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`Exhibit 1002
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`Exhibit 1002
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`Mako Surgical Corp. Ex. 1002
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`

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`Case 0:14-cv-61263-DPG Document 42 Entered on FLSD Docket 09/02/2014 Page 1 of 44
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF FLORIDA
`MIAMI DIVISION
`
`CASE NO: 1:14-CV-61263-DPG/WCT
`
`
`MAKO SURGICAL CORP.,
`a Delaware corporation,
`ALL-OF-INNOVATION GMBH,
`a German corporation,
`
`
`Plaintiffs,
`
`
`
`vs.
`
`
`BLUE BELT TECHNOLOGIES, INC.,
`a Pennsylvania corporation,
`
`
`Defendant.
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` /
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`DEFENDANT BLUE BELT TECHNOLOGIES, INC.’S SECOND AMENDED ANSWER
`TO PLAINTIFFS’ MAKO SURGICAL CORP. & ALL-OF-INNOVATION GMBH
`COMPLAINT; AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
`
`Defendant Blue Belt Technologies, Inc. (“Blue Belt”), for itself and no other party,
`
`answers as follows in response to the corresponding numbered paragraphs in Plaintiff Mako
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`Surgical Corp.’s (“Mako”) and All-of-Innovation GmbH’s (“AOI”) (collectively, “Plaintiffs”)
`
`Complaint, dated May 30, 2014:
`
`AS TO “PARTIES”
`
`1.
`
`Blue Belt lacks knowledge or information sufficient to form a belief about the truth
`
`of the allegations of Paragraph 1 of the Complaint and on that basis denies the same.
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`2.
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`Blue Belt lacks knowledge or information sufficient to form a belief about the truth
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`of the allegations of Paragraph 2 of the Complaint and on that basis denies the same.
`
`3.
`
`Blue Belt admits that it is a corporation organized and existing under the laws of
`
`the State of Pennsylvania, with a principal place of business at 2905 Northwest Boulevard, Suite
`
`40, Plymouth, Minnesota 55441.
`
`AS TO “JURISDICTION AND VENUE”
`
`4.
`
`Blue Belt admits that Mako purports to bring an action for patent infringement
`
`under 35 U.S.C. § 271 et seq. and that subject matter jurisdiction of Plaintiffs’ patent infringement
`
`claim is proper in this Court pursuant to 28 U.S.C. §§ 1331 and 1338, but Blue Belt denies that
`
`any Plaintiffs are entitled to any relief relating thereto. Except as expressly admitted, Blue Belt
`
`denies the allegations of Paragraph 4 of the Complaint.
`
`5.
`
`Blue Belt admits that that this Court has personal jurisdiction over Blue Belt in this
`
`matter. Except as expressly admitted, Blue Belt denies the allegations of Paragraph 5 of the
`
`Complaint.
`
`6.
`
`7.
`
`Blue Belt denies the allegations of Paragraph 6 of the Complaint.
`
`Blue Belt admits that the Southern District of Florida is a suitable venue for
`
`Plaintiffs’ patent infringement claim against Blue Belt. Except as expressly admitted, Blue Belt
`
`denies the allegations of Paragraph 7 of the Complaint.
`
`AS TO “BACKGROUND”
`
`8.
`
`Blue Belt admits
`
`that Mako markets a product and/or service called
`
`“MAKOplasty,” used with respect to knee and hip arthroplasty; Blue Belt denies the remaining
`
`allegations of Paragraph 8 of the Complaint.
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`2
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`Case 0:14-cv-61263-DPG Document 42 Entered on FLSD Docket 09/02/2014 Page 3 of 44
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`9.
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`Blue Belt lacks knowledge or information sufficient to form a belief about the truth
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`as to the date Mako was founded or as to the number of U.S. and foreign patents and patent
`
`applications Mako has, and on that basis denies said allegations; Blue Belt denies the remaining
`
`allegations in Paragraph 9 of the Complaint.
`
`10.
