DCT
1:20-cv-01543
CR Bard Inc v. ICU Medical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: C. R. Bard, Inc. (New Jersey)
- Defendant: Smiths Medical ASD, Inc. (Delaware)
- Plaintiff’s Counsel: Dorsey & Whitney LLP; Kirkland & Ellis, LLP
- Case Identification: 2:12-cv-00036, D. Utah, 07/19/2012
- Venue Allegations: Venue is based on Defendant conducting business in the District of Utah, including making, selling, or using the accused medical products within the district.
- Core Dispute: Plaintiff alleges that Defendant’s implantable medical port products infringe patents related to systems for identifying the capabilities of a port after it has been implanted.
- Technical Context: The technology concerns implantable vascular access ports used for delivering fluids or drugs; specifically, it addresses the need for clinicians to reliably identify whether an implanted port is safe for high-pressure "power injection" procedures, such as those used in CT scans.
- Key Procedural History: The complaint alleges that Defendant has had knowledge of the asserted patents since at least January 11, 2012, the filing date of the original complaint in this action, which forms the basis for the willfulness allegations.
Case Timeline
| Date | Event |
|---|---|
| 2005-03-04 | Earliest Priority Date ('022 and '302 Patents) |
| 2010-08-31 | U.S. Patent No. 7,785,302 Issued |
| 2011-05-24 | U.S. Patent No. 7,947,022 Issued |
| 2012-01-11 | Original Complaint Filed (Date of alleged knowledge) |
| 2012-07-19 | 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 and potential risk for clinicians in determining the specific model, design, or capabilities of a medical access port after it has been subcutaneously implanted in a patient ('022 Patent, col. 1:53-58).
- The Patented Solution: The invention is an access port that includes at least one "radiopaque identification feature" that is observable using imaging technology, such as an X-ray, after the port is implanted ('022 Patent, col. 11:15-26). This feature, which can include alphanumeric characters like "CT" engraved on the port's bottom surface (as shown in FIG. 53B), allows a practitioner to positively identify the port and confirm it is "power-injectable" ('022 Patent, col. 11:46-62).
- Technical Importance: The ability to reliably identify a port as power-injectable is critical for patient safety when performing procedures like power injection of contrast media for computed tomography (CT) scans, which could damage a non-compatible port ('022 Patent, col. 3:48-54).
Key Claims at a Glance
- The complaint asserts one or more claims, with independent claim 1 being representative of the core technology.
- Essential elements of independent claim 1 include:
- A body defining a fluid cavity accessible through a septum.
- At least one radiopaque identification feature observable via imaging technology after implantation.
- The feature includes one or more alphanumeric characters that identify the access port as being a "power-injectable port."
- The complaint reserves the right to assert additional claims.
U.S. Patent No. 7,785,302 - "Access Port Identification Systems and Methods", Issued August 31, 2010
The Invention Explained
- Problem Addressed: Like its continuation-in-part, the '302 Patent addresses the uncertainty faced by medical personnel when an implanted access port's specific characteristics cannot be determined by simple palpation, which is undesirable for ensuring patient safety and proper device use ('302 Patent, col. 1:45-54).
- The Patented Solution: The patent discloses a venous access port assembly with a specific housing structure that includes "radiopaque alphanumeric characters" on its housing base ('302 Patent, col. 12:6-12). These characters are designed to be visible on a post-implantation X-ray to convey to a practitioner that the port is suitable for power injection ('302 Patent, col. 12:6-12; FIG. 52B).
- Technical Importance: This identification feature allows medical staff to confirm that a port is designed to withstand the pressures of power injection, thereby preventing potential device failure and injury when administering contrast media for imaging procedures ('302 Patent, col. 4:8-10).
Key Claims at a Glance
- The complaint asserts one or more claims, with independent claim 1 being representative.
- Essential elements of independent claim 1 include:
- A venous access port assembly with a housing, discharge port, and needle-penetrable septum.
- The housing has a housing base with an outwardly facing bottom surface.
- The housing base includes radiopaque alphanumeric characters that convey to a practitioner, upon viewing an X-ray, that the assembly is power injectable.
- The complaint reserves the right to assert additional claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are implantable port products, specifically including the "PORT-A-CATH" and "P.A.S. PORT Power P.A.C." port products (Compl. ¶10).
Functionality and Market Context
- The complaint alleges these are implantable venous access systems used for patient therapy requiring repeated vascular access (Compl. ¶16, ¶29).
