DCT

1:25-cv-01409

Haemonetics Corp v. Terumo BCT Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01409, D. Colo., 05/05/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Colorado because Defendant resides in the district, maintains a regular and established place of business there, and has committed alleged acts of infringement within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s plasma collection systems infringe seven patents related to methods and systems for optimizing plasma collection by tailoring collection volumes to individual donors and accurately calculating the volume of pure plasma collected, distinct from any added anticoagulant.
  • Technical Context: The technology pertains to automated apheresis systems used for collecting human plasma, which is a critical source material for a variety of life-saving plasma-derived medicinal products.
  • Key Procedural History: The complaint alleges that Plaintiff sent Defendant a notice letter on October 1, 2024, detailing infringement allegations concerning five of the seven asserted patents. This event may be relevant to the allegations of willful infringement.

Case Timeline

Date Event
2017-05-30 Earliest Priority Date for Asserted Patents
2020-09-01 U.S. Patent No. 10,758,652 Issues
2020-10-06 U.S. Patent No. 10,792,416 Issues
2021-04-20 U.S. Patent No. 10,980,926 Issues
2021-04-20 U.S. Patent No. 10,980,934 Issues
2022-03-XX Rika System with Nomogram A/B Receives FDA Approval
2022-08-04 First Use of Rika System with Nomogram A/B Announced
2023-08-29 U.S. Patent No. 11,738,124 Issues
2024-05-09 Rika System with iNomi Nomogram Receives FDA Approval
2024-10-01 Plaintiff Sends Notice Letter to Defendant
2024-12-24 U.S. Patent No. 12,171,916 Issues
2025-01-07 U.S. Patent No. 12,186,474 Issues
2025-05-05 Complaint Filed

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

U.S. Patent No. 10,758,652 - "System and Method for Collecting Plasma"

  • Patent Identification: U.S. Patent No. 10,758,652, titled “System and Method for Collecting Plasma,” issued September 1, 2020.

The Invention Explained

  • Problem Addressed: The patent’s background section describes that prior art plasma collection systems base collection limits on the total volume of collected fluid, which is a mixture of plasma and anticoagulant. Because regulations limit the total volume that can be collected, this practice results in collecting less pure plasma than is permissible, making the process inefficient (Compl. ¶20; ’652 Patent, col. 2:36-44).
  • The Patented Solution: The invention proposes a system with a controller that addresses this inefficiency by calculating the volume of "pure plasma" being collected, separate from the anticoagulant. The controller calculates the volume of anticoagulant within the collected fluid and subtracts it from the total measured volume, thereby determining the volume of pure plasma. The system is configured to stop the collection process only when a target volume of pure plasma is reached ('652 Patent, Abstract; col. 2:61-67). This process is depicted in the patent’s flowchart in Figure 4 ('652 Patent, FIG. 4).
  • Technical Importance: This method allows plasma collection centers to maximize the yield of pure plasma from each donation within regulatory limits, increasing the overall supply of plasma for therapeutic use without requiring an increase in the number of donations (Compl. ¶22).

Key Claims at a Glance

  • The complaint asserts independent claim 11 (Compl. ¶52).
  • Essential elements of Claim 11 include:
    • A venous-access device, a blood component separation device, a blood draw line, and an anticoagulant line.
    • A controller configured to calculate (1) a volume of anticoagulant in the collected plasma component as it is being collected, and (2) a volume of pure plasma collected within the plasma container based, at least in part, upon the volume of anticoagulant.
    • The controller is further configured to stop the blood draw pump when a target volume of pure plasma is collected within the plasma container.

U.S. Patent No. 10,792,416 - "System and Method for Collecting Plasma"

  • Patent Identification: U.S. Patent No. 10,792,416, titled “System and Method for Collecting Plasma,” issued October 6, 2020.

