v.
`
`
`
`Defendants.
`
`
`
`
`BIOFIRE DIAGNOSTICS, LLC and
`BIOMERIEUX S.A.,
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`
`
`
`
`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 1 of 63 PageID #: 1
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`LABRADOR DIAGNOSTICS LLC,
`
`
`Plaintiff,
`
`C.A. No. ______________________
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`LABRADOR DIAGNOSTICS LLC'S COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Labrador Diagnostics LLC ("Labrador"), by and through its undersigned counsel,
`
`pleads the following against BioFire Diagnostics, LLC ("BioFire") and bioMerieux S.A.
`
`("bioMerieux") (collectively, "Defendants") and alleges as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Labrador is a Delaware limited liability company duly organized and
`
`existing under the laws of the State of Delaware.
`
`2.
`
`On information and belief, Defendant BioFire is a corporation duly organized and
`
`existing under the laws of the State of Delaware. On information and belief, Defendant BioFire is
`
`a wholly owned subsidiary of Defendant bioMerieux S.A.
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 2 of 63 PageID #: 2
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`3.
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`On information and belief, Defendant bioMerieux S.A. is a foreign corporation,
`
`formed under the laws of France.
`
`JURISDICTION AND VENUE
`
`4.
`
`This is an action arising under the patent laws of the United States, 35 U.S.C. § 1
`
`et seq. Accordingly, this Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
`
`1338(a).
`
`5.
`
`This Court has personal jurisdiction over Defendant BioFire because on
`
`information and belief BioFire manufactures infringing products that are and have been used,
`
`offered for sale, sold, and/or purchased in the District of Delaware, and BioFire has committed,
`
`and continues to commit, acts of infringement in the District of Delaware, has conducted business
`
`in the District of Delaware, and/or has engaged in continuous and systematic activities in the
`
`District of Delaware. For example, upon information and belief, Defendant BioFire makes, uses,
`
`offers for sale, sells, and induces and contributes to the infringement of its products known as the
`
`BioFire FilmArray System, BioFire FilmArray 2.0, BioFire FilmArray EZ, BioFire FilmArray
`
`Torch, BioFire FilmArray pouches and/or panels ("pouches"), and BioFire FilmArray software
`
`running on computers (individually and in combination the "Accused Products") in this District.
`
`Further, Defendant BioFire has submitted itself to the jurisdiction of this Court by electing to
`
`incorporate in the State.
`
`6.
`
`This Court has personal jurisdiction over Defendant bioMerieux because on
`
`information and belief bioMerieux directly or indirectly through control of its subsidiary BioFire
`
`manufactures infringing products that are and have been used, offered for sale, sold, and purchased
`
`in the District of Delaware, and bioMerieux has directly or indirectly through control of its
`
`subsidiary BioFire committed, and continues to commit, acts of infringement in the District of
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 3 of 63 PageID #: 3
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`Delaware, has directly or indirectly through control of its subsidiary BioFire conducted business
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`in the District of Delaware, and/or has engaged in continuous and systematic activities in the
`
`District of Delaware.
`
`7.
`
`For example, upon information and belief, Defendant bioMerieux through its
`
`subsidiary Defendant BioFire submitted FilmArray pouches, to be used in conjunction with the
`
`FilmArray 2.0, FilmArray EZ, and/or FilmArray Torch as part of the FilmArray System in an
`
`infringing manner, to the FDA for FDA clearance. See, e.g., bioMerieux Website, "bioMerieux
`
`submits for FDA Clearance of the BIOFIRE® FILMARRAY® Pneumonia Panel," April 19, 2018,
`
`https://www.biomerieux.com/en/biomerieux-submits-fda-clearance-biofirer-filmarrayr-
`
`pneumonia-panel; bioMerieux Website, "bioMerieux submits enhanced BIOFIRE® BCID2 Panel
`
`for FDA clearance," January 13, 2020, https://www.biomerieux.com/en/biomerieux-submits-
`
`enhanced-biofirer-bcid2-panel-fda-clearance.
