DCT

8:19-cv-02115

Medtronic Inc v. Axonics Modulation Tech Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 8:19-cv-02115, C.D. Cal., 11/26/2019
  • Venue Allegations: Venue is alleged to be proper as Defendant Axonics maintains regular and established places of business within the Central District of California and has committed acts of alleged infringement in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s rechargeable Sacral Neuromodulation (r-SNM) System infringes seven patents related to implantable medical stimulation leads and transcutaneous charging systems.
  • Technical Context: The technology at issue is sacral neuromodulation, a therapy that uses an implanted electrical stimulator to treat pelvic floor disorders such as overactive bladder and fecal incontinence.
  • Key Procedural History: This First Amended Complaint follows an original complaint. Post-grant proceedings at the U.S. Patent and Trademark Office have impacted several patents-in-suit. Inter Partes Review (IPR) proceedings have resulted in the cancellation of the asserted claims of U.S. Patent Nos. 8,626,314 and 7,774,069, and the disclaimer of the asserted claim of U.S. Patent No. 8,738,148. The asserted claims of U.S. Patent Nos. 8,036,756, 8,457,758, and 9,821,112 were found patentable in their respective IPRs. The complaint alleges Defendant had pre-suit knowledge of the patents based on due diligence and freedom-to-operate analyses.

Case Timeline

Date Event
2001-08-31 Priority Date for ’756 and ’314 Patents
2005-04-29 Priority Date for ’324, ’112, ’148, ’758, and ’069 Patents
2010-08-10 U.S. Patent No. 7,774,069 Issued
2011-10-11 U.S. Patent No. 8,036,756 Issued
2013-06-04 U.S. Patent No. 8,457,758 Issued
2014-01-07 U.S. Patent No. 8,626,314 Issued
2014-05-27 U.S. Patent No. 8,738,148 Issued
2016-01-01 Axonics obtains first regulatory approval in Europe and Canada (approx. date)
2016-10-11 U.S. Patent No. 9,463,324 Issued
2017-11-21 U.S. Patent No. 9,821,112 Issued
2019-09-09 Axonics r-SNM System receives FDA approval for fecal incontinence
2019-10-28 First commercial implants of Axonics r-SNM System in U.S. (approx. date)
2019-11-14 Axonics r-SNM System receives FDA approval for overactive bladder
2019-11-26 First Amended Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,036,756 - IMPLANTABLE MEDICAL ELECTRICAL STIMULATION LEAD FIXATION METHOD AND APPARATUS

  • Patent Identification: U.S. Patent No. 8,036,756, titled “IMPLANTABLE MEDICAL ELECTRICAL STIMULATION LEAD FIXATION METHOD AND APPARATUS,” issued October 11, 2011 (Compl. ¶22).

The Invention Explained

  • Problem Addressed: The patent addresses the clinical challenge of implanting sacral nerve stimulation leads in a way that prevents them from dislodging or migrating after surgery (Compl. ¶¶ 12-13; ’756 Patent, col. 4:1-6). Such movement can diminish therapeutic efficacy, require follow-up surgeries, and cause patient discomfort (’756 Patent, col. 3:39-43).
  • The Patented Solution: The invention is a method for implanting a medical lead that has a fixation mechanism comprised of multiple flexible "tines." These tines are designed to be folded inward against the lead's body as it passes through a surgical tube (an introducer) to the stimulation site (’756 Patent, col. 5:61-67). When the introducer is withdrawn, the tines are released and deploy outward, engaging with subcutaneous tissue to anchor the lead and resist proximal retraction (’756 Patent, col. 6:8-13, Fig. 8).
  • Technical Importance: This method allows for a minimally invasive, percutaneous implantation procedure that provides immediate and secure anchoring of the stimulation lead, reducing the likelihood of post-operative dislodgement (’756 Patent, col. 8:5-12).

