Cytiva Sweden Ab v. Bio Rad Laboratories Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: GE Healthcare Bio-Sciences AB (Sweden) and its affiliates (collectively, "GE Healthcare")
  • Defendant: Bio RAD Laboratories Inc (Delaware)
  • Plaintiff’s Counsel: Shaw Keller LLP
• Case Identification: 1:18-cv-01899, D. Del., 11/30/2018
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Bio-Rad Laboratories, Inc. is incorporated under the laws of Delaware.
• Core Dispute: Plaintiff alleges that Defendant’s Next Generation Chromatography ("NGC") systems infringe four patents related to modular automated fluid handling systems for protein purification.
• Technical Context: The technology concerns customizable liquid chromatography systems, a standard laboratory tool for separating and purifying proteins, which is a critical process in biopharmaceutical research and manufacturing.
• Key Procedural History: The parties have a significant litigation history. GE Healthcare previously sued Bio-Rad in the Southern District of New York over a parent patent to the current patents-in-suit. During that litigation, Bio-Rad filed an inter partes review (IPR) that resulted in some claims of the parent patent being found unpatentable by the Patent Trial and Appeal Board (PTAB). The complaint alleges that while the IPR and prior litigation were pending, GE Healthcare prosecuted the continuation applications that matured into the patents-in-suit and notified Bio-Rad of this prosecution via joint status reports, forming a basis for the current allegations of willful infringement.

Case Timeline

Date	Event
2009-06-09	Earliest Priority Date for all Patents-in-Suit (Swedish Application)
2009	GE Healthcare launches ÄKTA avant system
2012	GE Healthcare launches ÄKTA pure system
2013-01	Bio-Rad launches accused NGC system
2014-09-02	GE Healthcare files New York litigation against Bio-Rad over parent patent
2015-09-03	Bio-Rad files IPR petition against the parent '718 Patent
2017-02-06	PTAB issues Final Written Decision finding certain parent patent claims unpatentable
2017-06-06	U.S. Patent No. 9,671,420 issues
2017-07-18	U.S. Patent Nos. 9,709,589, 9,709,590, and 9,709,591 issue
2018-11-30	Complaint filed in D. Del.

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

U.S. Patent No. 9,709,589 - Automated Fluid Handling System, issued July 18, 2017

The Invention Explained

• Problem Addressed: The patent describes conventional fluid handling systems, such as those used for liquid chromatography, as lacking flexibility. Reconfiguring or upgrading these systems is often difficult, time-consuming, and requires external add-on equipment that increases the laboratory footprint and involves complex fluidic and electrical connections (’589 Patent, col. 1:26-44).
• The Patented Solution: The invention is a highly modular automated system. It features a main housing with a front-facing "liquid handling panel" containing multiple standardized receiving positions arranged in an array (’589 Patent, Fig. 2). Interchangeable components—such as pumps, valves, and sensors—are designed as self-contained modules that can be easily inserted, removed, or repositioned within these receiving positions to customize the system's fluid path (’589 Patent, col. 6:46-54). This architecture physically separates the "wet" external fluidics section from the "dry" internal electronics, enhancing serviceability and liquid resistance (’589 Patent, col. 6:11-21).
• Technical Importance: This modular design allows a single instrument to be easily adapted for a variety of different scientific applications, increasing flexibility and making it easier to optimize the fluid flow path for specific experiments (’589 Patent, col. 1:56-62).

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶65).
• Essential elements of Claim 1 include:
  • An automated liquid chromatography system with a housing unit and at least four modular fluid handling units.
  • The housing unit has an external side with a plurality of receiving positions arranged in a two-dimensional array.
  • These positions receive the modular units such that their fluid handling sections are external to the housing.
  • Each modular unit is readily interchangeable among the positions, permitting the fluid flow path to be readily modified.
  • The fluid flow path is formed by fluidic connections between the modular units.
  • Each modular unit includes a CPU for independently performing fluid control operations in response to instructions over a system BUS.
• The complaint alleges infringement of "one or more claims," reserving the right to assert additional claims (Compl. ¶64).

