DCT
1:20-cv-00232
Kaneka Corp v. Glanbia Nutritionals Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Kaneka Corporation (A Japanese Corporation)
- Defendant: Glanbia Nutritionals, Inc. (A Delaware Corporation) and Anthem Biosciences Private Limited (An Indian Company)
- Plaintiff’s Counsel: Bayard, P.A.
- Case Identification: 1:20-cv-00232, D. Del., 02/18/2020
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware based on statutory requirements and because Defendants allegedly induce and contribute to infringement within the district through marketing, sales, and distribution activities.
- Core Dispute: Plaintiff alleges that Defendants’ manufacture and sale of the supplement Ubiquinol Acetate infringes patents related to methods for producing and compositions for stabilizing reduced coenzyme Q10.
- Technical Context: The technology concerns Coenzyme Q10 (CoQ10), a popular nutritional supplement, specifically its reduced form (Ubiquinol), which is highly bioavailable but chemically unstable and prone to oxidation.
- Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patents-in-suit.
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 |
| 2006 | Plaintiff Kaneka begins sales of Ubiquinol in the U.S. |
| 2010-11-09 | U.S. Patent No. 7,829,080 Issued |
| 2020-02-18 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,145,044 - “Method for Producing Reduced Coenzyme Q10 Using Solvent with High Oxidation-Protective Effect,” issued December 5, 2006
The Invention Explained
- Problem Addressed: The patent’s background section describes that reduced coenzyme Q10 (CoQ10) is readily oxidized by molecular oxygen, a significant problem during commercial-scale production that can lead to impurities and reduced product quality (’044 Patent, col. 2:3-12).
- The Patented Solution: The invention proposes a method for synthesizing or crystallizing reduced CoQ10 that uses a specific class of solvents, such as certain hydrocarbons (e.g., heptanes), fatty acid esters, or ethers (’044 Patent, col. 3:25-41). These solvents are described as having an "oxidation-protective effect," which minimizes the formation of oxidized CoQ10 as a byproduct and allows for the production of a higher-quality final product (’044 Patent, Abstract; col. 2:60-66).
- Technical Importance: The described method provides a commercially viable process for producing high-purity reduced CoQ10, a compound useful in nutritional supplements and other health products (’044 Patent, col. 1:56-59).
Key Claims at a Glance
- The complaint asserts independent claims 14 and 17.
- Independent Claim 14 requires:
- A method of producing reduced coenzyme Q10
- Comprising using a specific solvent (hydrocarbons exclusive of hexane, fatty acid esters, and nitriles)
- In synthesizing reduced CoQ10 by reducing oxidized CoQ10
- Thereby protecting the reduced CoQ10 from oxidation
- Independent Claim 17 requires:
- A method for preparing reduced coenzyme Q10
- Comprising using a hydrocarbon and/or ether as a solvent in a deoxygenated atmosphere
- In synthesizing reduced CoQ10 by reducing oxidized CoQ10
- Thereby protecting the reduced CoQ10 from oxidation
- The complaint states that Defendants infringe "one or more claims" of the patent (Compl. ¶21).
U.S. Patent No. 7,829,080 - “Stabilization Method for of Reduced Coenzyme Q10,” issued November 9, 2010
The Invention Explained
- Problem Addressed: Reduced CoQ10 is chemically unstable and easily oxidizes, presenting a challenge for its use in foods and supplements, which require long-term stability. The patent notes that prior stabilization methods could be complex or introduce undesirable byproducts. (’080 Patent, col. 1:23-38).
- The Patented Solution: The invention addresses this stability problem by creating a composition where reduced CoQ10 is combined with a specific amount of its analogs, namely reduced coenzyme Q9 and/or reduced coenzyme Q11 (’080 Patent, col. 2:36-44). The co-presence of these specific analogs is described as stabilizing the reduced CoQ10 against oxidation, without requiring the addition of other potentially noxious reducing agents (’080 Patent, Abstract; col. 4:36-49).
