DCT

1:21-cv-01445

Globus Medical Inc v. Life Spine Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-01445, D. Del., 05/10/2022
  • Venue Allegations: Venue is asserted in the District of Delaware on the basis that Defendant is a Delaware corporation and therefore resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s PROLIFT and Dyna-Link lines of expandable spinal implants infringe eight U.S. patents related to expandable intervertebral fusion devices and associated surgical methods.
  • Technical Context: The technology involves orthopedic implants used in spinal fusion surgery that are inserted between vertebrae in a compressed state and then expanded in situ to restore disc height and facilitate bone growth.
  • Key Procedural History: This Second Amended Complaint follows prior pleadings in the case. The complaint alleges extensive pre-suit knowledge by Defendant, including multiple instances where Defendant cited the patents-in-suit as prior art during the prosecution of its own patent applications. Subsequent to the filing of this complaint, Inter Partes Review (IPR) proceedings at the Patent Trial and Appeal Board resulted in the cancellation of all asserted claims for U.S. Patent Nos. 9,956,087; 10,137,001; 10,925,752; and 10,973,649, as well as the cancellation of asserted claim 1 of U.S. Patent No. 8,845,732. These IPR outcomes may significantly narrow the scope of the present litigation.

Case Timeline

Date Event
2010-09-03 Priority Date for ’731, ’732, ’001, ’752, ’649 Patents
2014-02-07 Priority Date for ’739 Patent
2014-09-03 Priority Date for ’128 Patent
2014-09-30 U.S. Patent No. 8,845,731 Issues
2014-09-30 U.S. Patent No. 8,845,732 Issues
2015-05-18 Defendant allegedly cites application leading to ’732 Patent in an IDS
2015-07-17 Priority Date for ’087 Patent
2016-01-01 Defendant launches initial PROLIFT implant
2016-08-02 U.S. Patent No. 9,402,739 Issues
2018-05-01 U.S. Patent No. 9,956,087 Issues
2018-11-27 U.S. Patent No. 10,137,001 Issues
2021-02-23 U.S. Patent No. 10,925,752 Issues
2021-04-13 U.S. Patent No. 10,973,649 Issues
2021-07-20 U.S. Patent No. 11,065,128 Issues
2021-12-02 Defendant allegedly cites all eight Patents-in-Suit in an IDS
2022-03-25 Plaintiff informs Defendant of alleged infringement by Dyna-Link product of the ’128 Patent
2022-05-10 Second Amended Complaint filed

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

U.S. Patent No. 8,845,731 - “Expandable Fusion Device and Method of Installation Thereof”

  • Patent Identification: U.S. Patent No. 8,845,731, titled “Expandable Fusion Device and Method of Installation Thereof,” issued September 30, 2014.

The Invention Explained

  • Problem Addressed: The patent describes drawbacks with conventional, fixed-height spinal fusion devices, which often require surgeons to distract vertebral bodies to a height greater than the implant itself, making installation difficult and potentially traumatic. (’731 Patent, col. 1:47-57).
  • The Patented Solution: The invention is an expandable fusion device that can be inserted into the intervertebral space in a smaller, unexpanded state and then expanded after placement. (’731 Patent, col. 2:1-9). The expansion is achieved via a mechanism involving a "central ramp" and a "driving ramp" that interact to push the device's upper and lower endplates apart. (’731 Patent, col. 7:40-66).
  • Technical Importance: This technology facilitates minimally invasive surgical approaches by allowing a larger final implant height to be achieved through a smaller insertion profile, reducing trauma to surrounding tissues and bone. (Compl. ¶10).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶87).
  • Claim 1 is a method claim comprising the essential steps of:
    • Providing an expandable implant having a first endplate, a second endplate, a central ramp, and a driving ramp.
    • Moving the driving ramp in a first direction with respect to the central ramp.
    • Causing the first and second endplates to move outwardly into an expanded configuration.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,845,732 - “Expandable Fusion Device and Method of Installation Thereof”

  • Patent Identification: U.S. Patent No. 8,845,732, titled “Expandable Fusion Device and Method of Installation Thereof,” issued September 30, 2014.

