DCT

1:22-cv-01368

Spinal Generations LLC v. DePuy Synthes Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-01368, D. Del., 09/06/2023
  • Venue Allegations: Venue is alleged as proper in the District of Delaware because most Defendants are organized under the laws of Delaware. For Defendant Synthes Sales, venue is based on alleged acts of infringement within the district and maintenance of a regular and established place of business there.
  • Core Dispute: Plaintiff alleges that Defendants’ TFN-Advanced Proximal Femoral Nailing (TFNA) System, when used with its Augmentation System, infringes five patents related to orthopedic devices for delivering substances like bone cement to specific locations within a bone.
  • Technical Context: The technology concerns orthopedic surgical implants, specifically cannulated (hollow) bone screws and internal inserts designed to provide a precise, controllable pathway for delivering therapeutic agents or bone fillers to a fracture site.
  • Key Procedural History: The complaint alleges that the inventor, Dr. Patrick Sweeney, met with senior executives from Defendant DePuy Synthes in 2014-2015 to discuss a potential partnership, during which he disclosed his patented "Flow-Nail" technology and the existence of the patents-in-suit. After Defendants declined to partner, they allegedly launched the accused TFNA system in 2017, which Plaintiff asserts incorporates the patented technology. These allegations of pre-suit knowledge form the basis for claims of willful infringement.

Case Timeline

Date Event
2003-07-15 Earliest Priority Date for all Patents-in-Suit
2009-05-05 U.S. Patent No. 7,527,611 Issues
2009-08-18 U.S. Patent No. 7,575,572 Issues
2010-03-01 Dr. Sweeney forms Flow-FX (approx. date)
2011-11-22 U.S. Patent No. 8,062,270 Issues
2012-03-29 Plaintiff's UK counsel allegedly sends letter regarding related European patent to Synthes Ltd
2014-01-08 Dr. Sweeney allegedly emails DePuy representative with copies of the ’611 and ’572 patents
2014-07-02 Plaintiff’s licensee (Flow-FX) receives FDA marketing authorization for its product
2014-08-19 U.S. Patent No. 8,808,337 Issues
2015-04-17 Dr. Sweeney allegedly presents patented technology to senior DePuy executives
2015-07-22 DePuy allegedly informs Dr. Sweeney it is not interested in a partnership
2017-10-01 Defendants allegedly first sell the accused TFNA Augmentation System in the U.S. (approx. date)
2018-04-24 U.S. Patent No. 9,949,777 Issues
2023-09-06 First Amended Complaint Filed

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

U.S. Patent No. 7,527,611 - Method and Device for Delivering Medicine to Bone

The Invention Explained

  • Problem Addressed: The patent’s background section describes the difficulty of delivering therapeutic substances like medicants or bone cement to a specific, targeted area within a bone. Prior art devices such as delivery pins or simple cannulated screws allegedly lacked the ability to customize or precisely control the delivery location and amount once the device was implanted. (Compl. ¶¶25-28; ’611 Patent, col. 1:15-51).
  • The Patented Solution: The invention is a system comprising a hollow, "cannulated" bone screw with openings ("fenestrations") along its shaft, and a separate cannulated insert that slides inside the screw. The insert also has fenestrations. By positioning the insert, a surgeon can align the insert's openings with specific screw openings to create a precise delivery path, while the body of the insert blocks other screw openings, preventing leakage or waste. (’611 Patent, col. 2:5-15, Fig. 4).
  • Technical Importance: This approach allows a surgeon to tailor the substance delivery pathway after the bone screw has been fixed in the patient, enabling more precise application of therapeutics to a fracture interface. (Compl. ¶28, ¶41).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶100).
  • Claim 1 (System):
    • a bone screw comprising two ends connected by a shaft, wherein the shaft is threaded along at least a portion of its exterior and cannulated along at least a portion of its length, and further wherein the bone-screw is threaded along at least a portion of its interior;
    • one or more bone-screw fenestrations disposed along the cannulated portion of the bone-screw shaft;
    • an insert disposed inside the bone-screw cannulation, wherein the insert is cannulated along at least a portion of its length;
    • and further wherein the insert is threaded along at least a portion of its exterior and configured to interlock with the threaded portion of the bone-screw cannulation; and
    • one or more insert fenestrations disposed along the cannulated portion of the insert.
  • The complaint reserves the right to assert additional claims. (Compl. ¶100 n.1).

