DCT
1:15-cv-00218
C R Bard Inc v. Angiodynamics Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: C. R. Bard, Inc. (New Jersey) and Bard Peripheral Vascular, Inc. (Arizona)
- Defendant: AngioDynamics, Inc. (Delaware)
- Plaintiff’s Counsel: Ashby & Geddes
- Case Identification: 1:15-cv-00218, D. Del., 03/10/2015
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation that conducts business, sells products, and has allegedly committed acts of patent infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s Smart Port® implantable power-injectable port products infringe three U.S. patents related to the identification and structural integrity of vascular access ports designed for high-pressure injections.
- Technical Context: Vascular access ports are implantable medical devices used for long-term fluid delivery; power-injectable ports are a specific category engineered to withstand the high pressures required for injecting contrast media during modern diagnostic procedures like CT scans.
- Key Procedural History: The complaint alleges that Plaintiffs have marked their competing PowerPort® products with two of the patents-in-suit, which may serve as a basis for constructive notice to competitors.
Case Timeline
| Date | Event |
|---|---|
| 2005-04-27 | Earliest Priority Date for ’417, ’460, and ’478 Patents |
| 2012-01-01 | Plaintiff's PowerPort® ClearVUE® products first introduced |
| 2013-07-02 | U.S. Patent No. 8,475,417 Issues |
| 2013-10-01 | U.S. Patent No. 8,545,460 Issues |
| 2014-08-12 | U.S. Patent No. 8,805,478 Issues |
| 2015-03-10 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,475,417 - "Assemblies for Identifying a Power Injectable Access Port," issued July 2, 2013 (’417 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the risk of using conventional vascular access ports with high-pressure "power injector" systems common in CT imaging (Compl. ¶ 1; ’417 Patent, col. 1:13-2:4). Such misuse can cause the port or associated components to rupture, as they are not designed to tolerate the required pressures (’417 Patent, col. 1:18-24).
- The Patented Solution: The invention provides an assembly with multiple identifiable features to allow medical personnel to confirm that an implanted port is safe for power injection. It describes an access port with a first feature (e.g., indicating suitability for a high flow rate) and a second feature (e.g., indicating suitability for high pressure), complemented by a third, separate feature (e.g., information on packaging or a patient ID card) that confirms the port's capabilities (’417 Patent, Abstract; ’417 Patent, col. 25:25-26:67).
- Technical Importance: The invention provides a system of redundant verification to prevent dangerous misuse of medical devices that become unidentifiable after being implanted subcutaneously (’417 Patent, col. 2:35-39).
Key Claims at a Glance
- The complaint asserts dependent claims 8, 12, and 13, which rely on independent claim 1 (Compl. ¶19).
- Independent Claim 1 requires:
- A vascular access port with a body, cavity, septum, and outlet.
- A first identifiable feature incorporated into the access port, perceivable after implantation, identifying the port as suitable for a fluid flow rate of at least 1 ml/sec.
- A second identifiable feature incorporated into the access port, perceivable after implantation, identifying the port as suitable for accommodating a pressure of at least 35 psi.
- A third identifiable feature, separate from the port, confirming the port is suitable for both the specified flow rate and pressure.
U.S. Patent No. 8,545,460 - "Infusion Apparatuses and Related Methods," issued October 1, 2013 (’460 Patent)
The Invention Explained
- Problem Addressed: As with the ’417 Patent, the technology targets the potential for access port failure when subjected to the high pressures of power injectors used for contrast media delivery (’460 Patent, col. 1:16-2:4).
- The Patented Solution: The patent describes an access port with specific structural characteristics designed to withstand power injection forces. The solution focuses on the mechanical interface between the port's housing and its septum, describing a "tenon region" on the septum that fits into a complementary "mortise region" in the housing, creating a robust interlock that resists deformation under pressure (’460 Patent, col. 3:18-29; ’460 Patent, FIG. 8).
- Technical Importance: This approach provides an intrinsic structural solution to the problem of high-pressure tolerance, rather than relying solely on external identification methods.
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2 and 4 (Compl. ¶27).