The Invention Explained

  • Problem Addressed: As a continuation-in-part of the '731 Patent's application, this patent addresses the same technical challenge of installing intervertebral spacers without excessive distraction or force. (’732 Patent, col. 1:45-55).
  • The Patented Solution: The patent discloses an expandable fusion device comprising first and second endplates, a central ramp, and a driving ramp. (’732 Patent, Abstract). The driving ramp is moved relative to the central ramp, causing ramped surfaces on the components to engage and push the endplates apart, thereby expanding the implant's height. (’732 Patent, col. 8:39-66).
  • Technical Importance: The solution provides a mechanical means for in situ expansion, which is central to modern minimally invasive spinal fusion techniques. (Compl. ¶10).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶97).
  • Claim 1 is a device claim for an intervertebral implant comprising the essential elements of:
    • A first endplate and a second endplate.
    • A central ramp positioned between the endplates, having first and second ramped portions.
    • A driving ramp positioned between the endplates, having upper and lower ramped surfaces configured to engage the endplates.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,402,739 - “Variable Lordosis Spacer and Related Methods of Use”

  • Patent Identification: U.S. Patent No. 9,402,739, titled “Variable Lordosis Spacer and Related Methods of Use,” issued August 2, 2016.
  • Technology Synopsis: This patent describes an expandable fusion device with a "variable lordosis" capability. It uses a wedge-shaped ramp system that can have inclines along both the longitudinal and lateral axes, allowing for customized angular correction (lordosis) upon expansion. (’739 Patent, Abstract).
  • Asserted Claims: At least independent claim 1. (Compl. ¶108).
  • Accused Features: The complaint accuses the PROLIFT Lateral product of infringement, suggesting the alleged point of novelty is the device's suitability for lateral approaches and its expansion characteristics. (Compl. ¶109).

U.S. Patent No. 9,956,087 - “Intervertebral Spacer and Plate”

  • Patent Identification: U.S. Patent No. 9,956,087, titled “Intervertebral Spacer and Plate,” issued May 1, 2018.
  • Technology Synopsis: This patent discloses a vertebral fusion device that combines an interbody spacer with a fixation member or plate. The fixation member can be movably coupled to the spacer, allowing its position to be adjusted before being secured to the vertebrae, which accommodates varying patient anatomy. (’087 Patent, col. 10:1-8).
  • Asserted Claims: At least independent claim 1. (Compl. ¶119).
  • Accused Features: The complaint accuses the PROLIFT Lateral Fixated product, which features integrated fixation elements, suggesting the combination of an expandable spacer with fixation is the basis of the allegation. (Compl. ¶120).

U.S. Patent No. 10,137,001 - “Expandable Fusion Device and Method of Installation Thereof”

  • Patent Identification: U.S. Patent No. 10,137,001, titled “Expandable Fusion Device and Method of Installation Thereof,” issued November 27, 2018.
  • Technology Synopsis: This patent describes an expandable fusion device for minimally invasive insertion, deployable through an endoscopic tube. The invention comprises endplates and a central ramp, where movement of the central ramp expands the device. (’001 Patent, Abstract). The claims focus on a surgical method involving this type of implant. (’001 Patent, col. 23:3-62).
  • Asserted Claims: At least independent claim 1. (Compl. ¶130).
  • Accused Features: The complaint alleges that surgeons are induced to infringe by using the Accused Methods with the Accused Products, implicating the entire PROLIFT line. (Compl. ¶130).

U.S. Patent No. 10,925,752 - “Expandable Fusion Device and Method of Installation Thereof”

  • Patent Identification: U.S. Patent No. 10,925,752, titled “Expandable Fusion Device and Method of Installation Thereof,” issued February 23, 2021.
  • Technology Synopsis: This patent discloses an expandable fusion device composed of endplates, a central ramp, a driving ramp, and an actuator. The claims detail a specific arrangement where the actuator is rotationally coupled to the driving ramp and threadingly engaged with the central ramp to drive expansion. (’752 Patent, Abstract; col. 21:47-67).
  • Asserted Claims: At least independent claim 1. (Compl. ¶140).
  • Accused Features: The complaint accuses the PROLIFT product line, focusing on the mechanical structure of the actuator and ramp system that causes expansion. (Compl. ¶141).

