DCT

1:04-cv-00447

St Jude Medical Inc v. Guidant Corp

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:04-cv-00447, S.D. Ind., 03/09/2004
  • Venue Allegations: Plaintiff alleges venue is proper in the Southern District of Indiana because a principal place of business for Defendant Guidant Corporation is located within the district.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its implantable cardiac rhythm management devices and associated pacing leads do not infringe Defendants' patents, that the patents are invalid and unenforceable, and that Plaintiff has intervening rights.
  • Technical Context: The technology concerns implantable cardiac rhythm management systems, specifically pacemakers and cardioverter-defibrillators used to treat heart failure and arrhythmias by electrically stimulating heart tissue.
  • Key Procedural History: This declaratory judgment action follows two prior lawsuits filed by Defendants against Plaintiff: one in Delaware concerning the ’119 patent and another in Minnesota concerning the ’766 patent. Plaintiff notes its intent to transfer those cases to Indiana, arguing this Court is best suited to preside due to its experience with a prior litigation between the parties involving related technology and the same inventor as the ’119 patent. The ’119 patent is a reissue patent, and the ’766 patent recently emerged from re-examination, raising issues of improper recapture and intervening rights that are central to Plaintiff's claims.

Case Timeline

Date Event
1989-01-23 U.S. Patent No. RE 38,119 Priority Date
1997-01-24 U.S. Patent No. 5,755,766 Priority Date
1998-05-26 U.S. Patent No. 5,755,766 Issue Date
2003-05-20 U.S. Patent No. RE 38,119 Reissue Date
2004-02-02 Defendant files suit on ’119 patent in D. Del.
2004-02-24 U.S. Patent No. 5,755,766 Re-Examination Certificate C1 Issues
2004-02-24 Defendant files suit on ’766 patent in D. Minn.
2004-03-09 Complaint filed in S.D. Ind.

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

U.S. Reissue Patent No. RE 38,119 E - "Method and Apparatus for Treating Hemodynamic Disfunction"

Patent Identification: U.S. Reissue Patent No. RE 38,119 E, issued May 20, 2003. (Compl. ¶10)

The Invention Explained

  • Problem Addressed: The patent describes cardiac conduction deficiencies, such as bundle branch block, that cause an uncoordinated contraction between the left and right ventricles. (RE ’119 Patent, col. 2:43-55). This asynchrony reduces the heart's pumping efficiency, a condition that can exacerbate congestive heart failure. (RE ’119 Patent, col. 2:56-65).
  • The Patented Solution: The invention is a "bi-ventricular cardiac pacer" that separately senses electrical signals from both ventricles to detect asynchronous contractions. (RE ’119 Patent, col. 3:51-57). If one ventricle contracts but the other does not follow within a short time window, the device stimulates the lagging ventricle to restore a more coordinated, or "simultaneous," contraction, thereby improving hemodynamic performance. (RE ’119 Patent, Abstract).
  • Technical Importance: This method of resynchronizing the ventricles represented a therapeutic strategy for improving cardiac output in patients with certain types of heart failure, going beyond traditional pacemakers that typically paced a single ventricle. (RE ’119 Patent, col. 2:6-14).

Key Claims at a Glance

The complaint seeks a declaratory judgment of non-infringement of "any valid claim" and does not identify specific claims asserted by the Defendants (Compl. ¶19). Independent method Claim 5 is representative of the core invention and includes the following essential steps:

  • separately sensing for the presence of cardiac depolarization signals from both left and right ventricles;
  • determining whether said cardiac depolarization signals are simultaneously present in both the left and right ventricles; and
  • stimulating at least one ventricle substantially simultaneously with the contraction of at least one other ventricle in the event that said signals are determined not to be simultaneously present in both ventricles. (RE ’119 Patent, col. 8:26-39).

The complaint reserves the right to address any and all claims of the patent (Compl. ¶19).

U.S. Patent No. 5,755,766 - "Open-Ended Intravenous Cardiac Lead"

Patent Identification: U.S. Patent No. 5,755,766, issued May 26, 1998, and subject to Re-Examination Certificate C1, issued February 24, 2004. (Compl. ¶¶13-14).

