DCT
1:20-cv-03981
Medline Industries LP v. CR Bard Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Medline Industries, Inc. (Illinois)
- Defendant: C.R. Bard, Inc. (New Jersey)
- Plaintiff’s Counsel: Kent & Risley LLC; Sidley Austin LLP
- Case Identification: 1:20-cv-03981, N.D. Ga., 09/25/2020
- Venue Allegations: Plaintiff alleges venue is proper in the Northern District of Georgia because Defendant’s division, Bard Medical Division, is headquartered in Covington, Georgia. Activities related to the accused product, including design, development, engineering, sales, distribution, and sterilization, are alleged to occur at this "regular and established place of business."
- Core Dispute: Plaintiff alleges that Defendant’s method of using its "Current SureStep Foley Kit" infringes a patent related to methods for using a catheter package assembly to reduce infection risk.
- Technical Context: The technology concerns sterile packaging and procedural methods for urinary catheter kits, designed to minimize the risk of Catheter-Associated Urinary Tract Infections (CAUTIs) by improving aseptic technique during catheterization.
- Key Procedural History: The complaint details extensive prior litigation between the parties. A prior case, Medline I, involves the same patent-in-suit but is limited to an earlier version of the accused product ("Original SureStep Foley Kit"). Notably, Defendant previously challenged the patent-in-suit in an inter partes review (IPR) proceeding, but the Patent Trial and Appeal Board (PTAB) denied institution, finding Defendant had not established a reasonable likelihood that the claims were invalid.
Case Timeline
| Date | Event |
|---|---|
| 2009-06-30 | '786 Patent Priority Date |
| 2009 | Plaintiff launches its ERASE CAUTI tray |
| 2013-05-28 | U.S. Patent No. 8,448,786 ('786 Patent) Issues |
| 2014 | Defendant launches "Original SureStep Foley Kit" |
| 2014-05-16 | Plaintiff files Medline I litigation against Defendant |
| 2014-12-30 | Defendant files IPR petition against the '786 Patent |
| 2015-07-15 | PTAB denies institution of Defendant's IPR |
| 2016 (Early) | Defendant launches "Current SureStep Foley Kit" |
| 2020-09-25 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,448,786 - "Catheter Tray, Packaging System, Instruction Insert, and Associated Methods"
- Patent Identification: U.S. Patent No. 8448786, "Catheter Tray, Packaging System, Instruction Insert, and Associated Methods," issued May 28, 2013.
The Invention Explained
- Problem Addressed: The patent describes that conventional packaging for medical devices like catheters, particularly multi-level kits, made it difficult for healthcare providers to maintain a sterile procedure, increasing the risk of contamination and patient infection (Compl. ¶25; ’786 Patent, col. 1:46-55). Catheter-Associated Urinary Tract Infections (CAUTIs) were a significant and costly problem in hospitals (Compl. ¶¶20-21).
- The Patented Solution: The invention is a method of using a catheter package assembly that includes a wrap material, such as a Central Sterile Reprocessing (CSR) wrap. The method involves unfolding the wrap to create a sterile field on which the procedure can be performed, including placing a layer of the wrap beneath the patient to transform a non-sterile area (like a hospital bed) into part of the sterile field (’786 Patent, col. 26:21-26; Fig. 32). This integrated approach is intended to simplify the process and reduce opportunities for contamination (Compl. ¶26).
- Technical Importance: This method provided a systematic way to establish and maintain a sterile field using the product's own packaging, directly addressing a procedural weakness linked to a high incidence of hospital-acquired infections (Compl. ¶¶23, 26).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 2 (Compl. ¶¶47-48, 56).
- Independent Claim 1 of the ’786 Patent contains the following essential elements:
- A method of using a catheter package assembly, comprising:
- opening a thermally sealed bag disposed about a tray having a catheter assembly disposed therein;
- accessing an instruction manual;
- unfolding one or more layers of wrap to reveal an additional layer of wrap and the catheter assembly; and
- placing one of the one or more layers of wrap or the additional layer of wrap beneath a patient, thereby transforming an area beneath the patient from a non-sterile field to a sterile field.
III. The Accused Instrumentality
Product Identification
- The "Current SureStep Foley Kit" and its associated "Directions for Use" (Compl. ¶¶56, 69).
Functionality and Market Context
- The accused product is a single-layer Foley catheter kit sold for use by healthcare providers (Compl. ¶¶34, 66). The kit is provided in a thermally sealed bag and contains a tray with a catheter assembly, an instruction manual, and one or more layers of wrap (Compl. ¶¶73, 75, 76, 78).
- The complaint alleges that the product's "Directions for Use" instruct healthcare providers to perform the patented method, including unfolding the wrap and placing a layer of wrap (identified in the instructions as an "underpad") beneath the patient to create a sterile field (Compl. ¶¶81-82). The complaint alleges millions of the accused kits have been sold since early 2016 (Compl. ¶83).
