DCT
2:25-cv-01739
Biotronik Inc v. Niazi Patent Holdings LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biotronik, Inc. (Delaware) and Biotronik SE & Co. KG (Germany)
- Defendant: Niazi Patent Holdings, LLC (Wisconsin)
- Plaintiff’s Counsel: McCurdy Laud, LLC; Von Briesen & Roper, S.C.
- Case Identification: 2:25-cv-01739, E.D. Wis., 11/06/2025
- Venue Allegations: Venue is alleged to be proper in the Eastern District of Wisconsin because the defendant, Niazi Patent Holdings, LLC, is a Wisconsin company that resides and maintains its principal place of business within the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its cardiac rhythm management devices do not infringe Defendant’s reissue patent related to methods and devices for cardiac pacing using anodal stimulation.
- Technical Context: The dispute centers on advanced cardiac pacing technology, specifically implantable devices that use electrical signals to resynchronize heart chambers in patients with conditions like heart failure.
- Key Procedural History: This declaratory judgment action follows a series of pre-suit licensing communications initiated by the patent inventor’s entity. After Defendant provided Plaintiff with claim charts alleging infringement of the patent-in-suit and expressed interest in "ongoing payments," Plaintiff filed this action to seek judicial resolution of the dispute. The complaint also notes prior litigation between the inventor and Plaintiff in 2017 over a different patent, which was dismissed for improper venue.
Case Timeline
| Date | Event |
|---|---|
| 2009-10-06 | ’170 Patent Priority Date |
| 2011-03-22 | Original Patent (’237) Filing Date |
| 2014-09-16 | Original Patent (’237) Issue Date |
| 2017-03-10 | Prior litigation between inventor and Biotronik filed over a different patent |
| 2017-11-07 | Prior litigation dismissed for improper venue |
| 2021-07-02 | ’170 Reissue Application Filing Date |
| 2024-06-18 | Licensing discussions initiated by patent inventor’s entity |
| 2024-10-15 | ’170 Reissue Patent Issue Date |
| 2025-05-08 | Defendant’s counsel first raises the ’170 Patent with Plaintiff |
| 2025-06-06 | Defendant sends initial claim charts alleging infringement of the ’170 Patent |
| 2025-09-24 | Defendant sends updated claim charts alleging infringement of the ’170 Patent |
| 2025-11-06 | Complaint for Declaratory Judgment Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Reissue Patent No. RE50,170 - "Summation Anodal Pacing to Complement Multisite Stimulation"
- Patent Identification: U.S. Reissue Patent No. RE50,170, "Summation Anodal Pacing to Complement Multisite Stimulation," issued October 15, 2024.
The Invention Explained
- Problem Addressed: The patent addresses perceived limitations in conventional cardiac pacing, which relies on cathodal stimulation (from a negative electrode) to trigger heart muscle contraction (’170 Patent, col. 1:36-45). In conventional systems, stimulation from the anode (positive electrode), known as "anodal capture," is typically avoided by using a large surface area anode, which reduces current density (’170 Patent, col. 1:31-36).
- The Patented Solution: The invention intentionally leverages anodal capture to enhance cardiac therapy. It proposes using an anode with a sufficiently small surface area to create a high current density, which causes hyper-polarization of the nearby heart tissue and creates a "virtual cathode" at a location remote from the anode (’170 Patent, col. 2:11-17; Abstract). This effect can be used to stimulate a larger or more specific area of the heart, such as the His bundle, thereby improving cardiac resynchronization (’170 Patent, col. 2:25-29). The patent also describes "summation anodal pacing," where a single anode serves multiple cathodes, resulting in a larger virtual electrode and potentially a lower pacing threshold (’170 Patent, col. 4:56-65).
- Technical Importance: The technology represents a departure from conventional pacing by treating anodal stimulation not as an undesirable side effect but as a therapeutic tool for more precise and efficient cardiac resynchronization (’170 Patent, col. 2:17-29).
Key Claims at a Glance
- The complaint indicates that Defendant has asserted claims 1-3, 5, 7, 11-13, 22-24, and 29-30 (Compl. ¶¶8, 13). The complaint's non-infringement arguments focus on independent device claim 22 and independent method claim 29.
- Independent Claim 22 (Device): The essential elements include:
- A device with a current source and three leads connectable to the right atrium, right ventricle, and left ventricle.
- The third lead (for the left ventricle) has at least two electrodes.
- At least one electrode is an anode and at least one is a cathode.
- An electrode has a surface area "sized sufficiently small to cause anodal capture."
- The current source delivers cathodal stimulation to one electrode, making another electrode a "return electrode."
- This stimulation creates "resultant anodal capture... via the return electrode," which itself is a "pacing electrode."
- The cathodal stimulation is "simultaneous with anodal capture that occurs solely as a consequence of the cathodal stimulation of another electrode."
- Independent Claim 29 (Method): The essential elements include:
- A method of coupling three leads to the right atrium, right ventricle, and left ventricle, where the third lead has at least two electrodes.
- Delivering a cathodal stimulus current where another electrode acts as a return electrode.
- The stimulus causes simultaneous cathodal stimulation and "anodal capture of a portion of the heart."
- The anodal capture "occurs solely as a consequence of the cathodal stimulation of another electrode."
- The stimulus current is "delivered to the electrodes at different times."
III. The Accused Instrumentality
Product Identification
- The complaint identifies the "Accused Products" as Biotronik's Acticor, Rivacor, Ilivia Neo, Intica Neo, and Amvia Edge product lines (Compl. ¶8).
