DCT
1:16-cv-00358
Bio Rad Laboratories Inc v. Thermo Fisher Scientific Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bio-Rad Laboratories, Inc. (Delaware)
- Defendant: Thermo Fisher Scientific Inc. (Delaware)
- Plaintiff’s Counsel: Ashby & Geddes; Jones Day
- Case Identification: 1:16-cv-00358, D. Del., 07/28/2016
- Venue Allegations: Venue is alleged to be proper as Defendant is a Delaware corporation that transacts business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s real-time Polymerase Chain Reaction (PCR) systems infringe a patent related to a movable fluorescence detection module.
- Technical Context: The technology concerns fluorescence detection systems used in real-time PCR instruments, which are fundamental tools for genetic analysis and diagnostics in life sciences research.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with notice of infringement as early as March 2013, followed by licensing negotiations in which Defendant allegedly acknowledged a need for a license. The complaint also references a European counterpart patent which survived an opposition proceeding where thirteen prior art documents were considered, and notes that Plaintiff initiated a related infringement action in Germany in May 2016.
Case Timeline
| Date | Event |
|---|---|
| 2003-05-08 | ’504 Patent Priority Date |
| 2010 | Copyright date of brochure for accused StepOne™/StepOnePlus™ systems |
| 2012-08-07 | ’504 Patent Issue Date |
| 2013-03 | Plaintiff alleges first notice of infringement to Defendant |
| 2014-01 | Plaintiff alleges it sent proposed licensing terms to Defendant |
| 2015-05-06 | Plaintiff alleges it sent a letter to Defendant regarding infringement |
| 2016-01 | European Patent Office dismisses appeal of opposition to counterpart patent |
| 2016-05 | Plaintiff initiates infringement action in Germany |
| 2016-07-28 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,236,504 - "Systems and Methods for Fluorescence Detection with a Movable Detection Module," Issued August 7, 2012
The Invention Explained
- Problem Addressed: The patent describes issues with prior art real-time PCR fluorometers. When different light sources and detectors are used for different sample wells, variations between these components require complex and time-consuming individual calibration, which can introduce measurement errors. Furthermore, systems with fixed optical components are difficult to reconfigure for detecting different fluorescent labels used in new experiments (U.S. Patent No. 8,236,504, col. 2:11-34).
- The Patented Solution: The invention proposes a self-contained, movable detection module that houses both the excitation light source and the emission light detector. This module is mounted on a shuttle that scans across an array of sample wells. By using the same optical module for every well, the system aims to eliminate variations caused by different optical paths and components, simplifying calibration. The module is also designed to be removable, allowing a user to easily swap modules optimized for different experimental needs (’504 Patent, Abstract; col. 3:1-9).
- Technical Importance: This design sought to improve the accuracy, speed, and flexibility of high-throughput fluorescence detection in real-time PCR by standardizing the optical measurement across all samples in an array (’504 Patent, col. 2:52-56).
Key Claims at a Glance
- Independent Claim Asserted: 1
- Claim 1 Elements:
- A support structure attachable to a thermal cycler;
- A shuttle movably mounted on the support structure;
- A detection module attached to the shuttle, which includes:
- a housing with an opening oriented toward the sample wells;
- an excitation light generator disposed within the housing; and
- an emission light detector disposed within the housing.
- Wherein, when attached, a heating element is disposed between the detection module and the sample wells, and the shuttle is movable to position the module in optical communication with different wells through openings in the heating element.
- The complaint also asserts dependent claims 9 and 11 and states it may later assert other claims (Compl. ¶¶13, 23, 24).
III. The Accused Instrumentality
Product Identification
- The StepOne™ and StepOnePlus™ Real-Time PCR systems (Compl. ¶11).
Functionality and Market Context
- The accused products are described as systems used for real-time analysis of polymerase chain reactions, performing "all aspects of the real-time PCR process including sample and reaction setup, thermal cycling, and fluorescent detection" (Compl. ¶17). The complaint alleges the systems contain an "LED-based optical system" that records fluorescence from various dyes across a plurality of sample wells (48 for the StepOne™, 96 for the StepOnePlus™) (Compl. ¶¶17, 20). The complaint alleges Defendant is a direct competitor to Plaintiff (Compl. ¶27).