IV. Analysis of Infringement Allegations
’786 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| opening a thermally sealed bag disposed about a tray having a catheter assembly disposed therein; | The accused kit is provided in a "Thermally Sealed Bag" containing a tray and catheter assembly, which users are intended to open. The complaint provides a photo of the accused product highlighting this bag. (Compl. p. 20). | ¶¶73-75 | col. 11:18-20 |
| accessing an instruction manual; | The accused kit includes an instruction manual titled "Directions for use," which Bard intends for users to access. The complaint includes a photo of these instructions. (Compl. p. 21). | ¶¶76-77 | col. 10:34-36 |
| unfolding one or more layers of wrap to reveal an additional layer of wrap and the catheter assembly; | The kit's tray is enclosed in layers of wrap, and the instructions direct the user to "open CSR wrap," which reveals the catheter assembly and an additional wrap layer. The complaint includes photos of the wrapped tray and the instruction to unfold it. (Compl. pp. 22-24). | ¶¶78-80 | col. 26:12-14 |
| and placing one of the one or more layers of wrap or the additional layer of wrap beneath a patient, thereby transforming an area beneath the patient from a non-sterile field to a sterile field. | The "Directions for Use" instruct the user to "Place underpad beneath patient," which the complaint alleges is the placement of a layer of wrap to transform a non-sterile area into a sterile field. The complaint provides a photo from the instructions showing this step. (Compl. p. 25). | ¶¶81-82 | col. 26:21-26 |
Identified Points of Contention
- Scope Questions: A central dispute may arise over whether the "underpad" in the accused kit constitutes an "additional layer of wrap" as recited in the claim. The defense may argue that an "underpad" is distinct from the "CSR wrap" primarily discussed in the patent, while the plaintiff may point to specification language describing an "additional layer of wrap material" that can be used as an "Underbuttocks Drape" (’786 Patent, Fig. 38) as evidence that the claim term is broad enough to cover the accused feature.
- Technical Questions: The final claim step requires "transforming an area beneath the patient from a non-sterile field to a sterile field." This raises the evidentiary question of whether the use of the accused kit's "underpad" actually achieves this claimed function. The analysis may depend on evidence regarding the sterility of the "underpad" as supplied and the standard hospital procedures for preparing a patient area.
V. Key Claim Terms for Construction
The Term
- "additional layer of wrap"
Context and Importance
- The infringement allegation for the final method step hinges on this term reading on the "underpad" included in the accused kit (Compl. ¶81). The construction of this term—whether it is limited to materials like the primary packaging wrap or broadly covers various sterile drapes—is therefore critical to the infringement analysis.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification discloses an "additional layer of wrap material (2701)" that "can be a fenestrated wrap" and can be used as an "Underbuttocks Drape," suggesting the term is not limited to a single type of material (’786 Patent, col. 14:47-50, Fig. 38).
- Evidence for a Narrower Interpretation: The patent's primary embodiment focuses on "CSR wrap" for the wrapping material (’786 Patent, col. 13:21-23). A party could argue that an "additional layer of wrap" must therefore be a material of the same class as the primary CSR wrap, and that a simple "underpad" may not qualify.
VI. Other Allegations
Indirect Infringement
- The complaint alleges both induced and contributory infringement. The inducement theory is based on allegations that Defendant provides the accused kits with "Directions for Use" that specifically instruct and encourage healthcare providers to perform the patented method (Compl. ¶¶69-71, 84). The contributory infringement theory alleges the kit is a material part of the invention, is not a staple article of commerce, and has no substantial non-infringing use (Compl. ¶¶86-89).
Willful Infringement
- Willfulness is alleged based on Defendant's purported knowledge of the ’786 Patent dating back to at least the filing of the Medline I litigation on May 16, 2014 (Compl. ¶57). The complaint further cites Defendant's receipt of infringement contentions in that prior case and its own unsuccessful IPR petition as evidence of knowledge and a lack of a good faith belief in non-infringement or invalidity when it launched the currently accused product (Compl. ¶¶58, 60, 63).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "additional layer of wrap," which the patent links to both primary packaging material and patient drapes, be construed to cover the specific "underpad" included and referenced in the instructions for the accused kit? The outcome of this claim construction dispute may be dispositive.
- A key evidentiary question will be one of functional performance: does the directed use of the accused kit, specifically the step of placing the "underpad" beneath the patient, in fact achieve the claimed function of "transforming an area beneath the patient from a non-sterile field to a sterile field"? The resolution will likely depend on factual testimony and evidence regarding clinical practice and the properties of the accused product's components.
- Finally, given the extensive litigation history and the unsuccessful IPR cited in the complaint, a central question will be one of intent: if infringement is found, did the Defendant act willfully? The court will have to weigh the detailed history of notice alleged by the Plaintiff against any good-faith defenses presented by the Defendant.