Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 1 of 50 Page ID #:1 1 2 3 4 5 6 7 8 9 10 11 12 13 George C. Lombardi, Esq. (pro hac vice to be submitted) GLombard@winston.com J.R. McNair (pro hac vice to be submitted) JMcNair@winston.com Vivek V. Krishnan (pro hac vice to be submitted) VKrishnan@winston.com WINSTON & STRAWN LLP 35 W. Wacker Drive Chicago, IL 60601-9703 Telephone: (312) 558-5600 Facsimile: (312) 558-5700 Nimalka Wickramasekera (CA SBN: 268518) NWickramasekera@winston.com Joe S. Netikosol (CA SBN: 302026) JNetikosol@winston.com WINSTON & STRAWN LLP 333 S. Grand Avenue Los Angeles, CA 90071-1543 Telephone: (213) 615-1700 Facsimile: (213) 615-1750 Attorneys for Plaintiffs MEDTRONIC, INC.; MEDTRONIC PUERTO RICO OPERATIONS CO.; MEDTRONIC LOGISTICS, LLC; MEDTRONIC USA, INC. 14 UNITED STATES DISTRICT COURT 15 CENTRAL DISTRICT OF CALIFORNIA 16 17 18 19 MEDTRONIC, INC.; MEDTRONIC Case No. 8:19-cv-2115 PUERTO RICO OPERATIONS CO.; MEDTRONIC LOGISTICS, COMPLAINT FOR PATENT LLC; MEDTRONIC USA, INC., INFRINGEMENT Plaintiffs, 20 21 22 23 24 v. JURY TRIAL DEMANDED AXONICS MODULATION TECHNOLOGIES, INC., Defendant. 25 26 27 28 1 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 2 of 50 Page ID #:2 1 Plaintiffs Medtronic, Inc., Medtronic Puerto Rico Operations Co. (“MPROC”), 2 Medtronic Logistics, LLC (“Medtronic Logistics”), Medtronic USA, Inc. (“MDT 3 USA”) (individually and collectively “Medtronic” or “Plaintiffs”) bring this 4 Complaint against Defendant Axonics Modulation Technologies, Inc., alleging as 5 follows: THE PARTIES 6 7 8 1. Plaintiff Medtronic, Inc. is a Minnesota corporation having its principal place of business located at 710 Medtronic Parkway, Minneapolis, MN 55432. 9 2. Plaintiff MPROC is a Cayman Islands corporation, having its principal 10 place of business located at Ceiba Norte Industrial Park, 50 Road 31, Km. 24.4, 11 Juncos, Puerto Rico 00777-3869. 12 3. Plaintiff Medtronic Logistics is a Minnesota corporation having its 13 principal place of business located at 710 Medtronic Parkway, Minneapolis, MN 14 55432. 15 16 4. Plaintiff MDT USA is a Minnesota corporation having its principal place of business located at 710 Medtronic Parkway, Minneapolis, MN 55432. 17 5. Defendant Axonics Modulation Technologies, Inc. (“Axonics” or 18 “Defendant”) is a Delaware corporation having its principal place of business located 19 at 26 Technology Dr., Irvine, CA 92618. JURISDICTION AND VENUE 20 21 22 23 24 25 6. This is a civil action for patent infringement under 35 U.S.C. § 271 et 7. This Court has subject matter jurisdiction over this action under the laws seq. of the United States, 28 U.S.C. §§ 1331 and 1338(a). 8. This Court has general personal jurisdiction over Axonics because 26 Axonics is engaged in substantial and not isolated activity at its regular and 27 established places of business within this judicial district. This Court has specific 28 jurisdiction over Axonics because Axonics has committed acts giving rise to this 2 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 3 of 50 Page ID #:3 1 action and has established more than minimum contacts within this judicial district, 2 such that the exercise of jurisdiction over Axonics in this Court would not offend 3 traditional notions of fair play and substantial justice. 4 9. Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391(b)- 5 (c) and 1400(b) because Axonics maintains regular and establish places of business 6 and has committed acts of patent infringement within this judicial district. FACTUAL BACKGROUND 7 8 Medtronic’s Background 9 10. Medtronic is one of the world’s largest medical technology, services, and 10 solutions companies with the focus of alleviating pain, restoring health, and extending 11 life for millions of people around the world. In 2018, Medtronic was winner of the 12 prestigious USPTO Patents for Humanity award. Martin T. Gerber, an inventor on the 13 patents-in-suit, is named on a series of patents for which Medtronic was presented this 14 award. 15 11. Among its areas of specialty, Medtronic provides products and services 16 in the area of pelvic health. Pelvic floor disorders adversely affect the health and 17 quality of life of millions of people. Pelvic floor disorders include urinary control 18 disorders such as overactive bladder, fecal control disorders, sexual dysfunction, and 19 pelvic pain. Pelvic floor disorders can be treated with a variety of therapeutic options, 20 including surgical intervention. 21 12. Medtronic is the pioneer and leading provider of neuromodulation 22 solutions for bladder and bowel control issues. The Medtronic InterStim system for 23 bladder control and bowel control helps to control symptoms of overactive bladder, 24 non-obstructive urinary retention, and chronic fecal incontinence through direct 25 modulation of the nerve activity. The InterStim system electrically stimulates the 26 sacral nerves, which aims to normalize neural communication between the bladder 27 and brain, and between the bowel and brain. 28 13. Generally, implantation of InterStim therapy involves surgically 3 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 4 of 50 Page ID #:4 1 implanting a stimulation lead near the sacral nerves. The stimulation lead is a very 2 small, insulated electrical conductor with electrical stimulation contacts on the distal 3 end placed near the sacral nerves, and an electrical connector on the opposite proximal 4 end of the lead. The stimulation lead is connected to an implantable neurostimulator 5 that delivers small electrical pulses for stimulation of the sacral nerves. InterStim 6 therapy can improve the condition of a pelvic floor disorder and allow a patient to lead 7 a full life. The image below shows an example of the implantation of an InterStim 8 device. 1 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 14. Examples of Medtronic InterStim products include the InterStim and InterStim II neurostimulators. In October 2019, Medtronic filed a pre-market approval (PMA) supplement with the FDA for approval of its InterStim Micro neurostimulator (a rechargeable, implantable sacral neuromodulation device) and InterStim SureScan MRI leads, which will be used in implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, pending FDA approval. The image below shows an example of the Medtronic InterStim II and InterStim Micro devices. https://www.medtronic.com/us-en/healthcare-professionals/therapiesprocedures/urology/sacral-neuromodulation/education-training/about-thetherapy.html. 1 4 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 5 of 50 Page ID #:5 1 2 3 4 5 6 7 Accused Products and Activities 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 15. Upon information and belief, Axonics is a medical technology company that provides sacral neuromodulation solutions. 2 Upon information and belief, Axonics began working on a rechargeable Sacral Neuromodulation (“SNM”) System (“r-SNM”) (“Axonics r-SNM System”), and obtained regulatory approval in Europe and Canada for the first time in 2016.3 16. On September 9, 2019, Axonics announced that the Axonics r-SNM System had been approved by the FDA, granting Axonics the right to market the Axonics r-SNM System in the United States for the clinical indication of fecal incontinence. 17. As of the date of this Complaint, Axonics does not have approval from the FDA to market the Axonics r-SNM System in the United States for any other clinical indication, including the clinical indications of overactive bladder and urinary retention. 18. The Axonics r-SNM System includes various components, such as the Model 1101 neurostimulator, Model 1201 tined lead, Model 1801 lead implant kit, Model 1401 charging system, Model 1301 patient remote control, Model 1501 clinician programmer, and external trial system. The image below from the FDA website, shows an example of the components for Axonics’ r-SNM System. 4 http://www.axonicsmodulation.com/about/ See https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190006B.pdf at 7. 4 See id. at p. 6. 2 3 5 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 6 of 50 Page ID #:6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 19. According to the FDA Summary of Safety and Effectiveness Data for 16 Axonics’ r-SNM System, “[t]he components of the Axonics System are similar to 17 those used in … the Medtronic® InterStim® Therapy System.” 5 According to the 18 same regulatory filing, the Axonics r-SNM System is similar in design, technology, 19 performance, indication for use, output characteristics, and patient population to the 20 Medtronic InterStim System. 