BSC USP 8,048,032
`Exhibit 1026
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`CASE 0:13-cv-01172-JRT-SER Document 11 Filed 06/10/13 Page 1 of 40
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`Vascular Solutions, Inc.,
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`Plaintiff,
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`v.
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`Boston Scientific Corp.,
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`Defendant.
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`Civil File No. 0:13-cv-01172-JRT-SER
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`PLAINTIFF’S MEMORANDUM IN SUPPORT OF
`MOTION FOR PRELIMINARY INJUNCTION
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`TABLE OF CONTENTS
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`TABLE OF AUTHORITIES ........................................................................................... iii
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`INTRODUCTION ............................................................................................................ 1
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`STATEMENT OF FACTS ............................................................................................... 2
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`I.
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`II.
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`VSI IS A SUCCESSFUL SMALL MEDICAL DEVICE
`COMPANY, BUT DWARFED BY BOSTON’S RESOURCES .............. 2
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`VSI’S PATENTS SOLVED A LONG-STANDING PROBLEM
`IN INTERVENTIONAL CARDIOLOGY ................................................ 2
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`A.
`B.
`C.
`D.
`E.
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`Cardiac Catheterization Procedures ................................................ 2
`Limitations Of Guide Catheters ...................................................... 3
`Prior Attempts To Solve Guide Catheter Limitations ..................... 4
`Over-The-Wire And Monorail Systems .......................................... 5
`The GuideLiner And VSI’s Patents ................................................ 5
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`III. VSI’S GUIDELINER IS CLINICALLY AND COMMERCIALLY
`SUCCESSFUL ........................................................................................... 9
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`IV. BOSTON COPIES VSI’S GUIDELINER AND IFU .............................. 10
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`A.
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`B.
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`C.
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`D.
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`VSI Discovers And Boston Denies Development
`Of Guidezilla ................................................................................. 10
`VSI Verifies That Guidezilla Is A Copy Of GuideLiner And
`Infringes VSI’s Patents.................................................................. 11
`Boston’s DFU Copies GuideLiner’s IFU And Infringes VSI’s
`Copyright ....................................................................................... 14
`Boston Asserts One Infringement Defense ................................... 15
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`V.
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`BOSTON WILL CAUSE VSI SUBSTANTIAL AND
`IRREPARABLE HARM IF ALLOWED TO CONTINUE ITS
`INFRINGEMENT .................................................................................... 15
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`ARGUMENT .................................................................................................................. 18
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`I.
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`VSI IS LIKELY TO ESTABLISH THAT BOSTON IS
`INFRINGING THE VSI PATENTS ........................................................ 19
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`A.
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`Boston Is Infringing Multiple Claims Of The VSI Patents ........... 19
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`i
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`1.
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`2.
`3.
`4.
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`The Guidezilla Is Designed For Use With A
`Standard Guide Catheter .................................................... 20
`The Guidezilla Has The Claimed Flexible Tip .................. 20
`The Guidezilla Has The Claimed Transition / Collar ........ 21
`The Guidezilla Has The Claimed Substantially Rigid
`Portion ................................................................................ 21
`
`a.
`
`b.
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`c.
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`d.
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`A “Lumen” Requires A Passageway For
`Medical Devices And Contrast Medium ................. 22
`Guidezilla’s Substantially Rigid Portion Literally
`Infringes, Because It Does Not Have A Lumen ..... 25
`Boston Admits That Guidezilla’s Substantially
`Rigid Portion Does Not Contain A Lumen ............. 26
`Alternatively, Boston Infringes Under The
`Doctrine of Equivalents .......................................... 27
`
`B.
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`C.
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`Boston Is Inducing and Contributing To Infringement
`Of The ‘413 And ‘850 Patents ...................................................... 27
`The Infringed Claims Are Likely To Withstand Any
`Validity Challenge ......................................................................... 29
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`II.
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`VSI WILL SUFFER IRREPARABLE HARM IF BOSTON’S
`INFRINGEMENT IS NOT ENJOINED BEFORE TRIAL ..................... 20
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`III.