Key Claims at a Glance

  • The complaint asserts independent method claim 14 (Compl. ¶37).
  • Essential elements of Claim 14 include:
    • Percutaneously introducing an introducer through body tissue to a stimulation site.
    • Disposing an implantable medical lead within the introducer, where the lead has specific components including a lead body, connector elements, stimulation electrodes, and a plurality of tine elements.
    • The tine elements comprise flexible tines adapted to be folded inward when constrained by the introducer and to deploy outward to engage body tissue when the introducer is withdrawn.
    • The tine elements are separate from and axially displaced from the stimulation electrodes.
    • Withdrawing the introducer toward the lead's proximal end to release the tines.

U.S. Patent No. 8,626,314 - IMPLANTABLE MEDICAL LEAD INCLUDING PLURALITY OF TINE ELEMENTS

  • Patent Identification: U.S. Patent No. 8,626,314, titled “IMPLANTABLE MEDICAL LEAD INCLUDING PLURALITY OF TINE ELEMENTS,” issued January 7, 2014 (Compl. ¶24).

The Invention Explained

  • Problem Addressed: Similar to the '756 patent, this patent addresses the need for a reliable fixation mechanism on an implantable medical lead to prevent axial movement and dislodgement of stimulation electrodes from the target tissue, such as a sacral nerve (’314 Patent, col. 2:40-50).
  • The Patented Solution: The invention claims a system comprising an implantable pulse generator and a specially designed medical lead. The lead features a plurality of tine elements positioned proximal to the electrodes. Each tine element has multiple flexible, pliant tines designed to be folded inward against the lead body "without overlapping one another" when constrained inside an introducer and to deploy outward to engage tissue upon withdrawal of the introducer (’314 Patent, Abstract; col. 4:51-67).
  • Technical Importance: This patent focuses on the structural and systematic aspects of the lead's fixation, detailing the physical characteristics and specific placement of the tines to ensure reliable deployment and secure anchoring within a complete neuromodulation system (’314 Patent, col. 4:21-30).

Key Claims at a Glance

  • The complaint asserts independent system claim 11 (Compl. ¶56).
  • Essential elements of Claim 11 include:
    • A system comprising an implantable pulse generator and an implantable medical lead.
    • The lead has a lead body, conductors, a plurality of electrodes, and a plurality of tine elements.
    • All tine elements are positioned between the most proximal electrode and the proximal end of the lead body.
    • Each tine element comprises a plurality of flexible, pliant tines.
    • The tines are adapted to be folded inward against the lead body when constrained by an introducer lumen "without overlapping one another" and to deploy outward when the introducer is withdrawn.
    • The plurality of tine elements is separate from and axially displaced from the electrodes.

Multi-Patent Capsule: U.S. Patent No. 9,463,324

  • Patent Identification: U.S. Patent No. 9,463,324, titled “INDUCTIVELY RECHARGEABLE EXTERNAL ENERGY SOURCE, CHARGER, SYSTEM AND METHOD FOR A TRANSCUTANEOUS INDUCTIVE CHARGER FOR AN IMPLANTABLE MEDICAL DEVICE,” issued October 11, 2016 (Compl. ¶26).
  • Technology Synopsis: The patent describes a system for transcutaneously (through the skin) recharging an implantable medical device. The system includes an external device with a temperature sensor that monitors the temperature of the housing side near the patient's skin and control circuitry that uses this data to limit energy transfer, thereby preventing the patient from being exposed to excessive heat during charging (Compl. ¶75; ’324 Patent, Abstract).
  • Asserted Claims: Claims 1, 4, and 11 (Compl. ¶73).
  • Accused Features: The Axonics r-SNM System's Model 1101 Neurostimulator and Model 1401 charging system, which allegedly include temperature sensors and software controls to pause charging if skin temperature increases (Compl. ¶¶ 73, 78).

