Case 1:16-cv-01163-CFC-CJB Document 13 Filed 02/13/17 Page 1 of 78 PageID #: 367
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Boston Scientific Corp. and
`Boston Scientific Neuromodulation Corp.,
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`Nevro Corp.,
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`Plaintiffs,
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`v.
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`Defendant.
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`C.A. No. 16-1163-GMS
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`JURY TRIAL DEMANDED
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`FIRST AMENDED COMPLAINT
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`Plaintiffs Boston Scientific Corp. (“BSC”) and Boston Scientific Neuromodulation Corp.
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`(“BSNC”) (collectively, “Boston Scientific”), by their attorneys, hereby complain against
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`Defendant Nevro Corp. (“Nevro”) and allege 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 arising from Nevro’s infringement of Boston
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`Scientific’s U.S. Patent No. 6,895,280 (the “‘280 patent”), U.S. Patent No. 7,428,438 (the
`
`“‘438 patent”), U.S. Patent No. 7,437,193 (the “‘193 patent”), U.S. Patent No. 7,587,241 (the
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`“‘241 patent”), U.S. Patent No. 7,891,085 (the “‘085 patent”), U.S. Patent No. 8,019,439 (the
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`“‘439 patent”), U.S. Patent No. 8,644,933 (the “‘933 patent”), U.S. Patent No. 8,646,172 (the
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`“‘172 patent”), U.S. Patent No. 8,650,747 (the “‘747 patent”), and U.S. Patent No. 9,370,664
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`(the “‘664 patent”) (collectively, the “Asserted Patents”) via the manufacture, use, sale, offer to
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`sell, exportation, and/or importation, in whole or in part, of Nevro’s Senza® Spinal Cord
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`Stimulation System (the “Senza System”).
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`THE PARTIES
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`2.
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`Plaintiff BSC is a corporation organized and existing under the laws of the State
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`of Delaware and having a principal place of business at 300 Boston Scientific Way,
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`Marlborough, Massachusetts 01752.
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`3.
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`Plaintiff BSNC is a corporation organized and existing under the laws of the State
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`of Delaware and having a principal place of business at 25155 Rye Canyon Loop, Valencia,
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`California 91355. BSNC is a wholly-owned subsidiary of BSC.
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`4.
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`Upon information and belief, Defendant Nevro is a corporation organized and
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`existing under the laws of the State of Delaware and having a principal place of business at 1800
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`Bridge Pkwy, Redwood City, California, 94065.
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`JURISDICTION AND VENUE
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`5.
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`This action arises under the Patent Laws of the United States, Title 35 of the
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`United States Code.
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`6.
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`This Court has subject matter jurisdiction over the causes of action asserted herein
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`pursuant to 28 U.S.C. §§ 1331, 1338(a), and 2201 et seq.
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`7.
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`This Court has personal jurisdiction over Nevro. Upon information and belief,
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`Nevro is a resident of this judicial district, has systematic and continuous contacts in this judicial
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`district, regularly transacts business within this district, and regularly avails itself of the benefits
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`of this district. Upon information and belief, Nevro also sells and distributes the Senza System
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`in this district. Upon information and belief, Nevro derives substantial revenues from sales in
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`this district.
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`8.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(a), 1391(c), and 1400(b).
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`BOSTON SCIENTIFIC’S BACKGROUND
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`9.
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`Boston Scientific is a leading medical device manufacturer across a range of
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`medical specialties, including interventional cardiology, radiology, peripheral interventions,
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`neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular
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`surgery, endoscopy, oncology, urology, and gynecology. Boston Scientific is a pioneer and
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`innovator in the Spinal Cord Stimulation (“SCS”) industry, and has been developing and selling
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`SCS systems for the treatment of chronic pain for over a decade.
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`10.
