DCT
1:19-cv-00592
TruInject Corp v. Galderma SA
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Truinject Corp. (Delaware)
- Defendant: Galderma, S.A. (Switzerland), Galderma Laboratories LP (Texas), Nestlé Skin Health SA (Delaware)
- Plaintiff’s Counsel: Smith Katzenstein & Jenkins LLP; Beus Gilbert McGroder
- Case Identification: 1:19-cv-00592, D. Del., 04/30/2020
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Nestlé Skin Health, Inc. is a Delaware corporation, and the other Defendants have allegedly consented to venue through agreements or by requesting the case be transferred to the district.
- Core Dispute: Plaintiff alleges that Defendants’ "Holly" and "LucyLive/Gia" medical training products infringe three patents related to anatomically correct simulators for practicing cosmetic injections.
- Technical Context: The technology involves medical simulation systems that provide real-time, three-dimensional feedback to practitioners learning to administer cosmetic neurotoxins and dermal fillers, a market segment where improper technique can cause significant patient harm.
- Key Procedural History: The complaint details an extensive pre-suit history between the parties, beginning in 2014, involving multiple confidential disclosure agreements (CDAs) and an exclusive negotiation agreement, during which Plaintiff allegedly disclosed its technology and patent applications to Defendants. These interactions form the basis for the complaint's allegations of willful infringement and trade secret misappropriation.
Case Timeline
| Date | Event |
|---|---|
| 2012-10-30 | U.S. Patent No. 9,792,836 Priority Date |
| 2013-03-01 | Plaintiff develops rough prototype of "Kate" training device |
| 2014-01-24 | Defendant Galderma first contacts Plaintiff regarding its technology |
| 2014-03-13 | U.S. Patent Nos. 10,290,231 & 10,290,232 Priority Date |
| 2014-10-23 | Plaintiff demonstrates "Kate" at Galderma headquarters |
| 2017-10-17 | U.S. Patent No. 9,792,836 Issues |
| 2018-05-01 | Defendants launch "Holly" accused product |
| 2018-06-01 | Defendants launch "LucyLive" (Gia) accused product |
| 2019-05-14 | U.S. Patent No. 10,290,231 Issues |
| 2019-05-14 | U.S. Patent No. 10,290,232 Issues |
| 2020-04-30 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,792,836 - Injection Training Apparatus Using 3D Position Sensor
The Invention Explained
- Problem Addressed: The complaint and patent describe a market need for better training for medical providers administering cosmetic injections, as traditional methods using cadavers or live patients provide limited feedback and expose patients to risks such as blindness, paralysis, and tissue necrosis (Compl. ¶¶ 2, 7, 31-32; ’836 Patent, col. 2:11-45).
- The Patented Solution: The invention is a physical training apparatus shaped like a human body part (e.g., a head) constructed with multiple layers simulating skin and tissue. Crucially, it contains an internal three-dimensional (3D) tracking system that can determine the location of a needle as it is inserted, allowing for data collection and user feedback (Compl. ¶104; ’836 Patent, col. 4:45-53, Fig. 1).
- Technical Importance: The technology provides a safe, repeatable method for practitioners to refine injection techniques by receiving objective, data-driven feedback on needle placement, which was previously unavailable in cosmetic injection training (Compl. ¶¶ 7, 101).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶350).
- Essential elements of Claim 1 include:
- An anatomically shaped injection training apparatus
- An at least partially hollow base for structural support
- A clear layer of elastomer at least partially covering the base
- An opaque layer at least partially covering the clear layer, where the layers form an anatomical shape
- A three-dimensional (3D) tracking system inside the base configured to determine a needle's location when inserted into the clear elastomer layer
U.S. Patent No. 10,290,231 - Automated Detection of Performance Characteristics in an Injection Training System
The Invention Explained
- Problem Addressed: The patent background highlights the lack of a standardized or official certification process for injectors and notes that current training on live models is limited and restrictive, creating a need for more effective training systems ('231 Patent, col. 1:5-34).
- The Patented Solution: This patent claims a method for improving injection performance. The method uses a system that receives sensor-based data from a syringe, analyzes that data, evaluates it against performance criteria, and outputs two key pieces of feedback: a graphical depiction of the injection (including needle location and plunger movement in a 3D model) and a "recommended action to improve injection technique" ('231 Patent, Abstract, col. 33:40-34:21). This invention focuses on the complete feedback loop, from data capture to analysis and actionable recommendations.
- Technical Importance: The patented method moves beyond simple tracking to create an automated, analytical training and certification process that can objectively evaluate performance and guide improvement, which is a significant step in standardizing injector qualifications (Compl. ¶¶ 108, 125).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶376).
