DCT
1:23-cv-00281
Silcotek Corp v. Waters Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: SilcoTek Corporation (Pennsylvania)
- Defendant: Waters Corporation (Delaware)
- Plaintiff’s Counsel: Faegre Drinker Biddle & Reath LLP
- Case Identification: 1:23-cv-00281, D. Del., 03/16/2023
- Venue Allegations: Venue is alleged to be proper as Defendant Waters Corporation is incorporated in Delaware and has allegedly committed acts of infringement in the district.
- Core Dispute: Plaintiff alleges that Defendant’s "Premier" and "MaxPeak Premier" lines of high-performance liquid chromatography (HPLC) columns and systems, which feature a "MaxPeak High Performance Surfaces" coating, infringe patents related to specialized inert coatings for chromatography components.
- Technical Context: In high-performance liquid chromatography, inert coatings on the interior surfaces of components are critical for preventing unwanted chemical interactions between the sample (analyte) and metal surfaces, which can improve analytical accuracy and sensitivity.
- Key Procedural History: The complaint details a long history between the parties, including a 2009 confidentiality agreement and multiple visits by Defendant to Plaintiff’s facility. Plaintiff also alleges that Defendant had pre-suit knowledge of the patents-in-suit via a 2021 article published by Defendant’s employees citing one of the patents, public patent markings, and a formal notice letter sent in October 2021.
Case Timeline
| Date | Event |
|---|---|
| 2015-09-01 | ’020 Patent Priority Date |
| 2018-02-23 | ’986 Patent Priority Date |
| 2020 | Alleged Launch of Accused "Premier" Product Line |
| 2021-01-05 | ’986 Patent Issue Date |
| 2021-09-28 | ’020 Patent Issue Date |
| 2021-10-25 | Plaintiff sends letter to Defendant alleging infringement |
| 2023-03-16 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,881,986 - "Liquid Chromatography Technique" (Issued Jan. 5, 2021)
The Invention Explained
- Problem Addressed: The patent’s background section describes how materials commonly used in HPLC systems, such as titanium and polyether ether ketone (PEEK), are incompatible with certain chemicals, temperatures, or pressures, limiting the performance and application range of the analytical technique (’986 Patent, col. 1:25-42).
- The Patented Solution: The invention proposes a liquid chromatography technique that uses a metallic component with a special coating on its fluid-contacting surfaces. This combines the mechanical strength and pressure tolerance of metal with the chemical inertness of the coating, enabling the use of fluids and conditions that would be problematic for conventional, uncoated components (’986 Patent, Abstract; col. 3:39-44).
- Technical Importance: This approach allows for more robust and precise HPLC analysis by overcoming the material limitations of standard components, thereby permitting operation at higher pressures and temperatures and with a wider range of reactive chemicals (’986 Patent, col. 3:4-14).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2, 9, and 11-13 (Compl. ¶37).
- Independent Claim 1 recites a technique with the following essential elements:
- Providing a liquid chromatography system with a "coated metallic fluid-contacting element".
- Transporting a fluid to contact that element.
- The fluid has a "protein-containing analyte incompatible with" titanium or PEEK.
- The fluid has a "chelating agent incompatible with" titanium or PEEK.
- The fluid includes a specific analyte from a list including "adenosine triphosphate".
- The complaint reserves the right to assert additional claims.
U.S. Patent No. 11,131,020 - "Liquid Chromatography System and Component" (Issued Sep. 28, 2021)
The Invention Explained
- Problem Addressed: The patent describes challenges in applying uniform, defect-free coatings to the internal, non-line-of-sight surfaces of complex HPLC components. Prior art methods like flow-through chemical vapor deposition (CVD) are described as wasteful and limited to line-of-sight surfaces, while other thermal CVD processes can create silicon dust that compromises the coating’s integrity (’020 Patent, col. 1:41-65).
- The Patented Solution: The invention claims a liquid chromatography component and system featuring a specific type of multi-layer amorphous coating applied via a static thermal CVD process. The coating structure is defined by a "base layer including carboxysilane" and a surface layer, a configuration designed to coat complex internal geometries effectively and without dust contamination (’020 Patent, Abstract; col. 4:25-29).
- Technical Importance: This technology provides a method to manufacture HPLC components with high-quality, inert internal coatings on complex geometries, which can lead to improved analytical performance, consistency, and component longevity (’020 Patent, col. 2:50-55).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-5, 10, 11, and 19 (Compl. ¶58).
