CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 1 of 65
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`Court File No. 0:19-cv-1760 (PJS/TNL)
`
`REDACTED
`
`VASCULAR SOLUTIONS LLC;
`TELEFLEX INNOVATIONS S.à r.l.,
`ARROW INTERNATIONAL, INC.,
`and TELEFLEX LLC,
`
`Plaintiffs/
`Counterclaim Defendants,
`
`v.
`
`MEDTRONIC, INC. and
`MEDTRONIC VASCULAR, INC.,
`
`Defendants/
`Counterclaim Plaintiffs.
`
`DEFENDANTS’ OPPOSITION TO PLAINTIFFS’
`MOTION FOR PRELIMINARY INJUNCTION
`
`
`Page 1
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`Teleflex Ex. 2048
`Medtronic v. Teleflex
`IPR2020-00135
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`

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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 2 of 65
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .............................................................................................. iv
`
`INTRODUCTION ............................................................................................................... 1
`
`I.
`
`THE PARTIES’ CLAIMS AND TELEFLEX’S MOTION FOR A
`PRELIMINARY INJUNCTION. ............................................................................. 2
`
`A.
`
`B.
`
`C.
`
`D.
`
`Teleflex’s Claims and Medtronic’s Counterclaims. ...................................... 2
`
`Medtronic’s Recently Filed IPRs. ................................................................. 3
`
`Teleflex’s Request for Extraordinary Relief. ................................................ 4
`
`Teleflex’s Characterization of the Parties is Misleading. ............................. 5
`
`TELEFLEX’S INTERVENTIONAL BUSINESS UNIT AND
`ACQUISITION OF VSI. .......................................................................................... 5
`
`GUIDELINER IS THE LEADING GEC. ................................................................ 7
`
`TELEFLEX SUCCESSFULLY COMPETES AGAINST BSC. ............................. 8
`
`A.
`
`B.
`
`Teleflex Licensed the Patents-in-Suit to BSC in 2014. ................................. 8
`
`Teleflex Maintained its Large Market Share and High Margin on
`GuideLiner after BSC Started Selling Guidezilla. ........................................ 8
`
`II.
`
`III.
`
`IV.
`
`V.
`
`MEDTRONIC SPENT YEARS DEVELOPING TELESCOPE™ TO BE
`DIFFERENT FROM EXISTING GECS, INCLUDING GUIDELINER. ............. 10
`
`A.
`
`B.
`
`C.
`
`D.
`
`Medtronic Designed Telescope™ to Remedy the Deficiencies in
`GuideLiner and Guidezilla. ......................................................................... 10
`
`Telescope™ is Not a Copy of GuideLiner. ................................................. 10
`
`Medtronic Emphasizes the Differences between Telescope™ and
`Other GECs. ................................................................................................ 12
`
`Telescope™ Can be Successfully Used in Cases that GuideLiner
`Cannot. ........................................................................................................ 14
`
`VI.
`
`THE MINIMAL IMPACT TELESCOPE HAS ALLEGEDLY HAD ON
`GUIDELINER IS ADMITTELY QUANTIFIABLE. ........................................... 16
`
`i
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 3 of 65
`
`VII.
`
`STATE OF THE ART AT THE TIME OF THE ORIGINAL PATENT
`APPLICATION. ..................................................................................................... 18
`
`VIII. TELEFLEX’S INITIAL DESIGN AND ORIGINAL PATENT
`APPLICATION. ..................................................................................................... 20
`
`A.
`
`B.
`
`Teleflex Initially Worked on a Mother-and-Child GEC. ............................ 20
`
`Teleflex’s Original Patent Application Disclosed a GEC with an
`Opening Only in the Substantially Rigid Portion. ....................................... 21
`
`IX.
`
`TELEFLEX IMPROPERLY OBTAINED BROADER PATENT CLAIMS
`TRYING TO COVER ITS CHANGING PRODUCT DESIGN. .......................... 22
`
`ARGUMENT ..................................................................................................................... 25
`
`I.
`
`II.
