Case 6:20-cv-00973-ADA Document 39 Filed 04/28/21 Page 1 of 33
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF TEXAS
`WACO DIVISION
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`C.A. No. 6:20-cv-00973-ADA
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`DEMAND FOR JURY TRIAL
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`(cid:51)(cid:56)(cid:37)(cid:47)(cid:44)(cid:38)(cid:3)(cid:57)(cid:40)(cid:53)(cid:54)(cid:44)(cid:50)(cid:49)
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`TMT SYSTEMS, INC.,
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`Plaintiff,
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`v.
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`MEDTRONIC, INC. and MEDTRONIC
`USA, INC.,
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`Defendants.
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`SECOND AMENDED COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff TMT Systems, Inc. (“TMT”) hereby alleges, for its Second Amended Complaint
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`against Defendants Medtronic, Inc. (“Medtronic”) and Medtronic USA, Inc. (“Medtronic USA”)
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`on personal knowledge as to TMT’s own actions and on information and belief as to the actions
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`of others, as follows:
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`OVERVIEW OF THE ACTION
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`1.
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`This is a patent infringement action brought under 35 U.S.C. § 271 arising from
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`Medtronic’s and Medtronic USA’s infringement of TMT’s United States Patent No. 7,101,393
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`(the “’393 patent”) by the manufacture, importation and sale of, and offering to sell, stent graft
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`products, including the Endurant, Endurant II, Endurant II Aorto-uni-iliac (“AUI”), and Endurant
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`IIs stent grafts and Endurant II Aortic Extensions (collectively, the “Accused Products”). The
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`Accused Products are used in the treatment of abdominal aortic aneurisms (“AAA”) and
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`incorporate TMT’s patented M-stent technology as a means to seal and fixate the Accused
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`MEDTRONIC 1153
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`Case 6:20-cv-00973-ADA Document 39 Filed 04/28/21 Page 2 of 33
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`Products to the interior walls of a patient’s abdominal aorta, allowing blood flow to bypass the
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`patient’s life-threatening aneurysm.
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`2. Medtronic and Medtronic USA have been infringing the ’393 patent since at least
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`late 2010 (when Medtronic received regulatory approval to market the Endurant stent graft) and
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`have been on notice of the ’393 patent since at least 2008 (when Medtronic received notice that its
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`Endurant stent graft would infringe the ’393 patent). For years, TMT attempted to settle this
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`dispute without judicial intervention, but Medtronic’s and Medtronic USA’s infringing activities
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`only grew in scope such that the Accused Products have generated billions of dollars in revenue.
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`TMT brings this action to remedy Medtronic’s and Medtronic USA’s long-standing, ongoing, and
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`willful infringement.
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`THE PARTIES
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`TMT Systems, Inc.
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`3.
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`TMT is a corporation organized and existing under the laws of Delaware, having a
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`principal place of business at 23240 Chagrin Boulevard, Suite 600, Beachwood, Ohio 44122. TMT
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`was founded in 2003 by Dr. Timur Sarac, who currently acts as its Chief Executive Officer.
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`4.
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`Outside of his work for TMT, Dr. Sarac is the Chief of Vascular Surgery and
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`Director of the Aortic Center at The Ohio State University’s Wexner Medical Center. Previously,
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`Dr. Sarac was the Chief of Vascular Surgery at the Yale University Hospital and Vice Chairman
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`of Vascular Surgery at the Cleveland Clinic.
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`5.
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`In July 2002, Dr. Sarac filed a U.S. provisional patent application disclosing a novel
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`stent, referred to as an “M-stent,” for use in the treatment of abdominal aortic aneurysms. Dr. Sarac
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`is the sole inventor of the ’393 patent, which claims priority to that 2002 provisional application.
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`Medtronic, Inc.
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`6. Medtronic is a corporation organized and existing under the laws of the state of
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`Minnesota, having a principal place of business at 710 Medtronic Parkway, LC300, Minneapolis,
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`Minnesota 55432-5604, and may be served through its registered agent, Corporation Service
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`Company, at 2345 Rice Street, Suite 230, Roseville, Minnesota 55113-5603, or wherever else it
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`may be found. Medtronic has been registered to do business in Texas since at least 1976, has been
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`assigned Texas Taxpayer No.
