DCT
4:15-cv-14206
Waters Tech Corp v. Phenomenex Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Waters Technologies Corp. (Delaware)
- Defendant: Phenomenex, Inc. (California)
- Plaintiff’s Counsel: McCarter & English, LLP
- Case Identification: 4:15-cv-14206, D. Mass., 12/22/2015
- Venue Allegations: Venue is asserted based on Defendant having allegedly committed acts of infringement in the District of Massachusetts, regularly conducting business in the district by offering for sale and selling accused products to customers there, and purposefully availing itself of the privilege of conducting business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s solid phase extraction (SPE) well plates infringe a patent related to the specific structural design of such devices, and further alleges trademark infringement and unfair competition based on Defendant’s use of the same product mark and marketing materials.
- Technical Context: The technology concerns consumable laboratory devices known as 96-well plates used for solid phase extraction, a critical step in preparing chemical and biological samples for analysis by techniques such as high-performance liquid chromatography (HPLC).
- Key Procedural History: Plaintiff alleges it provided Defendant with constructive notice of the patent-in-suit by marking its own commercial products. Plaintiff also alleges it provided actual notice via a letter from counsel on December 22, 2015, the same day the complaint was filed. The complaint also includes counts for trademark infringement and unfair competition, alleging Defendant copied Plaintiff’s "µElution" trademark and marketing advantages.
Case Timeline
| Date | Event |
|---|---|
| 2002-03-19 | Priority Date for U.S. Patent No. 6,723,236 |
| 2002 (approx.) | Plaintiff begins selling patented Oasis µElution™ products |
| 2004-04-20 | U.S. Patent No. 6,723,236 Issues |
| 2015-10-01 (approx.) | Defendant begins selling accused Strata™ X µElution products |
| 2015-12-22 | Complaint Filed / Actual Notice Letter Sent |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 6,723,236, "Device for Solid Phase Extraction and Method for Purifying Samples Prior to Analysis," issued April 20, 2004. Note: The complaint incorrectly identifies the patent as No. 7,723,236 in one paragraph (Compl. ¶15) but correctly identifies it as No. 6,723,236 elsewhere (Compl. ¶4), which matches the provided patent document.
The Invention Explained
- Problem Addressed: Prior art solid phase extraction (SPE) devices required relatively large volumes of organic solvent to elute (i.e., wash out and collect) the target chemical compounds from the device. This large volume of solvent then had to be evaporated (a "drydown" step) and the dried sample reconstituted in a smaller volume of a different liquid before it could be analyzed, a process that was time-consuming and could lead to sample loss (’236 Patent, col. 2:46-60).
- The Patented Solution: The patent describes an SPE device, typically in a multi-well plate format, with a specific internal geometry designed to solve this problem. The core innovation is a well with an "internally tapered wall" containing a bed of sorbent particles sandwiched between two porous filters (’236 Patent, col. 4:16-26). Crucially, the second (downstream) filter is smaller than the first (upstream) filter. This geometry creates a conically shaped sorbent bed with a high ratio of bed height to diameter, which enhances capture efficiency and allows the target compounds to be eluted in a very small volume (e.g., 10-40 µL), thereby eliminating the need for the "drydown and reconstitution" steps (’236 Patent, col. 4:27-44, 5:3-7, Fig. 1).
- Technical Importance: This design sought to increase the sensitivity and throughput of sample analysis by concentrating the analyte in a small volume suitable for direct injection into an analytical instrument, saving time, cost, and reducing potential sample loss associated with post-elution processing steps (’236 Patent, col. 3:3-8).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" but does not specify them in the body, instead incorporating a claim chart (Exhibit B) by reference, which was not filed with the complaint (Compl. ¶21, ¶39). Independent claim 1 is representative of the apparatus claims.
- Independent Claim 1:
- A solid phase extraction device comprising:
- a reservoir with an opening for receiving fluids;
- a well comprising an internally tapered wall...;
- an exit spout at the second end of the well for discharging fluids;
- a first filter press sealed between the internally tapered walls of the well...;
- a second filter having a smaller diameter than the first filter press sealed between the internally tapered walls...; and
- a quantity of sorbent particles partially filling the volume in the well between the first and second filters.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
The accused products are Phenomenex’s "Strata™ X µElution 96-well plates" (Compl. ¶9). The complaint provides a list of specific part numbers for various models of the accused plates (Compl. ¶18).
Functionality and Market Context
The accused products are consumable 96-well plates used for solid phase extraction in laboratory settings (Compl. ¶8). The complaint alleges they are "virtual knock-offs" of Plaintiff's own Oasis® µElution™ plates and are marketed to compete directly with them, including to Plaintiff's own customers (Compl. ¶9, ¶13). A side-by-side photograph in the complaint shows the physical similarity between the Plaintiff's product and the accused product (Compl. ¶10). Functionally, the complaint alleges that Phenomenex markets its product by touting the same key advantages disclosed in the '236 patent, such as the ability to elute in very small volumes (as low as 25µL) and eliminate the "drydown and reconstitution" steps (Compl. ¶33, ¶35).
IV. Analysis of Infringement Allegations
The complaint incorporates an external claim chart (Exhibit B) that was not provided. The following summary is constructed from the narrative allegations and visual evidence within the complaint.
