CASE 0:19-cv-01760-PJS-TNL Document 76 Filed 10/11/19 Page 1 of 36
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MINNESOTA
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`
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`VASCULAR SOLUTIONS LLC,
`TELEFLEX INNOVATIONS S.à r.l.,
`ARROW INTERNATIONAL, INC.,
`and TELEFLEX LLC,
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`
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`v.
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`MEDTRONIC, INC., and
`MEDTRONIC VASCULAR, INC.,
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`No. 19:cv-01760-PJS-TNL
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`Jury Trial Demanded
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`CONFIDENTIAL
`FILED UNDER SEAL
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`Plaintiff,
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`Defendant.
`
`PLAINTIFFS’ MEMORANDUM IN SUPPORT OF MOTION FOR
`PRELIMINARY INJUNCTION
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`Page 1
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`CASE 0:19-cv-01760-PJS-TNL Document 76 Filed 10/11/19 Page 2 of 36
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`TABLE OF CONTENTS
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`VSI’S PATENTED GUIDE EXTENSION CATHETERS SOLVED
`A LONG-STANDING PROBLEM IN INTERVENTIONAL
`CARDIOLOGY .................................................................................................... 2
`
`VSI’S GUIDELINER HAS BEEN EXTREMELY SUCCESSFUL ................... 5
`
`INTRODUCTION ........................................................................................................... 1
`
`FACTS ............................................................................................................................. 2
`
`I.
`
`
`
`II.
`
`III. VSI’S PRIOR LAWSUITS TO DEFEND ITS PATENTED
`
`GUIDELINER PRODUCT .................................................................................. 6
`
`
`A.
`B.
`
`Vascular Solutions v. Boston Scientific .................................................... 6
`QXMédical, LLC v. Vascular Solutions LLC........................................... 8
`
`
`IV. MEDTRONIC’S RECENTLY-LAUNCHED COPY OF VSI’S
`
`GUIDELINER ...................................................................................................... 9
`
`ARGUMENT ................................................................................................................. 12
`
`I.
`
`
`VSI IS LIKELY TO SUCCEED ON THE MERITS ......................................... 12
`
`A.
`
`B.
`
`
`VSI Is Likely to Establish that Medtronic Infringes the
`Asserted Patents ...................................................................................... 12
`The Asserted Claims Are Likely to Withstand Any
`Validity Challenge ................................................................................... 16
`
`VSI WILL SUFFER IRREPARABLE HARM IF
`MEDTRONIC IS NOT ENJOINED FROM SELLING
`ITS INFRINGING PRODUCT BEFORE TRIAL ............................................. 17
`
`A.
`B.
`C.
`D.
`E.
`F.
`
`Lost Market Share .................................................................................. 18
`Irreparable Price Erosion ......................................................................... 20
`Lost Sales of VSI’s Other Products ......................................................... 23
`Sales Force Attrition ................................................................................ 24
`Loss of Reputation and Goodwill ............................................................ 25
`Loss of Revenue to Fund Research and Development ............................ 26
`
`THE BALANCE OF HARMS FAVORS VSI ................................................... 27
`
`
`i
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`II.
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`III.