`
`Blue Belt admits
`
`that Mako markets products and/or services called
`
`“MAKOplasty,” the RIO Robotic Arm Interactive Orthopedic device, and Restoris implants in the
`
`United States. Blue Belt lacks knowledge or information sufficient to form a belief about the
`
`truth as to the all the specific location(s) in which these products and/or services are offered or
`
`specifically how many procedures have been performed, and denies these allegations on this
`
`basis. Blue Belt denies the remaining allegations of Paragraph 10 of the Complaint.
`
`11.
`
`Blue Belt lacks knowledge or information sufficient to form a belief about the truth
`
`as to purported rankings or honors regarding Mako and/or its products and/or services, and denies
`
`these allegations on this basis. Blue Belt denies the remaining allegations of Paragraph 11 of the
`
`Complaint.
`
`12.
`
`13.
`
`Blue Belt denies the allegations of Paragraph 12 of the Complaint.
`
`Blue Belt admits that Mako’s products and/or services are sold and/or offered for
`
`sale in the United States; Blue Belt lacks knowledge or information sufficient to form a belief
`
`about the truth as to the remaining allegations of Paragraph 13 of the Complaint, and denies these
`
`allegations on this basis.
`
`14.
`
`Blue Belt lacks knowledge or information sufficient to form a belief about the truth
`
`as to purported rankings or honors regarding Tim Lüth and denies these allegations on this basis;
`
`Blue Belt denies the remaining allegations of Paragraph 14 of the Complaint.
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`3
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`
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`15.
`
`Blue Belt admits that on December 10, 2012, Blue Belt issued a press release
`
`announcing that it received clearance from the Food and Drug Administration (“FDA”) to market
`
`its NavioPFS® orthopedic surgical system in the United States, and that NavioPFS® was
`
`approved at that time for use in Unicondylar Knee Replacement (“UKR”); Blue Belt denies the
`
`remaining allegations of Paragraph 15 of the Complaint.
`
`16.
`
`Blue Belt admits that its 510(k) Summary to FDA describes the NavioPFS® as “a
`
`computer-assisted orthopedic surgical navigation and surgical burring system.” Blue Belt admits
`
`that the same document states that the NavioPFS® “uses established technologies of navigation
`
`via a passive infrared tracking camera to aid the surgeon in establishing a bone surface model for
`
`the target surgery and to plan the surgical implant location based on predefined bone landmarks
`
`and known configuration of the surgical implant”; and that it further states that the system “aids
`
`the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor
`
`and bur . . . which has been adapted using a tracking system.” Blue Belt admits that the same
`
`document further states that the NavioPFS® “software controls the position of the tip of the
`
`surgical bur relative to the end of a guard attached to the handpiece,” and notes that “[a]s the
`
`planned surface is reached the tip of the bur is fully retracted within the guard.” Blue Belt admits
`
`that the same document states that “[a]n alternative mode of operation is speed control mode,” in
`
`which “the speed of the bur is controlled and the bur stops as the planned surface is reached.”
`
`Blue Belt denies the remaining allegations of paragraph 16 of the Complaint.
`
`17.
`
`Paragraph 17 of the Complaint purports to quote statements by Blue Belt without
`
`offering a source for those statements. Consequently, Blue Belt lacks knowledge or information
`
`sufficient to form a belief about the truth as to the allegations of Paragraph 17 of the Complaint,
`
`and denies these allegations on this basis.
`
`
`
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`4
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`Case 0:14-cv-61263-DPG Document 42 Entered on FLSD Docket 09/02/2014 Page 5 of 44
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`18.
`
`Blue Belt admits that it has sold and/or offered to sell NavioPFS® systems in the
`
`United States, and has offered to sell NavioPFS® systems in the State of Florida. Except as
`
`expressly admitted, Blue Belt denies the allegations of Paragraph 18 of the Complaint.
`
`19.
`
`Blue Belt admits that Blue Belt has engaged in certain marketing activities with
`
`regard to the NavioPFS® system in the United States, including in the State of Florida. Blue Belt
`
`admits that it offers certain informational and instructional content to actual and potential
`
`customers for the NavioPFS® system. Except as expressly admitted, Blue Belt denies the
`
`allegations of Paragraph 19 of the Complaint.
