`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF PENNSYLVANIA
`
`
`Civil Action No. 14-cv-6650-WB
`
`JURY TRIAL DEMANDED
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`
`
`
`
`
`
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`BONUTTI SKELETAL INNOVATIONS, LLC
`
`
`Plaintiff,
`
`
`v.
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`GLOBUS MEDICAL, INC.
`
`
`Defendant.
`
`
`
`MEMORANDUM OF LAW IN SUPPORT OF GLOBUS’S MOTION TO DISMISS
`CLAIMS OF INDIRECT, WILLFUL, AND JOINT INFRINGEMENT
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`
`
`
`
`
`
`Exhibit 2001 Page 001
`
`Globus Medical, Inc. v. Bonutti Skeletal Innovations LLC
`Case IPR2015-01346
`Bonutti Skeletal Innovations LLC - Ex. 2001
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 2 of 29
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`TABLE OF CONTENTS
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`Page(s)
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`TABLE OF AUTHORITIES ......................................................................................................... iii
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`INTRODUCTION .......................................................................................................................... 1
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`BACKGROUND ............................................................................................................................ 3
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`A. Bonutti Skeletal’s Nationwide Litigation Campaign .......................................................... 3
`
`B.
`
`C.
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`Plaintiff Does Not Plead Facts to Support Its Vicarious Liability Claims ......................... 4
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`Plaintiff Does Not Plead Facts to Support its Indirect Infringement Claims ...................... 5
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`D. Plaintiff Alleges Pre-Suit Knowledge Only of ‘531 Patent ................................................ 7
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`E.
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`Plaintiff Does Not Plead Facts to Support its Willful Infringement Claims....................... 7
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`LEGAL STANDARD ..................................................................................................................... 7
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`ARGUMENT .................................................................................................................................. 9
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`I. PLAINTIFF’S DIRECT METHOD CLAIMS IN COUNTS I AND II SHOULD BE
`DISMISSED .............................................................................................................................9
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`A. Plaintiff Must Plead That Globus Directed or Controlled Direct Infringers .................... 10
`
`B.
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`Plaintiff Fails to Allege that Globus Directed or Controlled Others ................................ 11
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`II. PLAINTIFF’S INDIRECT INFRINGEMENT CLAIMS IN EVERY COUNT SHOULD BE
`DISMISSED ...........................................................................................................................13
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`A. Plaintiff’s Induced Infringement Claims Should Be Dismissed ....................................... 13
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`1.
`
`2.
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`Inducement Requires Knowledge of Infringement and Specific Intent .................... 13
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`Knowledge of Infringement and Specific Intent Not Adequately Pleaded ............... 15
`
`B.
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`Plaintiff’s Contributory Infringement Claims Should Be Dismissed ............................... 17
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`1.
`
`2.
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`Contributory Infringement Requires Knowledge and Intent .................................... 17
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`Knowledge and Intent Not Adequately Pleaded ....................................................... 18
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`C.
