DCT

1:21-cv-00053

Jackson MD v. NuVasive Inc

Key Events

Complaint

I. Executive Summary and Procedural Information

Parties & Counsel:
- Plaintiff: Roger P. Jackson, M.D. (Kansas)
- Defendant: NuVasive, Inc. (Delaware)
- Plaintiff’s Counsel: Polsinelli PC
Case Identification: 1:21-cv-00053, D. Del., 01/19/2021
Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware as it is the district of Defendant's incorporation and principal place of business.
Core Dispute: Plaintiff alleges that Defendant’s spinal implant systems, including the Armada, Precept, Reline, SpheRx, and VuePoint product lines, infringe eight patents related to polyaxial bone anchor and screw technology.
Technical Context: The technology pertains to polyaxial pedicle screws used in spinal fusion surgery to correct deformities and stabilize the spine, a significant segment of the orthopedic device market.
Key Procedural History: The complaint notes a prior licensing relationship between the parties governed by a 2008 agreement and a subsequent 2014 amended agreement, neither of which allegedly licensed the patents-in-suit. Plaintiff alleges it provided Defendant with actual notice of infringement via a letter offering to license the asserted patent families on March 7, 2019, which Defendant declined, forming the basis for the willfulness allegations.

Case Timeline

Date	Event
2003-06-18	Priority Date for U.S. Patent No. 9,808,292
2005-05-27	Priority Date for U.S. Patent Nos. 9,788,866 & 10,722,273
2005-09-30	Priority Date for U.S. Patent Nos. 8,353,932 & 8,696,711
2007-09-17	Priority Date for U.S. Patent Nos. 10,335,200 & 10,561,444
2008-01-01	Development and License Agreement executed between parties
2009-06-15	Priority Date for U.S. Patent No. 10,441,319
2013-01-15	U.S. Patent No. 8,353,932 Issues
2014-01-01	Amended Development and License Agreement executed
2014-04-15	U.S. Patent No. 8,696,711 Issues
2017-10-17	U.S. Patent No. 9,788,866 Issues
2017-11-07	U.S. Patent No. 9,808,292 Issues
2019-03-07	Plaintiff offers Defendant license to asserted patent families
2019-07-02	U.S. Patent No. 10,335,200 Issues
2019-10-15	U.S. Patent No. 10,441,319 Issues
2020-02-18	U.S. Patent No. 10,561,444 Issues
2020-07-28	U.S. Patent No. 10,722,273 Issues
2021-01-19	Complaint Filed

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

U.S. Patent No. 8,353,932 - "Polyaxial Bone Anchor Assembly with One-Piece Closure, Pressure Insert and Plastic Elongate Member" (Issued Jan. 15, 2013)

The Invention Explained

Problem Addressed: The patent’s background describes a problem in spinal surgery where longitudinal connecting members (rods) made of flexible polymers like PEEK can deform or "creep" over time. This deformation can cause the locking mechanism of a polyaxial screw to loosen, resulting in misalignment and stress on the implant components (U.S. Patent No. 8,353,932, col. 2:1-20).
The Patented Solution: The invention proposes a polyaxial bone screw assembly where a single-piece closure structure (e.g., a set screw) applies pressure to both the flexible connecting rod and a separate compression insert. This design aims to securely lock the angular position of the screw shank relative to the receiver, independent of any potential deformation of the rod, thereby maintaining long-term stability of the construct (’932 Patent, Abstract; col. 2:38-50; Fig. 10).
Technical Importance: This design addresses the need for long-term stability in semi-rigid or dynamic spinal stabilization systems that utilize polymer-based components, which offer different biomechanical properties than traditional metal rods (’932 Patent, col. 2:1-10).

Key Claims at a Glance

The complaint asserts independent claim 1 and dependent claims 22, 31, and 32 (Compl. ¶60).
Independent Claim 1 Essential Elements:
- A medical implant assembly having at least one polyaxial bone screw attached to a longitudinal connection member.
- The polyaxial bone screw comprises a shank, a receiver, and a compression insert.
- The shank has an upper portion that is pivotally receivable in the receiver.
- A one-piece closure structure is included.
- The closure structure presses upon the longitudinal connecting member and the compression insert to lock the angular position of the shank with respect to the receiver.