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`Boston Scientific entered the SCS system market in 2004 when it launched its
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`Precision™ SCS System, the first rechargeable SCS platform with unique current steering
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`technology, wireless remote, and wireless charger. In 2007, Boston Scientific launched its
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`improved Precision™ Plus SCS System, the first with EGL™ Scan technology, which displayed
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`the relative position of the implanted leads to increase programming accuracy. In 2013, Boston
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`Scientific launched the Precision™ Spectra™ SCS System, the world’s first and only SCS
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`platform with 32 contacts, to offer unprecedented coverage and a new level of flexibility
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`intended to provide therapy to a broader spectrum of patients. The Precision™ Spectra™ SCS
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`System included Illumina™ 3D Programming Technology, which provided advanced controls
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`including the ability to account for the environment of the lead placed in the epidural space of
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`the spine, with the design objective to optimize stimulation and pain relief. Boston Scientific
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`next introduced the Precision™ Montage™ and Precision™ Montage™ MRI SCS System—
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`which allows patients to undergo a full-body MRI—in 2016. Each of these systems and their
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`technological advances provided drastic improvements in the care and treatment of patients with
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`chronic pain.
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`11.
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`Boston Scientific’s position as a leader and innovator in the SCS industry has
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`resulted in the development and patenting of core technologies that are essential to SCS systems,
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`including battery charging, battery monitoring, zero volt recovery (“ZVR”) circuits, determining
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`and transmitting indications of errors, telemetry systems, and percutaneous leads. These
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`technologies form the foundation of every SCS system on the market, including Nevro’s Senza
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`System.
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`NEVRO’S INFRINGING SENZA SYSTEM
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`12.
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`Nevro’s Senza System is a neuromodulation device designed to deliver electrical
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`stimulation to spinal cord nerves for the treatment of chronic intractable pain. The Senza System
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`delivers stimulation using percutaneous leads and a rechargeable, implantable pulse generator
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`(“IPG”). The percutaneous leads are implanted within the spinal column, and deliver stimulation
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`to nerves through electrodes located on the distal portion of the percutaneous leads. The IPG is
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`implanted in a subcutaneous pocket and is designed to produce current-regulated, charge-
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`balanced, biphasic, capacitively-coupled, rectangular output pulses. The IPG is transcutaneously
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`recharged using an external charger and is controlled by a patient remote control and/or clinician
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`programmer. Other components of the Senza System include an external trial stimulator, lead
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`extensions, adaptors, operating room (“OR”) cables, and surgical accessories.
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`13.
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`The Senza System received CE Mark approval in Europe in 2010 and TGA
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`approval in Australia in 2011. In that same year, Nevro launched the Senza System in Europe
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`and Australia. In 2015, the Senza System received FDA approval and Nevro launched the
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`product in the United States shortly thereafter. Currently, Nevro is on the market in Europe,
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`Australia, and the United States.1
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`14.
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`Upon information and belief, C.C.C. Del Uruguay S.A. (“CCC”), a subsidiary of
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`Greatbatch Ltd., is Nevro’s single-source manufacturer of its IPG. Upon information and belief,
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`1 Source: http://www.nevro.com/English/About-Us/Who-We-Are/default.aspx.
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`CCC also manufactures Nevro’s external chargers, external trial stimulators, and programmer
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`wands.2 Upon information and belief, CCC’s manufacturing facility is located in Montevideo,
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`Uruguay.
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`15.
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`Upon information and belief, Stellar Technologies, Inc. (“Stellar,” currently
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`organized under the name Cirtec Medical LLC) is Nevro’s single-source supplier of its
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`percutaneous leads.3 Stellar previously manufactured Boston Scientific’s percutaneous leads.
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`Upon information and belief, Stellar manufactures Nevro’s leads with the same tool that it
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`previously used to manufacture Boston Scientific’s leads. Upon information and belief, Stellar’s
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`manufacturing facility is located in Brooklyn Park, Minnesota.
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`16.