Functionality and Market Context
- These products are described as cardiac rhythm management devices, including pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices (Compl. ¶21).
- The complaint alleges these devices are designed to be compatible with a variety of cardiac leads, including left ventricle leads that may have only one electrode (Compl. ¶28). The devices can also allegedly be configured in multiple ways, including in manners where no electrode on the left ventricle lead serves as an anode (Compl. ¶28).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The following table summarizes Biotronik's arguments for non-infringement as presented in the declaratory judgment complaint.
RE50,170 Infringement Allegations (Claim 22)
| Claim Element (from Independent Claim 22) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| wherein... the third lead has at least two electrodes, wherein at least one of the electrodes serves as a cathode and at least one of the electrodes serves as an anode | The accused devices are compatible with and can be used with left ventricle leads that do not have more than one electrode. The devices can also be configured such that no electrode on a multi-electrode left ventricle lead serves as an anode. | ¶28 | col. 7:22-26 |
| wherein cathodal stimulation is simultaneous with anodal capture that occurs solely as a consequence of the cathodal stimulation of another electrode | Anodal capture is described as a physical response of a patient's heart to therapy, not a property of the device itself. Whether it occurs depends on patient-specific physiological factors, physician choices of leads, and device settings, not solely the device's operation. | ¶29 | col. 8:36-41 |
RE50,170 Infringement Allegations (Claim 29)
| Claim Element (from Independent Claim 29) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a method of cardiac pacing, the method comprising the steps of: coupling... leads...; delivering solely cathodal stimulus current... | Biotronik itself does not perform the steps of the patented method, such as implanting, configuring, and operating the devices. These actions are performed by independent physicians whose actions are not under Biotronik's direction or control. | ¶34 | col. 12:38-40 |
| and the anodal capture occurs solely as a consequence of the cathodal stimulation of another electrode | The accused devices can be, and allegedly are, regularly implanted and operated in a manner such that no anodal capture occurs. | ¶31 | col. 12:53-56 |
- Identified Points of Contention:
- Scope Questions: A central dispute may be whether the claim language describes an inherent capability of the device itself or a result that only occurs when the device is implanted and operated in a specific configuration within a patient. Biotronik argues the latter, suggesting the device as sold does not meet the limitation concerning the occurrence of anodal capture (Compl. ¶29).
- Technical Questions: The complaint raises the question of whether the accused devices directly cause "anodal capture" as required by the claims. Biotronik frames anodal capture as a conditional, patient-dependent physiological event, suggesting its devices do not determine whether it will occur (Compl. ¶29). This framing presents a potential mismatch between the claimed function and the accused device's operation.
V. Key Claim Terms for Construction
The Term: "anodal capture that occurs solely as a consequence of the cathodal stimulation of another electrode"
- Context and Importance: This term is the linchpin of the invention and the infringement dispute. Its construction will determine whether the phenomenon must be an inherent and automatic function of the device's circuitry or if it can be a conditional outcome dependent on external factors like patient physiology and physician configuration. Biotronik's primary non-infringement argument hinges on this distinction (Compl. ¶29).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Language in the specification describes anodal pacing as occurring "when the current introduced to the heart at the cathode returns to the pacemaker circuit via the anode," which could be interpreted as a description of the device's electrical operation, regardless of the patient (RE50,170 Patent, col. 2:11-13).
- Evidence for a Narrower Interpretation: The claim's use of "occurs" and the specification's discussion of capturing specific cardiac structures like the "His bundle" could support an interpretation that the claim requires an actual, in-vivo result, not just the potential for one (’170 Patent, col. 2:28-29). This may favor Biotronik's argument that the device alone cannot satisfy the limitation.
The Term: "wherein the return electrode is a pacing electrode"
- Context and Importance: This term appears to require that the electrode completing the electrical circuit (the return electrode) also actively stimulates the heart (is a pacing electrode). Practitioners may focus on this term because it links the concept of anodal return current directly to a therapeutic pacing effect. The dispute will likely involve whether the accused devices are designed or configured to make the return electrode function as a "pacing electrode" in the manner claimed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract states the invention creates a "virtual cathode at a location remote from the anode," which results in depolarization. This could support a view that any return electrode that causes this effect inherently becomes a "pacing electrode."
- Evidence for a Narrower Interpretation: Biotronik argues its devices are used in ways that "no anodal capture occurs" (Compl. ¶31). This suggests that in such non-infringing configurations, the return electrode would not be functioning as a "pacing electrode," supporting a narrower, functional definition that requires actual capture to occur.
VI. Other Allegations
- Indirect Infringement: The complaint preemptively argues against liability for indirect infringement. It alleges the accused devices have substantial non-infringing uses, such as being used with single-electrode leads or being configured to prevent anodal capture, which would defeat a claim for contributory infringement (Compl. ¶31). It further alleges that Biotronik does not instruct or encourage physicians to implant or operate the devices in a manner that would cause anodal capture, which would defeat a claim for induced infringement (Compl. ¶32).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of infringement locus: Do the asserted claims, particularly the device claims, read on the accused products as manufactured and sold, or do they describe a method of use that only comes into existence post-implantation by a physician? The resolution will depend on whether "anodal capture" is construed as an inherent device capability or a conditional, in-vivo physiological event.
- A second key issue will be divided infringement: For the asserted method claims, the case will likely turn on whether the patentee can prove that Biotronik directs or controls the actions of independent physicians who implant and configure the devices. Biotronik's assertion that physicians act independently presents a significant hurdle for proving direct infringement by a single actor.