DCT
8:12-cv-00327
Medtronic Inc v. Edwards Lifesciences Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Medtronic, Inc. (Minnesota)
- Defendant: Edwards Lifesciences Corporation, Edwards Lifesciences LLC, and Edwards Lifesciences (U.S.) Inc. (collectively "Edwards") (Delaware / California)
- Plaintiff’s Counsel: Robins, Kaplan, Miller & Ciresi L.L.P.
- Case Identification: 8:12-cv-00327, C.D. Cal., 03/02/2012
- Venue Allegations: Plaintiff alleges venue is proper in the Central District of California because Defendants have their principal places of business in Irvine, California, and are alleged to be committing acts of patent infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s SAPIEN Transcatheter Heart Valve and associated delivery system infringe patents related to methods for controllably stimulating nerves and the heart to facilitate cardiac medical procedures.
- Technical Context: The technology addresses the challenge of performing surgery on the heart by enabling a surgeon to temporarily and intermittently slow or stop the heart's beating, creating a stable operative field without requiring a full cardiopulmonary bypass circuit.
- Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patents-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 1996-04-30 | Earliest Priority Date for ’741 and ’829 Patents |
| 2007-02-27 | U.S. Patent No. 7,184,829 Issues |
| 2011-10-11 | U.S. Patent No. 8,036,741 Issues |
| 2012-03-02 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,036,741 - "Method and System for Nerve Stimulation and Cardiac Sensing Prior to and During a Medical Procedure"
The Invention Explained
- Problem Addressed: The patent's background describes the risks associated with conventional coronary artery bypass graft (CABG) surgery, which requires stopping the heart and using a cardiopulmonary bypass (CPB) machine, leading to potential complications like systemic inflammatory response and myocardial ischemia (’741 Patent, col. 2:5-12). Performing surgery on a beating heart is difficult, and unpredictable "escape beats" can interfere with delicate procedures (’741 Patent, col. 2:42-49).
- The Patented Solution: The invention provides methods and systems to controllably and intermittently adjust the heart's beating during a medical procedure. This is achieved by stimulating a nerve (e.g., the vagus nerve) to slow or stop the heart, performing a procedural step, and then reducing nerve stimulation to allow the heart to resume beating, potentially aided by a cardiac stimulator or "pacer" (’741 Patent, Abstract; Fig. 6). This cycle can be repeated, giving the surgeon a series of stable windows in which to operate without the need for a CPB circuit.
- Technical Importance: This technology facilitates "off-pump" or "beating-heart" surgery, aiming to reduce the complications of CPB while providing the surgeon with a temporarily motionless operative field required for precision tasks (’741 Patent, col. 2:5-12).
Key Claims at a Glance
- The complaint asserts "at least one claim" without specifying which one (Compl. ¶15). Independent claim 10 is representative of a method for deploying a "stent device" using the patented cardiac control technique.
- Independent Claim 10: A method of performing a cardiac medical procedure, comprising:
- obtaining a stent device;
- electrically stimulating a heart to adjust beating of the heart to a first condition;
- delivering the stent device to the stimulated heart when the beating of the stimulated heart has been adjusted to the first condition, when the heart is beating in the first condition; and
- reducing electrical stimulation of the heart to adjust beating of the heart to a second condition after delivering the stent device.
- The complaint reserves the right to assert additional claims, which may include dependent claims (Compl. ¶13).
U.S. Patent No. 7,184,829 - "Method and System for Nerve Stimulation Prior to and During a Medical Procedure"
The Invention Explained
- Problem Addressed: The ’829 Patent, part of the same patent family as the ’741 Patent, addresses the identical problem: the need to perform cardiac surgery without the risks of a CPB circuit while still having a stable, motionless field for the surgeon to work (’829 Patent, col. 1:53-60).
- The Patented Solution: The invention describes a method for intermittently controlling the heart by using a "controllable nerve stimulator" to start and stop stimulation of the vagal nerve. This creates periods where the heart is stopped or slowed, allowing a medical procedure to be performed, followed by periods where stimulation ceases and the heart resumes beating (’829 Patent, Abstract; Fig. 4). The method emphasizes the intermittent nature of the control to allow for blood flow between procedural steps.
- Technical Importance: The method provides a way to achieve the benefits of a still operative field while mitigating the dangers of prolonged cardiac arrest by cycling between heart stoppage and normal beating (’829 Patent, col. 2:12-22).
Key Claims at a Glance
- The complaint asserts "at least one claim" without specifying which one (Compl. ¶22). Independent claim 1 is representative of the core method of intermittent nerve stimulation.
- Independent Claim 1: A method for controllably stopping or slowing a heart intermittently during a medical procedure, comprising:
- providing a controllable nerve stimulator capable of automatically stopping stimulation of a vagal nerve, the nerve stimulator comprising a nerve stimulation electrode;
- positioning the nerve stimulation electrode in a position suitable for stimulating a vagal nerve to stop or slow the heart;
- controllably starting stimulation of the vagal nerve; automatically stopping stimulation of the vagal nerve;
- continuing to start and stop stimulation of the vagal nerve in order to stop or slow the heart intermittently during the medical procedure.
- The complaint reserves the right to assert additional claims, which may include dependent claims (Compl. ¶20).
III. The Accused Instrumentality
Product Identification
- The SAPIEN Transcatheter Heart Valve and the Transfemoral RetroFlex 3 Delivery System (collectively, the "Accused Instrumentality") (Compl. ¶¶13, 20).
Functionality and Market Context
- The complaint alleges that the Accused Instrumentality is used by surgeons and physicians to perform medical procedures that directly infringe the patents-in-suit (Compl. ¶¶16, 23).
