DCT
1:24-cv-00146
Nutramax Laboratories Inc v. Digital Incorps LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nutramax Laboratories, Inc. (South Carolina)
- Defendant: Digital Incorporations LLC d/b/a GoSupps.com (Connecticut Service Address)
- Plaintiff’s Counsel: Dickinson Wright PLLC
- Case Identification: 1:24-cv-00146, W.D. Ky., 12/12/2024
- Venue Allegations: Plaintiff alleges venue is proper because the Accused Product is identified as having been manufactured or imported into the district, and Defendant has committed acts of infringement in the district, including selling the product to residents.
- Core Dispute: Plaintiff alleges that Defendant’s sale of a nutritional supplement infringes three patents related to compositions combining sulforaphane and glucans.
- Technical Context: The technology relates to nutritional supplement formulations, specifically combining compounds from broccoli (sulforaphane) and mushrooms (glucans) to achieve synergistic health benefits.
- Key Procedural History: The complaint alleges that Plaintiff sent Defendant a notice letter on October 31, 2024, identifying the asserted patents and the alleged infringement, which may form the basis for a willfulness claim.
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 |
| 2024-10-31 | Plaintiff sent notice letter to Defendant |
| 2024-12-12 | 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 describes a need for natural products that can act as chemoprotective and antioxidant agents to counter damage from environmental and biological challenges, such as harmful estrogen metabolites, which can lead to conditions like cancer (’178 Patent, col. 1:43-col. 2:29).
- The Patented Solution: The invention is a composition that combines sulforaphane (a compound found in broccoli) or its precursor with a glucan (a polysaccharide found in mushrooms) to create a synergistic combination (’178 Patent, Abstract; col. 5:40-44). This combination is intended to upregulate the body's natural detoxification enzymes (’178 Patent, col. 2:56-62).
- Technical Importance: The invention proposes combining specific natural compounds to achieve a greater-than-additive protective effect, offering a more potent formulation than either component could provide alone (’178 Patent, col. 15:15-20).
Key Claims at a Glance
- The complaint asserts independent claim 14 (’178 Patent, col. 24:4-8; Compl. ¶22).
- 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 other claims (Compl. p. 10).
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: The patent identifies the same problem as the ’178 Patent: the need for effective, natural chemoprotective agents (’057 Patent, col. 2:1-29). It specifically notes that the conversion of the sulforaphane precursor (glucoraphanin) to its active form can be inefficient in the body (’057 Patent, col. 2:49-54).
- The Patented Solution: The invention is a composition combining a broccoli extract (as a source of sulforaphane or its precursor) with a maitake or shiitake mushroom extract (as a source of glucans) (’057 Patent, col. 5:55-60). The composition is explicitly formulated to be "synergistically effective" in increasing the gene expression of NQO-1, a key protective enzyme (’057 Patent, col. 6:1-10).
- Technical Importance: This patent claims a specific formulation linking particular ingredient sources (broccoli and certain mushrooms) to a measurable biological outcome (increased NQO-1 expression), aiming to ensure efficacy (’057 Patent, col. 21:30-46).
Key Claims at a Glance
- The complaint asserts independent claim 1 (’057 Patent, col. 23:12-28; Compl. ¶28).
- 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 composition being formulated to provide synergistically effective amounts of sulforaphane/precursor and 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 other claims (Compl. p. 10).
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: This patent, part of the same family, also covers compositions of sulforaphane (or its derivative) and a glucan (’186 Patent, col. 5:45-49). It distinguishes itself by claiming a specific ratio range for the two key components, aiming to define an optimal formulation for the synergistic effect (’186 Patent, col. 7:7-10).
- Asserted Claims: The complaint asserts independent claim 16 (’186 Patent, col. 24:16-21; Compl. ¶34).
- Accused Features: The complaint alleges that the Accused Product contains a synergistic combination of sulforaphane and glucan that falls within the claimed ratio range of 50:1 to 1:50 (Compl. ¶¶ 34, 36).
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is a nutritional supplement identified as a "Liposomal Sulforaphane" product sold under the Osasuna® brand (Compl. ¶2).
- Functionality and Market Context: The product is an orally administrable softgel composition (Compl. p. 9). The complaint alleges the product is marketed and sold online via Defendant's GoSupps.com storefront (Compl. ¶¶ 2, 5). The product's packaging and online description allegedly state that it contains "Liposomal Sulforaphane (from Broccoli Seed Extract)" and "Maitake Mushroom Extract," and that these ingredients work synergistically (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 a softgel supplement intended for oral consumption (Compl. p. 9). | ¶36, p. 9 | col. 13:34-44 |
| comprising a synergistic combination of: | The Accused Product is alleged to be a composition comprising a "synergistic combination" of its key ingredients (Compl. ¶36). The GoSupps.com website allegedly states that the "Maitake Mushroom Extract... works synergistically with sulforaphane" (Compl. ¶42). | ¶¶36, 42 | col. 15:15-20 |
| a sulforaphane or sulforaphane derivative; and | The Accused Product's "SUPPLEMENT FACTS" label, depicted in the complaint, lists "Liposomal Sulforaphane (from Broccoli Seed Extract)" as an ingredient (Compl. p. 9). The complaint alleges this meets the "sulforaphane or sulforaphane derivative" limitation (Compl. ¶41). A visual from the complaint shows the product's supplement facts label listing its ingredients (Compl. p. 9). | ¶41, p. 9 | col. 7:11-24 |
| a glucan. | The Accused Product's label lists "Maitake Mushroom Extract" as an ingredient (Compl. p. 9). The complaint alleges this extract is a source of glucan (Compl. ¶41). | ¶41, p. 9 | col. 10:59-col. 11:4 |
- Identified Points of Contention:
- Scope Questions: A central question may be what evidence is required to prove a "synergistic combination." The patent defines synergy as an effect "greater than the sum of the effects produced by the agents when used alone" (’178 Patent, col. 15:17-20). The dispute may turn on whether the Defendant's marketing statements (Compl. ¶42) are sufficient to meet this limitation, or if scientific testing of the Accused Product is required.