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`, and has a Texas registered agent, Corporation Service
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`Company d/b/a CSC-Lawyers Inc., at 211 East 7th Street, Suite 620, Austin, Texas 78701.
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`7. Medtronic designates itself to the Food and Drug Administration (“FDA”), and
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`identifies itself to the public, as the corporation directly responsible for the development,
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`manufacturing and commercialization of the Accused Products. Specifically, Medtronic has
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`caused itself to be listed on FDA’s Establishment Registration and Device Listing website for
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`Endurant as the “Owner/Operator” of “establishments,” including one of its own divisions, at
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`which the Accused Products are manufactured, assembled, or otherwise processed. See 21 C.F.R.
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`§ 807.3(c) (“Establishment means a place of business under one management at one general
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`physical location at which a device is manufactured, assembled, or otherwise processed.”). FDA
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`regulations state that an “[o]wner or operator” is “the corporation, subsidiary, affiliated company,
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`partnership, or proprietor directly responsible for the activities of the registering establishment.”
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`21 C.F.R. § 807.3(f) (emphasis added).
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`8. Medtronic designates itself to FDA, and identifies itself to the public, as the
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`corporation directly responsible for the development and commercialization of the Accused
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`Products. Specifically, Medtronic has caused FDA’s Establishment Registration and Device
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`Listing website for Endurant to list “Medtronic Vascular” as a “Specification Developer” (see Ex.
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`4 at 1) and itself as the “Owner/Operator” of Medtronic Vascular (see Ex. 5). Medtronic Vascular
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`is the wholly owned subsidiary of Medtronic involved in the design, development, and marketing
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`of the Accused Products. As the “Owner/Operator” of Medtronic Vascular, Medtronic is the
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`corporation “directly responsible” for development and commercialization of the Accused
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`Products.
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`9. Medtronic designates itself to FDA, and identifies itself to the public, as the
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`corporation directly responsible for the manufacturing of the Accused Products. Specifically,
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`Medtronic has caused FDA’s Establishment Registration and Device Listing website for Endurant
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`to list each of “Medtronic Mexico EG,” “Medtronic Mexico S. de R.L. de CV,” and “Medtronic
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`Ireland” as a “Manufacturer” (see Ex. 4 at 1) and itself as the “Owner/Operator” of Medtronic
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`Mexico EG (see Ex. 6 at 1), Medtronic Mexico S. de R.L. de CV (see Ex. 7 at 1), and Medtronic
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`Ireland. See Ex. 8 at 1. 21 C.F.R. § 820.3(o) states that a “manufacturer” is “any person who
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`designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer
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`includes but is not limited to those who perform the functions of contract sterilization, installation,
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`relabeling, remanufacturing, repacking, or specification development, and initial distributors of
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`foreign entities performing these functions.” As the “Owner/Operator” of Medtronic Mexico EG,
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`Medtronic Mexico S. de R.L. de CV, and Medtronic Ireland, Medtronic is the corporation “directly
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`responsible” for manufacture of the Accused Products.
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`10. Medtronic designates itself to FDA, and identifies itself to the public, as the
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`corporation directly responsible for further manufacturing, including repackaging and relabeling,
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`of the Accused Products. See 21 C.F.R. § 807.3(d) (“Manufacture . . . of a device means the
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`making by chemical, physical, biological, or other procedures of any article that meets the
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`definition of device in section 201(h) of the act. These terms include the following activities:
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`(1) Repackaging or otherwise changing the container, wrapper, or labeling of any device package
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`in furtherance of the distribution of the device from the original place of manufacture to the person
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`who makes final delivery or sale to the ultimate consumer; (2) Initial importation of devices
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`manufactured in foreign establishments; or (3) Initiation of specifications for devices that are
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`manufactured by a second party for subsequent commercial distribution by the person initiating
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`specifications.”). Specifically, Medtronic has caused FDA’s Establishment Registration and
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`Device Listing website for Endurant to list each of “Medtronic Perfusion Systems” and “Medtronic
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`Inc, -Swinnea” (a division of Medtronic) as a “Repackager/Relabeler” (see Ex. 4 at 1) and itself as
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`the “Owner/Operator” of Medtronic Perfusion Systems (see Ex. 9 at 1) and Medtronic Inc, -
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`Swinnea. See Ex. 10 at 1. As the “Owner/Operator” of Medtronic Perfusion Systems and
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`Medtronic Inc, -Swinnea, Medtronic is the corporation “directly responsible” for further
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`manufacture, including repackaging and relabeling, of the Accused Products.
