Ge Healthcare Bio Sciences Ab v. Bio Rad Laboratories Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: GE Healthcare Bio-Sciences AB (Sweden), GE Healthcare Bio-Sciences Corporation (Delaware), and General Electric Company (New York)
  • Defendant: Bio-Rad Laboratories, Inc. (Delaware)
  • Plaintiff’s Counsel: Arnold & Porter LLP
• Case Identification: 1:14-cv-07080, S.D.N.Y., 09/02/2014
• Venue Allegations: Plaintiff alleges venue is proper in the Southern District of New York because Defendant has committed and intends to commit acts of infringement in the district.
• Core Dispute: Plaintiff alleges that Defendant’s Next Generation Chromatography (NGC) systems infringe a patent related to modular automated fluid handling systems.
• Technical Context: The technology concerns laboratory-grade protein purification systems, a critical tool in biopharmaceutical research and manufacturing for isolating specific proteins from complex mixtures.
• Key Procedural History: The complaint was filed on the same day the patent-in-suit was issued, suggesting a pre-planned litigation strategy. Plaintiff alleges that Defendant was aware of its competing modular products since at least 2009 and intentionally designed the accused product to resemble them. The complaint also notes that an Inter Partes Review (IPR) of the patent-in-suit was initiated in 2015, resulting in the cancellation of claims 1-3 and 5, which could significantly impact this case as it proceeds.

Case Timeline

Date	Event
2009-06-09	’718 Patent Priority Date
2013-01-01	Accused Bio-Rad NGC System Unveiled (approx. date)
2014-09-02	’718 Patent Issue Date
2014-09-02	Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,821,718 - Automated Fluid Handling System

• Patent Identification: U.S. Patent No. 8,821,718, Automated Fluid Handling System, issued September 2, 2014.

• The Invention Explained:

  • Problem Addressed: The patent describes conventional fluid handling systems, such as those used for liquid chromatography, as often lacking flexibility. Upgrading or altering the fluid flow path is difficult, often requiring external "add-on equipment" that increases the system's physical footprint and complexity (’718 Patent, col. 1:21-36).
  • The Patented Solution: The invention proposes a highly modular system architecture. It features a main housing with a "liquid handling panel" containing standardized "component positions." Interchangeable functional modules (e.g., pumps, valves, sensors) can be installed into these positions. A key aspect of the design is that this panel separates the "external fluidics section" (the "wet side" with tubing and fluid connections) from the "internal non fluidics section" (the "dry side" with electronics and control components), enhancing safety and serviceability (’718 Patent, Abstract; col. 1:43-54). Figure 5b illustrates this separation, with panel (22) dividing external fluidics (30) from internal non-fluidics (32).
  • Technical Importance: This modular design allows a system to be easily reconfigured, upgraded, or serviced by swapping individual components, without needing new external equipment or extensive modifications (’718 Patent, col. 1:50-54).

• Key Claims at a Glance:
  The complaint asserts infringement of "one or more claims" of the ’718 patent (Compl. ¶26). Independent claim 1 is central to the patent's scope.

  • Independent Claim 1:
    • An automated fluid handling system with a housing and at least two interchangeable modular components.
    • Each modular component includes:
      • a fluidics section.
      • a non-fluidics section with electronics or control means.
      • a panel member to separate the fluidics from the non-fluidics section and to attach to the housing.
    • The housing's liquid handling panel has component positions arranged to receive the panel members.
    • This arrangement places the fluidics sections external to the housing and the non-fluidics sections internal to the housing.

  The complaint does not specify any dependent claims but reserves the right to assert them.

III. The Accused Instrumentality

Product Identification

Defendant Bio-Rad’s Next Generation Chromatography (“NGC”) system (Compl. ¶21).

