DCT

1:26-cv-00546

PureWick Corp v. Medline Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00546, D. Del., 07/24/2026
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware based on the Defendants' state of incorporation or formation. For Medline Industries, LP, venue is additionally alleged based on its purported regular and established place of business within the state and acts of infringement committed there.
  • Core Dispute: Plaintiff alleges that Defendants' external catheters and associated urine management systems infringe eight U.S. patents related to non-invasive urine collection technology for incontinent individuals.
  • Technical Context: The technology resides in the medical device sector, offering a non-invasive alternative to indwelling catheters or bedpans for managing urinary incontinence, with a stated goal of reducing catheter-associated urinary tract infections and skin damage.
  • Key Procedural History: The complaint alleges that U.S. Patent Nos. 10,226,376 and 10,390,989 were previously litigated against a third party (Sage Products, LLC), resulting in a jury verdict finding the patents valid and infringed. The complaint also asserts that Defendants had pre-suit knowledge of the patents through various means, including a prior diligence investigation into Plaintiff's patent portfolio, being served with a subpoena in the Sage litigation, and citing the patents-in-suit in their own patent prosecution via Information Disclosure Statements.

Case Timeline

Date Event
2014-03-19 Priority Date for '376, '989, and '765 Patents
2014-11-20 Priority Date for '962 Patent
2014-11-25 Priority Date for '183 Patent
2018-05-01 Priority Date for '053 and '579 Patents
2019-03-12 '376 Patent Issued
2019-08-12 Plaintiff asserts '376 Patent against Sage Products, LLC
2019-08-27 '989 Patent Issued
2019-10-02 Plaintiff asserts '989 Patent in amended complaint against Sage Products, LLC
2020-01-03 Priority Date for '190 Patent
2020-06-18 Medline files patent application related to Versette
2020-06-19 Medline files IDS citing '376 and '989 Patents
2021-03-01 (approx.) Medline introduces the Accused "Versette" Product
2021-06-18 CM Technologies files IDS citing '376 and '989 Patents
2021-08-17 '183 Patent Issued
2022-04-01 Jury finds '376 and '989 Patents valid and infringed in Sage litigation
2022-12-15 Medline Industries, LP served with subpoena in Sage litigation
2024-03-26 '053 Patent Issued
2024-04-01 (approx.) Medline signs agreement to sell QiVi Male and QiVi Female
2024-12-10 '579 Patent Issued
2025-01-14 '962 Patent Issued
2025-06-01 (approx.) Medline begins selling the Accused "AUM" Product
2025-06-10 '765 Patent Issued
2025-07-08 '190 Patent Issued
2026-07-24 First Amended Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,226,376 - "Apparatus And Methods For Receiving Discharged Urine"

  • Patent Identification: U.S. Patent No. 10,226,376, "Apparatus And Methods For Receiving Discharged Urine", Issued March 12, 2019 Compl. ¶32

The Invention Explained

  • Problem Addressed: The patent's background describes the challenges individuals with impaired mobility face with urination, noting that conventional solutions like urinary catheters can be uncomfortable and lead to infections, while bed pans are prone to spills and hygiene issues '376 Patent, col. 1:55-2:16
  • The Patented Solution: The invention is a non-invasive external urine collection system. It comprises a fluid impermeable casing that defines a reservoir and an opening, a permeable membrane over a permeable support to wick fluid away from the user and into the reservoir, and a tube connected to a vacuum source to withdraw the collected urine from the device '376 Patent, abstract '376 Patent, col. 2:24-46
  • Technical Importance: The technology provided a non-invasive and comfortable method for managing incontinence, particularly for female patients, aiming to reduce the risk of catheter-associated infections and skin breakdown '376 Patent, col. 2:17-21

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claim 8 (Compl. ¶¶65; Compl. ¶82).
  • Independent Claim 1 includes these essential elements:
    • An apparatus comprising: a fluid impermeable casing with a fluid reservoir, a fluid outlet, and a longitudinally extending fluid impermeable layer defining an elongated opening.
    • A fluid permeable support within the casing extending across the opening.
    • A fluid permeable membrane on the support covering the opening.
    • A tube with one end in the reservoir and extending through the outlet to a discharge end.
    • The apparatus is configured to be disposed adjacent to a user's urethra to receive urine through the layers into the reservoir and have it withdrawn via the tube.

