DePuy Synthes Products Inc v. Globus Medical Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Synthes USA, LLC; Synthes USA Products, LLC; Synthes USA Sales, LLC (Delaware)
  • Defendant: Globus Medical, Inc. (Delaware)
  • Plaintiff’s Counsel: Young Conaway Stargatt & Taylor, LLP; Axinn, Veltrop & Harkrider LLP
• Case Identification: 1:11-cv-00652, D. Del., 07/22/2011
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because the defendant, Globus Medical, is a Delaware corporation and has previously been sued in the district without challenging personal jurisdiction.
• Core Dispute: Plaintiff alleges that Defendant’s intervertebral implant systems infringe three patents related to the design of spinal fusion cages, specifically concerning the methods for securing the implant and fixation screws.
• Technical Context: The technology relates to intervertebral implants used in spinal fusion surgery to replace a damaged or diseased vertebral disc, promoting bone growth between adjacent vertebrae.
• Key Procedural History: The asserted patents are part of a family stemming from earlier international (PCT) applications. The complaint notes that the defendant has previously been sued in this district.

Case Timeline

Date	Event
2002-02-19	Priority Date for ’076 Patent
2003-02-06	Priority Date for ’207 and ’616 Patents
2010-12-07	’207 Patent Issued
2011-01-04	’616 Patent Issued
2011-01-25	’076 Patent Issued
2011-07-22	Complaint Filed

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

U.S. Patent No. 7,846,207 - Intervertebral Implant, issued December 7, 2010

The Invention Explained

• Problem Addressed: The patent’s background section describes problems with prior art intervertebral implants where the fastening screws used to secure the implant to the vertebrae can loosen over time. This loosening can lead to implant migration, damage to surrounding blood vessels, and a failure of the spinal fusion (pseudoarthrosis) (’207 Patent, col. 2:21-46).
• The Patented Solution: The invention is a multi-component intervertebral implant designed to prevent screw loosening. It consists of a main three-dimensional body (a cage), a "front plate" that fits into the body as an insert, and a "securing plate." After fixation screws are inserted through the front plate into the vertebrae, the securing plate is fastened over the front plate, physically covering the screw heads and capturing them between the two plates. This configuration is intended to create a solid connection and prevent the screws from backing out (’207 Patent, Abstract; col. 2:50-65).
• Technical Importance: This design offers a method to secure all fixation elements simultaneously with a single locking component, while also allowing for "stress shielding," where the implant components can move slightly to promote bone healing (’207 Patent, col. 4:63-col. 5:2).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" without specification (Compl. ¶13). Independent claim 1 is representative.
• Essential elements of independent claim 1 include:
  • A three-dimensional body with teeth for engaging vertebrae.
  • A front plate mounted to the front surface of the body, with at least first and second boreholes.
  • First and second fixation elements (e.g., screws) that are anchorable within the boreholes.
  • A securing plate fastened to the front plate that covers the boreholes and the heads of the fixation elements.
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,862,616 - Intervertebral Implant, issued January 4, 2011

The Invention Explained

• Problem Addressed: As with the related ’207 Patent, this invention addresses the need for a rigid, reliable connection between an intervertebral implant and its bone fixation means to prevent loosening and associated complications (’616 Patent, col. 1:21-49).
• The Patented Solution: This patent claims an implant assembly with specific material and dimensional characteristics. It describes a three-dimensional body made of a non-metallic material (e.g., plastic) and a plate made of a metallic material. Critically, the height of the body and the height of the plate are claimed to be "substantially equal," ensuring the entire assembly fits properly within the disc space between two vertebrae (’616 Patent, col. 6:40-64). This combination of materials aims to leverage the benefits of each (e.g., radiolucency of plastic, strength of metal).
• Technical Importance: The use of dissimilar materials for the body and plate allows for implant optimization, while the "substantially equal" height limitation addresses the practical surgical requirement of creating a contained, low-profile construct that does not protrude from the vertebral space.

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" (Compl. ¶20). Independent claim 1 is representative.
• Essential elements of independent claim 1 include:
  • A plurality of bone fixation elements.
  • A three-dimensional body made from a biocompatible non-metallic material.
  • A plate made from a biocompatible metallic material, coupled to the front of the body.
  • The body having a first height and the plate having a second height, where the "first height being substantially equal to the second height."
• The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsule: U.S. Patent No. 7,875,076

• Patent Identification: U.S. Patent No. 7,875,076, Intervertebral Implant, issued January 25, 2011.
• Technology Synopsis: This patent, from the same family, also describes an intervertebral implant system designed for rigid fixation. The claims focus on the geometric relationship of the components, including a body and a coupled plate that are pre-assembled and inserted as a single unit, with the entire implant being contained between the vertebral endplates after insertion (’076 Patent, cl. 6; Abstract). The invention emphasizes features like divergent screw angles to improve purchase in the bone (’076 Patent, cl. 7).
• Asserted Claims: "one or more claims" (Compl. ¶27). Representative independent claims include 1 and 6.
• Accused Features: The complaint alleges that Defendant's Independence™ ALIF System, Coalition™ ACDF System, and InterContinental™ Plate-Spacer products infringe the patent (Compl. ¶27).

