DCT

2:18-cv-00585

Biedermann Tech GmbH & Co KG v. K2M Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-00585, E.D. Va., 11/23/2018
  • Venue Allegations: Venue is alleged to be proper in the Eastern District of Virginia because Defendant K2M maintains a regular and established place of business in the district and has allegedly committed acts of patent infringement there.
  • Core Dispute: Plaintiff alleges that Defendant’s spinal implant systems, including the EVEREST, YUKON, and CASCADIA product lines, infringe eleven U.S. patents related to polyaxial bone screws and multi-walled spinal placeholders.
  • Technical Context: The technology relates to mechanical devices used in spinal fusion and correction surgery to anchor stabilizing rods to vertebrae and promote bone growth between vertebral bodies.
  • Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the asserted patents, citing instances where Biedermann patents were referenced during the prosecution of Defendant's own patent applications and noting both parties' attendance at the same industry trade shows.

Case Timeline

Date Event
2000-11-10 Earliest Priority Date for ’820, ’194, ’093, ’353 Patents
2001-11-27 Earliest Priority Date for ’060, ’173 Patents
2003-03-11 Earliest Priority Date for ’784 Patent
2004-05-18 U.S. Patent No. 6,736,820 Issues
2005-12-23 Earliest Priority Date for ’595, ’485 Patents
2007-12-13 Earliest Priority Date for ’399 Patent
2009-08-20 Earliest Priority Date for ’600 Patent
2012-02-28 U.S. Patent No. 8,123,784 Issues
2012-09-04 U.S. Patent No. 8,257,399 Issues
2014-01-01 EVEREST Device Available (approx.)
2014-09-09 U.S. Patent No. 8,828,060 Issues
2015-02-03 U.S. Patent No. 8,945,194 Issues
2016-01-01 CASCADIA Device Launched (approx.)
2017-02-14 U.S. Patent No. 9,566,093 Issues
2017-02-21 U.S. Patent No. 9,572,600 Issues
2017-11-14 U.S. Patent No. 9,814,595 Issues
2018-02-20 U.S. Patent No. 9,895,173 Issues
2018-03-14 YUKON Device Launched
2018-08-28 U.S. Patent No. 10,058,353 Issues
2018-11-20 U.S. Patent No. 10,130,485 Issues
2018-11-23 Complaint Filed

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

U.S. Patent No. 6,736,820 - "Bone Screw"

  • Issued: May 18, 2004

The Invention Explained

  • Problem Addressed: The patent addresses the technical challenge of achieving a sufficient pivot angle for bone screws used in cervical vertebrae, where the small dimensions of the bones necessitate greater flexibility in screw orientation compared to thoracic or lumbar vertebrae (Compl. Ex. A, ’820 Patent, col. 1:49-56).
  • The Patented Solution: The invention provides a bone screw with a receiving part for a rod, where the opening at the bottom of the receiving part (the second bore) has an asymmetrically constructed edge. This asymmetry, for example through a countersink or an inclined plane, allows the screw member to pivot to a larger angle in a specific direction without compromising its seat within the receiving part (Compl. Ex. A, ’820 Patent, col. 2:3-7, 59-62).
  • Technical Importance: This design allows for greater surgical flexibility in placing pedicle screws, particularly in anatomically constrained areas like the cervical spine, without requiring a larger, more invasive implant.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶27).
  • The essential elements of claim 1 include:
    • A bone screw apparatus comprising a bone screw, a receiving part, and a nut or screw.
    • The bone screw has a threaded section and a head.
    • The receiving part has a U-shaped cross-section to receive a rod, an open first bore, and a second bore opposite the first.
    • The second bore has a diameter greater than the threaded section but smaller than the head, and it provides a seat for the head.
    • Critically, the edge bounding the free end of the second bore is "asymmetric" when viewed relative to the axis of the first bore.