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`THE BALANCE OF HARMS FAVORS VSI ......................................... 33
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`IV. THE PUBLIC INTEREST FAVORS A PRELIMINARY
`INJUNCTION .......................................................................................... 34
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`V.
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`VSI IS ENTITLED TO A PRELIMINARY INJUNCTION TO
`STOP BOSTON’S COPYRIGHT INFRINGEMENT ............................. 34
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`VI. BOND ....................................................................................................... 35
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`CONCLUSION .............................................................................................................. 35
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`ii
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`
`
`CASES
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Advanced Commc’n Design, Inc. v. Premier Retail Networks, Inc.,
`186 F. Supp. 2d 1009 (D. Minn. 2002), rev’d in part on other grounds by 46
`Fed. App’x 964 (Fed. Cir.) ...................................................................................................33
`
`AstraZeneca LP v. Apotex, Inc.,
`623 F. Supp. 2d 579 (D.N.J. 2009), aff’d 633 F.3d 1042 (Fed. Cir. 2011) ....................29
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010) ...............................................................................18, 19, 22
`
`Baxter Healthcare Corp. v. Spectramed, Inc.,
`49 F.3d 1575 (Fed. Cir. 1995)..............................................................................................19
`
`Butamax Advanced Biofuels LLC v. Gevo, Inc.,
`868 F. Supp. 2d 359 (D. Del. 2012) ....................................................................................31
`
`C & A Pro, LLC v. Pride Solutions, LLC,
`2005 WL 388602 (D. Minn. Jan. 17, 2005) .......................................................................34
`
`Capitol Records, Inc. v. Thomas-Rasset,
`680 F. Supp. 2d 1045 (D. Minn. 2010) ...............................................................................34
`
`Celsis In Vitro, Inc. v. CellzDirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012)..................................................................................29, 31, 32
`
`Cornucopia Products, LLC v. Dyson, Inc.,
`2012 WL 3094955 (D. Ariz. July 27, 2012) ................................................................31, 32
`
`Decade Indus. v. Wood Tech., Inc.,
`100 F. Supp. 2d 979 (D. Minn. 2000) ...........................................................................34, 35
`
`DF Institute, Inc. v. Marketshare EDS,
`84 U.S.P.Q.2d 1206 (D. Minn. 2007) .................................................................................34
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`--- F.3d ----, 2013 WL 2158423 (Fed. Cir. May 21, 2013) ..................................29, 30, 31
`
`DSU Med. Corp. v. JMS Co.,
`471 F.3d 1293 (Fed. Cir. 2006) (en banc) ..........................................................................28
`
`iii
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`
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`Econova, Inc. v. DPS Utah,
`2012 WL 5944257 (D. Utah Nov. 28, 2012) ...............................................................31, 32
`
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995), aff’d by 517 U.S. 370 (1996) ......................................19, 22
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ..........................................................................22
`
`Polymer Techs., Inc. v. Bridwell,
`103 F.3d 970 (Fed. Cir. 1996)..............................................................................................32
`
`Quantronix, Inc. v. Data Trak Techn., Inc.,
`536 F. Supp. 2d 1039 (D. Minn. 2008) ...............................................................................31
`
`Robert Bosch LLC v. Pylon Mfg. Corp.,
`659 F.3d 1142 (Fed. Cir. 2011) ...........................................................................................29
`
`Sanifo-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) ...........................................................................................34
`
`Scimed Life Sys., Inc. v. Advanced Cardiovascular Sys.,
`242 F.3d 1337 (Fed. Cir. 2001) ...........................................................................................22
`
`Titan Tire Corp v. Case New Holland, Inc.,
`566 F.3d 1372 (Fed. Cir. 2009) ...........................................................................................29
`
`Travelers Express Co., Inc. v. Transaction Tracking Tech.,
`305 F. Supp. 2d 1090 (D. Minn. 2003) ...............................................................................33
`
`Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
`520 U.S. 17 (1997) ..........................................................................................................19, 27
`
`STATUTES
`
`35 U.S.C. § 271(c) .......................................................................................................................28
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`35 U.S.C. § 282 ............................................................................................................................29
`
`
`
`iv
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`INTRODUCTION
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`Vascular Solutions, Inc. (“VSI”) invented, patented and brought to market a
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`medical device called the GuideLiner, a device that physicians describe as a “game-
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`changer” allowing them to perform “previously unimaginable” medical treatments. The
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`GuideLiner is so unique – it literally has no competition – that it created a new market
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`and quickly became VSI’s flagship product, with rapidly growing sales constituting 20%
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`of VSI’s revenue.
