DCT
1:18-cv-00666
TriMed Inc v. Arthrex Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: TriMed, Inc. (California)
- Defendant: Arthrex, Inc. (Delaware)
- Plaintiff’s Counsel: Connolly Gallagher LLP
- Case Identification: 1:18-cv-00666, D. Del., 07/26/2018
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant, Arthrex, Inc., is a Delaware corporation.
- Core Dispute: Plaintiff alleges that Defendant’s orthopedic plating systems for the wrist, foot, and ankle infringe two patents related to contoured bone plates featuring hook members for fixing small bone fragments.
- Technical Context: The technology concerns orthopedic implants used in surgery to repair bone fractures, particularly those near a joint (e.g., wrist, ankle) where a small fragment of bone makes traditional screw-based fixation challenging.
- Key Procedural History: The operative pleading is a Second Amended Complaint. The complaint alleges that Plaintiff marks its own products with the patent numbers-in-suit, which may be relevant to issues of notice and damages.
Case Timeline
| Date | Event |
|---|---|
| 2008-05-05 | Earliest Priority Date for ’822 and ’010 Patents |
| 2012-05-15 | U.S. Patent No. 8,177,822 Issues |
| 2016-03-15 | U.S. Patent No. 9,283,010 Issues |
| 2018-07-26 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,283,010 - “Contoured Bone Plate For Fracture Fixation Having Hook Members and Holder/Impactor For Same,” issued March 15, 2016 (’010 Patent)
The Invention Explained
- Problem Addressed: The patent identifies the difficulty of achieving stable fixation for bone fractures that create a small terminal fragment, such as at the wrist or ankle, where there is insufficient bone to accommodate traditional screws ('010 Patent, col. 1:37-44). Previous hook plate designs were often flat and would not sit flush against the naturally flared ends of bones, leading to incomplete seating and poor stability ('010 Patent, col. 2:12-18).
- The Patented Solution: The patent describes a bone plate with an elongated, contoured body designed to match the surface of a specific bone, like the distal radius ('010 Patent, col. 5:58-63). The plate features hook members with sharpened tips and edges, which are designed to be impacted directly into bone "like a nail or staple" without the need to first drill pilot holes ('010 Patent, col. 7:1-6). This combination of a contoured fit and impactable hooks aims to provide rigid subchondral support to the bone fragment.
- Technical Importance: This approach seeks to simplify the surgical procedure and enhance fixation stability for challenging fractures by eliminating the pre-drilling step and ensuring the implant conforms closely to the bone’s anatomy. ('010 Patent, col. 5:2-6).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2 and 4-11 (Compl. ¶17).
- Independent Claim 1 requires:
- An elongated body with a first end, a second end, and a contoured region.
- First and second hook members near the first end, each with a prong region.
- At least one hook member being sharpened at its distal tip and along a longitudinal edge.
- The sharpened surfaces permitting the hook member to be impacted through a cortical bone region "without drilling a pilot hole."
U.S. Patent No. 8,177,822 - “Contoured Bone Plate For Fracture Fixation Having Hook Members And Drill Guide For Same,” issued May 15, 2012 (’822 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the challenge of accurately placing hooks for a bone plate into a small bone fragment. It notes that achieving the correct depth and trajectory for the hooks is difficult, and reliance on manual pressure can result in the hooks failing to penetrate the bone properly, leading to "less than satisfactory engagement and fixation" ('822 Patent, col. 2:7-14).
- The Patented Solution: The invention is a "combination" of a bone plate and a "multiple barreled drill guide" ('822 Patent, Abstract). The drill guide is an instrument that is temporarily placed on the bone to direct a drill bit, ensuring that the resulting pilot holes are parallel and precisely located for the plate’s hooks. This system is designed to ensure the plate seats "flush against a bone" and achieves "full engagement of the small terminal fragment" ('822 Patent, col. 2:26-30). The drill guide itself has features like a positioning member to rest on the bone and sleeves to guide the drill bit ('822 Patent, Fig. 5).
- Technical Importance: The system aims to transform the placement of hook plates from a freehand technique into a more precise, guided procedure, thereby increasing the reliability and effectiveness of the fixation. ('822 Patent, col. 2:40-43).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 2 (Compl. ¶37).
- Independent Claim 1 is a combination claim requiring:
- A bone plate with a first region (for the main bone) and a second region with hook-shaped projections (to wrap around the bone fragment).
