-03-30 | ’057 Patent Issued |
| 2023-05-23 | ’186 Patent Issued |
| 2024-03-19 | 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 Mar. 10, 2020)
The Invention Explained
- Problem Addressed: The patent addresses the challenge of effectively delivering the health benefits of sulforaphane, a compound with known chemoprotective properties (Compl. Ex. 6, '178 Patent, col. 1:50-63). The conversion of its precursor, glucoraphanin (found in vegetables like broccoli), into active sulforaphane within the human body can be inefficient and variable among individuals, limiting its therapeutic potential ('178 Patent, col. 2:49-53).
- The Patented Solution: The invention proposes combining sulforaphane (or its precursor) with a glucan, a type of polysaccharide. The specification asserts that this combination produces a synergistic effect, enhancing the overall biological activity beyond what either component could achieve alone ('178 Patent, col. 15:16-20). The glucan can be sourced from mushroom extracts, such as maitake or shiitake ('178 Patent, Abstract).
- Technical Importance: This approach aims to provide a more reliable and potent method for delivering the benefits of sulforaphane by using a combination of ingredients to achieve a synergistic outcome.
Key Claims at a Glance
- The complaint asserts independent claim 14 (Compl. ¶26).
- Essential elements of claim 14:
- An orally administrable composition
- comprising a synergistic combination of:
- a sulforaphane or sulforaphane derivative; and
- a glucan.
- The complaint reserves the right to assert additional claims (Compl. ¶45).
U.S. Patent No. 10,960,057 - "Compositions comprising sulforaphane or a sulforaphane precursor and a mushroom extract or powder" (Issued Mar. 30, 2021)
The Invention Explained
- Problem Addressed: As with the related ’178 Patent, this patent addresses the need for effective delivery of sulforaphane's benefits, particularly its ability to induce protective Phase II enzymes like NAD(P)H:quinone oxidoreductase 1 (NQO-1) ('057 Patent, col. 2:20-29).
- The Patented Solution: The invention claims a specific composition comprising a broccoli extract (as a source of sulforaphane precursor) and a maitake or shiitake mushroom extract (as a source of glucans). The patent claims this specific formulation provides the components in amounts that are "synergistically effective" to increase the levels or gene expression of NQO-1 in a subject ('057 Patent, col. 23:11-20).
- Technical Importance: This patent ties a specific formulation of natural extracts to a measurable biological marker (NQO-1 expression), providing a potential basis for demonstrating efficacy.
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶32).
- 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
- being formulated to provide synergistically effective amounts of one or both of a sulforaphane and a sulforaphane precursor and one or more glucans
- wherein these components are provided in amounts synergistically effective to at least increase levels and/or gene expression of NAD(P)H:quinone oxidoreductase 1 (NQO-1).
- The complaint reserves the right to assert additional claims (Compl. ¶45).
Multi-Patent Capsule
- Patent Identification: 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: Building on the same technology as the ’178 and ’057 patents, the ’186 Patent claims an orally administrable composition of sulforaphane (or a derivative) and a glucan. The distinguishing feature of this patent is the requirement that the combination has a specific ratio of sulforaphane-to-glucan, ranging from approximately 50:1 to 1:50 (’186 Patent, col. 24:16-21).
- Asserted Claims: Independent claim 16 (Compl. ¶38).
- Accused Features: The complaint alleges that the formulation of the Accused Product contains sulforaphane and glucan in a ratio that falls within the claimed range (Compl. ¶49).
III. The Accused Instrumentality
Product Identification
- The accused product is the "Osasuna Liposomal Sulforaphane" nutritional supplement, sold as an oral softgel (Compl. ¶4, p. 10).
Functionality and Market Context
- The complaint presents a "Supplement Facts" label from the product's online advertising, which is a visual that lists the product's key ingredients (Compl. p. 11). This label indicates the product is an oral softgel containing "Liposomal Sulforaphane," "Glucoraphanin (from Broccoli Seed Extract)," and a "Proprietary Sulforaphane Boost Blend" that includes "Maitake Mushroom Extract (Grifola frondos)" (Compl. ¶46, Ex. 10).
- The term "Liposomal" in the product name suggests the formulation is designed to enhance the bioavailability of its ingredients (Compl. p. 10).
- The complaint alleges the product is sold through online storefronts, including Amazon.com and Gosupps.com, as part of what it characterizes as a "complex network of hidden online storefronts" (Compl. ¶41-42).
