DCT

2:17-cv-03003

Barry v. DePuy Synthes Companies

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-03003, E.D. Pa., 09/28/2017
  • Venue Allegations: Venue is asserted based on Defendants' regular and established places of business within the district, as well as alleged acts of infringement including the sale, promotion, and distribution of accused products within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s spinal correction systems infringe five patents related to methods and systems for aligning vertebrae en bloc.
  • Technical Context: The technology concerns surgical instruments and methods used in orthopedic procedures to correct complex spinal deformities, such as scoliosis, by simultaneously derotating multiple vertebrae.
  • Key Procedural History: The complaint notes that two of the patents-in-suit ('358 and '121) were previously asserted against Medtronic, resulting in a jury verdict of willful infringement and a finding that the patents were not invalid. The complaint alleges that Defendant DePuy Synthes was aware of this litigation and was served with a subpoena in that case that identified the '358 and '121 patents. Plaintiff also alleges a prior licensing history for the technology with Biomet.

Case Timeline

Date Event
2004-12-30 Earliest Priority Date for all Patents-in-Suit
2006-07-06 Publication date of application leading to '358 Patent
2010-03-02 Issue Date: U.S. Patent No. 7,670,358
2013-01-29 Issue Date: U.S. Patent No. 8,361,121
2016-01-27 DePuy Synthes allegedly served with subpoena in Medtronic case
2016-05-17 Issue Date: U.S. Patent No. 9,339,301
2017-06-06 Issue Date: U.S. Patent No. 9,668,787
2017-06-06 Issue Date: U.S. Patent No. 9,668,788
2017-09-28 Complaint Filing Date

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

U.S. Patent No. 7,670,358 - "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS"

  • Patent Identification: U.S. Patent No. 7,670,358, "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS," issued March 2, 2010.

The Invention Explained

  • Problem Addressed: The patent describes a "serious deficiency" in conventional treatments for spinal anomalies like scoliosis, noting that prior methods applying force to individual vertebrae sequentially (seriatim) are inadequate for substantial correction and risk vertebral fracture or spinal cord injury ('358 Patent, col. 2:38-62).
  • The Patented Solution: The invention proposes a system and method using a "pedicle screw cluster derotation tool" that simultaneously engages the heads of multiple pedicle screws implanted in adjacent vertebrae. This construct allows a practitioner to apply manipulative forces to a group of vertebrae en bloc, which disperses the force and facilitates a safer, more effective three-dimensional correction of the spinal column as a whole segment ('358 Patent, Abstract; col. 3:45-62). The overall concept is illustrated in the patent's Figure 1, which shows multiple linked wrenches engaged with a spinal model ('358 Patent, Fig. 1).
  • Technical Importance: This en bloc manipulation technique was presented as a way to achieve a more complete three-dimensional correction of severe spinal curvatures, a goal that the patent asserts had not been consistently and reproducibly achieved by prior methods ('358 Patent, col. 2:53-58).

Key Claims at a Glance

  • The complaint asserts claims 4 and 5, which depend from independent claim 1 ('358 Patent, col. 6:8-60; Compl. ¶14).
  • Independent Claim 1 recites a method with the essential elements of:
    • Selecting a set of pedicle screws and a "pedicle screw cluster derotation tool" with "mechanically linked" engagement members.
    • Implanting the pedicle screws into a "group of multiple vertebrae."
    • Engaging the tool's members with the implanted screws.
    • Applying manipulative force to the tool's handle "in a single motion" to "simultaneously" rotate the group of vertebrae.
  • The complaint does not explicitly reserve the right to assert other claims of the '358 Patent.

U.S. Patent No. 8,361,121 - "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS"

  • Patent Identification: U.S. Patent No. 8,361,121, "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS," issued January 29, 2013.

The Invention Explained

  • Problem Addressed: As a continuation of the '358 patent's application, the '121 Patent addresses the same problem of safely and effectively correcting severe, three-dimensional spinal deformities ('121 Patent, col. 2:56-62).
  • The Patented Solution: The '121 Patent claims a system for performing en bloc vertebral alignment. The system includes two sets of "pedicle screw cluster derotation tools"—one for each side of the spine—each comprising three or more "mechanically linked" engagement members (levers). A "cross-linking member" connects the two sets of tools, enabling them to be manipulated in unison to achieve derotation ('121 Patent, Claim 2, col. 7:58-8:34). This system is designed to be used with pre-contoured spinal rods to secure the correction ('121 Patent, col. 5:48-54).
  • Technical Importance: The claimed system provides a specific architecture for bilateral, coordinated control over multiple vertebrae, aiming to give surgeons a robust and comprehensive toolset for complex spinal reconstruction ('121 Patent, col. 4:5-16).