`
`A PRELIMINARY INJUNCTION IS AN EXTRAORDINARY REMEDY
`THAT CANNOT BE GRANTED IN THE ABSENCE OF
`IRREPARBALE HARM OR SUCCESS ON THE MERITS. .............................. 25
`
`TELEFLEX HAS NOT AND WILL NOT SUFFER IRREPARABLE
`HARM. ................................................................................................................... 26
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`The Welch Declaration Fails to Establish Irreparable Harm. ..................... 26
`
`Teleflex Concedes that Any Alleged Harm is Quantifiable. ....................... 29
`
`Teleflex Will Not Suffer Irreparable Loss of Market Share. ...................... 30
`
`Teleflex Will Not Suffer Irreparable Price Erosion. ................................... 32
`
`Teleflex Will Not Suffer Irreparable Lost Sales of Other Products. ........... 33
`
`Teleflex Will Not Suffer Irreparable Sales Force Attrition. ....................... 33
`
`Teleflex Will Not Suffer Irreparable Harm to Reputation. ......................... 34
`
`Teleflex Will Not Suffer Irreparable Loss of Revenue to Fund R&D. ....... 35
`
`III.
`
`TELEFLEX IS UNLIKELY TO SUCCEED ON THE MERITS.......................... 37
`
`A.
`
`The Asserted Claims of the Patents-in-Suit are Invalid. ............................. 38
`
`1.
`
`The Asserted Claims are Invalid under 35 U.S.C. §§ 102
`and/or 103. ........................................................................................ 38
`
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 4 of 65
`
`
`
`a.
`
`b.
`
`c.
`
`Itou, alone and in view of either Ressemann, Kataishi,
`or Enger, anticipate and make obvious every asserted
`patent claim. .......................................................................... 39
`
`Kontos in view of Adams makes obvious the ’380
`asserted patent claims, and in view of Ressemann
`makes obvious the ’776 asserted patent claims. ................... 42
`
`Ressemann, alone and in view of the Takahashi
`publication, anticipates or makes obvious each asserted
`claim of the ’379 and ’760 patents. ....................................... 44
`
`2.
`
`The Asserted Claims of the ’760, ’379, and ’776 Patents are
`Also Invalid Under 35 U.S.C. § 112 for Lack of Written
`Description. ...................................................................................... 46
`
`B. Medtronic Does Not Infringe the Asserted Claims. .................................... 48
`
`1.
`
`2.
`
`3.
`
`Medtronic Does Not Directly or Indirectly Infringe the ‘379
`Patent Because Neither It nor Anyone Else Forms a Device
`with a Guide Catheter. ...................................................................... 49
`
`Medtronic Does Not Directly or Indirectly Infringe the
`System Claims in the ’760 Patent. ................................................... 51
`
`Medtronic Does Not Directly or Indirectly Infringe the
`System Claims in the ’380 Patent. ................................................... 53
`
`IV.
`
`V.
`
`THE BALANCE OF HARMS FAVORS MEDTRONIC. .................................... 55
`
`THE PUBLIC INTEREST WOULD NOT BE SERVED BY AN
`INJUNCTION. ....................................................................................................... 55
`
`CONCLUSION ................................................................................................................. 57
`
`
`
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 5 of 65
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Abbott Cardiovascular Sys., Inc. v. Edwards Lifesciences Corp.,
`No. 19-cv-149 (MN), 2019 WL 2521305, (D. Del. June 6, 2019) ............ 25, 30, 34, 56
`
`Abbott Labs. v. Andrx Pharm., Inc.,
`452 F.3d 1331 (Fed. Cir. 2006) .................................................................................... 26
`
`Acumed LLC v. Stryker Corp.,
`551 F.3d 1323 (Fed. Cir. 2008) .................................................................................... 29
`
`Advanced Cardiovascular Sys., Inc. v. Medtronic Vascular, Inc.,
`579 F. Supp. 2d 554 (D. Del. 2008) ............................................................................. 29
`
`Altana Pharma AG v. Teva Pharm. USA, Inc.,
`566 F.3d 999 (Fed. Cir. 2009) ................................................................................ 37, 38
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) ........................................................................ 25, 37, 38
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003) .................................................................................... 48
`
`Apple Inc. v. Samsung Elecs. Co.,
`809 F.3d 633 (Fed. Cir. 2015) ...................................................................................... 30
`
`Apple, Inc. v. Samsung Elecs. Co.,
`678 F.3d 1314 (Fed. Cir. 2012) .................................................................................... 26