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`Pleadings Are Insufficient for Post-Suit Indirect Infringement Claims ............................ 19
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`
`
`i
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`Exhibit 2001 Page 002
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 3 of 29
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`III. PLAINTIFF’S WILLFUL INFRINGEMENT CLAIMS IN EVERY COUNT SHOULD BE
`DISMISSED ...........................................................................................................................21
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`A. Willfulness Claims in Counts 2-5 Deficient for Lack of Pre-Suit Knowledge ................. 21
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`B. All Willfulness Claims Should be Dismissed Given Threadbare Pleadings .................... 21
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`CONCLUSION ............................................................................................................................. 22
`
`ii
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`
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`Exhibit 2001 Page 003
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 4 of 29
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Aeritas, LLC v. Alaska Air Group, Inc.,
`893 F. Supp.2d 680 (D. Del. 2012) ..................................................................................... 12, 23
`
`Akamai Techs., Inc. v. Limelight Networks, Inc.,
`692 F.3d 1301 (Fed. Cir. 2012) ................................................................................................ 10
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) .......................................................................................................... 8, 9, 13
`
`Bell Atl. Corp. v. Twombly,
`550 U.S. 544 (2007) .................................................................................................................... 8
`
`BMC Resources, Inc. v. Paymentech, L.P.,
`498 F.3d 1373 (Fed. Cir. 2007) ................................................................................................ 10
`
`Bonutti Skeletal Innovations LLC v. Conformis, Inc.,
`No. CV 12-1109-GMS, 2013 WL 6040377 (D. Del. Nov. 14, 2013) .................... 10, 11, 15, 19
`
`Bonutti Skeletal Innovations LLC v. Smith & Nephew, Inc.,
`No. 12-1111-GMS, 2013 WL 6058472 (D. Del. Nov. 18, 2013) ...................................... passim
`
`ClinMicro Immunology Ctr., LLC v. PrimeMed, P.C.,
`No. 11-2213, 2013 WL 3776264 (M.D. Pa. July 17, 2013) ..................................................... 12
`
`Desenberg v. Google, Inc.,
`392 Fed. Appx. 868 (Fed. Cir. 2010) ........................................................................................ 12
`
`DSU Med Corp. v. JMS Co.,
`471 F.3d 1293 (Fed. Cir. 2006) .......................................................................................... 14, 15
`
`EON Corp. IP Holdings LLC v. FLO TV Inc.,
`802 F. Supp. 2d 527 (D. Del. 2011) .......................................................................................... 12
`
`Execware, LLC v. Staples, Inc.,
`No. CIV.A. 11-836-LPS, 2012 WL 6138340 (D. Del. Dec. 10, 2012) .................................... 22
`
`Fowler v. UPMC Shadyside,
`578 F.3d 203 (3d Cir. 2009) ....................................................................................................... 9
`
`iii
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`
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`Exhibit 2001 Page 004
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 5 of 29
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`Global Patent Holdings, LLC v. Panthers BRHC LLC,
`586 F. Supp. 2d 1331 (S.D. Fla. 2008) ..................................................................................... 13
`
`Global-Tech Appliances, Inc. v. SEB S.A.,
`131 S. Ct. 2060 (2011) .............................................................................................................. 14
`
`In re Bill of Lading Transmission & Processing Sys. Patent Litig.,
`681 F.3d 1323 (Fed. Cir. 2012) ......................................................................................... passim
`
`In re Seagate Tech., LLC,
`497 F.3d 1360 (Fed. Cir. 2007) ................................................................................................ 22
`
`In re Wellbutrin SR/Zyban Antitrust Litig.,
`281 F. Supp. 2d 751 (E.D. Pa. 2003) .......................................................................................... 4
`
`Lucent Techs. v. Gateway, Inc.,
`580 F.3d 1301 (Fed. Cir. 2009) ................................................................................................ 18
`
`Mallinckrodt Inc. v. E-Z-EM Inc.,
`670 F. Supp. 2d 349 (D. Del. 2009) ............................................................................................ 9
`
`Mikkelsen Graphic Eng’g Inc. v. Zund Am., Inc.,
`2011 WL 6122377 (E.D. Wis. Dec. 8, 2011) ........................................................................... 18
`
`MONEC Holding AG v. Motorola Mobility, Inc.,
`No. 11-798-LPS, 2012 WL 4340653 (D. Del. Sept. 20, 2012) ......................................... passim
`
`Muniauction, Inc. v. Thomson Corp.,
`532 F.3d 1318 (Fed. Cir. 2008) ................................................................................................ 11
`
`Neology, Inc. v. Kapsch Trafficcom IVHS, Inc.,
`2014 WL 4675316 (D. Del. Sept. 19, 2014) ............................................................................. 17