U.S. Patent No. 8,123,784 - "Anchoring Element for Use in Spine or Bone Surgery, Methods for Use and Production Thereof"

  • Issued: February 28, 2012

The Invention Explained

  • Problem Addressed: The patent identifies that manufacturing conventional bone screw receiving parts is "resource-consuming" because of the "thread runout"—an area where the internal thread diminishes and is poorly defined. This runout necessitates longer receiving part legs to ensure sufficient thread engagement, thereby increasing the overall implant height (Compl. Ex. B, ’784 Patent, col. 1:49-56).
  • The Patented Solution: The invention replaces the difficult-to-manufacture thread runout with a distinct "undercut" located adjacent to a shorter, fully-formed internal thread. This design is described as cheaper to manufacture and allows for a reduced overall implant height while maintaining secure fixation of the rod (Compl. Ex. B, ’784 Patent, col. 2:41-49; Abstract).
  • Technical Importance: This approach aimed to simplify the manufacturing process for a high-precision medical device and reduce its physical profile, which is clinically advantageous.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶38).
  • The essential elements of claim 1 include:
    • An anchoring element with a shaft, a rod, a receiving part, and a securing element.
    • The receiving part has a U-shaped recess and legs with a first internal thread.
    • The receiving part has an "undercut" on the inner surface of the legs adjacent to the internal thread.
    • A dimensional relationship is required: a first distance (A) from the end of the receiving part to the rod surface must be greater than or equal to a second distance representing the extent of the internal thread.
    • A further dimensional relationship is required: a third distance (B) from the end of the receiving part to the farthest edge of the undercut must be larger than distance (A).
    • The external thread of the securing element must be movable into the undercut.
    • The entire axial length of the securing element must be equal to or less than distance (A).

The complaint asserts nine additional patents. These are summarized below.

U.S. Patent No. 8,257,399 - "Anchoring Device for Anchoring a Rod in Bones or Vertebrae"

  • Issued: September 4, 2012 (Compl. ¶10)
  • Technology Synopsis: This patent describes a polyaxial bone anchor assembly designed to accommodate and clamp rods of at least two different diameters. The invention uses a pressure element with a specifically shaped contact surface (e.g., V-shaped) that allows it to securely clamp different sized rods along two contact lines, providing versatility for the surgeon (Compl. Ex. C, ’399 Patent, Abstract).
  • Asserted Claims: Independent claim 14 (Compl. ¶60).
  • Accused Features: The EVEREST and YUKON Devices are accused of infringing by having a bone anchoring device, pressure element, and fixation element configured to interchangeably receive and clamp rods of different diameters (Compl. ¶¶ 61, 69).

U.S. Patent No. 8,828,060 - "Element with a Shank and a Holding Element Connected to it for Connecting a Rod"

  • Issued: September 9, 2014 (Compl. ¶11)
  • Technology Synopsis: This patent discloses a bone anchor with a specific "flat thread" design, where the flanks of both the inner thread (on the holding portion) and the outer thread (on the locking element) enclose an angle of 90° with the screw axis. This design is intended to prevent the legs of the holding portion from splaying outwards under load without requiring an external locking mechanism (Compl. Ex. D, ’060 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶81).
  • Accused Features: The EVEREST and YUKON Devices are accused of infringing by employing a "modified square thread design" that allegedly has the 90° flank angles required by the claim (Compl. ¶¶ 83, 89).

U.S. Patent No. 8,945,194 - "Bone Screw"

  • Issued: February 3, 2015 (Compl. ¶12)
  • Technology Synopsis: This patent describes a polyaxial bone fixation assembly where the anchoring element (screw) can move at a greater angle in one direction than in another relative to the coupling element (rod holder). This differential mobility is achieved through the specific geometry of the coupling element's inner bores, allowing for greater surgical flexibility (Compl. Ex. E, ’194 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶98).
  • Accused Features: The YUKON Device is accused of infringing by having a coupling element and an anchoring element that allows for different ranges of angulation, such as 60 degrees in one direction and 45 degrees in another (Compl. ¶100).

U.S. Patent No. 9,566,093 - "Bone Screw"

  • Issued: February 14, 2017 (Compl. ¶13)
  • Technology Synopsis: This patent is related to the '194 patent and similarly describes a polyaxial bone fixation assembly with differential angulation. It specifies a coupling element with a U-shaped opening for receiving the rod and a seat for the anchoring element, which allows for greater movement in a second direction than a first (Compl. Ex. F, ’093 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶105).
  • Accused Features: The YUKON Device is accused of infringing by having an anchoring element capable of moving at different angles (e.g., 60 degrees vs. 45 degrees) relative to the coupling element's seat (Compl. ¶107).