6 Axonics has designed the Axonics r-SNM System such 21 that the implantation procedure is the same as that of the existing Medtronic SNM 22 system. 7 Indeed, Axonics analyzed Medtronic’s product in detail before making the 23 24 25 26 27 28 Id. at p. 3–5. Id. at p. 25. 7 See, e.g., Joshua A. Cohn, Casey G. Kowalik, Melissa R. Kaufman, W. Stuart Reynolds, Douglas F. Milam & Roger R. Dmochowski (2017), “Evaluation of the axonics modulation technologies sacral neuromodulation system for the treatment of urinary and fecal dysfunction,” Expert Review of Medical Devices (hereinafter “Cohn 2017”), at 4; available at: https://doi.org/10.1080/17434440.2017.1268913. 5 6 6 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 7 of 50 Page ID #:7 1 Axonics r-SNM System. 8 The image below shows the Axonics r-SNM system 2 implanted. 9 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 20. In at least its product manuals, documents relating to regulatory filings, and, by and through its representatives and consultants, Axonics provides instructions to its customers and health-care professionals for using the Axonics r-SNM System and its components. 10 21. Axonics announced that the first commercial implants of the Axonics r- 19 SNM System in the United States took place on October 29, 2019. 11 20 https://www.businessinfocusmagazine.com/2018/05/axonics-prepares-forintroduction-of-its-sacral-neuromodulation-system/ 9 See Elterman, “The novel Axonics® rechargeable sacral neuromodulation system: Procedural and technical impressions from an initial North American experience,” at 7, Wiley Periodicals, Neurourology and Urodynamics 2018;1–8 (December 19, 2017); available at: https://doi.org/10.1002/nau.23482. 10 See, e.g., Axonics Sacral Neuromodulation System – Physician’s Neurostimulator Implant Manual (“FDA Physician Manual”) at 56–64; available at: https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190006c.pdf; see also Axonics Sacral Neuromodulation System – Tined Lead Implant Manual (Model 1201 Tined Lead; Model 1801 Lead Implant Kit), at 13–21. 11 Axonics® Announces First Commercial U.S. Patient Implanted with its Sacral 21 22 23 24 25 26 27 28 8 7 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 8 of 50 Page ID #:8 THE PATENTS-IN-SUIT 1 2 3 4 22. Medtronic realleges and incorporates by reference, as if fully set forth herein, all of the allegations contained in paragraphs 1–2120 of this Complaint. 23. On October 11, 2011, the United States Patent and Trademark Office 5 (PTO) issued United States Patent No. 8,036,756 (“the ’756 patent”), titled - 6 IMPLANTABLE MEDICAL ELECTRICAL STIMULATION LEAD FIXATION 7 METHOD AND APPARATUS. The ’756 patent lists the following individual as 8 inventors: John M. Swoyer, Martin T. Gerber, Keith Carlton, George J. Mamo, 9 Michele Spinelli, and Steven David Hartle. The ’756 patent is valid and enforceable. 10 11 A copy of the ’756 patent is attached as Exhibit A. 24. Medtronic, Inc. is the owner of the ’756 patent by written assignment. 12 Medtronic, Inc. has granted to MPROC, via written agreements, the exclusive license 13 under the ’756 patent to use, make, have made, import, offer for sale, and sell. 14 MPROC has granted to Medtronic Logistics, via written agreements, the exclusive 15 sub-license under the ’756 patent to import, offer for sale, and sell. Medtronic 16 Logistics has granted to MDT USA, via written agreements, the exclusive sub-license 17 under the ’756 patent to offer for sale and sell. As a result of these agreements and 18 Medtronic’s ownership of the ’756 patent, Plaintiffs Medtronic, Inc., MPROC, 19 Medtronic Logistics, and MDT USA have standing to bring suit for infringement of 20 the ’756 patent. 21 25. On January 7, 2014, the PTO issued United States Patent No. 8,626,314 22 (“the ’314 patent”), titled IMPLANTABLE MEDICAL LEAD INCLUDING 23 PLURALITY OF TINE ELEMENTS. The ’314 patent lists the following individuals 24 as inventors: John M. Swoyer, Martin T. Gerber, Keith Carlton, George J. Mamo, 25 Michele Spinelli, and Steven David Hartle. The ’314 patent is valid and enforceable. 26 27 28 Neuromodulation System, available at: http://ir.axonicsmodulation.com/newsreleases/news-release-details/axonicsr-announces-first-commercial-us-patientimplanted-its. 8 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 9 of 50 Page ID #:9 1 2 A copy of the ’314 patent is attached as Exhibit B. 26. Medtronic, Inc. is the owner of the ’314 patent by written assignment. 3 Medtronic, Inc. has granted to MPROC, via written agreements, the exclusive license 4 under the ’314 patent to use, make, have made, import, offer for sale, and sell. 5 MPROC has granted to Medtronic Logistics, via written agreements, the exclusive 6 sub-license under the ’314 patent to import, offer for sale, and sell. Medtronic 7 Logistics has granted to MDT USA, via written agreements, the exclusive sub-license 8 under the ’314 patent to offer for sale and sell. As a result of these agreements and 9 Medtronic’s ownership of the ’314 patent, Plaintiffs Medtronic, Inc., MPROC, 10 Medtronic Logistics, and MDT USA have standing to bring suit for infringement of 11 the ’314 patent. 12 27. On October 11, 2016, the Patent and Trademark Office (PTO) issued 13 United States Patent No. 9,463,324 (“the ’324 patent”), titled INDUCTIVELY 14 RECHARGEABLE EXTERNAL ENERGY SOURCE, CHARGER, SYSTEM AND 15 METHOD FOR A TRANSCUTANEOUS INDUCTIVE CHARGER FOR AN 16 IMPLANTABLE MEDICAL DEVICE. The ’324 patent lists the following 17 individuals as inventors: David P. Olson, William C. Phillips, and Andrew L. 18 Schmeling. The ’324 patent is valid and enforceable. A copy of the ’324 patent is 19 attached as Exhibit C. 20 28. Medtronic, Inc. is the owner of the ’324 patent by written assignment. 21 Medtronic, Inc. has granted to MPROC, via written agreements, the exclusive license 22 under the ’324 patent to use, make, have made, import, offer for sale, and sell. 23 MPROC has granted to Medtronic Logistics, via written agreements, the exclusive 24 sub-license under the ’324 patent to import, offer for sale, and sell. Medtronic 25 Logistics has granted to MDT USA, via written agreements, the exclusive sub-license 26 under the ’324 patent to offer for sale and sell. As a result of these agreements and 27 Medtronic’s ownership of the ’324 patent, Plaintiffs Medtronic, Inc., MPROC, 28 Medtronic Logistics, and MDT USA have standing to bring suit for infringement of 9 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 10 of 50 Page ID #:10 1 the ’324 patent. 2 29. On November 21, 2017, the Patent and Trademark Office (PTO) issued 3 United States Patent No. 9,821,112 (“the ’112 patent”), titled INDUCTIVELY 4 RECHARGEABLE EXTERNAL ENERGY SOURCE, CHARGER, SYSTEM AND 5 METHOD FOR A TRANSCUTANEOUS INDUCTIVE CHARGER FOR AN 6 IMPLANTABLE MEDICAL DEVICE. The ’112 patent lists the following 7 individuals as inventors: David P. Olson, William C. Phillips, and Andrew L. 8 Schmeling. The ’112 patent is valid and enforceable. A copy of the ’112 patent is 9 attached as Exhibit D. 10 30. Medtronic, Inc. is the owner of the ’112 patent by written assignment. 11 Medtronic, Inc. has granted to MPROC, via written agreements, the exclusive license 12 under the ’112 patent to use, make, have made, import, offer for sale, and sell. 13 MPROC has granted to Medtronic Logistics, via written agreements, the exclusive 14 sub-license under the ’112 patent to import, offer for sale, and sell. Medtronic 15 Logistics has granted to MDT USA, via written agreements, the exclusive sub-license 16 under the ’112 patent to offer for sale and sell. As a result of these agreements and 17 Medtronic’s ownership of the ’112 patent, Plaintiffs Medtronic, Inc., MPROC, 18 Medtronic Logistics, and MDT USA have standing to bring suit for infringement of 19 the ’112 patent. 20 COUNT I 21 (Infringement of U.S. Patent No. 8,036,756) 22 23 24 31. Medtronic realleges and incorporates by reference, as if fully set forth herein, all of the allegations contained in paragraphs 1–30 of this Complaint. 32. Upon information and belief, Axonics has directly infringed, and 25 continues to directly infringe, literally and/or by the doctrine of equivalents, 26 individually and/or jointly, at least claim 14 of the ’756 patent by using and testing its 27 Axonics r-SNM System in the United States in accordance with and as covered by one 28 or more claims of the ’756 patent, including at least claim 14. Products that when 10 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 11 of 50 Page ID #:11 1 used or tested infringe the ’756 patent include, but are not limited to, Tined Lead Kit 2 Model 1201 and Surgical Tool Kit Model 1801 (collectively referred to in Count I as 3 the “Axonics r-SNM System”), and any other products, either alone or in 4 combination, that operate in substantially the same manner. 