`
`AS TO “THE ASSERTED PATENT”
`
`20.
`
`Blue Belt admits that U.S. Patent No. 7,346,417 (the “’417 patent”) is entitled
`
`“Method and Device System for Removing Material or for Working Material,” and on its face
`
`indicates that the USPTO issued it on March 18, 2008. Blue Belt lacks knowledge or information
`
`sufficient to form a belief about the truth as to the remaining allegations of Paragraph 20 of the
`
`Complaint, and denies these allegations on this basis.
`
`21.
`
`Blue Belt lacks knowledge or information sufficient to form a belief about the truth
`
`of the allegations of Paragraph 21 of the Complaint, and denies them on that basis.
`
`AS TO “COUNT I – INFRINGEMENT OF THE ’417 PATENT”
`
`22.
`
`Blue Belt incorporates its responses to and denials of the allegations contained in
`
`Paragraphs 1 through 21 of the Complaint, as if fully set forth herein.
`
`23.
`
`24.
`
`Blue Belt denies the allegations of Paragraph 23 of the Complaint.
`
`Blue Belt states that on May 29, 2014 it received a letter on Morrison & Foerster
`
`stationary alleging infringement of the ’417 patent and attaching the patent, but Blue Belt denies
`
`
`
`
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`5
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`that it infringes the ’417 patent; on that basis, Blue Belt denies the allegations of Paragraph 24 of
`
`the Complaint.
`
`25.
`
`Blue Belt denies the allegations of Paragraph 25 of the Complaint.
`
`AS TO “COUNT II – INDIRECT INFRINGEMENT OF THE ’417 PATENT”
`
`26.
`
`Blue Belt incorporates its responses to and denials of the allegations contained in
`
`Paragraphs 1 through 25 of the Complaint, as if fully set forth herein.
`
`27.
`
`28.
`
`29.
`
`30.
`
`31.
`
`Blue Belt denies the allegations of Paragraph 27 of the Complaint.
`
`Blue Belt denies the allegations of Paragraph 28 of the Complaint.
`
`Blue Belt denies the allegations of Paragraph 29 of the Complaint.
`
`Blue Belt denies the allegations of Paragraph 30 of the Complaint.
`
`Blue Belt denies any other allegation of the Complaint that has not been otherwise
`
`specifically admitted or responded to.
`
`RESPONSE TO PLAINTIFFS’ DEMAND FOR RELIEF
`
`Blue Belt denies that Plaintiffs are entitled to any relief whatsoever, either legal or
`
`equitable, from Blue Belt or this Court. Furthermore, Blue Belt denies that this is an exceptional
`
`case such that an award of attorney’s fees to Plaintiffs or an award of enhanced damages to
`
`Plaintiffs is appropriate.
`
`AFFIRMATIVE DEFENSES
`
`Without assuming any burden of proof that it would not otherwise bear, Blue Belt asserts
`
`the following separate and additional defenses, all of which are pled in the alternative, and none
`
`of which constitutes an admission that Blue Belt is in any way liable to Plaintiffs, that Plaintiffs
`
`have been or will be injured or damaged in any way, or that Plaintiffs are entitled to any relief
`
`whatsoever.
`
`
`
`
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`6
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`Case 0:14-cv-61263-DPG Document 42 Entered on FLSD Docket 09/02/2014 Page 7 of 44
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`
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`FIRST AFFIRMATIVE DEFENSE
`
`
`
`Blue Belt has not infringed and does not directly infringe, literally or by application of the
`
`doctrine of equivalents, either willfully or otherwise, any claim of the ’417 patent, nor does Blue
`
`Belt contribute to the infringement of, or actively induce others to infringe, either literally or by
`
`application of the doctrine of equivalents, any claim of the ’417 patent.