U.S. Patent No. 8,696,711 - "Polyaxial Bone Anchor Assembly with One-Piece Closure, Pressure Insert and Plastic Elongate Member" (Issued Apr. 15, 2014)

The Invention Explained

Problem Addressed: As a continuation of the ’932 Patent, the ’711 Patent addresses the same technical problem of potential loosening in polyaxial screw assemblies when used with flexible, polymer-based connecting rods that may exhibit material creep over time (U.S. Patent No. 8,696,711, col. 2:1-20).
The Patented Solution: The invention is a polyaxial bone screw assembly featuring a design where the closure structure directly engages both the connecting rod and the compression insert. This dual engagement is intended to ensure that the polyaxial mechanism remains securely locked, even if the connecting rod deforms, by maintaining pressure on the insert that fixes the shank's angle (’711 Patent, Abstract; col. 2:38-50).
Technical Importance: The invention provides an alternative mechanical configuration aimed at enhancing the reliability of spinal fixation systems that employ next-generation flexible materials instead of purely rigid metal components (’711 Patent, col. 2:1-10).

Key Claims at a Glance

The complaint asserts independent claim 1 (Compl. ¶75).
Independent Claim 1 Essential Elements:
- A medical implant assembly having at least one polyaxial bone screw attached to a longitudinal connection member.
- The polyaxial bone screw comprises a shank, a receiver, a compression insert, and a one-piece closure structure.
- The closure structure has a bottom surface that engages the longitudinal connecting member and the compression insert.
- This engagement locks an angular position of the shank with respect to the receiver.

U.S. Patent No. 9,788,866 - "Polyaxial Bone Screw with Shank Articulation Pressure Insert and Method" (Issued Oct. 17, 2017)

Technology Synopsis

This patent describes a polyaxial bone screw assembly that includes a pressure insert designed to articulate with the screw shank. The invention focuses on the method and structure for locking the angular orientation of the shank relative to the receiver by applying pressure via this separate insert, distinct from the connecting rod.

Asserted Claims: Independent claims 1 and 9 (Compl. ¶88).
Accused Features: The complaint alleges that the polyaxial screw assemblies in the Armada, Precept, Reline, and SpheRx II/III product lines incorporate the claimed features (Compl. ¶87).

U.S. Patent No. 10,335,200 - "Pivotal Bone Anchor Assembly with Twist-In-Place Insert Having Alignment Notches" (Issued Jul. 2, 2019)

Technology Synopsis

This patent details a bone anchor assembly with a "twist-in-place" insert. The insert is installed into the receiver and rotated until alignment notches on the insert engage with corresponding structures within the receiver bore, a mechanism designed to prevent further rotation and secure the insert's position before final locking.

Asserted Claims: Independent claims 1 and 18 (Compl. ¶101).
Accused Features: The complaint alleges the Armada, Precept, Reline, SpheRx II/III, and VuePoint products utilize this twist-in-place technology, specifically citing the rod-engaging inserts that are twisted or rotated into place within the receiver (Compl. ¶¶42, 45, 100).

U.S. Patent No. 10,561,444 - "Pivotal Bone Anchor Assembly With Twist-In-Place Insert Having Radially Offset Receiver Engaging Structures" (Issued Feb. 18, 2020)

Technology Synopsis

This patent is related to the '200 patent family and further specifies the twist-in-place insert mechanism. It focuses on the geometric relationship of the engaging structures, describing them as being "radially offset" to create a secure, rotation-inhibiting lock when the insert is twisted into its final position within the receiver.

Asserted Claims: Independent claim 1 (Compl. ¶116).
Accused Features: The complaint accuses the Armada, Precept, Reline, SpheRx II/III, and VuePoint products of infringing by using inserts with outer surfaces that engage inner surfaces of the receiver to inhibit movement (Compl. ¶¶42, 115).

U.S. Patent No. 10,722,273 - "Bone Anchor Assembly with Twist-In-Place Pressure Insert" (Issued Jul. 28, 2020)

Technology Synopsis

This patent describes a bone anchor assembly where a pressure insert is top-loaded and then rotated into a locked position. The invention focuses on the interaction between surfaces on the insert and corresponding surfaces within the receiver bore that inhibit upward movement and prevent further rotation once the insert is seated.