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`Upon information and belief, EaglePicher Medical Power LLC (“EaglePicher”) is
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`Nevro’s single-source supplier of its IPG’s battery and related products.4 Upon information and
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`belief, EaglePicher is headquartered in Joplin, Missouri.
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`17.
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`Upon information and belief, Pro-Tech Design and Manufacturing, Inc.
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`(“Pro-Tech”) is Nevro’s single-source supplier for conducting the inspection, labeling, packaging
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`and sterilization of its Senza System.5 Upon information and belief, Pro-Tech has two
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`manufacturing facilities: one in Arlington, Texas and one in Santa Fe Springs, California.6 Upon
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`2 Source: https://www.sec.gov/Archives/edgar/data/1444380/000119312516485541/
`d102615d10k.htm.
`3 Source: https://www.sec.gov/Archives/edgar/data/1444380/000119312516485541/
`d102615d10k.htm.
`4 Source: https://www.sec.gov/Archives/edgar/data/1444380/000119312516485541/
`d102615d10k.htm.
`5 Source: https://www.sec.gov/Archives/edgar/data/1444380/000119312516485541/
`d102615d10k.htm.
`6 Source: http://www.protechdesign.com/SitePages/Protech.aspx.
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`information and belief, Pro-Tech delivers the Senza System to Nevro FCA (Incoterms 2000) Pro-
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`Tech’s Santa Fe Springs, California manufacturing facility.7
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`BOSTON SCIENTIFIC’S PRE-SUIT INVESTIGATION
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`18.
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`Boston Scientific engaged in an extensive pre-suit investigation to determine that
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`Nevro’s Senza System infringed the core SCS technologies claimed in the Asserted Patents. In
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`addition to analyzing publicly available information regarding the Senza system, Boston
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`Scientific acquired and examined Nevro IPGs, external chargers, remote controls, external trial
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`stimulators, and percutaneous leads. As part of its examination, Boston Scientific disassembled
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`Nevro’s components to devise circuit schematics and part lists. Boston Scientific also performed
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`chemical testing and extensive bench testing. Photographs and x-rays were taken throughout the
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`process. Boston Scientific substantially completed its investigation by November 2016.
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`NEVRO’S KNOWLEDGE OF THE ASSERTED PATENTS
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`19.
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`Upon information and belief, Nevro had actual and constructive knowledge of the
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`Asserted Patents prior to the filing of the original Complaint or willfully blinded itself to the
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`existence of those patents. In any event, Nevro had actual knowledge of the Asserted Patents no
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`later than the filing of the original Complaint.
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`20.
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`Upon information and belief, Nevro obtained actual and constructive knowledge
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`of the Asserted Patents or willfully blinded itself to the existence of those patents through
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`competitive intelligence of its direct competitor, Boston Scientific. The SCS market primarily
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`consists of only four competitors: Boston Scientific, Nevro, Medtronic, and St. Jude. Nevro
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`itself routinely identifies Boston Scientific as a direct competitor and the companies compete for
`
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`7 Source: https://www.sec.gov/Archives/edgar/data/1444380/000104746914008300/
`a2221785zex-10_3.htm.
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`the same business from physicians, hospitals, and other health care providers. For instance,
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`Nevro stated the following in its February 29, 2016 Form 10-K filing:
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`Our competitors in both the United States and abroad, many of
`which have substantially greater resources and have made
`substantial
`investments
`in patent portfolios and competing
`technologies, may have applied for or obtained or may in the future
`apply for and obtain, patents that will prevent, limit, or otherwise
`interfere with our ability to make, use, sell, and/or export our
`products. For example, our major competitors, Medtronic plc,
`Boston Scientific Corporation and St. Jude Medical, Inc., each
`have significant patent portfolios covering systems, sub-systems,
`methods, and manufacturing processes. These competitors may
`have one or more patents for which they can threaten and/or
`initiate patent infringement actions against us and/or any of our
`third-party suppliers.8
`
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`Moreover, Nevro participated in an FDA-monitored randomized controlled trial in a head-to-
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`head comparison against Boston Scientific’s Precision™ SCS System. As evidenced by Nevro’s
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`statement above, it is standard practice in the SCS industry to monitor competitors’ patent
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`portfolios. Upon information and belief, Nevro monitored the patent portfolio of Boston
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`Scientific, whereby Nevro obtained actual and constructive knowledge of the Asserted Patents.
