DCT

1:19-cv-00943

Ge Healthcare Bio Sciences Ab v. Bio Rad Laboratories Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00943, D. Del., 06/18/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation and thus resides in the state.
  • Core Dispute: Plaintiff alleges that Defendant’s Next Generation Chromatography ("NGC") protein purification systems infringe a patent related to modular automated fluid handling systems.
  • Technical Context: The technology concerns modular designs for complex laboratory instruments, which aim to provide greater flexibility for customization, upgrades, and servicing.
  • Key Procedural History: The patent-in-suit, RE47,124, is a reissue of U.S. Patent No. 8,821,718. Defendant previously challenged the original '718 patent in an inter partes review (IPR), resulting in a Patent Trial and Appeal Board (PTAB) decision finding several claims unpatentable. Plaintiff subsequently filed for reissue, cancelling the invalidated claims and adding new claims, which resulted in the currently asserted '124 patent. This history may be relevant to the construction of the asserted claims.

I.A. Case Timeline

Date Event
2009-06-09 '124 Patent Priority Date
2009 Plaintiff launches ÄKTA avant system
2012 Plaintiff launches ÄKTA pure system
2013-01 Defendant launches accused NGC system
2014-09-02 Original U.S. Patent No. 8,821,718 issues
2014-09-02 Plaintiff notifies Defendant by letter of potential infringement
2015-09-03 Defendant files IPR petition against the '718 patent
2016-01-27 Reissue application for the '124 patent is filed
2017-02-06 PTAB issues final written decision finding claims 1-3 & 5 of '718 patent unpatentable
2018-11-13 U.S. Reissue Patent No. RE47,124 issues
2019-06-18 Second Amended Complaint is filed

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

II.A. U.S. Reissue Patent No. RE47,124 - "Automated Fluid Handling System"

  • Patent Identification: U.S. Reissue Patent No. RE47,124, issued November 13, 2018.

II.A.1. The Invention Explained

  • Problem Addressed: The patent’s background section describes prior art fluid handling systems, such as those used in laboratories, as often lacking flexibility. Upgrading or reconfiguring these systems could be difficult, requiring external add-on equipment that increases the system’s physical footprint, while replacement of individual components was described as a "time consuming and delicate task" (’124 Patent, col. 1:31-43).
  • The Patented Solution: The invention is a fluid handling system with a modular architecture. It comprises a main housing and multiple "interchangeable modular components" (e.g., pumps, valves, sensors) that can be easily installed or swapped. A key aspect of the design is that each module has a physically separate "external fluidics section" (the "wet" side handling fluids) and an "internal non fluidics section" (the "dry" side with electronics), which are separated by a panel member when installed in the housing (’124 Patent, Abstract; col. 5:10-24). This design aims to simplify customization and protect sensitive electronics from potential fluid leaks.
  • Technical Importance: This modular approach allows a user to "easily [upgrade] without need for add-on equipment" and to optimize the fluid flow path for different experimental setups, providing significant flexibility over more rigid, integrated systems (’124 Patent, col. 2:50-53).

II.A.2. Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 16.
  • The essential elements of independent claim 16 are:
    • A liquid chromatography system with a housing and at least two interchangeable fluid handling units.
    • The housing comprises a liquid handling panel with at least two component positions for receiving the interchangeable units.
    • The units are arranged as interchangeable modular components.
    • Each unit includes: a fluidics section; a non-fluidics section (with electronics/control); and a panel member separating the two sections.
    • The arrangement is such that the fluidics sections are external to the housing, and the non-fluidics sections are internal to the housing.
  • The complaint reserves the right to assert other claims, and the prayer for relief also references claim 18 (Compl. ¶29; Prayer for Relief ¶4).

III. The Accused Instrumentality

III.A. Product Identification

  • Defendant’s Next Generation Chromatography (“NGC”) systems (Compl. ¶23).

III.B. Functionality and Market Context

  • The NGC system is an automated liquid chromatography system used for protein purification (Compl. ¶23, ¶31). The complaint alleges that the NGC system features a modular design, allowing users to customize and modify it by inserting different "modules" into "bays" on the system's housing (Compl. ¶23, ¶31). The complaint alleges that these modules function as the claimed "interchangeable fluid handling units," with fluidics sections external to the housing and non-fluidics sections containing electronics internal to the housing (Compl. ¶31). The complaint relies on imagery from Bio-Rad's "NGC Instrument guide v.6.0" (Exhibit B) to illustrate the system's modular configuration of components (Compl. ¶31).
  • The complaint alleges that Defendant's modular design was "copied from" Plaintiff's own ÄKTA systems and that Defendant "specifically targeted" Plaintiff's customers (Compl. ¶23, ¶25).