Asserted Claims: Independent claims 1, 12, and 35 (Compl. ¶131).
Accused Features: The complaint alleges the Armada, Precept, Reline, SpheRx II/III, and VuePoint products infringe with their use of twist-in-place inserts that establish a "pre-lock friction fit" (Compl. ¶¶57, 130).

U.S. Patent No. 9,808,292 - "Cannulated Polyaxial Screw" (Issued Nov. 7, 2017)

Technology Synopsis

This patent addresses the structure of a cannulated polyaxial screw. Cannulation refers to a hollow passage through the length of the screw, which is used during surgery to guide the implant's placement over a wire. The claims are directed to the specific mechanical assembly of the cannulated anchor and head members.

Asserted Claims: Independent claims 1 and 25 (Compl. ¶146).
Accused Features: The complaint alleges that at least one version of the SpheRx screw products includes a "cannulated polyaxial screw" that infringes (Compl. ¶51, 146).

U.S. Patent No. 10,441,319 - "Pivotal Bone Anchor with Tool Engagement Grooves and Break-Off Extensions" (Issued Oct. 15, 2019)

Technology Synopsis

This patent focuses on features of a polyaxial bone anchor that facilitate its use during surgery. The claims are directed to specific tool engagement grooves on the anchor's receiver and break-off extensions, which are used for manipulation during implantation and are removed after the construct is finalized.

Asserted Claims: Independent claims 1 and 22, and dependent claims 5, 7-8, 10-11 (Compl. ¶153).
Accused Features: The complaint accuses the Precept and Reline screw products, which allegedly are used with surgical instruments for installation and adjustment, of infringement (Compl. ¶¶48, 152).

III. The Accused Instrumentality

Product Identification

The NuVasive Armada, Precept, Reline, SpheRx (including SpheRx II/III), and VuePoint product lines (Compl. ¶34).

Functionality and Market Context

The accused products are spinal fixation systems used in surgical procedures to treat a range of pathologies, from degenerative conditions to complex spinal deformities (Compl. ¶¶35, 38). Functionally, they consist of polyaxial bone screws, connecting rods, and locking mechanisms designed to stabilize vertebrae (Compl. ¶¶43, 49). The complaint highlights that these products are sold in both "fully assembled" and "modular" configurations, where the latter allows surgeons to pair a pre-assembled receiver and insert with a shank of their choice during surgery (Compl. ¶36). A product brochure image for the Armada system shows various implants and instruments organized in trays for surgical use (Compl. ¶39, Ex. 9 at p. 2). The complaint positions these products as crucial components of Defendant's "Spinal Hardware" business, which allegedly generated approximately $850 million in 2019 revenue (Compl. ¶22).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Exhibits 15, 16, 17, etc.) that detail its infringement theories but does not attach these exhibits to the pleading. Therefore, a table summarizing the allegations cannot be constructed. The narrative infringement theory is summarized below.

'932 Patent Infringement Allegations

The complaint alleges that when a surgeon implants components of the Accused Products (Armada, Precept, Reline, SpheRx II/III, and VuePoint), the resulting structure is a "medical implant assembly having at least one polyaxial bone screw attached to a longitudinal connection member" that directly infringes at least claims 1, 22, 31, and 32 of the ’932 Patent (Compl. ¶¶60, 62, 64, 66, 68). An image from a NuVasive brochure shows the "Provisional Locking Screw," described as providing "the flexibility of a polyaxial screw with the corrective capability of a fixed screw," which illuminates the accused polyaxial functionality (Compl. ¶40, Ex. 9 at p. 2). A key component of the infringement allegation is that the products establish a "pre-lock friction fit" by twisting an insert to engage the shank head, a feature alleged to be particularly present in the VuePoint product (Compl. ¶¶57, 68).

'711 Patent Infringement Allegations

The infringement theory for the ’711 patent mirrors that for the ’932 patent. The complaint alleges that the implanted Accused Products (Armada, Precept, Reline, and VuePoint) form a "medical implant assembly" that infringes at least claim 1 of the ’711 patent (Compl. ¶¶75, 77, 79, 81). The allegations for both the ’932 and ’711 patents depend on the actions of a surgeon assembling the components to create the infringing final configuration (Compl. ¶¶61, 76). Post-operative radiographs provided in the complaint for the Reline product depict the accused systems as they are installed in a patient, illustrating the final assembled state central to the infringement claims (Compl. ¶47, Ex. 12 at p. 1).