- Technical Importance: The invention provides a method to create a safe and stable reduced CoQ10 composition suitable for use in commercial products like nutritional supplements (’080 Patent, col. 4:39-46).
Key Claims at a Glance
- The complaint asserts independent claims 1, 5, and 15, providing the text for claim 5.
- Independent Claim 5 requires:
- A reduced coenzyme Q10-containing composition
- Comprising reduced CoQ10 and one or both of: (a) 1.5 wt % to 99 wt % of reduced CoQ9 relative to the reduced CoQ10, and/or (b) reduced CoQ11 wherein not less than 0.01 wt % of the reduced CoQ10 is contained in the composition
- Wherein the proportion of reduced CoQ10 relative to the total amount of CoQ10 is not less than 90 wt %
- The complaint reserves the right to assert other claims (Compl. ¶37).
III. The Accused Instrumentality
Product Identification
- The accused product is the supplement Ubiquinol Acetate, which is manufactured by Defendant Anthem and sold by Defendant Glanbia under the trademark "ActiQuinol 10" (Compl. ¶2, ¶18). The accused instrumentality also includes the manufacturing process used by Anthem (Compl. ¶20).
Functionality and Market Context
- The product is a nutritional supplement marketed as a form of CoQ10 that is "more stable than standard Ubiquinol" (Compl. ¶19). The complaint outlines a five-step manufacturing process allegedly used by Anthem, which begins with the reduction of ubiquinone in n-heptane to produce ubiquinol, followed by steps including filtration, drying, and acetylation to create the final Ubiquinol Acetate product (Compl. ¶20). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
7,145,044 Patent Infringement Allegations
| Claim Element (from Independent Claim 14) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of producing reduced coenzyme Q10 | Anthem's manufacturing process produces Ubiquinol Acetate, a form of reduced coenzyme Q10. | ¶20 | col. 12:13-14 |
| which comprises using at least one species selected from among hydrocarbons exclusive of hexane, fatty acid esters and nitriles as a solvent | Anthem’s process allegedly uses n-heptane, a hydrocarbon that is not hexane, as a solvent. | ¶20(i), ¶27 | col. 3:48-58 |
| in synthesizing reduced coenzyme Q10 by reduction of oxidized coenzyme Q10 | The process involves the reduction of ubiquinone (oxidized CoQ10) with a reducing agent to produce ubiquinol (reduced CoQ10). | ¶20(i), ¶29 | col. 12:15-17 |
| and thereby protecting reduced coenzyme Q10 from oxidation | The complaint cites Glanbia’s advertising, which claims the accused product has stability, as evidence that the process protects the reduced CoQ10 from oxidation. | ¶27 | col. 2:50-55 |
- Identified Points of Contention:
- Technical Questions: A primary question is whether the accused process, which produces Ubiquinol as an intermediate that is subsequently acetylated, constitutes a "method of producing reduced coenzyme Q10" as claimed. A related question is what evidence will be required to prove the "protecting... from oxidation" limitation. The complaint relies on marketing claims of product stability (Compl. ¶27), which raises the question of whether this is sufficient to prove that the process itself performs the claimed protective function.
- Scope Questions: The final accused product is Ubiquinol Acetate, an ester derivative. A potential dispute is whether a process that ultimately yields an ester falls within the scope of a claim for a method of producing "reduced coenzyme Q10."
7,829,080 Patent Infringement Allegations
| Claim Element (from Independent Claim 5) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A reduced coenzyme Q10-containing composition | The accused product, Ubiquinol Acetate, is alleged to be a reduced CoQ10-containing composition. | ¶37 | col. 5:17-18 |
| comprising reduced coenzyme Q10 and ... (b) reduced coenzyme Q11 wherein not less than 0.01 wt % of reduced coenzyme Q10 is contained in the composition | Plaintiff alleges its testing of Anthem's product shows it contains 0.267 wt % of reduced coenzyme Q11, which exceeds the 0.01 wt % threshold. | ¶37 | col. 11:20-24 |
| and wherein the proportion of reduced coenzyme Q10 relative to the total amount of coenzyme Q10 is not less than 90 wt %. | The complaint cites Anthem's "Certificate of Analysis," which allegedly shows that the amount of reduced coenzyme in the composition is 98.9%, satisfying the claim requirement. | ¶37 | col. 11:25-29 |
- Identified Points of Contention:
- Scope Questions: A central issue will be the construction of the term "reduced coenzyme Q10." The infringement analysis depends on whether the accused "Ubiquinol Acetate" product, an ester derivative, is encompassed by the claim term "reduced coenzyme Q10."