- Independent Claim 1 recites a system with the following essential elements:
- A liquid chromatography system comprising a "liquid chromatography component".
- The component comprises a "substrate".
- The component also comprises an "amorphous coating" on the substrate.
- The coating has a "base layer" and a "surface layer".
- The "base layer" includes "carboxysilane".
- The complaint reserves the right to assert additional claims.
III. The Accused Instrumentality
- Product Identification: The accused instrumentalities are Defendant’s “Premier” or “MaxPeak Premier” lines of HPLC columns and systems, such as the ACQUITY Premier System and Arc Premier System (Compl. ¶¶22, 24). The key accused feature is the "MaxPeak™ High Performance Surfaces (HPS)" coating (Compl. ¶22).
- Functionality and Market Context: The accused products are used for high-performance liquid chromatography. The complaint alleges that the MaxPeak HPS coating, described by Defendant as a "hybrid silica," is designed to "significantly reduce unwanted analyte/surface interactions that can lead to poor peak shape and losses in signal intensity" (Compl. ¶22). The complaint positions the accused products as direct competitors to Plaintiff’s own coating services and coated components (Compl. ¶32).
IV. Analysis of Infringement Allegations
’986 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| providing a liquid chromatography system having a coated metallic fluid-contacting element | Waters provides and uses systems like the ACQUITY Premier System with Atlantis PREMIER columns, which are alleged to be coated metallic elements. The complaint includes an XRF analysis screenshot (Figure 1) identifying the column substrate as 316 Stainless Steel. | ¶41 | col. 3:39-44 |
| transporting a fluid to contact the coated metallic fluid-contacting element | A technical article by Waters employees ("Smith article") describes separating solutions of AMP and ATP by passing them through an Atlantis PREMIER column. | ¶42 | col. 7:4-10 |
| wherein the fluid has a protein-containing analyte incompatible with one or both of titanium and polyether ether ketone | Waters promotes its columns for protein analysis and published an application note allegedly showing improved performance over a titanium-lined column, which is presented as evidence of the analyte's incompatibility with titanium. | ¶43 | col. 7:9-13 |
| and the fluid has a chelating agent incompatible with the one or both of the titanium or the polyether ether ketone | The Smith article allegedly indicates the fluid contains adenosine 5'-monophosphate (AMP) and adenosine 5'-triphosphate (ATP), which the complaint states "may be considered chelating agents." | ¶44 | col. 7:9-13 |
| and wherein the fluid includes an analyte selected from the group consisting of tetracycline, N-hydroxypyridine-2-on, adenosine triphosphate, and deoxynucleotide monophosphate | The Smith article and an included chromatogram (Figure 1 from Exhibit L) allegedly show the use of adenosine triphosphate (ATP) as an analyte. | ¶45 | col. 7:17-21 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis may turn on the definition of "incompatible with". A question for the court will be whether evidence of "improved chromatographic performance" against a titanium-lined column (Compl. ¶43) is sufficient to prove that an analyte is "incompatible" with titanium as required by the claim.
- Technical Questions: What evidence supports the allegation that AMP and ATP function as "chelating agent[s] incompatible with" titanium or PEEK in the accused method? The complaint's use of the phrase "may be considered" (Compl. ¶44) suggests this could be a point of dispute.
’020 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A liquid chromatography system, comprising: a liquid chromatography component, comprising: a substrate; | Waters sells the ACQUITY Premier System (system) containing an Atlantis PREMIER BEH C18 AX Column (component). XRF testing (Figure 1) allegedly confirms the column's substrate is 316 Stainless Steel. | ¶¶60, 62 | col. 8:8-14 |
| and an amorphous coating on the substrate | An article by Waters is cited as indicating that the accused products employ an "amorphous coating," supported by a diagram showing a "Hybrid Surface" on "Metal." This diagram is shown in the complaint. | ¶¶63, 18 | col. 4:26-27 |
| the amorphous coating having a base layer and a surface layer | The same diagram from the Waters article is alleged to show a multi-layer structure, which the complaint maps to the claimed "base layer" (Metal Oxide Layer) and "surface layer" (Hybrid Surface). | ¶¶64, 18 | col. 4:27-28 |
| the base layer including carboxysilane | The complaint alleges that the base layer includes carboxysilane based on two pieces of evidence: FTIR spectroscopy results (Figure 2) confirming the presence of C, Si, O, and H, and a chemical formula (O1.5SiCH2CH2SiO1.5)n from a Waters article. | ¶65 | col. 4:28-29 |
- Identified Points of Contention:
- Technical Questions: A central dispute will likely be whether Waters' coating, identified as (O1.5SiCH2CH2SiO1.5)n, is or "includ[es] carboxysilane" as required by the claim. The connection between the elemental analysis in Figure 2, the cited formula, and the specific claimed chemical compound will likely be contested.
