DCT
2:17-cv-02998
Barry v. Globus Medical Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Dr. Mark A. Barry (Nevada)
- Defendant: Globus Medical, Inc. (Delaware)
- Plaintiff’s Counsel: Hangley Aronchick Segal Pudlin & Schiller; Kilpatrick Townsend & Stockton, LLP
- Case Identification: 2:17-cv-02998, E.D. Pa., 07/05/2017
- Venue Allegations: Venue is alleged to be proper in the Eastern District of Pennsylvania because Defendant Globus Medical has its principal place of business in the district and has allegedly committed acts of infringement there.
- Core Dispute: Plaintiff alleges that Defendant’s spinal deformity correction systems infringe five patents related to systems and methods for the simultaneous, en bloc derotation of multiple vertebrae.
- Technical Context: The technology concerns complex surgical instruments and methods used by orthopedic surgeons to correct severe spinal deformities, such as scoliosis, by realigning the spinal column.
- Key Procedural History: The complaint alleges that Defendant was aware of the asserted technology due to Plaintiff’s prior successful litigation against Medtronic involving two of the patents-in-suit. Plaintiff further alleges that Defendant was served with a subpoena in that case which specifically identified the '358 and '121 patents, providing a basis for pre-suit knowledge and willfulness allegations.
Case Timeline
| Date | Event |
|---|---|
| 2004-12-30 | Earliest Priority Date for all five patents-in-suit |
| 2010-03-02 | U.S. Patent No. 7,670,358 ('358 Patent) Issues |
| 2013-01-29 | U.S. Patent No. 8,361,121 ('121 Patent) Issues |
| 2016-01-27 | Globus allegedly served with subpoena in prior Medtronic litigation |
| 2016-05-17 | U.S. Patent No. 9,339,301 ('301 Patent) Issues |
| 2017-06-06 | U.S. Patent No. 9,668,787 ('787 Patent) Issues |
| 2017-06-06 | U.S. Patent No. 9,668,788 B2 ('788 Patent) Issues |
| 2017-07-05 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,670,358 ('358 Patent) - “System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions”
The Invention Explained
- Problem Addressed: The patent describes a deficiency in prior surgical methods for correcting spinal deformities like scoliosis. Conventional techniques that corrected vertebrae individually or sequentially (seriatim) could not achieve a complete three-dimensional correction and risked vertebral fracture due to focused application of force (’358 Patent, col. 2:42-62).
- The Patented Solution: The invention is a method and system that allows a surgeon to correct a segment of the spine en bloc, or all at once. This is achieved using a “pedicle screw cluster derotation tool” that engages multiple pedicle screws implanted in adjacent vertebrae. By linking the engagement members, the tool allows a practitioner to apply manipulative force simultaneously across the entire cluster, dispersing the force and safely derotating multiple vertebrae in a single motion to achieve a 3D correction (’358 Patent, Abstract; col. 3:46-68).
- Technical Importance: This en bloc approach represented a shift from piecemeal correction to a holistic reconfiguration of an entire spinal segment, which the patent asserts allows for more effective and safer correction of complex, three-dimensional spinal deformities (’358 Patent, col. 2:63-68).
Key Claims at a Glance
- The complaint asserts method claims 4 and 5 (Compl. ¶10). Claim 1 is the independent claim from which they ultimately depend.
- Independent Claim 1 requires the steps of:
- Selecting and implanting a first set of pedicle screws into a first group of multiple vertebrae.
- Selecting a "first pedicle screw cluster derotation tool" with handle means and mechanically linked engagement members.
- Engaging the tool with the implanted pedicle screws.
- Applying manipulative force to the handle "in a single motion" to "simultaneously rotat[e]" the vertebrae.
- Securing the corrected vertebrae with a spinal rod.
U.S. Patent No. 8,361,121 ('121 Patent) - “System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions”
The Invention Explained
- Problem Addressed: Like its parent '358 patent, the '121 patent addresses the limitations of prior art scoliosis treatments that failed to achieve a full three-dimensional correction and posed a risk of injury from concentrated forces (’121 Patent, col. 2:60-65).
- The Patented Solution: This patent claims a system for performing a multi-stage, three-dimensional correction. The system includes pre-contoured spinal rods that, when rotated into place, provide an initial two-axis correction. The system is then used with a "pedicle screw cluster derotation tool" that applies force across multiple vertebrae simultaneously to achieve the final, third-axis rotational correction (’121 Patent, col. 6:48-65).
- Technical Importance: The claimed system provides the surgical hardware for a structured, multi-step procedure that aims to achieve a complete three-dimensional spinal realignment safely by first correcting for curvature and then for rotation (’121 Patent, col. 4:3-10).
Key Claims at a Glance
- The complaint asserts system claims 2, 3, and 4 (Compl. ¶15). Claim 1 is the independent claim.
- Independent Claim 1 requires a system comprising:
- A first set of pedicle screws.
- A "first pedicle screw cluster derotation tool" having a handle and "a first group of three or more pedicle screw engagement members which are mechanically linked."
- A spinal rod member that is contoured to define a desired post-operative alignment.