U.S. Patent No. 10,390,989 - "Apparatus And Methods For Receiving Discharged Urine"

  • Patent Identification: U.S. Patent No. 10,390,989, "Apparatus And Methods For Receiving Discharged Urine", Issued August 27, 2019 Compl. ¶33

The Invention Explained

  • Problem Addressed: Similar to the '376 Patent, the background addresses the shortcomings of urinary catheters and bed pans for bedridden or mobility-impaired patients, highlighting the need for a comfortable and hygienic alternative '989 Patent, col. 2:1-15
  • The Patented Solution: This patent claims a method of using a urine collection apparatus. The method involves disposing the apparatus in an "operative relationship" with a female user's urethra, allowing discharged urine to be received through the device's permeable layers into a reservoir, and allowing the collected urine to be withdrawn from the reservoir via a tube '989 Patent, abstract '989 Patent, col. 2:54-3:2
  • Technical Importance: By claiming the method of use, the patent protects the specific way the corresponding physical device is intended to be applied to achieve its therapeutic and hygienic benefits.

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claim 2 Compl. ¶93 Compl. ¶110
  • Independent Claim 1 is a method claim with these essential steps:
    • Disposing a specific urine collecting apparatus (comprising an impermeable casing, permeable support, permeable membrane, and a tube) in operative relationship with a female user's urethral opening.
    • Allowing urine to be received through the apparatus's layers into the reservoir.
    • Allowing the received urine to be withdrawn from the reservoir via the tube.

U.S. Patent No. 11,090,183 - "Container For Collecting Liquid For Transport"

  • Patent Identification: U.S. Patent No. 11,090,183, "Container For Collecting Liquid For Transport", Issued August 17, 2021 Compl. ¶34
  • Technology Synopsis: The patent describes a container for liquid collection that includes a "moisture-wicking material" and a "web of flexible porous material" that define a chamber for receiving liquid drawn through the materials via a partial vacuum '183 Patent, abstract The invention focuses on the internal structure for wicking and transporting fluid within the device.
  • Asserted Claims: The complaint asserts at least independent claim 1 Compl. ¶121
  • Accused Features: The complaint alleges that the "Versette" product infringes the '183 patent Compl. ¶120

U.S. Patent No. 11,938,053 - "Fluid Collection Devices, Systems, And Methods"

  • Patent Identification: U.S. Patent No. 11,938,053, "Fluid Collection Devices, Systems, And Methods", Issued March 26, 2024 Compl. ¶35
  • Technology Synopsis: This patent claims a method for collecting fluid by positioning a device with a fluid-impermeable barrier adjacent to a user's urethra, securing the device with at least one flange, and receiving fluid into a chamber '053 Patent, abstract The invention centers on the use of flanges for securing the device to the user.
  • Asserted Claims: The complaint asserts at least independent method claim 15 and dependent claim 19 (Compl. ¶¶189; Compl. ¶201).
  • Accused Features: The complaint alleges that the "QiVi Male and QiVi Female" products infringe the '053 patent Compl. ¶188

U.S. Patent No. 12,161,579 - "Apparatus And Methods For Receiving Discharged Urine"

  • Patent Identification: U.S. Patent No. 12,161,579, "Apparatus And Methods For Receiving Discharged Urine", Issued December 10, 2024 Compl. ¶36
  • Technology Synopsis: The patent describes a fluid collection device having a "fluid barrier" that defines a "sump" in its interior region. The device includes two tubes with open ends disposed in the sump to receive fluid, with the structure designed to create a space between the opening and the distal end of the device '579 Patent, abstract
  • Asserted Claims: The complaint asserts at least independent claim 1 Compl. ¶212
  • Accused Features: The complaint alleges that the "QiVi Male and QiVi Female" products infringe the '579 patent Compl. ¶211