`
`Neology, Inc. v. Kapsch Trafficcom IVHS, Inc.,
`No. CV 13-2052-LPS, 2014 WL 4675316 (D. Del. Sept. 19, 2014) ........................................ 20
`
`Pragmatus AV, LLC v. Yahoo! Inc.,
`No. 11-902, 2012 WL 6044793 (D. Del. Nov. 13,2012) .............................................. 14, 16, 19
`
`Senju Pharm. Co., Ltd v. Apotex, Inc.,
`Civ. No. 12-159, 2013 WL 444928 (D. Del. Feb. 6, 2013) ........................................................ 8
`
`SRI Int’l, Inc. v. Internet Sec. Sys., Inc.,
`647 F. Supp. 2d 323 (D. Del. 2009) .......................................................................................... 15
`
`iv
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`
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`Exhibit 2001 Page 005
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 6 of 29
`
`Stephenson v. Game Show Network, LLC,
`933 F. Supp.2d 674 (D. Del. 2013) ........................................................................................... 19
`
`Superior Indus., LLC v. Thor Global Enter. Ltd.,
`700 F.3d 1287 (Fed. Cir. 2012) .......................................................................................... 16, 19
`
`Tellabs, Inc. v. Makar Issues & Rights, Ltd.,
`551 U.S. 308 (2007) .................................................................................................................... 8
`
`Travel Sentry, Inc. v. Tropp,
`Nos. 2011-1023, 2011-1367, 2012 WL 5382736 (Fed. Cir. Nov. 5, 2012) ............................. 10
`
`Vasudevan Software, Inc. v. TIBCO Software Inc.,
`2012 WL 1831543 (N.D. Cal. May 18, 2012) .......................................................................... 17
`
`Statutes
`
`35 U.S.C. § 271 ....................................................................................................................... 10, 13
`
`35 U.S.C. § 271(a) ........................................................................................................................ 10
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`35 U.S.C. § 271(b) ........................................................................................................................ 14
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`35 U.S.C. § 271(b)-(c) .................................................................................................................. 13
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`35 U.S.C. § 271(c) ........................................................................................................................ 18
`
`v
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`Exhibit 2001 Page 006
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 7 of 29
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`INTRODUCTION
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`Plaintiff Bonutti Skeletal Innovations LLC (“Plaintiff” or “Bonutti Skeletal”) is a non-
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`practicing entity and frequent litigator. The named inventor of each of the asserted patents is Dr.
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`Peter Bonutti, who is a named inventor or co-inventor on over 150 issued patents. (Amended
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`Compl. ¶ 10.) Dr. Bonutti is a knee and hip specialist. His website lists 17 “licensed inventions”
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`and all of them relate to knee and hip procedures.1 To the extent the preferred embodiments and
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`drawings depict specific bones, they depict leg bones (as in figures 1 and 2 of the ‘066, ‘944, and
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`‘363 patents). But in this case, all of the accused products are “spinal spacers”; defendant Globus
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`Medical, Inc. (“Globus”), a maker of spinal implants headquartered in Audubon, PA, does not
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`make knee or hip devices, and none is accused in this case.
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`In this suit, Plaintiff alleges that Globus directly, indirectly, and jointly infringed
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`unknown claims in patents that have 354 claims, and that its infringement was willful. In doing
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`so, however, Plaintiff recites nothing more than bare legal conclusions and general facts to
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`support its claims for indirect, joint and willful infringement. This isn’t the first time Plaintiff
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`has lodged unsupported claims against a company using these bare pleadings. The six patents at
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`issue have also been asserted against other defendants in the District of Massachusetts, in a
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`complaint that relies largely on the same boilerplate allegations. In fact, over the last three
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`years, Plaintiff has filed seven lawsuits across the country using most of the same boilerplate
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`allegations. As further discussed below, at least two of those complaints were dismissed without
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`prejudice for the same pleading deficiencies that plague this complaint.