`
`Ariad Pharm., Inc. v. Eli Lily & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) .............................................................................. 46, 47
`
`Automated Merch. Sys., Inc. v. Crane Co.,
`357 F. App’x 297 (Fed. Cir. 2009) .............................................................................. 26
`
`CardioVention, Inc. v. Medtronic, Inc.,
`483 F. Supp. 2d 830 (D. Minn. 2007) .......................................................................... 11
`
`Celsis In Vitro, Inc. v. CellzDirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012) ...................................................................................... 26
`
`Centillion Data Sys., LLC v. Qwest Commc’ns Int’l, Inc.,
`631 F.3d 1279 (Fed. Cir. 2011) .................................................................................... 51
`
`iv
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 6 of 65
`
`
`
`Cordis Corp. v. Bos. Sci. Corp.,
`99 F. App’x 928 (Fed. Cir. 2004) ................................................................................ 56
`
`Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc.,
`424 F.3d 1293 (Fed. Cir. 2005) .............................................................................. 50, 53
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`717 F.3d 1336 (Fed. Cir. 2013) .................................................................................... 34
`
`DSU Med. Corp. v. JMS Co.,
`471 F.3d 1293 (Fed. Cir. 2006) .................................................................................... 53
`
`Eli Lily & Co. v. Amer. Cyanamid Co.,
`82 F.3d 1568 (Fed. Cir. 1996) ...................................................................................... 36
`
`Epcon Gas Sys., Inc. v. Bauer Compressors, Inc.,
`279 F.3d 1022 (Fed. Cir. 2002) .................................................................................... 52
`
`Erico Int’l Corp. v. Vutec Corp.,
`516 F.3d 1350 (Fed. Cir. 2008) .................................................................................... 37
`
`Ethicon Endo-Surgery, Inc. v. Hologic, Inc.,
`689 F. Supp. 2d 929 (S.D. Ohio 2010) ........................................................................ 11
`
`Hoist Fitness Sys., Inc. v. Tuffstuff Fitness Int’l, Inc.,
`No. 17-cv-01388-AB (KKx), 2017 WL 5640562 (C.D. Cal. Oct. 31, 2017) .............. 28
`
`Illinois Tool Works, Inc. v. Grip-Pak, Inc.,
`906 F.2d 679 (Fed. Cir. 1990) ...................................................................................... 37
`
`Intel Corp. v. ULSI Sys. Tech., Inc.,
`995 F.2d 1566 (Fed. Cir. 1993) .................................................................................... 25
`
`Interconnect Planning Corp. v. Feil,
`774 F.2d 1132 (Fed. Cir. 1985) .................................................................................... 38
`
`Intex Recreation Corp. v. Team Worldwide Corp.,
`541 F. Supp. 2d 113 (D.D.C. 2008), set aside on other grounds by 42 F.
`Supp. 3d 80 (D.D.C. 2013) .......................................................................................... 54
`
`InVue Security Prods. Inc. v. Vanguard Prods. Grp., Inc.,
`No. 8:18-cv-2548-T-33SPF, 2019 WL 4671143 (M.D. Fla. July 1, 2019) ................. 28
`
`Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342 (Fed. Cir. 2008) .................................................................................... 11
`
`v
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`
`Linear Tech. Corp. v. Impala Linear Corp.,
`379 F.3d 1311 (Fed. Cir. 2004) .............................................................................. 50, 54
`
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) ...................................................................................... 40
`
`Metalcraft of Mayville, Inc. v. Toro Co.,
`848 F.3d 1358 (Fed. Cir. 2017) .................................................................................... 30
`
`Mirror Worlds, LLC v. Apple Inc.,
`692 F.3d 1351 (Fed. Cir. 2012) .................................................................................... 52
`
`Murata Mach. USA v. Daifuku Co.,
`830 F.3d 1357 (Fed. Cir. 2016) .................................................................................... 25
`
`Nutrition 21 v. United States,
`930 F.2d 867 (Fed. Cir. 1991) ...................................................................................... 30
`
`Omega Patents, LLC v. CalAmp Corp.,
`920 F.3d 1337 (Fed Cir. 2019) ..................................................................................... 51
`
`Polymer Techs., Inc. v. Bridwell,
`103 F.3d 970 (Fed. Cir. 1996) ...................................................................................... 25
`
`Pruvit Ventures, Inc. v. Forevergreen Int’l LLC,
`No 4:15-CV-571-ALM-CAN, 2015 WL 9876952 (E.D. Tex. Dec. 23, 2015) ........... 32
