DCT
1:24-cv-00296
Starone IP Group Ltd v. Cardinal Health Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Starone Intellectual Property Group Ltd. (Canada)
- Defendant: Cardinal Health Inc. (Ohio)
- Plaintiff’s Counsel: Bochner PLLC
- Case Identification: 1:24-cv-00296, S.D. Ohio, 05/22/2024
- Venue Allegations: Venue is alleged to be proper in the Southern District of Ohio because Defendant is an Ohio corporation that resides in the district and has a regular and established place of business there.
- Core Dispute: Plaintiff alleges that Defendant’s "BiopSafe" biopsy sample systems infringe a patent related to dispensing closures for containers.
- Technical Context: The technology involves container caps designed to keep two or more substances separate until a user intentionally activates a mechanism to mix them, a feature valuable in medical, pharmaceutical, and chemical applications.
- Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patent-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2003-09-09 | ’774 Patent Priority Date |
| 2009-01-13 | ’774 Patent Issue Date |
| 2024-05-22 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,475,774 - "Dispensing Closure"
The Invention Explained
- Problem Addressed: The patent describes prior art dispensing closures as being relatively complicated and expensive to manufacture, sometimes requiring the assembly of three or more separate parts, or being susceptible to accidental actuation (Patent, col. 1:52-67; col. 2:6-12).
- The Patented Solution: The invention is a closure for a container that houses a substance in a sealed internal compartment. This compartment is defined by side walls, a top wall, and a "frangible" (breakable) bottom wall. The closure includes a "cutting means" that, when activated by a user (e.g., by rotating the cap), moves relative to the compartment and breaks open the frangible bottom wall, selectively releasing the compartment's contents into the main container (Patent, Abstract; col. 2:32-45; Fig. 1-2).
- Technical Importance: The design aims to provide a simple, reliable, and easy-to-use device for storing and selectively mixing components where on-demand combination is necessary, such as dispensing pharmaceuticals into a liquid or mixing chemicals (Patent, col. 1:31-46).
Key Claims at a Glance
- The complaint asserts independent claim 1 ('774 Patent, col. 10:16-37).
- The essential elements of independent claim 1 include:
- A body with an outer wall to secure the closure to a container neck.
- A compartment to hold a product, defined by a cylindrical side wall, a fixed top wall, and a frangible bottom wall.
- A cutting means that is moveable relative to the compartment walls to break open the frangible bottom wall.
- A shoulder to restrict inadvertent relative movement of the cutting means, with the components assembled before the closure is applied to the container neck.
- The complaint notes that Plaintiff may assert infringement of other claims of the ’774 Patent (Compl. ¶13).
III. The Accused Instrumentality
Product Identification
- The "BiopSafe" product line, including the "BiopSafe® Formalin Safety Container 20ml" and "BiopSafe® Formalin Safety Container 60ml" (collectively, the "Accused Products") (Compl. ¶11).
Functionality and Market Context
- The Accused Products are described as biopsy sample systems (Compl. ¶2). Based on the complaint's allegations and visual evidence, the products consist of a container and a cap that stores formalin in a sealed compartment. To preserve a collected biopsy sample, a user activates the cap, which releases the formalin into the main container (Compl. ¶19). An image in the complaint depicts this activation with the caption "Press of the thumb and the formalin is released," suggesting an axial force mechanism (Compl. p. 5).