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`IV. THE PUBLIC INTEREST FAVORS ENJOINING
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`MEDTRONIC’S INFRINGEMENT AND PROTECTING
`
`VSI’S PATENT RIGHTS .................................................................................. 28
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`CONCLUSION ............................................................................................................. 30
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`TABLE OF AUTHORITIES
`
`Cases 
`
`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2008) ......................................................................... 22, 27, 28
`
`Acumed LLC v. Stryker Corp.,
`551 F.3d 1323 (Fed. Cir. 2008) ............................................................................... 22, 28
`
`Apple Inc. v. Samsung Elecs. Co.,
`809 F.3d 633 (Fed. Cir. 2015) ....................................................................................... 29
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010) ............................................................................... 12, 13
`
`Bio-Technology Gen. Corp. v. Genentech, Inc.,
`80 F.3d 1553 (Fed. Cir. 1996) ................................................................................. 18, 27
`
`Celsis in Vitro, Inc. v. CellzDirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012) ..................................................................... 17, 18, 22, 29
`
`Covidien Sales LLC v. Ethicon Endo-Surgery, Inc.,
`No. 3:14-cv-917 (JCH), 2014 U.S. Dist. LEXIS 147060 (D. Conn. Oct. 15, 2014) ..... 30
`
`Decade Indus. v. Wood Tech., Inc.,
`100 F. Supp. 2d 979 (D. Minn. 2000) ...................................................................... 24, 27
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`717 F.3d 1336 (Fed. Cir. 2013) ......................................................................... 18, 22, 25
`
`Hybritech Inc. v. Abbott Labs.,
`849 F.2d 1446 (Fed. Cir. 1988) ......................................................................... 17, 22, 27
`
`i4i Ltd. P’ship v. Microsoft Corp.,
`598 F.3d 831 (Fed. Cir. 2010) ........................................................................... 18, 27, 28
`
`Interconnect Planning Corp. v. Feil,
`774 F.2d 1132 (Fed. Cir. 1985) ..................................................................................... 16
`
`Oakley, Inc. v. Sunglass Hut Int’l,
`316 F.3d 1331 (Fed. Cir. 2003) ............................................................................... 12, 16
`
`Polymer Techs., Inc. v. Bridwell,
`103 F.3d 970 (Fed. Cir. 1996) ....................................................................................... 12
`
`iii
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`Robert Bosch LLC v. Pylon Mfg. Corp.,
`659 F.3d 1142 (Fed. Cir. 2011) ................................................................... 18, 20, 22, 23
`
`Smith Int’l, Inc. v. Hughes Tool Co.,
`718 F.2d 1573 (Fed. Cir. 1983) ..................................................................................... 29
`
`Titan Tire Corp v. Case New Holland, Inc.,
`566 F.3d 1372 (Fed. Cir. 2009) ..................................................................................... 16
`
`Trebro Mfg. v. FireFly Equip., LLC,
`748 F.3d 1159 (Fed. Cir. 2014) ..................................................................................... 25
`
`Upjohn Co. v. Medtron Labs., Inc.,
`751 F. Supp. 416 (S.D.N.Y. 1990) ................................................................................ 26
`
`Statutes 
`
`35 U.S.C. § 271(a) ............................................................................................................. 13
`
`35 U.S.C. § 271(b) ............................................................................................................. 13
`
`35 U.S.C. § 271(c) ............................................................................................................. 13
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`35 U.S.C. § 271(g) ............................................................................................................. 13
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`35 U.S.C. § 282 ................................................................................................................. 16
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`INTRODUCTION
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` Vascular Solutions, Inc. (“VSI”)1 invented, patented, and brought to market a
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`revolutionary medical device called the GuideLiner ® guide extension catheter
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`(hereinafter “GuideLiner”). GuideLiner enabled physicians to perform medical
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`procedures previously thought to be impossible. GuideLiner created the market for a new
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`type of medical device that quickly became VSI’s flagship product. To this day, many
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`still know VSI as “the GuideLiner Company.”
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`Proving the value of VSI’s patented technology, Medtronic is now the third
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`company in the United States seeking to ride the coattails of GuideLiner’s success. The
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`first, Boston Scientific, was the beneficiary of a far below-fair-value license that VSI was
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`forced to grant as a result of unrelated business issues that it was struggling with at the
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`time. The second, QXMédical, is a very small company with no sales force and an
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`inferior product that has gained almost no traction in the market and that is the subject of
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`an ongoing patent infringement lawsuit in which VSI seeks a permanent injunction.
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`While Boston Scientific’s presence in the market has impacted VSI, key
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`differences between Boston Scientific’s product and VSI’s current and most successful
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`version, GuideLiner V3, have allowed VSI to maintain a dominant position despite
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`granting Boston Scientific a license. In contrast, the arrival of Medtronic, the world’s
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`largest medical device company, into the market will cause much greater, and irreparable,
`
`
`1 VSI converted to Vascular Solutions LLC on August 8, 2017. The business now
`operates as the Interventional Business Unit of Teleflex Incorporated (“Teleflex”).
`Unless otherwise noted, this brief references these past and current businesses
`collectively as “VSI.”
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`1
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`harm to VSI. Medtronic’s recently-launched guide extension catheter, called Telescope,
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`is a much closer copy of GuideLiner V3—and Medtronic is aggressively promoting it as
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`such in the market. Not only does Telescope infringe VSI’s patents, it incorporates
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`virtually every key feature of GuideLiner V3. With its far greater resources, market
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`power, and copycat Telescope product, Medtronic
`
` VSI has earned with its patented GuideLiner technology. In short, the harm
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`presented by Medtronic’s Telescope is not only likely,
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`
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`
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`Medtronic must therefore be enjoined while this case is litigated.