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`21.
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`Upon information and belief, Nevro obtained actual and constructive knowledge
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`of the Asserted Patents or willfully blinded itself to the existence of those patents through a pre-
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`suit investigation of Boston Scientific. In May 2015, Boston Scientific filed two Petitions for
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`Inter Partes Review of Nevro’s U.S. Patent No. 8,359,102. In November 2016, Nevro filed a
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`Complaint for Patent Infringement and Declaratory Judgment against certain of Boston
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`Scientific’s SCS Systems in the United States District Court for the Northern District of
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`California (Nevro Corp. v. Boston Scientific Corp. and Boston Scientific Neuromodulation Corp.,
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`8 Source: https://www.sec.gov/Archives/edgar/data/1444380/000119312516485541/
`d102615d10k.htm.
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`Case No. 3:16-cv-06830-VC (N.D. Cal.)). It is standard practice to conduct competitive
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`intelligence when sued and to conduct a pre-suit investigation prior to initiating a lawsuit. Upon
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`information and belief, Nevro investigated Boston Scientific’s patent portfolio no later than after
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`Boston Scientific filed its Petitions for Inter Partes Review and before filing its Complaint in the
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`Northern District of California, whereby Nevro obtained actual and constructive knowledge of
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`the Asserted Patents.
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`22.
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`Upon information and belief, Nevro obtained actual and constructive knowledge
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`of the Asserted Patents or willfully blinded itself to the existence of those patents through the
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`knowledge of current Nevro employees that previously worked for Boston Scientific, including
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`employees that staffed critical Boston Scientific SCS product development and management
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`positions responsible for its neuromodulation patent portfolio. For example, upon information
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`and belief, Kerry Bradley is currently the Director of Clinical Science & Research at Nevro. Mr.
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`Bradley worked for Boston Scientific (and its predecessors) from 2000 to 2012 as a Principal
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`Biomedical Systems Engineer, Senior Principal Biomedical Systems Engineer, Fellow in
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`Research & Development, and Manager II. During his time at Boston Scientific, Mr. Bradley
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`was an inventor or co-inventor on numerous neuromodulation patents and was a subject matter
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`expert reviewer of neuromodulation patents.
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`23.
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`Upon information and belief, Jim Thacker is currently the Director of Field
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`Clinical Engineering at Nevro. Mr. Thacker worked for Boston Scientific (and its predecessors)
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`from 2000 to 2006 as Manager of Field Clinical Engineering. During his time at Boston
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`Scientific, Mr. Thacker led Boston Scientific’s field clinical engineering group, which helped to
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`develop, administer, and analyze clinical studies, de-bugged SCS systems, and worked in
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`conjunction with Boston Scientific’s research & development group to develop, test, and
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`commercialize its core SCS technologies. Mr. Thacker was an inventor or co-inventor on
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`numerous neuromodulation patents.
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`24.
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`Upon information and belief, Dongchul Lee is currently the Director of
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`Theoretical Research at Nevro. Mr. Lee worked for Boston Scientific from 2006 to 2013 as a
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`Senior Biomedical System Engineer and Principal Research Scientist. During his time at Boston
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`Scientific, Mr. Lee developed numerous core SCS technologies, including stimulation algorithms
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`and sub-perception stimulation. Mr. Lee was an inventor or co-inventor on numerous
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`neuromodulation patents.
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`25.
