DCT
2:16-cv-04861
Kaneka Corp v. Purestar Chem Enterprises Co Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Kaneka Corporation (Japan)
- Defendant: Purestar Chem Enterprise Co., Ltd (China)
- Plaintiff’s Counsel: Carter Ledyard & Milburn LLP
- Case Identification: 2:16-cv-04861, E.D.N.Y., 08/31/2016
- Venue Allegations: Venue is alleged to be proper based on Defendant's purported acts of infringement and business transactions within the Eastern District of New York, including offers to sell the accused product to a customer located in the district.
- Core Dispute: Plaintiff alleges that Defendant’s ubiquinol nutritional supplement product infringes a patent claiming a high-purity crystalline form of reduced coenzyme Q10.
- Technical Context: The technology concerns the manufacturing of nutritional supplements, specifically a method to produce a stable, high-purity form of reduced coenzyme Q10 (ubiquinol) that is less prone to oxidation.
- Key Procedural History: The complaint alleges that prior to filing suit, Plaintiff conducted tests on a sample of Defendant's ubiquinol product to determine whether it infringed the patent-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2001-07-13 | '044 Patent Priority Date |
| 2006-12-05 | '044 Patent Issue Date |
| 2015-10-27 | Earliest Alleged Offer for Sale by Defendant |
| 2016-08-31 | Complaint Filing Date |
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 December 5, 2006
The Invention Explained
- Problem Addressed: The patent’s background section explains that reduced coenzyme Q10 (ubiquinol), a nutritional supplement with high oral absorbability, is readily oxidized by molecular oxygen back into oxidized coenzyme Q10 (ubiquinone) (’044 Patent, col. 1:16-18, col. 2:3-5). This oxidation presents a significant challenge during commercial-scale production, leading to the formation of impurities, adulteration of the final product, and reduced yield (’044 Patent, col. 2:5-12).
- The Patented Solution: The invention discloses methods for synthesizing and crystallizing reduced coenzyme Q10 using specific solvents—such as certain hydrocarbons, fatty acid esters, ethers, and nitriles—that have a "high oxidation-protective effect" (’044 Patent, col. 2:31-39, col. 3:9-16). This process minimizes the formation of the oxidized form as a by-product, enabling the production of a high-purity, stable, crystalline reduced coenzyme Q10 (’044 Patent, col. 2:60-67).
- Technical Importance: The disclosed methods and resulting high-purity product addressed a key manufacturing challenge, facilitating the industrial-scale production of a more bioavailable form of coenzyme Q10 for use in supplements and other products (’044 Patent, col. 1:18-22).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 13 (’044 Patent, col. 22:60-63; Compl. ¶19).
- The essential elements of independent claim 13 are:
- 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 other claims of the ’044 Patent (Compl. ¶21).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant Purestar's "ubiquinol" product, also referred to in communications as "reduced Coq10(ubiquinol)" (Compl. ¶8, ¶10; Compl. Ex. B, p. 25).
Functionality and Market Context
- The accused product is a bulk chemical ingredient intended for use in dietary and nutritional supplements (Compl. ¶3, ¶6). An email from a Purestar representative, included as an exhibit to the complaint, offers to sell "reduced Coq10(ubiquinol) 99%" (Compl. Ex. B, p. 25). The complaint alleges that offers for sale were made directly to one of Plaintiff's customers, suggesting direct competition in the market for this supplement ingredient (Compl. ¶8).
IV. Analysis of Infringement Allegations
’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 a sample of ubiquinol supplied by Defendant was tested and found to infringe, and that this product is offered for sale as "reduced Coq10(ubiquinol)." | ¶19 | col. 3:1-5 |
| with a reduced coenzyme Q10/oxidized coenzyme Q10 weight ratio of not lower than 96/4 | Plaintiff alleges its tests on the sample demonstrated infringement of claim 13. Defendant’s own marketing materials offer the product as "99%" pure, which corresponds to a 99/1 ratio. | ¶19 | col. 15:30-34 |
Identified Points of Contention
- Scope Questions: The claim requires a "crystal." A central question may be whether the accused product as sold by the Defendant is in a crystalline form, as opposed to an amorphous or other non-crystalline solid state. The complaint does not provide direct evidence, such as microscopy or crystallography data, on this element.
- Technical Questions: The infringement allegation relies on tests Plaintiff conducted on a single sample allegedly supplied by the Defendant (Compl. ¶19). Key questions will be whether that sample is representative of the Defendant's commercially available product and whether Plaintiff's testing methodology accurately determined the "reduced coenzyme Q10/oxidized coenzyme Q10 weight ratio" as contemplated by the patent.
V. Key Claim Terms for Construction
The Term: “crystal”
Context and Importance
- This term defines the physical structure of the claimed composition. Infringement requires the accused product to possess a specific, ordered solid-state structure. If the Defendant's product is found to be amorphous, it may not fall within the scope of the claim.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent does not provide an explicit definition of "crystal." A party might argue the term should be given its plain and ordinary meaning without reference to a specific degree of crystallinity or method of formation, so long as it is not amorphous.
- Evidence for a Narrower Interpretation: The patent specification is replete with references to crystallization as the key purification step, describing the resulting product as "white dry crystals" and "high-quality crystalline coenzyme Q10" (’044 Patent, col. 3:5, col. 18:18). This context, tied to a detailed crystallization process, may support an interpretation requiring a well-defined, regular atomic structure characteristic of a product produced by such a process.
The Term: “reduced coenzyme Q10/oxidized coenzyme Q10 weight ratio”
Context and Importance
- This quantitative limitation is the primary measure of purity and is likely to be a dispositive issue for infringement. The method used to measure this ratio is critical to determining whether the accused product meets the "not lower than 96/4" threshold.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: A party could argue that any scientifically acceptable method for determining the relative weights of the two compounds should be permissible.
- Evidence for a Narrower Interpretation: The patent explicitly discloses a specific High-Performance Liquid Chromatography (HPLC) protocol for determining the purity and weight ratio, including the column type, mobile phase, and detection wavelength (’044 Patent, col. 18:51-59). Practitioners may focus on this disclosure, as it provides a strong basis for arguing that this specific methodology is the standard by which infringement must be judged.
VI. Other Allegations
- Indirect Infringement: The complaint includes a general allegation of infringement through inducement and contribution (Compl. ¶21). However, it does not plead specific facts to support the requisite elements of knowledge and intent for these claims.
- Willful Infringement: The complaint alleges willful infringement, asserting that Defendant acted despite an objectively high likelihood of infringement and in reckless disregard of Plaintiff's rights (Compl. ¶23). The basis for pre-suit willfulness is pleaded on "information and belief," while post-suit willfulness is based on the notice provided by the filing of the complaint itself (Compl. ¶22).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of compositional identity: does the Defendant's commercial ubiquinol product, when tested according to the HPLC method disclosed in the ’044 patent, consistently meet the claimed "weight ratio of not lower than 96/4"? The outcome may depend heavily on discovery related to Defendant's manufacturing processes and quality control, as well as expert testing of accused product samples.
- A key legal and factual question will concern definitional scope: can the Plaintiff provide sufficient evidence that the Defendant's product is a "crystal" as the term is used in the patent? This will likely require the court to first construe the term and then for the parties to present evidence, potentially from materials science experts, on the physical structure of the accused product.