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`Now, the largest company in VSI’s industry, Boston Scientific Corporation
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`(“Boston”), has created a “copycat” device – the Guidezilla – that infringes VSI’s
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`patents. This is not a subtle case of copying – Boston not only appropriated the design,
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`materials and dimensions of VSI’s GuideLiner, it also copied, word for word, VSI’s
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`copyrighted Instructions for Use (“IFU”) deployment steps.
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`Even though its promotion of the infringing Guidezilla product only recently
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`began, Boston is already using its substantially greater resources – its 2012 revenues were
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`seventy times VSI’s – to target VSI’s customers and undercut VSI’s prices. If not
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`stopped very soon, Boston will immediately and irreparably alter the market for the
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`GuideLiner and damage VSI’s growth and expansion plans, all as a free ride on VSI’s
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`invention.
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`Due to the strong evidence of infringement and irreparable harm, VSI respectfully
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`requests that the Court grant a preliminary injunction to prevent Boston from continuing
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`its infringement during the pendency of this litigation.
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`1
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`STATEMENT OF FACTS
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`I. VSI IS A SUCCESSFUL SMALL MEDICAL DEVICE COMPANY, BUT
`DWARFED BY BOSTON’S RESOURCES
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`VSI is a medical device company focused on bringing clinically unique solutions
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`for vascular diseases to physicians. While VSI has been successful – its 2012 revenue
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`totaled $98 million, and its sales have grown more than 10% in each of the last nine years
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`– it still has a less than 1% share of the U.S. interventional cardiology market. Root
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`Decl. ¶¶ 4, 128; Ex. 18.
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`Boston is a huge medical device company. Boston markets a diverse group of
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`medical devices through seven divisions. Ex. 16 at 1-7; Ex. 17 at 1. It reported revenue
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`of $7.2 billion in 2012 and is the largest company in the U.S. market for interventional
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`cardiology devices, with a 40% share. Exs. 17-18.
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`II. VSI’S PATENTS SOLVED A LONG-STANDING PROBLEM IN
`INTERVENTIONAL CARDIOLOGY
`
`A.
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`Cardiac Catheterization Procedures1
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`In coronary artery disease, the artery is narrowed or occluded, often by the buildup
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`of plaque (a stenosis). To open the stenosis, a cardiologist will perform an interventional
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`cardiac catheterization procedure, which consists of delivering medical devices (usually a
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`stent) into the coronary artery where the stent is expanded to push the stenosis to the
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`arterial wall and restore flow. Root Decl. ¶¶ 6-11.
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`1 A more detailed description of the technology, including diagrams and photographs, is
`provided in the Root Declaration.
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`2
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`Interventional cardiac catheterization procedures are a minimally invasive
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`alternative to open heart surgery. A cardiologist starts the procedure by making a needle
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`puncture in a remote artery (in the patient’s groin or wrist) to gain access to the arterial
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`system. Once access has been gained, a guide catheter is inserted up the patient’s aorta
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`and into the beginning (ostium) of the coronary artery. Root Decl. ¶¶ 9-11.
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`B.
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`Limitations Of Guide Catheters
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`Because it must reach the patient’s heart from the groin (or wrist), and because it
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`must “hook” the beginning (ostium) of the coronary artery, a guide catheter must be a
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`long and somewhat rigid tube with a curve at the distal end (the end inserted into the
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`patient). A standard guide catheter is 100-cm long, somewhat rigid and made from a
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`springy plastic. Guide catheters are sold in a variety of distal curve shapes to match the
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`coronary artery (right or left) to be treated and the angle of connection of the patient’s
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`coronary artery to the aorta. Root Decl. ¶¶ 11-12.