- Evidentiary Questions: The allegation of infringement of the '080 patent rests on factual assertions from Plaintiff's own testing and a "Certificate of Analysis" that is referenced but not attached (Compl. ¶37). The methodology and accuracy of this evidence will likely be a significant point of contention and a focus of discovery.
V. Key Claim Terms for Construction
The Term: "reduced coenzyme Q10" (’080 Patent, Claim 5)
- Context and Importance: The accused product is "Ubiquinol Acetate." Whether this acetylated form is considered "reduced coenzyme Q10" under the patent's claims is critical to the infringement analysis for the '080 patent. Practitioners may focus on this term because its definition could be dispositive of the infringement claim for the composition patent.
- Intrinsic Evidence for a Broader Interpretation: Plaintiff’s position, as suggested in the complaint, is that Ubiquinol Acetate is a form of reduced CoQ10 (Compl. ¶13). The patent's overall objective is stabilization (’080 Patent, col. 1:25-28), which could support an interpretation that covers stable derivatives.
- Intrinsic Evidence for a Narrower Interpretation: The patent consistently distinguishes between "reduced coenzyme Q10" and "oxidized coenzyme Q10" as specific chemical entities (’080 Patent, col. 1:11-22). The specification does not appear to explicitly define the term to include ester derivatives, which could support an argument that "Ubiquinol Acetate" is a distinct, non-infringing chemical compound.
The Term: "protecting reduced coenzyme Q10 from oxidation" (’044 Patent, Claim 14)
- Context and Importance: This term defines the functional outcome of the claimed method. The complaint uses marketing language about product "stability" to allege this element is met (Compl. ¶27). The construction will determine what type and level of proof is needed to show infringement.
- Intrinsic Evidence for a Broader Interpretation: The specification describes the problem as oxidation by molecular oxygen in general terms (’044 Patent, col. 2:3-8), suggesting that any measurable protection afforded by the claimed solvent could meet the limitation.
- Intrinsic Evidence for a Narrower Interpretation: The patent links this protection to obtaining "highly pure reduced coenzyme Q10 in the form of crystals" (’044 Patent, col. 2:12-14) and achieving a high weight ratio of reduced-to-oxidized form, such as "not lower than 96/4" (’044 Patent, col. 2:57-59). A party could argue this implies a specific, high degree of protection is required, not just a marginal improvement in stability.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants induce infringement and contribute to infringement by their distributors and customers who make, use, or sell the accused product in the United States (Compl. ¶31-32, ¶39-40). The complaint alleges Anthem acts with "full knowledge" that its manufacturing and delivery will lead to infringing sales by Glanbia, which may support the intent element for inducement (Compl. ¶9).
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "reduced coenzyme Q10", which appears throughout the '080 patent’s claims and specification, be construed to cover "Ubiquinol Acetate", an acetylated ester derivative? The answer to this claim construction question may determine the outcome of infringement for the '080 patent.
- A key question of process infringement will be whether Anthem’s manufacturing process, which allegedly produces reduced CoQ10 as an intermediate before a final acetylation step, meets the limitations of the '044 patent’s claims for a "method of producing reduced coenzyme Q10."
- A central evidentiary question will be the proof for the '080 patent’s composition claims. The infringement allegation relies on Plaintiff’s own testing and a third-party document not attached to the complaint, raising the question of whether this evidence can be substantiated and withstand challenges during discovery and trial.