DCT
2:12-cv-00032
CR Bard v. Medical Components
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: C. R. Bard, Inc. (New Jersey)
- Defendant: Medical Components, Inc. (Pennsylvania)
- Plaintiff’s Counsel: Dorsey & Whitney LLP; Kirkland & Ellis, LLP
- Case Identification: 2:12-cv-00032, D. Utah, 07/02/2012
- Venue Allegations: Plaintiff alleges venue is proper in the District of Utah because Defendant operates a warehousing, inventory control, and shipping facility within the district.
- Core Dispute: Plaintiff alleges that Defendant’s implantable medical access ports infringe three patents related to systems for identifying such ports after they have been implanted subcutaneously.
- Technical Context: The technology concerns implantable ports used for long-term vascular access, with a focus on features that allow clinicians to identify a port's specific characteristics (e.g., suitability for high-pressure injection) via X-ray imaging or physical palpation.
- Key Procedural History: The complaint alleges Defendant has had knowledge of U.S. Patent No. 7,785,302 since February 18, 2011, based on Defendant’s alleged copying of claims from that patent during the prosecution of its own separate patent application. Knowledge of the other two patents-in-suit is alleged to have begun with the filing of the original complaint in this action on January 11, 2012.
Case Timeline
| Date | Event |
|---|---|
| 2005-03-04 | Priority Date for ’022, ’302, and ’615 Patents |
| 2010-08-31 | U.S. Patent No. 7,785,302 Issues |
| 2011-02-18 | Date of Alleged Knowledge of ’302 Patent by Defendant |
| 2011-05-24 | U.S. Patent No. 7,947,022 Issues |
| 2011-06-14 | U.S. Patent No. 7,959,615 Issues |
| 2012-01-11 | Original Complaint Filed; Date of Alleged Knowledge of ’022 and ’615 Patents |
| 2012-07-02 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,947,022 - "Access Port Identification Systems and Methods"
- Issued: May 24, 2011
The Invention Explained
- Problem Addressed: The patent describes the difficulty in determining the model, style, or design of an access port once it has been subcutaneously implanted, noting that conventional ports may exhibit substantially similar geometries that are not differentiable from one another by simple touch (Compl. ¶28; ’302 Patent, col. 1:47-54). This uncertainty is particularly problematic when a clinician needs to know if a port is safe for "power injection" procedures, such as injecting contrast media for a CT scan (’302 Patent, col. 3:47-54).
- The Patented Solution: The invention is an access port with a built-in "radiopaque identification feature" that is observable through imaging technology like X-rays after implantation (’022 Patent, Abstract). This feature includes alphanumeric characters (e.g., "CT") that explicitly identify the port as being "power-injectable," allowing a practitioner to confirm its capabilities by viewing an X-ray (’022 Patent, Claim 1; ’302 Patent, Fig. 52B).
- Technical Importance: This solution provides a non-invasive method for clinicians to positively identify the capabilities of an implanted device, enhancing patient safety by preventing the use of standard ports in high-pressure injection procedures for which they are not designed (’302 Patent, col. 3:6-11).
Key Claims at a Glance
- The complaint asserts "one or more claims" without specifying which ones (Compl. ¶12). Independent claim 1 is representative of the core invention.
- Claim 1 Elements:
- An access port for providing subcutaneous access to a patient, comprising:
- a body defining a fluid cavity accessible by inserting a needle through a septum; and
- at least one radiopaque identification feature of the access port observable via imaging technology subsequent to subcutaneous implantation, the feature including one or more alphanumeric characters identifying the port as power-injectable.
U.S. Patent No. 7,785,302 - "Access Port Identification Systems and Methods"
- Issued: August 31, 2010
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as the ’022 Patent: the difficulty of identifying the specific model and capabilities of a medical port after it has been implanted under a patient's skin (’302 Patent, col. 1:47-54).
- The Patented Solution: The patent discloses an access port assembly whose housing base includes "radiopaque alphanumeric characters" designed to convey information to a practitioner viewing an X-ray taken after implantation (’302 Patent, Claim 1). This feature allows the practitioner to confirm that the port is "power injectable," meaning it is suitable for use with high-pressure injection systems often used for contrast media in CT scans (’302 Patent, col. 11:56-col. 12:3).
- Technical Importance: By embedding a machine-readable identifier visible on standard medical images, the invention aims to reduce medical error and improve safety in radiological procedures involving implanted ports (’302 Patent, col. 3:6-11).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without further specification (Compl. ¶26). Independent claim 1 is representative.
- Claim 1 Elements:
- A venous access port assembly for implantation into a patient, comprising:
- A housing with a discharge port, a needle-penetrable septum, and a cap, with the housing having a base that defines a bottom wall of a reservoir and has an outwardly facing bottom surface.
- The housing base includes radiopaque alphanumeric characters that convey to a practitioner that the port is power injectable when an X-ray is taken after implantation.
U.S. Patent No. 7,959,615 - "Access Port Identification Systems and Methods"
- Issued: June 14, 2011
- Technology Synopsis: This patent addresses the same general problem of post-implantation port identification but focuses on a solution perceivable by palpation (touch) rather than imaging. The invention describes an access port with at least one unique structural feature, such as a concave side surface, that can be felt through the skin to identify the port and its capabilities (’615 Patent, Abstract; Claim 8).