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`FACTS
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`I.
`
`VSI’S PATENTED GUIDE EXTENSION CATHETERS SOLVED A LONG-
`STANDING PROBLEM IN INTERVENTIONAL CARDIOLOGY
`
`The Court is familiar with the technology from the related case, QXMédical, LLC
`
`v. Vascular Sols. LLC, 17:cv-01969-PJS-TNL (D. Minn.), and an overview is provided in
`
`the accompanying declaration of Peter Keith. (Declaration of Peter Keith, dated October
`
`10, 2019 (“Keith”) ¶¶ 7-41, 52-67.) In short, the GuideLiner was the first-of-its-kind
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`specialty catheter that allowed physicians to navigate medical devices, such as stents,
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`through narrow and tortuous vessels to treat lesions in coronary vessels that were
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`previously unreachable. (Declaration of Amy Welch, dated October 11, 2019 (“Welch”)
`
`¶¶ 9, 31.)
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`2
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`During a catheterization procedure, GuideLiner is loaded over the proximal end of
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`the exposed treatment guidewire such that the guidewire runs through the GuideLiner
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`lumen. (Keith ¶ 38.) GuideLiner is then advanced through the hemostatic valve on the
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`proximal end of the guide catheter. (Id.) The pushrod is used to advance GuideLiner
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`along the guidewire down the guide catheter until its distal tip emerges from the guide
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`catheter and is deep seated in the coronary artery, as shown in the diagram below. (Id. ¶
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`39.)
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`
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`Next, an interventional device, such as a stent delivery catheter, is advanced over
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`the proximal end of the guidewire and into the guide catheter. (Id. ¶ 40.) The side
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`opening guides the stent into GuideLiner’s distal tubular portion. (Id.) The stent then
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`emerges from the distal tip of GuideLiner where it may be advanced across the stenosis
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`with the aid of increased backup support provided by GuideLiner. (Id.) This deep
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`seating of GuideLiner allows stent delivery in procedures that were previously considered
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`impossible. (Declaration of J. Derek Vandenburgh, dated October 11, 2019, Ex. 25 at
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`278-79.)
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`
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`GuideLiner’s monorail construction provides multiple advantages. (Keith ¶¶ 32-
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`37.) Because only the pushrod extends through the hemostatic valve, a second
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`hemostatic valve is not needed, and there is no limit on the length of the devices used.
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`(Id. ¶ 38.) The monorail construction also allows for use of a standard length guidewire,
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`which can be controlled by a single operator. (Id. ¶ 32.) In addition, the guidewire
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`previously placed in the artery can remain in place while delivering GuideLiner. (Id.)
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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 the issuance of a number of U.S. patents, including U.S. Patent No.
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`8,048,032 (“the ’032 patent”), which is asserted in this case, but is not at issue with
`
`respect to VSI’s Motion for Preliminary Injunction. After the filing of the lawsuit against
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`Boston Scientific, discussed below, VSI also sought and obtained several reissue patents,
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`including four asserted in this case and in this preliminary injunction motion: U.S. Patent
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`4
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`No. RE45,380 (“the ’380 patent”); U.S. Patent No. RE45,776 (“the ’776 patent”); U.S.
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`Patent No. RE47,379 (“the ’379 patent”); and U.S. Patent No. RE45,760 (“the ’760
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`patent”). (Keith Exs. H-K.)
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`II.
`
`VSI’S GUIDELINER HAS BEEN EXTREMELY SUCCESSFUL
`
`VSI started in 1997 as a small medical device company focused on bringing
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`clinically unique solutions for vascular diseases to physicians. (Welch ¶ 8.) After years
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`of slowly increasing sales, VSI introduced its GuideLiner catheter in 2009, creating the
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`guide extension catheter market and transforming the business. (Id. ¶¶ 4, 9-18.) Sales of
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`GuideLiner alone
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`Guideliner not only became a great success in its own right, it paved the way for
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`continued growth by establishing the company as a trusted innovator and opening doors
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`for other VSI products. (Id. ¶¶ 4, 9-18.) Because of GuideLiner, VSI has earned a strong
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`reputation for developing innovative and revolutionary products for use in complex
`
`interventional cardiology procedures. (Id. ¶¶ 4, 15, 81, 83.) Even today, VSI is known
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`by customers as “the GuideLiner company.” (Id. ¶ 12.) Because GuideLiner has been
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`used in nearly every cardiac catheterization lab in the country, the product has given
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`VSI’s sales force credibility and access to physicians, both of which are critical to selling
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`VSI’s other niche products. (Id. ¶¶ 12, 15.) Customers who purchase GuideLiner as their
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`first VSI product end up purchasing, on average, five additional VSI products. (Id. ¶ 16.)
