DCT
2:25-cv-16949
Medical Components Inc v. Becton Dickinson Co
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Medical Components, Inc. (Pennsylvania)
- Defendant: Becton Dickinson and Company, C.R. Bard, Inc., and Bard Peripheral Vascular, Inc. (New Jersey)
- Plaintiff’s Counsel: Fisherbroyles, LLP
- Case Identification: 2:25-cv-16949, D.N.J., 10/27/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendants reside in, are engaged in business in, and sell the accused products within the district.
- Core Dispute: Plaintiff alleges that Defendant’s PowerPort line of implantable venous access ports infringes three patents related to ports with X-ray discernable indicia for post-implantation identification.
- Technical Context: The technology concerns implantable medical devices that include radiopaque markers, allowing clinicians to identify key attributes of a port, such as its suitability for high-pressure injection, using standard X-ray imaging.
- Key Procedural History: The complaint alleges that Plaintiff provides constructive notice of the asserted patents via a virtual marking website and, on information and belief, that Defendants had actual pre-suit knowledge of and analyzed each of the asserted patents.
Case Timeline
| Date | Event |
|---|---|
| 2007-07-19 | Earliest Priority Date Asserted for '329, '842, and '137 Patents |
| 2016-12-13 | U.S. Patent No. 9,517,329 Issues |
| 2019-10-01 | Alleged First Offer for Sale of Accused PowerPort Products with Indicia |
| 2020-12-29 | U.S. Patent No. 10,874,842 Issues |
| 2024-01-23 | U.S. Patent No. 11,878,137 Issues |
| 2025-10-27 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,517,329 - “Venous Access Port Assembly With X-Ray Discernable Indicia”
- Patent Identification: U.S. Patent No. 9517329, “Venous Access Port Assembly With X-Ray Discernable Indicia,” issued December 13, 2016.
The Invention Explained
- Problem Addressed: The patent describes the clinical challenge of identifying the specific properties of a venous access port after it has been implanted under a patient's skin, which makes it impossible to visually inspect (Compl. ¶19; ’329 Patent, col. 1:40-45).
- The Patented Solution: The invention solves this by incorporating X-ray discernable indicia into the port's housing base. These indicia, which can be radiopaque letters like "CT" or cutouts in a radiopaque disc, are designed to be clearly visible on an X-ray to inform practitioners of a key attribute, such as its rating for high-pressure contrast fluid injection used in computed tomography scans (’329 Patent, Abstract; col. 1:53-65). Figure 8 of the patent illustrates an exemplary disc with "CT" cutouts designed for this purpose (’329 Patent, Fig. 8).
- Technical Importance: This technology provides a non-invasive method for clinicians to verify the capabilities of an implanted device, enhancing patient safety by preventing misuse, such as attempting a power injection on a port not designed to withstand high pressures (’329 Patent, col. 2:1-6).
Key Claims at a Glance
- The complaint asserts independent claim 1 and reserves the right to assert dependent claims (Compl. ¶39, ¶83).
- Claim 1 Elements:
- An implantable venous access port assembly, comprising:
- a needle-penetrable septum; and
- a housing securing the needle-penetrable septum, the housing comprising a housing base having a bottom wall, including X-ray discernable indicia embedded into a thickness of the bottom wall,
- wherein the X-ray discernible indicia visually indicate, under X-ray examination, an attribute of the port assembly.
U.S. Patent No. 10,874,842 - “Venous Access Port Assembly With X-Ray Discernable Indicia”
- Patent Identification: U.S. Patent No. 10874842, “Venous Access Port Assembly With X-Ray Discernable Indicia,” issued December 29, 2020.
The Invention Explained
- Problem Addressed: The patent addresses the same clinical problem as the ’329 Patent: the need to identify the properties of a medical port after it has been implanted and is no longer visible (’842 Patent, col. 1:40-45).
- The Patented Solution: The ’842 Patent discloses a similar solution but describes the indicia with more specific structural limitations. The invention features a housing made at least partially of radiopaque material, with the indicia formed as "cut outs...through at least a portion of the radiopaque material" (’842 Patent, Abstract). This approach creates a visual identifier on an X-ray by forming characters or symbols from perforations in a radiopaque element (’842 Patent, col. 2:6-9).