The Invention Explained

  • Problem Addressed: The patent identifies challenges in placing pacing leads within the coronary venous system, which is necessary to stimulate the left ventricle. (’766 Patent, col. 1:46-49). Traditional leads were described as potentially too large or stiff to navigate the tortuous veins, and their fixation features were ill-suited for the delicate vessel walls. (’766 Patent, col. 1:55-62).
  • The Patented Solution: The invention discloses a cardiac lead with an "open distal lumen," creating a channel through the length of the lead body. (’766 Patent, col. 2:46-48). This design allows the lead to be guided over a pre-placed guidewire, facilitating more precise and less traumatic placement of the lead's electrode in a target coronary vein. (’766 Patent, col. 3:60-65).
  • Technical Importance: The "over-the-wire" technique described was an important advance for enabling reliable left ventricular lead placement, a critical component for the emerging field of cardiac resynchronization therapy. (’766 Patent, col. 2:26-29).

Key Claims at a Glance

The complaint seeks a declaratory judgment of non-infringement of "any valid claim" and does not identify specific claims asserted by the Defendants (Compl. ¶34). The Re-Examination Certificate C1 amended several claims. Amended independent Claim 1, covering a device, is representative of the patented lead technology and includes these elements:

  • an elongated, flexible body member...of a size to permit the distal end to be advanced...into the coronary veins;
  • a lumen extending through the body member...having a first opening through the proximal end and a second opening through the distal end...;
  • a conductive member...extending through the body member;
  • an electrode electrically coupled to said conductive member; and
  • a separate structure deployable through the lumen...said separate structure including an electrode. (’766 C1 Patent, col. 2:1-18).

The complaint reserves the right to address any and all claims of the patent (Compl. ¶34).

III. The Accused Instrumentality

Product Identification

The complaint identifies the accused instrumentalities for the ’119 patent as Plaintiff's EPIC HF and ATLAS HF implantable cardioverter-defibrillators, and its FRONTIER pacemaker device (Compl. ¶9). The accused instrumentality for the ’766 patent is Plaintiff's QUICKSITE 1056 K pacing lead (Compl. ¶12).

Functionality and Market Context

The complaint states that the EPIC HF, ATLAS HF, and FRONTIER devices are designed for cardiac rhythm management (Compl. ¶9). The QuickSite lead is described as a pacing lead intended for use with these devices (Compl. ¶12). Plaintiff notes it is seeking FDA approval to market these products in the United States, which establishes the basis for a justiciable controversy for declaratory relief (Compl. ¶¶9, 12). The complaint does not provide further technical detail regarding the operation of the accused instrumentalities.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

As a complaint for declaratory judgment of non-infringement, the filing does not contain affirmative infringement allegations or claim charts. It states only that Plaintiff's products do not infringe the ’119 or ’766 patents (Compl. ¶¶19, 34). The complaint does not provide sufficient detail for analysis of Defendants' infringement theories.

  • Identified Points of Contention:
    Based on the patents and the nature of the accused products, several points of contention may arise in the dispute.
    • For the ’119 Patent:
      • Scope Questions: A central issue may be the construction of "substantially simultaneous contraction" (RE ’119 Patent, col. 8:35-37). The dispute could focus on whether the operational timing delays inherent in the accused devices' sensing and pacing algorithms fall within the scope of this term as it is defined by the patent's specification and prosecution history.
      • Technical Questions: A key factual question may be whether Plaintiff's devices practice the claimed method of "separately sensing for the presence of cardiac depolarization signals from both left and right ventricles" and then "determining whether said...signals are simultaneously present" (RE ’119 Patent, col. 8:27-32). The court may need to determine if the accused devices' resynchronization algorithm operates in this specific manner or achieves a similar result through a different, non-infringing technical approach.
    • For the ’766 Patent:
      • Scope Questions: A likely point of contention for amended Claim 1 will be the interpretation of "a separate structure deployable through the lumen...including an electrode" (’766 C1 Patent, col. 2:15-18). This limitation was added during re-examination. The infringement analysis may turn on whether the accused QuickSite lead is used with such a structure, or if its intended use involves a standard guidewire without an electrode, potentially placing it outside the claim's scope.