5 33. Upon information and belief, Axonics has indirectly infringed, and 6 continues to indirectly infringe, literally and/or by the doctrine of equivalents, 7 individually and/or jointly, at least claim 14 of the ’756 patent by marketing and 8 selling its Axonics r-SNM System in the United States for use in accordance with and 9 as covered by one or more claims of the ’756 patent, including at least claim 14. 10 When used or tested, the Axonics r-SNM System, and any other products, either alone 11 or in combination, that operate in substantially the same manner, directly infringe the 12 ’756 patent. 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 34. Claim 14 of the ’756 patent is reproduced below: A method comprising: percutaneously introducing an introducer comprising an introducer lumen extending between an introducer lumen proximal end opening and an introducer lumen distal end opening through body tissue to locate the introducer lumen distal end opening adjacent to a stimulation site; disposing an implantable medical lead within the introducer lumen, wherein the implantable medical lead comprises: a lead body extending between a lead proximal end and a lead distal end; a plurality of connector elements formed in a connector array adjacent the lead proximal end; a plurality of stimulation electrodes arranged in an electrode array extending along a first segment of the lead body proximate to the lead distal end; a plurality of lead conductors extending between the connector elements and the stimulation electrodes; and a plurality of tine elements attached to the lead body along a second segment of the lead body between the first segment of the lead body and the lead proximal end, each tine element comprising a plurality of flexible tines that are 11 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 12 of 50 Page ID #:12 1 adapted to be folded inward against the lead body when fitted into and constrained by the introducer lumen and adapted to deploy outward to engage body tissue when the introducer is withdrawn, wherein the plurality of tine elements are separate from and axially displaced from each of the stimulation electrodes, and wherein the plurality of stimulation electrodes is between the plurality of tine elements and the lead distal end; and withdrawing the introducer toward the lead proximal end from the plurality of tine elements to release the plurality of tines. 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 35. As a non-limiting example, the Axonics r-SNM System is implanted according to a method. Upon information and belief, an implantation method of the Axonics r-SNM System provides for percutaneously introducing an introducer comprising an introducer lumen extending between an introducer lumen proximal end opening and an introducer lumen distal end opening through body tissue to locate the introducer lumen distal end opening adjacent to a stimulation site. Aspects of the method of implantation of the Axonics r-SNM System corresponding to this step are described in Axonics’ product manuals as shown below: 12 17 18 19 20 21 22 23 24 25 26 27 28 See, e.g., Axonics Sacral Neuromodulation System – Tined Lead Implant Manual (Model 1201 Tined Lead; Model 1801 Lead Implant Kit); see also Axonics SNM Implant Technique Best Practices at 19–21. 12 12 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 13 of 50 Page ID #:13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 13 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 14 of 50 Page ID #:14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 36. 20 Upon information and belief, an implantation method of the Axonics r- 21 SNM System provides for disposing an implantable medical lead within the introducer 22 lumen. Aspects of the method of implantation of the Axonics r-SNM System 23 corresponding to this step are described in Axonics’ SNM Manual as shown below: 13 24 25 26 27 28 13 See, e.g., id. 14 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 15 of 50 Page ID #:15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 37. Upon information and belief, an implantable medical lead of the Axonics 23 r-SNM System includes a lead body extending between a lead proximal end and a lead 24 distal end, a plurality of connector elements formed in a connector array adjacent the 25 lead proximal end, a plurality of stimulation electrodes arranged in an electrode array 26 extending along a first segment of the lead body proximate to the lead distal end, 27 plurality of lead conductors extending between the connector elements and the 28 15 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 16 of 50 Page ID #:16 1 stimulation electrodes. Aspects of the implantable medical lead of the Axonics r- 2 SNM System corresponding to this aspect are identified in further detail below: 14 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 See, e.g., Axonics Sacral Neuromodulation System – Tined Lead Implant Manual (Model 1201 Tined Lead; Model 1801 Lead Implant Kit); Axonics Sacral Neuromodulation System, Neurostimulator Implant Manual, Model 1101 Neurostimulator; Axonics SNM Implant Technique Best Practices at 38. 14 16 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 17 of 50 Page ID #:17 1 2 3 4 5 6 7 8 9 10 11 12 13 38. Upon information and belief, an implantable medical lead of the Axonics 14 r-SNM System includes a plurality of tine elements attached to the lead body along a 15 second segment of the lead body between the first segment of the lead body and the 16 lead proximal end, each tine element comprising a plurality of flexible tines that are 17 adapted to be folded inward against the lead body when fitted into and constrained by 18 the introducer lumen and adapted to deploy outward to engage body tissue when the 19 introducer is withdrawn, where the plurality of tine elements are separate from and 20 axially displaced from each of the stimulation electrodes, and wherein the plurality of 21 stimulation electrodes is between the plurality of tine elements and the lead distal end. 22 Aspects of the implantable medical lead of the Axonics r-SNM System corresponding 23 to this aspect are identified in further detail below: 15 24 25 26 27 28 See, e.g., Axonics Sacral Neuromodulation System – Tined Lead Implant Manual (Model 1201 Tined Lead; Model 1801 Lead Implant Kit); Elterman, “The novel Axonics® rechargeable sacral neuromodulation system: Procedural and technical impressions from an initial North American experience,” Wiley Periodicals, Neurourology and Urodynamics 2018;1–8 (December 19, 2017); available at: https://doi.org/10.1002/nau.23482. 15 17 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 18 of 50 Page ID #:18 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 18 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 19 of 50 Page ID #:19 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 39. Upon information and belief, the implantation method of the Axonics r- SNM System provides for withdrawing the introducer toward the lead proximal end from the plurality of tine elements to release the plurality of tines. Aspects of the method of implantation of the Axonics r-SNM System corresponding to this step are identified in further detail below: 16 23 24 25 26 27 28 See, e.g., Axonics Sacral Neuromodulation System – Tined Lead Implant Manual (Model 1201 Tined Lead; Model 1801 Lead Implant Kit). 16 19 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 20 of 50 Page ID #:20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 40. Upon information and belief, Axonics has been, and currently is engaged in actively inducing infringement of at least claim 14 of the ’756 patent under 35 U.S.C. § 271(b) and contributory infringement of at least claim 14 of the ’756 patent under 35 U.S.C. § 271(c) either literally and/or by the doctrine of equivalents. 