DCT
3:18-cv-04422
Bracco Diagnostics Inc v. Jubilant DraxImage Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bracco Diagnostics Inc. (Delaware)
- Defendant: Jubilant DraxImage Inc. (Canada), Jubilant Pharma Limited (Singapore), and Jubilant Life Sciences (India)
- Plaintiff’s Counsel: Greenberg Traurig LLP
- Case Identification: 3:18-cv-04422, D.N.J., 03/27/2018
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendants engage in the manufacturing, marketing, and sale of pharmaceutical products in the state, have availed themselves of the rights of New Jersey law, and because Plaintiff, headquartered in New Jersey, suffers foreseeable harm and injury in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Ruby-Fill® radioisotope infusion system infringes five U.S. patents related to the system's mechanical integration, safety features, and computer-controlled operation.
- Technical Context: The technology involves integrated systems for generating and infusing Rubidium-82, a radioactive agent used in Positron Emission Tomography (PET) imaging to assess blood flow to the heart muscle.
- Key Procedural History: Defendants received FDA approval for the accused Ruby-Fill® system on September 30, 2016, following the submission of a 505(b)(2) New Drug Application. Subsequent to the filing of this complaint, the asserted independent claims of U.S. Patent Nos. 9,299,467 and 9,299,468 were cancelled in Inter Partes Review (IPR) proceedings, which may significantly impact the viability of the infringement counts related to those patents.
Case Timeline
| Date | Event |
|---|---|
| 2008-06-11 | Earliest Priority Date for all Patents-in-Suit |
| 2010-06-18 | Defendants submit drug application for Ruby-Fill® system to the FDA |
| 2016-03-29 | U.S. Patent Nos. 9,299,467 and 9,299,468 Issue |
| 2016-09-30 | FDA approval for Defendants' Ruby-Fill® system |
| 2017-09-05 | U.S. Patent Nos. 9,750,869 and 9,750,870 Issue |
| 2017-11-14 | U.S. Patent No. 9,814,826 Issues |
| 2018-03-27 | Complaint Filed |
| 2022-01-07 | IPR Certificates issue cancelling asserted claims of the '467 and '468 patents |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,814,826 - "Integrated strontium-rubidium radioisotope infusion systems"
- Issued: November 14, 2017
The Invention Explained
- Problem Addressed: The patent describes the technical challenges of safely and efficiently operating radiopharmaceutical infusion systems, which involve handling radioactive materials and performing complex quality control procedures to protect both patients and technical personnel (US 9,814,826 B2, col. 1:46-56).
- The Patented Solution: The invention is a method of building an integrated, cart-based infusion system with a specific physical architecture. It requires installing shielded compartments for the radioisotope generator and a waste bottle at different elevations and configuring an on-board computer to automate a critical safety check—the strontium breakthrough test—and prevent patient infusion if the test fails ('826 Patent, col. 2:4-24; Fig. 1A).
- Technical Importance: This integrated approach aims to reduce manual steps and potential for error in quality control, enhancing the safety and efficiency of PET imaging procedures ('826 Patent, col. 2:51-56).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶58).
- The essential elements of Claim 1, a method of building an infusion system, are:
- installing a first shielding compartment, a second shielding compartment, and a shielded well on a platform of a cart, with specific configurations and relative elevations for a radioisotope generator and a waste bottle;
- configuring a computer with a touch screen display to:
- fill an eluate reservoir with a sample of rubidium radioactive eluate;
- determine a strontium breakthrough test result on that sample while it remains in the shielded well on-board the cart; and
- not allow a patient infusion if the breakthrough test result is greater than or equal to an allowed limit.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 9,750,869 - "Integrated strontium-rubidium radioisotope infusion systems"
- Issued: September 5, 2017
The Invention Explained
- Problem Addressed: The patent addresses the same technical challenges as the '826 patent, focusing on the need for new system configurations that facilitate more efficient setup, maintenance, and operation while minimizing radiation exposure (US 9,750,869 B2, col. 1:52-56).
