DCT
2:17-cv-01047
Medical Components Inc v. CR Bard Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Medical Components, Inc. (Pennsylvania)
- Defendant: C.R. Bard, Inc.; BARD Peripheral Vascular, Inc.; Bard Access Systems, Inc. (New Jersey)
- Plaintiff’s Counsel: Potter Minton; Buchanan Ingersoll & Rooney PC
- Case Identification: 6:17-cv-00237, E.D. Tex., 04/27/2017
- Venue Allegations: Venue is based on allegations that Defendants conduct business in the Eastern District of Texas, have committed acts of infringement in the district, and have placed the accused products into the stream of commerce with the knowledge they would be sold and used there, including at specific, named medical facilities within the district.
- Core Dispute: Plaintiff alleges that Defendant’s PowerPort and Vaxcess lines of implantable venous access ports infringe a patent related to using X-ray discernable indicia to identify port characteristics post-implantation.
- Technical Context: The technology concerns implantable medical ports used for long-term vascular access, where identifying specific device capabilities, such as the ability to withstand high-pressure injections for imaging procedures, is critical for patient safety after the device is implanted.
- Key Procedural History: The complaint highlights that Defendant previously challenged the patent-in-suit by filing a petition for inter partes review (IPR) with the U.S. Patent and Trademark Office, which was denied institution, a fact that may be significant for allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2007-06-20 | ’160 Patent Priority Date |
| 2014-10-07 | ’160 Patent Issue Date |
| 2015-07-31 | Date by which Defendant allegedly had specific knowledge of the ’160 Patent |
| 2016-02-04 | Defendant's IPR petition for the ’160 Patent is denied institution |
| 2017-04-27 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,852,160 - "Venous Access Port With Molded And/Or Radiopaque Indicia" (issued Oct. 7, 2014)
The Invention Explained
- Problem Addressed: Once a venous access port is implanted under a patient's skin, it can be difficult for a medical practitioner to identify its specific characteristics, such as whether it is safe for power injection of contrast fluids used in imaging procedures like computed tomography (CT) scans ( Compl. ¶24; ’160 Patent, col. 1:36-41).
- The Patented Solution: The invention integrates specific, X-ray visible markings ("indicia") directly into the port's structure, typically on a flange surrounding the main body. These indicia, which can be voids in the material forming letters like "CT," allow a practitioner to confirm the port's capabilities using a standard X-ray before performing a procedure (’160 Patent, col. 1:42-54, col. 2:1-10, Abstract).
- Technical Importance: This solution provides a reliable, non-invasive method to verify implanted device properties, enhancing patient safety by preventing the use of ports in procedures for which they are not rated (’160 Patent, col. 1:47-54).
Key Claims at a Glance
- The complaint asserts independent claims 1, 9, and 16 (Compl. ¶147).
- Independent Claim 1 requires:
- A venous access port assembly with a housing defining a reservoir and an adjacent flange.
- The flange must comprise "an X-ray discernable material."
- The flange must have "one or more voids extending through the X-ray discernable material... from the top surface... to the bottom surface."
- These voids must be "X-ray discernable indicia configured to indicate, under X-ray examination, that the assembly is rated for power injection."
- A "needle-penetrable septum" that communicates with the housing.
- Independent Claim 9 is structurally similar to Claim 1 but recites a "housing base" and that the septum is "secured to the housing."
- Independent Claim 16 adds a further limitation not present in Claim 1, requiring "a cap securing the needle-penetrable septum to the housing."
- The complaint reserves the right to assert dependent claims 2-8, 10-15, and 17-22 (Compl. ¶147).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendants' "PowerPort" line of implantable ports (including numerous specific models such as PowerPort M.R.I. Implantable Port and PowerPort CLEARVUE isp Implantable Port) and the "Vaxcess" port device (Compl. ¶¶27, 28, 82).
Functionality and Market Context
The accused products are implantable venous access ports used for controlled infusion and withdrawal of fluids (Compl. ¶23). The complaint alleges that these ports include a flange with a "radiopaque identifier" designed to aid in the "Identification of the PowerPort* device under X-ray" (Compl. ¶95). An annotated image in the complaint shows an accused product with a triangular port shape and an X-ray view revealing indicia within the flange (Compl. p. 18, images). The complaint alleges that these devices are sold, distributed, and used throughout Texas at major healthcare systems (Compl. ¶¶56-72).