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`Plaintiff does not identify which of the 354 claims Globus allegedly infringed. The only
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`details provided in the complaint are the identity of the accused Globus products and a document
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`1 http://bonutticlinic.com/physicians/bonutti.php
`1
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`Exhibit 2001 Page 007
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 8 of 29
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`purportedly showing Globus’s knowledge of one of the patents in 2011. The allegations are
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`insufficient to support many of the claims Plaintiff has lodged against Bonutti:
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`First, Plaintiff’s claims for direct infringement of the method claims contained in Counts
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`I and II should be dismissed because those claims necessarily rest on the theory that Globus—a
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`device maker—directed or controlled the actions of doctors, but Plaintiff fails to put forth facts to
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`support that implausible conclusion. Prior courts have dismissed similar claims asserted by
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`Plaintiff in the past. See Bonutti Skeletal Innovations LLC v. Conformis, Inc., No. 12-1109, 2013
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`WL 6040377 (D. Del. 2013); Bonutti Skeletal Innovations LLC v. Smith & Nephew, Inc., No. 12-
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`01111, 2013 WL 6058472 (D. Del. 2013).
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`Second, Plaintiff’s claims for indirect infringement in each Count should be dismissed
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`because Plaintiff pleads no facts to support Globus’s purported knowledge that (a) its products
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`infringed Plaintiff’s patents, (b) its products were specifically intended to infringe, or (c) its
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`products had no substantial non-infringing uses. The same courts have dismissed similar claims
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`filed by Plaintiff.
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`Finally, Plaintiff’s claims for willful infringement in each Count should be dismissed
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`because for every patent except one, Plaintiff fails to plead the required pre-suit knowledge of
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`the patent. Furthermore, all of the claims for willful infringement have zero factual support for
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`the required element that there be an objectively high likelihood that Globus’s products infringe.
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`The Supreme Court has made clear that the pleading rules are designed to ensure that a
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`plaintiff has a plausible and substantive basis for its allegations, and to put the defendant on
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`notice of those allegations. Plaintiff’s Amended Complaint does neither. Globus respectfully
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`2
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`Exhibit 2001 Page 008
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 9 of 29
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`submits that Plaintiff’s claims of direct infringement of the method claims, indirect infringement,
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`and willful infringement should be dismissed.
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`
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`For the Court’s convenience, the following chart summarizes which claims Globus is
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`seeking dismissal of:
`
`
`
`Count I (‘531)
`Count II (‘063)
`Count III (‘385)
`Count IV (‘066)
`Count V (‘944)
`Count VI (‘363)
`
`
`Direct Apparatus
`Claim
`No
`n/a
`No
`No
`No
`No
`
`Direct Method
`Claim
`Yes
`Yes
`n/a
`n/a
`n/a
`n/a
`
`Indirect Claims Willfulness
`Claims
`Yes
`Yes
`Yes
`Yes
`Yes
`Yes
`
`Yes
`Yes
`Yes
`Yes
`Yes
`Yes
`
`A.
`
`Bonutti Skeletal’s Nationwide Litigation Campaign
`
`BACKGROUND
`
`On December 19, 2014, Plaintiff filed its First Amended Complaint accusing Globus of
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`infringing six patents: U.S. Patent Nos. 6,099,531 (the “‘531 Patent”), 6,423,063 (the “‘063
`
`Patent”), 7,001,385 (the “‘385 Patent”), 8,486,066 (the “‘066 Patent”), 8,690,944 (the “‘944
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`Patent”), and 8,795,363 (the “‘363 Patent”) (Dkt. No. 5 at ¶¶ 6-12 (the “Amended Complaint” or
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`“Amend. Compl.”)).2 The six patents contain a total of 354 claims. Amend. Compl. Exs. A – E.
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`Plaintiff has not identified which of the 354 claims it accuses Globus of infringing, making it
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`impossible for Globus to analyze Plaintiff’s claims of infringement.
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` In Counts I and II of the Amended Complaint, Plaintiff seeks to hold Globus
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`vicariously liable for the direct infringement of method claims of the ‘531 and ‘063 by unnamed
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`2 A copy of the Amended Complaint, excluding exhibits, is attached as Exhibit 1. Unless
`otherwise noted, all references to ¶ numbers in this memorandum are to the Amended Complaint.