`
`8.
`
`As an additional example, upon information and belief, Defendant bioMerieux
`
`advertises use of the Accused Products on its website and in its literature for use in the United
`
`States in an infringing manner for example, by advertising its FDA status, (see, e.g., id.;
`
`bioMerieux
`
`2018
`
`Annual
`
`Report
`
`at,
`
`e.g.,
`
`16,
`
`available
`
`https://www.biomerieux.com/sites/corporate/files/biomerieux_annual_report_2018.pdf),
`
`at
`
`and
`
`providing contact information for the purchase of the Accused Products.
`
`9.
`
`As a further example, upon information and belief, Defendant bioMerieux has
`
`pervasive control over the activities of its subsidiary Defendant BioFire. As one illustration,
`
`Defendant bioMerieux directs and controls the infringing activities of its subsidiary Defendant
`
`BioFire as shown, for example, by its referral to the Accused Products as "our [bioMerieux's]
`
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 4 of 63 PageID #: 4
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`
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`BIOFIRE® product line" as "a clear growth driver that has propelled bioMerieux to the position of
`
`market leader." Id. at 2.
`
`10.
`
`As a yet further example of bioMerieux's pervasive control over the activities of its
`
`subsidiary Defendant BioFire, upon information and belief, Defendant bioMerieux directs and
`
`controls the infringing activities of its subsidiary Defendant BioFire by its direct control of BioFire
`
`senior management. In particular, Randy Rasmussen is both the "CEO of BioFire Diagnostics and
`
`Executive VP Molecular Biology of bioMerieux." See, e.g., bioMerieux Website,
`
`https://www.biomerieux-diagnostics.com/biomerieux-submits-enhanced-biofirer-bcid2-panel-
`
`fda-clearance. On an affiliated US website, bioMerieux lists Mr. Rasmussen among its "Corporate
`
`Governance" leaders, noting that "The Management Committee is responsible for putting
`
`bioMerieux's strategy into effect: overseeing strategic projects, deciding on priorities and
`
`implementing the necessary resources within the Company's various divisions." bioMerieux USA
`
`Website, "About bioMerieux: Corporate Governance," https://www.biomerieux-usa.com/about-
`
`us/corporate-governance. The "Corporate Governance" group of bioMerieux also lists Kirk Ririe
`
`as "Corporate VP, Chief Innovative Officer." Id. On information and belief, Mr. Ririe is also a co-
`
`founder of BioFire and identifies as the "CEO" at BioFire Diagnostics. See LinkedIn, Kirk Ririe,
`
`https://www.linkedin.com/in/kirk-ririe-81692bb.
`
`11.
`
`Defendant bioMerieux has additionally availed itself of the privileges of this Court.
`
`For example, bioMerieux has sought to enforce patent rights against an alleged infringer in this
`
`District. See bioMerieux, S.A. v. Hologic Inc., Case No. 1:18-cv-00021-LPS. The trial was
`
`completed only days ago, on February 25, 2020, and is currently undergoing post-trial motions.
`
`12.
`
`Under 28 U.S.C. §§ 1391(b)-(d) and 1400(b), venue is proper in this judicial district
`
`as to Defendant BioFire because at least BioFire resides within this District, as it is incorporated
`
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 5 of 63 PageID #: 5
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`in the State of Delaware. Further, on information and belief, venue is additionally proper because
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`Defendant BioFire has committed acts of infringement within this judicial district giving rise to
`
`this action.
`
`13.
`
`Further, under 28 U.S.C. §§ 1391(b)-(d), venue is proper in this judicial district as
`
`to Defendant bioMerieux because bioMerieux is a foreign corporation and, as described above, is
`
`subject to this Court's jurisdiction.
`
`FIRST CLAIM
`
`(Infringement of U.S. Patent No. 8,283,155)
`
`14.