`
`QXMédical, LLC v. Vascular Solutions, LLC et al.,
`No. 0:17-cv-01969-PJS-TNL (D. Minn.) ...................................................................... 4
`
`Retractable Techs., Inc. v. Becton, Dickinson & Co.,
`No. 2:07-cv-250, 2009 WL 8725107 (E.D. Tex. Oct. 8, 2009) ................................... 11
`
`Revolution Eyewear, Inc. v. Aspex Eyewear, Inc.,
`563 F.3d 1358 (Fed. Cir. 2009) .............................................................................. 46, 47
`
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994) ...................................................................................... 40
`
`Trilithic, Inc. v. Wavetek U.S., Inc.,
`64 F. Supp. 2d 816 (S.D. Ind. 1999) ............................................................................ 54
`
`Trustees of Columbia Univ. v. Roche Diagnostics GmbH,
`272 F. Supp. 2d 90 (D. Mass. Sept. 30, 2002) ............................................................. 50
`
`vi
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`
`Upjohn Co. v Medtron Labs., Inc.,
`751 F. Supp. 416 (S.D.N.Y. 1990) ............................................................................... 35
`
`Wavetronix, LLC v. Iteris, Inc.,
`No. A-14-CA-970-SS, 2015 WL 300726 (W.D. Tex. Jan. 22, 2015) ......................... 34
`
`Winter v. Nat. Res. Def. Council, Inc.,
`555 U.S. 7 (2008) ................................................................................................... 26, 32
`
`STATUTES
`
`35 U.S.C. § 102 .......................................................................................................... passim
`
`35 U.S.C. § 103 ............................................................................................................. 3, 38
`
`35 U.S.C. § 112 ................................................................................................. 3, 46, 47, 48
`
`35 U.S.C. § 251 ................................................................................................................. 46
`
`35 U.S.C. § 271 ........................................................................................................... 49, 50
`
`vii
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`
`
`INTRODUCTION
`
`Plaintiffs (collectively, “Teleflex”) have not come close to proving that they are
`
`entitled to the drastic and extraordinary relief they are seeking. To the contrary,
`
`Teleflex’s motion relies primarily on speculative allegations of irreparable harm to an
`
`entity that no longer exists based solely on a declaration from a salesperson
`
`
`
`Reality is remarkably different than the picture Teleflex tries to paint for the
`
`Court. The patents-in-suit are owned by a large, multinational company
`
`
`
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`
`
`
` Likewise,
`
`
`
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`
`
`
`Teleflex admits that the minimal losses it has allegedly suffered are easily quantified, a
`
`fact that is further supported by Teleflex’s 2014 license of the patents-in-suit to Boston
`
`Scientific, the interventional cardiology market leader.
`
`Teleflex’s claim is also flawed on the merits. In this response and its recently filed
`
`petitions for inter parties review, Medtronic raises substantial questions of invalidity and
`
`non-infringement. This is another reason to deny Teleflex’s motion.
`
`Finally, the accused product – Medtronic’s Telescope™ guide extension catheter
`
`(“GEC”) – is preferred by some physicians because it can be used successfully in
`
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 10 of 65
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`
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`procedures that GuideLiner cannot. Under these circumstances, injunctive relief is
`
`against the public interest.
`
`For these reasons and those set forth herein, the Court should deny Teleflex’s
`
`request for a preliminary injunction.
`
`FACTS
`
`I.
`
`THE PARTIES’ CLAIMS AND TELEFLEX’S MOTION FOR A
`PRELIMINARY INJUNCTION.
`A.
`
`Teleflex’s Claims and Medtronic’s Counterclaims.
`
`On July 2, 2019, Teleflex filed its Complaint against Medtronic asserting five
`
`claims for infringement of U.S. Patent Nos. 8,048,032 (the “’032 patent”), RE45,380 (the
`
`“’380 patent”), RE45,776 (the “’776 patent”), RE47,379 (the “’379 patent”), and
`
`RE45,760 (the “’760 patent”). Dkt. No. 1. The Complaint alleges that Teleflex
`
`Innovations S.à r.l. owns the patents-in-suit and that Teleflex LLC now has “the
`
`exclusive right to offer to sell and sell under the patents-in-suit. Id., ¶¶ 2-4. In other
`
`words, Vascular Solutions, LLC (formerly Vascular Solutions, Inc.) does not own the
`
`patents-in-suit or sell GuideLiner. See id.; Ex. A, 23:25-24:5, 246:12-25.1
`
`Medtronic filed its Answer, Defenses, and Counterclaims on August 23, 2019.