41. Upon information and belief, Axonics has committed, and continues to commit, affirmative acts that cause infringement of at least claim 14 of the ’756 patent with knowledge or willful blindness of the ’756 patent and knowledge or willful blindness that the induced acts constitute infringement of at least claim 14 of the ’756 patent. For example, Axonics induces such acts of infringement by its affirmative actions of intentionally providing products that when used in their normal and customary way as desired and intended by Axonics, infringe at least claim 14 of the ’756 patent and by providing instructions for using its products in a manner or configuration that infringes at least claim 14 of the ’756 patent. 42. Upon information and belief, Axonics provides the Axonics r-SNM System to others, such as hospitals, medical centers, clinics, clinicians, doctors, nurse 20 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 21 of 50 Page ID #:21 1 practitioners, and care providers, who, in turn, use, provision for use, or test the 2 Axonics r-SNM System in a manner that directly infringes at least claim 14 of the 3 ’756 patent. Upon information and belief, Axonics provides user instructions and 4 manuals accompanying its products for the Axonics r-SNM System as well as other 5 marketing and promotional materials that instruct, direct, and intentionally induce 6 others, such as hospitals, medical centers, clinics, clinicians, doctors, nurse 7 practitioners, and care providers, to use the Axonics r-SNM System in a manner that 8 directly infringes at least claim 14 of the ’756 patent, for the reasons discussed above. 9 43. Moreover, upon information and belief, Axonics has hired a U.S. sales 10 team, that includes former members of Medtronic’s sales team who received training 11 from Medtronic, and that team consists of at least 11 regional sales managers, between 12 85 and 90 sales professionals, and 30 clinical specialists. Upon information and 13 belief, Axonics’ U.S. sales team, who are fully trained regarding Axonics’ product, 14 have been and will be “strategically mapped to and located where current high volume 15 implanters are practicing in the United States.” 17 Upon information and belief, the 16 sales team has been responsible for and continues to be responsible for “supporting 17 cases in the [operating room], interacting with patients and programming the 18 implanted [Axonics] device.” 18 Upon information and belief, the sales team has been 19 involved with and continues to be involved with the distribution of marketing, 20 promotional, and training materials, which instruct Axonics’ customers regarding the 21 use of the Axonics r-SNM System in the United States in a manner that directly 22 infringes one or more claims of the ’756 patent. 23 44. Upon information and belief, Axonics has contributed to, and continues 24 to contribute to, the infringement of the ’756 patent by others by knowingly providing 25 the Axonics r-SNM System for use in practicing at least claim 14 of the ’756 patent, 26 27 28 See, e.g., Q1 2019 Axonics Modulation Technologies Inc. Earnings Call, (May 8, 2019, 8:30PM GMT). 18 Id. 17 21 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 22 of 50 Page ID #:22 1 and knowing the Axonics r-SNM System to be especially made or especially adapted 2 for use in infringement of the ’756 patent. Upon information and belief, Axonics has 3 also committed, and continues to commit contributory infringement by, inter alia, 4 knowingly offering for sale and selling the Axonics r-SNM System, which has no 5 substantial non-infringing uses, and which when used causes the direct infringement 6 of at least claim 14 of the ’756 patent by third parties, such as hospitals, medical 7 centers, clinics, clinicians, doctors, nurse practitioners, and care providers. 8 9 45. As discussed above, the Axonics r-SNM System is designed and sold to be used only for implanting its components in a specific way, as directed by the 10 instructions in the manuals and promotional materials. The manuals and promotional 11 materials provide specific instructions for using the Axonics r-SNM System in a way 12 that infringes at least one claim of the ’756 patent, and they do not contemplate any 13 non-infringing uses. 14 46. Upon information and belief, Axonics knew of the ’756 patent or was 15 willfully blind to its existence. Upon information and belief, Axonics had knowledge 16 of the ’756 patent and continues to have knowledge of the ’756 patent, including but 17 not limited to at least one or more of the following events: the filing of Medtronic’s 18 Complaint against Axonics; in the course of its due diligence and freedom to operate 19 analyses, including the “many initial months [spent] examining patents and IP 20 issues”; 19 and as part of the due diligence investigation performed for SEC filings. By 21 the time of trial, Axonics will have known and intended (since receiving such notice) 22 that its continued actions would infringe and actively induce and contribute to the 23 infringement of at least claim 14 of the ’756 patent. 24 25 47. has been and continues to be willful. 26 27 28 Upon information and belief, Axonics’ infringement of the ’756 patent 48. Axonics’ infringement of the ’756 patent has been without permission, https://www.businessinfocusmagazine.com/2018/05/axonics-prepares-forintroduction-of-its-sacral-neuromodulation-system/ 19 22 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 23 of 50 Page ID #:23 1 2 consent, authorization, or license from Medtronic. 49. As a result of Axonics’ infringement, Medtronic has suffered and will 3 continue to suffer damages in an amount to be proved at trial. In addition, Axonics’ 4 infringement caused and will continue to cause Medtronic irreparable harm, for which 5 there is no adequate remedy at law, warranting an injunction from the Court. 6 COUNT II 7 (Infringement of U.S. Patent No. 8,626,314) 8 9 10 50. Medtronic realleges and incorporates by reference, as if fully set forth herein, all of the allegations contained in paragraphs 1–49 of this Complaint. 51. Upon information and belief, Axonics has directly infringed, and 11 continues to directly infringe, literally and/or by the doctrine of equivalents, 12 individually and/or jointly, at least claim 11 of the ’314 patent by making, using, 13 testing, selling, offering for sale, and/or importing into the United States products 14 covered by at least claim 11 of the ’314 patent. Axonics’ products that infringe the 15 ’314 patent include, but are not limited to, Implantable Pulse Generator Model 1101, 16 Tined Lead Kit Model 1201, and Surgical Tool Kit Model 1801 (collectively referred 17 to in Count II as the “Axonics r-SNM System”), and any other Axonics products, 18 either alone or in combination, that operate in substantially the same manner. 19 52. Upon information and belief, Axonics has indirectly infringed, and 20 continues to indirectly infringe, literally and/or by the doctrine of equivalents, 21 individually and/or jointly, at least claim 11 of the ’314 patent by marketing and 22 selling its Axonics r-SNM System in the United States for use or sale in accordance 23 with and as covered by one or more claims of the ’314 patent, including at least claim 24 11. When used, tested, offered for sale, or sold, the Axonics r-SNM System, and any 25 other products, either alone or in combination, that operate in substantially the same 26 manner, directly infringe the ’314 patent. 27 53. Claim 11 of the ’314 patent is reproduced below: 28 23 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 24 of 50 Page ID #:24 1 A system comprising: an implantable pulse generator configured to generate electrical stimulation; an implantable medical lead configured to be electrically coupled to the implantable pulse generator and introduced through and released into body tissue via an introducer defining an introducer lumen, the implantable medical lead comprising: a lead body extending between a proximal end and a distal end; a plurality of conductors within the lead body; a plurality of electrodes, wherein each electrode is electrically connected to a conductor of the plurality of conductors; and a plurality of tine elements extending from the lead body, wherein all tine elements of the plurality of tine elements are positioned between a most proximal electrode of the plurality of electrodes and the proximal end of the lead body, each tine element comprising a plurality of flexible, pliant tines, each tine having a tine width and thickness and extending a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, wherein the plurality of tines of the plurality of tine elements are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of the introducer without overlapping one another and deploy outward to engage body tissue when the introducer is withdrawn proximally, wherein the plurality of tine elements is separate from and axially displaced from the plurality of electrodes. 