U.S. Patent No. 9,709,590 - Automated Fluid Handling System, issued July 18, 2017

The Invention Explained

• Problem Addressed: As with the related patents, the invention addresses the inflexibility and difficulty of reconfiguring prior art laboratory fluid handling and chromatography systems (’590 Patent, col. 1:20-44).
• The Patented Solution: This patent claims the method of using the modular system. The core of the method is the act of "interchanging" at least two of the interchangeable modular components within the housing's array of receiving positions (’590 Patent, Claim 1). This physical rearrangement of the modules allows a user to modify the system's overall liquid chromatography fluid flow path to suit a new experimental setup (’590 Patent, col. 2:50-54).
• Technical Importance: This patented method provides researchers with a straightforward, user-driven process for altering the fundamental capabilities of their purification instrument without needing specialized service or external hardware (’590 Patent, col. 1:56-62).

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶77).
• Essential elements of Claim 1 include:
  • A method of modifying a fluid flow path in an automated liquid chromatography system with at least four interchangeable modular components.
  • The method step comprises "interchanging at least two of the interchangeable modular components in a housing unit" that has at least four receiving positions in a two-dimensional array.
  • This interchanging allows for "modification of the liquid chromatography fluid flow path."
  • Each interchangeable modular component includes a CPU unit for independently performing fluid control operations based on instructions from a system controller.
• The complaint alleges infringement of "one or more claims," reserving the right to assert additional claims (Compl. ¶76).

U.S. Patent No. 9,709,591 - Automated Fluid Handling System, issued July 18, 2017

• Patent Identification: U.S. Patent No. 9,709,591, Automated Fluid Handling System, issued July 18, 2017 (Compl. ¶18).
• Technology Synopsis: This patent claims a system focused on the specific architecture of the interchangeable modules and their interaction with the housing. The claims detail modules comprising an "external fluidics section," an "internal non-fluidics section" with a bus connector, and a "panel member" separating the two, as well as a master control unit that can "automatically identify" the modules (’591 Patent, Claim 1).
• Asserted Claims: Independent Claim 1 (Compl. ¶89).
• Accused Features: The complaint alleges that the Bio-Rad NGC system's interchangeable "modules" possess the claimed external fluidics/internal non-fluidics structure, and that its master control unit automatically identifies the modules via a "unique electronic ID" (Compl. ¶¶90, 19).

U.S. Patent No. 9,671,420 - Automated Fluid Handling System, issued June 6, 2017

• Patent Identification: U.S. Patent No. 9,671,420, Automated Fluid Handling System, issued June 6, 2017 (Compl. ¶19).
• Technology Synopsis: This patent claims a system architecture very similar to the ’591 patent. It recites a system with at least three interchangeable modular components and a housing with at least four receiving positions in a two-dimensional array. The claims also require the modules to have separated external fluidics and internal non-fluidics sections and to be automatically identified by a master control unit (’420 Patent, Claim 1).
• Asserted Claims: Independent Claim 1 (Compl. ¶101).
• Accused Features: The allegations against the NGC system mirror those for the ’591 patent, focusing on the system's housing with its array of "bays," the interchangeable "modules" with their separated sections, and the master control unit's ability to automatically recognize the modules (Compl. ¶102).

III. The Accused Instrumentality

Product Identification

• Defendant's "Next Generation Chromatography ('NGC')" system (Compl. ¶24).

Functionality and Market Context

• The NGC system is a protein purification system that Bio-Rad launched in January 2013 (Compl. ¶24). The complaint alleges that Bio-Rad advertised the NGC system as having a "modular design that allowed users to customize and modify the system based on their changing needs" (Compl. ¶24). The complaint alleges this design was "copied from" GE's own ÄKTA systems and includes a housing with "bays" for inserting various hardware "modules" (Compl. ¶¶24, 66). The complaint provides a side-by-side photographic comparison to illustrate the alleged similarity between Bio-Rad's NGC system and GE's ÄKTA pure system (Compl. ¶24, p. 6).
• The complaint alleges that the NGC system's "modules" have unique electronic IDs, enabling the system to automatically recognize their function when placed in a bay (Compl. ¶90). It is also alleged that Bio-Rad specifically targeted GE's existing and potential customers in its marketing campaigns for the NGC system (Compl. ¶27).