- The Patented Solution: The invention is an integrated infusion system on a cart, defined by its physical structure. This includes a cabinet with a specific exterior shell, internal shielding compartments for the generator and waste bottle, accessible doors, and a computer with a touch screen mounted on a vertical post. The computer is configured to automate saline pumping, sample collection, and the strontium breakthrough safety test ('869 Patent, Abstract; Fig. 1C).
- Technical Importance: The claimed physical integration of shielding, access doors, and computer control on a mobile cart provides an ergonomic and self-contained system that simplifies complex radiopharmaceutical procedures ('869 Patent, col. 3:41-49).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶79).
- The essential elements of Claim 1, an infusion system, are:
- a cart with a cabinet structure comprising a platform, exterior shell, and openings for a generator and waste bottle;
- a computer with a touch screen mounted on a vertical post;
- first and second shielding compartments inside the cabinet for the generator and waste bottle, with corresponding accessible doors;
- a specific elevation difference between the generator and waste bottle openings;
- a radioactivity detector;
- a shielded well for a test sample; and
- a computer configured to pump saline, fill the reservoir, determine a strontium breakthrough test result, and prevent infusion if the result exceeds an allowed limit.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 9,750,870 - "Integrated strontium-rubidium radioisotope infusion systems"
- Issued: September 5, 2017
- Technology Synopsis: This patent claims a method of using an integrated infusion system on a cart. The claimed steps cover the entire user workflow, including installing a saline reservoir, inserting a waste bottle, placing tubing in fluid communication, pumping a sample for testing, and using the system's computer to perform automated calibration and breakthrough tests that gate patient infusion (Compl. ¶109).
- Asserted Claims: Independent claim 1 (Compl. ¶109).
- Accused Features: The complaint alleges that Defendants' user manuals and prescribing information instruct and encourage end-users to perform the claimed method steps using the Ruby-Fill® system (Compl. ¶¶110-121, 127).
U.S. Patent No. 9,299,467 - "Radioisotope generator system including activity measurement and dose calibration"
- Issued: March 29, 2016
- Technology Synopsis: This patent claims a system comprising a shielding assembly containing a radioisotope generator, a computer, and a dose calibrator. The system is defined by the computer's configuration to receive user input to generate a sample, receive activity data from the dose calibrator, calculate breakthrough test results, and prevent patient infusion if the result exceeds an allowable limit (Compl. ¶133). The asserted claim (Claim 1) was cancelled in IPR2018-01449 ('467 Patent, K1 Certificate, p. 2).
- Asserted Claims: Independent claim 1 (Compl. ¶133).
- Accused Features: The complaint accuses the Ruby-Fill® system's integrated shielding assembly, computer, and dose calibrator of meeting the claim limitations (Compl. ¶¶134-138).
U.S. Patent No. 9,299,468 - "Infusion system with radioisotope detector"
- Issued: March 29, 2016
- Technology Synopsis: This patent claims a mobile radioisotope generator system on a movable platform that includes an infusion tubing circuit, an activity detector, a dose calibrator, a computer, and a shielding assembly. The invention centers on the computer's configuration to use the dose calibrator for automated quality control testing (determining strontium-82 and strontium-85 activity) and to control the system to deliver a dose to a patient ('468 Patent, Claim 1). The asserted claim (Claim 1) was cancelled in IPR2018-01448 ('468 Patent, K1 Certificate, p. 2).
- Asserted Claims: Independent claim 1 (Compl. ¶148).
- Accused Features: The complaint alleges that the Ruby-Fill® system's combination of a cart, tubing, activity detector, dose calibrator, computer, and shielding assembly infringes the patent (Compl. ¶¶149-155).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the Defendants' Ruby-Fill® rubidium-82 generator and elution system (Compl. ¶9).
Functionality and Market Context
- The complaint describes the Ruby-Fill® system as an integrated, computer-controlled device on a mobile cart used to produce Rubidium-82 chloride for injection into patients for PET imaging (Compl. ¶¶30, 50, 52). The system pumps saline through a generator to elute Rubidium-82 and includes an integrated dose calibrator controlled by the system's software for quality assurance (Compl. ¶¶52, 67; Compl. Ex. F, p. 28). The complaint provides an image of the Ruby-Fill® system, showing a mobile cart with an integrated computer display and components for holding the saline, generator, and waste (Compl. ¶50). Defendants allegedly market the Ruby-Fill® system as a "pharmaceutical equivalent" to Plaintiff's CardioGen-82 system (Compl. ¶46).