- Crucially, the complaint alleges Defendant markets these products as including "CT identifiers for easy viewing using X-rays or CT scout scans" and provides "Instructions for Use" stating the ports are "indicated for power injection of contrast media" (Compl. ¶16, ¶18, ¶29, ¶31). This functionality is alleged to facilitate "quick acknowledgement that the ports can be used for power injection of contrast media" (Compl. ¶18, ¶31).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'022 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 body defining a fluid cavity accessible by inserting a needle through a septum; | The accused PORT-A-CATH and P.A.S. PORT Power P.A.C. products are implantable access ports with a body and septum for subcutaneous access. | ¶10, ¶16 | col. 3:35-45 |
| and at least one radiopaque identification feature of the access port observable via imaging technology subsequent to subcutaneous implantation of the access port, | The accused products are marketed as having "CT identifiers for easy viewing using X-rays or CT scout scans." | ¶18 | col. 1:55-59 |
| the at least one radiopaque identification feature including one or more alphanumeric characters identifying the access port as a power-injectable port. | The "CT identifiers" are alleged to be alphanumeric characters that inform users the port is indicated for "power injection of contrast media." | ¶16, ¶18 | col. 3:48-54 |
'302 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A venous access port assembly for implantation into a patient, comprising: a housing having a discharge port, a needle-penetrable septum...the housing having a housing base defining a bottom wall...and an outwardly facing bottom surface, | The accused products are implantable port assemblies that include a housing and septum. The infringement theory implies the "CT identifier" is on the housing's bottom surface. | ¶23, ¶31 | col. 3:35-45 |
| 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 of the patient is taken after implantation. | The accused products' "CT identifiers" are alleged to be radiopaque characters that convey to practitioners, via X-ray, that the port is indicated for "power injection of contrast media." | ¶29, ¶31 | col. 12:6-12 |
Identified Points of Contention
- Scope Questions: The claims require the feature to "identify" the port "as" power-injectable or "convey" that it "is" power-injectable. A central question for the court will be whether the alleged "CT identifiers" perform this specific identifying function. Defendant may argue the "CT" marking merely indicates compatibility with CT scanning procedures, not that the port is necessarily power-injectable, thus failing to meet the functional language of the claims.
- Technical Questions: The complaint's allegations are based on marketing materials and instructions. A key factual question will be the actual physical nature, composition, and placement of the "CT identifiers" on the accused products. Evidence will be required to determine if they are "radiopaque" and located on the "housing base" as claimed in the '302 Patent.
V. Key Claim Terms for Construction
Term: "radiopaque alphanumeric characters" ('022 Patent, claim 1; '302 Patent, claim 1)
- Context and Importance: This term is the central physical element of the invention. Its construction will determine what physical markings on an accused product can infringe. Practitioners may focus on this term because the required degree of radiopacity and what qualifies as an "alphanumeric character" in this context could be disputed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests the body can be made of various biocompatible materials, and a feature is radiopaque if it can be observed via x-ray imaging, without setting a specific threshold for contrast ('302 Patent, col. 4:60-65; col. 11:21-23). This could support a reading on any character that is discernibly more opaque on an X-ray than its surrounding material.
- Evidence for a Narrower Interpretation: The primary embodiments show specific alphanumeric characters ("CT") etched or engraved into a metal or plastic disk on the port's bottom surface ('302 Patent, FIG. 52B; col. 11:53-60). A party could argue the term should be limited to such distinct, engraved characters rather than, for example, markings made from a different molded material.
Term: "identifying the access port as a power-injectable port" ('022 Patent, claim 1) / "conveys to a practitioner that the venous access port assembly is power injectable" ('302 Patent, claim 1)
- Context and Importance: This functional language is critical to infringement, as it defines the purpose the radiopaque characters must serve. The dispute will center on what information is actually communicated to a clinician by the marking itself.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent background establishes a clear need to differentiate power-injectable ports from others ('302 Patent, col. 1:45-54). A plaintiff may argue that in this specific medical context, the presence of characters like "CT" inherently "conveys" the power-injectable capability to a trained practitioner.
- Evidence for a Narrower Interpretation: The language requires the characters themselves to perform the "identifying" or "conveying" function. A defendant may argue that this requires more than an ambiguous acronym; it may require a marking that is part of an established standard where its meaning is unequivocal, and that simply marking "CT" only suggests compatibility with a CT scanner, not the specific capability of power injection.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement, stating that Defendant provides "Instructions for Use," marketing materials, and promotional websites that instruct and encourage customers (e.g., radiologists, physicians, nurses) to use the accused ports in an infringing manner, specifically for power injection (Compl. ¶15-19, ¶28-32).
- Willful Infringement: Willfulness is alleged based on Defendant’s continued infringement after receiving notice of the patents and the infringement allegations via the original complaint filed on January 11, 2012 (Compl. ¶20, ¶33).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional interpretation: Do the "CT identifiers" on the accused products, as understood by a medical practitioner, actually perform the claimed function of "identifying" the port "as" power-injectable, or do they merely indicate a broader compatibility with CT imaging?
- A second central question will be one of evidentiary proof: Beyond marketing claims, what is the physical evidence of the accused products' construction? The case will likely depend on whether the physical characteristics, material composition, and location of the identifiers on the actual products align with the specific limitations of the asserted claims, such as being "radiopaque" and located on the "housing base."