`
`SECOND AFFIRMATIVE DEFENSE
`
`
`
`The claims of the ’417 patent are invalid, in whole or in part, for failing to meet the
`
`requirements for patentability under United States law, including, inter alia, 35 U.S.C. §§ 101,
`
`102, 103, 112, 116, and 256, and the non-statutory doctrine of obviousness-type double-patenting.
`
`THIRD AFFIRMATIVE DEFENSE
`
`
`
`Plaintiffs are estopped from asserting the claims of the ’417 patent against Blue Belt by
`
`reason of, among other things, statements made in the ’417 patent, amendments and/or statements
`
`made in and to the United States Patent and Trademark Office during the prosecution of the
`
`application that issued as the ’417 patent, prior statements made in this or any other Court, prior
`
`rulings of this or any other Court, Plaintiffs’ prior representations to foreign patent authorities
`
`and/or the courts of other nations, and/or other representations made by Plaintiffs.
`
`FOURTH AFFIRMATIVE DEFENSE
`
`
`
`Plaintiffs are not entitled to any injunctive relief because, inter alia, any alleged injury to
`
`Plaintiffs is not immediate or irreparable, and Plaintiffs have an adequate remedy at law for any
`
`alleged injury.
`
`FIFTH AFFIRMATIVE DEFENSE
`
`Plaintiffs’ Complaint fails to state a claim upon which relief may be granted.
`
`7
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`Case 0:14-cv-61263-DPG Document 42 Entered on FLSD Docket 09/02/2014 Page 8 of 44
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`SIXTH AFFIRMATIVE DEFENSE
`
`Plaintiffs are barred from asserting the claims of the ’417 patent against Blue Belt by the
`
`equitable doctrine of patent misuse.
`
`SEVENTH AFFIRMATIVE DEFENSE
`
`The ’417 patent is unenforceable because individuals associated with prosecution of the
`
`patent committed inequitable conduct in its procurement. Inventors of the ’417 patent had a duty
`
`of and good faith in dealing with the USPTO, yet at least Tim Lüth, Jürgen Bier, and Andreas
`
`Hein withheld material prior art with an intent to deceive the USPTO. But for that withholding of
`
`material prior art, the USPTO would not have issued the ’417 patent. Blue Belt incorporates
`
`paragraphs 63 through 95 from Count III of its Counterclaims below, which provide the factual
`
`bases in support of the allegations of this defense, as if fully set forth herein.
`
`RESERVATION OF RIGHT TO SUPPLEMENT DEFENSES
`
`Blue Belt reserves its right to supplement its Answer with additional defenses that are
`
`learned in the course of discovery.
`
`JURY DEMAND
`
`Blue Belt demands a trial by jury, pursuant to Rule 38(b) of the Federal Rules of Civil
`
`Procedure, of all issues presented by Plaintiffs’ Complaint that are so triable.
`
`BLUE BELT’S COUNTERCLAIMS AGAINST PLAINTIFFS
`
`1.
`
`Counterclaim-Plaintiff Blue Belt Technologies, Inc. (“Blue Belt”) seeks a
`
`declaratory judgment that the U.S. Patent No. 7,346,417 (the “’417 patent”) is not infringed by
`
`Blue Belt and is invalid and unenforceable. Blue Belt also seeks damages for and an injunction
`
`against a course of unfair and deceptive trade practices and tortious interference with business
`
`relationships undertaken by Counterclaim-Defendant Mako Surgical Corp. (“Mako”), which is
`
`
`
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`intended to undermine Blue Belt’s developing position in the market for knee replacement
`
`surgery. Blue Belt further seeks damages for and an injunction against Mako’s past and
`
`continuing infringement of U.S. Patent Nos. 6,757,582 (the “’582 patent”) and 6,205,411 (the
`
`“’411 patent”).
`
`PARTIES
`
`2.
`
`Blue Belt is a corporation organized and existing under the laws of the State of
`
`Pennsylvania, with a principal place of business at 2905 Northwest Boulevard, Suite 40,
`
`Plymouth, Minnesota 55441.
`
`3.
