DCT

2:20-cv-03271

Moskowitz Family LLC v. Globus Medical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-03271, E.D. Pa., 08/23/21
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant resides in the judicial district, maintains a regular and established place of business, and has committed acts of patent infringement within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s spinal fusion systems, including intervertebral spacers and fixation devices, infringe eight patents related to spinal implants, tools, and surgical methods.
  • Technical Context: The technology relates to medical devices for spinal fusion surgery, which are used to treat debilitating spine conditions by fusing two or more vertebrae, with a focus on minimally invasive and biomechanically stable solutions.
  • Key Procedural History: The complaint alleges that Plaintiff’s counsel notified Defendant of its patent portfolio, including U.S. Patent No. 8,353,913 and a pending application that issued as U.S. Patent No. 9,889,022, as early as June 2015. Following a review, Defendant allegedly made an offer to acquire the portfolio that Plaintiff deemed too low. These pre-suit communications may be central to Plaintiff’s allegations of willful infringement.

Case Timeline

Date Event
2005-04-12 Earliest Priority Date for all Asserted Patents
2013-01-15 U.S. Patent No. 8,353,913 Issues
2015-06-03 Plaintiff’s counsel sends letter to Globus identifying patents, including the ’913 patent
2015-07-13 Globus counsel confirms review of patent portfolio; Globus had recently launched Rise-L product
2015-07-16 Globus responds to letter with offer to acquire portfolio
2015-07-21 Plaintiff’s counsel responds to Globus, rejecting the offer
2018-02-13 U.S. Patent No. 9,889,022 Issues
2018-07-24 U.S. Patent No. 10,028,740 Issues
2018-09-18 U.S. Patent No. 10,076,367 Issues
2019-04-09 U.S. Patent No. 10,251,643 Issues
2019-06-04 U.S. Patent No. 10,307,268 Issues
2019-08-13 U.S. Patent No. 10,376,386 Issues
2019-09-10 Certificate of Correction issued for the ’268 Patent
2019-11-19 U.S. Patent No. 10,478,319 Issues
2019-11-20 Plaintiff files Original Complaint
2021-08-23 Plaintiff files Second Amended Complaint

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

U.S. Patent No. 8,353,913 - "Bi-directional Fixating Transvertebral Body Screws and Posterior Cervical and Lumbar Interarticulating Joint Calibrated Stapling Devices for Spinal Fusion"

  • Patent Identification: U.S. Patent No. 8,353,913, "Bi-directional Fixating Transvertebral Body Screws and Posterior Cervical and Lumbar Interarticulating Joint Calibrated Stapling Devices for Spinal Fusion," issued January 15, 2013.

The Invention Explained

  • Problem Addressed: The patent addresses complications associated with conventional spinal fusion techniques that use pedicle screws, such as misplaced screws causing neural or vascular injury, excessive blood loss, and excessive rigidity leading to disease in adjacent spinal segments (’367 Patent, col. 1:49-55).
  • The Patented Solution: The invention describes a system of bi-directional screws and related tools that can be inserted into vertebral bodies without penetrating the pedicles, thereby preserving healthy facet joints (’367 Patent, col. 3:15-24, col. 4:1-5). The system is designed to provide segmental fusion with a strength equal to or greater than conventional systems but with potentially fewer complications and greater flexibility.
  • Technical Importance: This approach sought to provide the stability of traditional fusion while minimizing tissue disruption and preserving more of the natural spinal anatomy and biomechanics (Compl. ¶5).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶33-34).
  • Claim 1 is directed to a tool for manipulating and inserting an intervertebral bone fusion spacer, comprising:
    • A gripper having a plurality of prongs, with distal ends capable of engaging a slot or indentation on the spacer.
    • A screw guide for controlling the direction of screws, positioned between the prongs.

U.S. Patent No. 9,889,022 - "Bi-Directional Fixating Transvertebral Body Screws and Posterior Cervical and Lumbar Interarticulating Joint Calibrated Stapling Devices for Spinal Fusion"

  • Patent Identification: U.S. Patent No. 9,889,022, "Bi-Directional Fixating Transvertebral Body Screws and Posterior Cervical and Lumbar Interarticulating Joint Calibrated Stapling Devices for Spinal Fusion," issued February 13, 2018.

The Invention Explained

  • Problem Addressed: The technology addresses the same problems as the ’913 Patent, namely the complications arising from conventional pedicle screw placement in spinal surgery (’022 Patent, col. 2:28-41).
  • The Patented Solution: The ’022 Patent describes an intervertebral implant that combines a spacer (or "cage") with internal screw guides. This integrated design allows screws to be inserted through the implant itself into the adjacent vertebrae at specific angles, providing fixation without the need for a separate, high-profile anterior plate (’022 Patent, col. 3:15-24; Compl. ¶5). This "zero-profile" design aims to reduce esophageal injuries and other complications associated with traditional plating systems.
  • Technical Importance: Integrated, zero-profile devices provide the biomechanical strength of a traditional plate and spacer system while minimizing the implant's anatomical footprint and associated surgical risks (Compl. ¶5).

