DCT
1:23-cv-05827
Medline Industries LP v. CR Bard Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Medline Industries, LP (Illinois)
- Defendant: C.R. Bard, Inc. (New Jersey)
- Plaintiff’s Counsel: KENT & RISLEY LLC; FELLOWS LABRIOLA LLP; Latham & Watkins LLP
- Case Identification: 1:23-cv-05827, N.D. Ga., 12/18/2023
- Venue Allegations: Plaintiff alleges venue is proper in the Northern District of Georgia because Defendant maintains a place of business in Covington, Georgia, where it conducts substantial business related to the Accused Products, including design, development, engineering, sterilization, marketing, and distribution.
- Core Dispute: Plaintiff alleges that Defendant’s SureStep™ Foley Catheter trays infringe three U.S. patents related to the design and packaging of medical procedure kits.
- Technical Context: The technology concerns sterile, single-use kits for urinary catheterization, with a focus on compartmentalized tray designs that organize components to improve procedural workflow and reduce the risk of contamination.
- Key Procedural History: The complaint states this is the fifth patent infringement action filed by Medline against Bard concerning related technology since 2014. It also alleges that Bard was on notice of the patent applications that matured into the Asserted Patents as early as October 2021, through disclosures in an inter partes review proceeding involving the parties.
Case Timeline
| Date | Event |
|---|---|
| 2009-06-03 | Priority Date for ’219, ’220, and ’347 Patents |
| 2014-05-16 | First of five related lawsuits filed by Medline against Bard |
| 2014 | Accused SureStep™ Products Launched |
| 2021-10-21 | Bard allegedly received notice of patent applications in IPR |
| 2023-05-30 | U.S. Patent No. 11,661,219 Issued |
| 2023-05-30 | U.S. Patent No. 11,661,220 Issued |
| 2023-06-27 | U.S. Patent No. 11,684,347 Issued |
| 2023-12-18 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,661,219 - "Catheter Tray, Packaging System, Instruction Insert, and Associated Methods"
- Patent Identification: U.S. Patent No. 11,661,219, entitled "Catheter Tray, Packaging System, Instruction Insert, and Associated Methods," issued May 30, 2023 (’219 Patent). (Compl. ¶19).
The Invention Explained
- Problem Addressed: The patent’s background describes traditional packaging for catheters as being prone to damage during shipment, occupying large amounts of storage and sterile workspace, and creating opportunities for contamination during deployment. (’219 Patent, col. 2:6-24).
- The Patented Solution: The invention is a medical procedure kit centered on a single-layer tray with multiple compartments. This design organizes a coiled catheter assembly and its associated procedural devices (e.g., syringes, lubricant) to facilitate a more effective and simpler deployment. A key feature is a compartment that is also configured to function as a lubricating jelly applicator, allowing a user to lubricate the catheter without removing it entirely from the tray. (’219 Patent, Abstract; col. 4:43-54).
- Technical Importance: This integrated tray design aims to improve the efficiency of the catheterization procedure and reduce the risk of catheter-associated infections by ordering components for intuitive use and minimizing handling.
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶27).
- Essential elements of Claim 1 include:
- A medical procedure kit, comprising:
- a single layer tray comprising a compartment separated by a wall from a lubricating jelly application chamber;
- a container of lubricating jelly disposed within the single layer tray;
- a coiled tubing coupled between a Foley catheter and a drain bag, disposed within the kit;
- wherein the lubricating jelly application chamber is configured to receive the jelly for lubricating the catheter;
- the container of lubricating jelly comprising a syringe; and
- the syringe situated within the lubricating jelly application chamber.
- The complaint alleges infringement of "one or more claims," reserving the right to assert others. (Compl. ¶27).
U.S. Patent No. 11,661,220 - "Catheter Tray, Packaging System, Instruction Insert, and Associated Methods"
- Patent Identification: U.S. Patent No. 11,661,220, entitled "Catheter Tray, Packaging System, Instruction Insert, and Associated Methods," issued May 30, 2023 (’220 Patent). (Compl. ¶21).
The Invention Explained
- Problem Addressed: The patent addresses the same problems as the ’219 Patent: bulky, inefficient, and contamination-prone packaging for catheter kits. (’220 Patent, col. 2:6-24).
- The Patented Solution: This invention claims a complete medical procedure kit that includes not only the single-layer compartmentalized tray but also "at least one layer of wrap material" enclosing the tray and "an outer packaging" disposed around both. The wrap material can be unfolded by a healthcare provider to create a sterile field on which the procedure is performed. (’220 Patent, Abstract; col. 10:50-67).
- Technical Importance: The claimed combination of a functionally organized tray with integrated sterile wrap provides a comprehensive system for delivering and deploying catheterization tools while maintaining sterility.