Key Claims at a Glance

  • The complaint asserts system claims 2, 3, and 4 (Compl. ¶19, ¶75).
  • Independent Claim 2 recites a system comprising:
    • A first set of pedicle screws.
    • A first "pedicle screw cluster derotation tool" having a handle and a group of "three or more" mechanically linked engagement members.
    • A second set of pedicle screws.
    • A second "pedicle screw cluster derotation tool" for the second set of screws.
    • A "cross-linking member" that links the first handle means to the second handle means.
  • The complaint reserves the right to assert other claims through its use of "for example" (Compl. ¶19).

U.S. Patent No. 9,339,301 - "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS"

  • Patent Identification: U.S. Patent No. 9,339,301, "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS," issued May 17, 2016.
  • Technology Synopsis: Continuing the same patent family, the '301 Patent claims both a system and method for aligning vertebrae. The invention addresses the challenge of 3D spinal correction by using interconnected engagement members to apply simultaneous rotative force to clusters of vertebrae, which are then fixed in place with spinal rods ('301 Patent, Abstract; col. 4:1-10).
  • Asserted Claims: Claims 1-10 are asserted (Compl. ¶24, ¶92). Independent claims include Claim 1 (a system) and Claim 6 (a method).
  • Accused Features: The EXPEDIUM and VIPER 3D systems are alleged to constitute the claimed system and be used to perform the claimed method of en bloc derotation (Compl. ¶91-100).

U.S. Patent No. 9,668,787 - "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS"

  • Patent Identification: U.S. Patent No. 9,668,787, "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS," issued June 6, 2017.
  • Technology Synopsis: This patent claims a method for applying manipulative force to the spine using a construct of at least four pedicle screws and at least four "elongated levers." The levers are linked axially and transversely, allowing an operator to move them in unison and rotate the vertebrae about a "spinal column roll axis" ('787 Patent, Abstract).
  • Asserted Claims: Claims 1-9 are asserted (Compl. ¶29, ¶107). Independent claim is 1 (a method).
  • Accused Features: The use of the EXPEDIUM and VIPER 3D systems by surgeons is alleged to be a performance of the claimed method of linking levers and rotating vertebrae simultaneously (Compl. ¶107-114).

U.S. Patent No. 9,668,788 - "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS"

  • Patent Identification: U.S. Patent No. 9,668,788 B2, "SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN THE AMELIORATION OF ABERRANT SPINAL COLUMN DEVIATION CONDITIONS," issued June 6, 2017.
  • Technology Synopsis: A counterpart to the '787 patent, the '788 Patent claims the system itself rather than the method. The claimed system comprises at least four pedicle screws, at least four elongated levers, and linking members that enable an operator to move the levers in unison to rotate the vertebrae ('788 Patent, Abstract).
  • Asserted Claims: Claims 1-6 are asserted (Compl. ¶34, ¶121). Independent claims include 1 and 3 (systems).
  • Accused Features: The EXPEDIUM and VIPER 3D systems are alleged to be infringing embodiments of the claimed system of linked levers (Compl. ¶121-130).

III. The Accused Instrumentality

Product Identification

  • The "DePuy Synthes Products," which are identified as the EXPEDIUM® Vertebral Derotation System and the VIPER® 3D MIS Correction Set (Compl. ¶47).

Functionality and Market Context

  • The complaint alleges that these products are instrument sets used by surgeons to "derotate en bloc multiple levels of vertebrae" (Compl. ¶47). The EXPEDIUM system is alleged to provide "360° control over anchor points" for "multiple level derotation," while the VIPER 3D system is alleged to address "torsional asymmetry created by scoliosis" through "en bloc derotation" (Compl. ¶52, ¶57).
  • The image of the EXPEDIUM system in the complaint shows an assembly of multiple long-handled levers attached to pedicle screws on a model spine, with the levers connected by cross-members (Compl. ¶50). A similar image provided for the VIPER 3D system also depicts a construct of multiple, interconnected levers attached to vertebrae for a surgical correction procedure (Compl. ¶55).
  • The complaint alleges these products were designed to compete in the market with Medtronic's VCM product and Biomet's Trivium Derotation System, the latter of which was allegedly developed under license to Dr. Barry's patents (Compl. ¶37, ¶48).

IV. Analysis of Infringement Allegations

'358 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
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 with said first handle means The EXPEDIUM and VIPER systems are alleged to be or include such tools, comprising engagement members (levers) that are linked together "one to another on both sides of the spine as well as across the spine." ¶63, ¶67 col. 5:1-7
implanting a each pedicle screw in a pedicle region of each of a first group of multiple vertebrae of a spinal column The accused systems are allegedly used with "at least two sets of pedicles screws implanted in multiple levels of vertebrae." ¶63, ¶67 col. 4:50-54
applying manipulative force to said first handle means in a manner for simultaneously engaging said first group of pedicle screw engagement members and first set of pedicle screws and thereby in a single motion simultaneously rotating said vertebrae The complaint alleges that when force is applied to the linked construct, it "is received simultaneously across the engagement members resulting in the derotation of the vertebrae." ¶63, ¶6g7 col. 5:25-35