`
`Upon information and belief, Mako is a corporation organized and existing under
`
`the laws of Delaware, and Mako maintains its principal place of business at 2555 Davie Road,
`
`Fort Lauderdale, Florida 33317.
`
`4.
`
`Upon information and belief, Counterclaim-Defendant All-of-Innovation GmbH
`
`(“AOI”) is a corporation organized and existing under the laws of Germany, and AOI maintains
`
`its principal place of business at Gleissenweg 1, Ismaning, Bayern 85737, Germany.
`
`JURISDICTION
`
`5.
`
`This Court has subject matter jurisdiction for the declaratory relief portion of Blue
`
`Belt’s counterclaims under 28 U.S.C. §§ 2201 and 2202.
`
`6.
`
`This Court further has subject matter jurisdiction over Blue Belt’s counterclaims
`
`under 28 U.S.C. §§ 1331, 1332(a), and 1338.
`
`7.
`
`This Court further has subject matter jurisdiction over Blue Belt’s counterclaims
`
`arising under state law pursuant to 28 U.S.C. § 1367, because Blue Belt’s state law claims are
`
`ancillary and/or pendant to Blue Belt’s federal claims, and therefore supplementary jurisdiction is
`
`appropriate over such state law claims.
`
`
`
`
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`9
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`8.
`
`The Court has personal jurisdiction over Mako because Mako made a general
`
`appearance in this case and maintains its headquarters in Florida.
`
`9.
`
`The Court has personal jurisdiction over AOI because AOI made a general
`
`appearance in this case.
`
`10.
`
`11.
`
`Venue is proper for Blue Belt’s counterclaims under 28 U.S.C. §§ 1391 and 1400.
`
`BACKGROUND
`
`Blue Belt’s NavioPFS® System
`
`Counterclaim-Plaintiff Blue Belt has developed revolutionary new technology in
`
`the field of orthopedic surgery, and is a recent entrant into that market.
`
`12.
`
`Blue Belt was founded in 2004 to provide a vehicle for the commercialization and
`
`public adoption of exciting new advances in robotics-assisted surgery being developed at the
`
`Robotics Institute at Carnegie Mellon University in Pittsburgh, Pennsylvania (“CMU”).
`
`13.
`
`In November 2012, Blue Belt was approved by the United States Food and Drug
`
`Administration (“FDA”) to market in the United States Blue Belt’s NavioPFS® surgical system
`
`for Unicondylar Knee Replacement (“UKR,” also known as partial knee replacement).
`
`14.
`
`Traditional UKR surgery is performed using manual instruments and is prone to
`
`human error, which can lead to inconsistent results and high revision and retreatment rates. The
`
`NavioPFS® surgical system, by contrast, combines a planning and navigation platform that
`
`presents to the surgeon a virtual cutting guide with detailed visualization and an intelligent hand-
`
`held instrument which enables the precision of robotics in the hand of the surgeon.
`
`15.
`
`To bring the NavioPFS® to market, Blue Belt leveraged many years of ground-
`
`breaking research and development that began at CMU and continued at Blue Belt after its
`
`founding. The result provides a uniquely efficient, open-architecture platform that allows for
`
`
`
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`
`10
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`multiple supported implant systems and that costs approximately two-thirds less than
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`Counterclaim-Defendant Mako’s proprietary system,
`
`the RIO Robotic Arm Interactive
`
`Orthopedic device.
`
`16.
`
`In 2012, Blue Belt’s NavioPFS® system was awarded the Frost & Sullivan Global
`
`Orthopedic Surgery Technology Innovation Award, earning the NavioPFS® praise for its
`
`“potential to alter the way the industry looks at knee replacements and other applications where
`
`precise bone shaping is critical.”
`
`Mako’s RIO System
`
`17.
`
`Today, robotics-assisted UKRs comprise approximately 10-15 percent of all UKRs
`
`performed in the United States annually, and that percentage is growing as healthcare providers
`
`increasingly seek to apply modern technology to address patients’ and payers’ heightened demand
`
`for reliable, safe, and cost-effective knee replacement.