Multi-Patent Capsule: U.S. Patent No. 9,821,112

  • Patent Identification: U.S. Patent No. 9,821,112, titled “INDUCTIVELY RECHARGEABLE EXTERNAL ENERGY SOURCE, CHARGER, SYSTEM AND METHOD FOR A TRANSCUTANEOUS INDUCTIVE CHARGER FOR AN IMPLANTABLE MEDICAL DEVICE,” issued November 21, 2017 (Compl. ¶28).
  • Technology Synopsis: This patent claims a medical system with an external charging device that includes a sensor to measure temperature, a control circuit to compare that temperature to a "programmable limit," and a memory to store that limit. The system controls energy transfer based on this comparison to ensure patient safety (’112 Patent, Abstract).
  • Asserted Claims: Claim 1 (Compl. ¶90).
  • Accused Features: The Axonics r-SNM System's charging components, which are alleged to have temperature sensors and software controls that function to compare temperature against a programmable limit to manage charging (Compl. ¶¶ 90, 95).

Multi-Patent Capsule: U.S. Patent No. 8,738,148

  • Patent Identification: U.S. Patent No. 8,738,148, titled “ALIGNMENT INDICATION FOR TRANSCUTANEOUS ENERGY TRANSFER,” issued May 27, 2014 (Compl. ¶30).
  • Technology Synopsis: This patent describes a transcutaneous energy transfer system where the external power source automatically adjusts its power output. This adjustment is based on a value measured inside the implanted device that is associated with the current passing through the implant's internal battery, creating a feedback loop to optimize charging (’148 Patent, Abstract).
  • Asserted Claims: Claim 1 (Compl. ¶107).
  • Accused Features: The Axonics r-SNM System's charging components, which allegedly employ a "real-time feedback loop algorithm" between the implanted pulse generator and the external charging device to optimize the output (Compl. ¶¶ 107, 112).

Multi-Patent Capsule: U.S. Patent No. 8,457,758

  • Patent Identification: U.S. Patent No. 8,457,758, titled “ALIGNMENT INDICATION FOR TRANSCUTANEOUS ENERGY TRANSFER,” issued June 4, 2013 (Compl. ¶32).
  • Technology Synopsis: This patent builds on the feedback loop concept, adding a feature where the external power source automatically terminates its power output if the charging current passing through the internal power source falls below a minimum amount. This function can indicate that the device is fully charged (’758 Patent, col. 2:1-4).
  • Asserted Claims: Claim 4 (Compl. ¶124).
  • Accused Features: The Axonics r-SNM charging system, which allegedly alerts the user with audible tones when charging is complete, suggesting a mechanism that terminates power delivery based on the charging status (Compl. ¶¶ 124, 130).

Multi-Patent Capsule: U.S. Patent No. 7,774,069

  • Patent Identification: U.S. Patent No. 7,774,069, titled “ALIGNMENT INDICATION FOR TRANSCUTANEOUS ENERGY TRANSFER,” issued August 10, 2010 (Compl. ¶34).
  • Technology Synopsis: This patent describes a transcutaneous charging system featuring an "alignment indicator." The indicator reports the quality of alignment between the external and internal coils based on the measured current, while the external source automatically varies its power output to generate a predetermined current in the internal power source, ensuring efficient energy transfer (’069 Patent, Abstract).
  • Asserted Claims: Claim 5 (Compl. ¶142).
  • Accused Features: The Axonics r-SNM System's external recharger, which allegedly includes an alignment indicator that provides audible and visual feedback (a tone and flashing green light) to help the user properly align the charger (Compl. ¶¶ 142, 147).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the Axonics rechargeable Sacral Neuromodulation (r-SNM) System (Compl. ¶17). Key components identified in the complaint include the Model 1101 neurostimulator (the implantable pulse generator or IPG), the Model 1201 tined lead, and the Model 1401 charging system (Compl. ¶17).

Functionality and Market Context

  • The Axonics r-SNM System is a medical device system designed to treat overactive bladder, urinary retention, and fecal incontinence by delivering electrical stimulation to the sacral nerves (Compl. ¶¶ 11, 16). The system's tined lead is surgically implanted near the sacral nerves and connected to the IPG (Compl. ¶19, p. 7, FIGURE 11). The IPG contains a rechargeable battery that is recharged transcutaneously using the external charging system (Compl. ¶¶ 77, 111). A diagram in the complaint illustrates the components of the permanent system, including the tined lead, IPG, and charging device (Compl. p. 6). The complaint alleges that the Axonics system is "similar in design, technology, performance, indication for use, output characteristics, and patient population to the Medtronic InterStim System" and that its implantation procedure is the same (Compl. ¶18).

