DCT
3:17-cv-01457
Fluidigm Corp v. Thermo Fisher Scientific Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Fluidigm Corporation (Delaware)
- Defendant: Thermo Fisher Scientific, Inc. (Delaware); Life Technologies Corporation (Delaware); Applied Biosystems, LLC (Delaware)
- Plaintiff’s Counsel: Bryan Cave LLP
- Case Identification: 3:17-cv-01457, N.D. Cal., 03/17/2017
- Venue Allegations: The complaint identifies Plaintiff's principal place of business as being in South San Francisco, California, which is located within the Northern District of California.
- Core Dispute: Plaintiff alleges that Defendants breached a patent cross-license agreement by failing to pay royalties on certain products that Plaintiff contends are "Instruments" covered by the agreement, which, absent the license, would infringe Plaintiff's patents.
- Technical Context: The dispute centers on instruments for real-time polymerase chain reaction (PCR) and other genomic analyses, which are foundational tools in the life sciences research and diagnostics markets.
- Key Procedural History: The central event is a "Patent Cross-License Agreement" executed between Plaintiff and Applied Biosystems on June 30, 2011. Plaintiff alleges that after a series of corporate acquisitions, Life Technologies, Thermo Fisher, and Affymetrix became "Affiliates" of Applied Biosystems under the agreement, and that sales of their instruments should have triggered royalty payments. The complaint notes that Plaintiff provided notice of an independent audit on December 16, 2016, to inspect records related to royalties due under the agreement.
Case Timeline
| Date | Event |
|---|---|
| 2004-06-07 | U.S. Patent No. 7,906,072 Priority Date |
| 2011-03-15 | U.S. Patent No. 7,906,072 Issued |
| 2011-06-30 | Plaintiff and Applied Biosystems enter Patent Cross-License Agreement |
| 2012-12-19 | Alleged failure to report and remit worldwide royalty payments begins |
| 2014-02-03 | Thermo Fisher acquires Life Technologies and Applied Biosystems |
| 2016-03-31 | Thermo Fisher acquires Affymetrix, Inc. |
| 2016-12-16 | Plaintiff provides notice of independent auditor's inspection |
| 2017-03-17 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
This report provides a full analysis for U.S. Patent No. 7,906,072, as it is the only patent for which the complaint provides a specific, exemplary infringement theory (Compl. ¶30). The complaint identifies nine other U.S. patents as being covered by the license agreement but provides no specific allegations for them (Compl. ¶29).
U.S. Patent No. 7,906,072 - Apparatus for Imaging a Microfluidic Device
- Patent Identification: U.S. Patent No. 7,906,072, “Apparatus for Imaging a Microfluidic Device,” issued March 15, 2011.
The Invention Explained
- Problem Addressed: The patent's prosecution history, which incorporates the specification of parent U.S. Patent No. 7,307,802, describes shortcomings with conventional imaging systems for microfluidic devices. These systems often operate in a "scanning mode" (raster scanning a laser) or a "stitching mode" (sequentially imaging small areas), which results in a low system frequency (area imaged per unit of time). This low frequency can be insufficient for assays requiring rapid, simultaneous data collection from all reaction sites, such as real-time PCR (’802 Patent, col. 2:8-34).
- The Patented Solution: The invention provides an apparatus that images a large area of, or the entire, microfluidic device at once, avoiding the need for scanning or stitching (’802 Patent, col. 8:5-14). The apparatus uses an optical system designed to simultaneously collect fluorescent signals from a plurality of processing sites (e.g., wells in a microfluidic plate) and direct them to a multi-pixel detector, allowing for high-throughput, real-time data acquisition from all sites (’072 Patent, Abstract).
- Technical Importance: This approach of simultaneous, full-field imaging enables the performance of high-frequency assays like real-time PCR across a large number of samples, which was a limitation of prior art scanning and stitching systems (’802 Patent, col. 2:31-34).
Key Claims at a Glance
- The complaint asserts that Defendants' product would, absent the license, infringe at least Claim 1 of the '072 Patent (Compl. ¶30).
- Independent Claim 1:
- An apparatus for imaging a fluidic device comprising a plurality of processing sites.
- An illumination system coupled to the fluidic device and adapted to illuminate the fluidic device with electromagnetic radiation.
- An imaging system coupled to the fluidic device and adapted to receive electromagnetic radiation emitted from the plurality of processing sites.
- A multi-pixel detector coupled to the imaging system for collection of emitted fluorescence, wherein a dimension of a detection area of the multi-pixel detector is less than a dimension of the fluidic device.
- A thermal controller coupled to the fluidic device.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The complaint identifies a number of products as "Instruments" that are allegedly covered by the license agreement, including the QuantStudio™, ViiA7™, StepOne™, GeneTitan™, and SOLiD™ systems (Compl. ¶29). The specific exemplary infringement theory focuses on the ViiA7™ Real-Time PCR Reader (Compl. ¶30).
Functionality and Market Context
- The complaint describes the ViiA7 instrument as an apparatus that monitors the amplification of targeted DNA molecules during PCR in real-time, allowing for accurate and sensitive data analysis (Compl. ¶30).
- It is alleged to be used for imaging a fluidic device with multiple processing sites, such as a 96- or 384-well plate or a microfluidic array card (Compl. ¶30). The complaint alleges that the products listed are configurable to read microfluidic chips or arrays and various non-microfluidic plates (Compl. ¶29).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The following table summarizes the exemplary infringement theory alleged in the complaint. The allegations are presented hypothetically, arguing that infringement would occur "absent the protections granted under the Agreement" (Compl. ¶30).
