DCT
1:17-cv-00469
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: Jones Day; Ashby & Geddes
- Case Identification: 1:17-cv-00469, D. Del., 04/25/2017
- Venue Allegations: Venue is asserted on the basis that Defendant is a Delaware corporation, is registered to conduct business in Delaware, and transacts business in the judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s polymerase chain reaction (PCR) systems, which feature multi-zone temperature control blocks, infringe a patent related to localized temperature control for spatial arrays of reaction media.
- Technical Context: The technology concerns thermal cyclers used for PCR, a foundational technique in molecular biology for amplifying DNA, with applications in research and clinical diagnostics.
- Key Procedural History: The complaint notes that Defendant became the owner of certain accused products, such as the Veriti™ thermal cycler, upon its 2014 acquisition of Life Technologies Corporation.
Case Timeline
| Date | Event |
|---|---|
| 2003-05-23 | ’414 Patent Priority Date |
| 2010 | Copyright date for Veriti™ Guide |
| 2015 | Copyright date for QuantStudio™ Guide |
| 2016 | Copyright date for ProFlex™ Guide and StepOnePlus™ Brochure |
| 2017-04-18 | ’414 Patent Issue Date |
| 2017-04-25 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,623,414 - "Localized Temperature Control for Spatial Arrays of Reaction Media"
- Issued: April 18, 2017
The Invention Explained
- Problem Addressed: The patent's background describes a limitation in conventional PCR instruments where a single multi-well plate is placed on a metal block that maintains a uniform temperature across all wells. This prevents researchers from running multiple experiments concurrently on a single plate if those experiments require different temperature cycling protocols. (’414 Patent, col. 1:40-54).
- The Patented Solution: The invention is an apparatus that divides a multi-well reaction plate into discrete thermal regions. This is achieved by using a plurality of "sample blocks," each corresponding to a region of the plate. Each sample block is coupled to its own independently controlled thermoelectric module (e.g., a Peltier device), allowing different regions to be heated or cooled to different temperatures simultaneously. Thermal barriers are positioned between adjacent blocks to minimize thermal interference. (’414 Patent, Abstract; col. 2:9-26; Fig. 1).
- Technical Importance: This approach allows for greater flexibility and efficiency in PCR, enabling researchers to optimize reaction conditions or run comparative experiments on a single microplate in one instrument run. (’414 Patent, col. 2:16-18).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 6 and 7. (Compl. ¶13).
- Independent Claim 1 recites an apparatus comprising:
- A plurality of thermally conductive sample blocks for PCR, arranged in a fixed horizontal array, with each block having a plurality of sample wells.
- A plurality of independently controlled thermoelectric modules, with a module positioned underneath each sample block to cycle its temperature.
- A layer of thermally conductive material between each sample block and its corresponding thermoelectric module.
- A solid barrier of thermally insulating material positioned between each pair of adjacent sample blocks.
- The complaint does not explicitly reserve the right to assert other claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the "TFS PCR Systems," which include the QuantStudio™ 3 and 5, ProFlex™, Veriti®, and StepOnePlus™ systems. (Compl. ¶11).
Functionality and Market Context
- The complaint alleges that each of the accused systems incorporates "VeriFlex™ blocks." (Compl. ¶19). This technology is described as enabling precise temperature control through segmented blocks. (Compl. ¶¶ 20-21). For example, the complaint references a brochure showing a 96-well VeriFlex™ block with "six independently controllable peltier blocks." (Compl. ¶20). This configuration allows a user to set different temperatures in different zones of the same thermal block, a key feature for applications like PCR optimization.
- The complaint presents a technical diagram from a Thermo Fisher document depicting the "VeriFlex technology construction," which shows three metal blocks positioned over three heating/cooling elements. (Compl. ¶20). The complaint alleges these systems are commercially significant products sold by Defendant for life science research. (Compl. ¶11).
IV. Analysis of Infringement Allegations
’414 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a plurality of thermally conductive sample blocks for polymerase chain reactions, arranged in a fixed horizontal array, wherein each sample block comprises a plurality of sample wells and is configured to retain a plurality of samples | The accused "VeriFlex™ blocks" are alleged to be "segmented metal blocks" or "independently controllable peltier blocks" that contain wells for holding samples and are arranged in a horizontal array. A product image shows a 96-well block with six distinct segments. (Compl. ¶20). | ¶20 | col. 5:31-38 |
| a plurality of independently controlled thermoelectric modules ... a thermoelectric module positioned underneath each said sample block, wherein the thermoelectric modules are configured to cycle the temperatures of the sample blocks for polymerase chain reactions | The accused systems are alleged to use "3 or more separate heating/cooling elements below each of the 3 or more segmented metal blocks," which are alleged to be the claimed thermoelectric modules. (Compl. ¶21). The complaint points to Defendant's documentation describing these as "independently controllable peltier blocks." (Compl. ¶20). | ¶¶20-21 | col. 5:42-44 |
| a layer of thermally conductive material between each sample block and each thermoelectric module | The complaint points to a photograph of a disassembled VeriFlex™ block from a Veriti® thermal cycler, which it alleges shows a "white substance" between the metal block and the heating/cooling element that is, upon information and belief, a thermally conductive material. (Compl. ¶22). | ¶22 | col. 4:1-6 |
| a solid barrier of thermally insulating material positioned between each pair of adjacent sample blocks to thermally isolate the sample blocks of the pair from each other | The complaint cites a Defendant application note stating that each "block is physically isolated using heat insulator material to minimize temperature interference among adjacent [] blocks." (Compl. ¶23). A photograph of the device appears to show this isolation. (Compl. ¶23). | ¶23 | col. 5:53-57 |
Identified Points of Contention
- Scope Questions: A central question may be the definition of "sample blocks". The patent specification discusses an alternative embodiment where thermal domains are "delineated by slits" in a "single block" (’414 Patent, col. 5:58-62), whereas Claim 1 recites a "plurality of... sample blocks." The court may need to determine if the "segmented metal blocks" (Compl. ¶21) of the accused devices, which may be part of a single larger assembly, meet the "plurality of... blocks" limitation, or if they must be entirely separate physical components.