`
`Labrador re-alleges and incorporates herein by reference Paragraphs 1-13 of its
`
`Complaint.
`
`15.
`
`The '155 Patent, entitled "Point-of-Care Fluidic Systems and Uses Thereof," was
`
`duly and lawfully issued on October 9, 2012. A true and correct copy of the '155 Patent is attached
`
`hereto as Exhibit 1.
`
`16.
`
`The '155 Patent has been in full force and effect since its issuance. Labrador owns
`
`by assignment the entire right, title, and interest in and to the '155 Patent, including the right to
`
`seek damages for past, current, and future infringement thereof.
`
`17.
`
`The '155 Patent relates generally to "the field of medical devices," including
`
`"portable medical devices that allow real-time detection of analytes from a biological fluid." Ex. 1
`
`at Abstract.
`
`18.
`
`Labrador is informed and believes, and on that basis alleges, that Defendants
`
`individually and collectively1 have infringed and, unless enjoined will continue to infringe, one or
`
`
`1 All reference to Defendants or Defendants' products refer to the Defendants individually
`and collectively and to products over which the Defendants individually and collectively control.
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 6 of 63 PageID #: 6
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`
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`more claims of the '155 Patent, in violation of 35 U.S.C. § 271, by, among other things, making,
`
`using, offering to sell, and selling within the United States, and/or supplying or causing to be
`
`supplied in or from the United States, without authority or license, the Accused Products for use
`
`in an infringing manner.
`
`19.
`
`The Accused Products embody at least claim 1 of the '155 Patent, literally or under
`
`the doctrine of equivalents, as set forth below. The further descriptions below, which are based on
`
`publicly available information, are preliminary examples and are non-limiting. On information and
`
`belief, the FilmArray 2.0, FilmArray EZ, and FilmArray Torch devices operate, together with the
`
`FilmArray pouches and software, similarly as pertinent to the non-limiting examples set forth
`
`below. On information and belief, the FilmArray EZ operates in substantially the same manner as
`
`the FilmArray 2.0, and as such is not separately addressed below. For the purposes of infringement,
`
`Plaintiff Labrador's non-limiting examples relating to the FilmArray 2.0 are equally applicable to
`
`the FilmArray EZ, albeit with use of at least the RP EZ Panel designed for use with the FilmArray
`
`EZ. See BioFire Diagnostics Website, https://www.biofiredx.com/products/the-filmarray-
`
`panels/filmarray-respiratory-panel-ez/.
`
`"1. A two-way communication system for detecting an analyte in a bodily fluid from
`a subject, comprising:"
`
`20.
`
`Defendants' FilmArray 2.0 and Torch systems are each two-way communication
`
`systems for detecting an analyte in a bodily fluid from a subject.
`
`21.
`
`Defendants' FilmArray 2.0 Instrument connected to a computer running FilmArray
`
`software, together with FilmArray pouches, is a system. This system is referred to herein as the
`
`"FilmArray 2.0 System."
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 7 of 63 PageID #: 7
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`22.
`
`The FilmArray 2.0 System is a two-way communication system. See, e.g.,
`
`FilmArray 2.0 Operator's Manual at 1:
`
`
`
`23.
`
`Defendant's FilmArray Torch Module connected to a FilmArray Torch System
`
`Base, together with FilmArray pouches, is a system. This system is referred to herein as the
`
`"FilmArray Torch System."
`
`24.
`
`The FilmArray Torch System is a two-way communication system. See, e.g.,
`
`FilmArray Torch Operators' Manual at 1:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 8 of 63 PageID #: 8
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`25.
`
`The FilmArray 2.0 System is designed to detect an analyte in a bodily fluid from a
`
`subject. See, e.g., BioFire Diagnostics Website, https://www.biofiredx.com/:
`
`26.
