1:19-cv-00943
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., 01/26/2015
- Venue Allegations: Plaintiff alleges venue is proper because Defendant has committed acts of patent infringement in the Southern District of New York.
- Core Dispute: Plaintiff alleges that Defendant’s modular protein purification systems infringe a patent related to automated fluid handling systems, and that Defendant’s control software for those systems infringes Plaintiff's copyright.
- Technical Context: The technology at issue involves modular chromatography systems used for protein purification, a critical process in biopharmaceutical research and manufacturing.
- Key Procedural History: The complaint alleges pre-suit notice was provided to Defendant on the same day the patent issued. Subsequent to the filing of this complaint, the asserted patent underwent significant post-grant proceedings. An Inter Partes Review (IPR) was instituted, which resulted in the cancellation of claims 1-3 and 5. The patent was later reissued as RE47,124 E with a new set of claims, indicating a substantial alteration of the patent's scope after this lawsuit was filed.
Case Timeline
| Date | Event |
|---|---|
| 2009-06-09 | '718 Patent Priority Date |
| 2009-01-01 | GE launches its ÄKTA avant modular system (approx.) |
| 2012-01-01 | GE launches its ÄKTA pure modular system (approx.) |
| 2013-01-01 | Bio-Rad unveils the accused NGC system (approx.) |
| 2014-09-02 | U.S. Patent No. 8,821,718 Issues |
| 2014-09-02 | GE notifies Bio-Rad of potential infringement |
| 2015-01-26 | Complaint Filing Date |
| 2015-09-03 | IPR2015-01826 filed against '718 Patent |
| 2018-02-22 | IPR Certificate issues, cancelling claims 1-3 and 5 |
| 2018-11-13 | U.S. Reissue Patent RE47,124 E issues |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,821,718 - "Automated Fluid Handling System," Issued September 2, 2014
The Invention Explained
- Problem Addressed: The patent describes prior art laboratory fluid handling systems, such as chromatography systems, as lacking flexibility. Upgrading or reconfiguring these systems was often difficult, requiring external add-on equipment that increased the system's physical footprint and complexity. (’718 Patent, col. 1:20-43).
- The Patented Solution: The invention is a highly flexible and configurable automated fluid handling system built on a modular architecture. It features a main housing with a "liquid handling panel" that has standardized positions for receiving various "interchangeable modular components" like pumps, valves, and sensors. (’718 Patent, Abstract). A key aspect of the design is that each module has an external "fluidics section" (the "wet" side with tubing and fluid paths) and an internal "non fluidics section" (the "dry" side with electronics), which are physically separated by a panel member. This architecture is intended to allow for easy customization and servicing while protecting sensitive electronics from fluid leaks. (’718 Patent, col. 5:10-24; Fig. 4a).
- Technical Importance: This design aimed to allow researchers to easily upgrade, reconfigure, and optimize a single instrument for a variety of different applications without requiring bulky external add-ons or entirely new systems. (’718 Patent, col. 1:46-51).
Key Claims at a Glance
- The complaint asserts "one or more claims" without specifying them (Compl. ¶44). The broadest independent claim at the time of filing was Claim 1.
- Independent Claim 1 (as originally issued):
- An automated fluid handling system comprising a housing and two or more interchangeable fluid handling units.
- The units are arranged as interchangeable modular components and include a fluidics section, a non-fluidics section (with electronics), and a panel member separating the two.
- The panel members are attached to a liquid handling panel in the housing such that the fluidics sections are external to the housing and the non-fluidics sections are internal to the housing.
- The complaint does not explicitly reserve the right to assert dependent claims, but the allegation against "one or more claims" implies this.
III. The Accused Instrumentality
Product Identification
Defendant Bio-Rad's "Next Generation Chromatography ('NGC') system" (Compl. ¶23).
Functionality and Market Context
The complaint alleges the NGC system is a suite of protein purification systems featuring a "modular design that allowed users to customize and modify the system based on their changing needs" (Compl. ¶23). The complaint does not provide technical details on the NGC system's architecture. Instead, it alleges that the design was "copied from the ÄKTA avant system," "looks strikingly similar to the ÄKTA pure system," and was "intentionally designed... to resemble the design of GE's products" (Compl. ¶23). The complaint also alleges that Bio-Rad targeted GE's existing and potential customers in its marketing campaigns for the NGC system (Compl. ¶25).
IV. Analysis of Infringement Allegations
The complaint does not contain specific visual evidence or technical descriptions of the accused NGC system's hardware. The infringement theory is presented in narrative form, primarily based on alleged copying of the commercial embodiment of the patent.