- Scope Questions: Does the "Metal Oxide Layer" depicted in the diagram from Defendant's article (Compl. ¶18) correspond to the claimed "base layer including carboxysilane"? The parties may dispute whether this intermediate layer meets the specific chemical and structural requirements of the claim.
V. Key Claim Terms for Construction
Term 1: "incompatible with" (’986 Patent, Claim 1)
- Context and Importance: This term is critical because it defines the specific technical problem that the patented technique purports to solve. Infringement of claim 1 hinges on whether Plaintiff can prove that the analytes and agents used in the accused methods are "incompatible" with titanium or PEEK. Practitioners may focus on this term because its definition dictates the type of evidence needed to prove infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not appear to provide a specific definition, which may support an interpretation based on the term's plain and ordinary meaning (e.g., any negative chemical or physical interaction that degrades analytical performance).
- Evidence for a Narrower Interpretation: The "Background of the Invention" section lists specific, severe incompatibilities, such as titanium's reaction with various acids and PEEK's degradation from certain organic solvents and UV light (’986 Patent, col. 1:26-42). A defendant could argue that "incompatible with" should be construed narrowly to mean these types of material-degrading interactions, not just suboptimal performance.
Term 2: "carboxysilane" (’020 Patent, Claim 1)
- Context and Importance: This term defines the specific chemical nature of the claimed coating's "base layer". The entire infringement theory for the ’020 patent depends on whether Waters' "MaxPeak HPS" coating contains this material. Practitioners may focus on this term because it is a technical limitation that will likely be adjudicated through a battle of expert witnesses.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses the base layer being formed from "thermally reacted material (for example, carbosilane and/or carboxysilane...)" (’020 Patent, col. 5:53-56), which a plaintiff might argue suggests "carboxysilane" is exemplary of a broader class of materials.
- Evidence for a Narrower Interpretation: The claim language recites "including carboxysilane," and the abstract states this explicitly (’020 Patent, Abstract). A defendant will likely argue this requires the specific chemical structure of carboxysilane, and that Plaintiff's inferential leap from elemental analysis (Compl. ¶65, Figure 2) and a generic "hybrid silica" formula to this specific compound is unsupported.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement of the ’986 patent, stating that Waters instructs customers on how to perform the infringing methods through its website, marketing materials, product manuals, and technical articles (Compl. ¶¶48-50). It also alleges contributory infringement on the basis that the accused columns are not suitable for substantial non-infringing use (Compl. ¶51).
- Willful Infringement: The complaint alleges that Defendant's infringement is willful. The allegations are based on both pre-suit and post-suit (but pre-filing) knowledge, citing a long-standing business relationship, Defendant's attendance at technical presentations by a named inventor, a 2021 article by Defendant's own employees that cited the '986 patent, and a formal notice letter sent from Plaintiff to Defendant on October 25, 2021 (Compl. ¶¶27, 30-31).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of chemical identity: can the "MaxPeak HPS" coating, described by Defendant as a "hybrid silica," be proven to contain the specific "carboxysilane" compound required by claim 1 of the ’020 patent? This question will likely depend heavily on competing expert testimony interpreting analytical data.
- A second central question is one of definitional scope: does "improved performance" relative to a titanium-lined column satisfy the "incompatible with" limitation in claim 1 of the ’986 patent? The court's construction of this term will determine whether Plaintiff's evidence of superior performance is sufficient to prove infringement.
- Finally, a key issue for damages will be willfulness: given the complaint’s detailed allegations of pre-suit knowledge—including direct citation to the '986 patent by Defendant's employees and a formal notice letter—the court will have to determine if any infringement was willful, which could expose Defendant to the risk of enhanced damages.