`
`Similarly, the FilmArray Torch System is designed to detect an analyte in a bodily
`
`fluid from a subject. See, e.g., BioFire Diagnostics Website, https://www.biofiredx.com/:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 9 of 63 PageID #: 9
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`
`
`See also, e.g., FilmArray Torch Operators' Manual at 1:
`
`
`
`"a) a reader assembly comprising a programmable processor that is operably linked
`to a communication assembly;"
`
`27.
`
`Defendants' FilmArray 2.0 and Torch systems each include a reader assembly
`
`comprising a programmable processor that is operably linked to a communication assembly.
`
`28.
`
`For example, Defendants' FilmArray 2.0 System includes one or more FilmArray
`
`2.0 Instruments. See, e.g., FilmArray 2.0 Operator's Manual at 1:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 10 of 63 PageID #: 10
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`29.
`
`Defendants' FilmArray Torch System includes one or more FilmArray Torch
`
`Modules. See, e.g., FilmArray Torch Operator's Manual at 1:
`
`
`
`30.
`
`Defendant's FilmArray 2.0 Instrument(s) include(s) a programmable processor
`
`connected to one or more Ethernet interfaces. See, e.g., FilmArray 2.0 Operator's Manual at 24:
`
`
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`Id. at 9:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 11 of 63 PageID #: 11
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`31.
`
`The Ethernet interface to which a programmable processor of the FilmArray 2.0
`
`Instrument connects is a communication assembly.
`
`32.
`
`Defendant's FilmArray Torch Module(s) include(s) a programmable processor
`
`connected to one or more Ethernet interfaces. See, e.g., FilmArray Torch Operator's Manual at 10:
`
`
`
`33.
`
`The Ethernet interface to which a programmable processor of the FilmArray Torch
`
`Module connects is a communication assembly.
`
`"b) an external device configured to transmit a protocol to the communication
`assembly;"
`
`34.
`
`Defendants' FilmArray 2.0 and Torch systems each include an external device
`
`configured to transmit a protocol to the communication assembly of a reader assembly.
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 12 of 63 PageID #: 12
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`35.
`
`For example, the FilmArray 2.0 System includes a computer external to FilmArray
`
`2.0
`
`Instruments.
`
`See,
`
`e.g.,
`
`BioFire
`
`Diagnostics
`
`Website,
`
`https://www.biofiredx.com/products/filmarray/:
`
`See also, e.g., FilmArray 2.0 Operator's Manual at 24:
`
`
`
`36.
`
`The FilmArray Torch System includes a FilmArray Torch System Base that is
`
`external to FilmArray Torch modules. See, e.g., FilmArray Torch Operators' Manual at 1:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 13 of 63 PageID #: 13
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`37.
`
`The external computer in a FilmArray 2.0 System is configured to transmit a
`
`protocol to an Ethernet interface of a FilmArray 2.0 Instrument. See, e.g., FilmArray 2.0 Operator's
`
`Manual at 24:
`
`Id. at 3-4:
`
`Id. at 9:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 14 of 63 PageID #: 14
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`38.
`
`The FilmArray Torch System Base is configured to transmit a protocol to an
`
`Ethernet interface of a FilmArray Torch Module. See, e.g., FilmArray Torch Operator's Manual at
`
`10:
`
`Id. at 27:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 15 of 63 PageID #: 15
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`"c) a test device configured to be inserted into the reader assembly, said test device
`comprising:"
`
`39.
`
`Defendants' FilmArray 2.0 and Torch systems each include a test device configured
`
`to be inserted into a reader assembly of the system.
`
`40.
`
`The FilmArray 2.0 system is used in combination with FilmArray test device
`
`pouches. See, e.g., FilmArray 2.0 Operator's Manual at 1:
`
`41.
`
`The FilmArray Torch system is used in combination with FilmArray test device
`
`pouches. See, e.g., FilmArray Torch Operator's Manual at 1:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 16 of 63 PageID #: 16
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`42.
`
`As a further example, each FilmArray pouch is configured to be inserted into a
`
`FilmArray 2.0 Instrument. See, e.g., FilmArray 2.0 Operator's Manual at 18:
`
`43.