- Independent Claim 1 requires:
- An access port with a housing defining an aperture for capturing a septum, where the housing and septum define a reservoir.
- The septum including a "tenon region."
- The housing defining a complementary "mortise region" structured for accepting at least a portion of the tenon region.
- The housing including a ring structure proximate to a side periphery of the septum.
U.S. Patent No. 8,805,478 - "Methods of Performing a Power Injection Procedure Including Identifying Features of a Subcutaneously Implanted Access Port for Delivery of Contrast Media," issued August 12, 2014 (’478 Patent)
Technology Synopsis
This patent claims a method for safely using a power-injectable port. The core of the method involves first taking an x-ray of a subcutaneously implanted port, identifying a specific radiographic feature on that x-ray that confirms the port is suitable for power injection, and only then proceeding to inject fluid at a high flow rate (at least 1 ml/sec) (’478 Patent, Abstract).
Asserted Claims
The complaint asserts independent claim 1 and dependent claims 3, 5, 8, 9, and 11 (Compl. ¶35).
Accused Features
The complaint alleges that Defendant induces infringement by its customers (e.g., radiologists, nurses, technicians) who use the accused Smart Port® products. This inducement is allegedly facilitated through Defendant's instructional materials, website information, and promotional brochures that guide users on performing power injections with the Smart Port® products (Compl. ¶¶36-40).
III. The Accused Instrumentality
Product Identification
- Defendant’s "implantable power-injectable port products, including its Smart Port® products" (Compl. ¶19).
Functionality and Market Context
- The complaint alleges these are medical devices used for vascular access that compete directly with Plaintiffs' own PowerPort® products (Compl. ¶8). The complaint asserts that these products are designed for and used in power-injection procedures, which involve the high-pressure, high-flow-rate delivery of fluids like contrast media for diagnostic imaging (Compl. ¶¶5, 38). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain specific claim charts mapping elements of the accused products to the patent claims. The following summaries are based on the broad allegations of infringement.
’417 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a vascular access port comprising a body defining a cavity, a septum, and an outlet... | The complaint alleges that the Smart Port® products are vascular access ports with these basic components. | ¶19 | col. 6:50-58 |
| a first identifiable feature incorporated into the access port... identifying the access port as suitable for flowing fluid at a fluid flow rate of at least 1 milliliter per second... | The complaint alleges, without specifying the feature, that the Smart Port® products include a feature indicating suitability for high flow rates. | ¶19 | col. 25:35-41 |
| a second identifiable feature incorporated into the access port... identifying the access port as suitable for accommodating a pressure within the cavity of at least 35 psi... | The complaint alleges, without specifying the feature, that the Smart Port® products include a feature indicating suitability for high pressures. | ¶19 | col. 25:42-47 |
| a third identifiable feature separated from the subcutaneously implanted access port, the third feature confirming that the implanted access port is both suitable for flowing fluid at a rate of at least 1 milliliter per second... and for accommodating a pressure... of at least 35 psi. | The complaint does not specify what constitutes the third identifiable feature for the accused products but alleges this element is met. | ¶19 | col. 25:48-57 |
’460 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an access port for providing subcutaneous access to a patient, comprising: a housing defining an aperture for capturing a septum, wherein the housing and septum define a reservoir; | The complaint alleges that the Smart Port® products are access ports with a housing and septum defining a reservoir. | ¶27 | col. 9:18-10:2 |
| the septum including a tenon region; | The complaint alleges, without technical detail, that the septum of the Smart Port® products includes a tenon region. | ¶27 | col. 9:35-41 |
| the housing of the access port defining a complimentary mortise region structured for accepting at least a portion of the tenon region of the septum; and | The complaint alleges, without technical detail, that the housing of the Smart Port® products includes a mortise region to accept the tenon. | ¶27 | col. 9:41-44 |
| the housing including a ring structure proximate to at least a portion of a side periphery of the septum. | The complaint alleges, without technical detail, that the housing of the Smart Port® products includes the claimed ring structure. | ¶27 | col. 8:28-34 |
Identified Points of Contention
- Factual Questions: For both the ’417 and ’460 patents, a primary point of contention will be factual: do the accused Smart Port® products actually incorporate the specific structures recited in the claims? The complaint makes conclusory allegations of infringement without providing technical details or evidence demonstrating, for instance, the existence of first, second, and third "identifiable features" (’417 Patent) or a specific "tenon region" and "mortise region" interlock (’460 Patent).