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`Upon information and belief, Messrs. Bradley, Thacker, and Lee had an extensive
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`knowledge of Boston Scientific’s neuromodulation patent portfolio, including many of the
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`Asserted Patents, their applications, and/or their patent families. Upon information and belief,
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`Nevro institutionalized this knowledge, whereby Nevro obtained actual and constructive
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`knowledge of the Asserted Patents.
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`26.
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`Upon information and belief, at least 48 past employees of Boston Scientific are
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`currently employed by Nevro, including: Lisa Earnhardt, Member Board of Directors; Doug
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`Alleavitch, Vice President, Quality; Reynaldo Nossa, Director of Technical Services; Andreas
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`Koenig, Sr. Clinical Affairs Manager; David Marco, Sr. Field Clinical Engineer; Tamara
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`Baynham, Sr. Field Clinical Engineer; Dan Hestera, Regional Sales Director; Jeff Orr, Regional
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`Sales Director; Jim Sackleh, Regional Sales Director; Richard James, Regional Sales Director;
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`Angela Holley, District Sales Manager; Laurie Cigan, District Sales Manager; Heather Moss-
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`Gad, District Sales Manager; Anthony Puglisi, District Sales Manager; Cable Hawkins, District
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`Sales Manager; Matt Goldstone, District Sales Manager; Phil Almeida, District Sales Manager;
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`Ryan Livingston, District Sales Manager; Chris White, District Sales Manager; Lindsay Molden,
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`District Sales Manager; Christine Biello, District Sales Manager; Chad Sellers, District Sales
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`Manager; Brian Warriner, District Sales Manager; Scott Shoultz, District Sales Manager; Croix
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`Paquin, District Sales Manager; Ashley Bailey, Therapy Consultant; Danielle Pronesti, Therapy
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`Consultant; Mandy Cash, Therapy Consultant; Gretchen Thomas, Therapy Consultant; Will
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`Windauer, Therapy Consultant; Kate Ginter, Therapy Optimization Specialist; and Kelly Engle,
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`Therapy Support Specialist. (Source: linkedin.com.) Many of these Nevro employees are
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`intimately familiar with Boston Scientific’s SCS systems and core SCS technologies, which
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`Boston Scientific has been developing for decades. Upon information and belief, Nevro strived
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`to acquire information regarding Boston Scientific’s SCS systems and core SCS technologies,
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`and its institutional knowledge of the SCS market and SCS business practices.
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`27.
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`Upon information and belief, Nevro obtained actual and constructive knowledge
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`of the Asserted Patents or willfully blinded itself to the existence of those patents through the
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`prosecution of its own patent portfolio. For example, the ‘280 patent is cited on the face of
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`numerous U.S. Patents assigned to Nevro, including U.S. Patent No. 9,403,013; U.S. Patent No.
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`8,849,410; U.S. Patent No. 8,255,057; U.S. Patent No. 8,509,906; U.S. Patent No. 9,399,137;
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`U.S. Patent No. 9,409,019; U.S. Patent No. 9,295,840; and U.S. Patent No. 9,517,344.
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`Mr. Thacker, previously an employee of Boston Scientific, is a co-inventor on U.S. Patent No.
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`9,295,840. Mr. Bradley, previously an employee of Boston Scientific, is the only named
`
`inventor on U.S. Patent No. 9,517,344.
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`28.
`
`The ‘193 patent is cited on the face of numerous U.S. Patents assigned to Nevro,
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`including U.S. Patent No. 9,227,076; U.S. Patent No. 9,409,020; and U.S. Patent No. 9,517,344.
`
`Mr. Bradley, previously an employee of Boston Scientific, is the only named inventor on U.S.
`
`Patent No. 9,517,344. The ‘193 patent is the parent of the ‘241 patent.
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`29.
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`The ‘439 patent is cited on the face of numerous U.S. Patents assigned to Nevro,
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`including U.S. Patent No. 9,403,020; U.S. Patent No. 8,805,519; U.S. Patent No. 9,358,388; U.S.
