Haemonetics Corp v. Terumo BCT Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Haemonetics Corporation (Massachusetts)
  • Defendant: Terumo BCT, Inc. (Colorado)
  • Plaintiff's Counsel: NOD Law PC; Proskauer Rose LLP
• Case Identification: 1:25-cv-01409, D. Colo., 08/12/2025
• Venue Allegations: Venue is alleged to be proper in the District of Colorado because Defendant Terumo BCT resides in the district, maintains a regular and established place of business, and has committed alleged acts of infringement there.
• Core Dispute: Plaintiff alleges that Defendant's plasma collection systems infringe nine patents related to methods and systems for optimizing plasma collection from donors by accounting for individual donor characteristics and calculating pure plasma volumes.
• Technical Context: The lawsuit concerns automated plasmapheresis systems, a medical technology critical for collecting human plasma, the source material for numerous plasma-derived medicinal products.
• Key Procedural History: This Second Amended Complaint follows an original complaint filed on May 5, 2025. Plaintiff allegedly put Defendant on notice of infringement for five of the asserted patents via a letter dated October 1, 2024.

Case Timeline

Date	Event
2017-05-30	Earliest Priority Date for all 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	Accused Rika System with Nomogram A/B Receives FDA Approval
2022-08-04	Accused Rika System First Use Announced
2023-08-29	U.S. Patent No. 11,738,124 Issues
2024-05-09	Accused Rika System with iNomi Nomogram Receives FDA Approval
2024-10-01	Plaintiff Sends Notice Letter to Defendant Regarding Five Patents
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	Original Complaint Filed
2025-06-10	U.S. Patent No. 12,324,873 Issues
2025-08-05	U.S. Patent No. 12,377,204 Issues
2025-08-12	Second Amended 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, "System and Method for Collecting Plasma," issued September 1, 2020 (the "'652 Patent").

The Invention Explained

• Problem Addressed: The patent asserts that prior art plasma collection systems were inefficient because they ended collection based on a total volume of anticoagulated plasma (pure plasma plus anticoagulant) Compl. ¶22 '652 Patent, col. 9:55-58 This method is described as inaccurate because the actual amount of pure plasma collected varies depending on the donor's hematocrit (the ratio of red blood cells to total blood volume), causing systems to collect more plasma from low-hematocrit donors than from high-hematocrit donors '652 Patent, col. 9:58-64
• The Patented Solution: The invention is a system and method that calculates the volume of pure plasma being collected by computationally accounting for the volume of anticoagulant mixed in with the plasma Compl. ¶22 '652 Patent, abstract By monitoring and calculating the pure plasma volume, the system can stop the collection process when a specific target volume of pure plasma is reached, rather than a target total volume of mixed fluid '652 Patent, col. 2:1-7 This process is depicted in a flowchart showing the steps of calculating the anticoagulant percentage and determining the pure plasma amount ʼ652 Patent, Fig. 4, steps 455, 465
• Technical Importance: This approach allows for the collection of a standardized, optimized volume of pure plasma from each donor, addressing the inconsistencies of prior art systems and increasing overall collection efficiency '652 Patent, col. 9:65-67

Key Claims at a Glance

• The complaint asserts independent claim 11 and dependent claims 13, 14, 15, 16, 17, and 18 Compl. ¶60
• Independent claim 11 recites:
  • A system for collecting plasma comprising a venous-access device, a blood component separation device, a blood draw line, an anticoagulant line, and a plasma container.
  • A controller configured to control the system's operation.
  • The controller is 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 container based on that anticoagulant volume.
  • The controller is configured to stop the blood draw pump when a target volume of pure plasma is collected.

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

• Patent Identification: U.S. Patent No. 10,792,416, "System and Method for Collecting Plasma," issued October 6, 2020 (the "'416 Patent").

The Invention Explained

• Problem Addressed: In addition to the issues described in the '652 Patent, the '416 Patent addresses the inefficiency of prior collection systems that did not tailor the collected plasma amount to an individual donor's specific physiology, such as height, weight, and hematocrit Compl. ¶20 '416 Patent, col. 1:50-55
• The Patented Solution: The invention is a system that personalizes the plasma collection target for each donor. A controller calculates a donor-specific plasma volume based on the donor's weight, height, and hematocrit '416 Patent, col. 4:1-10 '416 Patent, abstract It then calculates a target collection volume based on this individualized donor data and a target percentage, and proceeds to collect plasma while differentiating between pure plasma and anticoagulant, stopping when the pure plasma target is met '416 Patent, Fig. 5
• Technical Importance: This innovation allows for an individually tailored collection process that can safely yield an increased amount of plasma on average, thereby improving the efficiency of the plasma supply chain Compl. ¶21