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`Standard guide catheter
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`Once the guide catheter is in place, a guidewire is inserted through the guide
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`catheter and deeper into the coronary artery to the site of the stenosis. Next, medical
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`devices such as stents are delivered over the guidewire and through the guide catheter’s
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`lumen to reach the blockage for treatment. Root Decl. ¶ 11.
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`A guide catheter must be sufficiently rigid to maintain its distal curve and position
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`when relatively inflexible medical devices such as stents are directed through the guide
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`3
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`catheter and into the ostium of the coronary artery. The guide catheter also must provide
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`sufficient “backup” support to prevent it from moving backwards and becoming
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`dislodged as medical devices are pushed through a tortuous coronary artery and across a
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`stenosis. Without both guide catheter rigidity and backup support, medical devices may
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`not be able to enter the coronary artery or cross the stenosis, causing the treatment to fail.
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`Failure to securely place the guide catheter in the coronary artery most often occurs in
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`challenging cases where the anatomy is tortuous or the stenosis is severe, which are
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`precisely the cases where treatment is often most needed. Root Decl. ¶¶ 14-15.
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`C.
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`Prior Attempts To Solve Guide Catheter Limitations
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`While it would be desirable to insert the guide catheter deeper into the coronary
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`artery to provide stronger position and backup support, because of the curve and rigidity
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`of a guide catheter, it generally cannot be safely “deep seated” (extended past the
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`ostium). Root Decl. ¶ 15. One method used to provide safe deep seating of a guide
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`catheter is the “mother and child” guide system. This involves inserting, for example, a
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`120-cm “child” guide catheter with a relatively flexible and straight distal tip through a
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`standard, 100-cm “mother” guide catheter. Because the child catheter is flexible and
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`straight, it can safely extend beyond the ostium (where the mother catheter is positioned)
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`and deep into the artery to provide additional backup support. Root Decl. ¶¶ 16-17.
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`The mother and child guide system has several drawbacks. First, the system
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`requires two hemostatic valves: one to seal the mother guide catheter, and a second to
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`seal the child catheter. Second, the mother and child combination results in a 120-cm
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`long guide catheter, which limits the sites that can be treated since balloons and wires are
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`4
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`designed for 100-cm guide catheters. Third, to insert or remove the child catheter, all of
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`the previously inserted devices, such as guidewires, must be removed. As a result, before
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`the GuideLiner, the mother and child system was rarely used. Root Decl. ¶ 18.
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`D. Over-The-Wire And Monorail Systems
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`The mother and child guide system is an example of over-the-wire (“OTW”)
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`construction. An OTW catheter has a lumen that runs the entire length of the catheter,
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`used for delivery of the catheter over a guidewire and into the artery. Because an OTW
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`catheter is generally between 100cm and 150cm long, it requires a long (260-300cm)
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`guidewire, requiring two operators to control both ends of the catheter during
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`deployment. Root Decl. ¶ 19.
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`An alternative type of catheter is referred to as a monorail, rapid exchange, single
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`operator or sliding rail catheter. All of these names refer to the same type of
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`construction, with a relatively short (generally 20-40cm) lumen used to deliver the
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`catheter over a guidewire attached to a longer and stiffer rod used to push and retract the
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`catheter but running independent of the guidewire. With monorail construction, a single
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`operator can deliver the catheter, and it allows the use of shorter guidewires. Root Decl.
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`¶20; Ex. 1.
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`E.
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`The GuideLiner And VSI’s Patents
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`In 2004, VSI began working on a new idea for a guide extension catheter that
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`would provide “mother and child” guide extension without the disadvantages of OTW
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`construction. That idea developed into the GuideLiner, which provides the advantages of
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`5
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`guide extension with the ease of monorail delivery. VSI introduced the GuideLiner in
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`2009. Root ¶ 21.
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`VSI’s GuideLiner catheter
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` Flexible, with lumen
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` Substantially rigid, without lumen
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`Flexible portion. The distal end (the left side above) of the GuideLiner is a
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`relatively flexible tube with a lumen. The distal end has three zones: a very flexible
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`yellow tip, a less flexible yellow coil reinforced portion, and a further less flexible blue
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`portion made from stiffer polymer. Root Decl. ¶ 22.