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`3
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`
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`Exhibit 2001 Page 009
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 10 of 29
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`medical practitioners. ¶¶ 19 & 33. In each Count, Plaintiff accuses Globus of indirectly
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`infringing each of the patents indirectly, under both contributory and induced infringement
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`theories. Id. In addition, in every Count, Plaintiff asserts that Globus’s alleged infringement of
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`each of the patents-in-suit was “willful and deliberate.” See, e.g., ¶ 31.
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`Plaintiff recently filed another lawsuit against defendants in the District of Massachusetts,
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`alleging infringement of the same patents-in-suit and using similar threadbare pleadings.3 In the
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`last three years, Plaintiff filed seven lawsuits against seven other defendants accusing them of
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`infringing other patents.4 Each of the six counts of the Amended Complaint in this case sets
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`forth pre-packaged allegations similar to those asserted by Plaintiff in each of its other cases.
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`B.
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`Plaintiff Does Not Plead Facts to Support Its Vicarious Liability Claims
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`In order to plead a claim for vicarious liability, Plaintiff must plead facts to support the
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`assertion that Defendant controlled or directed another party to infringe the patent. See § I(A)
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`infra. In the Amended Complaint, Plaintiff simply states “on information and belief” that
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`Globus has infringed the method claims of the ‘531 and ‘063 patents by “employing, contracting
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`with, or otherwise entering into an agency relationship with medical practitioners to perform
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`procedures that infringe one or more of the method claims” of those patents. ¶ 33. Plaintiff’s
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`3 See Plaintiff’s case against Depuy Synthes Sales, Inc. et al. (Civ. No. 14-14580) (D. Mass.),
`Dkt. 1 (asserting same patents). A copy of that complaint is attached as Exhibit 2. Judicial notice
`may be taken of this and other Bonutti Skeletal complaints. See, e.g., In re Wellbutrin SR/Zyban
`Antitrust Litig., 281 F. Supp. 2d 751, 755 (E.D. Pa. 2003) (“[M]atters of public record may also
`be considered without converting the motion to dismiss into a motion for summary judgment”).
`
` 4
`
` See Plaintiff’s cases against Smith & Nephew, Inc., No. 12-01111 (D. Del.); Arthrex, Inc., No.
`12-01380 (M.D. Fla.), D.I. 6 (“Arthrex Compl.”); ConforMIS, Inc., No. 12-01109 (D. Del.), D.I.
`1 (“ConforMIS Compl.”); DePuy Mitek LLC, et al., No. 12-11667 (D. Mass), D.I. 6 (“DePuy
`Compl.”); Linvatec Corp, et al., No. 12-01379 (M.D. Fla.) D.I. 27 (“Linvatec Compl.”); Wright
`Medical Group, No. 12-01110 (D. Del.), D.I. 7 (“Wright Compl.”); Zimmer Holdings, Inc., et
`al., No. 12-01107 (D. Del.), D.I. 10 (“Zimmer Compl.”).
`4
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`
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`Exhibit 2001 Page 010
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 11 of 29
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`only allegation on this score is that it “provide[s] surgical technique guides and instruments for
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`implanting spinal spacers in a patient in a manner that infringes the” patents. ¶ 36.
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`The complaint fails to say whom Globus has allegedly contracted with, how these parties
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`acted as Plaintiff’s agent, or what the relationship was between them. Indeed, Plaintiff does not
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`even allege that Globus had any of these specific relationships with anyone – it merely alleges
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`that Plaintiff “employ[ed], contract[ed] with, or otherwise enter[ed] into an agency relationship.”
`
`¶ 33 (emphasis added). The lack of any detail is significant here given that Plaintiff’s
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`allegation—that medical doctors nationwide, despite federal and state rules requiring them to act
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`independently, are somehow controlled by Globus and act as its agents—is implausible on its
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`face. The only reason these allegations are made is so Plaintiff could charge Globus, which does
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`not practice the methods itself, with direct infringement.