`
`Each FilmArray pouch is configured to be inserted into a FilmArray Torch Module.
`
`See, e.g., FilmArray Torch Operator's Manual at 25-26:
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`
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`. . .
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 17 of 63 PageID #: 17
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`"i) a sample collection unit configured for collecting a sample of bodily fluid
`suspected to contain an analyte;"
`
`44.
`
`Each of Defendants' FilmArray pouches includes a sample collection unit
`
`configured for collecting a sample of bodily fluid suspected to contain an analyte.
`
`45.
`
`For example, each FilmArray pouch includes a sample injection port into which the
`
`FilmArray operators are instructed to insert a sample mixture for testing such that the sample is
`
`collected within the pouch. See, e.g., FilmArray RP2 Reagent Quick Guide:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 18 of 63 PageID #: 18
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`
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`See also FilmArray Pneumonia Panel Instructions for Use at 8:
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`
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`"ii) an assay assembly containing reactants that react with said sample of bodily
`fluid based on the protocol transmitted from said external device to yield a
`detectable signal indicative of the presence and/or concentration of said analyte;
`and"
`
`46.
`
`Each of Defendants' FilmArray pouches includes an assay assembly containing
`
`reactants that react with a sample of bodily fluid based on the protocol transmitted from an external
`
`device to yield a detectable signal indicative of the presence and/or concentration of said analyte.
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 19 of 63 PageID #: 19
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`47.
`
`For example, each FilmArray pouch contains polymerase chain reaction (PCR)
`
`reactants configured to react with a bodily fluid sample injected into the FilmArray pouches. See,
`
`e.g., FilmArray 2.0 Operator's Manual at 3:
`
`See also, e.g., FilmArray Torch Operator's Manual at 3 (same).
`
`48.
`
`The reactants in a FilmArray pouch are configured to react with a sample of bodily
`
`fluids based on the protocol transmitted from an external computer in a FilmArray 2.0 System or
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 20 of 63 PageID #: 20
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`
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`the FilmArray Torch System Base in a FilmArray Torch System, respectively, when each
`
`FilmArray System is used. See, e.g., FilmArray 2.0 Operator's Manual at 1:
`
`Id. at 24:
`
`Id. at 3-4:
`
`See also, e.g., FilmArray Torch Operator's Manual at 1:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 21 of 63 PageID #: 21
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`
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`Id. at 27:
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`49.
`
`The reactants in FilmArray pouches are configured to react with a sample of bodily
`
`fluid to yield a fluorescent signal indicative of the presence and/or concentration of a nucleic acid
`
`analyte. See, e.g., FilmArray 2.0 Operator's Manual at 1:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 22 of 63 PageID #: 22
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`
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`Id. at 4:
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`See also, e.g., FilmArray Torch Operator's Manual at 1:
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`Id. at 5:
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`
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`50.
`
`The reactants in a BioFire FilmArray Pneumonia Panel, for example, react with a
`
`sample of bodily fluids to yield a detectable signal indicative of the presence and/or concentration
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 23 of 63 PageID #: 23
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`
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`of various viruses and bacteria. See, e.g., FilmArray Pneumonia Panel Instructions for Use at 18-
`
`19:
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`. . .
`
`
`
`
`
`"iii) an identifier that is configured to provide the identity of said test device and is
`also configured to trigger the transmission of said protocol that is selected based on
`said identifier;"
`
`51.
`
`Defendants' FilmArray pouches each include an identifier that is configured to
`
`provide the identity of said test device and is also configured to trigger the transmission of said
`
`protocol that is selected based on said identifier.
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 24 of 63 PageID #: 24
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`52.
`
`For example, the FilmArray pouches include one or more identifiers, including
`
`barcode and human readable identifiers, that provide the identity of each pouch to the FilmArray
`
`2.0 external computer and the FilmArray Torch System Base, respectively, based on the FilmArray
`
`System being used. See, e.g., FilmArray 2.0 Operator's Manual at 3:
`
`See also, e.g., FilmArray Torch Operator's Manual at 3 (same).
