1:19-cv-01528
ConforMIS Inc v. Zimmer Biomet
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Conformis, Inc. (Delaware)
- Defendant: Medacta USA, Inc. (Delaware) and Medacta International SA (Switzerland)
- Plaintiff’s Counsel: Young Conaway Stargatt & Taylor LLP; Arnold & Porter Kaye Scholer LLP
- Case Identification: 1:19-cv-01528, D. Del., 06/27/2022
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Medacta USA, Inc. is a Delaware corporation and thus resides in the state.
- Core Dispute: Plaintiff alleges that Defendant’s MyKnee and MyShoulder patient-specific surgical instrument systems infringe four patents related to patient-specific joint arthroplasty devices and surgical tools.
- Technical Context: The technology concerns patient-customized surgical guides and implants for joint replacement surgery, which are designed using medical imaging to match a specific patient's anatomy, thereby aiming to increase surgical precision.
- Key Procedural History: The filing is a Third Amended Complaint in a consolidated action. Willfulness allegations are based on knowledge dating back to at least the filing of the original complaint.
Case Timeline
| Date | Event |
|---|---|
| 2001-05-25 | Earliest Priority Date for all Patents-in-Suit |
| 2013-02-19 | U.S. Patent No. 8,377,129 Issues |
| 2013-06-11 | U.S. Patent No. 8,460,304 Issues |
| 2015-11-17 | U.S. Patent No. 9,186,161 Issues |
| 2016-03-29 | U.S. Patent No. 9,295,482 Issues |
| 2022-06-27 | Third Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,377,129 - “Joint Arthroplasty Devices and Surgical Tools”
- Patent Identification: U.S. Patent No. 8,377,129, titled “Joint Arthroplasty Devices and Surgical Tools,” issued on February 19, 2013 (Compl. ¶22).
The Invention Explained
- Problem Addressed: The patent’s background describes the imprecision of conventional joint replacement surgery, where standard, non-customized instruments are used, which can lead to poor implant fit, instability, and pain for the patient (Compl. ¶16).
- The Patented Solution: The invention is a patient-specific surgical instrument system created from a patient’s medical imaging data, such as an MRI or CT scan. The instrument has a surface shaped to conform to the patient’s unique joint anatomy, allowing it to serve as a precise guide for surgical tools like drills or saws, thereby improving the accuracy of implant placement (’129 Patent, Abstract; col. 6:50-65).
- Technical Importance: This patient-specific approach reversed the traditional surgical paradigm by making the tools fit the patient, rather than forcing the patient's bone to fit standard tools (Compl. ¶17).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶38). The allegations also reference "one or more claims," suggesting the potential assertion of dependent claims (Compl. ¶36).
- The essential elements of independent claim 1 include:
- A patient-specific instrument system for knee surgery.
- A patient-specific surface for engaging a portion of a substantially uncut joint surface.
- The patient-specific surface includes cartilage information derived from image data.
- A guide for directing a surgical instrument.
- The guide has a predetermined position and orientation relative to an anatomical or biomechanical axis of the knee joint.
- The guide defines a drilling path having a position based on a predetermined rotation angle of an orthopedic implant.
U.S. Patent No. 8,460,304 - “Joint Arthroplasty Devices and Surgical Tools”
- Patent Identification: U.S. Patent No. 8,460,304, titled “Joint Arthroplasty Devices and Surgical Tools,” issued on June 11, 2013 (Compl. ¶23).
The Invention Explained
- Problem Addressed: The patent addresses the need for accurate and reproducible placement of surgical pins, which are used to guide bone cuts and align implants during joint repair surgery (’304 Patent, col. 2:48-55).
- The Patented Solution: The invention is a surgical instrument, described as a "mold," with an internal surface that includes joint information derived from a patient's image data. This mold features two or more guide holes for surgical pins. The position of at least one guide hole is determined based on both anatomical information and a predetermined rotation angle for the implant, ensuring precise pin placement for the subsequent surgical steps (’304 Patent, Abstract; col. 45:35-44).
- Technical Importance: The use of a patient-specific mold with precisely located guide holes aims to simplify the surgical technique while improving the accuracy of implant alignment (Compl. ¶18).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶50). The allegations also reference "one or more claims," suggesting the potential assertion of dependent claims (Compl. ¶48).
- The essential elements of independent claim 1 include:
- A surgical instrument for repairing a patient's joint.
- A mold with an internal surface including joint information derived from image data.
- Two or more guide holes configured to guide a surgical pin.
- At least one guide hole has a position based on anatomical information to facilitate placement of an articular repair system.
- The articular repair system has a predetermined rotation angle, and the guide hole's position is based on that angle.
