DCT
2:25-cv-16949
Medical Components Inc v. Becton Dickinson Co
Key Events
Amended Complaint
Table of Contents
amended 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., 02/02/2026
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendants are engaged in business in the district, including advertising, selling, and shipping the accused products, and maintain principal places of business there.
- Core Dispute: Plaintiff alleges that Defendants’ PowerPort line of implantable venous access ports infringes three patents related to using X-ray discernible indicia to identify key attributes of the port after it has been implanted in a patient.
- Technical Context: The technology provides a non-invasive method for clinicians to identify the specific type and capabilities of an implanted medical port using standard X-ray imaging, which is critical for ensuring patient safety during certain procedures like high-pressure contrast injections.
- Key Procedural History: The complaint references a 2016 motion in which Defendants allegedly made admissions regarding which corporate entity was "exclusively responsible" for marketing and selling the accused products, suggesting a history of procedural disputes between the parties over liability.
Case Timeline
| Date | Event |
|---|---|
| 2006-10-18 | Earliest Priority Date for U.S. Patent No. 11,878,137 |
| 2007-07-19 | Earliest Priority Date for U.S. Patent Nos. 9,517,329 and 10,874,842 |
| 2016-01-12 | Defendants' Motion to Dismiss cited in complaint |
| 2016-12-13 | U.S. Patent No. 9,517,329 Issues |
| 2019-10-01 | Alleged date from which Accused Products included X-ray indicia |
| 2020-12-29 | U.S. Patent No. 10,874,842 Issues |
| 2024-01-23 | U.S. Patent No. 11,878,137 Issues |
| 2026-02-02 | Complaint Filing Date |
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: Once a venous access port is implanted under a patient's skin, it is not visible, creating a need for medical professionals to safely identify the port's specific properties and orientation before accessing it with a needle (Compl. ¶35; ’329 Patent, col. 1:20-34).
- The Patented Solution: The invention incorporates X-ray discernible indicia into the port's housing to visually indicate a specific attribute of the port under X-ray examination ('329 Patent, Abstract). For example, indicia such as the letters "CT" would inform a practitioner that the port is suitable for high-pressure power injection of contrast fluid, a procedure associated with computed tomography scans (’329 Patent, col. 2:1-6). The invention describes embedding these indicia into the thickness of the port's bottom housing wall (’329 Patent, col. 4:10-15; Fig. 12).
- Technical Importance: This technology allows for non-invasive verification of an implanted port's capabilities, mitigating the risk of device failure or patient injury that could result from using an incompatible port for high-pressure injections Compl. ¶35
Key Claims at a Glance
The complaint asserts infringement of at least independent claim 1 and reserves the right to assert numerous other claims Compl. ¶99 The essential elements of independent claim 1 are:
- 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 technical challenge as the ’329 Patent: enabling post-implantation identification of a venous access port's attributes (’842 Patent, col. 1:20-43).
- The Patented Solution: The solution is again X-ray discernible indicia, but this patent claims a specific structure for them. The indicia are defined as "cut outs formed through at least a portion of the radiopaque material" (’842 Patent, Abstract; claim 1). The specification illustrates this with a disc of radiopaque material from which letters like "CT" have been cut out, creating a visible contrast on an X-ray image (’842 Patent, col. 2:37-43; Fig. 8).
- Technical Importance: This approach provides a distinct method for manufacturing and integrating identifying markers into a port, which may offer different radiographic characteristics or production efficiencies compared to embedding solid indicia.
Key Claims at a Glance
The complaint asserts infringement of at least independent claim 1 and reserves the right to assert numerous other claims Compl. ¶109 The essential elements of independent claim 1 are:
- 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 (Multi-Patent Capsule) - Venous Access Port Assembly With X-Ray Discernable Indicia
- Patent Identification: U.S. Patent No. 11878137, "Venous Access Port Assembly With X-Ray Discernable Indicia," issued January 23, 2024.
- Technology Synopsis: The ’137 Patent also discloses a venous access port with X-ray visible markers to solve the problem of post-implantation identification (’137 Patent, col. 1:47-53). The claimed solution is similar to that of the ’842 Patent, describing the indicium as being formed by "at least one cutout defined in at least a portion of the radiopaque material" (’137 Patent, claim 1).
- Asserted Claims: The complaint asserts at least independent claim 1 (Compl. ¶¶ 71, 119).
- Accused Features: The complaint alleges that the "Cut-Outs" present in the radiopaque identifiers of the Defendants' PowerPort products infringe the ’137 Patent Compl. ¶¶ 80-84, 120
III. The Accused Instrumentality
Product Identification
- Defendants' "PowerPort" line of implantable ports, including but not limited to the PowerPort isp, PowerPort Slim, PowerPort M.R.I., and PowerPort CLEARVUE models (Compl. ¶¶ 39, 73).
Functionality and Market Context
- The accused products are implantable venous access ports used for delivering and/or withdrawing fluids from a patient Compl. ¶34 The complaint alleges that since October 2019, these products have included "x-ray discernable indicia" that function as a "radiopaque identifier" to aid in the "Identification of the PowerPort® device under X-ray" and to identify it as a "power injectable port" (Compl. ¶¶ 42, 76, 77). The complaint includes an image of a PowerPort M.R.I. model that shows a triangular identifier with the letters "CT" visible as cut-outs Compl. ¶80 A separate image of a PowerPort isp M.R.I. model likewise shows a triangular radiopaque element with cut-outs Compl. ¶81 These products are allegedly marketed under the Becton Dickinson corporate brand Compl. ¶39
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. | ¶75, ¶80 | col. 3:10-11 |
| a housing securing the needle-penetrable septum, the housing comprising a housing base having a bottom wall | The accused PowerPort products include a housing that secures the septum. | ¶75, ¶80 | col. 3:12-13 |
| including X-ray discernable indicia embedded into a thickness of the bottom wall | The accused PowerPort products include "X-ray Discernable Indicia Embedded In Bottom Wall," as illustrated in product images. | ¶80, ¶81 | col. 4:10-15 |
| wherein the X-ray discernible indicia visually indicate, under X-ray examination, an attribute of the port assembly | The indicia allegedly aid in "Identification of the PowerPort® device under X-ray" and identify it as a power injectable port. | ¶76, ¶77 | col. 2:1-6 |
- Identified Points of Contention:
- Scope Questions: A central issue may be the construction of "embedded into a thickness of the bottom wall." The complaint's visual evidence shows a component labeled "X-ray Discernable Indicia Embedded In Bottom Wall" that also features "Cut-Outs" Compl. ¶80 This raises the question of whether a component affixed to or recessed within a surface, rather than fully enclosed within the material during molding, meets the "embedded" limitation.