'236 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a well comprising an internally tapered wall | The accused Strata™ X µElution plate is alleged to be a "virtual knock-off" and "substantially identical" to Plaintiff's patented plate, which embodies the claimed features. Visuals show a device with wells that appear to narrow toward the exit tip. | ¶9, ¶20, ¶27 | col. 6:35-43 |
| an exit spout at the second end of the well for discharging fluids | Photographs and drawings of the accused product show outlet tips at the bottom of each well for discharging fluids. | ¶10, ¶20 | col. 6:4-7 |
| a first filter press sealed between the internally tapered walls of the well | The complaint alleges infringement of the claims of the patent, which requires this structure, and alleges the accused product is a "knock-off." | ¶9, ¶39 | col. 6:10-14 |
| a second filter having a smaller diameter than the first filter | The complaint's general allegations of infringement of the patented technology imply the presence of this limitation. The patent teaches this feature is key to enabling low-volume elution. | ¶39 | col. 6:15-20 |
| a quantity of sorbent particles partially filling the volume in the well between the first and second filters | The accused products are sold as SPE devices containing sorbent material, such as "Strata-X, X-A, Strong Anion Mixed Mode" with a sorbent mass of "2 mg / 96-well plate." This is shown in a screenshot from Defendant's website. | ¶18 | col. 6:21-26 |
Identified Points of Contention
- Structural Questions: A primary question will be whether the precise internal geometry of the accused Strata™ X wells—including the angle of the taper, the diameters of the filters, and the method of sealing them—literally meets the limitations of Claim 1. The complaint's "virtual knock-off" theory suggests a straightforward literal infringement case (Compl. ¶9).
- Functional Questions: The complaint heavily relies on Phenomenex’s marketing materials which claim the ability to elute in "as low as 25µL" and to proceed "Without the Dry Down" (Compl. ¶35). A factual question will be whether the accused device achieves these results by practicing the specific structure claimed in the ’236 Patent, as Plaintiff alleges, or through some other, unclaimed mechanism.
V. Key Claim Terms for Construction
The Term: "internally tapered wall" (Claim 1)
- Context and Importance: The tapered geometry is fundamental to the patent's asserted solution of creating a packed bed shape that enables efficient elution in minimal volumes. The scope of "tapered" will be critical; Defendant may argue its product's specific geometry does not meet the claimed definition, while Plaintiff will likely argue for a broader construction covering any functionally similar tapered design.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim itself does not specify a particular angle of taper, only that the wall is "tapered." The summary of the invention describes the well as having a "wider interior diameter at an end closest to the opening than at an exit spout" (’236 Patent, col. 4:20-22), which is a general definition.
- Evidence for a Narrower Interpretation: The detailed description provides specific examples, such as a "molded well cavity having a 5° included angle taper" and another section with a "1° included angle" (’236 Patent, col. 8:5-6, 10-11). Defendant may argue these examples limit the term to a specific range of taper angles necessary to achieve the invention's purpose.
The Term: "press sealed" (Claim 1)
- Context and Importance: This term describes how the filters are held in place within the tapered well. Practitioners may focus on this term because the method of manufacture and assembly of the accused device could differ from what is described or implied by "press sealed," potentially creating a non-infringement argument.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not provide a specific definition of "press sealed." Plaintiff may argue it simply means the filter is held in place by a friction fit against the well walls, without requiring a specific manufacturing process.
- Evidence for a Narrower Interpretation: The specification describes how filters are "press sealed into a molded well cavity" (’236 Patent, col. 8:4-5). Defendant could argue this implies a specific interference fit achieved by forcing a filter into a slightly smaller tapered section, and that its own assembly method (e.g., using adhesive, thermal welding, or a different mechanical lock) falls outside this scope.
VI. Other Allegations
- Indirect Infringement: The complaint does not contain a specific count for indirect infringement. The allegations focus on Defendant's direct acts of making, using, selling, and offering to sell the accused devices (Compl. ¶39).
- Willful Infringement: Willfulness is explicitly alleged (Compl. ¶42). The claim is based on:
- Constructive Notice: Waters allegedly marked its own Oasis® µElution™ products with the ’236 Patent number, providing constructive notice under 35 U.S.C. § 287(a) (Compl. ¶17, ¶40).
- Actual Notice: Waters allegedly sent an actual notice letter to Phenomenex on the date of filing (Compl. ¶17).
- Deliberate Copying: The complaint alleges Phenomenex created a "virtual knock-off" (Compl. ¶9), misappropriated the "µElution" trademark used by Waters for its patented products (Compl. ¶27), and copied the specific technical advantages from the patent for use in its own marketing materials, allegedly demonstrating an "awareness of the patent and willful intent to infringe" (Compl. ¶32, ¶42). The complaint includes a marketing graphic from Phenomenex that promises "Successful Bioanalytical Sample Preparation Without the Dry Down," mirroring the key benefit described in the patent (Compl. ¶16, ¶35).
VII. Analyst’s Conclusion: Key Questions for the Case
A Core Issue of Structural Infringement: The case appears to hinge on a direct factual comparison. The central question for the court will be one of structural identity: does the accused Strata™ X µElution plate contain the specific combination of elements recited in the ’236 Patent's claims, particularly the "internally tapered wall" and the arrangement of a larger upstream filter with a smaller downstream filter? Plaintiff’s "knock-off" theory posits a direct copy, while Defendant will likely focus on subtle but material differences in geometry or assembly.
A Central Question of Intent: Given the strong allegations of copying not only the patented technology but also the associated "µElution" trademark and specific marketing claims (e.g., eliminating the "dry down" step), a key battleground will be willfulness. The court will need to determine if Phenomenex’s alleged conduct, if found to be infringing, constitutes the sort of "willful, wanton, and deliberate" behavior that could lead to enhanced damages under 35 U.S.C. § 284. The evidence of parallel marketing language will be a significant factor in this analysis.