`
`III. VSI’S PRIOR LAWSUITS TO DEFEND ITS PATENTED GUIDELINER
`PRODUCT
`
`VSI’s patents on GuideLiner have been litigated in two separate cases in this
`
`District.
`
`A.
`
`Vascular Solutions v. Boston Scientific
`
`In 2013, VSI sued Boston Scientific for infringement of the original GuideLiner
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`patents, including the ’032 patent. Vascular Sols., Inc. v. Bos. Sci. Corp., No. 13-cv-
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`01172-JRT-SER (D. Minn.). VSI was granted a preliminary injunction against Boston
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`Scientific’s product, called “Guidezilla,” on December 9, 2013. Id. at Dkt. 76 (Sealed
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`Order).
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`On April 15, 2014, the Federal Circuit vacated the preliminary injunction in a
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`three sentence decision. Id. at Dkt. 119 (Op. of USCA). The Federal Circuit stated that
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`there were “too many unresolved issues at this stage of the case and the record is too
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`incomplete on issues of claim construction, infringement, and ultimate validity to warrant
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`the grant of a preliminary injunction.” Id. at 2.
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`At the time the preliminary injunction was vacated, VSI was experiencing a
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`significant strain on its resources—both financial and employee time—as the result of a
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`federal criminal prosecution for alleged off-label promotion of a different medical device.
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`(Vandenburgh Ex. 20 at 270:21-271:25; 278:5-24; 284:21-285:6.) Although VSI and its
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`CEO were ultimately acquitted on all counts, the company was forced to spend $25
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`million mounting its defense. (Vandenburgh Ex. 21 at 1.) As a small company, VSI had
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`to choose between defending itself against serious criminal charges and continuing to
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`pursue the patent infringement litigation against Boston Scientific. (Vandenburgh Ex. 20
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`at 270:21-271:25; 278:5-24; 284:21-285:6.) Consequently, VSI reluctantly agreed to
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`grant a license to Boston Scientific to settle that litigation. (Id.) The Boston Scientific
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`license is the only license VSI has granted to a competitor for the GuideLiner patents.
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`(Welch ¶¶ 21, 34, 37.)
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`Because of this license, VSI suffered and continues to suffer significant harm.
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` However, VSI has been able to minimize the harm in part due to differences
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`between Guidezilla and GuideLiner. (Id. ¶ 36.) Both Guidezilla and the latest iteration,
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`Guidezilla II, feature a relatively short, angled collar, rather than an extended concave
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`track as in GuideLiner V3. (Id.)
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`GuideLinerV3
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`Boston Scientific’s Guidezilla
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`
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`(Keith ¶ 40; Welch ¶ 36.) Additionally, both Guidezilla catheters use braid
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`reinforcement, rather than the coil reinforcement used in GuideLiner. (Keith ¶ 35; Welch
`
`¶ 36.) These distinguishing features and performance differences have allowed VSI to
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`compete against Guidezilla and maintain its position as the market leader. (Welch ¶ 36.)
`
`B.
`
`QXMédical, LLC v. Vascular Solutions LLC
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`On June 8, 2017, QXMédical (“QXM”) filed a declaratory judgment action
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`against VSI. QXMédical, LLC v. Vascular Sols. LLC, 17:cv-01969-PJS-TNL (D. Minn.).
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`VSI responded with counterclaims for infringement of its guide extension catheter
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`patents. The Court has construed a number of claim terms and recently ruled on
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`summary judgment that, inter alia, QXM infringes claims 25, 36, and 52 of the ’776
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`patent and that the asserted claims in that case are not invalid for indefiniteness or
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`recapture. Id. at Dkts. 102, 122, 130, 1562; see (Keith ¶ 50.)