U.S. Patent No. 10,973,649 - “Expandable Fusion Device and Method of Installation Thereof”

  • Patent Identification: U.S. Patent No. 10,973,649, titled “Expandable Fusion Device and Method of Installation Thereof,” issued April 13, 2021.
  • Technology Synopsis: This patent describes an expandable implant system with interlocking endplates and multiple ramp structures. The claims focus on a configuration where the endplates have overlapping features in the collapsed state and are moved apart by the interaction of a central ramp and a driving ramp. (’649 Patent, col. 32:56-65; col. 33:1-40).
  • Asserted Claims: At least independent claim 1. (Compl. ¶150).
  • Accused Features: The complaint accuses the PROLIFT product line, focusing on the overall structural combination of interlocking endplates and multiple ramps that facilitate expansion. (Compl. ¶151).

U.S. Patent No. 11,065,128 - “Intervertebral Implants and Related Methods of Use”

  • Patent Identification: U.S. Patent No. 11,065,128, titled “Intervertebral Implants and Related Methods of Use,” issued July 20, 2021.
  • Technology Synopsis: This patent describes an intervertebral spacer with bores configured to receive either a linear fastener (like a screw) or a curvilinear fastener (like an anchor). This interchangeability provides surgeons with intraoperative flexibility to choose the best fixation method for the patient's anatomy. (’128 Patent, Abstract).
  • Asserted Claims: At least independent claim 1. (Compl. ¶160).
  • Accused Features: The complaint accuses the Dyna-Link product with "anchor fixation," suggesting infringement lies in the product's ability to use curved anchors for fixation. (Compl. ¶45, ¶161).

III. The Accused Instrumentality

Product Identification

The complaint names the "Prolift Accused Products," which include the PROLIFT, PROLIFT Lateral, PROLIFT Lateral Fixated, PROLIFT Lateral Helo, and PROLIFT Micro implants. (Compl. ¶38). It also separately names the "Dyna-Link Accused Product," described as the Dyna-Link Titanium product with "barb fixation." (Compl. ¶45).

Functionality and Market Context

The PROLIFT products are expandable intervertebral implants used for spinal fusion. (Compl. ¶33). Their core mechanism consists of two endplates connected by two wedge-shaped components, referred to as a "base ramp and nose ramp." (Compl. ¶39). An actuator assembly with a screw is turned to draw these ramps together, which in turn pushes the endplates apart to expand the implant's height. (Compl. ¶39-40). The complaint includes an image from Defendant's marketing showing the PROLIFT implant in both its compressed and expanded forms, illustrating this core functionality. (Compl. Figure 3, p. 13). The outer surfaces of the endplates are textured to grip the vertebrae, and the devices are designed to hold bone graft material. (Compl. ¶41). The complaint alleges the PROLIFT products are commercially successful, describing them as Life Spine's "top performing line of devices." (Compl. ¶48-49).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that are not provided with the pleading. Therefore, the narrative infringement theories are summarized below.

U.S. Patent No. 8,845,731 (Method Claim)

The complaint alleges infringement of at least method claim 1. (Compl. ¶87). The narrative theory is that surgeons using the PROLIFT products perform the claimed method of expansion. (Compl. ¶89). This theory relies on mapping the physical components of the PROLIFT device (endplates, "base ramp," "nose ramp") to the claimed components ("first endplate," "second endplate," "central ramp," "driving ramp") and alleging that the surgical procedure involves the claimed step of "moving the driving ramp" to cause expansion. (Compl. ¶¶ 39-40, 87). The complaint includes cross-sectional and exploded views from Defendant's own patent (U.S. Patent No. 9,801,733), which allegedly covers the PROLIFT, to illustrate the product's internal components and their interaction. (Compl. Figures 6 & 7, p. 14-15).

U.S. Patent No. 8,845,732 (Device Claim)

The complaint alleges infringement of at least apparatus claim 1. (Compl. ¶97). The narrative theory is that the PROLIFT products themselves have a physical structure that meets the limitations of the claim. (Compl. ¶97). This infringement theory depends on demonstrating that the accused product's structure of two endplates expanded by the interaction of a "base ramp and nose ramp" corresponds to the claimed structure of "a first endplate," "a second endplate," a "central ramp," and a "driving ramp" with their specified ramped surfaces. (Compl. ¶¶ 39-40, 98).