- Scope Questions: The dispute may raise the question of whether any inherent physical characteristic of the accused product can be considered an "identifiable feature" for the purposes of the ’417 patent, or if the feature must be something added specifically for identification, as suggested by the patent’s specification.
V. Key Claim Terms for Construction
For the ’417 Patent:
- The Term: "identifiable feature"
- Context and Importance: This term appears in three separate limitations of claim 1 and is central to the invention’s purpose of enabling verification. The scope of what constitutes an "identifiable feature" (e.g., a shape, a material, a marking) and how it must be "perceivable" (e.g., by palpation, by x-ray) will be critical to the infringement analysis.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is broad, not limiting the feature to a particular type. The specification notes that identification may be achieved "visually, by palpation, ultrasonically, radiographically, etc." (’417 Patent, col. 26:33-35), which may support a broad range of perceptible characteristics.
- Evidence for a Narrower Interpretation: The specification heavily features specific embodiments, such as a triangular port body shape for palpation and radiopaque markers forming symbols like "CT" for x-ray identification (’417 Patent, FIG. 51-53; FIG. 34-35). A defendant may argue that "identifiable feature" should be construed as limited to features added for the primary purpose of identification, consistent with these embodiments.
For the ’460 Patent:
- The Term: "tenon region" / "mortise region"
- Context and Importance: These terms define the specific mechanical coupling between the septum and housing that allegedly provides the necessary structural integrity for power injection. Infringement will depend on whether the accused product's septum-housing interface meets the definitions of these terms.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent uses the generic terms "tenon" and "mortise," which are well-understood in mechanical arts to mean a projecting member and a corresponding recess for forming a joint (’460 Patent, col. 9:59 - 10:2). This could support a construction covering a wide variety of male/female interlocking features.
- Evidence for a Narrower Interpretation: The patent’s detailed description and figures illustrate a specific embodiment where the tenon region and mortise region have complementary tapered surfaces (’460 Patent, FIG. 8; col. 10:4-16). A defendant may argue that the terms should be limited to the tapered structures shown, which the specification describes as securing the septum "even if a selected maximum pressure is developed within reservoir 166" (’460 Patent, col. 10:63-66).
VI. Other Allegations
- Indirect Infringement: The complaint makes specific allegations of induced infringement for the ’478 method patent. It alleges Defendant instructs its customers on how to perform power injections using the Smart Port® products through materials such as its "Guidelines for Health Care Providers," website content, and product brochures (Compl. ¶¶36-40). These allegations point to affirmative acts intended to encourage infringement by end-users.
- Willful Infringement: Willfulness is alleged for all three patents. The complaint bases this on "information and belief" that Defendant had pre-suit knowledge of the patents and lacked a good-faith belief of non-infringement or invalidity (Compl. ¶¶21, 28, 41). For the ’417 and ’460 patents, notice is also alleged via Plaintiffs' product marking (Compl. ¶17). For the '478 patent, knowledge is alleged to have occurred "after it issued" (Compl. ¶35).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: can the Plaintiff demonstrate that the accused Smart Port® products contain the specific physical elements required by the asserted apparatus claims? This includes the distinct "identifiable features" of the ’417 patent and the "tenon/mortise" structural interlock of the ’460 patent, neither of which are detailed in the complaint.
- A key legal question will be one of claim scope: how broadly will the court construe terms like "identifiable feature"? The resolution will determine whether conventional product design elements can satisfy the claim limitations or if the patent requires features implemented expressly for the purpose of post-implantation identification.
- For the ’478 method patent, the case will likely turn on intent for inducement: does the evidence show that Defendant's instructional and marketing materials not only teach every step of the claimed method but were distributed with the specific intent to encourage its customers to perform those infringing steps?