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`QXM is a small company with virtually no presence in the market and without a
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`sales force. (Welch ¶ 33.) Accordingly, VSI did not find it necessary to seek a
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`preliminary injunction against QXM’s infringing product, the Boosting Catheter. VSI is
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`seeking a permanent injunction against QXM, and VSI continues to assess QXM’s
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`market presence to determine whether moving for a preliminary injunction has or will
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`become warranted.
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`IV. MEDTRONIC’S RECENTLY-LAUNCHED COPY OF VSI’S
`GUIDELINER
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`In early 2019, Medtronic reached out to VSI to discuss licensing the GuideLiner
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`intellectual property portfolio. (Welch ¶ 21.) VSI declined. (Id.) Medtronic
`
`nevertheless proceeded to launch its copycat Telescope catheter in May of this year.
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`With Telescope, Medtronic copied key features of GuideLiner, leveraging those
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`similarities to gain FDA clearance and sales. (See Keith ¶ 63; Welch ¶¶ 25-30.) In its
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`510(k) application, Medtronic stated that Telescope is substantially equivalent to VSI’s
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`GuideLiner V3 catheter “based on similarities in intended use and technological
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`characteristics” which are “based on comparisons of the device functionality,
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`technological characteristics, and indications for use.” (Keith ¶ 63, Ex. E.) Medtronic’s
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`510(k) further stated that Telescope has a “Similar Intended Use,” “Similar Device
`
`
`2 Docket 156 is reported at 2019 U.S. Dist. LEXIS 171088 (D. Minn. Oct. 2, 2019). This
`order will be referred to herein as “the QXM SJ Order,” and page references will be made
`to the Court’s docket version (No. 156).
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`Design Component/Construction,” “Similar Packaging,” and “Similar Sterilization
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`Method” to GuideLiner. (Id.)
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`Medtronic’s advertising literature specifically targets GuideLiner and touts
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`Telescope’s similarities to important features that make GuideLiner successful. For
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`example, Medtronic touts its solid pushwire, flexible coil-reinforced main jacket and
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`extremely soft distal tip—all important features of GuideLiner:
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`(Keith Ex. A at 10; Welch ¶¶ 25-26.) Medtronic also touts Telescope’s “on-ramp,”
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`which is shown in VSI’s patents.
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`(Keith, Ex. H (’380 patent) at 6, 12.)
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`
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`(E.g., Keith Ex. A at 18.) This feature is very similar to VSI’s important “half pipe”
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`feature in GuideLiner V3. (Keith ¶ 41.) Medtronic’s Telescope in-service presentation
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`includes ten slides directly comparing Telescope to VSI’s GuideLiner. (Keith Ex. A at 6-
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`9, 13, 26-29, 39.)
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`ARGUMENT
`
`When evaluating a motion for preliminary injunction, courts consider four factors:
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`“(1) a reasonable likelihood of success on the merits; (2) irreparable harm if the
`
`injunction were not granted; (3) the balance of the hardships and (4) the impact of the
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`injunction on the public interest.” Polymer Techs., Inc. v. Bridwell, 103 F.3d 970, 973
`
`(Fed. Cir. 1996). While a preliminary injunction has been referred to as “extraordinary”
`
`relief, such statements “do not imply that it must be rare or practically unattainable, only
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`that it is not granted as a matter of right; it must be thoroughly justified.” Id. at 977.
`
`I.
`
`VSI IS LIKELY TO SUCCEED ON THE MERITS
`
`To establish that it is likely to succeed on the merits, VSI must demonstrate that it
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`is more likely than not to succeed in establishing infringement of at least one claim of the
`
`asserted patents, and, if Medtronic challenges validity, that at least one of those allegedly
`
`infringed claims will likely withstand the validity challenge, viewing these issues “in
`
`light of the burdens and presumptions that will inhere at trial.” AstraZeneca LP v.
`
`Apotex, Inc., 633 F.3d 1042, 1050 (Fed. Cir. 2010) (citation omitted).
`
`A.
`
`VSI Is Likely to Establish that Medtronic Infringes the Asserted
`Patents
`
`Assessing whether VSI is more likely than not to succeed in establishing
`
`infringement requires a two-step analysis. The Court first determines the scope of the
`
`asserted claims, and then compares those claims to the accused device. Oakley, Inc. v.
`
`Sunglass Hut Int’l, 316 F.3d 1331, 1339 (Fed. Cir. 2003). For this analysis, VSI has
`
`applied the constructions adopted by this Court in the QXM litigation. (See Keith ¶ 50.)
