Fujifilm Corp v. Hologic Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: FUJIFILM Corporation (Japan) and FUJIFILM Medical Systems U.S.A., Inc. (New York)
  • Defendant: Hologic, Inc. (Delaware)
  • Plaintiff’s Counsel: Ashby & Geddes; Orrick, Herrington & Sutcliffe LLP
• Case Identification: FUJIFILM Corp. et al v. Hologic, Inc., 1:18-cv-00343, D. Del., 03/02/2018
• Venue Allegations: Venue is asserted in the District of Delaware based on Hologic's incorporation in Delaware and its maintenance of a regular and established place of business in the district.
• Core Dispute: Plaintiff alleges that Defendant’s 3D digital mammography systems infringe four patents related to tomographic image acquisition, automatic radiation exposure control, user interface workflow, and biopsy methods.
• Technical Context: The technology at issue is 3D digital mammography (tomosynthesis), an advanced imaging modality for the early detection of breast cancer.
• Key Procedural History: The complaint alleges that this lawsuit follows an "anticompetitive campaign" by Hologic, which included Hologic initiating its own patent infringement litigation against Fujifilm at the International Trade Commission (ITC Investigation No. 337-TA-1062). Fujifilm characterizes Hologic’s ITC action as "objectively baseless."

Case Timeline

Date	Event
2000-11-21	Earliest Priority Date for U.S. Patent No. RE44,367
2004-07-13	Original U.S. Patent No. 6,762,429 (reissued as RE44,367) Issues
2006-10-26	Priority Date for U.S. Patent No. 7,453,979
2007-07-20	Priority Date for U.S. Patent No. 7,639,779
2008-11-18	U.S. Patent No. 7,453,979 Issues
2009-03-31	Priority Date for U.S. Patent No. 8,684,948
2009-12-29	U.S. Patent No. 7,639,779 Issues
2011-01-01	Hologic introduces first commercial 3D mammography system in the U.S.
2013-07-16	U.S. Patent No. RE44,367 Issues
2014-04-01	U.S. Patent No. 8,684,948 Issues
2017-01-01	Fujifilm receives FDA approval for its ASPIRE Cristalle 3D system
2018-03-02	Complaint Filed

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

U.S. Patent No. 7,453,979 - Tomographic Image Obtainment Apparatus and Method

The Invention Explained

• Problem Addressed: The patent’s background explains that in conventional tomosynthesis, radiographic imaging is often performed using fixed conditions (e.g., a standard range of X-ray angles) for all subjects, regardless of anatomical differences like breast density or size (’979 Patent, col. 1:23-35). This uniform approach may not produce the most appropriate or clearest image for every patient (’979 Patent, col. 2:31-35).
• The Patented Solution: The invention proposes an adaptive apparatus that first determines the "degree of overlap of anatomical structures" of the subject—a proxy for tissue density or thickness—and then sets the exposure conditions based on this determination (’979 Patent, Abstract). For example, if a high degree of overlap (e.g., a dense breast) is detected, the system can automatically increase the range of radiography angles to obtain clearer images of structures that might otherwise be obscured (’979 Patent, col. 4:58-64; Fig. 15).
• Technical Importance: This approach allows for patient-specific optimization of tomosynthesis scans, which may improve diagnostic image quality by tailoring the acquisition parameters to the individual's anatomy.

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶139).
• The essential elements of independent claim 1 include:
  • A radiation image detector for obtaining radiographic images of the subject.
  • A radiation irradiation unit that moves to a plurality of positions to irradiate the subject from various directions.
  • An "overlap-degree obtainment means" for obtaining the degree of overlap of the subject's anatomical structures.
  • An "exposure condition setting means" for setting the exposure conditions (e.g., range of angles) based on the obtained degree of overlap.
• The complaint also asserts dependent claims 2 and 5 (Compl. ¶140).

U.S. Patent No. 7,639,779 - Apparatus for and Method of Capturing Radiation Image

The Invention Explained

• Problem Addressed: The patent identifies the need for highly accurate radiation dose control in mammography. While a low-dose "pre-exposure" can be used to calculate the dose needed for the main diagnostic exposure, the accuracy of this calculation can be poor if the initial pre-exposure dose itself is not well-calibrated to the subject (’779 Patent, col. 2:1-6).
• The Patented Solution: The invention claims a multi-step automatic exposure control (AEC) method. First, a "pre-exposure-mode-required irradiation dose" is calculated using the measured thickness of the compressed breast as an input parameter. After this initial, thickness-informed pre-exposure is performed, a dose detecting sensor measures the radiation that passes through the breast. This real-time measurement is then used by a second calculator to determine the final, "main-exposure-mode-required irradiation dose" (’779 Patent, Abstract; col. 5:29-67).
• Technical Importance: This two-stage calculation, using both anatomical data (thickness) and sensor feedback (detected pre-exposure dose), provides a more refined method for automatically setting the optimal radiation level for the final diagnostic image.

