DCT
2:19-cv-00325
Biedermann Tech GmbH & Co KG v. K2M Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biedermann Technologies GmbH & Co. KG (Germany)
- Defendant: K2M, Inc. and K2M Group Holdings, Inc. (Delaware corporations with principal place of business in Virginia)
- Plaintiff’s Counsel: Kaufman & Canoles, P.C.; Kirkland & Ellis LLP
- Case Identification: 2:19-cv-00325, E.D. Va., 06/17/2019
- Venue Allegations: Venue is alleged to be proper in the Eastern District of Virginia because Defendant K2M has transacted business, committed acts of infringement, and maintains a regular and established place of business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s YUKON OCT Spinal System infringes a patent related to polyaxial bone anchoring devices used in spinal surgery.
- Technical Context: The technology involves polyaxial pedicle screws, which are medical implants used to stabilize the spine, allowing for angular adjustment before being locked into a final position with a connecting rod.
- Key Procedural History: The complaint notes that Plaintiff previously filed a related lawsuit (the "First Action," 2:18-cv-00585) against Defendant on November 2, 2018, involving the same parties and accused products. This prior action establishes a date of alleged notice for the purpose of willfulness and may provide a source for discovery, such as the product samples referenced in the current complaint.
Case Timeline
| Date | Event |
|---|---|
| 2012-01-30 | U.S. Patent No. 9,597,121 Priority Date |
| 2017-03-21 | U.S. Patent No. 9,597,121 Issued |
| 2018-03-14 | Commercial launch of the accused YUKON Device announced |
| 2018-11-02 | Plaintiff filed "First Action" against Defendant K2M |
| 2019-06-17 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,597,121 - "Bone Anchoring Device"
- Patent Identification: U.S. Patent No. 9,597,121, "Bone Anchoring Device", issued March 21, 2017.
The Invention Explained
- Problem Addressed: The patent addresses the need for an improved polyaxial bone anchoring device that is simpler in design and easier for a surgeon to handle (’121 Patent, col. 1:63-65). Specifically, it seeks to provide a way to temporarily fix the angular position of the screw head relative to the receiving part before final locking, which facilitates the alignment of multiple screws with a connecting rod without requiring complex spring mechanisms ('121 Patent, col. 2:5-18).
- The Patented Solution: The invention uses a "pressure member" that can be moved into a "first position" within the device's receiving part. In this first position, the pressure member simultaneously engages the screw head to create a "preload" via friction and engages the inner wall of the receiving part, which exerts a "holding force" to keep the pressure member in place ('121 Patent, Abstract; col. 2:10-14). This arrangement allows the surgeon to provisionally set the screw's angle, adjust it with sufficient force, and then proceed to final locking by inserting a rod and tightening a fixation screw ('121 Patent, col. 6:40-56).
- Technical Importance: This design allows for a temporary, yet stable, angular hold on the screw head without a positive lock, simplifying the surgical workflow for constructing spinal fixation systems ('121 Patent, col. 2:14-18).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶17).
- Independent Claim 1 of the ’121 Patent requires:
- A bone anchoring element with a head and a shaft.
- A receiving part to couple the element to a rod, itself having a bore and a bore axis.
- A pressure member movable in the bore, comprising a first section to engage the head and a one-piece second section to engage the rod.
- The pressure member is configured to have a "first position" where friction generates a "preload" on the head for a temporary angular hold, and a different "second position" where the head is locked.
- When in the first position, a portion of the receiving part's inner wall exerts a "holding force" on the pressure member's outer surface to restrict its movement, but the pressure member remains movable from that position by applying a sufficient axial force.
- The complaint does not explicitly reserve the right to assert dependent claims, though this is common practice.
III. The Accused Instrumentality
Product Identification
- The accused products are K2M's "YUKON Device" and the associated "YUKON OCT Spinal System" (Compl. ¶13).
Functionality and Market Context
- The YUKON Device is described as a "top-loading polyaxial screw with high angulation" (Compl. ¶13). The complaint alleges, based on K2M's marketing materials and product animations, that the device includes a "Friction Head to Aid in Improved Rod Placement" (Compl. ¶11). This feature is alleged to provide a temporary hold on the screw head's position before a connecting rod is fully secured, which mirrors the functionality described in the ’121 Patent (Compl. ¶21). The complaint includes a screenshot from promotional materials that states, "Friction Head to Aid in Improved Rod Placement" (Compl. ¶11). The YUKON Device was commercially launched around March 14, 2018 (Compl. ¶13).