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`11. Medtronic’s listing with the FDA as the “Owner/Operator” of Medtronic Vascular,
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`Medtronic Mexico EG, Medtronic Mexico S. de R.L. de CV, Medtronic Ireland, Medtronic
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`Perfusion Systems, and Medtronic Inc. -Swinnea is consistent with its identification as the
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`“Manufacturer” of the Accused Products on their respective instruction manuals and labels. See,
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`e.g., Ex. 11 at 44:
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`Medtronic also identifies itself as the “Manufacturer” of the Accused Products by placing its name
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`next to the symbol used to identify the “Manufacturer” on the product instruction manuals and
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`labels. See, e.g., Ex. 12 at 3 (associating a symbol with “Manufacturer”), 48 (associating the
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`symbol with Medtronic):
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`.
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`12.
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`FDA regulations require that if a company does not manufacture a product for
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`which its name appears on the label, the company must qualify its name by a phrase that reveals
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`the company’s connection with the product. See 21 C.F.R. § 801.1(c) (“Where a device is not
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`manufactured by the person whose name appears on the label, the name shall be qualified by a
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`phrase that reveals the connection such person has with such device; such as “Manufactured for
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`___”, “Distributed by ___”, or any other wording that expresses the facts.”). Medtronic does not
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`so qualify its name on the labeling for the Accused Products, and thus represents itself to FDA and
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`the public as their manufacturer. See, e.g., Ex. 13:
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`13. Medtronic designates itself to FDA, and identifies itself to the public, as the
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`corporation directly responsible for the activities of Medtronic Logistics, LLC (“Medtronic
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`6
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`Logistics”), which imports the Accused Products into the United States and sells them to
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`Medtronic USA, on behalf of Medtronic. Specifically, Medtronic has caused FDA’s Establishment
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`Registration and Device Listing website to list Medtronic as the “Owner/Operator” of “Medtronic
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`Logistics, LLC.” See Ex. 14 at 1.
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`Medtronic USA, Inc.
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`14. Medtronic USA is a corporation organized and existing under the laws of the state
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`of Minnesota, having a principal place of business at 710 Medtronic Parkway, LC300,
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`Minneapolis, Minnesota 55432-5604, and may be served through its registered agent, Corporation
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`Service Company, at 2345 Rice Street, Suite 230, Roseville, Minnesota 55113-5603, or wherever
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`else it may be found. Medtronic USA has been registered to do business in Texas since at least
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`1997, has been assigned Texas Taxpayer No.
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`, and has a Texas registered agent,
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`Corporation Service Company d/b/a CSC-Lawyers Inc., at 211 East 7th Street, Suite 620, Austin,
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`Texas 78701.
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`15. As discussed in more detail below, Medtronic USA acts at the direction, and for the
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`benefit of, Medtronic and is controlled by Medtronic. Medtronic exercises this control and
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`direction through a number of concurrent means. For example, Medtronic has caused Medtronic
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`USA to include among its officers at least ten Medtronic officers. Publicly available information
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`currently identifies these overlapping officers to include at least Philip J. Albert, Jason M. Bristow,
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`Martha Ha, Douglas A. Hoekstra, Anne M. Ziebell, Bradley E. Lerman, Karen L. Parkhill, Betsy
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`Van Hecke, Duane E. Schroeder, and Tim Vorgert. These individuals are employed and
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`compensated by Medtronic (or its parent, Medtronic plc); they are neither employed nor
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`compensated by Medtronic USA. They are nominally denoted as officers of Medtronic USA solely
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`to enable Medtronic to control and direct the activities of Medtronic USA and to cause Medtronic
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`USA to enter into the business arrangements and contracts desired by Medtronic. These individuals
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`are supervised by superior officers at Medtronic (or Medtronic plc); they are supervised by no one
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`at Medtronic USA.