`
`See also, e.g., FilmArray 2.0 Operator's Manual at 16:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 25 of 63 PageID #: 25
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`
`
`See also, e.g., FilmArray Torch Operator's Manual at 24 (same); see also FilmArray 2.0
`
`Operator's Manual at 19:
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`See also, e.g., FilmArray Torch Operator's Manual at 27:
`
`Id. at 56:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 26 of 63 PageID #: 26
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`53.
`
`Such barcode or other identifier on the FilmArray pouches are also configured to
`
`trigger the transmission of a protocol that is selected based on the barcode or other identifier. See,
`
`e.g., FilmArray 2.0 Operator's Manual at 19-20:
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`. . .
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 27 of 63 PageID #: 27
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`
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`See also, e.g., FilmArray Torch Operator's Manual at 39:
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`Id. at 53:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 28 of 63 PageID #: 28
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`
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`"wherein the programmable processor of the reader assembly is configured to
`receive said protocol from said external device, wherein said protocol in turn effects
`(1) a reaction in said assay assembly for generating said signal, and (2) selection of a
`detection method for detecting said signal, and wherein said reader further
`comprises a detection assembly for detecting said signal which is transmitted via
`said communication assembly to said external device."
`
`54.
`
`The programmable processors in the reader assemblies of Defendants' FilmArray
`
`2.0 and Torch systems are configured to receive a protocol from an external device, wherein the
`
`protocol in turn effects (1) a reaction in a FilmArray pouch assay assembly for generating a signal,
`
`and (2) selection of a detection method for detecting the signal, and wherein the reader further
`
`comprises a detection assembly for detecting said signal which is transmitted via said
`
`communication assembly to said external device.
`
`55.
`
`As an example, the programmable processor of the FilmArray 2.0 Instrument
`
`receives a protocol from the FilmArray 2.0 external computer. See, e.g., FilmArray 2.0 Operator's
`
`Manual at 20:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 29 of 63 PageID #: 29
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`56.
`
`As a further example, the programmable processor of the FilmArray Torch Module
`
`receives a protocol from the FilmArray Torch System Base. See, e.g., FilmArray Torch Operator's
`
`Manual at 39:
`
`Id. at 53:
`
`
`
`
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`57.
`
`Additionally, each protocol effects a reaction in the assay assembly of the
`
`FilmArray pouch inserted in the FilmArray 2.0 Instrument or FilmArray Torch Module, for
`
`generating a signal and effects the selection of a detection method. See, e.g., FilmArray 2.0
`
`Operator's Manual at 4:
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`Id. at 24:
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 30 of 63 PageID #: 30
`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 30 of 63 PagelD #: 30
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`
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`Id. at 25:
`Id. at 25:
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`PouchManagement
`
`The Pouch Management feature enables the operator to see which FilmArray pouch modules are
`cunently installed and available for use. This feature also enables the operator to install new pouch
`modules. These pouch modules contain definitions, instrument protocols, analysis and reporting for
`specific HImArray reagent kits.
`
`fl
`
`Pouch
`
`Available pnudlu
`Pouch "HIE
`
`Attire
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`Instai New Puldr
`“leis-Hallie. mm
`
`Respiratuy Panel 1:13
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`A
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`zone
`
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`I)- :l I:
`: l
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`Id. at 3-4:
`Id. at 3-4:
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`
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`lnstnrment and Pouch Interaction
`
`fitter the rut is started, a series of phngers, pneumatic actuators, and hard seas wort: togetherto
`more and mix liquid reagents between the blisters of the pouch. The FimAnay instrument controls
`
`these functions artematicdly based on the run protocol selected for a specific pouch and sample
`type in the Fimrlu'ray software.
