DCT
2:24-cv-00264
RSB Spine v. Innovasis
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: RSB Spine, LLC (Delaware)
- Defendant: Innovasis, Inc. (Utah)
- Plaintiff’s Counsel: Snell & Wilmer L.L.P.; Proskauer Rose LLP
- Case Identification: 2:24-cv-00264, D. Utah, 07/08/2024
- Venue Allegations: Venue is based on Defendant being a Utah corporation with its principal place of business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Ax® Stand-Alone ALIF System, a spinal fusion implant, infringes a patent related to a bone plate stabilization system.
- Technical Context: The technology involves medical devices used in spinal arthrodesis (fusion) surgery to stabilize vertebrae, a common procedure to treat degenerative or traumatic spinal conditions.
- Key Procedural History: The complaint notes that the patent-in-suit has a significant history of successful enforcement. This includes a $12 million jury verdict against DePuy Synthes, licensing agreements with at least four other defendants following litigation, and the survival of an inter partes review (IPR) proceeding where the Patent Trial and Appeal Board (PTAB) found all challenged claims not unpatentable. Plaintiff also alleges providing Defendant with notice of infringement as early as July 2018.
Case Timeline
| Date | Event |
|---|---|
| 2003-04-21 | '537 Patent Priority Date |
| 2006-08-01 | FDA approves Plaintiff's InterPlate™ product |
| 2017-07-25 | '537 Patent Issued |
| 2018-07-05 | Plaintiff sends first notice letter to Defendant |
| 2019-01-01 | IPR petitions filed challenging the '537 Patent |
| 2021-05-03 | Plaintiff sends second notice letter to Defendant |
| 2022-01-01 | Jury returns $12M verdict for Plaintiff against DePuy Synthes |
| 2023-11-09 | Plaintiff sends third notice letter to Defendant |
| 2024-02-12 | Dismissal of related case against Orthofix/SeaSpine after settlement |
| 2024-07-08 | Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,713,537 - "Bone Plate Stabilization System and Method For Its Use," issued July 25, 2017
The Invention Explained
- Problem Addressed: The patent describes challenges with prior spinal fixation devices, including stress shielding (where an overly rigid implant prevents bone from experiencing the stress needed for fusion), implant migration, screw backout, and insecure fixation that can lead to collapse of the bone graft and damage to surrounding tissues. (’537 Patent, col. 2:31-49).
- The Patented Solution: The invention is a low-profile bone plate system designed to be placed on the anterior surface of the spine, specifically configured to fit "primarily between" the bony protrusions (lip osteophytes) of adjacent vertebrae. (’537 Patent, Abstract). By anchoring screws at an angle into the strong cortical bone of the osteophytes and allowing for controlled micromotion, the system aims to provide secure fixation while permitting the necessary settling and load-sharing for bone to fuse properly. (’537 Patent, col. 11:46-53; col. 12:3-12).
- Technical Importance: This design attempts to balance the competing needs for rigid stability and controlled micromotion, addressing known failure modes of earlier anterior spinal plates. (’537 Patent, col. 2:15-24).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 21, and dependent claim 14. (Compl. ¶44).
- Independent Claim 1: Essential elements include:
- A base plate configured to fit primarily between the lip osteophytes of adjacent vertebral bones.
- A plurality of bone screws.
- Screw holes configured to direct screws at an angle, with one opening toward the side surface of a vertebra and another opening toward the lip osteophyte of a second vertebra.
- Independent Claim 21: Essential elements include:
- A base plate system for anchoring between side surfaces of adjacent vertebrae.
- The base plate is configured to fit primarily between the lip osteophytes of the adjacent vertebrae.
- The plate has first and second ends, each with a bone screw hole and an "uninterrupted" bone engaging region.
- Bone screws extend from the top surface of the plate to the side surface of the respective bones.
III. The Accused Instrumentality
- Product Identification: The Ax® Stand-Alone ALIF (Anterior Lumbar Interbody Fusion) System. (Compl. ¶40).
- Functionality and Market Context:
- The Accused Product is an intervertebral body fusion device, also known as a cage, which is implanted within the disc space between two vertebrae to restore height and facilitate fusion. (Compl. ¶41).
- It consists of a body made of PEEK-OPTIMA (a polymer) integrated with osteoconductive hydroxyapatite, and a titanium faceplate that holds the bone screws. (Compl. ¶41). The complaint includes an illustration of the device showing its cage-like structure and angled screws. (Compl. ¶40). This illustration depicts various views of the Ax® Stand-Alone ALIF System, highlighting its components, dimensions, and how screws are inserted at an angle. (Compl. ¶40).