IV. Analysis of Infringement Allegations
’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 an oral softgel supplement. | ¶40; Ex. 10 | col. 24:4 |
| comprising a synergistic combination of: | The complaint alleges the product contains a synergistic combination and cites marketing claims that the components "work synergistically." | ¶40; ¶47 | col. 24:5 |
| a sulforaphane or sulforaphane derivative; | The product's "Supplement Facts" label lists "Liposomal Sulforaphane" and its precursor, "Glucoraphanin." | ¶46; Ex. 10 | col. 24:6 |
| and a glucan. | The product's "Supplement Facts" label lists "Maitake Mushroom Extract," which the patent identifies as a source of glucans. | ¶46; Ex. 10 | col. 24:7 |
’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 | The product's "Supplement Facts" label lists "Glucoraphanin (from Broccoli Seed Extract)." | ¶48; Ex. 10 | col. 23:11-12 |
| and one or both of a maitake and a shiitake mushroom extract or powder, | The product's label lists "Maitake Mushroom Extract." | ¶48; Ex. 10 | col. 23:12-14 |
| 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 complaint alleges the product is formulated to provide these components in synergistically effective amounts. | ¶48 | col. 23:14-17 |
| wherein the one or both... are provided... in amounts synergistically effective to at least increase levels and/or gene expression of NAD(P)H:quinone oxidoreductase 1 (NQO-1). | The complaint alleges the product provides its components in amounts that are effective to increase NQO-1 levels. | ¶48 | col. 23:17-20 |
Identified Points of Contention
- Technical Questions: A primary question is whether Plaintiff can produce extrinsic evidence, such as laboratory tests, to prove the functional and results-oriented limitations in the claims. For the '178 and '186 patents, this involves demonstrating that the accused combination is in fact "synergistic." For the '057 patent, this raises the question of what evidence the complaint provides that the accused product actually "increase[s] levels and/or gene expression of... NQO-1." The complaint alleges this outcome but does not provide supporting test data for the accused product (Compl. ¶48).
- Scope Questions: The infringement analysis for the '186 patent will depend on the precise composition of the accused product. The complaint alleges the product meets the claimed ratio of sulforaphane-to-glucan, but the "Supplement Facts" label does not specify the amount of glucan within the maitake mushroom extract, making a direct calculation impossible from the complaint alone (Compl. ¶49; Ex. 10). This creates a factual question that may require discovery and product testing.
V. Key Claim Terms for Construction
The Term: "synergistic combination" / "synergistically effective"
Context and Importance: This concept is central to the asserted claims of all three patents. Its construction will define the evidentiary burden on the plaintiff. Practitioners may focus on this term because it determines whether infringement can be shown by merely identifying the ingredients, or whether a specific, measurable synergistic result must be proven for the accused product itself.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specifications define "synergy" as an effect where a combination "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). A party could argue that the patent teaches this synergy is an inherent property of the claimed combination, meaning any product containing the elements necessarily meets the limitation.
- Evidence for a Narrower Interpretation: The specifications include experimental data and figures (e.g., FIG. 5 and FIG. 6 in the ’178 Patent) to demonstrate the synergistic effect of specific formulations. A party could argue these examples imply that to be "synergistic," an accused product must be tested and shown to produce a statistically significant, greater-than-additive effect, similar to the data presented in the patent.
The Term: "glucan"
Context and Importance: The infringement allegations depend on the "Maitake Mushroom Extract" in the accused product meeting the "glucan" limitation. The construction of this term will determine whether providing an extract known to contain glucans is sufficient to meet the claim.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract states that the "glucan may be provided in a mushroom extract or powder," and the detailed description repeatedly links glucans to maitake and shiitake extracts (’178 Patent, Abstract; col. 10:55-58). This language may support an interpretation that a mushroom extract itself satisfies the "glucan" limitation.
- Evidence for a Narrower Interpretation: The specification also discusses specific types of glucans, such as "1,3-β-glucans and/or 1,6-β-glucans" (’178 Patent, col. 11:19-25). This could support a narrower construction requiring the presence of a particular type or purity of glucan, rather than just the unrefined extract.
VI. Other Allegations
- Indirect Infringement: The complaint's allegations focus on direct infringement by the Defendants for making, selling, offering for sale, and/or importing the accused composition (Compl. ¶40, 46).
- Willful Infringement: The complaint alleges that Defendants' infringement is willful, wanton, and egregious, warranting enhanced damages (Compl. ¶52-53). The allegations are based on the assertion that Defendants acted deliberately and recklessly, though the complaint does not plead specific facts regarding pre-suit knowledge of the patents.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof: Can the plaintiff develop sufficient factual evidence, likely through expert testimony and laboratory testing of the accused product, to demonstrate the "synergistic" effects and specific biological outcomes (i.e., increased NQO-1 expression) that are explicitly required by the asserted claims?
- The case may also turn on a question of claim construction: Will the court interpret the term "synergistic combination" to be met simply by combining the ingredients that the patent describes as synergistic, or will it require quantifiable proof that the accused product itself produces a greater-than-additive effect, thereby raising the evidentiary threshold for infringement?
- A key factual question for the '186 patent will be one of compositional analysis: Does the accused product, which lists a "proprietary blend," contain a ratio of sulforaphane-to-glucan that falls within the specific numerical range required by claim 16, an issue that can likely only be resolved through chemical analysis during discovery?