DCT
1:19-cv-01618
ConforMIS Inc v. Medacta
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: ConforMIS Inc (Delaware)
- Defendant: Medacta USA Inc (Delaware)
- Plaintiff’s Counsel: Young Conaway Stargatt & Taylor LLP; Arnold & Porter Kaye Scholer LLP
- Case Identification: 1:19-cv-01618, D. Del., 12/23/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation and thus resides in the state.
- Core Dispute: Plaintiff alleges that Defendant’s patient-specific instrument systems for knee and shoulder surgery infringe four patents related to patient-specific joint arthroplasty devices and surgical tools.
- Technical Context: The technology involves creating customized surgical instruments and implants for joint replacement based on a specific patient's CT or MRI scans to improve surgical accuracy and implant fit.
- Key Procedural History: This filing is an Amended Complaint. The complaint notes that prior allegations against Defendant's "MyHip" product line have been removed without prejudice based on representations from the Defendant. The complaint also seeks declaratory judgment of infringement for two patents against the "MyShoulder" product, which reportedly received FDA clearance six days before the filing of this amended complaint.
Case Timeline
| Date | Event |
|---|---|
| 2002-11-27 | 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 |
| 2019-12-17 | Medacta USA Inc announces FDA Clearance for MyShoulder |
| 2019-12-23 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,377,129 - Joint Arthroplasty Devices and Surgical Tools
The Invention Explained
- Problem Addressed: The patent’s background section describes the limitations of conventional joint arthroplasty, where standardized surgical instruments are not tailored to a patient’s specific anatomy, which can result in poor implant fit, instability, and pain post-surgery (Compl. ¶10; ’129 Patent, col. 2:48-51).
- The Patented Solution: The invention is a patient-specific surgical instrument system created from medical imaging. The system includes an instrument with a surface designed to mate precisely with a patient's unique, uncut joint surface (including cartilage). It also features a guide for surgical tools (e.g., a drill) that is pre-aligned with the patient's anatomical and biomechanical axes to ensure accurate placement and orientation of an orthopedic implant (’129 Patent, Abstract; col. 30:2-10).
- Technical Importance: This technology represents a shift from forcing a patient’s anatomy to conform to standard tools to creating custom tools that conform to the patient, with the stated goals of improving surgical reproducibility, reducing trauma, and achieving a better-seated implant (Compl. ¶¶ 11-12).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶30).
- The essential elements of independent claim 1 are:
- A patient-specific instrument system for knee surgery, comprising:
- a patient-specific surface for engaging at least a portion of a substantially uncut joint surface of the knee,
- the patient-specific surface including cartilage information derived from image data of the knee joint; and
- a guide for directing a surgical instrument,
- wherein the guide has a predetermined position and orientation relative to the patient-specific surface and at least one of an anatomical or biomechanical axis of the knee joint;
- wherein the guide defines a drilling path through the knee joint,
- the drilling path having a position based on a predetermined rotation angle of an orthopedic implant.
- The complaint alleges infringement of "one or more claims" of the patent, reserving the right to assert other claims (Compl. ¶29).
U.S. Patent No. 8,460,304 - Joint Arthroplasty Devices and Surgical Tools
The Invention Explained
- Problem Addressed: The patent addresses the same general problem as the ’129 Patent: the imprecision of using standard, non-patient-specific tools in joint repair surgery, which can compromise the outcome of the procedure (’304 Patent, col. 2:48-51).
- The Patented Solution: The invention is a surgical instrument in the form of a "mold" having an internal surface that conforms to the patient's joint, based on information from medical imaging. The mold contains at least two guide holes for surgical pins. The position of at least one guide hole is based on the patient's anatomical information and a predetermined rotation angle for the final implant, thereby ensuring accurate placement of the articular repair system (’304 Patent, Abstract; col. 48:45-55).
- Technical Importance: The patented solution provides surgeons with a custom-fit jig that precisely dictates the location for surgical pins, which serve as anchors and guides for subsequent bone cuts and implant positioning (Compl. ¶¶ 11-12).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶41).
- The essential elements of independent claim 1 are:
- A surgical instrument for repairing a joint, comprising:
- a mold having an internal surface that includes joint information derived from image data of the joint; and
- two or more guide holes, each configured to guide a surgical pin,
- wherein at least one guide hole has a position based on anatomical information of the joint to facilitate placement of an articular repair system when the mold's internal surface is aligned with the joint,
- wherein the articular repair system has a predetermined rotation angle and the guide hole's position is based on that predetermined rotation angle.
- The complaint alleges infringement of "one or more claims" of the patent, reserving the right to assert other claims (Compl. ¶40).