- A multiple-barreled drill guide comprising a body, at least two parallel sleeves, and an elongated positioning member.
- The geometric relationship between the drill guide's sleeves and its positioning member having a "predetermined value" such that using it to drill holes for the plate's hooks "results in coaptation" (contact/juncture) of the plate against the bone.
III. The Accused Instrumentality
Product Identification
The complaint accuses Arthrex's "Wrist Plating System," "5th Metatarsal Fracture System," and "Ankle Fracture Management System" (collectively, "Infringing Systems") (Compl. ¶8). For the ’822 Patent, the allegations are limited to the Wrist Plating System, which is alleged to include both hook plates and a drill guide (Compl. ¶31-32).
Functionality and Market Context
The accused products are orthopedic implants used to fix fractures of the wrist, foot, and ankle (Compl. ¶9-11). The complaint alleges that the hook plates are impacted into bone to secure fragments (Compl. ¶17). An accompanying Arthrex drill guide is alleged to facilitate the drilling of holes for the plate's hooks (Compl. ¶32, ¶34). A visual from the complaint shows the accused drill guide with two parallel barrels to guide a drill bit (Compl. Ex. D, p. 2). Plaintiff alleges that it and Defendant are direct competitors and that the accused products are "nearly identical" to its own patented systems (Compl. ¶22, ¶24).
IV. Analysis of Infringement Allegations
’010 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an elongated body having a first end, a second end, a top surface, a bottom surface, and a contoured region disposed between the first end and the second end, the contoured region having a longitudinal axis; | The accused hook plate has an elongated body with two ends, a contoured region, and top and bottom surfaces designed to fit against bone. This is depicted in a visual of the accused plate alone. (Compl. Ex. B, p. 1). | ¶17 | col. 5:10-24 |
| first and second hook members disposed proximate the first end, each of the first and second hook members having a prong region having a longitudinal axis; | The accused plate has two hooks at one end, each with a prong region. | ¶17 | col. 5:35-47 |
| at least one of the hook members having a distal tip and at least one longitudinal edge... and being sharpened at both the distal tip and along the longitudinal edge to create cutting surfaces... | The accused hooks have a tip and a longitudinal edge that are sharpened to form cutting surfaces. | ¶17 | col. 7:1-6 |
| ...permitting the hook member to be impacted through a cortical bone region without drilling a pilot hole into the cortical bone region for receipt of the hook member into the cortical bone region. | The sharpened hooks permit impaction into bone without pre-drilling. The complaint alleges that a video on Defendant's website shows this occurring. A complaint visual shows the hooks impacted into a wrist bone. (Compl. Ex. B, p. 5). | ¶17 | col. 7:1-17 |
- Identified Points of Contention:
- Technical Question: The central infringement question is factual and functional: do the accused Arthrex hook plates actually operate "without drilling a pilot hole" as required by the claim? The complaint's reference to an online video (Compl. ¶17) suggests this will be a key piece of evidence. The court will need to determine if the accused products' design and instructed use meet this negative limitation, or if some form of surface preparation or drilling is standard practice.
- Scope Question: Claim 1 is directed to "a bone plate for fixing a bone fracture." The complaint accuses systems for the wrist, ankle, and foot (Compl. ¶8). A potential issue for the court is whether the claim, which is exemplified in the patent with reference to the distal radius (wrist) and lateral malleolus (ankle), can be interpreted to cover fixation of other bones like the metatarsal.
’822 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A combination of a bone plate for fixing fractures of a bone... and drill guide... | The accused "Wrist Plating System" includes Arthrex’s volar hook plate and a drill guide. A visual shows the accused plate secured to the bone. (Compl. Ex. D, p. 4). | ¶37 | col. 11:49-53 |
| a bone plate having a first region configured for placement adjacent an outer surface of a bone and a second region configured to wrap around a terminal endpoint of the bone... | The accused bone plate has a portion that lies on the outer surface of the bone and a second portion with hooks that wraps around the end of the bone. | ¶37 | col. 5:7-22 |
| a multiple barreled drill guide facilitating drilling of at least two parallel holes at a distal end of the bone... comprising: a body; at least two sleeves... an elongated positioning member... | The accused drill guide has a body, two parallel barrels (sleeves) extending upwardly, and a flat positioning member that lies against the bone. A visual shows the accused drill guide with these features. (Compl. Ex. D, p. 2). | ¶37 | col. 8:6-34; col. 8:61-63 |
| wherein a distance between each distal tip of the at least two sleeves and the positioning member has a predetermined value such that insertion of the projections of the bone plate into the parallel holes results in coaptation of the first region of the bone plate on the outer surface of the bone; | The geometry of the accused drill guide is such that when holes are drilled and the plate’s hooks are inserted, the plate is positioned against the outer surface of the bone. | ¶37 | col. 12:1-8 |
- Identified Points of Contention:
- Scope Question: Claim 1 is for a "combination" of a plate and a drill guide. A primary legal question will be whether Arthrex directly infringes by making, using, or selling this combination. The analysis will depend on whether the accused plate and drill guide are sold together as a single product or kit (Compl. ¶32), or if they are separate products that are only combined by the end-user surgeon, which could raise questions of indirect infringement.