U.S. Patent No. 7,575,572 - Method and Device for Delivering Medicine to Bone

The Invention Explained

  • Problem Addressed: As with the ’611 Patent, this patent addresses the need for a device capable of delivering a substance to specific areas within a bone, such as a fracture interface, and the ability to customize the delivery location after the screw is in place. (’572 Patent, col. 1:45-51).
  • The Patented Solution: The patent describes a similar device with a cannulated, fenestrated bone screw and a corresponding internal insert. This patent’s claims emphasize the insert’s ability to be moved between two distinct positions: a "first position" where the insert’s shaft blocks the screw’s fenestrations to prevent material from entering, and a "second position" where the insert’s fenestrations align with the screw’s fenestrations to create a delivery pathway. (’572 Patent, Abstract; col. 4:26-43).
  • Technical Importance: This claimed functionality highlights the invention's role as a selective valve or gate, allowing a surgeon to open and close specific delivery ports on demand without repositioning the primary fixation screw. (Compl. ¶41).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶132).
  • Claim 1 (Device):
    • a bone screw comprising two ends connected by a shaft, wherein the shaft is cannulated along at least a portion of its length;
    • one or more bone-screw fenestrations disposed along the cannulated portion of the bone-screw shaft;
    • an insert disposed inside the cannulated bone-screw shaft, wherein the insert comprises two ends connected by a shaft and is cannulated along at least a portion of its length;
    • one or more insert fenestrations disposed along the cannulated portion of the insert between the two ends of the insert;
    • wherein the insert is movable between: a first position wherein none of the one or more insert fenestrations align with the one or more bone-screw fenestrations such that at least a portion of the shaft of the insert substantially prevents material from entering...and a second position wherein the insert provides a delivery pathway...
  • The complaint reserves the right to assert additional claims. (Compl. ¶100 n.1).

U.S. Patent No. 8,062,270 - Method and Device for Delivering Medicine to Bone

  • Technology Synopsis: This patent claims a system for implantation within a bone that focuses on the insert component. The claimed insert includes a self-sealing seal, such as an end cap, which is configured to provide access to the insert’s internal channel after the system has been implanted. (Compl. ¶154).
  • Asserted Claims: Independent claim 1 is asserted. (Compl. ¶154).
  • Accused Features: The complaint alleges that the "Luer-lock" mechanism, which connects the cement syringe to the "side-opening cannula" in the accused TFNA system, functions as the claimed self-sealing seal. (Compl. ¶155(d)).

U.S. Patent No. 8,808,337 - Method and Device for Delivering Medicine to Bone

  • Technology Synopsis: This patent claims a system combining an insert and a bone screw adapted to receive it. The claims focus on the movability of the insert between a first, blocking position and a second, delivery position, similar to the concept in the ’572 Patent. (Compl. ¶176).
  • Asserted Claims: Independent claim 1 is asserted. (Compl. ¶176).
  • Accused Features: The alleged infringement centers on the ability of the accused "side-opening cannula" (the insert) to be moved within the cannulated TFNA "helical blade or screw" (the bone screw) to either block or align with the screw's fenestrations. (Compl. ¶¶177(b)-(d)).

U.S. Patent No. 9,949,777 - Method and Device for Delivering Medicine to Bone

  • Technology Synopsis: This patent claims a method for the long-term delivery of fluids to a bone. The claimed steps include providing a cannulated bone screw and a threaded insert, creating an aperture in the patient's skin, inserting the components, and delivering a fluid. A key limitation is that the insert "at least partially protrudes through the skin when coupled to the bone screw." (Compl. ¶197).
  • Asserted Claims: Independent claim 11 is asserted. (Compl. ¶197).
  • Accused Features: Infringement is alleged based on the surgical procedure that Defendants instruct surgeons to perform using the TFNA system, which allegedly includes all the claimed steps. (Compl. ¶¶198-199).

III. The Accused Instrumentality

Product Identification

  • Defendants’ "TFN-Advanced Proximal Femoral Nailing System (TFNA)" when used in conjunction with the "TRAUMACEM V+ Augmentation System" (collectively, the "Accused Instrumentalities"). (Compl. ¶¶47, 50, 99).