Key Claims at a Glance

  • The complaint asserts independent claim 47 (Compl. ¶57-58).
  • Claim 47 is directed to an intervertebral combination internal screw guide and fixation apparatus, comprising:
    • An intervertebral cage with a top wall, bottom wall, and two sidewalls defining an open space.
    • An internal screw guide with a bore having an entry opening in the top surface of the top wall and an exit opening at least partially in a bottom surface of the top wall.
    • A threaded hole through the top wall.
    • A rectangular indentation in the top wall.

U.S. Patent No. 10,028,740 - "Spinal Fusion Implant with Curvilinear Nail-Screws"

  • Patent Identification: U.S. Patent No. 10,028,740, "Spinal Fusion Implant with Curvilinear Nail-Screws," issued July 24, 2018.
  • Technology Synopsis: The patent describes a spinal fusion implant featuring curvilinear, or curved, nail-screws. This design allows for horizontal transvertebral access, enabling surgeons to secure the implant without using angled instruments, which can be challenging in certain areas of the spine (’740 Patent, col. 2:4-7, 46-51).
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶80-81).
  • Accused Features: The complaint alleges that products including COALITION MIS, INDEPENDENCE MIS, and HEDRON infringe by being spinal fusion implants with a first and second curvilinear nail-screw and a connecting support structure (Compl. ¶79, 81-84).

U.S. Patent No. 10,076,367 - "Bi-Directional Fixating Transvertebral Body Screws, Zero-Profile Horizontal Intervertebral Miniplates, Total Intervertebral Body Fusion Devices, and Posterior Motion-Calibrating Interarticulating Joint Stapling Device for Spinal Fusion"

  • Patent Identification: U.S. Patent No. 10,076,367, "Bi-Directional Fixating Transvertebral Body Screws, Zero-Profile Horizontal Intervertebral Miniplates, Total Intervertebral Body Fusion Devices, and Posterior Motion-Calibrating Interarticulating Joint Stapling Device for Spinal Fusion," issued September 18, 2018.
  • Technology Synopsis: This patent covers a bidirectional fixating intervertebral implant system. The system combines an implant body (spacer) with an integrated plate and superior and inferior bone-piercing screws that extend in opposite directions to engage adjacent vertebrae (’367 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶106-107).
  • Accused Features: The complaint accuses the COALITION and FORTIFY-IR products of infringing by comprising an implant body, a plate, and superior and inferior bone-piercing screws (Compl. ¶105, 107-108).

U.S. Patent No. 10,307,268 - "Intervertebral Expandable Implant"

  • Patent Identification: U.S. Patent No. 10,307,268, "Intervertebral Expandable Implant," issued June 4, 2019.
  • Technology Synopsis: The patent describes an expandable intervertebral implant that can be inserted in a compressed state and then expanded in-situ to a desired height. The expansion is achieved via angled wedge portions and an adjusting screw, allowing for a custom fit to the patient's anatomy (’268 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claims 1 and 21 (Compl. ¶128).
  • Accused Features: The RISE and ELSA product families are accused of infringing by being systems with an expandable implant, vertebral body engagement surfaces, angled wedge portions, and an adjusting screw (Compl. ¶127, 129, 132).

U.S. Patent No. 10,251,643 - "Bi-Directional Fixating Transvertebral Body Screws, Zero-Profile Horizontal Intervertebral Miniplates, Expansile Intervertebral Body Fusion Devices, and Posterior Motion-Calibrating Interarticulating Joint Stapling Device for Spinal Fusion"

  • Patent Identification: U.S. Patent No. 10,251,643, "Bi-Directional Fixating Transvertebral Body Screws, Zero-Profile Horizontal Intervertebral Miniplates, Expansile Intervertebral Body Fusion Devices, and Posterior Motion-Calibrating Interarticulating Joint Stapling Device for Spinal Fusion," issued April 9, 2019.
  • Technology Synopsis: The patent discloses an artificial expansile (expandable) spinal implant. The device comprises first and second shells with an expansion mechanism positioned between them, which includes threaded bodies and a rotatable portion for tool engagement to adjust the height (’643 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶156).
  • Accused Features: The FORTIFY and XPAND product families are accused of infringement by comprising first and second shells and an expansion mechanism with threaded bodies and a rotatable tool engagement portion (Compl. ¶155, 157-161).