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 54. As a non-limiting example, upon information and belief, the Axonics r- 24 SNM System includes an implantable pulse generator configured to generate electrical 25 stimulation and an implantable medical lead configured to be electrically coupled to 26 the implantable pulse generator and introduced through and released into body tissue 27 via an introducer defining an introducer lumen. Aspects of the implantable pulse 28 generator and medical lead of the Axonics r-SNM System corresponding to this aspect 24 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 25 of 50 Page ID #:25 1 are identified in further detail below: 20 2 3 4 5 6 7 8 9 10 11 12 55. Upon information and belief, an implantable medical lead of the Axonics 13 r-SNM System includes a lead body extending between a proximal end and a distal 14 end, a plurality of conductors within the lead body, and a plurality of electrodes, 15 wherein each electrode is electrically connected to a conductor of the plurality of 16 conductors. Aspects of the implantable medical lead of the Axonics r-SNM System 17 corresponding to this aspect are identified in further detail below: 21 18 19 20 21 22 23 24 25 26 27 28 See, e.g., Axonics Sacral Neuromodulation System – Tined Lead Implant Manual (Model 1201 Tined Lead; Model 1801 Lead Implant Kit); Axonics SNM Implant Technique Best Practices at 38. 21 See, e.g., id; Axonics Sacral Neuromodulation System, Neurostimulator Implant Manual, Model 1101 Neurostimulator. 20 25 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 26 of 50 Page ID #:26 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 26 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 27 of 50 Page ID #:27 1 2 3 4 5 6 7 8 9 10 11 12 13 56. Upon information and belief, an implantable medical lead of the Axonics 14 r-SNM System includes a plurality of tine elements extending from the lead body, 15 wherein all tine elements of the plurality of tine elements are positioned between a 16 most proximal electrode of the plurality of electrodes and the proximal end of the lead 17 body, each tine element comprising a plurality of flexible, pliant tines, each tine 18 having a tine width and thickness and extending a tine length from an attached tine 19 end to a free tine end, the attached tine end attached to the lead body from a tine 20 attachment site and supporting the tine extending outwardly of the lead body and 21 proximally toward the lead proximal end, wherein the plurality of tines of the plurality 22 of tine elements are adapted to be folded inward against the lead body when fitted into 23 and constrained by the lumen of the introducer without overlapping one another and 24 deploy outward to engage body tissue when the introducer is withdrawn proximally, 25 wherein the plurality of tine elements is separate from and axially displaced from the 26 plurality of electrodes. Aspects of the implantable medical lead of the Axonics r- 27 28 27 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 28 of 50 Page ID #:28 1 SNM System corresponding to this aspect are identified in further detail below: 22 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 See, e.g., id; Elterman, “The novel Axonics® rechargeable sacral neuromodulation system: Procedural and technical impressions from an initial North American experience,” at 7, Wiley Periodicals, Neurourology and Urodynamics 2018;1–8 (December 19, 2017); available at: https://doi.org/10.1002/nau.23482. 22 28 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 29 of 50 Page ID #:29 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 30 of 50 Page ID #:30 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 57. Upon information and belief, Axonics has been and is currently engaged in actively inducing infringement of at least claim 11 of the ’314 patent under 35 U.S.C. § 271(b) and contributory infringement of at least claim 11 of the ’314 patent under 35 U.S.C. § 271(c) either literally and/or by the doctrine of equivalents. 58. Upon information and belief, Axonics has committed, and continues to commit, affirmative acts that cause infringement of at least claim 11 of the ’314 patent with knowledge or willful blindness of the ’314 patent, and knowledge or willful blindness that the induced acts constitute infringement of at least claim 11 of the ’314 patent. For example, Axonics induces such acts of infringement by its affirmative actions of intentionally providing products that when used in their normal and customary way as desired and intended by Axonics, infringe at least claim 11 of the ’314 patent and by providing instructions for using its products in a manner or configuration that infringes at least claim 11 of the ’314 patent. 59. Upon information and belief, Axonics provides the Axonics r-SNM System to others, such as customers, hospitals, medical centers, clinics, clinicians, 30 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 31 of 50 Page ID #:31 1 doctors, nurse practitioners, care providers, sales representatives, suppliers, 2 distributors, and resellers, who, in turn, use, provision for use, test, offer for sale, or 3 sell the Axonics r-SNM System in a manner that directly infringes at least claim 11 of 4 the ’314 patent. Upon information and belief, Axonics provides user instructions and 5 manuals accompanying its products for the Axonics r-SNM System, as well as other 6 marketing and promotional materials that instruct, direct, and intentionally induce 7 others, such as customers, hospitals, medical centers, clinics, clinicians, doctors, nurse 8 practitioners, and care providers, to use the Axonics r-SNM System in a manner that 9 directly infringes as least claim 11 of the ’314 patent. 10 60. Moreover, upon information and belief, Axonics has hired a U.S. sales 11 team that includes former members of Medtronic’s sales team who received training 12 from Medtronic, and that team consists of at least 11 regional sales managers, between 13 85 and 90 sales professionals, and 30 clinical specialists. Upon information and 14 belief, Axonics’ U.S. sales team, who are fully trained regarding Axonics’ product, 15 have been and will be “strategically mapped to and located where current high volume 16 implanters are practicing in the United States.” 23 Upon information and belief, the 17 sales team has been responsible for and continues to be responsible for “supporting 18 cases in the [operating room], interacting with patients and programming the 19 implanted [Axonics] device.” 24 Upon information and belief, the sales team has been 20 involved with and continues to be involved with the distribution of marketing, 21 promotional, and training materials, which instruct Axonics’ customers regarding the 22 use of the Axonics r-SNM System in the United States in a manner that directly 23 infringes one or more claims of the ’314 patent. 24 25 26 27 28 61. Upon information and belief, Axonics has contributed to, and continues to contribute to, the infringement of the ’314 patent by others by knowingly providing See Q1 2019 Axonics Modulation Technologies Inc. Earnings Call, May 8, 2019, 8:30PM GMT). 24 Id. 23 31 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 32 of 50 Page ID #:32 1 the Axonics r-SNM System that constitutes a material part of at least claim 11 of the 2 ’314 patent, with knowledge that the Axonics r-SNM System is to be especially made 3 or especially adapted for use in infringement of the ’314 patent. Upon information 4 and belief, Axonics has also committed, and continues to commit contributory 5 infringement by, inter alia, knowingly offering for sale and selling the Axonics r- 6 SNM System, which has no substantial non-infringing uses, and which constitutes a 7 material part of at least claim 11 of the ’314 patent. 