U.S. Patent No. 9,186,161 - Surgical Tools for Arthroplasty
- Patent Identification: ’161 Patent, “Surgical Tools for Arthroplasty,” issued November 17, 2015 (Compl. ¶18).
- Technology Synopsis: The patent claims a surgical system comprising both an articular repair system (the implant) and a patient-specific surgical instrument (the mold). The mold is derived from patient image data and includes guide holes to facilitate placement of the implant, with the position and/or orientation of the guide holes based on the implant’s predetermined rotation angle (Compl. ¶58).
- Asserted Claims: Independent claim 1 (Compl. ¶58).
- Accused Features: The MyKnee® System and the MyShoulder products are accused of infringement (Compl. ¶57).
U.S. Patent No. 9,295,482 - Patient Selectable Joint Arthroplasty Devices and Surgical Tools
- Patent Identification: ’482 Patent, “Patient Selectable Joint Arthroplasty Devices and Surgical Tools,” issued March 29, 2016 (Compl. ¶19).
- Technology Synopsis: The patent claims a joint arthroplasty system including an implant and a patient-specific block. The block has a patient-specific surface configured to have shapes that are negatives of both the subchondral bone surface and the cortical bone surface. A distinguishing feature is that the patient-specific surface is also "configured to reference an osteophyte" (a bony outgrowth) of the joint (Compl. ¶75).
- Asserted Claims: Independent claim 13 (Compl. ¶75).
- Accused Features: The MyKnee® System is accused of infringement (Compl. ¶74).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant’s MyKnee® System and MyShoulder products (Compl. ¶¶ 21, 24). The MyKnee® System includes MyKnee® instruments (such as cutting blocks) and is used with Medacta USA Inc's MyKnee® Implants (Compl. ¶¶ 21-22). The MyShoulder products are patient-specific instruments for shoulder surgery (Compl. ¶24).
Functionality and Market Context
The complaint alleges that the accused products are "patient-specific" instruments that are "based on CT or MRI images of the patient's knee" or shoulder (Compl. ¶¶ 21, 48). They are described as being "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. ¶31). The MyKnee® instruments are allegedly fixed to the bone using cortical pins during surgery (Compl. ¶31). An image included in the complaint shows the MyKnee® device fixed to a bone model with two pins (Compl. p. 7). The complaint asserts that these products compete directly with Plaintiff's patient-specific surgical products (Compl. ¶26).
IV. Analysis of Infringement Allegations
'129 Patent 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 patient-specific surface including cartilage information derived from image data... | The MyKnee® instrument is described as "patient-specific" and "based on ... CT or MRI images of the patient's knee." The complaint includes an image illustrating the contact area on the distal condyles (Compl. p. 8). | ¶31, 32 | col. 61:15-22 |
| a guide for directing a surgical instrument... wherein the guide defines a drilling path... having a position based on a predetermined... rotation angle of an orthopedic implant. | The MyKnee® instrument is allegedly fixed using cortical pins and guides bone cutting. A technique guide allegedly instructs surgeons to pre-plan "femoral rotation" and "angles" for the implantation. | ¶31, 32 | col. 61:23-39 |
- Identified Points of Contention:
- Scope Questions: A potential issue may arise over the meaning of "engaging at least a portion of a substantially uncut joint surface... including cartilage information." The complaint alleges the accused device's contact area is based on CT/MRI imaging (Compl. ¶32), but also states that for the related '482 Patent, the surgeon is instructed to "remove... cartilage... covering the cutting block contact areas" (Compl. ¶78). This raises the question of whether a surface that is derived from cartilage data but ultimately engages bone meets this limitation.
- Technical Questions: The claim requires the drilling path's position to be "based on a predetermined... rotation angle of an orthopedic implant." The complaint alleges the surgeon plans "femoral rotation" (Compl. ¶32). A potential point of dispute could be whether the general surgical plan for "femoral rotation" is sufficiently tied to the specific rotation angle of the implant itself to meet the "based on" requirement.
'304 Patent 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 alleged to be "based on CT or MRI images of the patient's knee." The MyShoulder instrument allegedly relies on CT images to prepare patient-specific guides and virtually position the implant before surgery. | ¶42, 48 | col. 62:10-14 |
| two or more guide holes, each configured to guide a surgical pin | The MyKnee® instrument is allegedly "fixed... using... cortical pins." The MyShoulder instrument is alleged to have "two or more guide holes, each of which is configured to guide a surgical pin." A screenshot from a video purportedly showing the MyShoulder in surgery is provided (Compl. p. 13). | ¶43, 49 | col. 62:15-16 |
| wherein at least one of the two or more guide holes has a position based on anatomical information... to facilitate the placement of an articular repair system... wherein the... system has a predetermined rotation angle and wherein the position is based on the predetermined rotation angle. | For MyKnee®, "femoral rotation" and "angles" are allegedly planned by the surgeon pre-operatively. For MyShoulder, the system allegedly allows a surgeon to "realize the pre-operative 3D planning and deliver accurate implant placement." | ¶45, 49 | col. 62:17-27 |
- Identified Points of Contention:
- Scope Questions: The claim recites a "mold." The accused products are described as "cutting blocks" and "pin guides" (Compl. ¶¶ 21, 48). The infringement analysis may turn on whether the term "mold," as defined by the patent's intrinsic evidence, can be construed to read on the structure and function of the accused "cutting blocks."