Key Claims at a Glance

• The complaint asserts independent claim 17 and dependent claims 25, 26, 27, 28, 29, and 30 Compl. ¶112
• Independent claim 17 recites:
  • A system for collecting plasma with a venous-access device, separation device, first line, anticoagulant line, and a controller.
  • The controller is configured to calculate (1) a donor plasma volume based on the donor's weight, height, and hematocrit.
  • The controller is also configured to calculate (2) a target plasma collection volume based on the calculated donor plasma volume and a target percentage of plasma.
  • The controller further calculates (3) the volume of anticoagulant and (4) the volume of pure plasma as it is being collected.
  • The controller is configured to stop the pump when the calculated pure plasma volume equals the target plasma collection volume.

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

• Patent Identification: U.S. Patent No. 10,980,926, "System and Method for Collecting Plasma," issued April 20, 2021.
• Technology Synopsis: The '926 Patent discloses a plasma collection system with a controller that calculates a target collection volume. This target is based on three components: (1) the volume of anticoagulant to be collected (itself based on donor hematocrit), (2) a target volume of pure plasma (based on donor weight), and (3) the combined total of the calculated anticoagulant and pure plasma volumes Compl. ¶167 The system stops collection when this final target collection volume is reached.
• Asserted Claims: At least claim 8 (independent) is asserted Compl. ¶166
• Accused Features: The complaint alleges the Accused Products contain a controller that performs the three-part calculation for the target collection volume as recited in claim 8 Compl. ¶¶175-177

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

• Patent Identification: U.S. Patent No. 10,980,934, "System and Method for Collecting Plasma," issued April 20, 2021.
• Technology Synopsis: The '934 Patent claims a plasma collection system with a controller configured to perform a sequence of calculations. It first calculates a donor plasma volume (based on donor weight, height, and hematocrit), then a target plasma volume (based on the donor plasma volume and a target percentage), and finally a target collection volume (based on the target plasma volume) Compl. ¶189
• Asserted Claims: At least claim 23 (independent) is asserted Compl. ¶188
• Accused Features: The Accused Products are alleged to have controllers that perform the sequential calculations for donor plasma volume, target plasma volume, and target collection volume based on donor-specific data Compl. ¶¶197-199

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

• Patent Identification: U.S. Patent No. 11,738,124, "System and Method for Collecting Plasma," issued August 29, 2023.
• Technology Synopsis: The '124 Patent is similar to the '652 Patent, claiming a system with a controller that calculates the volume of pure plasma by accounting for the volume of anticoagulant. It specifies that the anticoagulant calculation is based on the subject's hematocrit Compl. ¶210
• Asserted Claims: At least independent claim 11 and dependent claims 13-18 are asserted Compl. ¶209
• Accused Features: The Accused Products are alleged to have controllers that calculate anticoagulant and pure plasma volumes, with the anticoagulant calculation based on the subject's hematocrit Compl. ¶¶218-219

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

• Patent Identification: U.S. Patent No. 12,171,916, "System and Method for Collecting Plasma," issued December 24, 2024.
• Technology Synopsis: The '916 Patent describes a plasma collection system featuring a touchscreen and a controller. The controller is programmed to receive a donor's weight and hematocrit to determine a target volume for the plasma product and to control the system's draw and return phases Compl. ¶262
• Asserted Claims: At least claim 7 (independent) is asserted Compl. ¶261
• Accused Features: The Accused Products are alleged to have a touchscreen and a controller that receives donor weight/hematocrit, determines a target volume, and controls the collection phases accordingly Compl. ¶¶269-273

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

• Patent Identification: U.S. Patent No. 12,186,474, "System and Method for Collecting Plasma," issued January 7, 2025.
• Technology Synopsis: The '474 Patent is similar to the '916 Patent, claiming a system with a controller programmed to receive a donor's weight, height, and hematocrit. It adds the feature that the target volume is determined prior to withdrawing whole blood, based on the donor's total blood or plasma volume Compl. ¶284
• Asserted Claims: At least claim 9 (independent) is asserted Compl. ¶283
• Accused Features: The Accused Products are alleged to have controllers that determine a target volume based on donor characteristics prior to collection Compl. ¶294

Multi-Patent Capsule: U.S. Patent No. 12,324,873 - System and Method for Collecting Plasma

• Patent Identification: U.S. Patent No. 12,324,873, "System and Method for Collecting Plasma," issued June 10, 2025.
• Technology Synopsis: The '873 Patent claims a system with a controller configured to calculate a volume of pure plasma based on the volume of the collected plasma component, the ratio of anticoagulant added, and the subject's hematocrit Compl. ¶306
• Asserted Claims: At least independent claim 13 and dependent claims 17-21 are asserted Compl. ¶305
• Accused Features: The Accused Products are alleged to have a controller that calculates pure plasma volume based on the collected component volume, anticoagulant ratio, and hematocrit Compl. ¶313