U.S. Patent No. 9,186,161 - “Surgical Tools for Arthroplasty”
- Patent Identification: U.S. Patent No. 9,186,161, titled “Surgical Tools for Arthroplasty,” issued November 17, 2015 (Compl. ¶24).
Technology Synopsis
This patent claims a complete surgical system comprising both an articular repair system (the implant) and a patient-specific surgical instrument. The instrument, or "mold," is created from patient image data and includes guide holes whose position and/or orientation are based on anatomical information and a predetermined implant rotation angle, similar to the '304 Patent. (Compl. ¶¶68-69).
Asserted Claims
Independent claim 1 is asserted (Compl. ¶68).
Accused Features
The accused MyKnee and MyShoulder systems, which combine patient-specific cutting blocks (the instrument) with corresponding knee and shoulder implants (the articular repair system) (Compl. ¶¶69, 73-74).
U.S. Patent No. 9,295,482 - “Patient Selectable Joint Arthroplasty Devices and Surgical Tools”
- Patent Identification: U.S. Patent No. 9,295,482, titled “Patient Selectable Joint Arthroplasty Devices and Surgical Tools,” issued March 29, 2016 (Compl. ¶25).
Technology Synopsis
This patent claims a joint arthroplasty system that includes an implant and a patient-specific guide block. The invention's focus is on the block's patient-specific surface, which is configured to have separate portions that negatively match different types of bone surfaces (e.g., subchondral and cortical bone) and are also configured to reference an osteophyte (bone spur), thereby providing multiple, distinct anatomical reference points for a secure fit (Compl. ¶86).
Asserted Claims
Independent claim 13 is asserted (Compl. ¶86).
Accused Features
The MyKnee system, which allegedly includes a patient-specific cutting block used with an implant, where the block is alleged to contact both cortical and subchondral bone and to use osteophytes as bony references for positioning (Compl. ¶¶87-89).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant's MyKnee and MyShoulder patient-specific instrument and implant systems (Compl. ¶¶27, 30, 33).
Functionality and Market Context
The MyKnee system is described as a set of "patient-specific" instruments for knee replacement surgery that are "based on CT or MRI images of the patient's knee" (Compl. ¶27). The system is "designed for a single patient to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting" (Compl. ¶39). An illustrative image from a product brochure shows the MyKnee cutting block being fixed to a femur using cortical pins (Compl. ¶39, p. 10, Figs. 18-19). Similarly, the MyShoulder system allows a surgeon to use "CT based 3D printed cutting and pin guides" to achieve pre-planned, accurate implant placement during shoulder surgery (Compl. ¶57). A screenshot from a marketing video shows the MyShoulder surgical guide being used in a live surgery (Compl. ¶58, p. 17). The complaint alleges that these products compete with Plaintiff's own patient-specific surgical products (Compl. ¶32).
IV. Analysis of Infringement Allegations
8,377,129 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a patient-specific surface for engaging at least a portion of a substantially uncut joint surface of the diseased or damaged knee joint of the patient, | The MyKnee instrument is "patient-specific," designed for a single patient, and has a contact area that engages the patient's bone based on CT and MRI imaging. | ¶39 | col. 61:16-24 |
| the patient-specific surface including cartilage information derived from image data of the diseased or damaged knee joint of the patient; | The MyKnee instrument is "based on CT or MRI images of the patient's knee." | ¶39 | col. 61:25-28 |
| a guide for directing a surgical instrument, | The MyKnee instrument is used for "guiding the marking of bone before cutting" and is fixed to the bone with cortical pins inserted through guide holes. | ¶39 | col. 61:29-30 |
| wherein the guide has a predetermined position relative to the patient-specific surface and a predetermined orientation relative to at least one of an anatomical axis and a biomechanical axis associated with said knee joint; | The MyKnee system involves pre-operative planning of "parameters regarding femoral and tibial implantation," including "femoral rotation" and "angles." | ¶¶40-41 | col. 61:31-37 |
| wherein the guide defines a drilling path through at least a portion of the knee joint, the drilling path having a position based on a predetermined internal rotation angle or external rotation angle of an orthopedic implant. | The system's technique guide allegedly instructs that the "external rotation selected in the pre-operative planning" can be fixed by "inserting a pin in the central hole" of the guide. | ¶41 | col. 61:38-43 |
- Identified Points of Contention:
- Scope Questions: Does the phrase "including cartilage information" require the surface to be derived from specific data about the cartilage itself (e.g., its thickness or health), or is it satisfied by deriving the surface from a general CT/MRI scan that happens to include the cartilage as part of the overall joint anatomy?
- Technical Questions: The complaint alleges the surgeon "can decide to fix the external rotation selected in the pre-operative planning" during the surgery (Compl. ¶41). This may raise the question of whether the rotation angle is truly "predetermined" as required by the claim, or if it involves a degree of intra-operative selection that falls outside the claim's scope.