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶158).
• The essential elements of independent claim 1 include:
  • A dose detecting sensor.
  • A thickness measuring unit for measuring breast thickness.
  • A "pre-exposure-mode-required irradiation dose calculator" that uses the measured thickness as a parameter.
  • A "main-exposure-mode-required irradiation dose calculator" that uses the dose detected by the sensor during the pre-exposure mode.
  • A radiation source controller that applies radiation according to both calculated doses.
• The complaint also asserts dependent claims 8 and 9 (Compl. ¶159).

U.S. Patent No. RE44,367 - Image and Information Processor

Technology Synopsis

The ’367 Patent describes a user interface and workflow for managing "serial radiography," where multiple radiographic images are required for a single patient inspection (’367 Patent, Abstract). The system is constructed to display the plurality of planned radiographic shots for a single inspection as "tags" on a single screen. As each X-ray image is captured and processed, a thumbnail of that image is displayed in a predetermined region corresponding to its specific tag, allowing the operator to track the progress of the multi-image examination efficiently (’367 Patent, col. 4:1-12).

Asserted Claims

Independent claim 1 is asserted (Compl. ¶179). Claims 2, 8, 9, 11, 12, and 15 are also asserted (Compl. ¶180).

Accused Features

The graphical user interface on Hologic's systems, which allegedly permits a user to control and review a series of radiological images for a single patient inspection, displaying thumbnails corresponding to different examination views (Compl. ¶¶182-187).

U.S. Patent No. 8,684,948 - Biopsy Apparatus and Biopsy Method

Technology Synopsis

The ’948 Patent is directed to methods for performing a stereotactic or tomosynthesis-guided breast biopsy while reducing the number of X-ray exposures. The claimed method involves holding a biopsy needle obliquely relative to the radiation detector to prevent it from obscuring the target region (’948 Patent, Abstract). The 3D position of the biopsy region is calculated using at least two images taken from different angles; critically, the method allows for one of these images to be taken with the radiation source on the perpendicular axis (a "scout" image) and the other from an oblique angle, reducing the total number of exposures compared to methods requiring two separate oblique-angle images ('948 Patent, col. 15:3-24).

Asserted Claims

Method claim 13 (dependent on claim 12) and apparatus claim 11 are asserted (Compl. ¶¶199-200).

Accused Features

Hologic's Selenia Dimensions systems when used with the Affirm Breast Biopsy Guidance System, which allegedly performs a biopsy using an obliquely held needle and calculates a 3D target position based on tomosynthesis images taken from multiple angles (Compl. ¶¶202-205).

III. The Accused Instrumentality

Product Identification

• The "Accused Products" are Hologic's Selenia® Dimensions® Mammography Systems, including various packages such as the Selenia Dimensions 3000, 3D™ Performance System, 6000, and 9000 (Compl. ¶88). For allegations related to the ’948 Patent, the instrumentality is the Accused Products used in conjunction with the Affirm Breast Biopsy Guidance System (Compl. ¶200).

Functionality and Market Context

• The Accused Products are 3D digital mammography systems that perform tomosynthesis, a process wherein a radiation emitter moves in an arc to capture multiple images of the breast from different angles (Compl. ¶144). The complaint alleges these systems include Automatic Exposure Control (AEC) modes that automatically calculate radiation dose based on factors including measured breast thickness (Compl. ¶146, ¶164). The systems are also alleged to feature a graphical user interface for managing multi-image examinations for a single patient (Compl. ¶182, ¶185) and can be paired with a biopsy guidance system for performing biopsies (Compl. ¶200).
• The complaint alleges Hologic is the dominant market participant, accounting for over 80% of new 3D-capable mammography systems sold in the U.S. between October 2016 and October 2017 (Compl. ¶6).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'979 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
an overlap-degree obtainment means for obtaining the degree of overlap of anatomical structures of the subject	The Accused Products measure the compressed breast thickness via a "Compression Thickness Display" and allegedly use this measurement as a proxy for the degree of anatomical overlap.	¶145	col. 10:35-40
an exposure condition setting means for setting, based on the degree of overlap obtained by the overlap-degree obtainment means, a condition of exposure...	The Accused Products include Automatic Exposure Control modes (e.g., AEC: Auto-kV, AEC: Auto-Time) that automatically calculate the appropriate kV and/or mAs dose based, in part, on the measured breast thickness.	¶146	col. 10:41-48

Identified Points of Contention

• Scope Questions: A central question for the '979 patent will be the construction of the means-plus-function term "overlap-degree obtainment means." The dispute may focus on whether this term, as defined by the structures in the patent specification, can be read to cover a device that only measures compressed breast thickness, or if it requires a more complex analysis of an actual radiographic image to determine tissue density, an alternative embodiment also described in the specification (’979 Patent, col. 10:20-34).