- Essential elements of Claim 1 include:
- Providing an anatomically-shaped apparatus and a syringe with at least one sensor
- Receiving sensor-based injection information (indicative of syringe position and use)
- Electronically analyzing the information
- Electronically evaluating the information relative to at least one criterion
- Electronically comparing the information to a performance requirement
- Outputting a graphical depiction of the injection, including a 3D model of the apparatus, needle location, and dynamic plunger position
- Outputting a recommended action to improve injection technique based on the analysis
U.S. Patent No. 10,290,232 - Automated Detection of Performance Characteristics in an Injection Training System
Technology Synopsis
The ’232 patent claims an injection training system (as opposed to the method of the ’231 patent). It comprises a syringe, a human head training apparatus, a location sensing system that measures magnetic field characteristics to determine needle position and orientation, and a processing unit that calculates this position and displays 3D graphical feedback, including a simulated delivery of a therapeutic agent (’232 Patent, col. 33:42-34:52).
Asserted Claims
At least independent claim 1 is asserted (Compl. ¶364).
Accused Features
The complaint alleges that the complete "Holly" system—including its head-form apparatus, syringe, location sensing system using magnetic fields, processing unit, and display of a 3D graphical model with simulated delivery—infringes the claims of the ’232 Patent (Compl. ¶¶ 356-364).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendants' "Holly" injection training device and its companion interactive tablet application, "LucyLive," which is now branded as "Gia" (Compl. ¶¶ 26, 78, 346).
Functionality and Market Context
- The "Holly" device is alleged to be an anatomically shaped training apparatus that appears as a human head, used by physicians with a training syringe to practice cosmetic injections (Compl. ¶¶ 347, 358). The system is alleged to use a three-dimensional tracking system, including one based on magnetic fields, to determine the location and orientation of the syringe needle as it is inserted into the apparatus's multiple layers of simulated tissue (Compl. ¶¶ 348-349, 359). The system then provides feedback on a display device, including a three-dimensional graphical depiction of the injection (Compl. ¶362). A side-by-side photographic comparison in the complaint depicts the "Holly" device and the Plaintiff's "Kate" device, highlighting their similar appearance (Compl. p. 93, ¶316).
- The complaint alleges that Defendants marketed "Holly" as "the first smart cadaver used for patients' simulation in the world" and launched it in May 2018 after years of confidential discussions with Plaintiff, causing market confusion and harming Plaintiff's business (Compl. ¶¶ 26, 324, 337-338).
IV. Analysis of Infringement Allegations
U.S. Patent No. 9,792,836 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An anatomically shaped injection training apparatus | The accused "Holly" product is an anatomically shaped training apparatus used by physicians to practice injections and looks like a human head. | ¶347 | col. 4:5-9 |
| an at least partially hollow base configured to provide structural support | The "Holly" apparatus is alleged to be partially hollow. | ¶349 | col. 6:31-34 |
| a clear layer of elastomer coating at least partially covering a base layer | The "Holly" apparatus is alleged to have multiple layers, including clear layers. | ¶349 | col. 6:35-37 |
| an opaque layer at least partially covering the clear layer, wherein the base, clear layer, and opaque layer form an anatomical shape | The "Holly" apparatus is alleged to have multiple layers, including opaque layers, which together form the anatomical head shape. | ¶349 | col. 6:38-41 |
| a three-dimensional (3D) tracking system positioned inside the base and configured to determine a location of a needle inserted into the clear layer of elastomer | The "Holly" system is alleged to use a three-dimensional tracking system to determine the location of the needle inserted into the apparatus. The image at paragraph 346 shows the Holly device in use with a display showing a 3D anatomical model tracking the syringe. | ¶¶346, 348 | col. 6:42-46 |
- Identified Points of Contention:
- Scope Questions: A central question may be the scope of "three-dimensional (3D) tracking system." The complaint alleges Holly's system performs this function, but the specific technology used by Holly and whether it meets the definition as understood in the patent (which discloses light-based and electromagnetic systems) will be a key factual issue (Compl. ¶105).
- Technical Questions: The complaint's allegations are based on "information and belief" regarding the internal structure of Holly (e.g., its multiple opaque and clear layers and hollow base) (Compl. ¶349). Discovery will be required to confirm whether Holly's internal construction meets these specific claim limitations.