IV. Analysis of Infringement Allegations

’589 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
An automated liquid chromatography system comprising a housing unit and at least four modular fluid handling units,	The accused Bio-Rad NGC system is an automated liquid chromatography system with a housing and at least four "modules" (i.e., modular fluid handling units) inserted into "bays".	¶66	col. 9:16-19
wherein the housing unit comprises on one external side of the housing unit a plurality of receiving positions,...each receiving position adapted to receive the modular fluid handling units therein	The NGC system's housing has a front exterior side with a plurality of "bays" (i.e., receiving positions) that are adapted to receive the "modules".	¶66	col. 9:22-26
such that a fluid handling section thereof is on the external side of the housing unit, the receiving positions being arranged in a two dimensional array,	When modules are inserted, a section that handles fluid is on the external side of the NGC housing. The "bays" are arranged in a two-dimensional array.	¶66	col. 9:26-34
wherein each modular fluid handling unit...is readily interchangeable amongst similarly sized and shaped receiving positions...such that positioning...permits a fluid flow path to be readily modified	The NGC system's "modules" are alleged to be readily interchangeable among similarly sized and shaped positions, permitting the fluid flow path to be modified by changing the modules' positions.	¶66	col. 9:40-46
and includes a CPU for independently performing fluid control operations in response to instructions over a system BUS.	Each "module" is alleged to include a CPU that independently performs fluid control tasks in response to instructions over the system's bus.	¶66	col. 9:47-51

• Identified Points of Contention:
  • Scope Questions: A central question may be whether Bio-Rad’s “modules” meet the claim definition of a “modular fluid handling unit” that includes a “CPU for independently performing fluid control operations.” The analysis will likely focus on the degree of processing power and autonomy within each module versus the level of control exerted by a central system controller.
  • Technical Questions: What evidence does the complaint provide that the interchangeability of the accused modules "permits a fluid flow path to be readily modified"? The court may need to examine the extent of user action, software reconfiguration, and physical re-tubing required to alter the flow path in the NGC system, and whether this process meets the "readily modified" limitation.

’590 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of modifying a fluid flow path in an automated liquid chromatography system comprising at least four interchangeable modular components	Users of Bio-Rad’s NGC system are alleged to practice the claimed method. The system is alleged to comprise at least four interchangeable "modules" (i.e., modular components).	¶78	col. 9:14-18
interchanging at least two of the interchangeable modular components in a housing unit comprising at least four component receiving positions arranged in a two dimensional array,	The method practiced by users allegedly includes interchanging at least two of the "modules" within the NGC system's housing, which comprises at least four "bays" (i.e., component receiving positions) arranged in a two-dimensional array.	¶78	col. 9:19-25
so as to allow for modification of the liquid chromatography fluid flow path...	The alleged interchanging of modules is done to allow for modification of the liquid chromatography fluid flow path.	¶78	col. 9:25-28
wherein each of the at least four interchangeable modular components comprises a CPU unit for independently performing fluid control operations in response to instructions from a system controller...	Each of the interchangeable "modules" is alleged to include a CPU that can independently perform fluid control operations in response to instructions from the system controller when installed in a "bay" (i.e., a component receiving position).	¶78	col. 9:29-34

• Identified Points of Contention:
  • Evidentiary Questions: The claim requires the act of "interchanging...modular components...to allow for modification of the liquid chromatography fluid flow path." A primary issue will be evidentiary: what proof can be offered to show that users of the NGC system actually perform this physical interchanging step for the claimed purpose, as opposed to simply using the system in a static configuration?
  • Technical Questions: As with the ’589 Patent, a key technical question is whether the electronics in each of the accused "modules" rise to the level of a "CPU unit for independently performing fluid control operations." The dispute may turn on the specific capabilities of the microcontrollers within the modules and their relationship with the main system controller.