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`16. Moreover,
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`17.
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`A, in combination with
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`Medtronic’s deployment of its own officers to nominally serve as officers of Medtronic USA,
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`effectively provides the means for Medtronic to exercise control over and direction of the
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`operations of Medtronic USA. Medtronic and Medtronic USA operate in concert as integrated
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`parts of the same business enterprise, including for selling and offering for sale the Accused
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`Products in the United States.
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`Medtronic’s Control and Direction of Other Subsidiaries Involved in Development,
`Commercialization, and Importation of the Accused Products
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`18. Medtronic relies upon this same combination of overlapping officers and
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` to control and direct not just sales of the Accused Products, but also the
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`development, commercialization, and importation of the Accused Products into the United States.
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`Specifically, in addition to the
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`20. Medtronic has caused Medtronic Vascular to include among its officers at least ten
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`Medtronic officers—the same ten Medtronic officers who also serve as officers of Medtronic USA.
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`These individuals are employed and compensated by Medtronic; they are neither employed nor
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`compensated by Medtronic Vascular. They are nominally denoted as officers of Medtronic
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`Vascular solely to enable Medtronic to control and direct the activities of Medtronic Vascular and
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`to cause Medtronic Vascular to enter into the business arrangements and contracts desired by
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`Medtronic. These individuals are supervised by superior officers at Medtronic (or Medtronic plc);
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`they are supervised by no one at Medtronic Vascular.
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`21.
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`22. Medtronic has caused Medtronic Logistics to include among its officers at least ten
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`Medtronic officers—the same ten Medtronic officers who also serve as officers of Medtronic USA
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`and Medtronic Vascular. These individuals are employed and compensated by Medtronic; they are
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`neither employed nor compensated by Medtronic Logistics. They are nominally denoted as officers
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`of Medtronic Logistics solely to enable Medtronic to control and direct the activities of Medtronic
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`Logistics and to cause Medtronic Logistics to enter into the business arrangements and contracts
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`10
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`desired by Medtronic. These individuals are supervised by superior officers at Medtronic (or
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`Medtronic plc); they are supervised by no one at Medtronic Logistics.
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`23.
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`, in combination with Medtronic’s deployment of its own officers to nominally serve as
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`officers of Medtronic Vascular and Medtronic Logistics, effectively provides the means for
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`Medtronic to exercise control over and direction of the operations of Medtronic Vascular and
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`Medtronic Logistics—just as it does over the operations of Medtronic USA. Medtronic, Medtronic
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`USA, Medtronic Vascular, and Medtronic Logistics operate in concert as integrated parts of the
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`same business enterprise responsible for, among other things, the development, manufacture,
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`importation, marketing and sale of the Accused Products.
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`JURISDICTION AND VENUE
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`24. This is an action for patent infringement arising under the patent laws of the United
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`States, 35 U.S.C. § 1, et seq. This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331
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`and 1338(a).
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`Medtronic, Inc.
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`25. This Court has personal jurisdiction over Medtronic. Medtronic has continuous and
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`systematic business contacts with the State of Texas, including with the Western District of Texas.
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`Medtronic, through at least its control of and direction to Medtronic USA (which, among other
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`things, has acted as its agent) and other subsidiaries or intermediaries (including distributors,
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`customer service representatives, and others), conducts its business extensively throughout Texas,
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`by shipping, distributing, offering for sale, selling, and advertising (including through interactive
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`web pages) the Accused Products in the State of Texas and the Western District of Texas.
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`26. Medtronic, through at least its control of and direction to Medtronic USA (which,
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`among other things, has acted as its agent) and other subsidiaries or intermediaries (including
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`distributors, customer service representatives, and others), has purposefully and voluntarily placed
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`its infringing Accused Products into this District and into the stream of commerce with the
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`intention and expectation that the Accused Products will be purchased and used in this District.