- Technical Questions: The complaint's allegation for the "thermally conductive material" layer relies on "information and belief" based on a photograph of a "white substance." (Compl. ¶22). A technical question will be what that material is and whether its properties meet the claim limitation. Similarly, the evidence for a "solid barrier" relies on a statement about "heat insulator material" (Compl. ¶23); the physical nature and properties of this material will be subject to discovery and factual dispute.
V. Key Claim Terms for Construction
The Term: "sample blocks"
- Context and Importance: This term is foundational to the claim, as the invention is premised on having multiple, independently controlled blocks. The infringement analysis depends on whether the accused "segmented" blocks (Compl. ¶21) constitute a "plurality of... sample blocks" as required by the claim. Practitioners may focus on this term because its construction could determine whether a device with a single, internally-divided thermal block infringes.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses an "alternative to the use of individual sample blocks" as "a single block in which individual thermal domains are delineated by slits." (’414 Patent, col. 5:58-62). A party could argue this suggests the inventors considered "blocks" to encompass functionally separate regions within a monolithic structure.
- Evidence for a Narrower Interpretation: Figure 1 depicts the sample blocks (102) as physically distinct components separated by an air gap (104). The claim's use of "plurality of... sample blocks" in conjunction with a "barrier... positioned between each pair of adjacent sample blocks" may support an interpretation requiring physically separate and distinct units.
The Term: "solid barrier of thermally insulating material"
- Context and Importance: This limitation defines how thermal isolation between blocks is achieved. The accused products allegedly use "heat insulator material" to "physically isolate" the blocks. (Compl. ¶23). The dispute will turn on whether that material constitutes a "solid barrier."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's overall goal is thermal isolation. A party might argue that any non-gaseous material that achieves this function and is placed between the blocks meets the spirit of the invention, even if it is not a rigid, free-standing wall.
- Evidence for a Narrower Interpretation: The plain meaning of "solid barrier" suggests a non-fluid, non-gaseous structure. The specification explicitly distinguishes this from an "air gap" (’414 Patent, col. 5:39-40), which is described as an alternative. The use of "solid" in the claim, when the specification also discloses a non-solid (gaseous) alternative, suggests the patentee deliberately chose a narrower term for this specific claim. The specification also gives examples of "foamed plastics" as "thermally insulating solid materials." (’414 Patent, col. 4:64-65).
VI. Other Allegations
Indirect Infringement
- The complaint alleges Defendant has "committed, or aided, abetted, contributed, and/or participated in the commission of tortious acts of patent infringement." (Compl. ¶6). The basis for this appears to be the sale of the accused PCR systems along with user guides, brochures, and application notes that describe the infringing features and, by extension, instruct users on how to use them. (Compl. ¶¶ 15-19).
Willful Infringement
- The complaint does not contain a specific count for willful infringement or explicitly allege pre-suit knowledge. However, in the prayer for relief, Plaintiff requests that the court "declare this to be an exceptional case under 35 U.S.C. § 285" and award attorney fees. (Compl. ¶27(d), (e)). Such a request is typically predicated on allegations of willful infringement or other litigation misconduct.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "plurality of... sample blocks," which is depicted in patent figures as physically discrete components, be construed to read on the "segmented metal blocks" of the accused devices, which may be sections of a single, larger component? The patent's own disclosure of a "single block" with "slits" as an alternative may be central to this inquiry.
- A second key issue will be one of claim limitation: does the "heat insulator material" allegedly used in the accused systems meet the specific claim requirement of a "solid barrier"? The outcome may depend on whether the court adopts the plain meaning of "solid" or a broader functional definition, a question influenced by the specification's separate discussion of non-solid "air gaps" for achieving the same isolating purpose.
- An evidentiary question will be one of proof: can Plaintiff demonstrate, beyond its "information and belief" pleading, that the "white substance" photographed in the accused device is in fact a "thermally conductive material" as required by the third element of Claim 1?