Functionality and Market Context

  • The TFNA system is an orthopedic device used to treat femur and hip fractures. (Compl. ¶47). The system includes a "nail" inserted into the femur, which acts as an anchor for a "head" (either a "TFNA Screw" or a "TFNA Helical Blade"). (Compl. ¶50). These heads are cannulated and fenestrated. (Compl. ¶50(b)). The Augmentation System is used to deliver bone cement through these components and includes a "Side-Opening Cannula," which is inserted into the head, and a syringe kit to inject the cement. (Compl. ¶50(c)). The complaint alleges that the Accused Instrumentalities are a commercially significant product for Defendants and constitute a "core platform" that is central to their trauma product line. (Compl. ¶55, ¶104). The complaint provides an image from Defendant's materials showing the TFNA Screw and Helical Blade, identifying them as cannulated. (Compl. ¶101(b)).

IV. Analysis of Infringement Allegations

U.S. Patent No. 7,527,611 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a bone screw comprising two ends connected by a shaft, wherein the shaft is threaded along at least a portion of its exterior and cannulated along at least a portion of its length, and further wherein the bone-screw is threaded along at least a portion of its interior The TFNA system's "helical blade or screw" component, which is alleged to have two ends, a shaft, external threading, an internal cannulation, and internal threading. ¶101(b) col. 4:48-61
one or more bone-screw fenestrations disposed along the cannulated portion of the bone-screw shaft The helical blade and screw each have openings (fenestrations) along their cannulated shafts to allow cement to flow out. ¶101(c) col. 4:59-61
an insert disposed inside the bone-screw cannulation, wherein the insert is cannulated along at least a portion of its length The "side-opening cannula" of the Augmentation System, which is inserted into the cannulation of the helical blade or screw and is itself cannulated. The complaint provides an image showing the cannula being inserted into the guide sleeve toward the blade/screw. (Compl. ¶101(d)). ¶101(d) col. 5:14-20
and further wherein the insert is threaded along at least a portion of its exterior and configured to interlock with the threaded portion of the bone-screw cannulation The side-opening cannula is alleged to be threaded on its exterior and is designed to be inserted through the threaded portion of the bone-screw cannulation, which Plaintiff alleges constitutes an interlocking configuration. ¶101(d) col. 5:44-48
and one or more insert fenestrations disposed along the cannulated portion of the insert. The side-opening cannula has one or more openings ("insert fenestrations") along its cannulated portion. The complaint includes a close-up image labeling this feature. (Compl. ¶101(e)). ¶101(e) col. 5:15-25
  • Identified Points of Contention:
    • Scope Questions: A primary dispute may arise over the interpretation of "configured to interlock with the threaded portion of the bone-screw cannulation." The complaint alleges this is met because the cannula is inserted through the threaded portion and its position is adjusted by turning a sleeve. (Compl. ¶101(d)). The question for the court will be whether this arrangement satisfies the "interlock" limitation, or if the claim requires direct mating of threads between the insert and the screw itself.

U.S. Patent No. 7,575,572 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a bone screw comprising two ends connected by a shaft, wherein the shaft is cannulated along at least a portion of its length The TFNA helical blade or screw, which is cannulated. ¶133(b) col. 3:20-22
one or more bone-screw fenestrations disposed along the cannulated portion of the bone-screw shaft The fenestrations on the TFNA helical blade or screw. ¶133(c) col. 3:23-25
an insert disposed inside the cannulated bone-screw shaft...is cannulated along at least a portion of its length The "side-opening cannula" is an insert disposed inside the helical blade or screw and is itself cannulated. ¶133(d) col. 3:26-31
one or more insert fenestrations disposed along the cannulated portion of the insert between the two ends of the insert The side-opening cannula includes one or more insert fenestrations along its cannulated portion. ¶133(e) col. 3:32-35
wherein the insert is movable between: a first position wherein none of the one or more insert fenestrations align...such that at least a portion of the shaft of the insert substantially prevents material from entering...and a second position wherein the insert provides a delivery pathway The side-opening cannula is alleged to be movable. The "first position" is achieved when its fenestration is aligned with a solid, non-fenestrated portion of the helical blade/screw, blocking flow. The "second position" is achieved when its fenestration is aligned with a fenestration on the helical blade/screw, creating a delivery path. The complaint includes an image showing fenestrated and non-fenestrated portions of the accused screws. (Compl. ¶133(f)). ¶133(f) col. 4:26-43
  • Identified Points of Contention:
    • Technical Questions: The analysis will likely focus on whether the accused device's operation meets the functional language of the "first position." A key question is whether merely positioning the insert’s opening against a solid portion of the screw’s inner wall achieves the function of "substantially prevent[ing] material from entering the cannulated portion of the bone-screw." The evidence will need to show that this arrangement performs the claimed blocking function.