Multi-Patent Capsule: U.S. Patent No. 12,377,204 - System and Method for Collecting Plasma

• Patent Identification: U.S. Patent No. 12,377,204, "System and Method for Collecting Plasma," issued August 5, 2025.
• Technology Synopsis: The '204 Patent describes a system where a controller receives individual donor characteristics (weight, height, hematocrit) and calculates a target plasma amount tailored to those characteristics. The calculation is based on the donor's total blood volume, which is itself based on weight and height Compl. ¶347
• Asserted Claims: At least independent claim 23 and dependent claims 29 and 30 are asserted Compl. ¶346
• Accused Features: The Accused Products are alleged to have a controller that receives donor characteristics and calculates a tailored target plasma amount based on the donor's total blood volume Compl. ¶¶354-355

III. The Accused Instrumentality

Product Identification

• The complaint identifies the accused instrumentalities as Terumo BCT's Rika Plasma Donation System™ with Nomogram A and B and the Rika Plasma Donation System™ with iNomi™ Nomogram (collectively, the "Accused Products") Compl. ¶4

Functionality and Market Context

• The Accused Products are automated systems used to collect blood from a donor, separate it into components, retain the plasma, and return the remaining components to the donor Compl. ¶56 The complaint highlights a press release for the iNomi™ version, stating that one of its features is that "plasma collection volume can be determined by an individual donor's height, weight and hematocrit level on the day they donate plasma" Compl. ¶56 The complaint alleges that Terumo BCT has made these products available to third-party customers, such as CSL Plasma, for use in its plasma donation centers, and that CSL Plasma was previously a customer of Haemonetics Compl. ¶57 Compl. ¶58

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'652 Patent Infringement Allegations

Claim Element (from Independent Claim 11)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A system for collecting plasma comprising: a venous-access device... a blood component separation device... a blood draw line... an anticoagulant line...	The Accused Products are alleged to be plasma collection systems containing these standard hardware components.	¶63; ¶64; ¶65; ¶66; ¶67	col. 2:47-61
a controller configured to control the operation of the blood component separation device and the blood draw pump...	The Accused Products have a controller that controls the operation of the separation device and blood draw pump.	¶68	col. 2:61-62
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...	The controllers of the Accused Products are configured to calculate a volume of anticoagulant in the collected plasma component as it is being collected.	¶69	col. 8:12-24
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 configured to calculate a volume of pure plasma based on the calculated anticoagulant volume.	¶70	col. 8:12-24
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 configured to stop the blood draw pump when a target volume of pure plasma is collected.	¶71	col. 3:1-4

• Identified Points of Contention:
  • Technical Question: The core of the infringement allegation rests on the controller's specific functions. A central question for the court will be what evidence demonstrates that the Accused Products' controller actually performs the two-part calculation recited in the claim-calculating the anticoagulant volume and then using that to calculate a "pure plasma" volume.
  • Scope Question: The claim requires stopping the pump based on a "target volume of pure plasma." The analysis will question whether the accused system's stop condition is based on a direct or indirect calculation of pure plasma that falls within the scope of this limitation, or if it uses a different metric (e.g., total fluid volume, time) that is technically distinct.

'416 Patent Infringement Allegations

Claim Element (from Independent Claim 17)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A system for collecting plasma comprising: a venous-access device... a blood component separation device... a first line... an anticoagulant line...	The Accused Products are alleged to be plasma collection systems containing these standard hardware components.	¶115; ¶116; ¶117; ¶118; ¶119	col. 4:11-30
a controller configured to control the operation of the blood component separation device and the first pump...	The Accused Products have a controller that controls the separation device and pump.	¶120	col. 4:31-33
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 configured to calculate a donor plasma volume based on the donor's weight, height, and hematocrit.	¶121	col. 4:1-5
(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 configured to calculate a target plasma collection volume based on the calculated donor plasma volume and a target percentage.	¶122	col. 4:5-7
(3) a volume of anticoagulant... and (4) a volume of pure plasma collected...	The controllers are configured to calculate the volumes of anticoagulant and pure plasma in the collected component.	¶123; ¶124	col. 10:11-20
the controller configured to stop the first pump when the calculated volume of pure plasma collected... equals the target plasma collection volume.	The controllers are configured to stop the pump when the calculated pure plasma volume equals the target plasma collection volume.	¶125	col. 5:29-33

• Identified Points of Contention:
  • Technical Question: Claim 17 requires a specific, multi-step series of calculations that build on each other. A key evidentiary question will be whether the Accused Products, particularly the iNomi™ version, perform this exact sequence of calculations (donor plasma volume -> target plasma volume -> pure plasma volume) or if they use a simplified algorithm that merely takes the same inputs to arrive at a final volume.
  • Scope Question: The claim requires calculating a "donor plasma volume" from weight, height, and hematocrit. The specification provides an example using Body Mass Index '416 Patent, col. 13:10-23 This raises the question of whether any method using these inputs infringes, or if the claim scope is implicitly narrowed to methods that are similar to the specification's example.