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`C.
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`Plaintiff Does Not Plead Facts to Support its Indirect Infringement Claims
`
`To support its claims of induced infringement, Plaintiff must plead facts that show that
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`Globus knew of the infringement and possessed the specific intent to induce another’s
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`infringement. See § II(A)(1) infra. Likewise, to support its claims of contributory infringement,
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`Plaintiff must plead facts that show that Globus knew that the combination for which its products
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`were especially made was both patented and infringing and that it knew that its products were
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`especially made or adapted for that infringing use. See § II(B)(1) infra.
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`Plaintiff has not alleged facts to support the elements of knowledge of infringement,
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`intent to induce, or knowledge that Globus’s products were especially made or adapted for use in
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`an infringing manner. Indeed, the Amended Complaint includes nothing more than conclusory
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`legal conclusions to this effect. For each Count, Plaintiff asserts “on information and belief” that
`
`5
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`Exhibit 2001 Page 011
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 12 of 29
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`“Globus Medical has induced the infringement of and continues to induce the infringement of the
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`[patent-in-suit].” Id. ¶ 20. Its only support for this conclusion are the statements that “Globus
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`Medical encouraged and intended and continues to encourage and intend medical practitioners to
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`perform surgical techniques using Globus Medical products in a manner that directly infringes
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`the [patent-in-suit] (e.g., ¶ 22), and that Globus has, inter alia, sold instruments designed for use
`
`with its products and distributed surgical technique guides and instructions to alleged direct
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`infringers. See, e.g., ¶¶ 22-23. With respect to contributory infringement, Plaintiff merely
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`alleges that instruments distributed by Globus are “key to practicing the methods claimed in the
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`[patent-in-suit],” especially adapted for performing infringing procedures, and are not staple
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`articles of commerce suitable for a substantial non-infringing use “are specially designed to
`
`promote, encourage, and assist [direct infringers] in techniques that infringe [the patents].” See,
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`e.g., ¶ 16-28.
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`These cut-and-paste allegations, which are substantially the same as those that Plaintiff
`
`has alleged against other Defendants,5 fail to support a plausible inference that Globus
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`knowingly induced infringement, had specific intent to induce infringement, knew that its
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`products were patented and would infringe, or knew that its products were especially made to
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`infringe.
`
`
`
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`5 See, e.g., Zimmer Compl. ¶¶ 40-43, Wright Compl. ¶¶ 30-33, ConMed Compl. ¶¶ 28, 31,
`Arthrex Compl. ¶¶ 22, 23, ConforMIS Compl. ¶ 21, DePuy Compl. ¶¶ 40-44.
`6
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`
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`Exhibit 2001 Page 012
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 13 of 29
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`D.
`
`Plaintiff Alleges Pre-Suit Knowledge Only of ‘531 Patent
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`In order to support its claims that Globus indirectly and willfully infringed the patents-in-
`
`suit, Plaintiff must plead facts that show that Globus had knowledge of those specific patents.
`
`See § III(A) infra. The Amended Complaint includes only an allegation that Globus purportedly
`
`had actual knowledge of one of the six patents at issue—the ‘531 patent— “no later than July
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`21, 2011,” when it filed an Information Disclosure Statement that listed the ‘531 patent along
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`with 60 other patents. ¶ 21; Amend. Compl. Ex. F. For the remainder of the patents-in-suit,
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`Plaintiff solely alleges that Globus obtained actual knowledge of the rest of the patents-in-suit
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`“no later than the filing of this complaint.” ¶¶ 35, 48, 62, 76, 90.
`
`E.
`
`Plaintiff Does Not Plead Facts to Support its Willful Infringement Claims
`
`To plead willful infringement, Plaintiff must allege facts that not only show that Globus
`
`had subjective knowledge of the patents-in-suit, but also that Globus acted despite an objectively
`
`high likelihood that its actions constituted infringement. See § III infra. Plaintiff does not do so.
