Barry v. DePuy Synthes Companies

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Dr. Mark A. Barry (Nevada)
  • Defendant: DePuy Synthes Products, Inc. (Delaware/Pennsylvania); Medical Device Business Services, Inc. (Indiana); and DePuy Synthes Sales, Inc. (Massachusetts/Pennsylvania) (collectively "DePuy Synthes")
  • Plaintiff's Counsel: Hangley Aronchick Segal Pudlin & Schiller
• Case Identification: 2:17-cv-03003, E.D. Pa., 09/28/2017
• Venue Allegations: Venue is alleged to be proper based on Defendant DePuy Synthes having a regular and established place of business in the district and committing acts of infringement, such as sales and promotion, within the district.
• Core Dispute: Plaintiff alleges that Defendant's spinal surgery systems, specifically the EXPEDIUM® Vertebral Derotation System and the VIPER® 3D MIS Correction Set, infringe five patents related to systems and methods for correcting spinal deformities.
• Technical Context: The technology at issue falls within the field of orthopedic spinal surgery, addressing methods and devices for correcting complex spinal curvatures, such as scoliosis, through the simultaneous, or "en bloc", manipulation of multiple vertebrae.
• Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the patents-in-suit. This knowledge is purportedly based on Defendant being served a subpoena on January 27, 2016, that identified the '358 and '121 patents in a prior case brought by the Plaintiff against Medtronic. That prior case resulted in a jury verdict of willful infringement and no invalidity. The complaint also alleges Defendant cited the application for the '358 patent during the prosecution of its own patent.

Case Timeline

Date	Event
2004-12-30	Earliest Priority Date for '358, '121, '301, '787, '788 Patents
2006-07-06	'358 Patent Application Published (as US 2006/0149236)
2010-03-02	U.S. Patent No. 7,670,358 ('358 Patent) Issued
2013-01-29	U.S. Patent No. 8,361,121 ('121 Patent) Issued
2016-01-27	DePuy Synthes allegedly served with subpoena in Medtronic Case
2016-05-17	U.S. Patent No. 9,339,301 ('301 Patent) Issued
2017-06-06	U.S. Patent No. 9,668,787 ('787 Patent) Issued
2017-06-06	U.S. Patent No. 9,668,788 ('788 Patent) Issued
2017-09-28	Amended Complaint Filed

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

U.S. Patent No. 7,670,358

• 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 deficiency in conventional treatments for spinal deformities like scoliosis Compl. ¶10 '358 Patent, col. 1:11-14 Prior methods focused on fixing vertebrae one by one, which limited the degree of possible correction and risked vertebral fracture if significant force was applied to a single point '358 Patent, col. 2:40-49
• The Patented Solution: The invention is a method that allows a surgeon to manipulate an entire segment of the spine "en bloc" '358 Patent, col. 2:63-68 This is achieved using a "pedicle screw cluster derotation tool" that simultaneously engages multiple pedicle screws implanted in adjacent vertebrae '358 Patent, abstract By linking the engagement points, the tool disperses the corrective force across a "cluster" of vertebrae, enabling a more significant, three-dimensional correction without the high risk of localized injury '358 Patent, col. 5:26-35
• Technical Importance: This method enabled surgeons to achieve a more complete three-dimensional correction of spinal deformities, including the axial rotation that is a key component of conditions like scoliosis, which was a perceived goal that existing methods could not consistently achieve '358 Patent, col. 2:51-57

Key Claims at a Glance

• The complaint asserts method claims 4 and 5 Compl. ¶14 These depend from independent claim 1.
  • Independent Claim 1, Essential Elements:
    • Selecting a set of pedicle screws.
    • Selecting a "pedicle screw cluster derotation tool" with "handle means" and a group of "pedicle screw engagement members which are mechanically linked."
    • Implanting the pedicle screws into a group of multiple vertebrae.
    • Engaging the engagement members with the heads of the pedicle screws.
    • Applying manipulative force to the handle means "in a single motion" to "simultaneously" rotate the vertebrae.
    • Selecting and securing a spinal rod to hold the corrected position.

U.S. Patent No. 8,361,121

• 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 with the parent '358 patent, the '121 Patent addresses the limitations of prior art spinal correction techniques that could not safely apply sufficient force to correct complex, multi-vertebrae deformities as a single unit '121 Patent, col. 3:1-11
• The Patented Solution: The '121 patent claims a system for performing the "en bloc" derotation. The system comprises sets of pedicle screws and corresponding "pedicle screw cluster derotation tools" for each side of the spine, linked by a "cross-linking member" '121 Patent, claim 2 This construct provides the physical apparatus for a surgeon to apply coordinated forces across the spine, simultaneously moving multiple levers to achieve a powerful, controlled rotation of a spinal segment around its "roll axis" '121 Patent, col. 6:62-65
• Technical Importance: The claimed system provides the specific instrumentation to execute the "en bloc" correction method, translating the concept into a defined set of mechanically linked tools that can be used predictably in a surgical setting '121 Patent, col. 4:5-15

Key Claims at a Glance

• The complaint asserts system claims 2, 3, and 4 Compl. ¶19 Claim 2 is independent.
  • Independent Claim 2, Essential Elements:
    • A first set of pedicle screws.
    • A first "pedicle screw cluster derotation tool" comprising a "first handle means" and a first group of "three or more pedicle screw engagement members which are mechanically linked."
    • A second set of pedicle screws.
    • A second "pedicle screw cluster derotation tool" with a "second handle means" and a second group of linked engagement members.
    • A "cross-linking member" that links the first handle means to the second handle means.