'121 Patent Infringement Allegations

Claim Element (from Independent Claim 2) Alleged Infringing Functionality Complaint Citation Patent Citation
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 accused systems allegedly have engagement members acting as levers attached to pedicle screws, as shown in the image at Paragraph 50 which depicts six such levers. ¶78, ¶83 col. 6:38-46
a second pedicle screw cluster derotation tool... The allegations describe linking members "on both sides of the spine," suggesting a bilateral system with two sets of tools as claimed. ¶78, ¶83 col. 7:6-10
a cross-linking member that links the first handle means to the second handle means. The complaint alleges, and the images at Paragraphs 50 and 55 appear to show, linking members that connect the levers "across the spine," which corresponds to the claimed cross-linking member. ¶78, ¶83 col. 8:32-34
  • Identified Points of Contention:
    • Scope Questions: A primary question may be how the term "pedicle screw cluster derotation tool" is construed. Does the term, as used in the patents, require a single, pre-assembled instrument, or can it be read on a set of individual components (levers, connectors) that are assembled by the surgeon during the procedure, as is suggested by the accused products?
    • Technical Questions: For the method claims of the '358 Patent, a factual question will be whether the accused systems are used to perform a "single motion" that results in "simultaneously rotating" the vertebrae. The defense may argue that the tools allow for sequential or adjusted movements that fall outside the literal scope of this claim language.

V. Key Claim Terms for Construction

  • The Term: "pedicle screw cluster derotation tool" ('358 Patent, Claim 1; '121 Patent, Claim 2)

  • Context and Importance: This term is the central component of the claimed inventions. Its scope will be critical, as the infringement analysis depends on whether the accused EXPEDIUM and VIPER systems, which appear to be kits of parts, meet the definition of a singular "tool." Practitioners may focus on this term because it distinguishes the invention from prior art that manipulated vertebrae individually.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification focuses on the function of applying force en bloc to a "cluster" of vertebrae, stating the tool's object is to "facilitate simultaneous application of manipulative forces to multiple pedicle screws" ('358 Patent, col. 5:25-29). This functional language may support a construction that covers any apparatus, whether pre-assembled or assembled in-situ, that performs this role.
    • Evidence for a Narrower Interpretation: The repeated use of the singular term "tool" could support a narrower construction requiring a single, integrated instrument. The abstract refers to "A pedicle screw cluster derotation tool," which a party could argue points toward a unitary device rather than a collection of separate components ('358 Patent, Abstract).

  • The Term: "mechanically linked" ('358 Patent, Claim 1; '121 Patent, Claim 2)

  • Context and Importance: The nature of the connection between the individual levers is a core technical feature. The dispute may turn on whether the specific connectors and cross-bar mechanisms of the accused products create a "link" sufficient to compel the unified, simultaneous movement required by the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the purpose of the linking members is to join the wrenches "to act in unison during use" ('358 Patent, col. 5:4-5). This suggests that any form of mechanical connection that achieves this coordinated motion could fall within the claim's scope.
    • Evidence for a Narrower Interpretation: A defendant could argue for a more limited scope by pointing to the specific disclosed "wrench cross linking members" and "pedicle screw wrench linking members" as the only supported structures for the link ('358 Patent, col. 5:3-11). This could raise the question of whether the accused products' connectors are structurally equivalent to these embodiments.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on allegations that DePuy Synthes provides instructions, education, and training that encourage surgeons to assemble and use the accused systems in an infringing manner (Compl. ¶62, ¶66, ¶69). The basis for contributory infringement is the allegation that, when assembled as instructed, the accused systems have no substantial non-infringing use and are not staple articles of commerce (Compl. ¶64, ¶68).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged knowledge of the patents. This knowledge is purportedly established through multiple events, including: Defendant's alleged general awareness of Dr. Barry's patents since 2010 (Compl. ¶37); Defendant citing the application for the '358 patent during the prosecution of its own patent (Compl. ¶38); and, most notably, Defendant's alleged awareness of prior litigation against Medtronic on the '358 and '121 patents, which included a subpoena served on DePuy Synthes that specifically identified those patents and resulted in a verdict of willful infringement (Compl. ¶40-42).

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 recited in the singular, be construed to read on the accused EXPEDIUM and VIPER systems, which are provided as kits of assemblable parts? The outcome may depend on whether the term is defined by its integrated en bloc function or by a more restrictive physical structure.
  • A key question for willfulness will be the impact of prior notice: The complaint alleges that Defendant had pre-suit knowledge of the patents-in-suit and of a prior court ruling where two of those patents were found to be willfully infringed by a competitor. A central issue will be whether Defendant's continued marketing of the accused products in light of this alleged knowledge was objectively reckless.
  • An evidentiary question will be one of operative function: For the method claims, the case may turn on evidence of how surgeons actually use the accused systems in the operating room. Does the standard, instructed use of the EXPEDIUM and VIPER systems result in the "simultaneously rotating" of vertebrae in a "single motion" as required by the claims, or is there a material difference in the real-world application of the technology?