DCT
8:22-cv-00220
Lonza Walkersville Inc v. Miltenyi Biotec North America Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Lonza Walkersville, Inc. (Maryland) and Octane Biotech Inc. (Canada)
- Defendant: Miltenyi Biotec North America, Inc. (Maryland)
- Plaintiff’s Counsel: Crowell & Moring LLP
- Case Identification: 8:22-cv-00220, D. Md., 01/28/2022
- Venue Allegations: Venue is alleged to be proper in the District of Maryland because Defendant resides there, has committed alleged acts of infringement there, and has a regular and established place of business at its headquarters in Gaithersburg, Maryland.
- Core Dispute: Plaintiffs allege that Defendant’s CliniMACS Prodigy® System infringes four patents related to automated systems and methods for cell therapy manufacturing.
- Technical Context: The technology concerns automated, point-of-care bioreactor systems designed to culture and process patient cells for therapeutic use, a critical component in the field of personalized medicine.
- Key Procedural History: The complaint alleges that Plaintiff Lonza sent Defendant a notice letter on May 12, 2021, informing Defendant of the alleged infringement of the Asserted Patents, a fact central to the claim of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2002-04-08 | Priority Date for ’932, ’195, ’986, and ’338 Patents |
| 2017-01-03 | U.S. Patent No. 9,534,195 Issued |
| 2017-07-11 | U.S. Patent No. 9,701,932 Issued |
| 2020-07-28 | U.S. Patent No. 10,723,986 Issued |
| 2020-11-24 | U.S. Patent No. 10,844,338 Issued |
| 2021-05-12 | Plaintiffs allegedly sent notice letter to Defendant |
| 2022-01-28 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,701,932 - “Automated Tissue Engineering System”
The Invention Explained
- Problem Addressed: Conventional methods for manufacturing cell therapies are described as labor-intensive and requiring patient cells to be sent to centralized facilities, a process that can take weeks and introduces risks of contamination and human error, which is particularly problematic for terminally ill patients (Compl. ¶19; ’986 Patent, col. 1:55-2:4).
- The Patented Solution: The patent describes a portable, "all-in-one" module for engineering cell cultures (Compl. ¶15, ¶22). The system integrates a bioreactor, a fluid containment system, a heating/mixing chamber, and sensors into a single automated unit. This allows the manufacturing process to occur at the point-of-care, such as a hospital, significantly reducing turnaround time (Compl. ¶19; ’986 Patent, col. 2:27-33). The core of the invention is the use of sensors that actively monitor environmental and metabolic conditions and generate signals for a microprocessor to "actively adjust the changing environmental conditions" throughout the cell development process (Compl. ¶22).
- Technical Importance: This integrated, automated approach was designed to make complex cell therapies more viable and accessible by decentralizing manufacturing from specialized labs to clinical sites (Compl. ¶19).
Key Claims at a Glance
- The complaint asserts independent claim 1, as well as dependent claims 2-3, 10-11, and 13-22 (Compl. ¶34, ¶69).
- The essential elements of independent claim 1 include:
- A portable tissue and/or cell culture engineering module.
- At least one bioreactor for cell culture/tissue engineering functions.
- A fluid containment system in fluid communication with the bioreactor.
- A heating and/or mixing chamber for fluids flowing to the bioreactor.
- One or more sensors configured to actively detect environmental and metabolic conditions and generate signals to a microprocessor to "actively monitor and actively adjust the changing environmental conditions" until completion of the process.
U.S. Patent No. 9,534,195 - “Automated Tissue Engineering System”
The Invention Explained
- Problem Addressed: The problem is consistent with that described for the ’932 Patent, focusing on the need for a more efficient, reliable, and automated cell culturing system (’986 Patent, col. 1:55-2:4).
- The Patented Solution: This patent focuses specifically on the bioreactor component of the automated system. The invention is a bioreactor that includes a housing, ports for media flow, a chamber for cellular functions, and integrated sensors (’195 Patent, Abstract; Compl. ¶24). The key feature is the bioreactor's adaptation to "automatically monitor parameters" and "automatically re-adjust" those parameters in response to the status of cell proliferation, ensuring optimal conditions are maintained to generate a desired cell population (’195 Patent, Abstract; Compl. ¶24).
- Technical Importance: By integrating automated monitoring and adjustment capabilities directly into the bioreactor, the invention aims to improve the consistency and success rate of cell culture processes with minimal human intervention (Compl. ¶15).
Key Claims at a Glance
- The complaint asserts independent claim 1, as well as dependent claims 2, 7, 9, 13, 18-19, 21, 26, and 28 (Compl. ¶35, ¶77).
- The essential elements of independent claim 1 include:
- A bioreactor for supporting cellular functions, comprising a housing, ports, and at least one chamber.