U.S. Patent No. 12,193,962 - "Using Wicking Material To Collect Liquid For Transport"

  • Patent Identification: U.S. Patent No. 12,193,962, "Using Wicking Material To Collect Liquid For Transport", Issued January 14, 2025 Compl. ¶37
  • Technology Synopsis: This patent covers a liquid collection system comprising a flexible shell that defines a chamber and a "window opening." A "wicking article" with a porous material and a convex region is positioned to be exposed through this window, with the entire assembly configured to be curved '962 Patent, abstract
  • Asserted Claims: The complaint asserts at least independent claim 1 Compl. ¶145
  • Accused Features: The complaint alleges that the "Versette" product infringes the '962 patent Compl. ¶144

U.S. Patent No. 12,324,765 - "Apparatus And Methods For Receiving Discharged Urine"

  • Patent Identification: U.S. Patent No. 12,324,765, "Apparatus And Methods For Receiving Discharged Urine", Issued June 10, 2025 Compl. ¶38
  • Technology Synopsis: This invention is a fluid collection device featuring an "elongated member configured to adjust to a nonlinear configuration" to maintain the device's shape when applied to the body. The device also includes a fluid-permeable membrane and an internal, distinct elongated tube for fluid removal '765 Patent, abstract
  • Asserted Claims: The complaint asserts at least independent claim 1 Compl. ¶166
  • Accused Features: The complaint alleges that the "Versette" product infringes the '765 patent Compl. ¶165

U.S. Patent No. 12,350,190 - "Urine Collection Devices Having a Relatively Wide Portion And An Elongated Portion and Related Methods"

  • Patent Identification: U.S. Patent No. 12,350,190, "Urine Collection Devices Having a Relatively Wide Portion And An Elongated Portion and Related Methods", Issued July 8, 2025 Compl. ¶39
  • Technology Synopsis: The patent describes a urine collection device with a "receptacle sized to receive a head of a penis" and a fluid-permeable body to wick fluid away. A key feature is a fluid-impermeable barrier with an elongated portion that is equal to or longer than a second portion defining the fluid aperture '190 Patent, abstract
  • Asserted Claims: The complaint asserts at least independent claim 17 Compl. ¶233
  • Accused Features: The complaint alleges that the "QiVi Male" product infringes the '190 patent Compl. ¶232

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the Versette External Catheter ("Versette"), the QiVi Male External Catheter ("QiVi Male"), the QiVi Female External Catheter ("QiVi Female"), and the Medline Automated Urine Management Device ("AUM") Compl. ¶1

Functionality and Market Context

  • The complaint describes the accused products as a system for non-invasive management of urinary incontinence (Compl. ¶¶41; Compl. ¶46; Compl. ¶52). The Versette, QiVi Male, and QiVi Female are external catheters designed to be placed against the user's body to collect urine (Compl. ¶¶46; Compl. ¶50; Compl. ¶59). The AUM is a portable suction pump and collection canister designed to work with external catheters, explicitly including the Versette and QiVi products, to withdraw the collected urine Compl. ¶¶60-62
  • The complaint provides images from instructional videos demonstrating the application and use of these products. For the Versette, this includes "Flat," "Folded," and "Hybrid" application methods to accommodate different patient anatomies Compl. ¶43 An image from Medline's instructional video shows these different configurations for the Versette product Compl. p. 10 The QiVi Male is shown being applied to a mannequin's penal shaft Compl. p. 12 The QiVi Female is shown as a device with a "flexible frame" and adhesive for placement Compl. p. 14 The AUM is depicted as a canister with a base and tubing to connect to a catheter Compl. p. 16
  • The complaint positions the Defendants as direct competitors who have introduced these products to compete with Plaintiff's own PureWick line of devices Compl. ¶75