IV. Analysis of Infringement Allegations
’121 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A polyaxial bone anchoring device comprising: a bone anchoring element having a head and a shaft for anchoring to a bone; | The YUKON Device is a polyaxial bone anchoring device with a head and shaft. The complaint provides an image of the screw component to support this allegation. A screenshot from a product animation shows the YUKON screw, which has a threaded shaft for bone anchoring and a polyaxial head (Compl. ¶18). | ¶18 | col. 3:10-13 |
| a receiving part for coupling the bone anchoring element to a rod, the receiving part having a first end and a second end, a head receiving portion at the second end...and a rod receiving portion at the first end, the rod receiving portion having an inner wall defining a bore, the bore having a bore axis; | The YUKON Device includes a receiving part that couples the anchoring element to a rod. The complaint uses screenshots from an animation to depict the receiving part holding both the screw and a rod (Compl. ¶19). | ¶19 | col. 3:26-34 |
| a pressure member movable in the bore and comprising a first section defining a first surface for engaging the head, and a one-piece second section that is axially connected to the first section and that defines both a second surface for engaging the rod and an outer surface; | Based on product samples and animations, the YUKON Device is alleged to contain a movable pressure member with sections for engaging the head and the rod. A cutaway view from a product animation is provided to show this internal component (Compl. ¶20). | ¶20 | col. 5:1-15 |
| wherein when the bone anchoring element and the pressure member are in the receiving part, the pressure member is configured to assume and be held at a first position where friction between the first surface and the head generates a preload on the head to maintain the shaft at a temporary angular position...and a second position...where the head is locked; | The YUKON Device's "Friction Head" feature allegedly creates a frictional preload to hold the screw at a temporary angle, which is distinct from the final locked position. The complaint cites marketing text stating, "Friction Head to Aid in Improved Rod Placement," to support the existence of this temporary hold state (Compl. ¶11, 21). | ¶21 | col. 2:27-34 |
| wherein when the pressure member is at the first position, a portion of the inner wall of the receiving part that is directed towards the bore axis exerts a holding force on the outer surface of the pressure member to restrict movement...and wherein the pressure member is movable out of the first position...by applying a sufficient axial force... | When the YUKON pressure member is in its first position, a portion of the receiving part's inner wall allegedly exerts a holding force on it, restricting movement until a sufficient axial force is applied. A product animation screenshot shows this interaction and is captioned "FRICTION HEAD CAPABILITY" (Compl. ¶13, 22). | ¶22 | col. 6:30-34 |
- Identified Points of Contention:
- Technical Questions: A primary question will be whether the accused YUKON Device's "Friction Head" functionality operates in the specific manner claimed. The complaint relies heavily on marketing animations. The case may turn on evidence from the physical device showing whether a "portion of the inner wall" actually "exerts a holding force on the outer surface of the pressure member" as required, or if the temporary hold is achieved through a different mechanism not covered by the claim.
- Scope Questions: The interpretation of "holding force" will be central. The analysis will question whether the term requires a specific structural cause, such as the "interference fit" described in the patent's preferred embodiments, or if it can be read more broadly to encompass any force that frictionally restricts the pressure member's movement.
V. Key Claim Terms for Construction
The Term: "holding force"
Context and Importance: This term is critical because it defines the mechanism that maintains the temporary "preload" state. The infringement analysis will depend on whether the force that restricts the pressure member's movement in the accused YUKON Device is the same type of "holding force" contemplated by the patent. Practitioners may focus on this term to determine if the claims are limited to the specific embodiments disclosed, such as an interference fit, or cover a broader range of frictional retention mechanisms.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims describe the term functionally as a force that "exerts a holding force on the outer surface of the pressure member to restrict movement" ('121 Patent, cl. 1). The summary also describes it as a "radial force which...frictionally holds the pressure member in position" (col. 2:12-14), which could be read broadly.
- Evidence for a Narrower Interpretation: The specification repeatedly links the holding force to a specific structure. It states that "an outer diameter of the pressure member 6 is slightly larger than an inner diameter of the coaxial bore 41 to achieve an interference fit" ('121 Patent, col. 5:5-9). This suggests the holding force is generated by the elastic deformation of an interference fit, potentially narrowing its scope to such an arrangement.
The Term: "one-piece second section"
Context and Importance: Claim 1 requires the pressure member to have a "one-piece second section that is axially connected to the first section." The structural integrity and definition of the pressure member is a core part of the claimed device. The dispute may involve whether the accused pressure member is constructed in a way that meets this "one-piece" limitation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not specify the material or manufacturing process, only that the section is "one-piece" and "axially connected." This could be interpreted to mean functionally integral, rather than necessarily monolithic.
- Evidence for a Narrower Interpretation: The drawings, such as Figure 5a, depict the pressure member (6) as a single, monolithic component where the first section (recess 61) and second section (area around recess 63) are formed from the same continuous piece of material. This could support an argument that "one-piece" implies a unitary, non-assembled construction.
VI. Other Allegations
- Indirect Infringement: The complaint alleges K2M induces infringement by "instructing and encouraging purchasers (including through product documentation) to operate and use" the YUKON Device in a manner that infringes the ’121 Patent (Compl. ¶16).
- Willful Infringement: Willfulness is alleged based on K2M's purported knowledge of the ’121 Patent. The complaint alleges this knowledge arises from multiple sources: K2M's awareness of Biedermann as a competitor, evidenced by K2M's 2016 Annual Report; K2M's regular filing of patent applications in the same technology area, where Biedermann's patents are often cited; K2M's attendance at trade shows where the patented technology was displayed; and, most directly, the filing of the "First Action" in November 2018, which allegedly put K2M on notice (Compl. ¶5).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical mechanism: Does the accused YUKON Device's "Friction Head" achieve its temporary hold via the claimed mechanism—specifically, does a "portion of the inner wall" of the receiving part exert a "holding force" on the "outer surface of the pressure member" to restrict its movement, or is there a fundamental mismatch in technical operation?
- A central legal question will be one of claim scope: How will the term "holding force" be construed? Will the court define it broadly based on its function of restricting movement, or will it be narrowed by the specification's detailed description of an "interference fit" as the primary embodiment for generating such a force?
- A key evidentiary question will be the weight assigned to the product animations and marketing slogans cited in the complaint. The case will likely depend on whether discovery concerning the actual physical construction and operation of the YUKON Device confirms or contradicts the functional descriptions presented in K2M's promotional materials.