IV. Analysis of Infringement Allegations
’504 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a support structure attachable to the thermal cycler | The accused systems comprise a support structure attached to a thermal cycler. The complaint provides a labeled photograph of this structure with the exterior casing removed. | ¶18 | col. 4:36-42 |
| a shuttle movably mounted on the support structure | A shuttle is allegedly mounted on the support structure and is capable of moving during operation. A photograph of the alleged shuttle is provided. | ¶19 | col. 5:46-49 |
| a detection module attached to the shuttle, the detection module including: a housing having an opening oriented toward the plurality of wells; an excitation light generator disposed within the housing; and an emission light detector disposed within the housing | The accused systems allegedly have a module attached to the shuttle that comprises a housing with openings. This module is described as an "LED-based optical system" containing both the light source (LED) and detectors. A photograph of the alleged module is provided. | ¶20 | col. 6:4-12 |
| wherein, when the support structure is attached to the thermal cycler, a heating element is disposed between the detection module and the sample wells and the shuttle is movable to position the detection module in optical communication with different wells of the plurality of wells through a plurality of openings extending through the heating element | A heating element is allegedly positioned between the detection module and sample wells. The complaint alleges this heating element has openings and that the shuttle moves the module over these openings to communicate with the wells below. This allegation is supported by two photographs showing the detection module positioned above the heating element. | ¶21 | col. 5:1-14 |
Identified Points of Contention
- Technical Questions: The complaint's infringement theory relies on a direct structural mapping supported by photographs. A potential question is whether the accused "LED-based optical system" (Compl. ¶20) functions as the claimed "detection module," which the patent describes as being self-contained and facilitating easy replacement (’504 Patent, Abstract). The evidence presented does not detail the modularity or interchangeability of the accused optical system.
- Scope Questions: The interpretation of "heating element" may become a point of dispute. The claim requires this element to be "disposed between the detection module and the sample wells" and have "openings." The court may need to determine if the specific component identified in the accused products (Compl. ¶21) meets the functional and structural requirements of this term as defined by the patent specification.
V. Key Claim Terms for Construction
- The Term: "detection module"
- Context and Importance: This term is central to the invention's core concept of a single, movable optical unit. The infringement allegation hinges on mapping the accused "LED-based optical system" to this term (Compl. ¶20). Practitioners may focus on this term because its construction will determine whether the accused product’s integrated optical system falls within the scope of a claim that, based on the patent's abstract and specification, appears to emphasize modularity and interchangeability.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Claim 1 itself defines the module by its structural components (housing, light generator, detector) without an explicit requirement for detachability, which could support an argument that any integrated unit containing these components qualifies (col. 15:7-14).
- Evidence for a Narrower Interpretation: The abstract states, "The detection module is removable from the support structure to allow easy replacement." The specification also describes that the connectors for the module are "adapted to allow easy insertion and removal of detection module... to facilitate replacement" (col. 6:28-31). Further, separate dependent claim 8 explicitly adds the limitation that the module is "detachably attached to the shuttle" (col. 15:46-47), which could be used to argue the term in claim 1 should be read more broadly under the doctrine of claim differentiation, but could also inform the meaning of "module" as something inherently distinct and separable.
VI. Other Allegations
- Indirect Infringement: The complaint includes general language that Defendant has "aided, abetted, contributed, and/or participated" in infringement (Compl. ¶6), but does not plead a separate count for indirect infringement or provide specific factual allegations to support the elements of inducement or contributory infringement, such as instructing users in an infringing manner. The allegations focus on direct infringement by making and selling the apparatus.
- Willful Infringement: The complaint alleges a basis for willfulness by asserting that Defendant had pre-suit knowledge of the ’504 Patent and its infringement at least as early as March 2013 (Compl. ¶25). The allegations are supported by claims of subsequent licensing discussions where Defendant allegedly "acknowledge[ed] its need for a license" and its continued sales of the accused products despite these interactions (Compl. ¶¶25, 27). The complaint further cites a 2011 document produced by Defendant comparing an accused product to one of Plaintiff's products as evidence of awareness (Compl. ¶26).
VII. Analyst’s Conclusion: Key Questions for the Case
- Validity in Light of Foreign Proceedings: A primary issue will be the validity of the ’504 Patent. The complaint proactively raises the patent's survival of a European opposition that considered thirteen prior art references (Compl. ¶28). The key question for the court will be whether the asserted claims are valid over prior art that will be presented in the U.S. litigation, and what weight, if any, to give the outcome of the European proceeding.
- Definitional Scope of "Detection Module": A central claim construction question will be the required characteristics of a "detection module." While the infringement allegations map the accused product's structures to the claim elements, the case may turn on whether the accused "LED-based optical system" must possess the modularity and interchangeability emphasized in the patent's specification to meet the definition of a "detection module," or if merely containing the recited optical components is sufficient.
- Objective Recklessness for Willfulness: Given the detailed allegations of pre-suit notice, licensing negotiations, and continued sales by a direct competitor (Compl. ¶¶25-27), a critical question of fact will be whether Defendant's alleged infringement was objectively reckless. The resolution will depend on the strength of any non-infringement or invalidity defenses Defendant can articulate.