- Technical Questions: What evidence demonstrates that the "position" of the accused guide holes is directly "based on the predetermined rotation angle" of the implant, as required by the claim? While the complaint alleges pre-operative planning of rotation, the precise technical linkage between the implant's final rotational orientation and the specific placement of the guide holes on the instrument may be a central point of dispute.
V. Key Claim Terms for Construction
The Term: "patient-specific surface" (’129 Patent, Claim 1)
Context and Importance: This term defines the critical interface between the surgical guide and the patient's anatomy. Its construction will determine whether the guide must make contact with intact cartilage or whether a guide that contacts bone (in an area where cartilage was removed), but which was designed using data that included that cartilage, satisfies the claim. Practitioners may focus on this term because it appears to be a foundational element of the claimed invention.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim requires the surface to "includ[e] cartilage information derived from image data" (’129 Patent, col. 61:19-21). This could be interpreted to mean the surface's shape is merely informed by cartilage data, not that it must physically touch it. The specification describes creating a "three-dimensional representation of the cartilage" from which a device is made, which does not strictly require physical contact in the final application (e.g., ’129 Patent, col. 40:45-55).
- Evidence for a Narrower Interpretation: The same claim requires the surface to be for "engaging at least a portion of a substantially uncut joint surface" (’129 Patent, col. 61:16-18). This language may suggest direct physical contact with the uncut surface, which includes cartilage. Figures in the patent, such as Figure 24A, depict a mold (600) resting directly on the articular cartilage surface (620), which may support a narrower construction requiring contact with cartilage.
The Term: "substantially uncut joint surface" (’129 Patent, Claim 1)
Context and Importance: This term is closely related to "patient-specific surface" and is critical to defining the state of the patient's anatomy when the claimed instrument is engaged. The dispute will likely involve whether this limitation permits any preparation of the joint surface, such as the removal of cartilage in the contact areas as alleged in connection with the accused products, prior to the instrument's use.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term "substantially" suggests some deviation from a completely "uncut" surface is permissible. The specification's focus is on avoiding the large-scale bone resection of traditional arthroplasty, which might suggest that minor surface preparations like cartilage removal fall within the scope of "substantially uncut" (e.g., ’129 Patent, col. 4:25-30, contrasting with procedures requiring bone resection).
- Evidence for a Narrower Interpretation: An ordinary meaning of "uncut" implies no surgical alteration. The patent emphasizes creating tools that fit the patient, rather than forcing the patient to fit the tools (Compl. ¶¶10-11), which could imply the instrument is designed to fit the native, unaltered joint surface.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement for all four patents-in-suit. The allegations are based on Defendant's marketing, selling, providing instructions and product manuals, and promoting the use of the MyKnee® and MyShoulder systems (Compl. ¶¶ 34, 51, 68, 81). The complaint also pleads contributory infringement, alleging the accused products are used in infringing systems and are not suitable for substantial non-infringing use (Compl. ¶¶ 35, 52, 69, 82).
- Willful Infringement: Willfulness is alleged for all four patents. The complaint asserts that Defendant had notice of the patents "at least as early as the filing of the original Complaint" and that its infringement has been and continues to be willful (Compl. ¶¶ 37, 54, 71, 84).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: Can a surgical instrument's "patient-specific surface," which is designed using medical imaging that includes cartilage data but which physically engages bone where cartilage has been removed, be construed to meet the claim limitation of "engaging at least a portion of a substantially uncut joint surface... including cartilage information"?
- A key evidentiary question will be one of technical causality: Does the pre-operative surgical planning of "femoral rotation" for the accused systems establish that the position of the instrument's guide holes is "based on" the "predetermined rotation angle" of the specific orthopedic implant, as required by the claims, or is there a disconnect in the technical linkage?
- A third question concerns the claims against the MyShoulder product, for which the complaint seeks declaratory judgment: Did an "actual and immediate controversy" exist at the time of filing, given that Defendant's announcement of FDA clearance for the product occurred less than a week prior, and what level of preparation to market the product in the U.S. can Plaintiff demonstrate?