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,036,756 Infringement Allegations

Claim Element (from Independent Claim 14) Alleged Infringing Functionality Complaint Citation Patent Citation
percutaneously introducing an introducer... through body tissue to locate the introducer lumen distal end opening adjacent to a stimulation site; The Axonics implantation method involves using tools such as an introducer sheath and dilator to create a path through body tissue to the sacral foramen (the stimulation site). ¶40 col. 5:46-51
disposing an implantable medical lead within the introducer lumen, wherein the implantable medical lead comprises: a lead body... a plurality of connector elements... a plurality of stimulation electrodes... a plurality of lead conductors; and a plurality of tine elements... The Axonics Model 1201 Tined Lead is inserted into the introducer sheath. The lead has a body, connectors, four stimulation electrodes, and flexible tines for fixation. ¶¶41-43 col. 6:21-41
each tine element comprising a plurality of flexible tines that are 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 The tines on the Axonics lead are described as flexible and are constrained within the introducer sheath during insertion. When the sheath is removed, the tines are deployed outward to anchor the lead in place. ¶43 col. 5:61-67
withdrawing the introducer toward the lead proximal end from the plurality of tine elements to release the plurality of tines. The Axonics Tined Lead Implant Manual instructs users to withdraw the introducer sheath to deploy the tines, anchoring the lead. An illustration from the manual depicts this withdrawal step. ¶44 col. 6:8-13

Identified Points of Contention

  • Scope Questions: A potential dispute may arise over the definition of "engage body tissue." The patent suggests the tines "dig into" the muscle, which may imply a more aggressive anchoring than what Defendant argues its product achieves (’756 Patent, col. 8:50-54). The analysis will question whether the stabilization provided by the accused lead's tines constitutes "engagement" as required by the claim.
  • Technical Questions: The infringement theory for this method claim relies on Axonics's instructions and training materials (Compl. ¶46). A key question for the court will be whether the actions actually performed by surgeons implanting the Axonics r-SNM System necessarily include every step recited in claim 14 in the specified order. A visual in the complaint from Axonics's manual explicitly shows withdrawing the introducer sheath to deploy the tines (Compl. p. 21, Figure 18).

U.S. Patent No. 8,626,314 Infringement Allegations

Claim Element (from Independent Claim 11) Alleged Infringing Functionality Complaint Citation Patent Citation
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... The Axonics r-SNM System includes the Model 1101 implantable pulse generator and the Model 1201 tined lead, which is electrically coupled to the generator's connector block. ¶59 col. 4:15-20
a lead body... a plurality of conductors... a plurality of electrodes... and a plurality of tine elements extending from the lead body, wherein all tine elements... are positioned between a most proximal electrode... and the proximal end of the lead body The Axonics tined lead allegedly has a lead body, conductors, four electrodes, and tine elements that are located proximal to the most proximal electrode. A product image shows the tines positioned away from the distal tip electrodes. ¶¶60-61 col. 4:21-30
each tine element comprising a plurality of flexible, pliant tines... supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end The complaint alleges the Axonics tined lead has tine elements with multiple flexible tines that extend outward and toward the proximal (connector) end of the lead. A close-up image of the lead illustrates this configuration. ¶61 col. 4:31-41
wherein the plurality of tines... 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... The complaint alleges the tines of the Axonics lead are designed to fold inward within an introducer without overlapping and then deploy outward when the introducer is removed to engage tissue. ¶61 col. 4:42-50

Identified Points of Contention

  • Procedural Questions: A threshold issue for the court is that asserted claim 11 of the ’314 patent was cancelled in an Inter Partes Review proceeding (IPR2020-00679). This raises the dispositive question of whether a claim for infringement of a cancelled claim can be maintained.
  • Scope Questions: Should the claim survive, a central dispute may concern the term "without overlapping one another." The interpretation of this term will be critical—whether it means the tines are structurally incapable of overlapping under any condition, or if it means they are designed not to overlap during the intended folding process within the introducer. The complaint provides an image of the Axonics lead's tine structure, which will be central to this analysis (Compl. p. 29).