V. Key Claim Terms for Construction

  • For the ’611 Patent:

    • The Term: "configured to interlock with the threaded portion of the bone-screw cannulation"
    • Context and Importance: This term is critical because the accused product uses a sleeve adjustment mechanism, not a direct screw-in fit between the insert and the bone screw. The definition of "interlock" will determine whether this element is met. Practitioners may focus on this term because the complaint's theory appears to rely on an interpretation that does not require direct thread-on-thread mating.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent states that the insert threads "interlock with bone screw threads 140 of FIG. 1 to help fix an insert 300 into a bone screw 100." (’611 Patent, col. 5:44-48). Plaintiff may argue that any configuration that uses threads to achieve a fixed, stable position—even indirectly via a sleeve—satisfies this functional language.
      • Evidence for a Narrower Interpretation: The plain language and the embodiment shown in Figure 4 (depicting insert 400 being placed in screw 410) suggest a direct engagement between threads on the insert and threads on the screw. (’611 Patent, Fig. 4). Defendants may argue that "interlock" requires this direct, mating engagement, which is absent in the accused sleeve mechanism.

  • For the ’572 Patent:

    • The Term: "a first position wherein...the insert substantially prevents material from entering the cannulated portion of the bone-screw"
    • Context and Importance: This is a negative functional limitation that defines the "closed" or "blocking" state of the device. Infringement requires showing that the accused device is used in a manner that achieves this state. Practitioners may focus on this term because it requires a functional, not merely structural, analysis of how the accused device operates.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The summary of the invention explains that the inserts "allow one to selectively block the bone-screw fenestrations to which substance delivery is not desired." (’572 Patent, col. 2:8-10). This suggests the primary function is blocking egress, which could be accomplished by simple misalignment of openings.
      • Evidence for a Narrower Interpretation: The specification also states the insert may initially serve the purpose of "preventing bone fragments, blood, fat, or other materials from entering the cannulated portion of the bone screw." (’572 Patent, col. 2:37-41) (emphasis added). This could suggest a more robust sealing function is required for the "first position" than simply misaligning the delivery ports.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for each asserted patent. Inducement is based on allegations that Defendants provide end-users (surgeons) with extensive instructional materials, including a 117-page "Surgical Technique" guide and videos, that expressly instruct on how to assemble and use the Accused Instrumentalities in a manner that directly infringes. (Compl. ¶¶113-114). Contributory infringement is based on allegations that the components of the Accused Instrumentalities are a material part of the invention, are not staple articles of commerce suitable for substantial non-infringing use, and were known by Defendants to be especially adapted for use in an infringing manner. (Compl. ¶¶121, 126-128).
  • Willful Infringement: Willfulness is alleged based on extensive pre-suit knowledge. The complaint details communications and a presentation in 2014-2015 where the inventor allegedly disclosed his technology and the patents-in-suit to senior DePuy executives. (Compl. ¶¶60-67). The complaint asserts that Defendants, with this knowledge, launched a "virtually indistinguishable" product years later, allegedly demonstrating egregious and willful conduct. (Compl. ¶¶3, 76-77, 218-220).

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

  • A central issue for the ’611 patent will be one of mechanical interpretation: does the accused product’s sleeve-based adjustment mechanism for positioning the cannula constitute an insert that is "configured to interlock with" the bone screw's internal threads as required by claim 1, or does the claim demand direct thread-on-thread engagement?
  • A key evidentiary question for the ’572 and ’337 patents will be one of functional performance: does the accused system’s ability to move the insert’s opening opposite a solid portion of the screw’s wall achieve the claimed function of a "first position" that "substantially prevents material from entering," or does this claim language require a more affirmative sealing action?
  • Given the detailed allegations of pre-suit meetings and technology disclosures, a critical factual dispute will concern Defendants' knowledge and intent: what is the evidence that Defendants had knowledge of the specific patents-in-suit prior to launching the accused system, and does their subsequent conduct support a finding that they deliberately copied the patented technology, thereby making the alleged infringement willful?