`
`18.
`
`Prior to the FDA’s approval of the Blue Belt NavioPFS® surgical system, Mako’s
`
`RIO system was the only publicly available, FDA-approved robotics-assisted UKR system
`
`available for purchase and permanent installation in the United States.
`
`19. Mako’s RIO system relies on computed tomography (“C-T”) scans to map a
`
`desired path for the surgeon’s hand-held cutting apparatus, which provides haptic sensory
`
`feedback to the surgeon when movements deviate from the desired path.
`
`Superiority of Blue Belt’s New Technology
`
`20.
`
`On information and belief, the list price for a new RIO system exceeds $1 million,
`
`not including service costs, which on information and belief can add $100,000 or more annually
`
`to the cost of owning a RIO system.
`
`
`
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`21.
`
`New NavioPFS® systems are available for less than $400,000, with an optional
`
`service agreement that costs less than $40,000 annually.
`
`22.
`
`Blue Belt’s own patented technology, which does not infringe any of Mako’s
`
`patents or patents licensed by Mako for its RIO system, allows Blue Belt to deliver comparable or
`
`better performance at a drastically more affordable price point.
`
`23.
`
`Blue Belt’s innovation, cost-effective methods, and competitive pricing have
`
`allowed healthcare providers to help many patients. Since 2012, Blue Belt has sold
`
`approximately 20 NavioPFS® systems in the United States, to hospitals, private practitioners, and
`
`ambulatory surgery centers (“ASCs”), and has received uniformly positive reviews for the
`
`NavioPFS® system’s accuracy, reliability, and cost-effectiveness.
`
`24.
`
`Blue Belt has beaten Mako in fair competition for sales in the United States. In at
`
`least nine confirmed instances where prospective buyers were considering both NavioPFS® and
`
`RIO, the buyer selected Blue Belt’s product and completed the purchase.
`
`25.
`
`Blue Belt’s burgeoning success has not gone unnoticed by Mako and by AOI.
`
`Indeed, both Counterclaim-Defendants know that consumers, given the choice between Mako’s
`
`and Blue Belt’s systems, will favor the more cost-effective option. But rather than competing
`
`against Blue Belt lawfully on price or through product differentiation, Mako has undertaken a
`
`national campaign of unlawful tactics with the intention of destabilizing Blue Belt’s business,
`
`imposing remedial costs on Blue Belt, and unfairly forcing Blue Belt to raise its prices, all to the
`
`detriment of healthcare providers and patients throughout the United States.
`
`Mako’s and AOI’s Sham Patent Claims in the Florida Action
`
`26. Mako has licensed, among other intellectual property, the ’417 patent, which is
`
`entitled “Method and device system for removing material or for working material.”
`
`
`
`
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`27.
`
`On information and belief, Mako’s license to the ’417 patent imposes a production
`
`cost on Mako that Blue Belt does not, and need not, face. On information and belief, Mako and
`
`AOI believe that imposing the costs of licensing the ’417 patent on Blue Belt will force Blue Belt
`
`to raise its prices.
`
`28.
`
`AOI and Mako have asserted the ’417 patent against Blue Belt and the NavioPFS®
`
`in this action, No. 1:14-cv-61263-DPG/WCT (S.D. Fla.) (the “Florida Action”). In the Florida
`
`Action, AOI and Mako purport to seek damages and an injunction in connection with Blue Belt’s
`
`alleged infringement.
`
`29.
`
`On information and belief, Mako and AOI know that Blue Belt does not practice
`
`any valid claims of the ’417 patent in connection with the NavioPFS® system. Therefore,
`
`Counterclaim-Defendants’ claims for damages and an injunction are an unlawful attempt to
`
`leverage the patent system in order to raise Blue Belt’s costs and, eventually, its retail prices.