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`Turning to the second step, VSI need only demonstrate that it is more likely than
`
`not to succeed in establishing infringement of one claim. See AstraZeneca LP, 633 F.3d
`
`at 1050. As detailed in the claim charts attached to the declaration of Mr. Keith, VSI is
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`likely, however, to succeed in establishing that Medtronic infringes multiple claims of
`
`multiple VSI patents. (Keith ¶¶ 68-87, Exs. M-P.) As shown therein, Medtronic’s
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`Telescope product infringes at least claims 25, 36, and 37 of the ’776 patent and claims
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`25, 33, 34, 38, and 44 of the ’379 patent under at least 35 U.S.C. §§ 271(a) and 271(g),
`
`respectively. (Keith ¶¶ 75, 77, Exs. N, O; see also id. ¶¶ 78-79.) Medtronic’s sales of
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`Telescope and guide catheters collectively infringe at least claims 12, 13, and 15 of the
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`’380 patent and claims 25, 28, 29, 32, and 48 of the ’760 patent under 35 U.S.C. § 271(a),
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`while its sales of Telescope alone contribute to and induce infringement of those same
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`claims under 35 U.S.C. §§ 271(b) and 271(c). (Keith ¶¶ 71-74, 80-82, Exs. M, P.)
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`That VSI is likely to establish infringement in this case is supported by the Court’s
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`recent QXM SJ Order. First, the Court found that QXM’s product infringes claims 25
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`and 36 of the ‘776 patent as a matter of law. QXM SJ Order at 39-40. Like the QXM
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`product, Telescope meets all the limitations of these two claims (among others) of the
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`‘776 patent. Id. at 39-40, 42; (Keith ¶ 75, Ex. N.) This includes having a side opening
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`with inclined and non-inclined regions as recited in claim 36:
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`(Keith Ex. N.)
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`Second, for some claims at issue in the QXM case, the Court found a triable issue
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`of fact as to whether QXM’s products have a pushrod “without a lumen.” QXM SJ Order
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`at 16-17. But unlike in QXM, Telescope’s pushrod is a “[s]olid, round pushwire.” (Keith
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`Ex. A at 10; see also id. at 7.) There is no dispute that Telescope meets the “without a
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`lumen” limitation.
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`Finally, unlike QXM, Medtronic not only sells coronary guide catheters for use
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`with its Telescope guide extension catheters, it expressly instructs physicians to use a
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`guide catheter that is one French size different from the Telescope catheter:
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`(Keith Ex. B (emphasis added).) Medtronic’s literature further provides:
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`
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`(Id. at Ex. A at 39 (emphasis added).) Such explicit instructions show that Medtronic
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`knows its Telescope products are going to be used, and encourages use, in a manner that
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`infringes VSI’s claims reciting a one French size difference between the guide catheter
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`and the guide extension catheter.3 (See Keith ¶¶ 51, 67, 70, 77-82, Exs. A, B, F, O, P);
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`see Liqwd, Inc. v. L’Oréal USA, Inc., 2018 U.S. App. LEXIS 1078, *12 (Fed. Cir. Jan.
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`16, 2018) (nonprecedential) (reversing denial of preliminary injunction, stating,
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`“[Plaintiff] must demonstrate, inter alia, that it is reasonably likely to succeed in proving
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`that the instructions for use induce infringement and that [defendant] knows, at the time a
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`preliminary injunction is to take effect, that the instructions for use will induce
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`infringement.”); Sanofi v. Watson Labs. Inc., 875 F.3d 636, 646 (Fed. Cir. 2017)
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`3 The asserted claims of the ‘760 patent recite a difference of “one French size” between
`the guide catheter and the guide extension catheter. (See Keith Ex. P.) The phrase “one
`French size” is defined in the specification in a way that encompasses a greater difference
`than the mathematical definition of “one French,” a phrase recited in claims not at issue
`on this motion. (Keith ¶ 51.) Moreover, an asserted dependent claim of the ‘379 patent
`recites a difference of “about one French” and a further dependent claim recites diameters
`of the guide catheter and guide extension catheter greater than or equal to 0.056 and
`0.070 inches, respectively. (See Keith Ex. O.)
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`(affirming finding of inducement, stating that inferences about intended effects can rest
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`on circumstantial evidence and finding that “[t]he content of the label in this case permits
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`the inference of specific intent to encourage the infringing uses”).