`
`Dkt. No. 16. Among others, Medtronic asserted non-infringement and invalidity
`
`defenses. Id., p. 40. Medtronic also brought five counterclaims seeking declaratory
`
`
`1
`Unless otherwise indicated, lettered exhibits are attached to the Declaration of
`Lora M. Friedemann and numbered exhibits are attached to the Declaration of Kurt J.
`Niederluecke.
`
`2
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`
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`judgment that the patents-in-suit are invalid for several reasons, including under
`
`35 U.S.C. §§ 102, 103, and 112. Id., pp. 43-45.
`
`B. Medtronic’s Recently Filed IPRs.
`
`Medtronic recently filed 13 petitions for inter parties review of the patents-in-suit,
`
`asserting that all the claims are invalid due to anticipation and/or obviousness. See
`
`Niederluecke Decl., ¶ 2. U.S. Patent No. 7,736,355 (the “Itou patent”), one of the
`
`primary references cited in the IPRs that was not before the examiner during prosecution
`
`of the patents-in-suit, is new to this Court as well. Id., ¶ 3; Dkt. No. 77-9. The Itou
`
`patent discloses the combination of a guide catheter and a rapid exchange extension
`
`catheter placed inside the guide catheter. Ex. 1. As shown in the exemplary figure
`
`below, the claimed extension catheter contains a pushrod, an onramp and entry port, a
`
`reinforced portion, and a soft tip:
`
`Id., Fig. 1 (color annotations added); 2:22-3:24. The Itou patent also teaches placing a
`
`guide catheter in the ostium of the coronary artery in an interventional cardiology
`
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`3
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`
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`procedure, while allowing the extension catheter to extend into the coronary artery. Id.,
`
`1:66-2:11.
`
`C.
`
`Teleflex’s Request for Extraordinary Relief.
`
`After filing its Complaint, Teleflex notified Medtronic of its intent to seek a
`
`preliminary injunction. See Friedemann Decl., ¶ 3. This was surprising since Teleflex
`
`has licensed the patents-in-suit to one of its largest competitors, Boston Scientific
`
`Corporation (“BSC”), and did not seek a preliminary injunction in its pending
`
`infringement case against QXMédical, LLC (“QXM”). See id., Ex. B; see also
`
`QXMédical, LLC v. Vascular Solutions, LLC et al., No. 0:17-cv-01969-PJS-TNL (D.
`
`Minn.).
`
`Teleflex’s motion is based on a cursory discussion of infringement as well as
`
`speculative and grossly-exaggerated allegations of irreparable harm. See Dkt. No. 75.
`
`Teleflex claims success based on four of the five patents-in-suit and identifies a handful
`
`of claims in each that are allegedly infringed. See id., p. 13. The purported harm is based
`
`entirely on a specious declaration of one of two sales directors in Teleflex’s
`
`Interventional North America business unit who
`
`
`
` See Ex. A, 10:5-25,
`
`12:10-13:3, 13:20-25, 18:12-21, 158:15-159:9, 213:3-9. Teleflex also relies heavily on
`
`the alleged harm to the former owner of the patents-in-suit, Vascular Solutions, Inc.
`
`(“VSI”), as opposed to the current owner and seller of GuideLiner. See Dkt. Nos. 75, 78.
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`4
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`
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`D.
`
`Teleflex’s Characterization of the Parties is Misleading.
`
`In its attempt to persuade the Court to focus on the now-defunct VSI, Teleflex
`
`deceptively groups all Plaintiffs together as “VSI.” See Dkt. No. 75, p. 1; Dkt. No. 78,
`
`¶ 3. Doing so resulted in numerous misleading statements in Teleflex’s motion papers,
`
`e.g., that GuideLiner is the “core” of Teleflex’s business and Teleflex’s “best-selling,”
`
`“most profitable,” and “most successful” product with the “highest profit margin.” See,
`
`e.g., Dkt. No. 75, pp. 20, 23, 28; Dkt. No. 78, ¶¶ 13, 14, 62.
`
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`Ex. A at 250:13-18, 258:14-259:11; see also id. at 320:15-321:9.