8 9 62. As discussed above, the Axonics r-SNM System is designed and sold to be used only for implanting its components in a specific way, as directed by the 10 instructions in the manuals and promotional materials. The manuals and promotional 11 materials provide specific instructions for using the Axonics r-SNM System in a way 12 that infringes at least one claim of the ’314 patent, and they do not contemplate any 13 non-infringing uses. 14 63. Upon information and belief, Axonics knew of the ’314 patent or was 15 willfully blind to its existence. Upon information and belief, Axonics had knowledge 16 of the ’314 patent and continues to have knowledge of the ’314 patent, including but 17 not limited to at least one or more of the following events: the filing of Medtronic’s 18 Complaint against Axonics; in the course of its due diligence and freedom to operate 19 analyses, including the “many initial months [spent] examining patents and IP 20 issues”; 25 and as part of the due-diligence investigation performed for SEC filings. By 21 the time of trial, Axonics will have known and intended (since receiving such notice) 22 that its continued actions would infringe and actively induce and contribute to the 23 infringement of at least claim 11 of the ’314 patent. 24 25 64. has been and continues to be willful. 26 27 28 Upon information and belief, Axonics’ infringement of the ’314 patent 65. Axonics’ infringement of the ’314 patent has been without permission, https://www.businessinfocusmagazine.com/2018/05/axonics-prepares-forintroduction-of-its-sacral-neuromodulation-system/ 25 32 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 33 of 50 Page ID #:33 1 2 consent, authorization, or license of Medtronic. 66. As a result of Axonics’ infringement, Medtronic has suffered and will 3 continue to suffer damages in an amount to be proved at trial. In addition, Axonics’ 4 infringement caused and will continue to cause Medtronic irreparable harm, for which 5 there is no adequate remedy at law, warranting an injunction from the Court. 6 COUNT III 7 (Infringement of U.S. Patent No. 9,463,324) 8 9 10 67. Medtronic realleges and incorporates by reference, as if fully set forth herein, all of the allegations contained in paragraphs 1–66 of this Complaint. 68. Upon information and belief, Axonics has directly infringed, and 11 continues to directly infringe, literally and/or by the doctrine of equivalents, 12 individually and/or jointly, at least claims 1, 4, and 11 of the ’324 patent by making, 13 using, testing, selling, offering for sale, and/or importing into the United States 14 products covered by at least claims 1, 4, and 11 of the ’324 patent. Axonics’ products 15 that infringe the ’324 patent include, but are not limited to, the Model 1101 16 Neurostimulator and Model 1401 charging system, (collectively referred to in Count 17 III as the “Axonics r-SNM System”), and any other Axonics products, either alone or 18 in combination, that operate in substantially the same manner. 19 69. Upon information and belief, Axonics has indirectly infringed, and 20 continues to indirectly infringe, literally and/or by the doctrine of equivalents, 21 individually and/or jointly, at least claims 1, 4, and 11 of the ’324 patent by marketing 22 and selling its Axonics r-SNM System in the United States for use or sale in 23 accordance with and as covered by one or more claims of the ’324 patent, including at 24 least claims 1, 4, and 11. When used, tested, offered for sale, or sold, the Axonics r- 25 SNM System, and any other products, either alone or in combination, that operate in 26 substantially the same manner, directly infringe the ’324 patent. 27 28 70. Claim 1 of the ’324 patent is reproduced below: A system, comprising: 33 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 34 of 50 Page ID #:34 1 an implantable medical device comprising a secondary coil; and an external device comprising: a primary coil adapted to be transcutaneously coupled to the secondary coil to transfer energy to the implantable medical device; a housing having a side adapted to be positioned in proximity to the secondary coil when the primary coil is transcutaneously coupled to the secondary coil; a temperature sensor adapted to provide an output indicative of a temperature of the side of the housing; and control circuitry adapted to control the transfer of energy to the implantable medical device based on the output of the temperature sensor to limit a temperature to which a patient is exposed during the transfer of energy to the implantable medical device. 2 3 4 5 6 7 8 9 10 11 12 71. As a non-limiting example, upon information and belief, the Axonics r- 13 SNM System includes an implantable medical device comprising a secondary coil. 14 Aspects of the implantable pulse generator of the Axonics r-SNM System 15 corresponding to this aspect are identified in further detail below: 26 16 17 18 19 20 21 22 23 24 25 26 27 28 See, e.g., Axonics Sacral Neuromodulation System – Tined Lead Implant Manual (Model 1201 Tined Lead; Model 1801 Lead Implant Kit); Axonics SNM Implant Technique Best Practices; Elterman, “The novel Axonics® rechargeable sacral neuromodulation system: Procedural and technical impressions from an initial North American experience,” at 7, Wiley Periodicals, Neurourology and Urodynamics 2018;1–8 (December 19, 2017); available at: https://doi.org/10.1002/nau.23482. 26 34 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 35 of 50 Page ID #:35 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 72. Upon information and belief, the Axonics r-SNM System includes an external device comprising a primary coil adapted to be transcutaneously coupled to 35 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 36 of 50 Page ID #:36 1 the secondary coil to transfer energy to the implantable medical device and a housing 2 having a side adapted to be positioned in proximity to the secondary coil when the 3 primary coil is transcutaneously coupled to the secondary coil. Aspects of the 4 external recharger of the Axonics r-SNM System corresponding to this aspect are 5 identified in further detail below: 27 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 27 See, e.g., id.; Axonics r-SNM System Charging System User Manual. at p. 18. 36 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 37 of 50 Page ID #:37 1 2 3 4 5 6 7 8 9 10 11 12 73. 13 Upon information and belief, the Axonics r-SNM System includes an 14 external device comprising a temperature sensor adapted to provide an output 15 indicative of a temperature of the side of the housing, and control circuitry adapted to 16 control the transfer of energy to the implantable medical device based on the output of 17 the temperature sensor to limit a temperature to which a patient is exposed during the 18 transfer of energy to the implantable medical device. Aspects of the external 19 recharger of the Axonics r-SNM System corresponding to this aspect are identified in 20 further detail below: 28 21 22 23 24 25 26 27 28 See, e.g., id at p. 33; Blok, “Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder,” Wiley Periodicals, Neurourology and Urodynamics 2018;1–6 (November 29, 2017); available at: https://doi.org/10.1002/nau.23476. 28 37 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 38 of 50 Page ID #:38 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 74. Upon information and belief, Axonics has been and is currently engaged in actively inducing infringement of at least claims 1, 4, and 11 of the ’324 patent under 35 U.S.C. § 271(b) and contributory infringement of at least claims 1, 4, and 11 of the ’324 patent under 35 U.S.C. § 271(c) either literally and/or by the doctrine of equivalents. 75. Upon information and belief, Axonics has committed, and continues to commit, affirmative acts that cause infringement of at least claims 1, 4, and 11 of the ’324 patent with knowledge or willful blindness of the ’324 patent, and knowledge or willful blindness that the induced acts constitute infringement of at least claims 1, 4, and 11 of the ’324 patent. For example, Axonics induces such acts of infringement by its affirmative actions of intentionally providing products that when used in their normal and customary way as desired and intended by Axonics, infringe at least claims 1, 4, and 11 of the ’324 patent and by providing instructions for using its products in a manner or configuration that infringes at least claims 1, 4, and 11 of the ’324 patent. 76. Upon information and belief, Axonics provides the Axonics r-SNM System to others, such as customers, patients, hospitals, medical centers, clinics, 38 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 39 of 50 Page ID #:39 1 clinicians, doctors, nurse practitioners, care providers, sales representatives, suppliers, 2 distributors, and resellers, who, in turn, use, provision for use, test, offer for sale, or 3 sell the Axonics r-SNM System in a manner that directly infringes at least claims 1, 4, 4 and 11 of the ’324 patent. Upon information and belief, Axonics provides user 5 instructions and manuals accompanying its products for the Axonics r-SNM System, 6 as well as other marketing and promotional materials that instruct, direct, and 7 intentionally induce others, such as customers, patients, hospitals, medical centers, 8 clinics, clinicians, doctors, nurse practitioners, and care providers, to use the Axonics 9 r-SNM System in a manner that directly infringes as least claims 1, 4, and 11 of the 10 ’324 patent. 