- The claim describes a method of use wherein the spinal rod is first rotated into place for a 2D correction, followed by the application of the derotation tool.
U.S. Patent No. 9,339,301 ('301 Patent)
- Technology Synopsis: The '301 patent, a continuation of the '121 patent, claims both a system and method for aligning vertebrae. The invention involves using interconnected engagement members that are coupled to pedicle screws to apply simultaneous rotational force to a group of vertebrae, thereby achieving an en bloc correction (’301 Patent, Abstract).
- Asserted Claims: Claims 1-10 are asserted (Compl. ¶20, ¶87). Claims 1 and 6 are independent.
- Accused Features: The REVERE® and CREO® systems are accused of infringing when used by surgeons to perform spinal derotation procedures (Compl. ¶¶87, 92).
U.S. Patent No. 9,668,787 ('787 Patent)
- Technology Synopsis: The '787 patent claims a method for applying manipulative force using a system of at least four elongated levers temporarily engaged with at least four pedicle screws. The levers are linked to move in unison, allowing an operator to simultaneously rotate the vertebrae about a "spinal column roll axis" (’787 Patent, Abstract).
- Asserted Claims: Claims 1-9 are asserted (Compl. ¶25, ¶103). Claim 1 is independent.
- Accused Features: The REVERE® and CREO® systems, which the complaint describes as using levers attached to pedicle screws, are accused of infringing when used by surgeons to perform derotation (Compl. ¶¶103, 107).
U.S. Patent No. 9,668,788 B2 ('788 Patent)
- Technology Synopsis: The '788 patent claims a system for applying manipulative force, rather than the method of the '787 patent. The system comprises at least four pedicle screws, at least four elongated levers, a linking member, and a cross-linking member, which together permit an operator to simultaneously rotate the vertebrae (’788 Patent, Abstract).
- Asserted Claims: Claims 1-6 are asserted (Compl. ¶30, ¶117). Claim 1 is independent.
- Accused Features: The REVERE® and CREO® systems are accused of infringing by providing the components of the claimed system for assembly and use by surgeons (Compl. ¶¶117, 122).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the REVERE® Deformity Vertebral Derotation Instruments and the CREO® Derotation System (collectively, "Globus Products") (Compl. ¶43).
Functionality and Market Context
- The complaint alleges that the Globus Products are designed to "derotate en bloc multiple levels of vertebrae" (Compl. ¶43). The complaint includes a visual of the REVERE® system, described as showing "six levers or rods attached to six pedicle screws and connected via rods" (Compl. ¶46). For the CREO® system, a visual is provided showing "four levers or rods attached to four pedicle screws and connected" (Compl. ¶51).
- Marketing materials cited in the complaint state that the REVERE® system's "coupling feature allows for en bloc vertebral derotation which distributes the forces over multiple vertebral levels" (Compl. ¶48, Ex. F). The CREO® system is described as being for "en bloc" derotation maneuvers (Compl. ¶53, Ex. G).
- The complaint alleges these products were designed to compete with similar systems from Medtronic and Biomet and that they are used with Globus's respective REVERE® and CREO® lines of implantable products (Compl. ¶¶44, 49, 54).
IV. Analysis of Infringement Allegations
’358 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| implanting a each pedicle screw in a pedicle region of each of a first group of multiple vertebrae... | The Globus Products (e.g., REVERE® Instruments) are used with "at least two sets of pedicles screws implanted in multiple levels of vertebrae." | ¶59 | col. 4:50-54 |
| selecting a first pedicle screw cluster derotation tool, said first pedicle screw cluster derotation tool having first handle means and a first group of pedicle screw engagement members which are mechanically linked... | The Globus Products include "engagement members which act as levers attached to the pedicle screws" and are linked "one to another on both sides of the spine as well as across the spine." The complaint's visual at ¶46 depicts this alleged construct. | ¶59, ¶46 | col. 5:1-26 |
| applying manipulative force to said first handle means in a manner for simultaneously engaging said first group of pedicle screw engagement members...and thereby in a single motion simultaneously rotating said vertebrae... | When assembled, force is allegedly "applied to the entire construct" and "received simultaneously across the engagement members resulting in the derotation of the vertebrae." | ¶59 | col. 6:21-34 |
| extending said first length of said spinal rod member through said spinal rod conduits of one or more of said pedicle screws...and after applying said manipulative force...actuating said spinal rod engagement means to secure said vertebrae... | The accused systems are used with implantable spinal rods that are secured to the pedicle screws after the derotation procedure to hold the correction. The complaint alleges the products are used with the REVERE® and CREO® lines of implantable products, which include such rods. | ¶49, ¶54 | col. 5:46-58 |
’121 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| selecting a first pedicle screw cluster derotation tool...having a first handle means...and a first group of three or more pedicle screw engagement members which are mechanically linked... | The assembled REVERE® and CREO® systems allegedly form the claimed tool. They include "engagement members which act as levers," and are linked "one to another on both sides of the spine as well as across the spine." The complaint's visual at ¶51, showing the CREO® system, illustrates an alleged infringing configuration. | ¶74, ¶79, ¶51 | col. 5:7-24 |
| implanting each pedicle screw of said first set of pedicle screws in a pedicle region of each of a first group of vertebrae... | The REVERE® and CREO® systems are used with pedicle screws implanted in multiple vertebrae. The complaint alleges the REVERE® system uses "at least two sets of pedicles screws...totaling six pedicle screws" and the CREO® system uses "at least two sets...totaling six pedicle screws." | ¶74, ¶79 | col. 5:56-61 |