- Technical Question: The claim requires that the drill guide's geometry has a "predetermined value" that "results in coaptation" of the plate on the bone. This is a functional limitation. The court will have to determine whether the accused system is in fact designed to achieve this specific result, or if this outcome is merely an incidental possibility of using the two components together.
V. Key Claim Terms for Construction
For the ’010 Patent:
- The Term: "without drilling a pilot hole"
- Context and Importance: This negative limitation is the core technical distinction alleged for the '010 patent and is central to the infringement theory. Practitioners may focus on this term because its definition will determine whether any form of bone preparation short of creating a full pilot hole falls outside the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., prohibiting any hole creation): The patent states the hooks can be "impacted like a nail or staple" ('010 Patent, col. 7:3-4), which implies direct entry into unprepared bone. The abstract also notes the hooks are sharpened to "facilitate their impaction... without the need to pre-drill pilot holes."
- Evidence for a Narrower Interpretation (i.e., allowing some preparation): A defendant might argue that in the context of orthopedic surgery, "drilling a pilot hole" is a term of art that does not preclude using an awl or other sharp instrument to create a starting point. However, the '010 patent specification does not appear to provide explicit support for this distinction, focusing instead on the ability to directly impact the hooks.
For the ’822 Patent:
- The Term: "coaptation"
- Context and Importance: This term defines the required functional outcome of using the claimed drill guide and plate combination. The infringement case hinges on whether the accused system achieves this result. Practitioners may focus on this term because its required degree of "fit" or "contact" is undefined in the claim itself.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., general contact): The patent's figures, such as Figure 10, show the plate simply lying adjacent to the bone surface, which could support a plain-meaning interpretation of coaptation as bringing two surfaces together.
- Evidence for a Narrower Interpretation (i.e., a specific, snug fit): Dependent claim 2 specifies that the plate is directed "down to seat snugly against the bone surface" ('822 Patent, col. 12:11-12). The specification also describes the invention as providing a plate that can be "seated flush against a bone" ('822 Patent, col. 2:26-27). This language may support an argument that "coaptation" requires more than simple contact, but rather a precise, flush, and snug fit.
VI. Other Allegations
- Indirect Infringement: While the complaint focuses on direct infringement, the prayer for relief for the ’010 Patent seeks to enjoin Defendant from "inducing others to infringe" (Compl. p. 11, ¶(b)). The factual basis for this may be the allegation that Defendant's website includes a video demonstrating the infringing procedure, which could be construed as instruction that encourages infringement by others (Compl. ¶17).
- Willful Infringement: The complaint alleges willful infringement for both patents (Compl. ¶27, ¶47). The allegations are based on pre-suit knowledge, asserting that Defendant knew of Plaintiff's patented products and began selling "nearly identical" systems after Plaintiff had already launched and marked its products with the patent numbers (Compl. ¶23-26, ¶43-46).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question for the ’010 patent will be one of technical operation: does the Defendant’s promotional material and the actual surgical use of its hook plates demonstrate impaction "without drilling a pilot hole" as claimed, or is some form of bone preparation a necessary or standard step that places the accused method outside the literal scope of the claim?
- A key issue for the ’822 patent will be one of infringement liability: does the Defendant sell the accused bone plate and drill guide together as a single "combination" or kit, making it liable for direct infringement, or are they sold as separate components, shifting the analysis to whether the Defendant's marketing and instructions make it liable for inducing infringement by surgeons?
- A dispositive claim construction question for the ’822 patent will be the definitional scope of "coaptation." Will the court construe this term to mean any general contact between the plate and bone, or will it require a more precise, "snug" fit, as suggested by language in the patent's specification, raising the evidentiary bar for the Plaintiff to prove infringement?