IV. Analysis of Infringement Allegations
U.S. Patent No. 7,475,774 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a body having an outer wall portion adapted to engage an outer surface of the container neck to releasably secure said closure to the container; | The Accused Products include a body with an outer wall portion that engages the container neck to secure the closure, as depicted in an annotated product image. | ¶17 | col. 4:63-67 |
| a compartment to contain at least one product to be dispensed, said compartment being adapted to fit at least partly within the container neck and being defined by a substantially cylindrical side wall, a top wall fixed to said side wall, and a frangible bottom wall; | The Accused Products include a compartment for holding a product (e.g., formalin), which fits within the container neck and is defined by a cylindrical side wall, top wall, and a breakable bottom wall. | ¶18 | col. 4:56-59 |
| a cutting means moveable relative to said side wall and said frangible bottom wall to break open said frangible bottom wall of said compartment to selectively dispense contents of said compartment into the container; | The Accused Products are alleged to have a "cutting means" that is moveable relative to the compartment walls to break the frangible bottom wall and dispense the contents. A cross-section image shows this internal cutting feature. | ¶19 | col. 2:41-45 |
| and a shoulder for restricting inadvertent relative movement of said cutting means, said closure and product to be dispensed being assembled together prior to application of the closure to the container neck. | The Accused Products are alleged to include a shoulder that restricts inadvertent movement of the cutting means, with the closure being pre-assembled. This is supported by a cross-section image showing the purported shoulder. | ¶20 | col. 9:1-7 |
Identified Points of Contention
- Scope Questions: The complaint's visual evidence suggests the accused product is activated by a "Press of the thumb," implying axial movement (Compl. p. 5). Many embodiments in the ’774 Patent describe a rotational activation mechanism (e.g., '774 Patent, col. 5:35-39). This raises the question of whether the claim term "moveable relative", as used in the patent, can be construed to read on the apparent axial actuation of the accused product. The patent does disclose embodiments with axial movement, which may support the plaintiff's position ('774 Patent, col. 7:48-56).
- Technical Questions: The complaint alleges the existence of a "shoulder for restricting inadvertent relative movement" and provides a cross-section image (Compl. ¶20, p. 6). A key factual dispute may arise over whether the identified structure in the accused product actually performs this specific function as claimed, particularly the function of restricting movement prior to application of the closure to the container.
V. Key Claim Terms for Construction
The Term: "cutting means"
- Context and Importance: This term defines the core mechanism of the invention. Its construction will be critical in determining whether the specific structure within the Accused Products, apparently activated by axial pressure, infringes the claim.
- Intrinsic Evidence for a Broader Interpretation: The patent defines the term functionally as "cutting means moveable relative to the side wall and the bottom wall to break open the frangible bottom wall" ('774 Patent, col. 2:41-43). This language is not explicitly limited to a particular structure or mode of activation (e.g., rotational vs. axial).
- Intrinsic Evidence for a Narrower Interpretation: The first and most detailed embodiment describes the "cutting means" as a "cutting blade 31" on a flange that operates via relative rotation of the components ('774 Patent, col. 5:12-15; col. 5:35-39). A party could argue that the term's meaning is informed by these prominent examples.
The Term: "shoulder for restricting inadvertent relative movement"
- Context and Importance: This limitation appears directed at a safety or usability feature to prevent premature activation. Practitioners may focus on this term because the plaintiff must prove that the structure identified in the accused product (Compl. p. 6) meets this functional requirement.
- Intrinsic Evidence for a Broader Interpretation: The claim uses the general term "shoulder" and the patent discloses several distinct features that could arguably perform a movement-restricting function, such as the "tamper evident tab 32a" which prevents "inadvertent relative rotation" ('774 Patent, col. 9:1-7) or "shoulder 41" which restricts "relative rotation of the blade carrier" ('774 Patent, col. 6:55-58). This suggests the inventor contemplated various structures for this purpose.
- Intrinsic Evidence for a Narrower Interpretation: The patent also describes a specific "shoulder 27" that engages a "shoulder 27a" to snap-fit the main components together ('774 Patent, col. 5:5-9). A party could argue that this is the intended structure for the term "shoulder" in the context of pre-application assembly.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), asserting that Defendant provides "instructions or information to explain how to use the Accused Products in an infringing manner" through promotional materials and videos (Compl. ¶24). The complaint also pleads contributory infringement under § 271(c) (Compl. ¶25).
- Willful Infringement: Willfulness is alleged based on Defendant’s knowledge of the ’774 Patent "at least as of the filing of this Complaint" (Compl. ¶30). This allegation appears to be asserted to support potential enhanced damages for any post-suit infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope: can the term "moveable relative," which is described in the patent’s primary embodiment in the context of rotational activation, be construed to cover the apparent axial "press of the thumb" actuation mechanism of the accused BiopSafe product?
- A key evidentiary question will be one of factual correspondence: does the internal structure identified by Plaintiff as a "shoulder" in the accused product (Compl. p. 6) actually perform the specific claimed function of "restricting inadvertent relative movement" of the cutting mechanism before the cap is applied to the container, or is there a mismatch in its structure or function?