IV. Analysis of Infringement Allegations

IV.A. RE47,124 Infringement Allegations

Claim Element (from Independent Claim 16) Alleged Infringing Functionality Complaint Citation Patent Citation
A liquid chromatography system arranged to provide a controlled fluid flow through a chromatography column... Bio-Rad's NGC system is an automated liquid chromatography system arranged to provide a controlled fluid flow through a chromatography column. ¶31 col. 2:41-44
...the system comprising a housing and two or more interchangeable fluid handling units... The NGC system comprises a housing and at least four "modules" which are alleged to be the claimed interchangeable fluid handling units. ¶31 col. 2:30-34
...the housing comprising a liquid handling panel including two or more component positions for receiving said interchangeable units... The NGC housing has a liquid handling panel with two or more "bays" which are alleged to be the claimed component positions for receiving the modules. ¶31 col. 2:35-38
...wherein said units are arranged as interchangeable modular components, and include: a fluidics section; a non fluidics section in turn comprising electronics or electrical components or control means; and a panel member arranged to separate the fluidics section from the non fluidics section... The "modules" allegedly have external fluidics sections and internal non-fluidics sections (containing electronics/control), separated by a panel member. ¶31 col. 5:58-65
...and wherein the liquid handling panel of the housing and the panel members are arranged such that the fluidics sections are external to the housing and respective non fluidics sections are internal to the housing. The NGC modules are allegedly arranged such that their fluidics sections are external to the housing and their non-fluidics sections are internal to the housing. ¶31 col. 2:38-40

IV.B. Identified Points of Contention

  • Scope Questions: The dispute may turn on the definition of "interchangeable modular components." The court will have to determine the required degree of interchangeability (e.g., simple plug-and-play versus more involved replacement) and whether the accused NGC "modules" meet that standard as it is defined by the patent.
  • Technical Questions: A central evidentiary question will be whether the physical architecture of the accused NGC system maps onto the specific structural limitations of claim 16. The complaint's theory rests on the allegation that the NGC system has a "panel member" that "separate[s]" an "external" fluidics section from an "internal" non-fluidics section. The case will require factual evidence demonstrating this specific physical arrangement in the accused products.

V. Key Claim Terms for Construction

V.A. "interchangeable modular components"

  • Context and Importance: This term is fundamental to the patent's claimed advance over the prior art. The definition of what makes a component sufficiently "interchangeable" and "modular" under the patent will be critical to the infringement analysis.
  • Intrinsic Evidence for a Broader Interpretation: The specification's summary discusses the invention in broad terms, stating that "the system may easily be upgraded without need for add-on equipment, and that the flow path may be easily optimized" (’124 Patent, col. 2:50-53). This could support a construction focused on the functional outcome of flexibility rather than a specific mechanism.
  • Intrinsic Evidence for a Narrower Interpretation: An embodiment described in the specification suggests a more specific "plug and play" configuration, where "each modular component is retained in a mating component position by a single screw, and it is connected to the master control unit by a single bus cable" (’124 Patent, col. 5:50-55). This language could support a narrower construction requiring a high degree of simplicity for a component to be deemed "interchangeable."

V.B. "panel member arranged to separate the fluidics section from the non fluidics section"

  • Context and Importance: This structural limitation defines the core physical layout of the claimed invention. Infringement will depend on whether the accused NGC systems possess this specific separating element between their "wet" and "dry" components.
  • Intrinsic Evidence for a Broader Interpretation: The claim language itself is general, and could be read to cover any physical barrier that divides the fluid-handling parts of a module from its electronic parts.
  • Intrinsic Evidence for a Narrower Interpretation: The specification describes the panel as "providing a high degree of liquid resistance at the external part of the fluid handling panel" and separating fluid connections on a "wet side" from electrical components on a "dry side" (’124 Patent, col. 5:15-24). This functional requirement for creating a liquid-resistant barrier between a wet and dry zone could be imported into the construction, narrowing its scope to arrangements that perform this specific protective function.

VI. Other Allegations

VI.A. Indirect Infringement

  • The complaint alleges that Defendant induces and contributes to infringement, asserting that Bio-Rad has actual knowledge of the '124 patent and intends for its customers to infringe by using the NGC systems (Compl. ¶33-34).

VI.B. Willful Infringement

  • Willfulness is alleged based on Defendant’s knowledge of the patent family. The complaint cites a certified letter sent to Defendant on September 2, 2014, concerning the parent '718 patent, as well as a court filing from December 4, 2018, that provided notice of the reissued '124 patent (Compl. ¶26). These allegations of pre-suit notice form the basis of the willfulness claim.

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

  • A core issue will be one of structural correspondence: does the physical architecture of Bio-Rad’s NGC system—specifically its use of "modules" and "bays"—meet the claimed structural requirements of a "liquid handling panel" and a "panel member" that separates "external" fluidics from "internal" electronics, as those terms are defined by the patent?
  • A second key question involves the impact of the prosecution and IPR history: how will the successful invalidation of original claims in the IPR and the subsequent claim amendments and additions during the reissue process affect the interpretation and scope of the asserted claims of the '124 patent? The court will likely examine whether the patentee narrowed the claims to overcome the prior art that invalidated the original patent, and whether that narrowing places the accused products outside the scope of the asserted claims.