`
`Id. at 4:
`Id. at 4:
`
`Optics and Imaging
`To identify targets from positive PCR reactions, DNA melting curve analysis is performed. The
`fluorescence emitted by the LCGreen® Plus dye is imaged by a camera. DNA melting curves are
`captured by slowly increasing the temperature of the PCR array and capturing the fluorescent signal.
`These images are processed automatically by the computer, and the data is analyzed to determine if
`the control reactions passed and which targets were detected in the sample.
`
`The optics system contained in the FilmArray instrument is aligned, focused, and calibrated at the
`factory. Proper operation and calibration of instrument optics is monitored by the instrument self tests
`and pouch control reactions.
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 31 of 63 PageID #: 31
`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 31 of 63 PagelD #: 31
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`
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`Id. at 14:
`Id. at 14:
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`FilmArray System Specifications
`
`Sample Description
`- One sample capacity per instrument
`
`Run Time
`- Sample run time about one hour
`
`User Interface
`- Computer and (optional) barcode reader
`
`Data Output
`- Automatic analysis with end—of—run interpretive reports
`Fluorescence Acquisition
`Single color optics module: 47'5nm excitation, 545nm emis-
`sion, and sensor imaging
`
`
`
`See also, e.g., FilmArray Torch Operator's Manual at 4:
`See also, e. g., FilmArray Torch Operator's Manual at 4:
`
`FilmArray Pouch Modules
`Each Fimhrray reagent pouch requires a pouch specific sottware caled a pouch moduleto be
`'nstaled on the Frlmnnay Torch in orderto perform a test “time pouch modrles corrta'n definitions,
`protocols, anaysis and report'ng for specific Flhthnay reagent ltits. See the Pooch Homilies section
`it Chapter E for more irformation.
`
`Id. at 40:
`Id. at 40:
`
`Pouchllllodules
`
`This feature enables the operator to hate", and inactivateluninstall pouch modules. These pouch
`modules oontain definitions, protocols, analysis and reporting for specific Filmhrray reagent lrits.
`
`Id. at 5:
`Id. at 5:
`
`FilmArray Torch Module and Pouch Interaction
`Afterthe run is started, a series of plmgers, pneumatic actuators, and had seals work together
`to moire and "Tilt. iquid reagents between the blisters of the pouch. The FimAnay Torch Module
`controls these firnctions automaticth based on the pouch modrle rm protocol selected for a
`specific pouch and sample type in the FimArray Torch softirrae.
`
`. . .
`
`Optics and Imaging
`To identify targets from positive PCR reactions, DNA melting curve analysis is performed. The
`fluorescence emitted by the LCGreen' PMs dye is 'maged by a camera. DNA melt'ng ctr-es are|
`captued by slowly increasing the temperature of the FER array and capurfing the fluorescent
`signal. These images are processed automaticaty by the System Base, and the data is analyzed to
`determ'ne if the control reactions passed and which targets were detected in the sample.
`
`The optics system contained 'n the Fimfirray Torch Module is aligned, focused, and calibrated at
`the factory. Proper operation and caibration of Flhvltnay Torch Module optics is monitored by the
`film Torch Marine self—tests aid i'rternal pouch controls.
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 32 of 63 PageID #: 32
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`
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`Id. at 22:
`
`58.
`
`A FilmArray 2.0 Instrument includes a detection assembly for detecting a signal,
`
`which is transmitted through one or more Ethernet interfaces to the FilmArray 2.0 external
`
`computer. See, e.g., FilmArray 2.0 Operator's Manual at 4:
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`
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`Id. at 4:
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`Id. at 14:
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`- 32 -
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 33 of 63 PageID #: 33
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`59.
`
`A FilmArray Torch Module includes a detection assembly for detecting a signal,
`
`which is transmitted through one or more Ethernet interfaces to the FilmArray Torch System Base.
`
`See, e.g., FilmArray Torch Operator's Manual at 5:
`
`Id. at 5:
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`Id. at 22:
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`* * *
`
`60.