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`B.
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`The Asserted Claims Are Likely to Withstand Any Validity Challenge
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`The party attacking validity carries the burden of raising a substantial question
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`concerning validity. Oakley, 316 F.3d at 1339. This requires a showing that it is more
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`likely than not that each asserted claim of the patents is invalid, bearing in mind the
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`presumption of validity and the challenger’s high burden of proof at trial (clear and
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`convincing evidence). See Titan Tire Corp v. Case New Holland, Inc., 566 F.3d 1372,
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`1379 (Fed. Cir. 2009); 35 U.S.C. § 282.
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`In addition to enjoying a presumption of validity, VSI’s patents have been
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`examined by five separate patent examiners and several panels of examiners in reissue
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`proceedings, and have been found patentable over dozens of prior art references. This
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`supports the conclusion that the validity of the patents will likely be upheld. See, e.g.,
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`Oakley, Inc., 316 F.3d at 1342 (“[R]ecognizing the presumption of validity and the fact
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`that the [patent in suit] has already been subjected to reexamination, Oakley has at this
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`point in the case shown that it is reasonably likely to withstand such a validity
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`challenge.”); Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1139 (Fed. Cir. 1985)
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`(following reissue, “the burden of proving invalidity was made heavier” due to the
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`repeated examination by the Patent Office).
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`Furthermore, the asserted patents have been litigated in two separate cases. The
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`accused infringers in both cases were highly motivated to advance arguments and identify
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`prior art references that would render VSI’s patents invalid. To the extent prior art has
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`been identified in these litigations, it, along with the parties’ arguments as to how that
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`prior art invalidates VSI’s claims, was submitted to the PTO in connection with
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`examination of subsequent patents. (Keith Exs. H at 1-2, I at 1-2, J at 1-3, and K at 1-2.)
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`The PTO also was given the arguments raised in Petitions for Inter Partes Review filed
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`by Boston Scientific. (Vandenburgh Exs. 22-24; Keith Ex. J at 2-3.)
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`Finally, this Court granted motions for summary judgment that the ‘380, ‘760 and
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`‘776 patents are not invalid for indefiniteness based on “substantially rigid,” and that the
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`‘760 and ‘776 patents are not invalid for recapture. QXM SJ Order at 8, 16, 41-42. The
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`Court also rejected QXM’s arguments that the Adams reference discloses a “side
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`opening.” Id. at 36-39.
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`II.
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`VSI WILL SUFFER IRREPARABLE HARM IF MEDTRONIC IS NOT
`ENJOINED FROM SELLING ITS INFRINGING PRODUCT BEFORE
`TRIAL
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`The principal value of a patent is its statutory right to exclude. Hybritech Inc. v.
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`Abbott Labs., 849 F.2d 1446, 1456-57 (Fed. Cir. 1988). Thus, if some, or even all, of the
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`harm caused by the infringement may be compensable by money damages, it does not
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`make injunctive relief inappropriate. Id.; Celsis in Vitro, Inc. v. CellzDirect, Inc., 664
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`F.3d 922, 930 (Fed. Cir. 2012) (“[T]he simple fact that one could, if pressed, compute a
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`money damages award does not always preclude a finding of irreparable harm.”).
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`Moreover, the evidence submitted herewith shows that
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`,
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`and is likely to suffer substantial additional irreparable harm if Medtronic is not enjoined
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`from selling its infringing product now. The irreparable harm includes (a) loss of market
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`share; (b) price erosion; (c) lost sales of other VSI products; (d) sales force attrition; (e)
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`loss of reputation and goodwill; and (f) loss of revenue to fund research and
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`development. Each of these types of harm has been recognized as irreparable injury
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`justifying preliminary injunctive relief. See, e.g., Douglas Dynamics, LLC v. Buyers
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`Prods. Co., 717 F.3d 1336, 1344 (Fed. Cir. 2013) (lost sales and erosion in reputation and
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`brand distinction); Celsis in Vitro, Inc., 664 F.3d at 930 (price erosion, loss of goodwill,
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`damage to reputation, and loss of business opportunities); Robert Bosch LLC v. Pylon
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`Mfg. Corp., 659 F.3d 1142, 1151 (Fed. Cir. 2011) (loss in market share and access to
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`potential customers); i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 862 (Fed. Cir.
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`201