Identified Points of Contention

  • Scope Questions: A primary point of contention may be whether the terms "central ramp" and "driving ramp" in the Globus patents can be construed to read on the "base ramp and nose ramp" structure allegedly used in the PROLIFT products. The difference in terminology suggests a potential claim construction dispute over the scope and definition of these key structural components.
  • Technical Questions: For both patents, a technical question will be whether the specific mechanical interactions described in the claims occur in the accused devices. For the '732 Patent's device claim, this involves a direct structural comparison. For the '731 Patent's method claim, this raises the evidentiary question of what steps surgeons actually perform when using the PROLIFT system and whether those steps align with the claim language.

V. Key Claim Terms for Construction

  • The Term: "central ramp" and "driving ramp" (appearing in asserted claim 1 of the ’731 Patent and asserted claim 1 of the ’732 Patent)
  • Context and Importance: The construction of these terms appears central to the dispute, as the complaint describes the accused PROLIFT products as having a "base ramp and nose ramp." (Compl. ¶39). Practitioners may focus on these terms because the infringement analysis will likely depend on whether the distinct "base" and "nose" ramps of the accused product, individually or in combination, meet the definitions of the claimed "central" and "driving" ramps.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification of the ’732 Patent describes the "driving ramp" in functional terms as a "generally wedge-shaped" component that is moved to cause expansion. (’732 Patent, col. 7:8-12). Parties advocating for a broader scope may argue that any wedge-shaped component performing this function meets the limitation.
    • Evidence for a Narrower Interpretation: The detailed description and figures of the ’732 Patent depict the "central ramp" (18) and "driving ramp" (260) as specific, distinct components with particular interlocking features, such as grooves and guides that direct their movement relative to each other. (’732 Patent, Fig. 8-9; col. 7:14-26). Parties advocating for a narrower scope may argue that these terms are limited to structures possessing these specific disclosed features, which may not be present in the accused "base ramp and nose ramp" design.

VI. Other Allegations

Indirect Infringement

The complaint alleges active inducement of infringement, asserting that Defendant encourages and instructs surgeons and distributors to use the accused products in an infringing manner. (Compl. ¶67). The alleged acts of inducement include providing surgical technique guides, marketing videos, product inserts, and hands-on training programs, such as cadaver labs. (Compl. ¶¶ 69, 71, 75, 78).

Willful Infringement

Willfulness is alleged for all asserted patents based on Defendant’s purported pre-suit knowledge. (Compl. ¶¶ 93, 104, 115, 126, 135, 146, 156, 166). The complaint alleges that Defendant studied existing patents when designing its PROLIFT product and cited Globus's products in FDA submissions. (Compl. ¶35, ¶53). Crucially, the complaint alleges that Defendant cited several of the patents-in-suit, including the ’732 Patent, as prior art in Information Disclosure Statements (IDS) during the prosecution of its own patents, with some citations occurring as early as 2015. (Compl. ¶¶ 58-62). The complaint further alleges that on December 2, 2021, Defendant cited every patent-in-suit in an IDS filed in one of its own patent applications. (Compl. ¶63.b).

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

  • A core issue will be one of structural equivalence and claim scope: Can the patent claims reciting a "central ramp" and a "driving ramp" be construed to cover the accused products' "base ramp and nose ramp" architecture? The outcome will likely depend on whether the court adopts a broad, functional definition of these terms or a narrower one tied to the specific embodiments shown in the patents.
  • A dispositive issue for much of the case will be the impact of subsequent IPR proceedings: With the asserted claims of five of the eight patents-in-suit having been cancelled by the PTAB after the complaint was filed, a key question is which, if any, of these infringement counts can survive. The case may be significantly narrowed to focus only on the claims of the '731 and '128 patents, and the surviving claims of the '732 patent.
  • Should any claims survive and be found infringed, a key evidentiary question will be one of intent and willfulness: Given the extensive allegations that Defendant cited the patents-in-suit during its own patent prosecution activities long before the lawsuit, the court will have to determine whether this conduct rises to the level of egregious behavior necessary to support a finding of willful infringement and enhanced damages.