- Asserted Claims: The complaint asserts "one or more claims" without specification (Compl. ¶39).
- Accused Features: The complaint alleges that Defendant's "Dignity port products" infringe by including "concave sides that provide a way to identify" them (Compl. ¶48).
III. The Accused Instrumentality
Product Identification
- Defendant’s "Pro-Fuse CT" and "Dignity" implantable port products (Compl. ¶12, 26).
Functionality and Market Context
- The accused products are identified as "Power Injectable Implantable Infusion Ports" designed to provide repeated access to a patient's vascular system (Compl. ¶19, 32). The complaint alleges that Defendant markets these products as being suitable for the "power injection of contrast media" and as being identifiable "by the letters ‘CT’ under radiographic imaging" (Compl. ¶19, 21, 34). It is further alleged that the Dignity port products include "concave sides" that serve as an identification feature (Compl. ¶48).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
7,947,022 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a body defining a fluid cavity accessible by inserting a needle through a septum | The accused products are described as implantable access devices designed to provide repeated access to the vascular system. | ¶19 | col. 3:35-46 |
| at least one radiopaque identification feature ... observable via imaging technology ... including one or more alphanumeric characters identifying the access port as a power-injectable port | Defendant allegedly markets its accused ports as being able to "be identified by the letters ‘CT’ under radiographic imaging." | ¶21 | col. 11:15-24 |
7,785,302 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a housing having a discharge port, a needle-penetrable septum ... the housing having a housing base defining a bottom wall of at least one reservoir | The accused products are described as "Power Injectable Implantable Infusion Port[s]" used to provide repeated access to the vascular system. | ¶32 | col. 3:35-46 |
| the housing base including radiopaque alphanumeric characters that convey to a practitioner that the venous access port assembly is power injectable when an X-ray ... is taken after implantation | Defendant allegedly markets the accused products as being identifiable by the letters 'CT' under radiographic imaging. | ¶34 | col. 11:56-60 |
Identified Points of Contention
- The infringement analysis for the ’022 and ’302 Patents may turn on both technical and scope-related questions.
- Scope Questions: A central question may be how the term "radiopaque alphanumeric characters" is construed. The analysis may explore whether this limitation requires characters formed from a specific material or integrated into the port's housing in a particular manner, such as via an etched metal plate as shown in patent figures (’302 Patent, Fig. 52B).
- Technical Questions: The complaint's allegations rely on Defendant's marketing statements (Compl. ¶¶21, 34). A key factual question will be what physical mechanism the accused products actually use to make the letters "CT" visible under radiographic imaging, and whether that mechanism meets the claim limitations as construed by the court. For the ’615 Patent, a question will be whether the "concave sides" of the Dignity port are a structural feature capable of identifying the device by palpation as claimed.
V. Key Claim Terms for Construction
- The Term: "radiopaque alphanumeric characters" (’022 Patent, Claim 1; ’302 Patent, Claim 1)
- Context and Importance: This term is the core of the inventive concept for the radiographically-identifiable ports. The outcome of the infringement analysis for the ’022 and ’302 Patents will likely depend on whether the accused products' alleged "CT" marking is found to be a structure that falls within the court's construction of this term.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims require "radiopaque alphanumeric characters that convey" information, without limiting the specific material or method of manufacture. The specification mentions that the feature may be implemented via a "metal feature (e.g., a plate or other metal geometry)" or by incorporating a "metal disk in the bottom of the plastic port" (’302 Patent, col. 11:47-56), which may support an interpretation covering various structural implementations.
- Evidence for a Narrower Interpretation: The primary embodiment disclosed shows an "alphanumeric message etched in a disk or plate... in the bottom of a port" (’302 Patent, col. 11:56-60; Figs. 52A-52B). A party could argue that the claims, when read in light of the specification, are limited to characters physically formed (e.g., etched or molded) into a radiopaque component of the port's housing base itself.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement for all three patents. The basis for this allegation is Defendant's provision of materials, such as "Instructions for Use," that allegedly instruct medical professionals on how to use the accused products in an infringing manner, specifically for power injection (Compl. ¶¶19-20, 32-33).
- Willful Infringement: Willfulness is alleged for all three patents. The complaint alleges knowledge of the ’022 and ’615 patents based on the filing of the original complaint on January 11, 2012 (Compl. ¶¶14, 41). For the ’302 patent, the complaint alleges pre-suit knowledge as of February 18, 2011, asserting that during the prosecution of its own patent application, Defendant copied claims from the issued ’302 patent (Compl. ¶28).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case may depend on the court's answers to several central questions:
- A core issue will be one of structural correspondence: Does the physical construction of the accused ports, particularly the feature that makes the letters "CT" visible on an X-ray, fall within the scope of the term "radiopaque alphanumeric characters" as it is construed from the patent claims and specification?
- A related evidentiary question will be one of factual proof: Beyond Defendant’s marketing claims, what evidence will demonstrate that the accused products actually contain the physical structures required by the asserted claims of the ’022 and ’302 patents?
- For the ’615 patent, a key question will be one of functional identification: Do the "concave sides" of the accused Dignity port function as a tactile identification feature as claimed, and does the physical geometry of those sides meet the specific limitations of the asserted claims?