- Technical Questions: The analysis may focus on whether the "Maitake Mushroom Extract" in the Accused Product necessarily contains "a glucan" as required by the claim. While the patent identifies maitake mushrooms as a source of glucans (’178 Patent, col. 10:24-25), the question for the court will be whether the specific extract used in the accused product actually contains them.
’057 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An orally administrable composition | The Accused Product is sold as an oral softgel (Compl. p. 9). | ¶28, p. 9 | col. 13:40-44 |
| comprising a broccoli extract or powder | The Accused Product's label lists "Liposomal Sulforaphane (from Broccoli Seed Extract)" and "Glucoraphanin (from Broccoli Seed Extract)" (Compl. p. 9). | ¶41, p. 9 | col. 9:22-34 |
| and one or both of a maitake and a shiitake mushroom extract or powder, | The Accused Product's label lists "Maitake Mushroom Extract (Grifola frondosa)" as an ingredient (Compl. p. 9). | ¶41, p. 9 | col. 10:50-55 |
| the orally administrable composition being formulated to provide synergistically effective amounts of... sulforaphane... and... glucans... to... increase levels and/or gene expression of... NQO-1. | The complaint alleges the Accused Product falls within the scope of this claim (Compl. ¶36). It further alleges that the GoSupps.com website states the ingredients work synergistically to provide "immune support" (Compl. ¶42). | ¶¶36, 42 | col. 2:20-29 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis for the ’057 Patent will likely hinge on the functional limitation requiring the composition to be "synergistically effective to at least increase... gene expression of... NQO-1." The complaint alleges the product provides "immune support" (Compl. ¶42), but does not present direct evidence that it increases NQO-1 expression. The question is whether the product's composition inherently meets this functional requirement, or if the Plaintiff must provide empirical evidence of this specific biological effect.
- Technical Questions: Does the presence of "Broccoli Seed Extract" and "Maitake Mushroom Extract" in the Accused Product, combined with marketing claims of synergy, suffice to prove that the product is formulated for the specific purpose of increasing NQO-1 expression, as the claim requires?
V. Key Claim Terms for Construction
For the ’178 Patent:
- The Term: "synergistic combination"
- Context and Importance: This term is the core of claim 14 and distinguishes the invention from a simple mixture. Its construction will determine the type of evidence needed to prove infringement, specifically whether marketing claims of synergy are sufficient or if scientific proof of a greater-than-additive effect is required.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent uses the term broadly in the summary and claims without always tying it to a specific quantitative test, which may support an argument that any combination intended to be synergistic falls within the scope (’178 Patent, col. 5:41).
- Evidence for a Narrower Interpretation: The specification provides a clear 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). The patent also includes experimental examples (Examples 6 and 7) with quantitative data showing this effect, which may support a requirement for empirical proof (’178 Patent, col. 21:30-22:46).
For the ’057 Patent:
- The Term: "synergistically effective to at least increase levels and/or gene expression of NAD(P)H:quinone oxidoreductase 1 (NQO-1)"
- Context and Importance: This is a functional limitation that defines the claimed composition by its biological effect. The case may turn on whether the Accused Product must be proven to actually cause this specific result. Practitioners may focus on this term because proving a specific biological effect can be a high evidentiary bar.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language includes "formulated to provide" this effect, which could be interpreted as a matter of intent or composition design rather than a guarantee of the outcome in every user. This may support an argument that a product containing the key ingredients in known-effective forms meets the limitation.
- Evidence for a Narrower Interpretation: The patent's examples (FIGS. 5 and 6) provide specific, quantitative data showing the fold increase in NQO-1 gene expression when sulforaphane is combined with maitake or shiitake extracts (’057 Patent, col. 21-22). This detailed data could be used to argue that "synergistically effective" requires achieving a specific, measurable, and greater-than-additive increase in NQO-1 expression.
VI. Other Allegations
- Indirect Infringement: The complaint does not contain specific counts for indirect infringement.
- Willful Infringement: Willfulness is alleged based on Defendant’s continued sale of the Accused Product after receiving an "Asserted Patents Notice Letter" on October 31, 2024, which allegedly provided notice of the patents and the infringement (Compl. ¶39).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary sufficiency: must the Plaintiff provide empirical, scientific evidence that the accused supplement demonstrates a "synergistic" effect and specifically increases "NQO-1" gene expression, or are the product's ingredient list and associated marketing claims sufficient to meet the claim limitations as a matter of law?
- A key question will be one of claim scope: does the functional language in the ’057 Patent—requiring a formulation that is "synergistically effective" to increase NQO-1—define the invention by its intended purpose and composition, or does it require proof of a specific, measurable biological result for infringement to be found?
- The outcome of the willfulness allegation will likely depend on the substance of the pre-suit notice: did the October 31, 2024 letter provide specific and sufficient information to establish that the Defendant proceeded to infringe with knowledge that its conduct was objectively reckless?