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` GuideLiner Coil reinforced portion _
` very flexible tip More flexible Less flexible
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`Collar transition between flexible and substantially rigid portions. The
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`GuideLiner’s flexible portion is joined to a relatively inflexible metal collar portion,
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`where the lumen ends. The collar provides the transition to allow devices such as stents
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`to enter the flexible portion when delivered through the guide catheter. Root Decl. ¶ 23.
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`GuideLiner collar side view GuideLiner collar top down view
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`6
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`Substantially rigid portion. The collar is connected to a substantially rigid push
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`rod that extends for the remainder of the GuideLiner. The proximal end of the push rod
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`is embedded into a tab to prevent it from being inadvertently pushed too far into the guide
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`catheter during deployment. Root Decl. ¶¶ 24-25.
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`GuideLiner substantially rigid push rod
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`By extending the GuideLiner’s flexible portion past the end of the guide catheter
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`and into the coronary artery to be treated, the GuideLiner provides effective deep seating
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`without the risks associated with deep seating standard guide catheters. In the figure
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`below on the left, a standard guide catheter without the GuideLiner has backed out of the
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`coronary ostium. In the figure on the right, however, the GuideLiner is deep seated in the
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`coronary artery, providing a secure passageway to deliver devices deep into the coronary
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`artery. Root Decl. ¶¶ 27-28.
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`7
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`
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` Without GuideLiner With GuideLiner
` (backed out of ostium) (deep seated)
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`Guide catheter
`(blue)
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`GuideLiner
`(yellow)
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`
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`Deep seating of the GuideLiner also allows stent delivery in procedures where it
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`previously was impossible. In the figure below on the left, without the GuideLiner the
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`stent cannot navigate the artery’s sharp downward angle to reach the stenosis. On the
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`right, however, use of the GuideLiner’s flexible extension changes the artery’s sharp
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`angle into a gentle curve, allowing the stent to be delivered to the stenosis. Root Decl. ¶
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`29.
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` Without GuideLiner With GuideLiner
` (failure to deliver stent) (stent delivered to stenosis)
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`Stent
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`Guide catheter
`(blue)
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`GuideLiner
`(yellow)
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`Stent
`(across stenosis)
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`8
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`The monorail construction of the GuideLiner provides multiple advantages over
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`the OTW construction used in prior “mother and child” systems. Because only the push
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`rod extends through the hemostatic valve, a second hemostatic valve is not needed and
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`there is no limitation on the length of devices used. The monorail construction also
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`allows the guidewires previously placed in the artery to remain in place while delivering
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`the GuideLiner. Root Decl. ¶ 30.
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`After launching the original GuideLiner in 2009, VSI developed a second version,
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`called V2, for sale in 2012. All material features and techniques of the GuideLiner
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`remained the same with the V2. Root Decl. ¶ 31.
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`On May 3, 2006, VSI filed a patent application on the GuideLiner invention. This
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`application led to three U.S. patents: Patent No. 8,048,032 (‘032 patent) (device), issued
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`November 1, 2011; Patent No. 8,142,413 (‘413 patent) (method for using the device),
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`issued March 27, 2012; and Patent No. 8,292,850 (‘850 patent) (system comprised of the
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`device and a standard guide catheter), issued October 23, 2012. Root Decl. ¶¶ 32-35.
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`VSI includes an IFU with each GuideLiner. VSI copyrighted its GuideLiner V1
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`and V2 IFUs. Exs. 26-27.
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`III. VSI’S GUIDELINER IS CLINICALLY AND COMMERCIALLY
`SUCCESSFUL
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`VSI’s GuideLiner catheter pioneered an entirely new concept of mother-and-child
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`guide extension with monorail delivery, and, until Guidezilla was introduced, was the
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`only catheter available worldwide that provided those benefits. Multiple cardiologists
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`have hailed the GuideLiner catheter as a “game changer” and a substantial advance in
`
`9
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`interventional cardiology. Cardiologists worldwide described the clinical benefits of
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`using the GuideLiner as allowing them “to successfully complete previously
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`unimaginable interventions.” Root Decl. ¶ 45. According to users, because of the
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`GuideLiner, impossible cases have been made possible, thereby allowing patients to
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`avoid undergoing invasive coronary bypass surgery.