- Technical Questions: The court may need to resolve whether the same physical structure in the accused device can simultaneously satisfy the "embedded" limitation of the ’329 Patent and the "cut outs" limitation of the ’842 and ’137 Patents, or if these claim terms describe mutually exclusive configurations.
’842 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. | ¶75, ¶80 | col. 3:25-26 |
| a housing securing the needle-penetrable septum, at least a portion of the housing comprising radiopaque material | The accused PowerPort products include a housing with a "Unique radiopaque identifier." | ¶80 | col. 4:60-67 |
| the housing further comprising X-ray discernable indicia to identify an attribute of the access port assembly | The indicia allegedly serve to identify the port and its attributes, such as being a power-injectable device. | ¶76, ¶77 | col. 2:1-6 |
| wherein the X-ray discernable indicia are cut outs formed through at least a portion of the radiopaque material | The accused products' radiopaque identifiers feature "Cut-Outs," as illustrated in multiple product images. | ¶80, ¶81 | col. 4:55-59 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis may focus on the meaning of "cut outs formed through." The question for the court will be whether the voids in the accused products' identifiers, such as the letters "CT", constitute "cut outs" that are "formed through" the radiopaque material as required by the claim language.
- Technical Questions: Evidence will be required to establish the precise manufacturing process and final structure of the accused identifiers. A dispute could arise over whether the voids are full perforations or merely surface-level depressions, and if that distinction is material to the claim construction of "formed through."
V. Key Claim Terms for Construction
Term from ’329 Patent: "embedded into a thickness of the bottom wall"
- The Term: "embedded into a thickness of the bottom wall"
- Context and Importance: Practitioners may focus on this term because its construction is critical to distinguishing the scope of the ’329 Patent from the other asserted patents, which claim "cut outs." The infringement case for this patent will depend on whether the defendant's single product design can be read to meet this specific structural limitation.
- 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" (’329 Patent, col. 2:11-14). Plaintiff may argue this supports a construction where being placed in a recess on the surface qualifies as "embedded."
- Evidence for a Narrower Interpretation: An embodiment shows a disc "insert molded embedded within the bottom wall of the base," which is depicted as being fully enclosed by the housing material (’329 Patent, col. 2:48-49; Fig. 12). Defendants may argue this embodiment defines "embedded" as requiring complete encapsulation within the material of the wall.
Term from ’842 Patent: "cut outs formed through at least a portion of the radiopaque material"
- The Term: "cut outs formed through at least a portion of the radiopaque material"
- Context and Importance: This term defines the core inventive concept of the ’842 Patent. The infringement analysis will turn on whether the accused products' features, which the complaint labels as "Cut-Outs" Compl. ¶80, meet the specific requirements of being "cut outs" that are "formed through" the radiopaque component.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The abstract states that indicia can be "depicted as cutouts through a disc of radiopaque material" (’842 Patent, Abstract). A plaintiff could argue that this supports a broad functional definition where any manufactured void that creates X-ray contrast qualifies as a "cut out."
- Evidence for a Narrower Interpretation: The phrase "formed through" could be interpreted to require complete perforation of the radiopaque material. The patent figures illustrate this concept with a disc having clear apertures (’842 Patent, Fig. 8). A defendant could argue that mere indentations or depressions that do not fully penetrate the material would not infringe.
VI. Other Allegations
- Indirect Infringement: The complaint alleges Defendants induce infringement of all three patents by providing product literature and instructions that direct medical professionals to use an X-ray imaging procedure to identify the PowerPort and its attributes, thereby causing them to perform the claimed functions Compl. ¶¶ 78, 101, 111, 121
- Willful Infringement: Willfulness is alleged for all asserted patents. The complaint bases this on claims of pre-suit actual knowledge, alleging that Defendants had "analyzed" the patents prior to the lawsuit, and on continued infringement post-filing, which constitutes notice Compl. ¶¶ 89-91, 95-97, 107, 117, 127
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "embedded into a thickness" from the ’329 Patent be construed to read on the same physical structure that is also alleged to be a "cut out" under the ’842 and ’137 Patents? The outcome will likely depend on whether the court views these claim limitations as describing overlapping or mutually exclusive technologies.
- A second key question will be one of factual interpretation: does the specific manufacturing and construction of the accused PowerPort identifiers meet the precise technical requirements of the asserted claims? This will require an evidentiary deep-dive into whether the indicia are truly "embedded," whether the voids are "cut outs formed through" the material, or whether the design constitutes a non-infringing alternative.
- Finally, a significant procedural question will be inter-entity liability: the complaint dedicates substantial attention to the roles of the various Becton Dickinson corporate defendants Compl. ¶¶ 22-32 The court may need to untangle the corporate structure to determine which entity, if any, is legally responsible for the alleged acts of making, using, selling, and inducing infringement of the accused products in the United States.
Analysis metadata