U.S. Patent No. 10,376,386 - "Spinal Staple"

  • Patent Identification: U.S. Patent No. 10,376,386, "Spinal Staple," issued August 13, 2019.
  • Technology Synopsis: The technology concerns a spinal staple used for fixation. The staple includes a base, two spikes for piercing bone, and a threaded hole positioned along its midline axis, designed for use in anterior spinal procedures (’386 Patent, Abstract; Compl. ¶182).
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶181).
  • Accused Features: The complaint accuses Globus's Revere Anterior Staple System (RASS) of infringing by being a spinal staple with a staple base, a first staple spike, a second staple spike, and a threaded hole along the midline axis (Compl. ¶180, 182).

U.S. Patent No. 10,478,319 - "System with Tool Assembly and Expandable Spinal Implant"

  • Patent Identification: U.S. Patent No. 10,478,319, "System with Tool Assembly and Expandable Spinal Implant," issued November 19, 2019.
  • Technology Synopsis: The patent describes a system that includes both an expandable spinal implant and a tool assembly for its insertion and adjustment. The tool assembly includes a first tool for holding the implant and a second, adjusting tool that can pass through the first tool to engage and operate the implant's expansion mechanism (’319 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claims 1, 8, and 20 (Compl. ¶205).
  • Accused Features: Numerous products, including RISE, ELSA, and MONUMENT, are accused of infringing by being tool assemblies with a first tool, a second tool, and an expandable implant (Compl. ¶204, 206, 216, 225).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are multiple families of Globus spinal fusion products, including but not limited to COALITION, INDEPENDENCE, MONUMENT, FORTIFY-IR, HEDRON, MAGNIFY-S, CORBEL, RISE, ELSA, XPAND, and the Revere Anterior Staple System (RASS) (Compl. ¶32, 56, 79, 105, 127, 155, 180, 204).
  • Functionality and Market Context: The accused products are described as various types of intervertebral spacers, cages, and fixation systems used in spinal fusion surgeries (Compl. ¶5). For example, COALITION is an integrated plate and spacer system for anterior cervical discectomy (Compl. ¶58). RISE is an expandable lumbar fusion device designed to minimize insertion force and provide controlled distraction (Compl. ¶129). The complaint provides an annotated product image of the accused COALITION device, identifying its intervertebral cage, walls, and internal screw guides (Compl. p. 17). RASS is a dual rod staple system used in anterior deformity, trauma, and tumor cases (Compl. ¶182). These products are marketed and sold by Globus, which the complaint identifies as a large, publicly-traded medical device company (Compl. ¶15).

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,353,913 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a tool for manipulating and inserting a universal, intervertebral bone fusion spacer... The accused product lines are identified as tools for manipulating and inserting intervertebral bone fusion spacers. ¶34 col. 4:15-18
wherein the universal, intervertebral bone fusion spacer includes an intervertebral cage having a first integral screw guide and a second integral screw guide... The accused intervertebral bone fusion spacers are alleged to include an intervertebral cage with first and second integral screw guides. ¶34 col. 8:43-46
wherein each longitudinal end of the intervertebral cage includes a slot or indentation formed adjacent to an edge of an upper surface of the intervertebral cage... The longitudinal ends of the accused intervertebral cages are alleged to include a slot or indentation adjacent to an edge of an upper surface. ¶34 col. 8:56-62
  • Identified Points of Contention:
    • Scope Questions: Claim 1 is for a "tool," which the complaint alleges includes the spacer/implant itself. A question may arise as to whether the claims to a "tool" can be read to cover the combination of instruments and the implant, and whether the defendant's sale of implants constitutes infringement of a tool claim.
    • Technical Questions: A key question will be whether the features of the accused cages, such as the COALITION device, constitute an "integral screw guide" as that term is used and described in the patent. The complaint shows a labeled image of the accused COALITION MIS device, identifying curvilinear nail-screws and a support structure, which Plaintiff will likely argue meet this limitation (Compl. p. 27).