Key Claims at a Glance
- The complaint asserts independent claim 8. (Compl. ¶48).
- Essential elements of Claim 8 include:
- A medical procedure kit, comprising:
- a single layer tray with a first compartment defining a lubricating jelly application chamber and a second compartment separated by a wall;
- a container of lubricating jelly in the tray;
- a coiled tubing coupled between a fluid drain bag and a Foley catheter, disposed within the kit;
- at least one layer of wrap material enclosing the tray within one or more folds;
- an outer packaging disposed about the tray and wrap material; and
- wherein the lubricating jelly application chamber is configured to receive jelly for lubricating the catheter.
- The complaint alleges infringement of "one or more claims," reserving the right to assert others. (Compl. ¶48).
U.S. Patent No. 11,684,347 - "Catheter Tray, Packaging System, Instruction Insert, and Associated Methods"
- Patent Identification: U.S. Patent No. 11,684,347, entitled "Catheter Tray, Packaging System, Instruction Insert, and Associated Methods," issued June 27, 2023 (’347 Patent). (Compl. ¶23).
- Technology Synopsis: This patent claims a medical kit having a single-layer tray with a specific spatial arrangement: a first compartment for receiving syringes and a second, adjacent compartment for receiving a medical assembly (e.g., a catheter). This compartmentalization is intended to organize components by type and function to facilitate an orderly procedure. (’347 Patent, Abstract).
- Asserted Claims: The complaint asserts independent claim 1. (Compl. ¶70).
- Accused Features: The complaint accuses Bard's trays of infringing by providing a single-layer tray with a first compartment containing two syringes (one with water, one with lubricating jelly) and a second, adjacent compartment containing the catheter assembly, separated by a barrier. (Compl. ¶¶72-76).
III. The Accused Instrumentality
Product Identification
- Defendant C.R. Bard, Inc.’s SureStep™ Foley Catheter trays ("Accused Products"). (Compl. ¶3).
Functionality and Market Context
- The Accused Products are described as competing catheterization kits designed for use in Foley catheter insertion. (Compl. ¶¶3, 28). The complaint alleges, through text and annotated photographs, that the kits contain a single-layer tray with distinct compartments, a syringe containing lubricating jelly, a second syringe containing water, a coiled Foley catheter assembly with a drain bag, wrap material, and an outer package. (Compl. ¶¶29-31, 53-54, 72-75). An annotated image of the accused tray shows text stating "DISPENSE LUBE" printed within a compartment, which the complaint alleges constitutes a "lubricating jelly application chamber." (Compl. ¶32).
IV. Analysis of Infringement Allegations
’219 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a single layer tray comprising a compartment separated by a wall from a lubricating jelly application chamber | The Accused Products allegedly include a single layer tray with a compartment separated by a wall from a distinct lubricating jelly chamber. The complaint provides an image identifying these features. (Compl. p. 7). | ¶29 | col. 5:21-27 |
| a container of lubricating jelly disposed within the single layer tray | The Accused Products allegedly include a syringe containing lubricating jelly placed within the tray. | ¶30 | col. 6:4-6 |
| a coiled tubing coupled between a Foley catheter and a drain bag...disposed within the medical procedure kit | The kit allegedly includes a coiled tubing, drain bag, and Foley catheter, as shown in an annotated photograph. (Compl. p. 8). | ¶31 | col. 9:35-40 |
| wherein the lubricating jelly application chamber is configured to receive lubricating jelly...for lubricating...the Foley catheter | The tray in the Accused Products is allegedly configured for this purpose, evidenced by the printed text "DISPENSE LUBE" on the bottom of the chamber. | ¶32 | col. 4:43-54 |
| the container of lubricating jelly comprising a syringe containing the lubricating jelly | The lubricating jelly is allegedly supplied in a syringe. | ¶33 | col. 9:6-7 |
| the syringe situated within the lubricating jelly application chamber | The syringe of lubricating jelly is allegedly positioned within the boundaries of the application chamber, as depicted in an annotated photograph. (Compl. p. 10). | ¶34 | col. 6:3-7 |
- Identified Points of Contention:
- Scope Questions: A potential issue is the scope of "lubricating jelly application chamber." The defense may argue this term requires a specific structure that facilitates the application of jelly, whereas the complaint's allegation relies on a general compartment with printed text to show it is "configured" for this purpose (Compl. ¶32).
- Technical Questions: The dispute may turn on the meaning of "situated within." The complaint's visual evidence shows the syringe resting across a portion of the area identified as the application chamber (Compl. p. 10). A question for the court will be whether this placement meets the "within" limitation, or if the term requires the object to be fully contained inside the chamber's vertical boundaries.