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`Supporting the GuideLiner’s uniqueness, twenty-two medical journal articles have
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`been published and five medical symposia held in the United States and Europe on the
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`GuideLiner. Root Decl. ¶ 43. Because one of the clinical benefits of the GuideLiner is in
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`delivering stents into otherwise untreatable stenoses, the sales and marketing employees
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`of companies that sell coronary stents, such as Boston, have become aware of the
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`GuideLiner’s use and utility.
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`Through promotion of these clinical benefits, VSI has created a new $20 million
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`market that continues to grow rapidly. Root Decl. ¶¶ 39-40. Almost since launch, the
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`GuideLiner has been VSI’s fastest growing product, and after just three years on the
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`market, the GuideLiner is on track to be VSI’s highest-selling product both in the United
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`States and worldwide in 2013. Root Decl. ¶ 41. In addition, the one-of-a-kind nature and
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`substantial utility of the GuideLiner makes it VSI’s most visible product, which has
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`opened the door for VSI’s sales force into many new customers. Root Decl. ¶ 42.
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`IV. BOSTON COPIES VSI’S GUIDELINER AND IFU
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`A.
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`VSI Discovers And Boston Denies Development Of Guidezilla
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`In October, 2012, after hearing rumors that Boston was developing a competing
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`product, VSI’s CEO Howard Root asked the president of Boston’s interventional
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`cardiology division, Kevin Ballinger, whether Boston was developing a new guide
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`catheter called “Guidezilla” or “Godzilla.” Ballinger denied it. Root Decl. ¶ 51. Root
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`followed up by sending a letter to Ballinger informing him of VSI’s patents. Ballinger
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`did not reply. Root Decl. ¶ 52; Ex. 20.
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`In March 2013, VSI discovered that Boston had received 510(k) clearance for the
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`Guidezilla. On April 12, 2013, VSI learned that Boston had provided a Guidezilla
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`catheter for clinical use at a hospital in St. Louis, Missouri. Shortly thereafter, VSI
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`learned that Boston has provided additional Guidezilla catheters for clinical use in
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`California, Illinois, New York, and elsewhere. Root Decl. ¶¶ 53, 36, 59. At roughly the
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`same time, a Boston marketing employee (a former VSI employee) contacted a VSI
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`employee to ask for confidential GuideLiner pricing information. Root Decl. ¶ 58. On
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`April 25, 2013, VSI sent another letter to Ballinger, asking to see any analysis performed
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`on Guidezilla with respect to the patents-in-suit, to purchase a sample Guidezilla for
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`evaluation, and to discuss the issue. Ex. 22. Ballinger referred the letter to his legal
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`department, which never replied. Root Decl. ¶ 60; Ex. 23.
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`B.
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`VSI Verifies That Guidezilla Is A Copy Of GuideLiner And Infringes
`VSI’s Patents
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`In its 510(k) filing for the Guidezilla, Boston identifies the GuideLiner as the only
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`predicate device to Guidezilla. In comparing the two products, Boston went far beyond
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`what is necessary to establish “substantial equivalence” for regulatory purposes, stating
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`that the Guidezilla “incorporates substantially equivalent device materials and design,
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`packaging materials and design, fundamental technology, manufacturing processes,
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`sterilization process and intended use as the GuideLiner V2 (K112082).” Ex. 21 at 1;
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`Root Decl. ¶¶ 54-55. In its Directions for Use (“DFU”), Boston describes Guidezilla as
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`“a single lumen rapid exchange catheter” with “a stainless steel proximal shaft with a 25
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`cm single lumen distal guide segment . . .” designed to be used with a standard guide
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`0.070” guide catheter. This description is identical to VSI’s description of its GuideLiner
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`in its IFU. Compare Exs. 25 and 26.