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`Medtronic, through at least its control of and direction to Medtronic USA and other subsidiaries
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`or intermediaries (including distributors, customer service representatives, and others), has offered
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`and sold and continues to offer and sell the Accused Products for delivery and use in this District.
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`27. Venue is proper in this Court under 28 U.S.C. § 1400(b) because Medtronic
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`committed, and continues to commit, acts of infringement in this judicial district and has a regular
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`and established place of business in this judicial district.
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`28. Medtronic conducts business, itself and through subsidiaries such as Medtronic
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`USA, whose activities it controls and directs and which acts as its agent, from at least one
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`permanent, physical location in this District, located at 18302 Talavera Ridge, San Antonio, Texas
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`78257 (the “San Antonio Facility”).
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`29. Medtronic has itself continuously conducted business from the San Antonio
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`Facility since at least 2009, including through the direct employment of people physically located
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`at this facility. These Medtronic employees have performed and continue to perform vital business
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`functions for Medtronic, including compliance and business conduct, corporate human resources,
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`information technology support and management, enterprise applications, infrastructure, legal,
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`real estate and facilities support and management, and strategy and business development. As of
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`November 1, 2017, Medtronic had at least 21 employees working at the San Antonio Facility who
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`are paid separately from employees of any Medtronic affiliate working at the same location. As of
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`December 21, 2020, Medtronic had at least 20 employees working at the San Antonio Facility who
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`are paid separately from employees of any Medtronic affiliate working at the same location. As of
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`February 26, 2021, 10 of those 20 employees had been employed by Medtronic for at least 6 years.
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`30. Medtronic lists “San Antonio, TX” on the Medtronic.com website as one of the
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`“Medtronic Locations” and, more specifically, as one of its “Regional Locations” within the
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`United States. Medtronic does not specify any other entity (i.e., a subsidiary or other affiliated
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`entity) as resident in this or any other listed “United States” location. In contrast, Medtronic lists
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`distinct affiliated entities—not Medtronic—as resident in each of the Regional Locations outside
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`the United States. The Medtronic.com website is registered to Medtronic.
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`31. The San Antonio Facility bears the official, trademarked Medtronic logo, as shown
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`below from a March 2020 Google Maps image capture:
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`32. Medtronic is the record owner of the Medtronic trademark registrations in the
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`United States. Medtronic authorized the placement of its trademarked logo on the San Antonio
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`Facility to prominently convey to the public that this facility is a regular and established place of
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`business for Medtronic. Similarly, in order to convey to the public that Medtronic and its
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`subsidiaries operate as a single integrated business enterprise, Medtronic and its subsidiaries use
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`this trademarked logo throughout all of their business operations, including all public facing
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`materials such as webpages, advertising, and product literature and packaging—including product
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`literature and packaging for the Accused Products.
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`33. Although a Medtronic subsidiary, MiniMed Distribution Corp. (“MiniMed”), is
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`nominally named as the “Tenant” in the Office Lease Agreement (“Lease”) for the San Antonio
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`Facility,
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`35. Medtronic exercises attributes of possession and control over the San Antonio
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`Facility.
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`36.
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`In addition, the Lease provides that all notices to the Tenant must be sent to the
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`address of Medtronic’s Real Estate Department. Moreover, as of last amendment, dated January 5,
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`2021, the Landlord, in order to show the premises to brokers or other potential tenants, must
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`provide notice to Medtronic by sending an email to a Medtronic email address. The Landlord may
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`provide further notice, either orally or by email, to a particular Medtronic employee on-site at the
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`San Antonio Facility.
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`37.
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`38.
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`Medtronic’s deployment of its own officers to nominally serve as officers of its subsidiaries,
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`effectively provide the means for Medtronic to exercise control over and direction of the operations
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`of Medtronic USA and MiniMed. Medtronic has caused MiniMed to include among its officers at
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`least ten Medtronic officers—all of whom (except for Betsy Van Hecke ) are the same Medtronic
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`officers who also serve as officers of Medtronic USA, Medtronic Vascular, and Medtronic
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`Logistics. These individuals are employed and compensated by Medtronic; they are neither
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`employed nor compensated by MiniMed. They are nominally denoted as officers of MiniMed
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`solely to enable Medtronic to control and direct the activities of MiniMed and to cause MiniMed
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`to enter into the business arrangements and contracts desired by Medtronic, including the Lease.