U.S. Patent No. 10,290,231 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| providing the anatomically-shaped apparatus... configured to receive a training injection... | The Holly system provides an anatomically shaped apparatus (the head) that is configured to receive training injections from a user. | ¶369-370 | col. 33:46-49 |
| providing the syringe having a needle, a barrel, and a plunger... further comprising at least one syringe sensor... | The Holly system provides a syringe with a needle, barrel, and plunger, which is alleged to have at least one sensor. | ¶370 | col. 33:50-53 |
| receiving... sensor-based injection information associated with the training injection... | The Holly system's signal processor allegedly receives sensor-based injection information from the syringe sensor that is indicative of the syringe's position and use characteristics. | ¶371 | col. 33:54-59 |
| analyzing electronically... the sensor-based injection information | The system is alleged to electronically analyze the information about the injection gathered from the sensors. | ¶372 | col. 34:1-3 |
| evaluating electronically... the analyzed sensor-based injection information relative to at least one evaluation criterion; and comparing electronically... to determine whether the training injection met the at least one performance requirement | The Holly system's signal processor is alleged to analyze the sensor-based information and evaluate it against a criterion to determine if the injection met a performance requirement. | ¶373 | col. 34:4-10 |
| outputting... a graphical depiction of the training injection, wherein the graphic depiction includes a digital three-dimensional model of the anatomically-shaped apparatus a location of the needle... and a dynamic position of the plunger in real time... | The system allegedly outputs a three-dimensional display of the injection on the apparatus, showing the syringe position in real time on the model. | ¶374 | col. 34:11-21 |
| outputting electronically... a recommended action to improve injection technique | The output device is alleged to provide a "recommended action to improve injection technique" based on the sensor data. | ¶375 | col. 34:22-25 |
- Identified Points of Contention:
- Functional Questions: A key point of contention may be whether the Holly system performs the distinct steps of "analyzing," "evaluating," and "comparing" as required by the claim, or if it simply displays raw position data. Furthermore, the evidence that Holly's output constitutes a "recommended action to improve injection technique" versus merely a display of performance will be critical.
- Evidentiary Questions: The complaint alleges on "information and belief" that the Holly system performs these internal software method steps (Compl. ¶¶ 371-375). Plaintiff will need to substantiate these allegations regarding the system's software architecture and analytical processes through discovery, such as source code review.
V. Key Claim Terms for Construction
Term 1 ('836 Patent, Claim 1): "three-dimensional (3D) tracking system"
- Context and Importance: The definition of this term is central to infringement of the '836 patent. The dispute will likely focus on what types of technology are covered. Practitioners may focus on this term because its construction will determine whether the specific technology used in the "Holly" device, once revealed in discovery, falls within the scope of the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim itself is not limited to a specific type of tracking technology. The specification explicitly states that the patent "is not limited to a light emission device and sensor, but can include other location technology including, for example, electromagnets" (Compl. ¶105).
- Evidence for a Narrower Interpretation: The primary embodiment described in detail involves a light emission device at the needle's tip and a camera or light detection device inside the apparatus that reads the light to pinpoint location, depth, and angle ('836 Patent, col. 4:54-62; Compl. ¶105). A defendant may argue that the term should be construed in light of this primary embodiment.
Term 2 ('231 Patent, Claim 1): "a recommended action to improve injection technique"
- Context and Importance: This term represents the final, crucial output of the claimed method. Infringement will depend on whether the Holly system's feedback constitutes a "recommended action." Practitioners may focus on this term because if Holly merely displays performance data without providing a specific recommendation for improvement, this entire claim limitation may not be met.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests various forms of feedback, including performance metrics and comparisons to an evaluation standard ('231 Patent, col. 26:45-67). A plaintiff could argue that graphically showing an error (e.g., a needle path deviating from an ideal path) implicitly recommends the action of correcting that path.
- Evidence for a Narrower Interpretation: The plain language "recommended action" suggests more than a data display; it suggests a specific instruction or piece of advice. The specification mentions providing "training resources directed at an aspect of the injection technique" as an example of a recommended action, which implies a more direct form of guidance than just displaying an error ('231 Patent, col. 8:14-16).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant Nestlé Skin Health, Inc. induced infringement by providing doctors and other providers with instructions, demonstrations, and videos on how to use the "Holly" device to improve injection performance, thereby encouraging them to perform the steps of the patented method (Compl. ¶¶ 377-379, 582, 591, 601).
- Willful Infringement: The complaint alleges willful infringement based on Defendants' alleged pre-suit knowledge of the patents and patent applications. It is alleged that Truinject provided its patent application for the technology that became the '836 patent to Defendants as early as November 2014 during business negotiations, long before the '836 patent issued and before Defendants allegedly began developing the infringing "Holly" device (Compl. ¶¶ 351, 583). This alleged pre-issuance knowledge of the application, combined with the launch of a similar product, may support the claim for willfulness.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical evidence: can Plaintiff, through discovery, prove that the accused "Holly" system contains the specific internal components (e.g., hollow base, distinct elastomer layers) required by the '836 patent's apparatus claims and performs the specific analytical and feedback steps (e.g., evaluating, comparing, recommending action) required by the '231 patent's method claims?
- A second central issue will be one of claim scope: how broadly will the court construe key terms like "three-dimensional (3D) tracking system" from the '836 patent and "recommended action" from the '231 patent? The resolution of these terms will likely determine whether the technical operation of the "Holly" product, once fully understood, falls within the boundaries of the patent claims.
- Finally, a key question for damages and potential enhancement will be one of intent: does the extensive evidence of pre-suit interaction, including the alleged sharing of patent applications and confidential technical information under CDAs, rise to the level of egregious conduct required to support a finding of willful infringement?