The Invention Explained

  • Problem Addressed: The patent identifies the inefficiency of prior art systems that do not tailor plasma collection amounts to an individual donor's specific physiology, such as height and hematocrit, beyond classifying them into broad weight-based categories (Compl. ¶20; '416 Patent, col. 2:50-55).
  • The Patented Solution: The invention describes a more personalized system that first calculates an individual "donor plasma volume" based on the donor's specific weight, height, and hematocrit. From this, it calculates a "target plasma collection volume" (e.g., a set percentage of the donor's total plasma). The system then monitors the collection of "pure plasma" (accounting for anticoagulant, as in the '652 Patent) and stops the procedure when this individualized target volume is reached ('416 Patent, Abstract; col. 4:1-12). This multi-step calculation process is illustrated in the flowchart in Figure 5 of the patent ('416 Patent, FIG. 5).
  • Technical Importance: This "individualized nomogram" approach moves beyond fixed volume targets to a dynamic, donor-specific target, which is alleged to further optimize plasma yield while maintaining donor safety (Compl. ¶21, ¶25).

Key Claims at a Glance

  • The complaint asserts independent claim 17 (Compl. ¶73).
  • Essential elements of Claim 17 include:
    • A venous-access device, a blood component separation device, a first line, and an anticoagulant line.
    • A controller configured to calculate (1) a donor plasma volume based on the donor's weight, height, and hematocrit; (2) a target plasma collection volume based on the calculated donor plasma volume and a target percentage; (3) a volume of anticoagulant; and (4) a volume of pure plasma.
    • The controller is configured to stop the pump when the calculated volume of pure plasma equals the target plasma collection volume.

U.S. Patent No. 10,980,926 - "System and Method for Collecting Plasma"

  • Patent Identification: U.S. Patent No. 10,980,926, titled “System and Method for Collecting Plasma,” issued April 20, 2021.
  • Technology Synopsis: This patent addresses inaccurate plasma volume measurement by teaching a system that calculates a "target collection volume" based on both a "target volume of pure plasma" (derived from donor weight) and the "volume of anticoagulant" needed (derived from donor hematocrit). The system stops collection when this combined target volume is reached, which is intended to ensure a precise amount of pure plasma is collected regardless of variations in anticoagulant volume (Compl. ¶20-21; ’926 Patent, Abstract).
  • Asserted Claims: Independent Claim 8 is asserted (Compl. ¶97).
  • Accused Features: The complaint alleges the controller in the Accused Products calculates anticoagulant volume based on hematocrit and a target pure plasma volume based on donor weight, and then stops collection based on a combined target collection volume (Compl. ¶105-108).

U.S. Patent No. 10,980,934 - "System and Method for Collecting Plasma"

  • Patent Identification: U.S. Patent No. 10,980,934, titled “System and Method for Collecting Plasma,” issued April 20, 2021.
  • Technology Synopsis: Similar to the ’416 Patent, this invention concerns the inefficiency of non-individualized collection protocols. It teaches a system with a controller that performs a multi-step calculation for a highly tailored donation: (1) calculate an individualized "donor plasma volume" (using weight, height, hematocrit), (2) calculate a "target plasma volume" (using the donor plasma volume and a target percentage), and (3) calculate a "target collection volume" based on that individualized target (Compl. ¶21; '934 Patent, col. 4:1-10).
  • Asserted Claims: Independent Claim 23 is asserted (Compl. ¶119).
  • Accused Features: The controllers of the Accused Products are alleged to perform a three-step calculation for donor plasma volume, target plasma volume, and target collection volume based on donor-specific characteristics (Compl. ¶127-129).

U.S. Patent No. 11,738,124 - "System and Method for Collecting Plasma"

  • Patent Identification: U.S. Patent No. 11,738,124, titled “System and Method for Collecting Plasma,” issued August 29, 2023.
  • Technology Synopsis: This patent focuses on accurately measuring pure plasma volume by accounting for the donor's hematocrit. It describes a system with a controller that calculates the volume of anticoagulant based on the donor's hematocrit, uses that value to calculate the volume of pure plasma being collected, and stops the blood draw pump when a target volume of pure plasma is reached (Compl. ¶22; '124 Patent, Abstract).
  • Asserted Claims: Independent Claim 11 is asserted (Compl. ¶140).
  • Accused Features: The complaint alleges the controllers of the Accused Products calculate anticoagulant volume based on donor hematocrit and then use that data to determine the volume of pure plasma collected, stopping the procedure when a pure plasma target is met (Compl. ¶148-150).