III. The Accused Instrumentality

Product Identification

• The accused instrumentalities are Defendant’s Independence™ ALIF System, Coalition™ ACDF System, and InterContinental™ Plate-Spacer products (Compl. ¶13, 20, 27).

Functionality and Market Context

• The complaint identifies these as medical device products but does not provide any specific technical details, diagrams, or descriptions of their components or operation. The product names suggest they are intervertebral implants for different surgical approaches (ALIF: Anterior Lumbar Interbody Fusion; ACDF: Anterior Cervical Discectomy and Fusion). The complaint does not provide sufficient detail for analysis of their specific functionality or market positioning.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-chart analysis. The infringement allegations are made at a high level, asserting that the accused products infringe "one or more claims" of the patents-in-suit by being made, used, or sold in the United States (Compl. ¶13, 20, 27). The complaint lacks specific factual allegations mapping features of the accused products to the elements of any asserted claim.

Identified Points of Contention

• ’207 Patent: A central question will be whether the accused Globus products possess the specific three-part structure claimed: a main body, a separate front plate, and a distinct "securing plate" that captures the heads of fixation elements. The analysis will depend on whether the accused products contain components that meet these structural and functional definitions.
• ’616 Patent: An initial point of dispute will likely be factual: are the accused products constructed with a non-metallic body and a metallic front plate as claimed? If so, the analysis will turn on a question of claim scope: does the dimensional relationship of the components in the accused products meet the "substantially equal" height limitation of claim 1?

V. Key Claim Terms for Construction

’207 Patent

• The Term: "securing plate" (claim 1)
• Context and Importance: The "securing plate" is the primary locking mechanism in the claimed invention. Its definition is critical to distinguishing the invention from prior art and from potentially different locking mechanisms in the accused products. The dispute will center on whether this term requires a structurally separate component from the "front plate" or if an integrated locking feature could meet the definition.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Narrower Interpretation: The specification and figures consistently depict the "securing plate" (18) as a distinct component that is fastened to the "front plate" (8) via a separate fastening means (16) (’207 Patent, Fig. 1; col. 4:4-17). This suggests the two plates are separate and non-integral.
  • Evidence for a Broader Interpretation: A party might argue that the functional language—that the plate is "fastened...in such a manner that the...boreholes...are covered" (’207 Patent, col. 6:55-59)—is paramount, and any component that performs this securing function, regardless of its specific form, could fall within the scope.

’616 Patent

• The Term: "substantially equal" (claim 1)
• Context and Importance: This term of degree defines the required dimensional relationship between the non-metallic body and the metallic plate. Its construction will determine the literal scope of infringement. A narrow definition could allow a product with even a small height mismatch to escape infringement, while a broad one would cover a wider range of designs. Practitioners may focus on this term because its ambiguity makes it a likely subject for litigation.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Narrower Interpretation: A defendant could argue "substantially equal" means nearly identical in height, as necessary to create a flush, unified construct that sits cleanly between the vertebrae, which is a goal of such implants. The patent does not provide a numeric range, suggesting a strict interpretation may be warranted.
  • Evidence for a Broader Interpretation: The patent’s objective is to create an implant that is "contained between the adjacent vertebral bodies" (’616 Patent, col. 6:61-64). A plaintiff could argue that any height relationship that achieves this functional goal without creating a clinically significant protrusion would be "substantially equal" from the perspective of a person of ordinary skill in the art.

VI. Other Allegations

• Indirect Infringement: The complaint makes conclusory allegations of induced and contributory infringement for all three patents (Compl. ¶14, 21, 28). It does not, however, plead specific facts to support the required elements of knowledge and intent, such as referencing user manuals or marketing materials that instruct on an infringing use.
• Willful Infringement: Willfulness is alleged for all three patents "upon information and belief," based on alleged knowledge of the patents (Compl. ¶15, 22, 29). The complaint does not allege any specific facts to support pre-suit knowledge, such as prior correspondence or litigation on these specific patents.

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

Given the notice-pleading style of the complaint, the case presents several fundamental open questions that will define the litigation as it proceeds.

1. A core issue will be one of evidentiary proof: As the case moves into discovery, will the technical details of Globus’s accused implant systems reveal the specific multi-component structures required by the patents? Specifically, do they employ a distinct, separate "securing plate" as described in the ’207 patent, and do they use the metallic/non-metallic material combination with "substantially equal" heights as claimed in the ’616 patent?

2. The case will likely involve a significant dispute over claim construction, particularly for terms of degree. The meaning of "substantially equal" in the context of the ’616 patent’s height limitation will be a critical battleground that could either narrowly restrict the patent's scope to near-identical dimensions or broaden it to include any clinically acceptable variance.

3. A third key question relates to infringement theory: With three patents-in-suit from the same family, a central issue will be how Plaintiff differentiates its infringement contentions for each patent. The court will expect a clear explanation of how the accused products are alleged to meet the distinct limitations of each asserted patent and claim.