11 77. Moreover, upon information and belief, Axonics has hired a U.S. sales 12 team that includes former members of Medtronic’s sales team who received training 13 from Medtronic, and that team consists of at least 11 regional sales managers, between 14 85 and 90 sales professionals, and 30 clinical specialists. Upon information and 15 belief, Axonics’ U.S. sales team, who are fully trained regarding Axonics’ product, 16 have been and will be “strategically mapped to and located where current high volume 17 implanters are practicing in the United States.” 29 Upon information and belief, the 18 sales team has been responsible for and continues to be responsible for “supporting 19 cases in the [operating room], interacting with patients and programming the 20 implanted [Axonics] device.” 30 Upon information and belief, the sales team has been 21 involved with and continues to be involved with the distribution of marketing, 22 promotional, and training materials, which instruct Axonics’ customers regarding the 23 use of the Axonics r-SNM System in the United States in a manner that directly 24 infringes one or more claims of the ’324 patent. 25 26 27 28 78. Upon information and belief, Axonics has contributed to, and continues See Q1 2019 Axonics Modulation Technologies Inc. Earnings Call, May 8, 2019, 8:30PM GMT). 30 Id. 29 39 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 40 of 50 Page ID #:40 1 to contribute to, the infringement of the ’324 patent by others by knowingly providing 2 the Axonics r-SNM System that constitutes a material part of at least claims 1, 4, and 3 11 of the ’324 patent, with knowledge that the Axonics r-SNM System is to be 4 especially made or especially adapted for use in infringement of the ’324 patent. 5 Upon information and belief, Axonics has also committed, and continues to commit 6 contributory infringement by, inter alia, knowingly offering for sale and selling the 7 Axonics r-SNM System, which has no substantial non-infringing uses, and which 8 constitutes a material part of at least claims 1, 4, and 11 of the ’324 patent. 9 79. As discussed above, the Axonics r-SNM System is designed and sold to 10 be used only for recharging in a specific way, as directed by the instructions in the 11 manuals and promotional materials. The manuals and promotional materials provide 12 specific instructions for using the Axonics r-SNM System in a way that infringes at 13 least one claim of the ’324 patent, and they do not contemplate any non-infringing 14 uses. 15 80. Upon information and belief, Axonics knew of the ’324 patent or was 16 willfully blind to its existence. Upon information and belief, Axonics had knowledge 17 of the ’324 patent and continues to have knowledge of the ’324 patent, including but 18 not limited to at least one or more of the following events: the filing of Medtronic’s 19 Complaint against Axonics; in the course of its due diligence and freedom to operate 20 analyses, including the “many initial months [spent] examining patents and IP 21 issues”; 31 and as part of the due-diligence investigation performed for SEC filings. By 22 the time of trial, Axonics will have known and intended (since receiving such notice) 23 that its continued actions would infringe and actively induce and contribute to the 24 infringement of at least claims 1, 4, and 11 of the ’324 patent. 25 26 27 28 81. Upon information and belief, Axonics’ infringement of the ’324 patent has been and continues to be willful. https://www.businessinfocusmagazine.com/2018/05/axonics-prepares-forintroduction-of-its-sacral-neuromodulation-system/. 31 40 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 41 of 50 Page ID #:41 1 2 3 82. Axonics’ infringement of the ’324 patent has been without permission, consent, authorization, or license of Medtronic. 83. As a result of Axonics’ infringement, Medtronic has suffered and will 4 continue to suffer damages in an amount to be proved at trial. In addition, Axonics’ 5 infringement caused and will continue to cause Medtronic irreparable harm, for which 6 there is no adequate remedy at law, warranting an injunction from the Court. 7 COUNT IV 8 (Infringement of U.S. Patent No. 9,821,112) 9 10 11 84. Medtronic realleges and incorporates by reference, as if fully set forth herein, all of the allegations contained in paragraphs 1–83 of this Complaint. 85. Upon information and belief, Axonics has directly infringed, and 12 continues to directly infringe, literally and/or by the doctrine of equivalents, 13 individually and/or jointly, at least claim 1 of the ’112 patent by making, using, 14 testing, selling, offering for sale, and/or importing into the United States products 15 covered by at least claim 1 of the ’112 patent. Axonics’ products that infringe the 16 ’112 patent include, but are not limited to, the Model 1101 Neurostimulator and 17 Model 1401 charging system, (collectively referred to in Count IV as the “Axonics r- 18 SNM System”), and any other Axonics products, either alone or in combination, that 19 operate in substantially the same manner. 20 86. Upon information and belief, Axonics has indirectly infringed, and 21 continues to indirectly infringe, literally and/or by the doctrine of equivalents, 22 individually and/or jointly, at least claim 1 of the ’112 patent by marketing and selling 23 its Axonics r-SNM System in the United States for use or sale in accordance with and 24 as covered by one or more claims of the ’112 patent, including at least claim 1. When 25 used, tested, offered for sale, or sold, the Axonics r-SNM System, and any other 26 products, either alone or in combination, that operate in substantially the same 27 manner, directly infringe the ’112 patent. 28 87. Claim 1 of the ’112 patent is reproduced below: 41 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 42 of 50 Page ID #:42 1 A medical system, comprising: an implantable medical device; an external charging device configured to transcutaneously transfer energy to the implantable medical device comprising; a sensor configured to measure a temperature indicative of heat resulting from the transcutaneous transfer of energy to the implantable medical device; a control circuit configured to compare the measured temperature to a programmable limit and to control the transfer of energy based on the comparison; and a memory configured to store the programmable limit. 2 3 4 5 6 7 8 9 10 11 12 13 88. As a non-limiting example, upon information and belief, the Axonics r- SNM System is a medical system that includes an implantable medical device. Aspects of the implantable pulse generator of the Axonics r-SNM System corresponding to this aspect are identified in further detail below: 32 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 See, e.g., Axonics Sacral Neuromodulation System – Tined Lead Implant Manual (Model 1201 Tined Lead; Model 1801 Lead Implant Kit); Axonics SNM Implant Technique Best Practices; Elterman, “The novel Axonics® rechargeable sacral neuromodulation system: Procedural and technical impressions from an initial North American experience,” at 7, Wiley Periodicals, Neurourology and Urodynamics 2018;1–8 (December 19, 2017); available at: https://doi.org/10.1002/nau.23482. 32 42 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 43 of 50 Page ID #:43 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 89. Upon information and belief, the Axonics r-SNM System includes an external charging device configured to transcutaneously transfer energy to the 43 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 44 of 50 Page ID #:44 1 implantable medical device. 2 System corresponding to this aspect are identified in further detail below: 33 Aspects of the external recharger of the Axonics r-SNM 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 33 See, e.g., id.; Axonics r-SNM System Charging System User Manual. 44 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 45 of 50 Page ID #:45 1 2 3 4 5 6 7 8 9 10 11 12 90. 