7,906,072 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an apparatus for imaging a fluidic device comprising a plurality of processing sites | The ViiA7 instrument is used for imaging a fluidic device, such as a 96- or 384-well plate or microfluidic array card, which comprises a plurality of processing sites. | ¶30 | col. 4:16-18 |
| an illumination system coupled to the fluidic device and adapted to illuminate the fluidic device with electromagnetic radiation | The ViiA7 comprises an illumination system coupled to the fluidic device (e.g., a well plate) and adapted to illuminate it with electromagnetic radiation in the form of fluorescence. | ¶30 | col. 4:21-25 |
| an imaging system coupled to the fluidic device and adapted to receive electromagnetic radiation emitted from the plurality of processing sites | The ViiA7 includes an imaging system, referred to as the OptiFlex™ System, that is coupled to the fluidic device and adapted to receive emitted electromagnetic radiation. | ¶30 | col. 4:26-29 |
| a multi-pixel detector coupled to the imaging system for collection of emitted fluorescence, wherein a dimension of a detection area of the multi-pixel detector is less than a dimension of the fluidic device | The ViiA7 comprises a multi-pixel detector coupled to the imaging system for collecting emitted fluorescence, with a detection area allegedly less than the device dimension. | ¶30 | col. 4:29-32 |
| a thermal controller coupled to the fluidic device | The ViiA7 includes a thermal controller coupled to the fluidic device, which is required for thermocycling. | ¶30 | col. 4:32-33 |
Identified Points of Contention
- The complaint's primary goal is to establish that the ViiA7 and similar products are "Instruments" covered by the license agreement. The exemplary infringement theory raises technical questions that may inform that contractual determination.
- Scope Questions: A central question for the contract dispute may be the definition of "fluidic device." The complaint alleges this term covers standard 96- or 384-well plates (Compl. ¶30). The scope of this term as used in the patent may be disputed to determine whether such conventional labware is covered by the licensed patent rights, which could in turn affect whether royalties are owed on instruments designed to read them.
- Technical Questions: The complaint alleges the ViiA7's detector has a "detection area less than the device dimension" (Compl. ¶30), which mirrors the claim language. The technical and evidentiary basis for this assertion, and how it relates to the patent's goal of simultaneous full-field imaging, may become a point of focus in determining if the ViiA7 practices the patented invention.
V. Key Claim Terms for Construction
The construction of the following terms from the '072 Patent may be relevant to the court's interpretation of what constitutes a royalty-bearing "Instrument" under the license agreement.
The Term: "fluidic device"
- Context and Importance: This term's scope is critical, as it defines the type of object the claimed apparatus is designed to image. Plaintiff's contractual argument appears to depend on this term being construed broadly enough to cover not only specialized microfluidic chips but also conventional multi-well plates (Compl. ¶30).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims do not appear to limit the "fluidic device" to a specific material (e.g., elastomeric) or manufacturing method (e.g., microfabrication). The patent discusses imaging "reaction chambers" and "processing sites," which could arguably be read to include the wells of a standard plate (’072 Patent, col. 4:16-18, col. 2:13-16).
- Evidence for a Narrower Interpretation: The patent is titled "Apparatus for Imaging a Microfluidic Device" and the background repeatedly refers to "microfluidic device," "microfluidic systems," and "micro-sized devices" (’802 Patent, col. 1:12-32). This context may suggest an interpretation limited to devices with micro-scale fluidic features, potentially excluding standard well plates.
The Term: "a thermal controller coupled to the fluidic device"
- Context and Importance: Practitioners may focus on this term because the complaint explicitly links it to the function of "thermocycling" (Compl. ¶30), a key feature of real-time PCR instruments. Whether the term inherently requires the complex temperature ramping capabilities of thermocycling, or could read on a simpler device that merely maintains a constant temperature, could be a point of analysis.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not specify the function of the "thermal controller" beyond being "coupled to the fluidic device" (’072 Patent, col. 4:32-33). The plain meaning could encompass any device that controls temperature.
- Evidence for a Narrower Interpretation: The specification of the parent '802 patent, in discussing the limitations of the prior art, specifically notes the challenge of performing "real-time PCR" (’802 Patent, col. 2:33-34). The detailed description illustrates a "Thermal Controller" (240) as an integral part of an exemplary PCR system, which may suggest the term should be construed in the context of enabling such temperature-cycling-dependent assays (’802 Patent, col. 23:45-67).
VI. Other Allegations
This section is not applicable as the complaint does not allege direct, indirect, or willful patent infringement as a cause of action for which relief is sought.
VII. Analyst’s Conclusion: Key Questions for the Case
The dispute is fundamentally a breach of contract case, with the patent analysis serving as a technical predicate for the contractual claims. The case will likely turn on the following open questions for the court:
- A core issue will be one of contractual scope: does the term "Instruments" as defined in the 2011 Patent Cross-License Agreement encompass products like the ViiA7 reader? The answer may depend on whether the technical operation of such products falls within the scope of the licensed patents, such as the asserted '072 Patent.
- A key technical question underlying the contract dispute will be one of definitional interpretation: can the patent term "fluidic device," which arises in the context of microfluidics, be construed to cover conventional 96- and 384-well plates as alleged by the Plaintiff? The court's interpretation of this and other technical terms will inform its ultimate decision on whether royalties were due.
- A central corporate law question will be whether Thermo Fisher and Affymetrix qualify as an "Affiliate" of Applied Biosystems under the specific definition provided in the license agreement, thereby making their product sales royalty-bearing.