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`Instead, like its other claims, Plaintiff merely recites pre-packaged legal conclusions that
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`Defendant knew or should have known of the objectively high likelihood that Globus’s actions
`
`constituted infringement of a valid patent (e.g., id. at ¶ 30) and that Globus’s “infringement of
`
`the [patents-in-suit] is and has been willful and deliberate.” E.g., ¶ 31. This language is copied
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`wholesale from Plaintiff’s complaints against other defendants.6
`
`LEGAL STANDARD
`
`A complaint must contain “sufficient factual matter, accepted as true, to ‘state a claim to
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`relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell
`
`
`6 See, e.g., Zimmer Compl. ¶¶ 45-46, Wright Compl. ¶¶ 35-36, DePuy Compl. ¶ 45.
`7
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`
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`Exhibit 2001 Page 013
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 14 of 29
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`Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007); Senju Pharm. Co., Ltd v. Apotex, Inc., Civ. No.
`
`12-159, 2013 WL 444928, at *2 (D. Del. Feb. 6, 2013). The pleading requirements for indirect
`
`infringement, and for direct infringement through an agent, must meet the Twombly standards.
`
`See In re Bill of Lading Transmission & Processing Sys. Patent Litig., 681 F.3d 1323, 1337 (Fed.
`
`Cir. 2012) (indirect infringement); Bonutti Skeletal Innovations LLC v. Smith & Nephew, Inc.,
`
`No. 12-1111-GMS, 2013 WL 6058472, at *1 (D. Del. Nov. 18, 2013) (agency pleading for direct
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`infringement).
`
`The Supreme Court has described a two-pronged approach to determine the sufficiency
`
`of the claims. First, the court must separate factual and legal allegations, accepting the well-
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`pleaded facts as true and disregarding legal conclusions. See Iqbal, 556 U.S. at 678 (“[T]he tenet
`
`that a court must accept as true all of the allegations contained in a complaint is inapplicable to
`
`legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere
`
`conclusory statements, do not suffice.”); Twombly, 550 U.S. at 555 (“[A] plaintiff’s obligation to
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`provide the ‘grounds’ of his ‘entitlement to relief’ requires more than labels and conclusions, and
`
`a formulaic recitation of the elements of a cause of action will not do.” (citation omitted)).
`
`Second, the court must determine whether the facts alleged state a plausible claim by providing
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`factual support for each element of the claim. See Iqbal, 556 U.S. at 679. A plaintiff does not
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`plead a plausible claim “where the well-pleaded facts do not permit the court to infer more than
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`the mere possibility of misconduct,” and a complaint that “pleads facts that are merely consistent
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`with a defendant’s liability . . . stops short of the line between possibility and plausibility.” Id. at
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`678, 679 (internal quotation omitted).
`
`8
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`
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`Exhibit 2001 Page 014
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 15 of 29
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`If the plaintiff does not meet this pleading standard, its claims must be dismissed
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`pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. See Iqbal, 556
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`U.S. at 678 (the rules of civil procedure “demand[] more than an unadorned, the-defendant-
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`unlawfully-harmed-me accusation”); Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir.
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`2009) (“After Iqbal, it is clear that conclusory or ‘bare-bones’ allegations will no longer survive
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`a motion to dismiss.”); see also Mallinckrodt Inc. v. E-Z-EM Inc., 670 F. Supp. 2d 349, 354-55
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`(D. Del. 2009) (dismissing allegations of indirect infringement where plaintiff did not set forth
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`any basis for required elements of the claims).
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`ARGUMENT
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`I.
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`PLAINTIFF’S DIRECT METHOD CLAIMS IN COUNTS I AND II SHOULD BE
`DISMISSED
`
`For every method claim in Counts I and II,7 Plaintiff alleges that unnamed “medical
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`practitioners” performed the steps of the method claims and that Globus is liable for their direct
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`infringement because Globus directed or controlled that activity. E.g., ¶ 19.8 Plaintiff offers no
`
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`7 The ‘385 patent asserted in Count III also has method claims, but Bonutti does not allege direct
`infringement of those method claims. The patents asserted in Counts IV through VI do not have
`method claims.