`
`30. Mako and AOI’s claims against Blue Belt in the Florida Action are a sham: their
`
`claims of patent infringement are objectively baseless, and on information and belief they have
`
`filed those claims with the subjective intent to inflict unlawful injury on Blue Belt, including by
`
`exerting undue pressure on Blue Belt to raise the prices of the NavioPFS® and related products to
`
`account for costs that Blue Belt legally should not have to bear.
`
`31.
`
`On or about March 14, 2014, at a conference of the American Academy of
`
`Orthopedic Surgeons in New Orleans, a Mako senior executive met with a consultant to Blue Belt
`
`who has a relationship with Blue Belt’s upper-level management. Mako’s senior executive told
`
`Blue Belt’s consultant that Mako believes that Blue Belt is undermining Mako’s sales of capital
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`equipment by making it harder for Mako to consummate sales of the RIO system at its current
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`prices. On information and belief, the Mako senior executive conveyed to Blue Belt’s consultant
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`that Blue Belt was impairing Mako’s ability to charge elevated prices for installed UKR systems.
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`The Mako senior executive then told Blue Belt’s consultant that Mako would not pursue the
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`Florida Action or other legal action if Blue Belt agreed to raise its prices.
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`32.
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`On information and belief, Mako intended by this interaction to secure Blue Belt’s
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`agreement to raise its own prices to an unfairly elevated level, even higher than the level at which
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`Blue Belt would need to price its products if it were deemed to owe Mako and AOI a reasonable
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`royalty on the ’417 patent (which Blue Belt denies it owes, as Blue Belt does not practice the ’417
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`patent and thus has no obligation to pay any royalty for it). Blue Belt refused to entertain Mako’s
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`proposal.
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`33.
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`On information and belief, AOI has authorized and approved of Mako’s assertion
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`of baseless claims of the ’417 patent as part of Mako’s unfair and unlawful tactics.
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`Mako’s Other Unlawful Actions
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`34.
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`Separately and in addition to its abuse of the patent laws in the Florida Action,
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`Mako has unlawfully attempted to further interfere with Blue Belt’s business in other ways.
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`35.
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`On information and belief, Mako has sought to collude with owners of other
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`intellectual property, in order to impose further illegitimate costs on Blue Belt’s business. On or
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`between June 5 and June 7, 2014, a representative of Stryker Corporation (“Stryker”), Mako’s
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`parent corporation, approached an employee from Think Surgical (formerly known as Curexo),
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`the maker of the ROBODOC Surgical System for, among other things, Total Hip Arthroplasty
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`(“THA”). The Stryker representative proposed that Think Surgical join the Florida Action as a
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`plaintiff to assert against Blue Belt certain patents already licensed by Mako.
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`36. Mako has engaged in unfair competition in order to stunt Blue Belt’s progress with
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`key healthcare providers. For example, at the Community Regional Medical Center in Fresno,
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`California, Mako sales representatives offered to provide practitioners with a free RIO system, on
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`the condition that they uninstall their NavioPFS® system.
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`37.
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`On information and belief, Mako is pursuing a nationwide plan to “swap out”
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`NavioPFS® systems, at a loss, in order to prevent Blue Belt from obtaining a critical mass of
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`practitioners who use the NavioPFS®. On information and belief, Mako has pursued these “swap
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`out” at, inter alia, Community Regional Medical Center in Fresno, California. On information
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`and belief, Mako is pursuing this plan in order to prevent Blue Belt from obtaining further market
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`credibility for NavioPFS® and to prevent Blue Belt from obtaining further data regarding the
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`efficacy of NavioPFS® in the field, as Mako knows that such data would result from surgeons’
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`use of NavioPFS® and would further demonstrate that NavioPFS® is just as effective as Mako’s
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`RIO system but at approximately one-third the cost.
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`38.
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`On information and belief, in addition to such “swap out” activities, Mako is
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`pursuing a nationwide plan to sell or give away its RIO system for free or below cost to its
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`customers in return for those customers executing exclusive sales contracts with Mako and/or its
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`corporate parent, Stryker.
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`Mako’s False Statements to the Marketplace
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`39.