IV. Analysis of Infringement Allegations
U.S. Patent No. 9,713,537 Infringement Allegations (Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a base plate having a top surface, first and second ends, a bottom surface, and a plurality of bone screw holes, wherein the base plate is configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes to bear weight... | The Accused Product is a bone stabilization system with a base plate (the titanium faceplate) having a top surface, bottom surface, and multiple screw holes. | ¶47, ¶48 | col. 8:33-38 |
| a plurality of bone screws configured to fit in the plurality of bone screw holes, respectively; | The Accused Product has multiple bone screws designed to fit in its multiple screw holes. | ¶49 | col. 9:40-44 |
| wherein a first of the bone screw holes... extends at least partially from the top surface of the base plate and opens at least partially toward the side surface of a first of the vertebral bones; | The Accused Product has a first screw hole configured to receive a screw that extends from the top surface and opens toward the side surface of a vertebra. | ¶50 | col. 10:10-24 |
| wherein a second of the bone screw holes... extends at least partially from the top surface of the base plate and opens at least partially toward the lip osteophyte of a second of the vertebral bones; | The Accused Product has a second screw hole configured to receive a screw that extends from the top surface and opens toward a lip osteophyte of a vertebra. | ¶51 | col. 10:25-34 |
| wherein each and every one of the plurality of bone screw holes is configured to receive one of the bone screws angled relative to the base plate and oriented generally in an anterior-posterior direction... | The Accused Product has screw holes configured to receive screws that are angled relative to the base plate and oriented in an anterior-posterior direction. | ¶52 | col. 9:53-65 |
U.S. Patent No. 9,713,537 Infringement Allegations (Claim 21)
| Claim Element (from Independent Claim 21) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a base plate having a top surface, a first end nearer the first bone comprising a first bone screw hole extending at least partially therethrough and a first bone engaging region fully extending uninterrupted between lateral extents of the first end, a second end nearer the second bone comprising a second bone screw hole extending at least partially therethrough, and a bottom surface, and configured to fit primarily between an anterior portion of the first bone's lip osteophyte and an anterior portion of the second bone's lip osteophyte while bearing weight... | The Accused Product has a base plate with a top surface, bottom surface, first and second ends with screw holes, and is designed to fit between vertebral bones. | ¶61, ¶62 | col. 9:66-col. 11:7 |
| a first bone screw configured to secure the base plate to the first bone by insertion through the first bone screw hole and to extend from at least partially the top surface of the base plate to at least partially the side surface of the first bone, and a second bone screw configured to secure the base plate to the second bone by insertion through the second bone screw hole and to extend from at least partially the top surface of the base plate to at least partially the side surface of the second bone. | The Accused Product uses first and second bone screws inserted through screw holes to secure the plate to first and second bones. | ¶63, ¶64 | col. 11:12-23 |
- Identified Points of Contention:
- Scope Questions: A primary question may be whether an interbody device (the Accused Product), which resides within the surgically cleared disc space, can meet the limitation of being "configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes." The patent figures depict an on-lay plate that appears to sit on the anterior surface of the vertebrae, which may suggest a different location and function than an interbody cage.
- Technical Questions: The infringement allegation identifies the "titanium faceplate" of the accused ALIF cage as the claimed "base plate." (Compl. ¶48). A potential dispute is whether this component, which is affixed to a larger PEEK cage, constitutes the "base plate" as described and claimed in the patent, or if the patent's "base plate" is described as the primary, self-contained structural element of the system.
V. Key Claim Terms for Construction
The Term: "base plate"
- Context and Importance: The plaintiff's infringement theory depends on construing the titanium faceplate of the accused interbody cage as the "base plate." The definition will be critical, as the accused product's main structural body is a PEEK cage, not the titanium plate.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not explicitly limit the material or composition of the base plate, stating it "may be made of any suitable material." (’537 Patent, col. 8:40-42). Plaintiff may argue that any component that serves to hold the screws and interface with the bone qualifies.
- Evidence for a Narrower Interpretation: The patent consistently depicts the "base plate 20" as the unitary, primary structural component of the invention, including integral lateral tabs and angled members. (’537 Patent, FIG. 1-4; col. 8:33-38). This may support an argument that a mere faceplate on a separate structural cage is not what the patent describes.
The Term: "configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes"
- Context and Importance: This limitation defines the unique positioning and function of the invention. The case may turn on whether the accused interbody cage, which sits inside the disc space, meets this locational requirement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Plaintiff may argue that because an interbody cage occupies the space which is anatomically between the vertebrae, it inherently fits "between" their anterior portions, including the osteophytes.
- Evidence for a Narrower Interpretation: The patent’s abstract, figures, and description emphasize a device placed on the front of the spine that specifically engages the lip osteophytes, which are bony growths on the edge of the vertebral body. (’537 Patent, Abstract; FIG. 3; col. 11:46-53). This could be interpreted to mean an external plate, distinct from an internal cage that replaces the disc itself.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement through Defendant's marketing, distribution, instruction manuals, and training provided to surgeons and other end users. (Compl. ¶¶66-67).
- Willful Infringement: The willfulness claim is based on alleged pre-suit knowledge of the patent and infringement. The complaint alleges that Plaintiff sent a notice letter with a preliminary claim chart to Defendant on July 5, 2018, and sent two subsequent letters, but Defendant was unwilling to engage in licensing discussions. (Compl. ¶¶33-39, 71).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: Can the term "base plate," as described in a patent for an on-lay fixation device, be construed to read on the titanium "faceplate" of an interbody cage, where the primary structural component is the PEEK cage itself?
- A central conflict will be one of locational and functional interpretation: Does the accused ALIF cage, an interbody device designed to sit within the prepared disc space, meet the claim requirement of being "configured to fit primarily between... lip osteophytes" in the manner described by the patent, which appears to depict an on-lay plate that anchors to the anterior surface of the vertebrae?
- A key evidentiary question will concern willfulness: Given the patent's extensive and successful litigation history, including a favorable IPR outcome and a jury verdict, and the multiple alleged pre-suit notices, what evidence will demonstrate whether Defendant's continued alleged infringement was objectively reckless?