V. Key Claim Terms for Construction

"a volume of pure plasma" (from Claim 11 of the '652 Patent)

• Context and Importance: This term is central to distinguishing the invention from prior art that measured total fluid volume (plasma plus anticoagulant). The definition of what constitutes a "volume of pure plasma" and how it must be "calculated" will be critical to the infringement analysis. Practitioners may focus on whether an estimate or a proxy calculation meets this limitation, or if a more direct computation is required.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language states the volume of pure plasma is calculated "based, at least in part, upon the volume of anticoagulant" '652 Patent, col. 11:58-60 This phrasing may support an argument that the calculation does not need to be perfectly precise and can incorporate other factors or estimations.
  • Evidence for a Narrower Interpretation: The patent's background explicitly criticizes prior art for being "unable to determine the total volume of plasma that has been collected" '652 Patent, col. 1:38-41 This suggests the invention's purpose is to solve this specific problem, which may support a narrower construction requiring a direct and accurate calculation of the plasma-only volume, distinguishing it from mere approximations.

"calculate a donor plasma volume" (from Claim 17 of the '416 Patent)

• Context and Importance: This term defines the personalization aspect of the invention. Its construction will determine the type and complexity of the calculation required for infringement. The dispute will likely hinge on whether the accused system's algorithm, which allegedly uses donor height, weight, and hematocrit Compl. ¶56, performs a function that can be considered "calculating a donor plasma volume."
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim requires the calculation to be "based, at least in part, on a weight and height of the donor and a hematocrit of the donor" '416 Patent, col. 20:25-28 The "at least in part" language suggests flexibility and that the calculation is not limited to a rigid formula derived only from these three inputs.
  • Evidence for a Narrower Interpretation: The specification provides a specific example of calculating the donor's Body Mass Index (BMI) from height and weight, then using the BMI to determine total blood volume, and finally using hematocrit to derive the plasma volume '416 Patent, col. 13:10-40 A party could argue that this detailed example implicitly defines what it means to "calculate" the donor plasma volume, potentially narrowing the claim to methods that follow a similar multi-step, physiological model.

VI. Other Allegations

Indirect Infringement

• The complaint alleges that Terumo BCT induces infringement by advertising and distributing the Accused Products and providing instruction materials, training, and services to partners and customers like CSL Plasma Compl. ¶105 Compl. ¶159 It further alleges contributory infringement, stating that the Accused Products are a material component specifically made for an infringing use and are not staple articles of commerce suitable for substantial non-infringing use Compl. ¶106 Compl. ¶160

Willful Infringement

• The complaint alleges that Terumo BCT had pre-suit knowledge of at least the '652, '416, '926, '934, and '124 patents as of October 1, 2024, due to a notice letter sent by Haemonetics' counsel Compl. ¶55 For the remaining patents, knowledge is alleged from the filing dates of the original and subsequent complaints Compl. ¶55 These allegations form the basis for a claim of willful infringement.

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

This case presents a complex, multi-patent dispute over the core technology of modern, optimized plasma collection systems. The resolution will likely depend on the court's determination of the following central questions:

• A primary issue will be one of definitional scope and functional equivalence: does the accused Rika system's method for determining a collection volume, which is alleged to use donor height, weight, and hematocrit, constitute "calculating a volume of pure plasma" as claimed in patents like the '652 Patent? The case will likely require a deep dive into the specific algorithms of the accused system to determine if there is a functional match with the claimed computational steps.
• A second key question will be one of evidentiary proof regarding personalization: can Haemonetics demonstrate that the accused system performs the specific, multi-step, and layered calculations for individualizing collection targets as recited in patents like the '416 and '934 patents? The complaint's allegations closely track the claim language, suggesting that discovery into the technical operation and source code of the accused system's controller will be the central battleground for proving infringement.
• A final point of contention may involve the patent family's evolution: given the number of asserted patents with shared specifications and overlapping concepts, the court will need to carefully delineate the distinct contribution of each patent's claims. The analysis may focus on whether the subtle differences in claim language across the nine patents create distinct lines of infringement or if they represent variations on a single inventive concept, which could impact both infringement and damages analyses.