U.S. Patent No. 9,889,022 Infringement Allegations

Claim Element (from Independent Claim 47) Alleged Infringing Functionality Complaint Citation Patent Citation
An intervertebral combination internal screw guide and fixation apparatus comprising: an intervertebral cage including a top wall, bottom wall, and two sidewalls defining an open space... The accused COALITION product is alleged to be an intervertebral cage with a top wall, bottom wall, and two sidewalls. This is supported by a labeled diagram from Defendant's materials. ¶58; p. 17 col. 4:19-21
an internal screw guide having an internal bore with an entry opening and an exit opening, the entry opening...formed only in a top surface of the top wall and the exit opening formed at least partially in a bottom surface of the top wall... The accused COALITION product is alleged to contain two internal screw guides. The complaint's visual aid shows these guides integrated into the cage structure. ¶58; p. 17 col. 4:22-26
a threaded hole...extends through the top wall in a direction substantially normal to the top surface of the top wall... The accused product is alleged to have a hole positioned between the two internal screw guides. ¶58 col. 4:32-35
  • Identified Points of Contention:
    • Scope Questions: A central issue will be the construction of "internal screw guide." The claim requires the entry opening to be "only in a top surface of the top wall." The analysis may focus on whether the accused devices, like the COALITION AGX with its "low profile plating system," meet this specific geometric constraint or if portions of the guide opening are formed in other surfaces (Compl. ¶63).
    • Technical Questions: Evidence will be needed to determine if the "hole positioned between the two internal screw guides" in the accused products is a "threaded hole" that extends "substantially normal to the top surface" as required by the claim. The complaint’s annotated image of the FORTIFY-IR product depicts a superior and inferior screw, a plate, and an implant body, which will be central to this factual determination (Compl. p. 37).

V. Key Claim Terms for Construction

U.S. Patent No. 8,353,913

  • The Term: "universal, intervertebral bone fusion spacer" (Claim 1)
  • Context and Importance: The term "universal" is not explicitly defined. Its construction is critical because it may limit the scope of spacers to which the claimed manipulation "tool" can apply. Practitioners may focus on this term because if construed narrowly to a specific type of spacer not sold by the defendant, the claim may not be infringed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the invention as relating to a "unique universal bidirectional screw (UBS) system" and its application to the spine, suggesting "universal" may refer to applicability across different spinal regions (cervical, thoracic, lumbar) or surgical approaches (’367 Patent, col. 2:25-30).
    • Evidence for a Narrower Interpretation: The detailed descriptions focus on specific embodiments of bi-directional screw devices. A defendant may argue "universal" is limited to spacers designed to work specifically with the patent's disclosed bi-directional fixation systems, rather than any generic spacer.

U.S. Patent No. 9,889,022

  • The Term: "internal screw guide" (Claim 47)
  • Context and Importance: The location and nature of the screw guide is central to the claim. The term "internal" and the specific locations of its entry and exit openings ("only in a top surface," "at least partially in a bottom surface") define the zero-profile nature of the invention. The infringement analysis will turn on whether the accused products' screw pathways meet these precise geometric limitations.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the goal of obviating the need for supplemental "vertically oriented anterior plating" (’022 Patent, col. 2:42-44). This purpose might support a construction where "internal" means any guide structure that avoids a separate, overlying plate, even if it is not entirely flush with the cage body.
    • Evidence for a Narrower Interpretation: The claim language is highly specific, requiring the entry opening to be "only in a top surface of the top wall." Figures in the family of patents (e.g., ’367 Patent, Fig. 1A-C) depict screw-driving mechanisms contained entirely within the implant body's profile. This could support a narrow construction requiring the screw guide to be fully embedded within the cage's outer dimensions.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement under 35 U.S.C. § 271(b), stating that Globus provides "product manuals, brochures, videos, demonstrations, and website materials" that encourage and instruct medical professionals to use the accused products in an infringing manner (Compl. ¶35, 66). It also alleges contributory infringement under § 271(c), asserting that components of the accused products are not staple articles of commerce and were especially made for use in an infringing manner (Compl. ¶40-41).
  • Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. It asserts that Globus has known its activities infringed the ’913 patent since at least July 2015, following direct communications from Plaintiff’s counsel (Compl. ¶49). For patents issued after this communication, the complaint alleges Globus was aware of them shortly after issuance or no later than the filing of the original complaint, and that Globus made "no attempt to design around the claims" (Compl. ¶29, 73).

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

  • A core issue will be one of claim construction and technical scope: can terms rooted in the patents' specific embodiments, such as "internal screw guide" with an entry "only in a top surface," be construed to cover the varied designs of Defendant's extensive product portfolio, including those with low-profile integrated plates? The resolution will depend on a detailed comparison of the accused product mechanics against the court's interpretation of the patent language.
  • A second key question will be the impact of pre-suit knowledge on willfulness: the complaint details communications from 2015 concerning the earliest patents in the asserted family. A central legal question will be whether this early notice regarding parent patents establishes deliberate or reckless infringement for the entire family of subsequently issued patents, potentially exposing Defendant to enhanced damages.
  • A third issue will be one of dividing infringement across multiple patents: Plaintiff asserts eight patents from a single family, with significant technological overlap, against many of the same products. The case will likely require a meticulous parsing of which specific product features are alleged to map to the distinct claims of each patent, raising questions of potential double recovery and the precise contribution of each patented invention.