IV. Analysis of Infringement Allegations

'376 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An apparatus comprising: a fluid impermeable casing having a fluid reservoir at a first end, a fluid outlet at a second end, and a longitudinally extending fluid impermeable layer coupled to the fluid reservoir and the fluid outlet The Versette and QiVi Female are alleged to be apparatuses that include a fluid impermeable casing structure with a reservoir and outlet. ¶66 col. 36:9-13
[the layer] defin[es] a longitudinally elongated opening between the fluid reservoir and the fluid outlet The longitudinally extending layer of the accused products is alleged to define an elongated opening. ¶67 col. 36:13-15
a fluid permeable support disposed within the casing with a portion extending across the elongated opening, wherein the fluid permeable support is distinct from and at least proximate to the fluid reservoir The accused products allegedly include a fluid permeable support (e.g., internal wicking material) within their casings. ¶68 col. 36:16-19
a fluid permeable membrane disposed on the support and covering at least the portion of the support that extends across the elongated opening... The accused products allegedly include a fluid permeable membrane (e.g., mesh fabric) disposed on the support structure. ¶69 col. 36:20-24
a tube having a first end disposed in the reservoir and extending behind at least the portion of the support...and extending through the fluid outlet to a second, fluid discharge end The accused products allegedly contain a suction tube that extends from the reservoir area to an external outlet. ¶70 col. 36:25-29
the apparatus configured to be disposed with the opening adjacent to a urethral opening of a user, to receive urine...and to have the received urine withdrawn from the reservoir via the tube... The complaint alleges that instructional materials direct users to place the accused products against the urethra to collect urine, which is then withdrawn by the tube. ¶71 col. 36:30-36

'989 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
disposing in operative relationship with the urethral opening of a female user a urine collecting apparatus... The complaint alleges that users of the Versette and QiVi Female are instructed to place the apparatus adjacent to the urethral opening. ¶97 col. 27:45-47
wherein the urine collecting apparatus includes [a fluid impermeable casing, a fluid permeable support, a fluid permeable membrane, and a tube] The complaint alleges the Versette and QiVi Female possess the recited structural components of the apparatus. ¶¶94-96 col. 27:48-65
allowing urine discharged from the urethral opening to be received through the longitudinally elongated opening...and into the fluid reservoir The complaint alleges that when used as instructed, urine passes through the layers of the accused devices into a reservoir area. ¶98 col. 28:8-12
allowing the received urine to be withdrawn from the fluid reservoir via the tube and out of the fluid discharge end of the tube The complaint alleges the accused devices operate by withdrawing the collected urine through the suction tube. ¶99 col. 28:13-15
  • Identified Points of Contention:
    • Scope Questions: A central point of contention may be the construction of the structural elements. For the '376 patent, the analysis will question whether the multi-layer absorbent pad structures of the accused products (Compl. ¶¶44; Compl. ¶46) map to the distinct claimed elements of a "fluid permeable membrane" disposed on a "fluid permeable support" which is in turn distinct from a "fluid reservoir". The defense may argue that the accused products are an integrated wicking pad, not a combination of these separate claimed components.
    • Technical Questions: For the '989 method patent, a key question will be whether the actions instructed by Defendants' user guides and videos (Compl. ¶44; Compl. ¶45; Compl. ¶46) constitute "disposing in operative relationship" as required by the claim. The court will need to determine if the instructed placement and use align with the claimed method steps, particularly regarding the function of the alleged "reservoir" and the step of "allowing" urine to be received and then withdrawn in the claimed sequence.