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`As part of its campaign to dislodge Blue Belt’s growing foothold with surgeons
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`and hospitals, Mako has resorted to a variety of unlawful, false, and misleading statements.
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`Among other things, Mako and its agents have falsely stated to current and prospective Blue Belt
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`customers that: Blue Belt infringes on Mako’s intellectual property; Blue Belt was forced to recall
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`all of its NavioPFS® systems because of safety malfunctions; pending legal actions will require
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`customers to cease using their NavioPFS® systems; Blue Belt requires NavioPFS® users to also
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`use Blue Belt’s implants; the NavioPFS® system is not actually robotic; the NavioPFS® system
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`is incompatible with burs larger than four millimeters; the NavioPFS® system cannot be used to
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`perform lateral UKR procedures; certain customers were returning their NavioPFS® systems
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`and/or abandoning their use; and Blue Belt will soon be forced to discontinue sales of the
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`NavioPFS® system entirely. Each and every one of these statements by Mako and its
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`representatives is false and misleading.
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`40.
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`For example, in 2013, one or more Mako representatives made false, misleading,
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`and deceptive statements about Blue Belt to employees of St. Francis Memorial hospital in
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`Francisco (“St. Francis Memorial”), a prospective Blue Belt customer. Mako tried to convince St.
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`Francis Memorial staff that one or more of Blue Belt’s products were not lawfully
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`commercialized because they allegedly lacked clinical data, resulted in long case durations, and
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`did not contain certain features. These statements were false and misleading.
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`41.
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`In mid- to late-2013, one or more Mako representatives spoke with employees of
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`McBride Orthopedic Hospital in Oklahoma City (“McBride”) and made false, deceptive, and
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`misleading statements meant to convince McBride to use Mako’s products instead of Blue Belt’s
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`products. These statements included false suggestions that Blue Belt’s technology was not
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`“proven,” that NavioPFS® infringes on Mako’s intellectual property, and that Blue Belt would
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`soon be forced to discontinue the NavioPFS® system and support for it.
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`42.
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`In late 2013, one or more Mako representatives contacted employees of Valley
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`Baptist Medical Center in Brownsville, Texas (“Valley Baptist”) and made false, misleading, and
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`deceptive statements about the NavioPFS® system in order to convince Valley Baptist to use
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`Mako products instead. Mako representatives falsely suggested that NavioPFS® was unproven
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`and that the system could not do what comparable Mako products can do.
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`43.
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`In or between March and May of 2014, Mako representatives made false,
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`misleading, and deceptive statements about the NavioPFS® system to an orthopedic surgeon in or
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`around Fremont, California. Mako representatives falsely stated that a four-millimeter bur is the
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`largest bur the NavioPFS® system can utilize, that the NavioPFS® system cannot be used to
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`perform lateral UKR surgeries, and that St. Francis Memorial was returning its NavioPFS®
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`system and discontinuing use of it in the meantime.
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`44.
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`In early June 2014, representatives of Mako and/or Stryker contacted a physician
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`at Southcoast Physicians Group (“Southcoast”) and made false, deceptive, and misleading
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`statements about Blue Belt and its products. The Mako and/or Stryker representatives falsely
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`stated that this physician could no longer use his NavioPFS® system because of a recent alleged
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`recall and because of the Florida Action against Blue Belt, and that Blue Belt would soon be put
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`out of business by intellectual property lawsuits, including the Florida Action.
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`45.
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`On or about June 5, 2014, representatives of Mako and/or Stryker, including at
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`least Bill Peters, made false, deceptive, and misleading statements to doctors and other potential
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`customers associated with the Southeast Alabama Medical Center (“SAMC”). The Mako and/or
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`Stryker representatives, including Mr. Peters, falsely and misleadingly stated that the NavioPFS®
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`is “not a robotic system,” that the NavioPFS® “was recalled last week due to failures in surgery,”
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`including a “clinical failure to keep the bur[] in the field,” and that Blue Belt “also [has] another
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`major problem, St[r]yker just filed a lawsuit because they [Blue Be