| contouring said spinal rod member whereby, in a first plane, said spinal rod member substantially defines...a post-operative spinal column alignment...rotating said spinal rod substantially along its length...to effect a correction...in reference to two axes; | The complaint does not provide sufficient detail for analysis of the pre-contouring and rod rotation elements, but alleges that the systems are used to perform derotation procedures that infringe the claims generally. | ¶71, ¶76 | col. 6:48-61 |
| applying manipulative force to said first handle means...thereby in a single motion simultaneously rotating said vertebrae...to achieve an amelioration of an aberrant spinal column deviation condition in reference to a third axis. | Force is allegedly "applied to the entire construct" and "received simultaneously across the engagement members resulting in the derotation of the vertebrae." This is the alleged third-axis correction. | ¶74, ¶79 | col. 6:62-65 |
Identified Points of Contention
- Scope Questions: A central issue will be whether the specific mechanical structures of the REVERE® and CREO® systems fall within the scope of the patent term "pedicle screw cluster derotation tool." The case raises the question of whether the accused products' individual levers, linked together by connecting rods, constitute the "mechanically linked" "engagement members" of a single "tool" as described in the patents.
- Technical Questions: The complaint makes conclusory allegations that force is "received simultaneously." A key technical question will be what evidence exists to show that the accused systems, in actual use, achieve the "single motion simultaneously rotating" of the vertebrae required by the method claims, as opposed to a rapid sequential rotation or a different mechanism of action.
V. Key Claim Terms for Construction
’358 Patent (Method Claim 1)
- The Term: "a first pedicle screw cluster derotation tool"
- Context and Importance: The definition of this term is fundamental to the infringement analysis. The dispute will center on whether the collection of levers, connectors, and rods that comprise the accused REVERE® and CREO® systems constitutes a single "tool" as contemplated by the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the tool in functional terms, stating its object is "to facilitate simultaneous application of manipulative forces to multiple pedicle screws" and that significant variations are contemplated (’358 Patent, col. 5:19-30). This may support an argument that any collection of linked components that achieves this function is a "tool."
- Evidence for a Narrower Interpretation: The patent figures, particularly Figure 1, depict a specific embodiment where multiple "wrenches" (32) are joined by linking members (42) into a more integrated apparatus. This could support a narrower construction limited to structures that more closely resemble the depicted embodiment, rather than a collection of separate components assembled during surgery.
’121 Patent (System Claim 1)
- The Term: "mechanically linked"
- Context and Importance: This term is critical for determining whether the engagement members of the accused systems are connected in the manner required by the claim. Practitioners may focus on this term because the nature of the "link" determines whether the components act in unison as a single system.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that linking members (42) are used to join screw wrenches "to act in unison during use" (’121 Patent, col.5:7-14). This functional language could be argued to cover any mechanical connection that causes the components to move together.
- Evidence for a Narrower Interpretation: The claims require a "group of three or more pedicle screw engagement members which are mechanically linked." The specific depiction in Figure 1 shows distinct wrenches joined by separate linking bars. This might be argued to require a direct, rigid, or semi-rigid connection between the engagement members themselves, potentially excluding systems where levers are only indirectly connected via a rod that spans across the spine.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Globus provides "instruction, education, or encouragement to surgeons performing spinal derotation procedures" that infringe the patents (Compl. ¶¶58, 65, 73).
- Willful Infringement: Willfulness is alleged for all five patents. The complaint bases these allegations on Globus's alleged pre-suit knowledge of the patents and technology. The primary factual bases cited are: (1) Globus's alleged citation to a related Barry patent during its own patent prosecution (Compl. ¶34); and (2) Globus's receipt of a subpoena on January 27, 2016, in prior litigation between Dr. Barry and Medtronic, which allegedly identified the '358 and '121 patents specifically (Compl. ¶¶37-38).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "pedicle screw cluster derotation tool," which is described in the patents as a potentially integrated apparatus, be construed broadly enough to read on the accused REVERE® and CREO® systems, which appear to be collections of individual levers and connectors assembled in situ during a surgical procedure?
- A second central question will revolve around willfulness: given the specific allegation that Globus received a subpoena in prior litigation that expressly identified the '358 and '121 patents more than a year before this suit was filed, a key focus will be on what actions, if any, Globus took to assess infringement and validity, and whether it formed a good-faith belief of non-infringement.
- A key evidentiary question will be one of technical operation: does the application of force to the accused systems' linked levers result in the "simultaneously rotating" of vertebrae as required by the method claims, or is there a functional difference in how the corrective forces are applied and distributed compared to the specific methods disclosed in the patents?