DCT
1:21-cv-00209
Kaneka Corp v. Designs for Health Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Kaneka Corporation (Japan)
- Defendant: Designs For Health, Inc. (Delaware); American River Nutrition LLC (Delaware)
- Plaintiff’s Counsel: Bayard, P.A.
- Case Identification: 1:21-cv-00209, D. Del., 04/28/2021
- Venue Allegations: Venue is alleged to be proper based on Defendants’ incorporation in Delaware and their advertising, marketing, and sales of the Accused Products within the district.
- Core Dispute: Plaintiff alleges that Defendants’ nutritional supplements containing Ubiquinol (a form of Coenzyme Q10) infringe two patents related to methods of producing and stabilizing reduced Coenzyme Q10.
- Technical Context: Coenzyme Q10 (CoQ10) is a popular nutritional supplement, and its reduced form, Ubiquinol, is claimed to have higher oral absorbability but is also highly susceptible to oxidation, which degrades its quality.
- Key Procedural History: The complaint alleges that Defendant American River Nutrition (ARN) is familiar with patent litigation, having previously filed at least three patent infringement suits as a plaintiff. It also alleges that ARN’s founder had prior business discussions with Kaneka and was familiar with its technology and patent portfolio.
Case Timeline
| Date | Event |
|---|---|
| 2001-07-13 | U.S. Patent No. 7,145,044 Priority Date |
| 2006-04-28 | U.S. Patent No. 7,829,080 Priority Date |
| 2006-12-05 | U.S. Patent No. 7,145,044 Issued |
| 2010-11-09 | U.S. Patent No. 7,829,080 Issued |
| 2020-12-02 | Defendant DFH publishes first YouTube video about Accused Products |
| 2021-01-04 | Defendant DFH publishes second YouTube video about Accused Products |
| 2021-04-28 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,145,044 - "Method of Producing Reduced Coenzyme Q10 Using Solvent with High Oxidation-Protective Effect" (issued Dec. 5, 2006)
The Invention Explained
- Problem Addressed: The patent describes that reduced coenzyme Q10 (Ubiquinol) is readily oxidized by molecular oxygen, particularly during large-scale commercial production (Compl. ¶12; ’044 Patent, col. 2:3-11). This oxidation converts it back to the less-absorbable oxidized form, resulting in product adulteration and reduced purity (’044 Patent, col. 2:9-12).
- The Patented Solution: The invention provides a method for producing and crystallizing high-purity reduced CoQ10 by using a specific class of solvents (hydrocarbons, fatty acid esters, ethers, and nitriles) that protect the reduced CoQ10 from oxidation during the manufacturing process (’044 Patent, Abstract; col. 2:32-39). This allows for the creation of a stable, high-purity crystalline product.
- Technical Importance: This technology enabled the industrial-scale production of a stable, high-purity form of reduced CoQ10, which was previously difficult to achieve (Compl. ¶12).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 13 (Compl. ¶28).
- Independent Claim 1 (Method Claim):
- A method of crystallizing reduced coenzyme Q10,
- which comprises crystallizing the reduced coenzyme Q10,
- using, as a solvent, at least one species selected from the group consisting of hydrocarbons, fatty acid esters, ethers and nitriles.
- Independent Claim 13 (Product Claim):
- A reduced coenzyme Q10 crystal,
- with a reduced coenzyme Q10/oxidized coenzyme Q10 weight ratio of not lower than 96/4.
- The complaint reserves the right to assert additional claims.
U.S. Patent No. 7,829,080 - "Stabilization Method of Reduced Coenzyme Q10" (issued Nov. 9, 2010)
The Invention Explained
- Problem Addressed: Reduced CoQ10’s instability and tendency to oxidize presents a significant challenge when processing it into foods or supplements for long-term preservation (’080 Patent, col. 2:22-36). Conventional stabilization methods involved adding reducing agents like ascorbic acid, which can create noxious byproducts (’080 Patent, col. 2:4-21).
- The Patented Solution: The invention claims to stabilize reduced CoQ10 by creating a composition that includes specific, small quantities of its structural analogs: reduced coenzyme Q9 and/or reduced coenzyme Q11 (’080 Patent, Abstract; col. 2:37-44). The co-presence of these analogs is alleged to protect the reduced CoQ10 from oxidation.