- Technical Importance: As with the related ’329 patent, this solution allows for post-implantation verification of a port's specific medical capabilities, which is critical for ensuring proper and safe clinical use (’842 Patent, col.2:1-6).
Key Claims at a Glance
- The complaint asserts independent claim 1 and reserves the right to assert dependent claims (Compl. ¶47, ¶93).
- Claim 1 Elements:
- An implantable venous access port assembly, comprising:
- a needle-penetrable septum, and
- a housing securing the needle-penetrable septum, at least a portion of the housing comprising radiopaque material, the housing further comprising X-ray discernable indicia to identify an attribute of the access port assembly,
- wherein the X-ray discernable indicia are cut outs formed through at least a portion of the radiopaque material.
U.S. Patent No. 11,878,137 - “Venous Access Port Assembly With X-Ray Discernable Indicia”
- Multi-Patent Capsule: U.S. Patent No. 11878137
- Patent Identification: U.S. Patent No. 11,878,137, “Venous Access Port Assembly With X-Ray Discernable Indicia,” issued January 23, 2024.
- Technology Synopsis: Continuing the technology of the asserted family, this patent describes a venous access port with an X-ray visible identifier. The invention covers a port assembly with a housing made of a radiopaque material that has "at least one cutout defined in" the material, with the cutout itself forming an indicium indicating an attribute of the port (’137 Patent, Abstract).
- Asserted Claims: Independent claim 1 is asserted (Compl. ¶55, ¶104).
- Accused Features: The complaint alleges that the X-ray visible identifiers in the PowerPort product line infringe this patent (Compl. ¶¶104-105).
III. The Accused Instrumentality
Product Identification
- The accused products are Defendants' line of "PowerPort" implantable ports and accessories (Compl. ¶22). The complaint identifies specific product families, including the PowerPort Implantable Port, PowerPort M.R.I. Implantable Port, and PowerPort CLEARVUE ports (Compl. ¶23, ¶57).
Functionality and Market Context
- The accused devices are implantable venous access ports used for delivering or withdrawing fluids from a patient (Compl. ¶18). The complaint alleges that since October 2019, these products have included "x-ray discernable indicia" specifically to assist medical practitioners in identifying the port's characteristics after implantation (Compl. ¶26, ¶59). A visual provided in the complaint shows a representative product, the PowerPort M.R.I. Implantable Port, which includes a triangular identifier with the letters "CT" on its bottom surface to aid in X-ray identification (Compl. ¶64, p. 11). Product literature allegedly describes this feature as a "radiopaque identifier" for "Identification of the PowerPort* device under X-ray" (Compl. ¶60).
IV. Analysis of Infringement Allegations
’329 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a needle-penetrable septum | The accused PowerPort products include a needle-penetrable septum for accessing the internal reservoir. | ¶59, ¶84 | col. 3:11-14 |
| a housing securing the needle-penetrable septum, the housing comprising a housing base having a bottom wall | The accused PowerPort products have a housing that secures the septum and includes a housing base with a bottom wall. A diagram in the complaint identifies this structure. | ¶59, ¶84 | col. 3:25-30 |
| including X-ray discernable indicia embedded into a thickness of the bottom wall | The accused PowerPort products include radiopaque indicia, such as the letters "CT", that are allegedly embedded in the bottom wall of the housing base. An image provided in the complaint labels this feature as "X-ray Discernable Indicia Embedded In Bottom Wall." | ¶64, ¶84 | col. 4:11-14 |
| wherein the X-ray discernible indicia visually indicate, under X-ray examination, an attribute of the port assembly | The indicia allegedly serve to identify the port as a PowerPort device suitable for power injection, which is a key attribute. | ¶60-¶61, ¶84 | col. 1:56-62 |
’842 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a needle-penetrable septum, and a housing securing the needle-penetrable septum | The accused PowerPort products include a septum secured by a housing. | ¶59, ¶94 | col. 3:11-14 |
| at least a portion of the housing comprising radiopaque material | The accused products' housing includes a "radiopaque identifier" for X-ray visibility. | ¶60-¶61, ¶94 | col. 2:6-9 |
| the housing further comprising X-ray discernable indicia... wherein the X-ray discernable indicia are cut outs formed through at least a portion of the radiopaque material | The complaint alleges the indicia are cut outs. The accompanying image shows the letters "CT" formed as part of a radiopaque identifier, which is alleged to meet this limitation. The complaint also separately labels "Cut-Outs" on a diagram of the PowerPort M.R.I. port. | ¶64, ¶94 | col. 4:6-10 |
| to identify an attribute of the access port assembly | The indicia allegedly identify the port as a "PowerPort device," indicating its suitability for power injection. | ¶60-¶61, ¶94 | col. 1:56-62 |
Identified Points of Contention
- Scope Questions: A central issue may be the distinction between the claims of the asserted patents. The infringement analysis may focus on whether the structure of the accused PowerPort indicia meets the specific limitation of being "embedded into a thickness of the bottom wall" as required by the ’329 Patent, or being "cut outs formed through" radiopaque material as required by the ’842 Patent, or both. The complaint's visual evidence labels features corresponding to both "embedded" indicia and "cut-outs," raising the question of how these distinct elements map to the different patent claims (Compl. ¶64, p. 11).