U.S. Patent No. 9,572,600 - "Bone Anchoring Device, Tool and Method for Assembling the Same and Tool for Use with the Same"

  • Issued: February 21, 2017 (Compl. ¶14)
  • Technology Synopsis: This patent describes a bone anchoring device where a pressure element features a monolithic spring element formed by a slot in its side wall. This spring element engages a recess in the receiving part to hold the pressure element in a preliminary position that allows the anchoring screw to pivot, but can be overcome by an upward force to fully assemble or disassemble the device (Compl. Ex. G, ’600 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶112).
  • Accused Features: The EVEREST Device is accused of infringing by allegedly incorporating a pressure element with a monolithic spring element that engages a recess in the receiving part to restrict upward movement (Compl. ¶¶ 115, 117).

U.S. Patent No. 9,814,595 - "Multi-Walled Placeholder"

  • Issued: November 14, 2017 (Compl. ¶15)
  • Technology Synopsis: This patent describes a spinal implant (placeholder) with an inner wall and an outer wall that are spaced apart to promote bone in-growth. The inner and outer walls are fixed relative to each other by at least one connecting portion, such as an end wall, and the placeholder features projections that project longitudinally from one end (Compl. Ex. H, ’595 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶122).
  • Accused Features: The CASCADIA Device is accused of infringing by being a placeholder with inner and outer walls, connecting portions, and longitudinal projections designed to promote bone integration (Compl. ¶¶ 123-126).

U.S. Patent No. 9,895,173 - "Element with a Shank and a Holding Element Connected to it for Connecting to a Rod"

  • Issued: February 20, 2018 (Compl. ¶16)
  • Technology Synopsis: This patent is related to the '060 patent and describes a polyaxial bone anchor with a specific thread geometry designed to prevent splaying of the receiving part's legs. It claims a cross-section of the outer thread that is substantially rectangular and, when assembled, matches the shape of the inner thread's flank to avoid outward pressure (Compl. Ex. I, ’173 Patent, Abstract).
  • Asserted Claims: Independent claim 35 (the complaint text mistakenly references claim 25 in ¶131 but claim 35 in ¶133).
  • Accused Features: The EVEREST and YUKON Devices are accused of infringing by using a "modified square thread design" that allegedly has a substantially rectangular cross-section and matching flanks to prevent leg splay (Compl. ¶¶ 142, 151).

U.S. Patent No. 10,058,353 - "Bone Screw"

  • Issued: August 28, 2018 (Compl. ¶17)
  • Technology Synopsis: This patent describes the screw member of a pivotable bone screw, focusing on an asymmetric portion of the screw member itself. It claims a screw member where a portion extending from the second end of its elongate section toward the head is asymmetric with respect to the longitudinal axis, allowing for greater pivot angles (Compl. Ex. J, ’353 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶156).
  • Accused Features: The EVEREST Device's screw member is accused of infringing by allegedly having a portion that is asymmetric with respect to its longitudinal axis (Compl. ¶160).

U.S. Patent No. 10,130,485 - "Multi-Walled Placeholder"

  • Issued: November 20, 2018 (Compl. ¶18)
  • Technology Synopsis: This patent is related to the '595 patent and describes a spinal placeholder with inner and outer walls containing diamond-shaped openings. A key feature is that at least one opening in the inner wall aligns with an opening in the outer wall to create an entirely unobstructed pathway from the inner cavity to the outside of the placeholder, promoting in-growth (Compl. Ex. O, ’485 Patent, Abstract).
  • Asserted Claims: Independent claim 14 (Compl. ¶165).
  • Accused Features: The CASCADIA Device is accused of infringing by having inner and outer walls with diamond-shaped openings and connecting portions, with at least one set of openings allegedly forming an unobstructed pathway (Compl. ¶¶ 167-170).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are certain spinal implant systems and devices within Defendant K2M's product lines, specifically identified as the EVEREST Device, the YUKON Device, and the CASCADIA Device (Compl. ¶21).

Functionality and Market Context

  • The complaint describes the EVEREST and YUKON Devices as "top-loading polyaxial pedicle screw system[s]" designed to anchor stabilizing rods to the spine. A key feature advertised for both is the ability to accommodate rods of two different diameters, providing surgical flexibility (Compl. ¶¶ 22-23). The YUKON Device is also advertised as having "high angulation" capability (Compl. ¶23).
  • The CASCADIA Device is described as an "interbody system" designed to be implanted between vertebrae. Its functionality is centered on a porous structure and rough surfaces intended to "allow[] for bony integration throughout the implant" (Compl. ¶24). The complaint alleges the EVEREST Device has been available since at least 2014, the CASCADIA Device was launched in 2016, and the YUKON Device was launched in March 2018 (Compl. ¶¶ 22-24). The screenshot from a product brochure for the EVEREST system highlights features like "Variable Rod Compatibility" and "Mixed Material Screw," underscoring its versatility (Compl. p. 17).