`
`Defendants have had knowledge of the '155 Patent and their infringement of the
`
`'155 Patent at least since shortly after June 5, 2018 when bioMerieux, Inc., a US subsidiary of
`
`Defendant bioMerieux S.A., entered into an agreement with the former owner of the '155 Patent
`
`to allow it and its subsidiaries and affiliates, including Defendants, to inspect patent assets, which
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 34 of 63 PageID #: 34
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`
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`included the '155 Patent. As such, Defendants were at least aware of the portfolio which included
`
`the '155 Patent. Yet despite this notice, Defendants proceeded to infringe the '155 Patent.
`
`61.
`
`Additionally, to the extent that Defendants have continued or continue to make,
`
`have made, use, sell, or offer for sale products or services that infringe the '155 Patent following
`
`their awareness of the '155 Patent, Defendants' infringement is willful and entitles Labrador to an
`
`award of enhanced damages pursuant to 35 U.S.C. § 284 and attorneys' fees pursuant to 35 U.S.C.
`
`§ 285.
`
`62.
`
`Labrador is informed and believes, and on that basis alleges, that Defendants
`
`actively, knowingly, and intentionally induced infringement of one or more claims of the '155
`
`Patent following their awareness of the '155 Patent by, for example, controlling the design and
`
`manufacture of, offering for sale, selling, supplying, and otherwise providing instruction and
`
`guidance regarding the Accused Products with the knowledge and specific intent to encourage and
`
`facilitate infringing uses of such products by its customers both inside and outside the United
`
`States.
`
`63.
`
`For example, Defendants publicly provide documentation, including product
`
`manuals and instruction booklets available through both BioFire's and bioMerieux's websites,
`
`instructing customers on uses of Defendants' products that infringe the '155 Patent. See, e.g.,
`
`BioFire Diagnostics Website, https://www.biofiredx.com/support/documents, bioMerieux
`
`Diagnostics Website, https://www.biomerieux-diagnostics.com/molecular-diagnostics. As a
`
`further example, Defendants' manuals and instruction booklets direct customers to contact BioFire
`
`sales support and bioMerieux's website directs customers to contact bioMerieux's sales force for
`
`each country,
`
`including
`
`the United States. See, e.g., bioMerieux Contact Us Page,
`
`https://www.biomerieux-usa.com/contact-us (listing sales contacts in Boston, MA and Lombard,
`
`
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`Case 1:20-cv-00348-MN Document 1 Filed 03/09/20 Page 35 of 63 PageID #: 35
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`
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`IL among others). On information and belief, Defendants' customers directly infringe the '155
`
`Patent by, for example, at least using within the United States, without authority or license, the
`
`above-described BioFire products.
`
`64.
`
`Labrador is informed and believes, and on that basis alleges, that Defendants have
`
`contributed to the infringement by its customers of the '155 Patent by, without authority, selling
`
`and offering to sell within the United States materials and products for practicing the claimed
`
`invention of the '155 Patent both inside and outside the United States. For example, the above-
`
`described products each and in combination constitute a material part of the inventions of the '155
`
`Patent and are not staple articles or commodities of commerce suitable for substantial
`
`noninfringing use.
`
`65.
`
`On information and belief, Defendants know that the above-described products
`
`each and in combination constitute a material part of the inventions of the '155 Patent and are not
`
`staple articles or commodities of commerce suitable for substantial noninfringing use. On
`
`information and belief, Defendants' customers directly infringe the '155 Patent by, for example,
`
`making, using, offering to sell, and selling within the United States, without authority or license,
`
`the above-described products.
`
`66.
`
`As a result of Defendants' infringement of the '155 Patent, Labrador has been
`
`damaged. Labrador is entitled to recover for damages sustained as a result of Defendants' wrongful
`
`acts in an amount subject to proof at trial.
`
`67.
`
`To the extent 35 U.S.C. § 287 is determined to be applicable, its requirements have
`
`been satisfied with respect to the