'779 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a thickness measuring unit for measuring a thickness of the breast along a direction in which the radiation passes through the breast...	The Accused Products include a "Compression Thickness Display" that provides a measure of the breast thickness.	¶163	col. 5:29-33
a pre-exposure-mode-required irradiation dose calculator for calculating a...dose required to apply said radiation to the breast in a pre-exposure mode...using the measured thickness of the breast as a parameter	The Accused Products allegedly include AEC functionality where the radiation dose (mAs) of a pre-exposure pulse is based on the measured breast thickness.	¶164	col. 5:49-55
a main-exposure-mode-required irradiation dose calculator for calculating a...dose required to apply said radiation to the breast in the main exposure mode, based on a pre-exposure-mode irradiation dose which represents the dose of said radiation detected by said dose detecting sensor...	The Accused Products allegedly use AEC modes that automatically calculate the final kV and/or mAs dose, with the starting dose being determined from a "short pre-exposure targeting a specific exposure index (EI)."	¶165	col. 5:56-62

Identified Points of Contention

• Technical Questions: The infringement analysis will likely focus on the precise operational logic of Hologic's AEC software. A key question is whether the accused system performs the specific, sequential two-step calculation recited in claim 1: first calculating a pre-exposure dose using thickness as a parameter, and then separately using the result of that pre-exposure to calculate the main exposure dose. The court will need to determine if Hologic's system maps onto this claimed structure or uses a different, integrated algorithm.

V. Key Claim Terms for Construction

For the ’979 Patent

• The Term: "overlap-degree obtainment means" (Claim 1)
• Context and Importance: This is a means-plus-function term, meaning its scope is limited to the corresponding structures described in the patent's specification and their equivalents. The viability of Fujifilm's infringement theory, which equates this "means" with a thickness sensor, depends entirely on whether that structure is disclosed in the patent as performing the claimed function.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification explicitly states that "the thickness of the breast may be used as the degree of overlap of anatomical structures" (’979 Patent, col. 10:38-40). This language may support Fujifilm’s position that a thickness measurement alone can satisfy the claim.
  • Evidence for a Narrower Interpretation: The specification also discloses obtaining the degree of overlap based on "the pixel values of a radiographic image" from a pre-exposure (’979 Patent, col. 10:28-31). A defendant may argue that the primary disclosed structure involves image analysis, and that simple thickness measurement is a less-emphasized alternative, potentially limiting the scope of equivalents.

For the ’779 Patent

• The Term: "a pre-exposure-mode-required irradiation dose calculator ... using the measured thickness of the breast as a parameter" (Claim 1)
• Context and Importance: The infringement case hinges on whether Hologic's AEC system performs this specific calculation. Practitioners may focus on this term because the dispute will likely be whether Hologic's algorithm uses thickness "as a parameter" in the specific manner claimed for the pre-exposure dose calculation, or if thickness is merely one of many inputs to a holistic dose calculation algorithm that does not follow the claim's sequential structure.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The phrase "using... as a parameter" could be interpreted broadly to encompass any calculation where breast thickness is an input variable, regardless of the complexity of the overall algorithm.
  • Evidence for a Narrower Interpretation: The patent's description of the operation suggests a more direct relationship, where the calculator determines the required dose for the pre-exposure mode based on thickness and then proceeds to the next step (’779 Patent, col. 5:49-67). This may support a narrower construction requiring a distinct, thickness-driven calculation for the pre-exposure dose itself.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Hologic induces infringement by providing customers with user manuals, brochures, and other instructional materials that teach the use of the accused features, such as the AEC modes and the multi-image user interface (Compl. ¶¶147, 167, 188, 207). It also alleges contributory infringement, asserting that Hologic provides material components for its systems that are not suitable for substantial noninfringing use (Compl. ¶¶148, 168, 189, 208).
• Willful Infringement: The complaint alleges pre-suit knowledge for two patents. For the ’979 Patent, knowledge is alleged since at least November 2015 because a Hologic-assigned patent cited the application that issued as the ’979 patent (Compl. ¶150). For the ’779 Patent, knowledge is alleged since at least January 2016 because a Hologic European patent application cited the corresponding U.S. application (Compl. ¶170). For the ’367 and ’948 patents, the complaint alleges knowledge and willfulness based on notice from the filing of the complaint itself (Compl. ¶¶191, 210).

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

• A core issue will be one of definitional scope: For the ’979 patent, can the means-plus-function term "overlap-degree obtainment means," which is rooted in analyzing anatomical structures, be construed to cover a simple measurement of compressed breast thickness, or does it require a more sophisticated analysis of an actual image as also described in the patent?
• A second central issue will be one of algorithmic mapping: For the ’779 patent, does Hologic's Automatic Exposure Control software perform the specific, sequential two-step calculation required by Claim 1—first determining a pre-exposure dose using thickness, then determining a main dose using the detected pre-exposure radiation—or does the accused system employ a fundamentally different computational logic?
• A third key question will relate to user interface functionality: For the ’367 patent, the case may turn on whether the accused system's workflow for managing a series of images contains all specific elements of the claim, such as displaying "tags" for planned radiographic conditions and populating adjacent "predetermined regions" with corresponding thumbnails in a one-to-one manner.