’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 fluid handling units, wherein said units are arranged as interchangeable modular components... | The NGC system is alleged to have a "modular design that allowed users to customize and modify the system based on their changing needs," which is alleged to be covered by the patent claims. | ¶23 | col. 9:1-3 |
| ...and include: a fluidics section; a non fluidics section comprising electronics...; and a panel member arranged to separate the fluidics section from the non fluidics section... | The complaint does not provide specific factual allegations describing a "panel member" or the separation of fluidics and non-fluidics within the accused NGC system. It makes a general allegation that the modular features of the NGC system are covered by the '718 patent claims. | ¶23 | col. 9:4-8 |
| ...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... | The complaint does not contain specific allegations detailing the physical arrangement of the NGC system's components relative to its housing. Infringement of this limitation is asserted based on the general allegation that the NGC system's design resembles GE's products and is covered by the patent. | ¶23 | col. 9:9-14 |
Identified Points of Contention
- Technical Questions: A central question for the court would be what technical evidence supports the claim that the accused NGC system meets the specific structural limitations of the patent. The complaint’s infringement theory rests heavily on allegations of "copying" and "resembling" a commercial product (Compl. ¶23), rather than on a technical breakdown of the accused device's architecture.
- Scope Questions: The complaint was filed asserting claims, including Claim 1, that were later cancelled in an IPR proceeding. This raises a fundamental question about the viability of the case as pleaded. Any ongoing dispute would have to focus on the narrower scope of the surviving dependent claims or the claims of the subsequently reissued patent, which were not part of the original complaint.
V. Key Claim Terms for Construction
Term: "panel member arranged to separate the fluidics section from the non fluidics section"
- Context and Importance: This term describes the core structural innovation of the patent. The infringement analysis hinges on whether the accused NGC system contains a structure that meets this definition. Practitioners may focus on this term because it defines the boundary between the "wet" and "dry" parts of each module, a key functional aspect of the invention.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is functional ("arranged to separate"). Plaintiff may argue that any physical barrier within a module that serves to isolate fluidic components from electronic components meets this limitation, regardless of its specific form. (’718 Patent, col. 9:6-8).
- Evidence for a Narrower Interpretation: The specification and figures consistently depict a distinct panel (22) in the main housing and a faceplate (28) on each module that plugs into it, creating a clear physical division. Defendant may argue the term should be limited to this specific architecture where a module's own panel member mates with a larger system panel. (’718 Patent, Fig. 2, Fig. 4a, Fig. 5b).
Term: "interchangeable"
- Context and Importance: The meaning of "interchangeable" is critical to the scope of the claims. The dispute may turn on whether it simply means components can be replaced or upgraded, or if it requires a more advanced "plug-and-play" capability where different types of modules can be placed in various positions.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's background emphasizes the goal of creating a flexible system that can be easily upgraded and optimized for new experiments, suggesting "interchangeable" refers to this general serviceability and customizability. (’718 Patent, col. 1:28-34, col. 5:37-45).
- Evidence for a Narrower Interpretation: The specification describes a master control unit that can automatically identify different component modules, which could suggest that "interchangeable" implies a system-level ability to recognize and integrate different module types, not just replace like-for-like. (’718 Patent, col. 7:7-14).
VI. Other Allegations
Copyright Infringement
The complaint includes a separate count for copyright infringement, alleging that Bio-Rad copied the "original design, structure, selection, and organization" of the graphical user interface (GUI) for GE's UNICORN 6 control software (Compl. ¶¶38, 52). The complaint provides visual evidence to support this claim. A side-by-side screenshot compares the overall layout of GE's "UNICORN 6 Method Editor GUI" with Bio-Rad's "ChromLab 'Method Editor' GUI" to allege substantial similarity (Compl. p. 12). Another visual provides a focused comparison of the "Phase Library" menus from each software, alleging they contain a similar menu of options displayed in a similar manner (Compl. p. 13).
Willful Infringement
The complaint alleges willful infringement of the ’718 patent. This allegation is based on pre-suit knowledge, stating that "GE notified Bio-Rad by certified letter dated September 2, 2014 that the NGC system potentially infringes claims of the '718 patent" (Compl. ¶26, ¶48).
Indirect Infringement
The complaint does not provide sufficient detail for analysis of indirect infringement. The allegations focus on direct infringement by Bio-Rad through its making, using, and selling of the NGC system (Compl. ¶44).
VII. Analyst’s Conclusion: Key Questions for the Case
Claim Viability: A dispositive issue for the patent claim is its validity and scope. Given that the broadest independent claims asserted in the complaint were subsequently cancelled during Inter Partes Review, a threshold question is whether Plaintiff could prove infringement under any of the remaining, narrower dependent claims, or if the case would need to be re-evaluated entirely under the claims of the reissued patent.
Evidentiary Disconnect: The case presents a potential disconnect between the patent and copyright allegations. The complaint's strongest evidence, in the form of detailed visual comparisons, supports the copyright claim related to the software GUI. A key question is whether the factual basis for patent infringement of the physical hardware—which lacks similar detailed support in the complaint—can be proven independently of the GUI copying allegations.
The "Panel Member" Limitation: The core technical question for patent infringement will likely be one of structural definition: does the accused Bio-Rad NGC system incorporate a "panel member arranged to separate the fluidics section from the non fluidics section" as required by the claims? The resolution will depend on how the court construes this term and what technical evidence is presented regarding the NGC system's internal architecture.