13 Upon information and belief, the Axonics r-SNM System includes an 14 external device comprising a sensor configured to measure a temperature indicative of 15 heat resulting from the transcutaneous transfer of energy to the implantable medical 16 device, a control circuit configured to compare the measured temperature to a 17 programmable limit and to control the transfer of energy based on the comparison, and 18 a memory configured to store the programmable limit. Aspects of the external 19 recharger of the Axonics r-SNM System corresponding to this aspect are identified in 20 further detail below: 34 21 22 23 24 25 26 27 28 See, e.g., id; Blok, “Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder,” Wiley Periodicals, Neurourology and Urodynamics 2018;1–6 (November 29, 2017); available at: https://doi.org/10.1002/nau.23476. 34 45 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 46 of 50 Page ID #:46 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 91. Upon information and belief, Axonics has been and is currently engaged in actively inducing infringement of at least claim 1 of the ’112 patent under 35 U.S.C. § 271(b) and contributory infringement of at least claim 1 of the ’112 patent under 35 U.S.C. § 271(c) either literally and/or by the doctrine of equivalents. 92. Upon information and belief, Axonics has committed, and continues to commit, affirmative acts that cause infringement of at least claim 1 of the ’112 patent with knowledge or willful blindness of the ’112 patent, and knowledge or willful blindness that the induced acts constitute infringement of at least claim 1 of the ’112 patent. For example, Axonics induces such acts of infringement by its affirmative actions of intentionally providing products that when used in their normal and customary way as desired and intended by Axonics, infringe at least claim 1 of the ’112 patent and by providing instructions for using its products in a manner or configuration that infringes at least claim 1 of the ’112 patent. 93. Upon information and belief, Axonics provides the Axonics r-SNM System to others, such as customers, patients, hospitals, medical centers, clinics, clinicians, doctors, nurse practitioners, care providers, sales representatives, suppliers, distributors, and resellers, who, in turn, use, provision for use, test, offer for sale, or 46 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 47 of 50 Page ID #:47 1 sell the Axonics r-SNM System in a manner that directly infringes at least claim 1 of 2 the ’112 patent. Upon information and belief, Axonics provides user instructions and 3 manuals accompanying its products for the Axonics r-SNM System, as well as other 4 marketing and promotional materials that instruct, direct, and intentionally induce 5 others, such as customers, patients, hospitals, medical centers, clinics, clinicians, 6 doctors, nurse practitioners, and care providers, to use the Axonics r-SNM System in a 7 manner that directly infringes as least claim 1 of the ’112 patent. 8 9 94. Moreover, upon information and belief, Axonics has hired a U.S. sales team that includes former members of Medtronic’s sales team who received training 10 from Medtronic, and that team consists of at least 11 regional sales managers, between 11 85 and 90 sales professionals, and 30 clinical specialists. Upon information and 12 belief, Axonics’ U.S. sales team, who are fully trained regarding Axonics’ product, 13 have been and will be “strategically mapped to and located where current high volume 14 implanters are practicing in the United States.” 35 Upon information and belief, the 15 sales team has been responsible for and continues to be responsible for “supporting 16 cases in the [operating room], interacting with patients and programming the 17 implanted [Axonics] device.” 36 Upon information and belief, the sales team has been 18 involved with and continues to be involved with the distribution of marketing, 19 promotional, and training materials, which instruct Axonics’ customers regarding the 20 use of the Axonics r-SNM System in the United States in a manner that directly 21 infringes one or more claims of the ’112 patent. 22 95. Upon information and belief, Axonics has contributed to, and continues 23 to contribute to, the infringement of the ’112 patent by others by knowingly providing 24 the Axonics r-SNM System that constitutes a material part of at least claim 1 of the 25 ’112 patent, with knowledge that the Axonics r-SNM System is to be especially made 26 27 28 See Q1 2019 Axonics Modulation Technologies Inc. Earnings Call, May 8, 2019, 8:30PM GMT). 36 Id. 35 47 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 48 of 50 Page ID #:48 1 or especially adapted for use in infringement of the ’112 patent. Upon information 2 and belief, Axonics has also committed, and continues to commit contributory 3 infringement by, inter alia, knowingly offering for sale and selling the Axonics r- 4 SNM System, which has no substantial non-infringing uses, and which constitutes a 5 material part of at least claim 1 of the ’112 patent. 6 96. As discussed above, the Axonics r-SNM System is designed and sold to 7 be used only for recharging in a specific way, as directed by the instructions in the 8 manuals and promotional materials. The manuals and promotional materials provide 9 specific instructions for using the Axonics r-SNM System in a way that infringes at 10 least one claim of the ’112 patent, and they do not contemplate any non-infringing 11 uses. 12 97. Upon information and belief, Axonics knew of the ’112 patent or was 13 willfully blind to its existence. Upon information and belief, Axonics had knowledge 14 of the ’112 patent and continues to have knowledge of the ’112 patent, including but 15 not limited to at least one or more of the following events: the filing of Medtronic’s 16 Complaint against Axonics; in the course of its due diligence and freedom to operate 17 analyses, including the “many initial months [spent] examining patents and IP 18 issues”; 37 and as part of the due-diligence investigation performed for SEC filings. By 19 the time of trial, Axonics will have known and intended (since receiving such notice) 20 that its continued actions would infringe and actively induce and contribute to the 21 infringement of at least claim 1 of the ’112 patent. 22 23 98. has been and continues to be willful. 24 25 99. 28 Axonics’ infringement of the ’112 patent has been without permission, consent, authorization, or license of Medtronic. 26 27 Upon information and belief, Axonics’ infringement of the ’112 patent 100. As a result of Axonics’ infringement, Medtronic has suffered and will https://www.businessinfocusmagazine.com/2018/05/axonics-prepares-forintroduction-of-its-sacral-neuromodulation-system/ 37 48 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 49 of 50 Page ID #:49 1 continue to suffer damages in an amount to be proved at trial. In addition, Axonics’ 2 infringement caused and will continue to cause Medtronic irreparable harm, for which 3 there is no adequate remedy at law, warranting an injunction from the Court. PRAYER FOR RELIEF 4 5 6 WHEREFORE, Plaintiffs request that the Court: A. Adjudge that Axonics has infringed and is infringing one or more claims 7 of each of the above patents-in-suit, directly and/or indirectly, literally, and/or under 8 the doctrine of equivalents; 9 B. Award damages sufficient to compensate Plaintiffs for Axonics’ 10 infringement under 35 U.S.C. § 284, including an award of treble damages for willful 11 infringement; 12 13 14 C. Find this case exceptional under 35 U.S.C. § 285 and awarding Medtronic its reasonable attorneys’ fees; D. Permanently enjoin Axonics, and all persons in concert or participation 15 with it, from directly or indirectly infringing one or more claims of each of the above 16 patents-in-suit, directly and/or indirectly, literally, and/or under the doctrine of 17 equivalents; 18 E. Award Plaintiffs their costs and expenses incurred in this action; 19 F. Award Plaintiffs pre-judgment and post-judgment interest; and 20 G. Grant Plaintiffs such further relief as the Court deems just and 21 appropriate. 22 DEMAND FOR JURY TRIAL 23 Plaintiffs demand trial by jury of all claims so triable. 24 25 26 27 28 Dated: November 4, 2019 WINSTON & STRAWN LLP By: /s/ Nimalka Wickramasekera George C. Lombardi Nimalka Wickramasekera J.R. McNair 49 COMPLAINT Case 8:19-cv-02115 Document 1 Filed 11/04/19 Page 50 of 50 Page ID #:50 1 2 3 4 5 Vivek V. Krishnan Joe Netikosol Attorneys for Plaintiffs MEDTRONIC, INC.; MEDTRONIC PUERTO RICO OPERATIONS CO.; MEDTRONIC LOGISTICS, LLC; MEDTRONIC USA, INC. 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 50 COMPLAINT