IV. Analysis of Infringement Allegations

’820 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a bone screw having a screw member a threaded section, a head end and a head at the head end The YUKON Device is a bone screw with a threaded screw member and a head. A product animation screenshot shows these components (Compl. p. 8). ¶28 col. 2:27-28
a receiving part at the head end for receiving a rod...wherein the receiving part has an open first bore...a substantially U-shaped cross-section...and a second bore...hav[ing] a seat for the head The YUKON Device includes a receiving part with a U-shaped channel for a rod, an upper bore, and a lower bore that acts as a seat for the screw head. A screenshot shows a top-down view of this part (Compl. p. 10). ¶29 col. 2:31-41
a nut or screw acting together with the thread The YUKON Device uses a set screw that engages with threads on the receiving part's legs to secure the rod. A product animation screenshot shows this screw being tightened (Compl. p. 10). ¶30 col. 2:48-53
wherein, when viewed relative to the axis of the first bore, the edge bounding the free end of the second bore is asymmetric The complaint alleges that the edge of the lower bore in the YUKON Device is asymmetric, supporting this with a product animation screenshot (Compl. p. 11). ¶31 col. 2:5-7

Identified Points of Contention

  • Scope Questions: The central dispute may involve the term "asymmetric." The complaint provides a conclusory statement supported by a visual, but does not explain the specific geometry that renders the accused product's bore "asymmetric." The question for the court will be whether the specific structure of the YUKON Device's second bore, which facilitates polyaxial movement, meets the definition of "asymmetric" as taught in the ’820 Patent, which discloses specific structures like a countersink or an inclined plane to achieve this property (Compl. Ex. A, ’820 Patent, col. 2:59-62).
  • Technical Questions: A key factual question will be what structural evidence demonstrates that the YUKON Device's design achieves its high angulation through an "asymmetric" bore edge, as claimed, rather than through other polyaxial mechanisms not covered by the patent's claims.

’784 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a receiving part that is structured and arranged to connect the rod to the shaft, the receiving part...comprising a U-shaped recess forming a channel...and two legs having free ends, the legs comprising a first internal thread The EVEREST Device includes a receiving part (tulip) with a U-shaped channel and two legs containing an internal thread to accept a set screw. A product brochure image shows this component (Compl. p. 17). ¶40 col. 3:5-10
a securing element comprising a screw member having a first external thread that engages and cooperates with the first internal thread to...fix the rod in its position The EVEREST Device uses a set screw (securing element) with external threads that engage the receiving part's internal threads to press down on and secure the rod. A screenshot from a video shows the set screw securing the rod (Compl. p. 20). ¶41 col. 3:11-15
wherein, when the rod is located in the channel, a first distance...is a pre-determined distance (A), the first internal thread extending...a second distance...smaller than or equal to the pre-determined distance (A) The complaint alleges the internal thread of the EVEREST Device is higher than the top surface of the rod, resulting in the claimed dimensional relationship where the extent of the thread is less than or equal to the distance from the top of the device to the rod. ¶42 col. 3:16-24
wherein the receiving part further comprising an undercut on an inner surface of the legs adjacent to the first internal thread...the distance (B) being larger than the predetermined distance (A) The complaint asserts the EVEREST Device contains an undercut below the internal threads and that the distance from the top of the receiving part to the bottom of this undercut is greater than the distance to the top of the rod. A screenshot from a video highlights this alleged feature (Compl. p. 23). ¶43-44 col. 3:25-33
wherein the first external thread of the securing element is movable into the undercut The complaint alleges the securing element's threads can be screwed past the internal thread and into the undercut area. ¶45 col. 3:34-35
wherein an entire length of the securing element in the axial direction is equal to or less than the predetermined distance (A) The complaint alleges that when the securing element is tightened, its top surface is below the exterior surface of the receiving part, satisfying the claimed length-to-distance relationship. ¶46 col. 3:36-39

Identified Points of Contention

  • Scope Questions: The analysis will likely focus on the term "undercut." The question is whether the accused device's structure below the main internal thread is an "undercut" as specified in the patent, or simply part of a different thread design or manufacturing artifact. The complaint supports this with a dark grey line depicted in a product animation, which raises the question of whether this visual representation accurately reflects the physical product's structure (Compl. p. 23).
  • Technical Questions: A critical evidentiary question will be one of measurement. The infringement allegation hinges on specific dimensional relationships (B > A; securing element length ≤ A). These are factual questions that may require detailed analysis of the accused products to determine if they meet the precise geometric constraints required by claim 1.