V. Key Claim Terms for Construction

  • The Term: "fluid reservoir" (from Claim 1 of the '376 Patent)

  • Context and Importance: This term is critical because infringement requires the accused device to have this specific component, distinct from the permeable support and membrane. Practitioners may focus on this term because the accused products appear to be primarily wicking-and-suction devices, and Defendants may argue they lack a structure intended to "hold" or act as a "reservoir" for fluid, but rather function as a simple conduit.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification suggests the reservoir can be a very small space and can function as a "sump," implying it may not need to be a large or separate container but simply a collection point, stating it can "form a portion of a passageway for urine" '376 Patent, col. 8:5-10 This may support the Plaintiff's allegation that the internal collection area of the accused devices constitutes a reservoir.
    • Evidence for a Narrower Interpretation: The patent figures, such as Figure 1, depict the Reservoir 110 as a distinct structural block, separate from the Permeable Support 140 '376 Patent, FIG. 1 This could support an argument that the term requires a separately identifiable component designed for fluid accumulation, not merely the internal space of a wicking pad.

  • The Term: "fluid permeable support" (from Claim 1 of the '376 Patent)

  • Context and Importance: The distinction between the "fluid permeable support" and the "fluid permeable membrane" is a cornerstone of the claim. The infringement case rests on identifying two separate corresponding components in the accused products. Practitioners may focus on this term because the accused products' multi-layer pad construction raises the question of whether it is a single integrated wicking element or two distinct components as claimed.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the support as potentially being a flexible framework, made of materials like "spun plastic," "porous glass," or even "natural... plant fibers," and its purpose is to "maintain the permeable membrane... in a particular shape" '376 Patent, col. 6:45-7:3 This could be read broadly to cover any internal layer that gives shape to an outer wicking layer.
    • Evidence for a Narrower Interpretation: The claim requires the support to be "distinct from and at least proximate to the fluid reservoir." The patent also describes embodiments where the support is a rigid plastic or includes structural "struts" '376 Patent, col. 6:59-60 '376 Patent, col. 7:11-14 This could support a narrower construction requiring a physically separate, semi-rigid structural component, which the defense may argue is absent in the accused soft pads.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is primarily based on allegations that Defendants provide detailed "Instructions for Use" and instructional videos that actively encourage and direct customers and end-users to operate the Versette, QiVi, and AUM products in a manner that directly infringes the method claims of the patents-in-suit (Compl. ¶¶74; Compl. ¶83; Compl. ¶102; Compl. ¶111). Contributory infringement is alleged on the basis that the accused products are especially made for an infringing use and are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶¶85; Compl. ¶113).
  • Willful Infringement: The complaint makes extensive allegations to support willful infringement. It alleges that Defendants had pre-suit knowledge of the patents-in-suit due to: (1) Medline's prior diligence investigation into PureWick's products and patent portfolio; (2) PureWick's successful assertion of the '376 and '989 patents in a separate litigation against Sage Products, in which Medline was served with a subpoena; and (3) Defendants' own patent prosecution history, where they cited several of the patents-in-suit in Information Disclosure Statements (Compl. ¶75; Compl. ¶76; Compl. ¶77; Compl. ¶78; Compl. ¶79; Compl. ¶80). The complaint further alleges that Defendants copied the patented technology despite this knowledge Compl. ¶89

VII. Analyst's Conclusion: Key Questions for the Case

  • A core issue will be one of structural interpretation: can the multi-component language of the apparatus claims, which requires distinct elements such as a "fluid permeable membrane," a "fluid permeable support," and a "fluid reservoir," be construed to read on the integrated, multi-layer pad design of the accused external catheters? The outcome will likely depend on whether the court views these terms as requiring physically separate components or as functional descriptions of different zones within a single wicking structure.
  • A second central question will be one of scienter and intent: given the complaint's detailed allegations of pre-suit knowledge-stemming from prior litigation, due diligence, and Defendants' own patent filings-a key focus will be whether Defendants' actions constitute willful infringement. The evidence presented regarding what Defendants knew and when they knew it will be critical in determining the potential for enhanced damages.
  • A key evidentiary question will be one of instructed use: for the asserted method claims, the analysis will turn on whether the steps detailed in Defendants' "Instructions for Use" and marketing videos for the accused products align with the specific sequence and limitations of the patented methods, thereby establishing infringement by the end-users that Defendants are alleged to have induced.
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