Functionality and Market Context

The complaint alleges that the NGC system features a "modular design that allowed users to customize and modify the system based on their changing needs" (Compl. ¶21). Plaintiff alleges that this modular design was "copied from" its own ÄKTA avant and ÄKTA pure systems and was "intentionally designed...to resemble the design of GE's products" (Compl. ¶21). The complaint further alleges that Bio-Rad targeted GE's existing customers in its marketing campaign for the NGC system (Compl. ¶23). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’718 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
an automated fluid handling system comprising a housing and two or more interchangeable modular components	The accused NGC system is described as a "system for preparative protein purification" with a "modular design" that allows users to "customize and modify the system."	¶21, ¶26	col. 1:43-48
said units...include...a fluidics section; a non fluidics section comprising electronics or electrical components or control means;	The NGC is an automated chromatography system, which inherently requires both fluidic components and electronic controls.	¶21, ¶24	col. 5:61-65
and a panel member arranged to separate the fluidics section from the non fluidics section and for attachment of the modular component to a component position of the liquid handling panel	The complaint alleges Bio-Rad copied the "attractive panel design separating the fluidics section from the non-fluidics section" from GE's own products, which embody the patent.	¶15, ¶21	col. 5:10-17
wherein the two or more component positions of the liquid handling panel are arranged for attachment of the panel members such that said respective fluidics sections are external to the housing and said respective non fluidics sections are internal to the housing.	The complaint alleges the NGC's modular design "is copied from the ÄKTA avant system and looks strikingly similar to the ÄKTA pure system," which are designed with this external/internal separation.	¶21	col. 9:9-14

Identified Points of Contention:

• Scope Questions: A central dispute may be the construction of the claim term "panel member arranged to separate the fluidics section from the non fluidics section." The litigation will likely focus on whether the physical architecture of the NGC system includes a structure that meets this specific definition of a separating panel that also serves as the mounting point for modular components.
• Technical Questions: The complaint's allegations are based heavily on the visual and functional resemblance between the NGC system and GE's products (Compl. ¶21). A key question for the court will be whether the NGC system's modularity functions in the specific manner claimed—namely, with interchangeable modules that have integrated panels creating a distinct external "wet" side and internal "dry" side relative to the main housing.

V. Key Claim Terms for Construction

• The Term: "panel member arranged to separate the fluidics section from the non fluidics section"
• Context and Importance: This term is the structural heart of Claim 1, defining the core architectural innovation. Whether the NGC system infringes will likely depend on whether its components have a structure that satisfies this limitation. Practitioners may focus on this term because it appears to be the primary point of novelty over prior art systems that may have been modular but lacked this specific wet/dry separation architecture.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim uses the general term "separate," which could be argued to encompass any form of division, not necessarily a hermetic seal.
  • Evidence for a Narrower Interpretation: The specification consistently describes and illustrates a distinct physical barrier (element 22 in Fig. 5b) that divides the system into an "external fluidics section" and an "internal non fluidics section" (’718 Patent, col. 5:61-65; Abstract). A party could argue the term is limited to this specific physical partition that also functions as the mounting surface for the modules.

VI. Other Allegations

• Indirect Infringement: The complaint does not plead a separate count for indirect infringement. It states that Bio-Rad is "providing" the infringing system, but does not allege specific facts to support active inducement, such as citing user manuals that instruct on an infringing use (Compl. ¶24).
• Willful Infringement: The complaint does not use the word "willful," but it alleges facts that could support such a claim. It states that Bio-Rad was "well aware" of GE's competing modular products on the market since 2009 and "intentionally designed the NGC to resemble the design of GE's products" (Compl. ¶21-22). These allegations of knowing and intentional copying of a competitor's product design could be used to argue for enhanced damages, particularly for any infringement occurring after the complaint was filed.

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of architectural equivalence: Does the physical construction of Bio-Rad’s NGC system incorporate a "panel member" that "separates" the fluid-handling parts of its modules from the electronic parts in the specific manner required by the patent claims, creating a distinct external "wet" side and internal "dry" side?
• A key evidentiary question will be one of intent and copying: The complaint alleges that Bio-Rad "intentionally designed the NGC to resemble" GE's commercial products. The degree to which GE can substantiate this claim of copying may influence the analysis of infringement, particularly under the doctrine of equivalents, and will be central to any future arguments regarding enhanced damages.
• A dispositive procedural question will be the impact of the subsequent IPR: The cancellation of several asserted claims, including the primary independent claim (Claim 1), after the complaint was filed presents a significant hurdle for the Plaintiff. The viability of the case may depend on whether infringement can be proven under any remaining, valid claims.