- One or more sensors for monitoring and automatically adjusting parameters selected from a group including temperature, pH, dissolved gases, metabolic turnover, and others.
- The bioreactor is adapted to automatically monitor and re-adjust these parameters based on sensor feedback to maintain optimal conditions and generate a desired cell population.
Multi-Patent Capsule: U.S. Patent No. 10,723,986 - “Automated Tissue Engineering System”
- Patent Identification: U.S. Patent No. 10,723,986, titled “Automated Tissue Engineering System,” issued July 28, 2020.
- Technology Synopsis: The ’986 Patent claims an automated method for cell culture. The method comprises the steps of loading cells into a sensor-equipped bioreactor, seeding the cells onto a substrate, proliferating them, and using a microprocessor to "actively monitor and automatically adjust" the culturing parameters to obtain the desired cells or tissue (Compl. ¶26).
- Asserted Claims: Independent claim 1 and dependent claims 2-5 (Compl. ¶36, ¶85).
- Accused Features: The complaint alleges that the standard operation of the CliniMACS Prodigy® System constitutes direct infringement of this method and that Defendant induces infringement by publishing brochures and other materials that instruct customers on how to use the system in an infringing manner (Compl. ¶38, ¶41). A visual in the complaint depicts the accused multi-day transduction process (Compl. p. 12).
Multi-Patent Capsule: U.S. Patent No. 10,844,338 - “Automated Tissue Engineering System”
- Patent Identification: U.S. Patent No. 10,844,338, titled “Automated Tissue Engineering System,” issued November 24, 2020.
- Technology Synopsis: The ’338 Patent is directed to a cell culture engineering module. The claimed module comprises a bioreactor, a fluid containment system, and sensors configured to generate signals to a microprocessor to "automatically monitor and automatically alter the changing environmental conditions" responsive to different stages of cell culture (Compl. ¶28).
- Asserted Claims: Independent claim 1 and dependent claims 2-8, 10-11 (Compl. ¶37, ¶93).
- Accused Features: The CliniMACS Prodigy® Instrument is accused of being an infringing "module for cell engineering" (Compl. ¶30).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant’s “CliniMACS Prodigy® System,” which includes the “CliniMACS® Prodigy Instrument,” related “CliniMACS Prodigy® Tubing Sets,” and the “CliniMACS® Electroporator” (Compl. ¶3).
Functionality and Market Context
The CliniMACS Prodigy® is described as an “automated cell processing platform that enables scalable GMP-compliant manufacturing of cell therapy products, on a single device and within a single process setup” (Compl. ¶30). The complaint alleges the system is designed for “[f]ully-automated, sensor-controlled processes” and uses its sensors to maintain optimal conditions through “sensor-controlled, cell processing capabilities” (Compl. ¶32). An annotated image provided in the complaint identifies key components of the Instrument, including a bioreactor, a fluid containment system, a heating chamber, and sensors (Compl. p. 10; ¶31). A separate schematic illustrates the system's configuration for hematopoietic stem cell engineering (Compl. p. 10; ¶33). The complaint asserts that Plaintiffs and Defendant are direct competitors in the automated cell therapy market (Compl. ¶29).
IV. Analysis of Infringement Allegations
U.S. Patent No. 9,701,932 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A portable tissue and/or cell culture engineering module | The CliniMACS Prodigy® Instrument is alleged to be an automated cell processing platform on a single device (Compl. ¶30). | ¶30 | col. 2:44-46 |
| at least one bioreactor | The Instrument is alleged to contain a component labeled "Bioreactor" in a provided image (Compl. p. 10). | ¶31 | col. 6:49-54 |
| a fluid containment system in fluid communication with said at least one bioreactor | The Instrument is alleged to include a "Fluid containment system" connected to the bioreactor, as labeled in a provided image (Compl. p. 10). | ¶31 | col. 6:55-58 |
| a heating and/or mixing chamber to heat and/or mix fluids flowing to said at least one bioreactor | The Instrument is alleged to possess a "Heating chamber," as labeled in a provided image (Compl. p. 10). | ¶31 | col. 16:29-34 |
| one or more sensors configured to actively detect environmental conditions ... and ... generate signals to a ... microprocessor to actively monitor and actively adjust the changing environmental conditions | The Instrument is alleged to be designed for "fully-automated, sensor-controlled processes" that use sensors to maintain optimal conditions (Compl. ¶32). | ¶31, ¶32 | col. 3:23-27, col. 3:51-54 |
U.S. Patent No. 9,534,195 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A bioreactor for facilitating and supporting cellular functions ... comprising; a bioreactor housing; one or more ports for media flow; at least one chamber defined within said bioreactor housing | The CliniMACS Prodigy® Instrument is alleged to have a "Housing," "Ports," and a "Bioreactor" containing a chamber, as depicted in an annotated image (Compl. p. 10). | ¶31 | col. 7:22-24, 59-64 |
| one or more sensors for monitoring and automatically adjusting parameters related to said cellular functions ... the parameter selected from the group consisting of temperature, pH, dissolved gases... | The Instrument is alleged to use its sensors to maintain optimal conditions using "sensor-controlled, cell processing capabilities" (Compl. ¶32). | ¶32 | col. 7:65-8:3 |
| wherein: the bioreactor is adapted to automatically monitor parameters ... and to automatically re-adjust the parameters in the bioreactor responsive to the status of cell proliferation | The complaint alleges the Instrument operates using "fully-automated, sensor-controlled processes" (Compl. ¶32). | ¶32 | col. 3:48-54 |
Identified Points of Contention
- Technical Questions: A primary question will be the precise technical function of the accused "sensors." The complaint alleges the system performs "sensor-controlled processes" to "maintain optimal conditions" (Compl. ¶32), but provides limited detail on whether this constitutes the specific "active adjustment" and "automatic re-adjustment" required by the claims. The dispute may focus on whether the accused system forms a closed-loop feedback system that alters conditions without user intervention, or if it primarily functions as a monitoring and alert system.