- Technical Importance: This method provides a way to maintain the stability of reduced CoQ10 in a final product formulation without relying on potentially unsafe reducing agents (Compl. ¶12; ’080 Patent, col. 2:45-49).
Key Claims at a Glance
- The complaint asserts independent claims 1, 5, and 15, with a focus on claim 5 (Compl. ¶¶ 35-37).
- Independent Claim 5 (Composition Claim):
- A reduced coenzyme Q10-containing composition, comprising reduced coenzyme Q10 and one or both of (a) and (b):
- (a) not less than 1.5 wt% to not more than 99 wt % of reduced coenzyme Q9 relative to reduced coenzyme Q10, and
- (b) reduced coenzyme Q11,
- wherein not less than 0.01 wt% of reduced coenzyme Q10 is contained in the composition, and
- wherein the proportion of reduced coenzyme Q10 relative to the total amount of coenzyme Q10 is not less than 90 wt %.
- The complaint reserves the right to assert additional claims.
III. The Accused Instrumentality
Product Identification
- The accused products are nutritional supplements named DuoQuinol and CoQnol (Compl. ¶2).
Functionality and Market Context
- The products are supplements containing Ubiquinol, the reduced form of CoQ10 (Compl. ¶17). CoQnol is a formulation that includes DuoQuinol along with GeranylGeraniol (GG) and ascorbyl palmitate (Compl. ¶17). The complaint alleges that Defendant DFH markets these products as a lower-priced alternative to what it describes as a "patented form of Ubiquinol" previously supplied by Kaneka (Compl. ¶20). The products are allegedly produced by Ashley-Martin Manufacturing, which is identified as DFH's manufacturing unit (Compl. ¶17, fn. 1). A YouTube video published by DFH on December 2, 2020, allegedly contains statements by DFH's Chief Science Officer about creating the "DuoQuinol proprietary process" to offer a lower-priced product (Compl. ¶¶ 18, 20).
IV. Analysis of Infringement Allegations
The complaint references claim charts in an attached Exhibit E, which was not provided with the filing. The following analysis is based on the narrative infringement allegations contained in the body of the complaint.
’044 Patent Infringement Allegations
| Claim Element (from Independent Claim 13) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A reduced coenzyme Q10 crystal | The complaint alleges that its testing shows the reduced Q10 found in the CoQnol capsule is "crystalized." | ¶30 | col. 2:56-59 |
| with a reduced coenzyme Q10 /oxidized coenzyme Q10 weight ratio of not lower than 96/4 | The complaint alleges that its testing of the CoQnol capsule shows a reduced Q10 ratio of 99.7, which is higher than the required 96/4 ratio. | ¶30 | col. 2:56-59 |
- Identified Points of Contention:
- Technical Question: Infringement of Claim 13 hinges on Plaintiff's own testing (referenced as Exhibit D), which will be a primary focus of discovery. A key factual question is whether the CoQ10 in the final product formulation—mixed with oils and other excipients—exists as a "crystal" in the manner required by the claim, or if it is dissolved or suspended in a non-crystalline state.
- Scope Question: The claim recites "A reduced coenzyme Q10 crystal." The court may need to determine if this language covers a final formulation where crystalline CoQ10 powder is an ingredient, or if it is limited to the isolated, purified crystal itself.
’080 Patent Infringement Allegations
| Claim Element (from Independent Claim 5) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A reduced coenzyme Q10-containing composition, comprising reduced coenzyme Q10 and one or both of (a)... and (b) reduced coenzyme Q11 | The complaint alleges its testing (Exhibit D) shows that 88ug of coenzyme Q11 was present in the accused CoQnol capsule, satisfying part (b) of this element. | ¶37 | col. 11:55-61 |
| wherein not less than 0.01 wt% of reduced coenzyme Q10 is contained in the composition | The complaint does not provide sufficient detail for analysis of this specific element, though it is implicitly met by the allegation that the product is a CoQ10 supplement. | ¶37 | col. 11:61-64 |
| and wherein the proportion of reduced coenzyme Q10 relative to the total amount of coenzyme Q10 is not less than 90 wt %. | The complaint alleges its testing (Exhibit D) shows the proportion of reduced CoQ10 relative to the total amount of CoQ10 was 99.7%, which exceeds the 90 wt % requirement. | ¶37 | col. 11:64-67 |
- Identified Points of Contention:
- Technical Question: What evidence demonstrates that the 88ug of coenzyme Q11 allegedly detected is a consistent component of the accused product across all batches, rather than a one-off trace contaminant?