U.S. Patent No. 12,171,916 - "System and Method for Collecting Plasma"

  • Patent Identification: U.S. Patent No. 12,171,916, titled “System and Method for Collecting Plasma,” issued December 24, 2024.
  • Technology Synopsis: This patent describes the system with an emphasis on the user interface and operational flow. A controller, coupled to a touchscreen, receives a donor's weight and hematocrit, determines a target plasma volume, and controls the system to operate the necessary draw and return cycles to collect the plasma, thereby integrating the calculation logic with the physical operation of the machine (Compl. ¶23; '916 Patent, Abstract).
  • Asserted Claims: Independent Claim 7 is asserted (Compl. ¶161).
  • Accused Features: The Accused Products are alleged to have a touchscreen and a controller that receives donor weight and hematocrit, determines a target volume, and controls the draw/return cycles of the system (Compl. ¶168-172).

U.S. Patent No. 12,186,474 - "System and Method for Collecting Plasma"

  • Patent Identification: U.S. Patent No. 12,186,474, titled “System and Method for Collecting Plasma,” issued January 7, 2025.
  • Technology Synopsis: This invention teaches determining the target collection volume prior to withdrawing any blood, based on the donor's total blood volume and/or plasma volume (calculated using inputs like weight, height, and hematocrit). The controller then operates a plurality of draw and return cycles to achieve this pre-calculated, individualized target (Compl. ¶25; '474 Patent, Abstract).
  • Asserted Claims: Independent Claim 9 is asserted (Compl. ¶183).
  • Accused Features: The complaint alleges that the controllers of the Accused Products determine a target volume for plasma product before collection begins, based on donor parameters, and then operate a series of draw and return cycles to meet that target (Compl. ¶192-194).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant’s Rika Plasma Donation System™ when used with either its Nomogram A and B or its iNomi™ Nomogram (collectively, the "Accused Products") (Compl. ¶4).

Functionality and Market Context

  • The Accused Products are automated systems that collect blood from a donor, process it to separate and remove plasma, and return the remaining blood components to the donor (Compl. ¶48). According to materials cited in the complaint, a feature of the iNomi™ Nomogram is its ability to determine plasma collection volume based on an individual donor's height, weight, and hematocrit on the day of donation (Compl. ¶48). The complaint alleges that these systems are used in plasma donation centers operated by third parties, such as CSL Plasma (Compl. ¶49), and that Defendant lured at least one customer away from Plaintiff with the promise of improved collection efficiency allegedly enabled by the patented technology (Compl. ¶50).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

10,758,652 Patent Infringement Allegations

Claim Element (from Independent Claim 11) Alleged Infringing Functionality Complaint Citation Patent Citation
a controller configured to control the operation of the blood component separation device and the blood draw pump, the controller configured to calculate (1) a volume of anticoagulant in the collected plasma component as the plasma component is being collected in the plasma container, and (2) a volume of pure plasma collected within the plasma container based, at least in part, upon the volume of anticoagulant in the collected plasma component, The controllers of the Accused Products are alleged to be configured to calculate both a volume of anticoagulant and a volume of pure plasma during the collection process. ¶61-62 col. 2:61-67
the controller configured to stop the blood draw pump when a target volume of pure plasma is collected within the plasma container. The controllers of the Accused Products are alleged to be configured to stop the blood draw pump once a target volume of pure plasma is collected. ¶63 col. 3:1-5