V. Key Claim Terms for Construction

For U.S. Patent No. 8,036,756 (Claim 14):

  • The Term: "engage body tissue"
  • Context and Importance: This term defines the function of the tines after the introducer is withdrawn. The scope of "engage" is critical, as it determines the required level of interaction between the tines and the patient's tissue for infringement to occur. Practitioners may focus on this term because it distinguishes simple contact or stabilization from the active anchoring taught by the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states the deployed tines "resist being folded or inverted distally and present a folded cross-section profile that exceeds the lumen diameter inhibiting retraction proximally," suggesting "engage" could mean providing sufficient resistance to prevent dislodgement (’756 Patent, col. 6:8-13).
    • Evidence for a Narrower Interpretation: The specification describes the tines as having "relatively harp, non-tapered, tine edges... provided to 'dig into' the muscle," which could support a narrower construction requiring some degree of tissue penetration beyond mere frictional contact (’756 Patent, col. 8:50-54).

For U.S. Patent No. 8,626,314 (Claim 11):

  • The Term: "without overlapping one another"
  • Context and Importance: This limitation describes the spatial relationship of the tines when they are folded inward within an introducer. Infringement will depend on whether the physical structure of the accused Axonics lead results in a folded configuration that meets this requirement. The term is central because it relates directly to the patent's purported improvement of reliable deployment.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification explains that distributing the tines (e.g., by offsetting them radially) ensures retention forces are "distributed more uniformly around the lead body," which suggests "without overlapping" relates to this design goal of preventing stacking and ensuring proper deployment rather than an absolute prohibition of any incidental contact (’314 Patent, col. 6:33-40).
    • Evidence for a Narrower Interpretation: A defendant might argue that the plain meaning requires that no part of any tine can lie on top of any part of another tine when constrained. The specification's focus on interleaving tines from different elements could be used to support an interpretation that requires complete spatial separation of the folded tines (’314 Patent, col. 6:40-44).

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement for all asserted patents. Inducement allegations are based on Defendant’s affirmative acts of providing products with user manuals, marketing materials, and training that allegedly instruct and encourage customers (e.g., surgeons, hospitals) to use the Axonics r-SNM System in a manner that directly infringes (Compl. ¶¶ 46-47, 63-64). Contributory infringement is alleged on the basis that the Axonics system is especially made for an infringing use and has no substantial non-infringing uses (Compl. ¶¶ 49, 66).

Willful Infringement

  • The complaint alleges willful infringement for all asserted patents. The basis for willfulness includes alleged pre-suit knowledge from Defendant's "due diligence and freedom to operate analyses," public statements by its CEO indicating familiarity with the "competitive landscape" and specific patents, and the filing of Medtronic's original complaint in the matter (Compl. ¶¶ 51-52, 68-69).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A primary issue will be the impact of post-grant proceedings: With asserted claims from U.S. Patent Nos. 8,626,314, 8,738,148, and 7,774,069 having been cancelled or disclaimed in Inter Partes Reviews, a threshold question is whether the infringement counts based on those specific claims can survive. This procedural history appears dispositive for a significant portion of the lawsuit.
  • For the surviving patent claims, a core issue will be one of definitional scope: Can the term "engage body tissue" in the ’756 patent, described in the specification as tines that "dig into" muscle, be construed to cover the anchoring mechanism of the accused Axonics lead? Similarly, for the charging patents, does the accused system's method of monitoring temperature and adjusting power fall within the specific claim language requiring comparison to a "programmable limit" (’112 patent) or variation based on a "value measured in said implantable medical device" (’148 patent)?
  • A key evidentiary question will be one of induced infringement: Given that the ’756 patent claims a method of implantation, the case will likely focus on evidence from Axonics's instruction manuals, training videos, and marketing materials. The central question will be whether this evidence demonstrates that Axonics specifically intended for surgeons to perform the patented method, thereby inducing infringement by its customers.