Identified Points of Contention

Scope Questions: A central question for both the ’932 and ’711 patents will be the construction of the claim requirement that the closure structure acts upon both the connecting member and the compression insert. Does the phrase "pressing upon the... compression insert" (’932 Patent) or a "bottom surface that engages... the compression insert" (’711 Patent) require direct physical contact between the closure structure and the insert, or is an indirect transfer of force through the connecting member sufficient to meet the limitation?
Technical Questions: What is the specific locking mechanism of each accused product line? The litigation may require evidence demonstrating whether the polyaxial lock in the accused devices is achieved solely by force transmitted through the rod, or if there is a separate mechanical engagement between the closure and the insert that contributes to locking the shank's angle, as taught in the patents.

V. Key Claim Terms for Construction

"closure structure pressing upon the... compression insert" (from '932 Patent, Claim 1)

Context and Importance: The entire inventive concept appears to hinge on whether the closure structure creates a locking force on the insert that is independent of the connecting member. Practitioners may focus on this term because if "pressing upon" is construed to require a direct and independent locking force, it could be more difficult for the Plaintiff to prove infringement if the accused products lock the insert solely via force transmitted through the rod.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the overall function where the "closure structure or top 16 is then inserted into and advanced... so as to bias or push against the upper surface 140 of the connecting member 14," which in turn locks the assembly (U.S. Patent No. 8,353,932, col. 11:55-61). This language does not explicitly require direct contact with the insert, potentially supporting an interpretation where force transmitted through the rod constitutes "pressing upon" the insert.
- Evidence for a Narrower Interpretation: Figure 10 of the patent depicts the bottom surface (158) of the closure structure (16) simultaneously contacting both the connecting member (14) and the top surfaces (122) of the insert (12). This figure could support a narrower construction requiring direct, simultaneous contact with both elements to achieve the claimed function.

"bottom surface that engages the... compression insert" (from '711 Patent, Claim 1)

Context and Importance: Similar to the term in the ’932 patent, the definition of "engages" is critical. If it is construed to mean direct physical contact, infringement will depend on the specific geometry of the accused closure tops.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The word "engages" can mean functional interaction rather than strictly physical contact. The specification states the closure structure "engages the compression insert for securing the assembly in a wide range of angular orientations" (U.S. Patent No. 8,696,711, col. 2:48-50), which could be interpreted functionally.
- Evidence for a Narrower Interpretation: The plain meaning of "engages" in a mechanical context often implies direct contact. Figure 10, shared with the parent '932 patent, visually depicts the bottom surface of the closure making contact with the insert, which strongly supports a construction requiring direct physical engagement.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement for all asserted patents. Inducement is based on allegations that NuVasive provides the unassembled components with instructions and tools, intending for surgeons to assemble them into an infringing final product (Compl. ¶¶70, 83). Contributory infringement is based on allegations that NuVasive sells material components in surgical trays that have no substantial non-infringing use and are not staple articles of commerce (Compl. ¶¶71, 84).

Willful Infringement

Willfulness is alleged for all asserted patents based on Defendant’s alleged actual knowledge. The complaint asserts this knowledge arises from at least the date of Plaintiff's March 7, 2019 letter that identified the asserted patent families and offered a license, which Defendant allegedly rejected (Compl. ¶¶72, 85, 98, 113, 128, 143, 150, 159).

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

A core issue will be one of claim construction: Can the claim terms requiring the closure to act on the compression insert (e.g., "pressing upon" or "engages") be met by a mechanism where the locking force is transmitted exclusively through the connecting rod, or do the claims require a direct and independent engagement between the closure and the insert?
A key evidentiary question will be one of technical operation: Do the accused NuVasive products employ a locking mechanism that is functionally equivalent to the patents' teachings of an independent lock on the insert, or is there a fundamental mismatch where the accused products rely entirely on the integrity of the connecting rod to maintain the polyaxial lock?
A third central issue relates to damages and willfulness: Given the alleged prior licensing relationship and the specific pre-suit notice letter, the case will examine Defendant’s conduct after March 7, 2019, to determine if any continuing infringement was objectively reckless, which would expose the defendant to the possibility of enhanced damages.