IV. Analysis of Infringement Allegations
U.S. Patent No. 9,814,826 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of building an infusion system ... comprising: (a) installing a first shielding compartment, a second shielding compartment, and a shielded well on a platform of a cart... | Defendants manufacture the Ruby-Fill® system by installing a first shielding compartment (generator well), a second shielding compartment (waste well), and a shielded well (dose calibrator) on the cart's platform. | ¶59 | col. 3:45-50 |
| (i) the first shielding compartment has a first opening facing vertically upwardly... | The generator well has an opening facing upward. An annotated photograph from Defendants' materials shows this upward-facing opening. | ¶60 | col. 4:51-53 |
| (iii) the second shielding compartment has a second opening facing vertically upwardly... | The waste well has an upward-facing opening for the waste bottle. | ¶62 | col. 4:54-56 |
| (v) the first opening is located at a lower elevation than the second opening... | A system component diagram allegedly shows the generator well opening ("The first opening") is at a lower elevation than the waste well opening ("The second opening"). | ¶64 | col. 4:59-61 |
| (b) configuring a computer with a touch screen display ... to: (ii) determine a strontium breakthrough test result on the sample ... while the eluate reservoir remains in the shielded well on-board the cart... | The Ruby-Fill® system's computer is configured to perform a breakthrough test on a sample collected in the dose calibrator (the eluate reservoir), and the system assays the sample while it remains in the on-board calibrator. | ¶68 | col. 2:16-24 |
| (iii) not allow a patient infusion if the strontium breakthrough test result is greater than or equal to an allowed limit. | The Ruby-Fill® system is configured to prevent patient infusions if the breakthrough limit is reached, displaying a "Sr Breakthrough Too High" error message. A table from Defendants' materials shows a "FAIL" condition where use must be discontinued. | ¶69 | col. 2:21-24 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether Defendants' manufacturing process constitutes "building an infusion system" as claimed. Practitioners may explore whether the specific sequence and nature of Defendants' assembly actions fall within the scope of the method steps of "installing" and "configuring."
- Technical Questions: The allegation that the first opening is at a "lower elevation" than the second relies on a 2D schematic diagram (Compl. ¶64, referencing Figure 2). The evidentiary basis for this relative elevation and its significance may be a point of inquiry.
U.S. Patent No. 9,750,869 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An infusion system on-board a cart comprising: (a) a cabinet structure that comprises: (i) a platform... | The Ruby-Fill® system is a mobile cart that includes a platform on which the system components are built. | ¶80 | col. 3:9-11 |
| (ii) an exterior shell that extends upwardly above the platform and has a front side; a rear side; two sidewalls... and a top surface... | The Ruby-Fill® system has an exterior shell with a front, rear, sides, and a top surface, as shown in annotated photographs. | ¶81 | col. 3:12-16 |
| (c) a first shielding compartment in the interior space of the cabinet structure having a first opening facing vertically upwardly through which the strontium-rubidium radioisotope generator can be inserted... | The Ruby-Fill® system includes a generator well inside the cabinet with an upward-facing opening for inserting and removing the generator. | ¶87 | col. 3:56-61 |
| (d) a first door accessible via the opening through the exterior shell, the first door being configured to provide access to the first shielding compartment... | The system has a door that provides access to the generator well. | ¶88 | col. 3:62-65 |
| (h) a radioactivity detector positioned to measure radioactivity of the rubidium radioactive eluate flowing through an eluate tubing line... | The Ruby-Fill® system includes a Photo Multiplier Tube (PMT) that is positioned to measure the radioactivity of the eluate flowing through the tubing. | ¶92 | col. 4:18-24 |
| (j) wherein the computer of the infusion system is configured to: ... (v) not allow a patient infusion if the strontium breakthrough test result is greater than or equal to an allowed limit. | The Ruby-Fill® computer is configured to prevent infusions if the breakthrough test fails, as evidenced by system error messages and instructional tables in the product's documentation. | ¶99 | col. 4:48-51 |
- Identified Points of Contention:
- Scope Questions: The claim requires a "cabinet structure" and an "exterior shell" with specific features. How these terms are construed will be critical. The analysis may question whether the accused product's housing meets the structural limitations as defined in the patent's specification.