`
`
`
`II.
`
`TELEFLEX’S INTERVENTIONAL BUSINESS UNIT AND ACQUISITION
`OF VSI.
`
`In February 2017, Teleflex Incorporated, a global provider of medical technology
`
`products, acquired VSI and combined it with two existing Teleflex entities to form one
`
`business unit known as Teleflex Interventional. See Ex. C at VSIMDT00002880-81. As
`
`shown below, the North American portion of that business unit constituted only 11% of
`
`Teleflex Incorporated’s revenues in 2018.
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`5
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`
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`Ex. D, .pdf p. 3; see also Ex. A at 112:17-21.
`
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`
`
`
`
`
` Dkt. No. 78, ¶ 14;
`
`Ex A at 115:5-17, 254:17-258:13; Ex. HHH (Declaration of Rich Lettiere), ¶ 24.
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`III. GUIDELINER IS THE LEADING GEC.
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`Teleflex sells a wide variety of products used in interventional cardiology. See
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`Ex. C. One of those products is GuideLiner, which is used only in complex percutaneous
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`coronary interventions (“PCI”). Ex. A at 33:5-10, 46:2-7.
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 16 of 65
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`IV. TELEFLEX SUCCESSFULLY COMPETES AGAINST BSC.
`A.
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`Teleflex Licensed the Patents-in-Suit to BSC in 2014.
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`Teleflex sued BSC for infringement in 2013. See Dkt. No. 75, p. 6. After the
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`Federal Circuit reversed this Court’s entry of a preliminary injunction because “there are
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`too many unresolved issues at this stage of the case and the record is too incomplete on
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`issues of claim construction, infringement, and ultimate validity to warrant the grant of a
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`preliminary injunction,” Teleflex and BSC entered into a settlement agreement in 2014.
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`See Exs. J, B. Teleflex granted BSC a license to the patents-in-suit
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` Since that time, BSC has been selling its
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`Guidezilla GEC and paying royalties to Teleflex. See Ex. K.
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`B.
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`Teleflex Maintained its Large Market Share and High Margin on
`GuideLiner after BSC Started Selling Guidezilla.
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`When Teleflex moved for a preliminary injunction against BSC, it made the same
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`arguments it is making against Medtronic, e.g., irreparable price erosion, loss of
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`associated sales of other products, lack of profits to fund new R&D projects, sales force
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`attrition, and change in reputation from innovator to competitor. Ex. L at
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`VSIQXM_E00049669-71. Indeed, parts of Teleflex’s current motion appear to be lifted
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`directly from its motion against BSC. See, e.g., id. at VSIQXM_E00049655 (“Now, the
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`largest company in VSI’s industry, Boston Scientific Corporation [ ], has created a
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`‘copycat’ device – the Guidezilla – that infringes VSI’s patents. . . . If not stopped very
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`soon, Boston will immediately and irreparably alter the market for the GuideLiner and
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`damage VSI’s growth and expansion plans, all as a free ride on VSI’s invention.”).
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`None of Teleflex’s doomsday scenarios came to fruition.
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 18 of 65
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`V. MEDTRONIC SPENT YEARS DEVELOPING TELESCOPE™ TO BE
`DIFFERENT FROM EXISTING GECS, INCLUDING GUIDELINER.
`A. Medtronic Designed Telescope™ to Remedy the Deficiencies in
`GuideLiner and Guidezilla.
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`In 2015, Medtronic started seeking input from hundreds of interventional
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`cardiologists concerning their experiences with GuideLiner and Guidezilla. Declaration
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`of James Phelan, dated November 15, 2019 (“Phelan”), ¶ 6. Medtronic also analyzed 580
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`reports of adverse events involving these products from the FDA MAUDE database. Id.
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`After identifying the opportunity for improvement, Medtronic began working to design a
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`GEC that would work better than GuideLiner and Guidezilla. Id., ¶ 7. Medtronic
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`invested years
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` develop Telescope™, focusing on designing a
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`GEC with superior deliverability and an improved entry port for interventional
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`cardiology devices. Id., ¶¶ 7-22. Medtronic’s efforts resulted in several unique features
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`in Telescope™, including a stiffer pushrod, a softer distal tip, and a tapered pushrod that
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`feeds into a polymer-coated onramp with two distinct tapers to help channel a stent or
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`balloon. See id.