V. Key Claim Terms for Construction

’119 Patent

  • The Term: "substantially simultaneous contraction" (from Claim 5)
  • Context and Importance: This term is at the heart of the invention's purpose: to restore coordinated ventricular function. Its construction will determine the permissible time delay between ventricular events for an accused device to be found infringing. Practitioners may focus on this term because its breadth could encompass a wide range of cardiac resynchronization therapies or be limited to a very narrow timing window.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's objective is to "increase hemodynamic efficiency" and "improve its contraction pattern" (RE ’119 Patent, col. 3:23-26, 3:37-39). A party could argue this supports a functional definition where any timing that achieves this clinical outcome qualifies as "substantially simultaneous."
    • Evidence for a Narrower Interpretation: The specification notes that natural contractions occurring within "5-10 milliseconds of each other result in sufficient hemodynamic efficiency so as to not require treatment" (RE ’119 Patent, col. 6:23-26). A party could argue this passage limits the scope of "substantially simultaneous" to this specific, narrow timeframe.

’766 Patent

  • The Term: "a separate structure deployable through the lumen...including an electrode" (from amended Claim 1)
  • Context and Importance: This limitation was added to Claim 1 during re-examination, making its interpretation critical for assessing both infringement and the validity of the amendment. Infringement of this claim will likely depend entirely on whether the accused QuickSite lead is used with a structure meeting this definition.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification explicitly discloses an embodiment where the lumen is "used to insert a small separate structure with an electrode" and provides Figure 3 showing a "second, miniaturized lead 42" with an "electrode 46" being deployed. (’766 Patent, col. 3:65-col. 4:2; col. 4:13-16). This provides direct support for the claim language.
    • Evidence for a Narrower Interpretation: A party could argue that the phrase requires more than just a wire with a conductive tip, pointing to the detailed "miniaturized lead" embodiment as defining the full scope of the "structure." Further, the specification also describes using the lumen for other purposes, such as advancing a simple guidewire or injecting contrast fluid, without mentioning an electrode. (’766 Patent, col. 3:60-65; col. 4:4-6).

VI. Other Allegations

  • Indirect Infringement: Plaintiff seeks a declaratory judgment that it is not liable for contributory infringement or inducement for either patent (Compl. ¶¶19, 34).
  • Willful Infringement: The complaint does not allege willfulness by Defendants. However, it establishes a basis for a potential willfulness claim against Plaintiff by acknowledging Defendants' "recent assertion" of the patents in prior lawsuits, which serves as notice (Compl. ¶¶18, 33).
  • Invalidity and Unenforceability: Plaintiff alleges that both patents are invalid for failure to meet requirements under 35 U.S.C. §§ 101, 102, 103, and 112 (Compl. ¶¶23, 38). Plaintiff specifically attacks the validity of both patents based on "improper recapture of subject matter surrendered during its initial prosecution" (Compl. ¶¶24, 39). For the ’119 reissue patent, Plaintiff also alleges invalidity because there was "no legally cognizable 'mistake' that could be corrected by reissue" (Compl. ¶25). Finally, Plaintiff alleges both patents are unenforceable due to "unclean hands" (Compl. ¶¶26, 40).
  • Intervening Rights: Plaintiff asserts it has intervening rights in both the ’119 reissue patent and the ’766 re-examined patent, which, if successful, could limit or eliminate liability for damages for products made or sold prior to the date the reissue patent or re-examination certificate was issued (Compl. ¶¶28-31, 42-45).

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

  • A primary procedural question is one of venue and consolidation: Will this declaratory judgment action proceed in Indiana, as Plaintiff requests, or will the parties be forced to litigate in Delaware and Minnesota where Defendants filed first? The Court’s decision may be influenced by its prior experience with the parties and related technology, as argued by Plaintiff.
  • A dispositive validity question will be one of prosecution history estoppel: Did Defendants, in obtaining the ’119 reissue patent and the ’766 re-examination certificate, improperly recapture claim scope that they had previously surrendered to overcome prior art? The case may turn on the court's detailed analysis of the original and subsequent prosecution histories.
  • A key infringement question will be one of claim scope and use: For the ’766 patent, does the standard use of Plaintiff's QuickSite lead involve deploying "a separate structure...including an electrode" as required by the amended claims? The answer will depend on both the construction of this critical limitation and evidence regarding how the accused product actually functions in clinical practice.