10,792,416 Patent Infringement Allegations

Claim Element (from Independent Claim 17) Alleged Infringing Functionality Complaint Citation Patent Citation
a controller configured to control the operation of the blood component separation device and the first pump, the controller configured to calculate (1) a donor plasma volume based, at least in part, on a weight and height of the donor and a hematocrit of the donor, The controllers of the Accused Products are alleged to be configured to calculate a donor's total plasma volume based on that donor's weight, height, and hematocrit. ¶82 col. 4:1-10
(2) a target plasma collection volume based, at least in part, on the calculated donor plasma volume and a target percentage of plasma, The controllers are alleged to be configured to calculate a target plasma collection volume based on the calculated donor plasma volume and a target percentage. ¶83 col. 4:1-10
(3) a volume of anticoagulant... and (4) a volume of pure plasma collected... the controller configured to stop the first pump when the calculated volume of pure plasma collected within the plasma container equals the target plasma collection volume. The controllers are alleged to calculate the volume of pure plasma collected and to stop the pump when this calculated volume equals the target collection volume. ¶85-86 col. 3:11-20
  • Identified Points of Contention:
    • Scope Questions: The claims recite a "controller configured to calculate" various parameters. A potential point of contention may be whether the specific algorithms and calculation methods used in the Accused Products fall within the scope of these functional claim limitations, or if they operate in a materially different way from what is described and claimed in the patents.
    • Technical Questions: The complaint relies on Defendant’s public statements about the iNomi™ Nomogram's capabilities to support its infringement allegations (Compl. ¶48). A central evidentiary question will be what proof can be adduced regarding the internal software logic of the Accused Products. The analysis will likely turn on evidence from discovery demonstrating precisely how the accused controller calculates collection volumes and whether that process maps onto the specific multi-step calculations required by the asserted claims.

V. Key Claim Terms for Construction

  • The Term: "pure plasma" (’652 Patent, Claim 11)

  • Context and Importance: This term is central to the core novelty of the '652 Patent, which distinguishes itself from prior art by targeting a volume of plasma without anticoagulant. The infringement analysis depends on whether the Accused Products calculate and target a metric equivalent to "pure plasma." Practitioners may focus on this term to dispute whether the accused system's calculated "plasma collection volume" is functionally and legally the same as the claimed "pure plasma."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a straightforward definition: "the volume of pure plasma (e.g., plasma without anticoagulant) that has been collected" ('652 Patent, col. 4:15-17). This could support a broad construction covering any calculated volume that excludes anticoagulant.
    • Evidence for a Narrower Interpretation: The specification discloses a specific equation for calculating the percentage of anticoagulant ('652 Patent, col. 8:22-27). A party could argue that "pure plasma" is not just any estimate, but a value derived from a calculation that relies on the principles embodied in that formula, potentially narrowing the claim's scope.

  • The Term: "donor plasma volume" (’416 Patent, Claim 17)

  • Context and Importance: This term is the foundational, individualized parameter in the multi-step calculation claimed in the '416 Patent. Infringement of claim 17 requires a showing that the accused device calculates this specific value. The construction of this term will determine what types of calculations for estimating a person's total plasma volume are covered by the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification defines the term functionally as "the volume of plasma within the donor's blood" ('416 Patent, col. 13:13-14). This may support an interpretation that covers any scientifically reasonable method for estimating an individual's total plasma volume based on their physical characteristics.
    • Evidence for a Narrower Interpretation: The detailed description provides a specific example of calculating this value using the donor's Body Mass Index (BMI) and an equation for Indexed Blood Volume ("InBV") ('416 Patent, col. 13:17-29). A party may argue that "donor plasma volume" should be limited to values derived from this specific disclosed methodology, rather than any and all possible estimation formulas.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. Inducement is based on allegations that Defendant provides instruction materials, training, and advertising that encourage and instruct customers like CSL Plasma to use the Accused Products in an infringing manner (Compl. ¶66, ¶89, ¶111). Contributory infringement is based on the allegation that the Accused Products are material components specifically made for an infringing use and have no substantial non-infringing uses (Compl. ¶67, ¶90, ¶112).
  • Willful Infringement: Willfulness is alleged based on pre-suit knowledge for five of the asserted patents, stemming from a notice letter sent on October 1, 2024 (Compl. ¶47, ¶65). For the two most recently issued patents, the complaint alleges knowledge "at least since the filing of this Complaint," which may support a claim for post-filing willful infringement (Compl. ¶47).

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

  • A core issue will be one of functional scope: do the specific algorithms used by the accused Rika system's controller to determine collection volumes perform the same multi-step calculations required by the asserted claims? The case will likely require a detailed comparison of the accused software's logic against claim elements such as "calculat[ing] a volume of pure plasma" and "calculat[ing] a donor plasma volume."
  • A key evidentiary question will be one of operational proof: beyond marketing materials describing the system's capabilities, what technical evidence can be presented to demonstrate the internal software operations of the Rika system? The dispute may turn on discovery of source code, design documents, and internal testing data to establish whether the accused controller functions in the manner claimed by the patents.