IV. Analysis of Infringement Allegations
’160 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 comprising: a base defining at least one reservoir; and a flange adjacent to the at least one reservoir | The PowerPort products are venous access port assemblies that include a housing and a flange. | ¶94, ¶109, ¶111 | col. 3:20-31 |
| the flange comprising an X-ray discernable material, a top surface, a bottom surface | The flange of the PowerPort products includes x-ray discernable material. An annotated photograph of an accused product identifies the flange. | ¶105, ¶115, ¶152, p. 28 | col. 5:22-26 |
| and one or more voids extending through the X-ray discernable material of the flange from the top surface of the flange to the bottom surface of the flange | The PowerPort products include one or more voids in the X-ray discernable material of the flange that define the indicia. An annotated image highlights these voids. | ¶106, ¶115, p. 18 | col. 6:1-5 |
| wherein the one or more voids are X-ray discernable indicia configured to indicate, under X-ray examination, that the assembly is rated for power injection | The complaint alleges the X-ray discernable material is configured to provide indicia indicating that the port is rated for power injection. | ¶108, ¶119, ¶132 | col. 6:3-9 |
| and a needle-penetrable septum communicating with the housing | The PowerPort products include a needle-penetrable septum. An annotated photograph of an accused product identifies the septum. | ¶94, ¶109, p. 18 | col. 3:20-22 |
Identified Points of Contention
- Technical/Functional Question: The complaint alleges the accused indicia are "configured to indicate... that the assembly is rated for power injection" (Compl. ¶108). However, it also cites Defendant's literature stating the identifier is for "Identification of the PowerPort* device under X-ray" (Compl. ¶95). A central dispute may be whether identifying the device itself is sufficient to meet the claim limitation of indicating a specific "power injection" rating, or if Plaintiff must present additional evidence linking the indicia to that specific function.
- Scope Question: The claims require voids "extending through" the flange material "from the top surface... to the bottom surface" (’160 Patent, col. 6:1-5). An annotated diagram in the complaint shows voids that appear to fully penetrate the flange material of an accused device (Compl. p. 23, images). The factual accuracy of this allegation and whether there is any physical variance in the accused products will be a matter for discovery and expert testimony.
V. Key Claim Terms for Construction
Term: "X-ray discernable indicia configured to indicate... that the assembly is rated for power injection"
- Context and Importance: This term links the physical structure (indicia) to a specific purpose. The dispute will likely focus on what evidence is required to show the indicia are "configured" for this purpose. Practitioners may focus on this term because its construction will determine whether the shape of the indicia alone is sufficient, or if extrinsic evidence of the manufacturer's intent or the medical community's understanding is necessary.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests that the letters "CT" themselves imply the function: "the letters 'CT' would be understood in medical practice to indicate that the port is suitable for the high pressure injection of contrast fluid" (’160 Patent, col. 2:4-7). This may support an argument that the visual form of the indicia is the "configuration."
- Evidence for a Narrower Interpretation: The patent consistently discusses the inventor's intent to create markings for this purpose. A defendant could argue that "configured" requires more than an incidental resemblance and must be tied to the manufacturer's own design purpose, which the complaint quotes as being for "Identification of the PowerPort* device" (Compl. ¶95), a potentially different and broader purpose.
Term: "a cap securing the needle-penetrable septum to the housing"
- Context and Importance: This term appears in independent claim 16 but not in claims 1 or 9 (Compl. ¶147; ’160 Patent, col. 6:35-38). Its presence makes claim 16 narrower. The complaint explicitly alleges that accused products include this feature and provides annotated images identifying the "Cap securing septum to housing" on different models (Compl. ¶115, ¶151, p. 20, images). The existence and function of this component on all accused products will be a factual question critical to infringement of claim 16.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the cap's function simply as securing the septum to the housing base (’160 Patent, col. 3:55-60). This functional language may allow for various structures that perform this securing action.
- Evidence for a Narrower Interpretation: The patent figures (e.g., FIG. 1, FIG. 3) show a distinct, ring-like component (48) that performs this function. A defendant might argue that its product's securing mechanism is structurally different from the specific embodiments disclosed, potentially avoiding infringement of this claim.
VI. Other Allegations
Indirect Infringement
The complaint alleges inducement by asserting that Defendant provides instructions and literature (e.g., an "Instructions for Use" document) that direct customers to use the accused ports in an infringing manner, specifically by instructing them to use an imaging procedure to verify the port type before use (Compl. ¶¶102-103, 148).
Willful Infringement
The willfulness claim is supported by allegations of both pre-suit and post-suit knowledge. The complaint alleges Defendant had knowledge from Plaintiff's patent markings (Compl. ¶135), had "specific knowledge" of the patent as early as July 31, 2015 (Compl. ¶137), and, most notably, filed an IPR petition against the ’160 patent which was denied institution on February 4, 2016 (Compl. ¶¶138-141). The complaint alleges that Defendant continued to infringe after this denial (Compl. ¶144).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of indicated function: Does the "radiopaque identifier" on Bard's products, which the complaint alleges Bard describes as for general "Identification," meet the claim requirement of being "configured to indicate... that the assembly is rated for power injection"? The resolution will depend on whether the physical similarity of the indicia to the letters "CT" is sufficient on its own, or if more direct evidence of functional intent is required.
- A key question for damages will be willfulness: Given that a court may find Bard's unsuccessful IPR challenge demonstrates knowledge of the patent and awareness of its potential infringement, the central question for willfulness will be whether Bard’s continued sales of the accused products after the IPR denial rises to the level of objective recklessness required for enhanced damages.
- A third determinative question will be one of direct evidence: The complaint makes numerous direct comparisons between patent figures and photographs of accused products, such as showing the claimed voids in a patent drawing next to a photo of an accused port (Compl. p. 28). The case may turn on the factual accuracy of these side-by-side comparisons and how closely the physical structures of the accused devices map onto the specific limitations recited in the asserted claims.