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`In May 2013, VSI obtained samples of the Guidezilla and confirmed that
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`Guidezilla is a nearly identical copy of the GuideLiner. Root Decl. ¶¶ 61, 69. All three
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`parts of the Guidezilla catheter are essentially the same in construction, dimension and
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`function as the same three sections of the GuideLiner catheter:
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`• Both catheters have a nearly identical (but different colored) flexible tip portion
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`made up of a tubular structure that is about 25 cm long, with nearly identical inner
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`diameters. Root Decl. ¶¶ 70-71; Exs. 30.
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` Guidezilla flexible tip GuideLiner flexible tip
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`
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`• Both catheters have a metal collar section that transitions the flexible tip to the
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`substantially rigid push rod section by using a tapered cut. Ex. 30.
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` Guidezilla collar GuideLiner V1 collar
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`
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`• Both catheters have a substantially rigid section constructed of stainless steel that
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`proceeds from the collar on the distal end to a plastic tab on the proximal end
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`where it is embedded and sealed. Root Decl. ¶¶ 73-74.
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` Guidezilla substantially rigid portion GuideLiner substantially rigid portion
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`• The substantially rigid portion of both catheters have no lumen – in the Guidezilla
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`
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`device, the distal end of the substantially rigid portion is crushed flat for 2cm and
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`welded shut to the collar so that nothing can pass through the substantially rigid
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`portion of Guidezilla. Root Decl. ¶ 78.
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` Guidezilla substantially rigid portion GuideLiner substantially rigid portion
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`
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`Boston also copied, on an almost exact basis, the construction and dimensions of
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`the GuideLiner catheter, as shown in the schematic below. Root Decl. ¶ 70; Ex. 29.
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`Root, an inventor of VSI’s patented GuideLiner and an expert in the technology,
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`analyzed Boston’s Guidezilla as compared to the claims of the patents-in-suit. His
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`analysis, described in detailed claim charts, determined that Boston is infringing at least
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`forty-one claims of VSI’s patents. Root Decl. ¶¶ 80-87, 104-06; Exs. 31, 39-40.
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`C.
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`Boston’s DFU Copies GuideLiner’s IFU And Infringes VSI’s
`Copyright
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`Beyond copying the product, Boston also copied virtually every word of VSI’s
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`copyrighted “Deployment Procedure” section of its GuideLiner IFU and used it in
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`Guidezilla’s DFU. In fact, the only words that Boston changed in the seven deployment
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`steps were to globally replace “GuideLiner catheter” with “Guidezilla device.” Root
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`Decl. ¶ 66 (comparing language); Exs. 25-26.
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`D.
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`Boston Asserts One Infringement Defense
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`Having received no response to its letters, VSI filed its Complaint on May 16,
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`2013. Boston finally responded on June 3, 2013, with a letter identifying one patent
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`infringement defense – that the substantially rigid portion is “comprised of a hypotube
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`with a continuous lumen running its entire length” and therefore does not meet the
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`“without a lumen” limitation of the asserted claims. Ex. 32. Contrary to Boston’s
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`allegation, no space exists in the distal 2cm of Guidezilla’s hypotube where it is crushed
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`prior to attachment to the collar and therefore it is not continuous, there is no opening for
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`any item to be passed into or through the hypotube and therefore it does not constitute a
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`lumen, and Boston’s own statements in the Guidezilla DFU (as explained in the
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`infringement section below) confirm that the substantially rigid portion does not contain a
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`lumen. Ex. 25.
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`V. BOSTON WILL CAUSE VSI SUBSTANTIAL AND IRREPARABLE
`HARM IF ALLOWED TO CONTINUE ITS INFRINGEMENT
`
`Even though Boston’s commercialization of its Guidezilla catheter is only in the
`
`early stages, VSI is already hearing from its sales staff and customers that Guidezilla is
`
`impacting the market VSI created. Boston is asking physicians to compare Guidezilla to
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`GuideLiner and using its evaluation form to gather information regarding physicians’
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`GuideLiner practices and pricing in order for Boston to compete on promotion and
`
`un