V. Key Claim Terms for Construction

• The Term: "modular fluid handling unit"

  • Context and Importance: This term is the fundamental building block of the claimed invention and appears in various forms across all asserted patents. The infringement case hinges on whether Bio-Rad's accused "modules" fall within the scope of this term.
  • Evidence for a Broader Interpretation: The specification provides a wide-ranging list of potential units, including "pumps, valves, mixers, sensor units etc of different types" (’589 Patent, col. 1:30-32), which may support an interpretation covering any self-contained component that can be placed in a receiving position and contributes to fluid handling.
  • Evidence for a Narrower Interpretation: Defendants may argue that the term is narrowed by claim limitations and specification details, such as the requirement for an independent "CPU" (’589 Patent, cl. 1) and the explicit architectural separation of an "external fluidics section" from an "internal non-fluidics section" (’589 Patent, col. 6:15-21).

• The Term: "CPU for independently performing fluid control operations"

  • Context and Importance: Practitioners may focus on this term because it appears in the independent claims of both system and method patents and distinguishes a "smart," self-contained module from a passive one. Infringement will depend on whether the electronics within Bio-Rad's modules possess sufficient autonomy.
  • Evidence for a Broader Interpretation: The specification describes a "dedicated CPU unit allowing the component to independently perform operations in response to instructions over the BUS" (’589 Patent, col. 8:16-19). This could be interpreted to cover any on-board microcontroller capable of executing received commands without continuous, real-time supervision from the master controller.
  • Evidence for a Narrower Interpretation: The term "independently" could be argued to require more than simple command execution, suggesting a need for some level of local decision-making. The description of a "master control unit... arranged to communicate with all modular components" (’589 Patent, col. 8:12-16) could be used to argue that the system architecture is fundamentally one of centralized control, limiting the "independence" of any module-level processor.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for all four patents-in-suit. The inducement allegations are based on Bio-Rad's alleged marketing, selling, and providing of instructional materials, such as product manuals and videos, that instruct and encourage customers to use the accused NGC systems in an infringing manner (e.g., by interchanging modules to modify the fluid path) (Compl. ¶¶68, 80, 92, 104). Contributory infringement is alleged on the basis that the NGC systems and their components are not suitable for any substantial non-infringing use (Compl. ¶¶69, 81, 93, 105).
• Willful Infringement: The complaint alleges that Bio-Rad’s infringement has been willful, knowing, and deliberate (Compl. ¶¶70-72, 82-84, 94-96, 106-108). The allegations are based on Bio-Rad’s alleged actual knowledge of the patents-in-suit, which the complaint claims was established through GE Healthcare's disclosures during prior litigation. Specifically, GE alleges it notified Bio-Rad of the prosecution of the continuation applications that became the patents-in-suit via joint status reports filed in the earlier New York litigation (Compl. ¶61).

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

• A central issue will be one of willful infringement: can GE Healthcare prove that its alleged disclosures of pending continuation applications during prior litigation placed Bio-Rad on sufficient notice to render any subsequent infringement, from the moment the patents-in-suit issued, "objectively reckless"?
• The case will also turn on a question of technical scope, driven by claim construction: do the accused Bio-Rad "modules" possess the requisite level of autonomy and processing power to be considered a "modular fluid handling unit" with a "CPU for independently performing fluid control operations," as claimed, or does the evidence show a more centralized control architecture that falls outside the patent's scope?
• Finally, for the asserted method claims, a key evidentiary question will be one of direct infringement: what evidence can be presented to demonstrate that end-users of the accused NGC system actually perform the claimed method step of physically "interchanging" modules for the purpose of modifying the system's fluid flow path?