- The complaint does not provide specific technical details about the operation of the Accused Instrumentality itself. The infringement theory is based on the use of the products during a medical procedure, rather than on the inherent functionality of the products in isolation. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint provides a high-level "notice pleading" of infringement without detailed factual allegations or a claim chart. The following tables summarize the infringement theory as inferred from the complaint's general allegations that the use of the Accused Instrumentality by surgeons constitutes infringement of the claimed methods.
- 8,036,741 Infringement Allegations
| Claim Element (from Independent Claim 10) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) obtaining a stent device; | The complaint alleges that surgeons use the Accused Instrumentality, which includes the SAPIEN valve—a device mounted on a stent-like frame—to perform an infringing medical procedure. | ¶13, ¶16 | col. 37:35-36 |
| b) electrically stimulating a heart to adjust beating of the heart to a first condition; | The complaint alleges the use of the Accused Instrumentality infringes. This implies that the surgical procedure involves electrically stimulating the heart (e.g., via rapid pacing) to reduce cardiac output and stabilize the heart for valve deployment. | ¶13, ¶16 | col. 37:37-39 |
| c) delivering the stent device to the stimulated heart when the beating of the stimulated heart has been adjusted to the first condition, when the heart is beating in the first condition; and | The complaint's allegations suggest that surgeons deliver and deploy the SAPIEN valve while the heart is in the paced "first condition" of reduced output. | ¶13, ¶16 | col. 37:40-44 |
| d) reducing electrical stimulation of the heart to adjust beating of the heart to a second condition after delivering the stent device. | This implies that after the SAPIEN valve is deployed, the electrical stimulation (pacing) is reduced or stopped, allowing the heart to return to a normal beating rhythm. | ¶13, ¶16 | col. 37:45-48 |
- 7,184,829 Infringement Allegations
The complaint does not provide sufficient detail to construct a meaningful claim chart for the ’829 Patent. The asserted method claim requires specific steps of providing and using a "controllable nerve stimulator" to start and "automatically" stop vagal nerve stimulation. The complaint makes no factual allegations that connect the use of the SAPIEN Transcatheter Heart Valve or its delivery system to any form of nerve stimulation.
- Identified Points of Contention:
- Scope Questions: For the ’741 Patent, a central issue may be whether the term "electrically stimulating a heart to adjust beating...to a first condition" can be construed to cover the practice of rapid ventricular pacing used in transcatheter valve replacement procedures to reduce cardiac output, or if the claim is limited to other forms of stimulation disclosed in the patent.
- Technical Questions: For the ’829 Patent, a threshold evidentiary question will be whether the complaint provides any plausible basis to allege that procedures using the Accused Instrumentality involve the claimed method of intermittent vagal nerve stimulation. The complaint appears to lack any factual connection between the accused products and this central claim element.
V. Key Claim Terms for Construction
The Term: "electrically stimulating a heart to adjust beating of the heart to a first condition" (’741 Patent, Claim 10)
Context and Importance: The infringement case for the ’741 Patent may depend on whether this term covers rapid ventricular pacing used during SAPIEN valve deployment. Practitioners may focus on this term because its scope will determine if the common surgical technique for using the accused device falls within the claim.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is broad, referring generally to "electrically stimulating" to "adjust beating." The patent also contemplates pacing for purposes other than simply restarting the heart, such as "maintaining a normal cardiac output," which could support a broader functional definition of "adjusting" the heart's beating (’741 Patent, col. 10:67-68).
- Evidence for a Narrower Interpretation: The specification predominantly discusses cardiac stimulation (pacing) in the context of restarting a heart that has been stopped or slowed by nerve stimulation (’741 Patent, col. 12:35-39; col. 2:17-19). An argument could be made that the "first condition" must be one achieved by nerve stimulation, and the "electrical stimulation" is a secondary, responsive step, not the primary means of achieving the first condition.
The Term: "stent device" (’741 Patent, Claim 10)
Context and Importance: This term's construction is critical because the accused product is a transcatheter heart valve, not just a bare-metal stent. The case requires that the SAPIEN valve be considered a "stent device."
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's own claims provide strong evidence. Dependent claim 9, which depends from claim 8 (a method for a heart valve replacement procedure), explicitly states, "wherein the stent device is a replacement heart valve" (’741 Patent, col. 37:9-10). This language suggests the patentee explicitly contemplated a heart valve as a type of "stent device."
- Evidence for a Narrower Interpretation: The complaint does not provide a basis for analysis of a narrower interpretation, and the intrinsic evidence strongly favors a broad reading inclusive of the accused product.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement against Edwards. The basis for this allegation is that Edwards provides "manuals, written instructions and other printed materials" and "training and instruction" that allegedly direct surgeons and physicians to use the Accused Instrumentality in an infringing manner (Compl. ¶¶16, 23).
- Willful Infringement: The complaint does not use the term "willful." It alleges that Edwards has knowledge of the patents "at least by the time of the filing and service of the Complaint" (Compl. ¶¶14, 21). This allegation, on its own, would only support a claim for post-suit willful infringement. The prayer for relief requests a finding that the case is "exceptional" under 35 U.S.C. § 285, which is often associated with findings of willfulness (Compl. p. 6, ¶4).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary evidentiary question will be one of factual connection: what evidence, if any, can be produced to demonstrate that medical procedures using the Edwards SAPIEN valve system employ the intermittent vagal nerve stimulation method required by the claims of the ’829 patent? The complaint's lack of factual allegations on this point suggests it will be a central area of dispute.
- A core issue for the ’741 patent will be one of claim scope: can the phrase "electrically stimulating a heart to adjust beating... to a first condition" be construed to read on the technique of rapid ventricular pacing used to stabilize the heart during transcatheter valve deployment, or is the claim's scope limited by the specification's primary focus on pacing as a means to restart a heart previously stopped by nerve stimulation?