- Scope Questions: The infringement analysis may depend on the construction of "portable tissue and/or cell culture engineering module" as used in the ’932 Patent. The parties may dispute whether the accused CliniMACS Prodigy® Instrument, a piece of laboratory equipment, falls within the scope of "portable" as understood in the context of the patent.
V. Key Claim Terms for Construction
The Term: "actively adjust" (’932 Patent, cl. 1); "automatically re-adjust" (’195 Patent, cl. 1)
Context and Importance: This language is central to the claimed automation and feedback control. The case may turn on whether the accused system’s "sensor-controlled" functionality meets this active/automatic limitation. Practitioners may focus on this term because the complaint's support relies on general marketing statements rather than specific technical disclosures of the accused system's operation (Compl. ¶32).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract describes a general linkage: "a microprocessor linked to one or more of the sensors" ('986 Patent, Abstract), which might suggest any microprocessor-driven response to sensor data could suffice.
- Evidence for a Narrower Interpretation: The specification provides a specific example of adjustment: the CPU "triggers a control intervention such as replacing the media within the bioreactor" ('986 Patent, col. 16:1-3). A defendant may argue this limits the scope of "adjust" to specific, pre-programmed actions like media replacement rather than continuous, real-time modulation of parameters.
The Term: "bioreactor" (’932 Patent, cl. 1; ’195 Patent, cl. 1)
Context and Importance: The definition of "bioreactor" is fundamental to determining infringement. The complaint identifies a component labeled "Bioreactor" on the accused Instrument (Compl. p. 10), but the patents contemplate bioreactors that can perform various functions including tissue digestion, cell proliferation, and tissue formation (’986 Patent, col. 18:41-47). The analysis will require mapping the functions of the accused component to the functions described for a "bioreactor" in the patent specification.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims define the bioreactor broadly as "facilitating cell culture and/or tissue engineering functions" (’932 Patent, cl. 1) or "facilitating and supporting cellular functions" (’195 Patent, cl. 1).
- Evidence for a Narrower Interpretation: Specific embodiments in the patent describe multi-chamber bioreactors with distinct zones for digestion, proliferation, and differentiation, complete with funnels and filters between them (’986 Patent, Fig. 12a, Type II & III). A defendant might argue that to qualify as the claimed "bioreactor," the accused component must possess these more complex, multi-functional structural features.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement of the ’986 method patent, asserting that Defendant publishes brochures and other materials instructing customers on how to use the CliniMACS Prodigy® System in an infringing manner (Compl. ¶38-39). The complaint also pleads contributory infringement, alleging that Defendant sells "convoyed products," such as specific Tubing Sets, that are not suitable for any other use and are designed to work exclusively with the allegedly infringing Instrument (Compl. ¶45, ¶47, ¶57).
- Willful Infringement: The willfulness allegation is based on alleged pre-suit knowledge. The complaint states that Plaintiff Lonza sent Defendant a letter on May 12, 2021, providing actual notice of the asserted patents and the alleged infringement (Compl. ¶59, ¶63).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional operation: what is the precise, evidence-based functionality of the accused CliniMACS Prodigy® System's "sensor-controlled" features? The dispute will likely focus on whether the system's automation performs the specific, closed-loop "active adjustment" and "automatic re-adjustment" of cell culture conditions as required by the claims, or if its capabilities are more limited to monitoring and reporting.
- A key evidentiary question will be one of structural correspondence: does the accused Instrument's component labeled "Bioreactor" meet the structural and functional definition of a "bioreactor" as contemplated by the patent specification? This may involve a detailed comparison of the accused product's internal chambers, flow paths, and capabilities against the specific embodiments disclosed in the patents.