- Scope Question: Does the term "comprising ... reduced coenzyme Q11" read on any detectable trace amount of the substance? Or, given the patent's stated purpose of stabilization, does the term imply a functionally significant quantity added for that purpose? This raises the question of whether an unavoidable process impurity can satisfy a claim limitation for an active stabilizing component.
V. Key Claim Terms for Construction
Term: "reduced coenzyme Q10 crystal" (’044 Patent, Claim 13)
- Context and Importance: The infringement allegation for the ’044 Patent depends on the accused product being or containing a "crystal" that meets a purity ratio. Defendants may argue that once formulated in an oil-based softgel, the CoQ10 is dissolved and no longer a "crystal" as claimed, thereby avoiding infringement.
- Intrinsic Evidence for a Broader Interpretation: The patent's objective is to produce "high-quality crystalline coenzyme Q10" for use in various applications (’044 Patent, col. 1:49-54). A party could argue that if the starting material is a crystal meeting the claim limitations, its inclusion in a final product falls within the claim's scope.
- Intrinsic Evidence for a Narrower Interpretation: The patent’s detailed examples describe a process of crystallization followed by filtering and drying to obtain "white dry crystals" (’044 Patent, col. 16:16-17). This may support an interpretation that the claim is directed to the CoQ10 in its solid, isolated state, not as a component dissolved or suspended in a liquid matrix.
Term: "comprising ... reduced coenzyme Q11" (’080 Patent, Claim 5)
- Context and Importance: The infringement allegation for the ’080 Patent is based on the alleged presence of a small amount of coenzyme Q11. The definition of "comprising" will be critical. Practitioners may focus on this term because if any trace amount satisfies the limitation, infringement may be easier to prove; if a functional or intentional amount is required, the burden becomes higher.
- Intrinsic Evidence for a Broader Interpretation: "Comprising" is a transitional phrase that is presumptively open-ended, meaning the composition can include other unrecited elements. A plaintiff would argue that as long as reduced coenzyme Q11 is present, this limitation is met, regardless of its quantity or purpose.
- Intrinsic Evidence for a Narrower Interpretation: The patent specification repeatedly frames the invention as a "stabilization method" that works via the "co-presence" of these analogs (’080 Patent, col. 2:37-44). A defendant may argue that, in this context, "comprising" requires the presence of Q11 in an amount sufficient to perform the claimed stabilization function, not merely as a trace impurity from the manufacturing process.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant ARN induced DFH's direct infringement (Compl. ¶42). The factual basis includes allegations that ARN's founder, Dr. Tan, created the infringing DuoQuinol product, provided DFH with the information to produce it, and that ARN supplies a key ingredient (GG) for the final CoQnol product, all while allegedly knowing of Kaneka's patents (Compl. ¶¶ 17, 21, 44).
- Willful Infringement: Willfulness is alleged based on both pre- and post-suit knowledge. The complaint alleges Defendants had pre-suit knowledge based on public statements acknowledging Kaneka's "patented form of Ubiquinol" (Compl. ¶20) and Dr. Tan's alleged familiarity with Kaneka's technology from prior business discussions (Compl. ¶23). The complaint further alleges that if Defendants did not have actual knowledge, they were willfully blind by deliberately failing to investigate the "high probability" of infringement (Compl. ¶¶ 43-44).
VII. Analyst’s Conclusion: Key Questions for the Case
A central issue will be one of factual evidence: The infringement case, as pled, relies heavily on Plaintiff's own testing of the accused products. The litigation will likely focus on discovery battles over the validity of those tests and the consistent composition of Defendants' products. Do the products, as sold commercially, reliably meet the purity and composition requirements of the asserted claims?
The case will also turn on a question of claim scope: Can the term "comprising ... reduced coenzyme Q11" in the ’080 Patent be satisfied by the presence of a trace amount of the substance, or does the patent’s context require a functionally significant quantity added for the stated purpose of stabilization? The resolution of this claim construction issue may be dispositive for infringement of the ’080 Patent.
A key question for damages will be one of intent: The complaint makes detailed allegations of willful blindness based on Defendants' public statements and alleged prior dealings. The court will need to assess whether these facts establish that Defendants subjectively believed there was a high probability of infringement and took deliberate actions to avoid learning the truth, which could support an enhancement of damages.