Multi-Patent Capsules for Additional Patents-in-Suit

• U.S. Patent No. 9,339,301

  • Patent Identification: U.S. Patent No. 9,339,301, issued May 17, 2016.
  • Technology Synopsis: The '301 patent discloses both a system and a method for spinal alignment. The invention involves using sets of pedicle screws and corresponding derotation tools with interconnected engagement members, allowing a surgeon to apply rotative force simultaneously to multiple vertebrae on both sides of the spine to correct deformities "en bloc" Compl. ¶24 '301 Patent, abstract
  • Asserted Claims: Claims 1-10 are asserted, including independent system claim 1 and independent method claim 6 Compl. ¶24
  • Accused Features: Both the EXPEDIUM® and VIPER® systems are accused of infringing the system claims, and their use by surgeons is accused of infringing the method claims. The infringement theory focuses on the systems' use of linked levers attached to pedicle screws for simultaneous derotation Compl. ¶¶94 Compl. ¶99

• U.S. Patent No. 9,668,787

  • Patent Identification: U.S. Patent No. 9,668,787, issued June 6, 2017.
  • Technology Synopsis: The '787 patent claims a method for applying manipulative force to the spine. The method involves implanting at least four pedicle screws, temporarily engaging them with at least four elongated levers, and linking the levers together in both axial and transverse directions. This allows a surgeon to move the linked levers in unison to rotate multiple vertebrae simultaneously Compl. ¶29 '787 Patent, abstract
  • Asserted Claims: Claims 1-9 are asserted, including multiple independent method claims Compl. ¶29
  • Accused Features: The use of the EXPEDIUM® and VIPER® systems is accused of infringing the method claims, based on the allegation that surgeons use these systems by attaching linked levers to multiple pedicle screws and moving them in unison to derotate vertebrae Compl. ¶¶109 Compl. ¶113

• U.S. Patent No. 9,668,788

  • Patent Identification: U.S. Patent No. 9,668,788 B2, issued June 6, 2017.
  • Technology Synopsis: The '788 patent claims a system for applying manipulative force. The system comprises at least four pedicle screws, four corresponding elongated levers, a linking member for axial connection, and a cross-linking member for transverse connection. This construct permits an operator to move the levers in unison to rotate the vertebrae Compl. ¶34 '788 Patent, abstract
  • Asserted Claims: Claims 1-6 are asserted, including independent system claims 1 and 6 Compl. ¶34
  • Accused Features: The EXPEDIUM® and VIPER® systems are accused of infringing the system claims, as they are alleged to be constructs of pedicle screws, levers, and linking members that enable simultaneous vertebral derotation Compl. ¶¶124 Compl. ¶129

III. The Accused Instrumentality

• Product Identification: The accused instrumentalities are the EXPEDIUM® Vertebral Derotation System and the VIPER® 3D MIS Correction Set Compl. ¶47
• Functionality and Market Context:
  • The complaint alleges these products are instrument sets used in spinal surgery to correct deformities like scoliosis (Compl. ¶52; Compl. ¶53). Functionally, they are described as comprising levers or rods that are attached to pedicle screws implanted in a patient's vertebrae (Compl. ¶¶50; Compl. ¶55).
  • The complaint contains an image of the EXPEDIUM® system, described as showing "six levers or rods attached to six pedicle screws and connected via rods both along the length of the spine as well as conversely across the spine" Compl. ¶50 A similar visual and description are provided for the VIPER® 3D MIS Correction Set Compl. ¶55
  • The stated purpose of the accused products is to achieve "en bloc derotation," provide "360° control over anchor points," and "address the torsional asymmetry created by scoliosis" Compl. ¶52 Compl. ¶57 The complaint alleges these products were designed to compete with products from Medtronic and Biomet Compl. ¶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 accused systems include "engagement members which act as levers" which are linked "one to another on both sides of the spine as well as across the spine."	¶63; ¶67	col. 5:1-6
implanting a each pedicle screw in a pedicle region of each of a first group of multiple vertebrae of a spinal column...	Surgeons are instructed to use the systems with "at least two sets of pedicles screws implanted in multiple levels of vertebrae."	¶63; ¶67	col. 6:21-25
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...	When force is applied to the construct, it "is received simultaneously across the engagement members resulting in the derotation of the vertebrae."	¶63; ¶67	col. 6:44-49