`
` 8
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` Plaintiff does not, and cannot, allege that Globus itself infringed any method claims for the
`simple reason that, as the ‘531 and ‘063 patents state, the patented methods are for “Changing
`Relationship Between Bones,” and Globus is a supplier of medical products, not a medical
`practitioner that changes the relationship between bones in patients. Cf. Bonutti Skeletal
`Innovations LLC v. Conformis, Inc., No. CV 12-1109-GMS, 2013 WL 6040377, at *2 (D. Del.
`Nov. 14, 2013) (“In the instant case, Bonutti clearly asserts a joint infringement theory [for the
`method claims]. Indeed, Bonutti must assert joint infringement because, as the ‘896 patent states,
`the ‘896 patent is for “[a]n improved method of performing surgery on a joint in a patient’s body,
`such as a knee....” There is no indication that ConforMIS performs surgery on patients.”
`(citations added).
`
`9
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`
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`Exhibit 2001 Page 015
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 16 of 29
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`facts to support these allegations, and at least two of its prior complaints alleging similar claims
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`have been dismissed for the same reason.
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`A.
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`Plaintiff Must Plead That Globus Directed or Controlled Direct Infringers
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`A party may be liable for direct infringement under 35 U.S.C. § 271(a) if it performs each
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`and every step of a claimed method or process. It also may be liable for direct infringement
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`committed by another person if it does not perform the steps itself, but exercises “control or
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`direction” over the performance of each claimed step, such that every step is attributable to it.
`
`See Travel Sentry, Inc. v. Tropp, Nos. 2011-1023, 2011-1367, 2012 WL 5382736, at *6 (Fed.
`
`Cir. Nov. 5, 2012) (citing BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir.
`
`2007), overruled on other grounds by Akamai Techs., Inc. v. Limelight Networks, Inc., 692 F.3d
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`1301, 1306, 1309 (Fed. Cir. 2012)).
`
`Plaintiff’s vicarious claim for direct infringement of the method claims requires it to
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`plead facts from which a Court can infer that the defendant “directs or controls” the third party’s
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`conduct. See e.g., Bonutti Skeletal Innovations LLC v. Conformis, Inc., No. CV 12-1109-GMS,
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`2013 WL 6040377, at *2 (D. Del. Nov. 14, 2013) (“only if the complaint pleads facts from
`
`which the court can infer that [defendant] directs or controls the surgeons’ performance of the
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`‘896 patent’s method can Bonutti’s direct infringement claim survive.”). “‘Direction or control’
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`requires that there be an agency relationship between the alleged infringers or the equivalent.”
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`Bonutti Skeletal Innovations LLC v. Conformis, Inc., No. CV 12-1109-GMS, 2013 WL 6040377,
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`at *2 (D. Del. Nov. 14, 2013). The “control or direction” standard is “satisfied in situations
`
`where the law would traditionally hold the accused direct infringer vicariously liable for the acts
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`committed by another party that are required to complete performance of a claimed method.”
`
`10
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`
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`Exhibit 2001 Page 016
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`
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`Case 2:14-cv-06650-WB Document 17-1 Filed 02/23/15 Page 17 of 29
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`Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1330 (Fed. Cir. 2008).
`
`
`B.
`
`Plaintiff Fails to Allege that Globus Directed or Controlled Others
`
`Plaintiff has done nothing more than use the words “agency,” “direct and control” and
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`“vicarious liability” in its Amended Complaint to describe any claim for vicarious direct
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`infringement. It has not even alleged that Globus directed or controlled any other directly
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`infringing party; much less offered any facts to support that conclusion. While it makes the
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`conclusory allegation that Globus “employ[ed], contract[ed] with, or otherwise enter[ed] into an
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`agency relationship” with medical practitioners that directly infringed, Plaintiff fails to plead a
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`single fact in support of those allegations. Two pri