- Technical Questions: A technical question for the court may be how the accused product's indicia are manufactured and integrated into the housing. The evidence will need to show whether the letters "CT" are formed by perforating a solid radiopaque disc (a cutout) or by embedding discrete, pre-formed radiopaque letters into the housing material, as this distinction may be critical for differentiating infringement between the asserted patents.
V. Key Claim Terms for Construction
- The Term: "embedded into a thickness of the bottom wall" (’329 Patent, Claim 1)
- Context and Importance: This term is central to the infringement theory for the ’329 Patent. The definition will determine whether indicia must be fully encased within the material of the housing wall, or if being set into a recess on the surface is sufficient. Practitioners may focus on this term because the complaint's visual evidence appears to show an identifier component affixed within a recess on the bottom of the port, which may or may not satisfy a strict definition of "embedded" (Compl. ¶64, p. 11).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses that indicia "may be affixed to the bottom surface of the housing base, preferably within complementary recesses thereinto" (’842 Patent, col. 2:11-14), language which is also present in the ’329 Patent's shared specification. This could support a construction that does not require full encapsulation.
- Evidence for a Narrower Interpretation: The plain meaning of "embedded" suggests being enclosed within a surrounding mass. The patent's Figure 12 explicitly depicts an embodiment where a disc is shown fully encased "within the thickness of the bottom wall," which could be used to argue for a narrower construction limited to that configuration (’329 Patent, Fig. 12; col. 4:11-14).
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement for all three patents (Compl. ¶85, ¶96, ¶107). The factual basis alleged is that Defendants provide instructions, literature, and training that direct and encourage medical professionals to use the accused PowerPort products in an infringing manner—specifically, by performing an X-ray imaging procedure to identify the port via its radiopaque indicia before use (Compl. ¶¶62-63).
- Willful Infringement: Willfulness is alleged for all three patents, based on both pre- and post-suit knowledge (Compl. ¶¶79-81). The complaint alleges Defendants had constructive notice through Plaintiff's virtual patent marking (Compl. ¶¶36, 70-72) and, upon information and belief, also had pre-suit actual knowledge from having "analyzed" each of the asserted patents (Compl. ¶¶73-75). Continued sales after the patents issued are alleged to be deliberate and in reckless disregard of Plaintiff's patent rights (Compl. ¶¶76-78).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope and differentiation: can Plaintiff prove that the single design of the accused PowerPort indicia infringes the distinct structural limitations of multiple patents in the same family—specifically, the requirement of being "embedded into a thickness" (’329 Patent) versus being "cut outs formed through" radiopaque material (’842 and ’137 Patents)? The resolution will depend heavily on claim construction and the precise manufacturing details of the accused device.
- A key evidentiary question will be one of scienter for willfulness: beyond the complaint's allegations, what specific evidence can Plaintiff produce to demonstrate that Defendants had pre-suit knowledge of and "analyzed" the asserted patents? The strength of the willfulness claim, and any potential for enhanced damages, will likely turn on the discovery of such evidence.