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`These individuals are supervised by superior officers at Medtronic (or Medtronic plc); they are
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`supervised by no one at MiniMed.
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`39.
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`40. Medtronic’s employees in this District conduct Medtronic’s business at the San
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`Antonio Facility on a regular and established basis. These employees have workstations and
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`offices at the San Antonio Facility, use Medtronic computers at their workstations and offices in
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`the San Antonio Facility, access Medtronic’s intranet to perform their duties at the San Antonio
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`Facility, have dedicated telephones and telephone numbers to make and receive telephone calls at
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`the San Antonio Facility, and receive mail and courier deliveries on behalf of Medtronic at the San
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`Antonio Facility. In addition, as Medtronic employees, they are permitted to park their automobiles
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`at the San Antonio Facility.
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`41. Medtronic also conducts business directly from home offices of multiple employees
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`who permanently reside in this District and work from their home offices, whereby each such
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`home office is a permanent, physical location in this District. Such Medtronic employees perform
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`vital business functions, including executive-level management, corporate training, and clinical
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`research management, and use their home offices as Medtronic’s regular and established places of
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`business in this District, including by using Medtronic computers at their home offices, accessing
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`Medtronic’s intranet to perform their duties from their home offices, having dedicated telephones
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`and telephone numbers to make and receive telephone calls at their home offices, and receiving
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`mail and courier deliveries on behalf of Medtronic at their home offices. As of November 1, 2017,
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`Medtronic had at least three employees permanently and regularly working from home offices in
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`Case 6:20-cv-00973-ADA Document 39 Filed 04/28/21 Page 18 of 33
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`this District. By December 21, 2020, Medtronic had at least 18 employees permanently and
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`regularly working from home offices in this District. These Medtronic employees who work from
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`home offices are in addition to those Medtronic employees who work at the San Antonio Facility.
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`42. Medtronic, through at least its control of and direction to Medtronic USA (which,
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`among other things, has acted as its agent) and other subsidiaries or intermediaries (including
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`distributors, customer service representatives, and others), has committed acts of infringement in
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`this District by offering for sale and selling the Accused Products for delivery and use in this
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`District. For example, pursuant to Medtronic’s Shared Services Agreement with Medtronic USA,
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`Medtronic provides the executive, legal and financial management and infrastructure necessary to
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`enable Medtronic USA employees to sell and offer to sell the Accused Products for delivery and
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`use in this District.
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`43. Medtronic has also induced infringement in this District by directing Medtronic
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`USA, through the executive, legal and financial management and infrastructure provided to
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`Medtronic USA under the Shared Services Agreement, and through the Medtronic officers who
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`also serve as Medtronic USA’s officers, to offer for sale and sell the Accused Products for delivery
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`and use in this District, and to provide manuals and documentation teaching use of the infringing
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`Accused Products by physicians who work and reside in this District.
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`Medtronic USA, Inc.
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`44. This Court has personal jurisdiction over Medtronic USA. Medtronic USA has
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`continuous and systematic business contacts with the State of Texas, including with the Western
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`District of Texas. Medtronic USA, directly or through subsidiaries or intermediaries (including
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`distributors, customer service representatives, and others), and as the agent of Medtronic, conducts
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`its business extensively throughout Texas, by shipping, distributing, offering for sale, selling, and
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`Case 6:20-cv-00973-ADA Document 39 Filed 04/28/21 Page 19 of 33
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`advertising (including through interactive web pages) the Accused Products in the State of Texas
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`and the Western District of Texas.
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`45. Medtronic USA, directly and through subsidiaries or intermediaries (including
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`distributors, customer service representatives, and others), and as the agent of Medtronic, has
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`purposefully and voluntarily placed its infringing Accused Products into this District and into the
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`stream of commerce with the intention and expectation that the Accused Products will be
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`purchased and used in this District. Medtronic USA has offered and sold and continues to offer
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`and sell the Accused Products for delivery and use in this District.