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`B.
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`Telescope™ is Not a Copy of GuideLiner.
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`Teleflex’s motion papers repeatedly state that Telescope™ is a “copy” of
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`GuideLiner. Welch conceded that
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`Teleflex also implies that Telescope™ is a copy because Medtronic identified
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`GuideLiner as a predicate device in its 510(k) application to the FDA. Teleflex ignores
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`the explicit references to the “technological differences in the new device” and that the
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`relevant inquiry is substantial equivalence, not whether the new device is a copy of the
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`predicate device.2 See Dkt. No. 77-5, p. 5; Declaration of Heather Rosecrans, dated
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`November 15, 2019 (“Rosecrans”), ¶ 66.
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`Telescope™ was designed to be better than GuideLiner; it is not a copy. See
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`Phelan, ¶¶ 6-22; Declaration of Mark Cardoso, dated November 14, 2019 (“Cardoso”),
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`2
`It is well established that “FDA equivalence is irrelevant to patent law because it
`involves fundamentally different inquiries.” Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342, 1349 n.3 (Fed. Cir. 2008) (explaining possibility of jury confusion); see
`also Ethicon Endo-Surgery, Inc. v. Hologic, Inc., 689 F. Supp. 2d 929, 936 (S.D. Ohio
`2010) (stating that “[s]everal district courts have held that it is not proper to consider
`statements made in a FDA 510(k) notification” in patent litigation); Retractable Techs.,
`Inc. v. Becton, Dickinson & Co., No. 2:07-cv-250, 2009 WL 8725107, at *5 (E.D. Tex.
`Oct. 8, 2009) (granting motion in limine to preclude evidence from an FDA 510(k)
`submission as irrelevant); CardioVention, Inc. v. Medtronic, Inc., 483 F. Supp. 2d 830,
`840 (D. Minn. 2007) (“Courts have repeatedly refused to allow FDA 510(k) notification
`of substantial equivalence as admission of infringement in patent cases.”).
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`¶ 6. Yet, in an effort to avoid expensive and unnecessary litigation, Medtronic,
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`recognizing that BSC already had a license, reached out to Teleflex about obtaining a
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`license to the patents-in-suit. See Ex. O. Teleflex seemed receptive to the idea, but
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`ultimately decided to proceed with this case instead. See id.
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`C. Medtronic Emphasizes the Differences between Telescope™ and Other
`GECs.
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`Contrary to Teleflex’s mischaracterization, Medtronic promotes Telescope™ by
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`emphasizing the differences between Telescope™ and GuideLiner. See Cardoso, ¶¶ 6-7.
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`Likewise, as shown in the examples below, Medtronic also highlights the differences
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`between Telescope™ and Guidezilla. See id.
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 21 of 65
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`Dkt. No. 79-4, pp. 8, 27, 29, 32, 34. Some of the differences between Telescope™ and
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`GuideLiner are the same as the ones Teleflex has relied on to successfully compete
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 22 of 65
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`against Guidezilla. For example, Telescope™ has a smaller effective inner diameter than
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`GuideLiner, a hydrophilic coating, and is offered in fewer sizes (two versus GuideLiner’s
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`five sizes). See Ex. M. Telescope™ also has a short on-ramp as compared to
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`GuideLiner’s long half-pipe. See id.
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`D.
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`Telescope™ Can be Successfully Used in Cases that GuideLiner
`Cannot.
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`The differences between the products cause Telescope™ to have better
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`deliverability and pushability:
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 23 of 65
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`Dkt. No. 79-4, pp. 7, 10. The unique soft tip on Telescope™ also requires less force to
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`deflect:
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`Id., p. 14. As a result, some physicians prefer the way Telescope™ moves in the body
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`and have found that they can use it in certain procedures where GuideLiner would not be
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`successful. See Cardoso, Ex. B
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 24 of 65
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`55:21-56:15.
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` Ex. A at
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`VI. THE MINIMAL IMPACT TELESCOPE HAS ALLEGEDLY HAD ON
`GUIDELINER IS ADMITTELY QUANTIFIABLE.
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`Telescope has been on the U.S. market for nearly six months. See Cardoso, ¶ 4.
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`Yet Teleflex’s motion papers
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`CASE 0:19-cv-01760-PJS-TNL Document 104 Filed 11/15/19 Page 25 of 65
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