'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 with said first handle means...	The accused systems allegedly have "engagement members which act as levers" and are "designed to be grasped by one's hand, linking the engagement members one to another on both sides of the spine..."	¶78; ¶83	col. 5:7-14
a second pedicle screw cluster derotation tool...	The allegations describe a two-sided construct with levers linked "on both sides of the spine."	¶78; ¶83	col. 7:6-21
a cross-linking member that links the first handle means to the second handle means.	The accused systems are described as "linking the engagement members... across the spine." The image in the complaint depicts this cross-spinal linkage.	¶78; ¶50	col. 5:9-12 ('358 Patent)

• Identified Points of Contention:
  • Scope Questions: A central dispute may concern the definition of a "pedicle screw cluster derotation tool." The question is whether the accused systems-allegedly kits of individual levers and separate linking rods assembled during surgery-constitute a "tool" as claimed, or if the claims require a more integrated, pre-assembled device.
  • Technical Questions: The analysis may focus on the claim term "mechanically linked." A question for the court will be what level of integration is required to meet this limitation. Does the temporary connection of levers with rods during a procedure, as depicted for the accused products Compl. ¶50, constitute a "mechanical link," or does the term imply a more permanent or pre-configured connection like a hinge?

V. Key Claim Terms for Construction

• The Term: "pedicle screw cluster derotation tool"

  • Context and Importance: This term is central to both the '358 and '121 patents and defines the core of the invention. Whether the accused kits of parts meet this definition will be a critical issue for infringement. Practitioners may focus on this term because the accused products appear to be modular systems assembled in-situ, whereas the word "tool" could imply a singular, pre-fabricated instrument.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the tool's purpose is to "facilitate simultaneous application of manipulative forces to multiple pedicle screws" '358 Patent, col. 5:26-29 The patent also contemplates "significant variations" of the tool, suggesting the term is not limited to the exact embodiment shown '358 Patent, col. 5:18-19 This may support an argument that any assembly performing this function is a "tool."
    • Evidence for a Narrower Interpretation: The primary embodiment shows "pedicle screw wrenches 32, joined together by pedicle screw wrench linking members 42 to act in unison" '358 Patent, col. 5:2-5 This description of parts being "joined together" could be used to argue for a more integrated, pre-linked structure than a temporary assembly of separate levers and rods.

• The Term: "mechanically linked"

  • Context and Importance: This term defines how the "engagement members" of the "tool" are connected. Its construction is vital because the infringement allegation hinges on the linking rods of the accused systems creating this specific type of connection.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patents use the term generally, and the figures show components (wrenches 32) connected by other components (linking members 42 and 40) '358 Patent, Fig. 1 This could support a view that any physical connection that constrains motion and transfers force, such as the rods in the accused systems, constitutes a "mechanical link."
    • Evidence for a Narrower Interpretation: A defendant may argue that the term, in the context of the patent, implies a dedicated "linking member" that creates a specific, defined joint, rather than a generic rod that is simply placed to connect separate levers during a procedure. The claims of the '121 patent, for example, separately recite the "engagement members" and a "linking member," suggesting they are distinct components '121 Patent, claim 2

VI. Other Allegations

• Indirect Infringement: The complaint alleges both inducement and contributory infringement. The inducement claim is based on DePuy Synthes allegedly providing instructions, education, and training to surgeons on how to use the accused systems in an infringing manner, with the intent that they do so Compl. ¶¶62 Compl. ¶69 The contributory infringement claim is based on allegations that the accused systems have no substantial non-infringing use when assembled and are not staple articles of commerce Compl. ¶¶64 Compl. ¶79
• Willful Infringement: The complaint places significant emphasis on willful infringement. The allegations are based on purported pre-suit knowledge stemming from multiple sources: (1) DePuy Synthes allegedly cited the '358 patent's application during the prosecution of its own patent Compl. ¶38; (2) DePuy Synthes was allegedly served with a subpoena in prior litigation involving the '358 and '121 patents Compl. ¶¶41-42; and (3) DePuy Synthes's alleged awareness of a competitor's product (Biomet's Trivium system) that licensed the patent rights Compl. ¶37 The complaint asserts this knowledge makes the alleged infringement "deliberate and willful" Compl. ¶71 Compl. ¶87

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 central to the patents-in-suit, be construed to read on the accused EXPEDIUM® and VIPER® products, which are described as modular systems of separate levers and rods assembled during surgery, or is the claim term limited to a more integrated, pre-manufactured instrument?
• A critical question for damages will be one of culpability: what was the nature and timing of Defendant's alleged knowledge of the patents-in-suit, particularly in light of the allegation that it was served a subpoena identifying the patents in prior, successful litigation against a competitor, and does its subsequent conduct constitute willful infringement?
• A key strategic question will be the impact of prior litigation: how will the previous jury verdict finding the '358 and '121 patents not invalid and willfully infringed by a competitor influence the parties' strategies and the court's management of this case, particularly with respect to issues of willfulness and potential invalidity defenses?