’220 Patent Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a single layer tray comprising a first compartment defining a lubricating jelly application chamber and a second compartment separated from the first compartment by a wall | The Accused Products are alleged to have a single layer tray with a first compartment (lubricating chamber) separated by a wall from a second compartment. | ¶50 | col. 5:21-27 |
| a container of lubricating jelly disposed within the single layer tray | The Accused Products allegedly include a syringe containing lubricating jelly disposed within the tray. | ¶51 | col. 6:4-6 |
| a coiled tubing coupled between a fluid drain bag and a Foley catheter | The kit allegedly includes a coiled tubing, fluid drain bag, and Foley catheter. | ¶52 | col. 9:35-40 |
| at least one layer of wrap material enclosing the single layer tray within one or more folds of the at least one layer of wrap material | The Accused Products allegedly include wrap material that encloses the tray using folds, as depicted in an annotated photograph. (Compl. p. 18). | ¶53 | col. 10:50-54 |
| an outer packaging disposed about both the single layer tray and the at least one layer of wrap material | The Accused Products allegedly have an outer packaging around both the tray and the wrap material. | ¶54 | col. 10:50-57 |
| wherein...the lubricating jelly application chamber is configured to receive lubricating jelly...for lubricating...the Foley catheter | The tray is allegedly configured for this purpose, as evidenced by printed text inside the chamber. | ¶56 | col. 4:43-54 |
- Identified Points of Contention:
- Scope Questions: A central point of contention may be the construction of "enclosing...within one or more folds." The parties may dispute whether the manner in which the wrap material is packaged around the accused tray constitutes "enclosing" via "folds" as contemplated by the patent.
- Technical Questions: As with the ’219 Patent, the analysis raises the question of what specific features are required for a compartment to be "configured to receive lubricating jelly for lubricating" the catheter, beyond simply being a space where jelly can be placed.
V. Key Claim Terms for Construction
The Term: "lubricating jelly application chamber" (’219 Patent, Claim 1; ’220 Patent, Claim 8)
Context and Importance: This term is central to the asserted claims of both lead patents. The dispute will likely focus on whether this limitation requires a specific structure that enables a particular method of lubrication (e.g., passing the catheter through it), or if it can be read more broadly to cover any compartment designated for holding lubricant. Practitioners may focus on this term because the complaint relies on printed text on the tray ("DISPENSE LUBE") as evidence of its function. (Compl. ¶¶32, 56).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims themselves describe the chamber as being "configured to receive" jelly, which could be interpreted broadly as simply being designed to hold it. (’219 Patent, col. 28:1-4).
- Evidence for a Narrower Interpretation: The specification describes an embodiment where the chamber is not just a passive receptacle, but part of an active process: "a medical services provider then passes the catheter from another compartment through an opening in a barrier... into the lubricating jelly." (’219 Patent, col. 4:48-53). This could support a narrower construction requiring a structure that facilitates this pass-through application method.
The Term: "situated within" (’219 Patent, Claim 1)
Context and Importance: The infringement allegation for this term relies on a photograph where the accused syringe appears to rest across, rather than being fully contained in, the designated chamber. (Compl. p. 10). The definition of "situated within" is therefore critical to determining infringement of this element.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not appear to provide an explicit definition of the term, which may support giving it a plain and ordinary meaning that does not strictly require full containment.
- Evidence for a Narrower Interpretation: The patent's figures, such as Figure 8, depict syringes (701, 702) resting fully inside the boundaries of their compartment (101). A party could argue that these embodiments limit the scope of "within" to require that the object be substantially contained by the chamber's walls. (’219 Patent, Fig. 8).
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement based on Defendant's instructions and marketing materials, which allegedly encourage and instruct clinicians to use the Accused Products in an infringing manner. (Compl. ¶¶35, 37, 57, 59). A website is cited stating the products were "designed to help provide a consistent step-by-step process... by displaying the recommended steps directly on the tray." (Compl. ¶37).
- Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged pre-suit knowledge of the patent applications dating back to at least October 21, 2021, via an IPR proceeding, as well as through Plaintiff's patent marking website. (Compl. ¶¶36, 58, 78). The complaint further supports its willfulness claim by referencing the extensive litigation history between the parties, noting this is the fifth such lawsuit since 2014. (Compl. ¶¶42, 64, 84).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional scope: can the term "lubricating jelly application chamber," which the patent specification links to a specific method of applying lubricant, be construed to cover a general-purpose compartment in the accused tray that simply bears the printed instruction "DISPENSE LUBE"?
- A key factual question will be one of physical positioning: does the accused product's syringe, which rests across a region of the tray, satisfy the claim requirement of being "situated within" that region, or does the term require a greater degree of containment?
- A central question for damages will be one of culpability: given the extensive litigation history between the parties and the alleged notice provided during prior administrative patent challenges, was Bard’s alleged infringement willful from the moment the patents-in-suit issued, potentially justifying enhanced damages?