`
`Patent No. 9,345,891; U.S. Patent No. 8,965,482; and U.S. Patent No. 9,308,022. Mr. Thacker,
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`previously an employee of Boston Scientific, is a co-inventor on U.S. Patent No. 8,805,519; U.S.
`
`Patent No. 9,358,388; U.S. Patent No. 9,345,891; and U.S. Patent No. 8,965,482. The ‘439
`
`patent is the child of the ‘085 patent.
`
`30.
`
`Upon information and belief, Nevro was aware of the references cited on the face
`
`of Nevro patents, whereby Nevro obtained actual and constructive knowledge of the Asserted
`
`Patents.
`
`31.
`
`To the extent that Nevro lacked actual and constructive knowledge of the
`
`Asserted Patents prior to the filing of the original Complaint, then Nevro willfully blinded itself
`
`to the existence of those patents. Upon information and belief, Nevro monitored and
`
`investigated Boston Scientific’s patent portfolio, institutionalized the extensive knowledge of
`
`Boston Scientific’s patent portfolio from past employees of Boston Scientific, and knew that
`
`certain of the Asserted Patents were cited on the face of Nevro patents.
`
`32.
`
`Despite Nevro’s actual and constructive knowledge of the Asserted Patents, it
`
`continues its infringing conduct to this day.
`
`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 6,895,280
`
`Boston Scientific realleges paragraphs 1-32 above as if fully set forth herein.
`
`The ‘280 patent, entitled “Rechargeable Spinal Cord Stimulator System,” is a
`
`33.
`
`34.
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`valid, enforceable patent that was duly issued by the United States Patent and Trademark Office
`
`(“USPTO”) on May 17, 2005 in full compliance with Title 35 of the United States Code. A true
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`and correct copy of the ‘280 patent is attached as Exhibit A.
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`35.
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`BSNC is the assignee of the ‘280 patent with ownership of all substantial rights in
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`the ‘280 patent, including the right to exclude others and to enforce, sue, and recover damages
`
`for past and future infringements. BSC is the exclusive licensee of the ‘280 patent.
`
`36.
`
`The claims of the ‘280 patent cover spinal cord stimulation systems. Claim 8 is
`
`illustrative of the claims of the ‘280 patent and is directed to a spinal cord stimulation system
`
`comprising a multi-channel IPG, which includes a replenishable power source, processing
`
`circuitry, and a housing that contains the processing circuitry. The IPG provides a multiplicity of
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`stimulation channels, each of which is independently programmable with different stimulation
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`parameters. The system includes an implantable electrode array detachably connected to the IPG
`
`and having a multiplicity of electrodes, wherein the number of stimulation channels is equal to or
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`less than the number of electrodes. The system includes an external trial stimulator and a
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`percutaneous extension which temporarily connects the external trial stimulator with the
`
`implantable electrode array.
`
`37.
`
`Nevro has directly infringed, and continues to directly infringe, at least claim 8 of
`
`the ‘280 patent in violation of 35 U.S.C. § 271(a) by, for example and without limitation,
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`making, using, offering to sell, selling, and/or importing in and into the United States the Senza
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`System.
`
`38.
`
`The Senza System is a spinal cord stimulation system comprising a multi-channel
`
`IPG, implantable electrode array, and external trial stimulator. Boston Scientific, through its
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`investigation of the Senza System via publicly available information and an examination of
`
`Nevro’s IPG, has determined that the Senza System meets every element of at least claim 8 of
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`the ‘280 patent, either literally or under the doctrine of equivalents:
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`Claim Element
`A spinal cord
`stimulation system
`comprising:
`
`Senza System
`The Senza System is a spinal cord stimulation system, which delivers
`electrical stimulation to the spinal cord via percutaneous leads.