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`46. Venue is proper in this Court under 28 U.S.C. § 1400(b) because Medtronic USA
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`committed, and continues to commit, acts of infringement in this judicial district and has a regular
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`and established place of business in this judicial district.
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`47. Medtronic USA conducts business, itself and through its agents, from at least one
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`permanent, physical location in this District—the San Antonio Facility. Medtronic USA conducts
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`business from the San Antonio Facility, including through the direct employment of people
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`physically located at this facility. Medtronic USA has approximately 54 employees working at the
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`San Antonio Facility who are paid separately from employees of any Medtronic affiliate working
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`at the same location. Medtronic USA, a subsidiary of Medtronic, is allowed to have its employees
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`work at the San Antonio Facility, and is allowed to use the San Antonio Facility as a regular and
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`established place of business, because the Lease provides that any entity affiliated with Medtronic
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`or MiniMed may use the premises for the Primary Permitted Use.
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`48. Moreover, as discussed in paragraph 37,
`
`
`
`
`
`, Medtronic provides the executive, legal and financial management and
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`Case 6:20-cv-00973-ADA Document 39 Filed 04/28/21 Page 20 of 33
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`infrastructure necessary to enable Medtronic USA employees to sell and offer to sell the Accused
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`Products for delivery and use in this District.
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`49. Medtronic USA’s employees in this District conduct Medtronic USA’s business at
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`the San Antonio Facility on a regular and established basis.
`
`
`
`, these Medtronic USA employees have workstations and
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`offices at the San Antonio Facility, use Medtronic computers at their workstations and offices in
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`the San Antonio Facility, access Medtronic’s intranet to perform their duties at the San Antonio
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`Facility, have dedicated telephones and telephone numbers to make and receive telephone calls at
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`the San Antonio Facility, and receive mail and courier deliveries on behalf of Medtronic USA at
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`the San Antonio Facility. In addition, as Medtronic USA employees, they are permitted to park
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`their automobiles at the San Antonio Facility.
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`50. Medtronic USA also conducts business directly from home offices of multiple
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`employees who permanently reside in this District and work from their home offices, whereby
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`each such home office is a permanent, physical location in this District. Such Medtronic USA
`
`employees perform vital business functions, and use their home offices as Medtronic USA’s
`
`regular and established places of business in this District, including by having dedicated telephones
`
`and telephone numbers to make and receive telephone calls at their home offices, and receiving
`
`mail and courier deliveries on behalf of Medtronic USA at their home offices. Medtronic USA has
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`approximately 103 employees permanently and regularly working from home offices in this
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`District. At least 10 of those 103 employees have job responsibilities related to the sale or offer for
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`sale of the Accused Products. These Medtronic USA employees who work from home offices are
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`in addition to those Medtronic USA employees who work at the San Antonio Facility.
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`Case 6:20-cv-00973-ADA Document 39 Filed 04/28/21 Page 21 of 33
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`51. Medtronic USA, subject to control by and direction from Medtronic, and acting as
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`its agent, has committed acts of infringement in this District by offering for sale and selling the
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`Accused Products for delivery and use in this District. Pursuant to these sales, Medtronic USA has
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`delivered (either itself or through authorized agents) the Accused Products at multiple healthcare
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`facilities in this District.
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`BACKGROUND OF THE INVENTION
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`52. An AAA (abdominal aortic aneurysm) is an abnormal enlargement of the arterial
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`walls of the aorta at the level of the abdomen, usually below the renal arteries, and may extend
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`into the common iliac arteries. This enlargement can rupture, which results in life-threatening
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`internal bleeding. An AAA is depicted in the illustration below:
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`
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`53. An AAA is typically treated using a minimally invasive procedure called
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`endovascular stent grafting. A stent graft comprises flexible wire frames (i.e., the “stents”)
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`integrated with a woven fabric tube (i.e., the “graft”). As depicted below, the anatomy of the
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`abdominal aorta requires an AAA stent graft to roughly form the shape of an upside down “Y,”
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`Case 6:20-cv-00973-ADA Document 39 Filed 04/28/21 Page 22 of 33
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`enabling the graft to split blood flow from the renal artery