V. Key Claim Terms for Construction

’820 Patent

  • The Term: "asymmetric"
  • Context and Importance: This term is the central inventive concept of claim 1. The definition of "asymmetric" will determine whether a wide range of polyaxial screw designs, including the accused YUKON Device, fall within the scope of the claim. Practitioners may focus on whether "asymmetric" requires a specific, deliberately engineered feature intended to create differential pivot angles, or if any deviation from perfect symmetry suffices.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself is broad, simply requiring the edge to be "asymmetric." The specification notes that four different approaches are presented and that it is "possible to combine the individual approaches," suggesting the invention is not limited to a single embodiment (Compl. Ex. A, ’820 Patent, col. 3:25-34).
    • Evidence for a Narrower Interpretation: The specification's embodiments describe specific structures to achieve asymmetry, such as a "circular countersink" in a specific region or an "inclined" opening plane (Compl. Ex. A, ’820 Patent, col. 2:59-62; col. 3:3-8). A defendant may argue that the term should be limited to these disclosed structural implementations.

’784 Patent

  • The Term: "undercut"
  • Context and Importance: The distinction between a conventional "thread runout" and the claimed "undercut" is the core of the invention's purported advance over the prior art. The construction of this term will be critical to determining infringement, as the accused EVEREST device may have a region below its primary threads that Defendant could characterize as something other than the claimed "undercut."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent abstract describes the undercut simply as being "adjacent to the thread," without imposing strict geometric limitations beyond the B > A distance requirement. This could support a reading that covers any recessed area below the thread that meets the claimed dimensional criteria.
    • Evidence for a Narrower Interpretation: The detailed description refers to the undercut as being provided "before the first thread is provided therein," framing it as a distinct manufacturing step and feature separate from the thread itself (Compl. Ex. B, ’784 Patent, col. 2:42-45). A defendant may argue this implies a feature that is structurally distinct from the thread geometry, not merely a continuation or termination of it.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement for at least the ’784, ’399, and ’173 patents. The allegations for inducement are based on Defendant's marketing, distribution, and sale of the accused devices, as well as instructing and encouraging purchasers, via product documentation, to use the products in an infringing manner (Compl. ¶¶ 36, 58, 131). The allegations for contributory infringement assert that the accused devices are especially made or adapted for infringement and are not staple articles of commerce with substantial non-infringing uses (Compl. ¶¶ 37, 59, 132).

Willful Infringement

  • The complaint alleges willful infringement for all asserted patents. The basis for willfulness is alleged pre-suit knowledge. The complaint specifically alleges that Defendant knew or was willfully blind to the asserted patents because Biedermann's patents were cited during the prosecution of K2M's own patent applications. Further, it is alleged that K2M attended trade shows where the patented technology was displayed (Compl. ¶4).

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

This case presents a broad challenge to a significant portion of the defendant’s spinal products portfolio, involving numerous patents. The litigation will likely center on the following key questions:

  • A core issue will be one of definitional scope and measurement: Can the general term "asymmetric" in the ’820 patent be construed to cover the accused polyaxial mechanism, and do the specific physical dimensions of the accused EVEREST and YUKON devices meet the precise numerical and relational limitations (e.g., "undercut," B>A, 90° thread flanks) required by the claims of the ’784, ’060 and ’173 patents? This may evolve into a highly technical, fact-intensive dispute requiring expert analysis and testimony.
  • A second key question will be one of intent and knowledge: Does the evidence that Biedermann’s patents were cited during the prosecution of K2M’s own patents establish pre-suit knowledge sufficient to support the claim of willful infringement? The court will have to determine whether this record constitutes clear and convincing evidence of egregious conduct beyond typical competitive awareness.
  • A third question will be one of technological distinction: Across the eleven asserted patents, the court will need to parse whether the accused features—such as the "modified square thread" or the multi-angle pivot mechanism—function in substantially the same way as the claimed inventions or represent distinct, non-infringing technological alternatives.