- Technical Questions: Claim 1(h) requires a "radioactivity detector." The complaint identifies the accused component as a Photo Multiplier Tube (PMT) (Compl. ¶92, citing Ex. F, p. 32). The functional and structural correspondence between the claimed "radioactivity detector" and the accused PMT may be an area of dispute.
V. Key Claim Terms for Construction
For the '826 Patent (Method Claim):
- The Term: "installing"
- Context and Importance: This term is the active verb for the primary step of the claimed method of "building" the system. The definition of "installing" will be central to determining whether the Defendants' manufacturing and assembly process constitutes direct infringement of this method claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification does not appear to provide an explicit definition, which may suggest the term should be given its plain and ordinary meaning, a potentially covering a wide range of assembly activities.
- Evidence for a Narrower Interpretation: The detailed description focuses on an "arrangement of features formed in upper surface 131 of shell 13" and how various components are placed within it ('826 Patent, col. 4:42-49). This context might be used to argue that "installing" requires a specific sequence or method of placement related to the pre-formed shell, rather than any general act of assembly.
For the '869 Patent (System Claim):
- The Term: "configured to"
- Context and Importance: This term appears repeatedly in claim 1(j) to define the required functions of the on-board computer (e.g., "configured to... pump saline," "configured to... determine a strontium breakthrough test result"). Practitioners may focus on this term because its construction determines whether the accused computer must merely be capable of performing the functions or if it must be programmed or structured in a specific way to perform them as part of its normal operation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the system as being "computer-facilitated" and including "pre-programmed instructions" ('869 Patent, Abstract). This could support a construction where the system as sold is already set up and thus "configured to" perform the claimed functions.
- Evidence for a Narrower Interpretation: The patent details specific user interface screens and operational sequences (e.g., '869 Patent, Figs. 4-9C). A defendant might argue that "configured to" requires the specific software architecture or logic disclosed in the patent's embodiments, potentially narrowing the claim scope to exclude different software implementations.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement for all asserted patents. For the method claims ('826 and '870 patents), it alleges that Defendants' instructions, product manuals, and marketing materials encourage customers and end-users to build and use the Ruby-Fill® system in an infringing manner (Compl. ¶¶74, 127). For the system claims ('869, '467, '468 patents), it alleges Defendants induce infringement by selling the systems to customers who then use them as claimed (Compl. ¶¶104, 143, 160). The complaint also alleges contributory infringement, stating that the Ruby-Fill® system and its generator have no substantial non-infringing uses (Compl. ¶¶75, 129).
- Willful Infringement: For each patent, the complaint alleges that Defendants have had "knowledge and notice of the... patent at least as early as the filing of this Complaint" (Compl. ¶¶72, 102, 124, 141, 158). This allegation appears to support a claim for willful infringement based only on post-suit conduct.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim validity: The asserted independent claims of the '467 and '468 patents were cancelled in Inter Partes Review proceedings after this suit was filed. This raises a fundamental question about the continued viability of Counts Four and Five of the complaint and may invite heightened scrutiny of the validity of the remaining asserted claims from the same patent family.
- A key infringement question will be one of technical and functional mapping: The patents claim specific structural arrangements (e.g., relative elevations of shielded compartments) and computer-implemented logic (e.g., automated breakthrough testing that gates infusion). The case will likely turn on whether the physical construction and software operation of the accused Ruby-Fill® system practice each limitation of the asserted claims, or if there are legally significant technical distinctions.
- A central dispute for the method claims ('826 and '870 patents) will be one of attribution of action: Can Plaintiff prove that Defendants' own actions in manufacturing the system constitute the claimed method of "building" it ('826 patent), and that their instructions to end-users are sufficient to establish inducement for the claimed method of "using" it ('870 patent)?