`
`
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022d.pdf
`The Senza System includes a multi-channel (see below) IPG having a
`rechargeable battery (“replenishable power source”) and a hermetic IPG
`titanium enclosure (“housing”), which contains circuitry for recharging the
`battery and providing stimulation pulses, among other processes.
`
`
`
`
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022d.pdf
`
`Upon information and belief derived from Boston Scientific’s investigation
`of the Senza System, the hermetic IPG titanium enclosure contains circuitry
`for recharging the battery and providing stimulation pulses, among other
`processes.
`
`
`
`
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022c.pdf
`The Senza System includes percutaneous leads (“implantable electrode
`arrays”) that are designed to connect to and disconnect from the IPG
`(“detachably connected”).
`
`
`
`
`a multi-channel
`implantable pulse
`generator (IPG)
`having a
`replenishable
`power source, the
`IPG having a
`housing which
`contains IPG
`processing
`circuitry;
`
`an implantable
`electrode array
`detachably
`connected to the
`IPG, the electrode
`array having a
`multiplicity of n
`
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`Case 1:16-cv-01163-CFC-CJB Document 13 Filed 02/13/17 Page 14 of 78 PageID #: 380
`
`
`
`electrodes (En)
`thereon;
`
`
`
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022d.pdf
`
`The percutaneous leads include up to 16 electrodes (“multiplicity of n
`electrodes (En) thereon”).
`
`
`
`
`
`Source: http://www.nevro.com/English/Physicians/Senza-
`System/default.aspx
`The IPG includes 16 output channels capable of stimulating the spinal cord
`nerves through electrode leads (“stimulation channels”), each of which can
`be independently programmed to deliver stimulation with different
`parameters, including amplitude, voltage, pulse width, and frequency,
`among other parameters.
`
`
`a multiplicity of m
`stimulation
`channels provided
`by the IPG,
`wherein each
`stimulation
`channel is
`independently
`programmable
`with different
`stimulation
`parameters,
`
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`Case 1:16-cv-01163-CFC-CJB Document 13 Filed 02/13/17 Page 15 of 78 PageID #: 381
`
`
`
`wherein m is equal
`to or less than n,
`and m is 2 or
`greater;
`
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022b.pdf
`
`
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022d.pdf
`
`The number of output channels (16) is equal to the number of electrodes
`(16).
`The Senza System includes an external trial stimulator.
`
`
`an external trial
`stimulator (ETS);
`and
`
`a percutaneous
`extension which
`temporarily
`couples the ETS
`
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022d.pdf
`The Senza System includes OR cables (“percutaneous extension”) that
`make electrical and mechanical connections between the trial stimulator
`and the percutaneous leads.
`
`
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`

`Case 1:16-cv-01163-CFC-CJB Document 13 Filed 02/13/17 Page 16 of 78 PageID #: 382
`
`
`
`with the
`implantable
`electrode array.
`
`
`
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022d.pdf
`
`
`
`39.
`
`Nevro has actively induced others to infringe at least claim 8 of the ‘280 patent in
`
`violation of 35 U.S.C. § 271(b) by causing, instructing, urging, encouraging, and/or aiding
`
`others, including physicians, hospitals, other health care providers, and patients, to directly
`
`infringe at least claim 8 of the ‘280 patent by making, using, offering to sell, selling, and/or
`
`importing in and into the United States the Senza System, as detailed above. Nevro’s active
`
`inducement includes, for example and without limitation, marketing, selling, and offering to sell
`
`the Senza System, providing instructions on how to use the Senza System, and promoting the use
`
`of the Senza System. For example, Nevro encourages physicians, hospitals, other health care
`
`providers, and patients to use the Senza System by means of marketing materials9 and videos10.