8,460,304 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a mold having an internal surface that includes joint information derived from image data of the joint of the patient; | The MyKnee instrument is "based on CT or MRI images of the patient's knee"; the MyShoulder instrument relies on CT images to prepare patient-specific guides. | ¶¶51, 57 | col. 61:18-22 |
| and two or more guide holes, each configured to guide a surgical pin, | The MyKnee instrument is fixed using cortical pins; the MyShoulder instrument has two or more guide holes for guiding surgical pins. | ¶¶52, 58 | col. 61:23-24 |
| wherein at least one of the two or more guide holes has a position based on anatomical information of the joint of the patient to facilitate the placement of an articular repair system... | The position of the MyKnee cutting block is based on CT/MRI imaging of the patient's anatomy; the MyShoulder guide is based on CT images for pre-operative planning of implant placement. | ¶¶53, 58 | col. 61:25-31 |
| wherein the articular repair system has a predetermined rotation angle and wherein the position is based on the predetermined rotation angle. | For the MyKnee system, "femoral rotation" is planned pre-operatively; for the MyShoulder system, pre-operative planning is used to determine implant position and orientation. | ¶¶54, 58 | col. 61:32-35 |
- Identified Points of Contention:
- Scope Questions: What is the scope of an "articular repair system"? The complaint applies the term to both total knee and total shoulder replacement systems, but the court may need to determine if the term encompasses such extensive replacements or is limited to more minor repairs.
- Technical Questions: As with the '129 Patent, the allegation that the surgeon "can decide to fix" the rotation during surgery raises a potential factual dispute over whether the rotation angle is "predetermined" before the procedure begins.
V. Key Claim Terms for Construction
The Term: "patient-specific surface" (from '129 Patent, claim 1 and related concepts in other patents)
Context and Importance: This term is the foundation of the patented technology. Its construction will determine the required level of customization. A narrow construction might require a near-perfect negative mold of the patient's anatomy, while a broader construction could cover instruments generally adapted or selected for an individual patient. Practitioners may focus on this term because the accused products are generated from patient-specific data, but the precise nature of the fit is a central technical question.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification describes creating a "virtual" or "derived" surface and discusses selecting the "best fitting implant in library," which may suggest that a perfect, unique match is not always required ('129 Patent, col. 13:14-25, Fig. 1).
- Evidence for a Narrower Interpretation: The patent abstract and detailed description repeatedly emphasize achieving a "near anatomic fit" with the patient's actual cartilage and bone, and figures show instruments closely conforming to the underlying anatomical contours ('129 Patent, Abstract; col. 6:50-55).
The Term: "predetermined rotation angle" (from '129 Patent, claim 1 and '304 Patent, claim 1)
Context and Importance: This term is critical to the infringement allegation, which relies on "pre-operative planning" of rotation and angles. The dispute may turn on whether the accused systems' workflow, which allows a surgeon to "decide to fix the external rotation" during surgery, meets the "predetermined" requirement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses a process flow where various parameters are measured and used to "generate" a custom implant or select one from a library, suggesting a planning phase that precedes the final determination ('304 Patent, Fig. 1). This could support the idea that planning is sufficient, even with final intra-operative confirmation.
- Evidence for a Narrower Interpretation: The claim language requires the position of the drilling path or guide hole to be "based on" this predetermined angle. This may suggest that the angle must be fixed before the instrument is manufactured, as the instrument's physical geometry depends on it, leaving no room for intra-operative decision-making on this specific parameter.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that both Medacta USA and Medacta International actively induce infringement by providing the accused MyKnee and MyShoulder systems to surgeons and instructing them on their infringing use through marketing materials, product manuals, surgical guides, and videos (Compl. ¶¶42-43, 60-61, 78-79, 93-94).
- Willful Infringement: The complaint alleges willful infringement based on Defendants having had notice of the patents "at least as early as the filing of the original Complaint (or soon thereafter)" (Compl. ¶¶45, 63, 81, 96). This suggests the willfulness allegation is primarily based on continued infringement after the lawsuit was initiated.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: does the term "patient-specific surface" require a unique, negative contour of a patient's anatomy, or can it be construed more broadly to cover a device that is selected or configured for a single patient based on their imaging data without requiring a perfect topographical match?
- A key evidentiary question will be one of temporal predetermination: what factual proof exists that the "rotation angle" in the accused systems is "predetermined" before surgery, as the claims require, versus being a parameter that is finalized or selected by the surgeon from a set of options during the operation?
- A central technical question for the '482 patent will be whether the accused MyKnee system is "configured to reference an osteophyte." The infringement theory rests on an inference from an instruction not to remove osteophytes, which will likely be a significant point of factual and expert contention.