`
`Nevro also instructs physicians, hospitals, other health care providers, and patients on how to use
`
`9 Exemplary marketing materials:
`http://www.nevro.com/English/Physicians/Clinical-Evidence/default.aspx;
`http://www.nevro.com/English/Physicians/SENZA-RCT-Design/default.aspx;
`http://www.nevro.com/English/Physicians/HF10-Therapy-Superiority/default.aspx;
`http://www.nevro.com/English/Physicians/HF10-Therapy-Benefits/default.aspx;
`http://www.nevro.com/English/Physicians/Senza-System/default.aspx.
`10 Exemplary marketing videos:
`https://www.youtube.com/watch?v=s2LtOcCiMVg;
`https://www.youtube.com/watch?v=Ua7rJ97S2Bk;
`https://www.youtube.com/watch?v=I0RJaWyFeCQ;
`https://www.youtube.com/watch?v=6773eKbZQis;
`https://www.youtube.com/watch?v=-t82yCBSjE0;
`https://www.youtube.com/watch?v=LeLq1lvlJvs;
`https://www.youtube.com/watch?v=-SLx9qwWXqs;
`https://www.youtube.com/watch?v=YuuwSTRq2ls;
`https://www.youtube.com/watch?v=-FXhOFNKHgU;
`https://www.youtube.com/watch?v=W1Q3p7YYgPs;
`https://www.youtube.com/watch?v=kQHTF1fS0ik;
`https://www.youtube.com/watch?v=V4RX_2W4OMk;
`https://www.youtube.com/watch?v=fr08-nZy-cY;
`https://www.youtube.com/watch?v=Ry8UJTzCfVw.
`
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`Case 1:16-cv-01163-CFC-CJB Document 13 Filed 02/13/17 Page 17 of 78 PageID #: 383
`
`
`
`the Senza System by means of physician and patient manuals11. Upon information and belief,
`
`Nevro also has a clinical engineer, sales representative, therapy consultant, therapy optimization
`
`specialist, and/or therapy support specialist present in the operating room, as is customary in the
`
`SCS industry. These Nevro employees will provide guidance and instruction to the physicians
`
`during and after surgery, including by advising on lead placement, setting the stimulation
`
`parameters of the external trial stimulator or IPG, and otherwise programming the external trial
`
`stimulator or IPG and familiarizing the patient with the Senza System. Upon information and
`
`belief, Nevro knows or is willfully blind to the existence of the ‘280 patent, knows or is willfully
`
`blind to the fact that Nevro’s actions will induce infringement thereof, and has induced such
`
`infringement with the intent that one or more claims of the ‘280 patent be infringed.
`
`40.
`
`The foregoing actions by Nevro also constitute infringement of at least claim 8 of
`
`the ‘280 patent in violation of 35 U.S.C. § 271(f)(1), wherein Nevro has supplied and/or caused
`
`to be supplied in or from the United States, and it continues to supply and/or cause to be supplied
`
`in or from the United States, the Senza System. Upon information and belief, Nevro has
`
`exported the Senza System from the United States to at least Europe and Australia.
`
`41.
`
`Nevro has contributed to infringement by others of at least claim 8 of the
`
`‘280 patent in violation of 35 U.S.C. § 271(c) by offering to sell, selling, and/or importing the
`
`Senza System and/or one or more components of the Senza System to physicians, hospitals, and
`
`other health care providers, which, as detailed above, are components of a patented combination
`
`and which constitute a material part of the inventions claimed in the ‘280 patent, including
`
`without limitation the invention in at least claim 8 of the ‘280 patent. Nevro has offered to sell,
`
`
`11 Physician Manual: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022d.pdf; Patient
`Manual: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022c.pdf.
`
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`Case 1:16-cv-01163-CFC-CJB Document 13 Filed 02/13/17 Page 18 of 78 PageID #: 384
`
`
`
`sold, and/or imported the Senza System and/or one or more components of the Senza System
`
`knowing the same to be especially made or especially adapted for use in an infringement of at
`
`least claim 8 of the ‘280 patent, and that the Senza System and/or one or more components of the
`
`Senza System are not staple articles or co