Cochlear Ltd v. Oticon Medical Ab

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Cochlear Ltd. (Australia) and Cochlear Bone Anchored Solutions AB (Sweden)
  • Defendant: Oticon Medical AB (Sweden) and Oticon Medical LLC (New Jersey)
  • Plaintiff’s Counsel: Sheppard Mullin Richter & Hampton LLP
• Case Identification: 1:16-cv-01700, D. Colo., 07/01/2016
• Venue Allegations: Venue is alleged to be proper in the District of Colorado because Defendant Oticon Medical has offered for sale and sold the accused products within the state and district, including through clinics promoted on its website.
• Core Dispute: Plaintiff alleges that Defendant’s Ponto bone anchored hearing systems infringe four patents related to the mechanical design and function of hearing aid implants, connectors, and systems for treating single-sided deafness.
• Technical Context: The technology involves osseointegrated auditory implants, which are surgically placed in the skull to transmit sound via bone conduction, bypassing the outer and middle ear to address certain types of hearing impairment.
• Key Procedural History: The complaint alleges that a 2010 license agreement between Cochlear and Defendant's parent company, William Demant Holding A/S, provided Defendant with knowledge of the patents-in-suit. It also notes that the sole inventor of the ’222 and ’040 patents, a former Vice President at a Cochlear predecessor company, is now affiliated with Defendant, forming the basis for an allegation of assignor estoppel, which may preclude Defendant from challenging the validity of those two patents.

Case Timeline

Date	Event
1994-12-02	U.S. Patent 5,735,790 Priority Date
1998-04-07	U.S. Patent 5,735,790 Issue Date
2001-06-21	U.S. Patent 7,043,040 Priority Date
2001-06-29	U.S. Patent 7,074,222 Priority Date
2002-01-01	Inventor Westerkull leaves Cochlear predecessor (approx.)
2003-05-30	U.S. Patent 7,409,070 Priority Date
2004-01-01	Oticon Medical AB founded (approx.)
2006-05-09	U.S. Patent 7,043,040 Issue Date
2006-07-11	U.S. Patent 7,074,222 Issue Date
2008-08-05	U.S. Patent 7,409,070 Issue Date
2010-01-01	License agreement executed (approx.)
2016-07-01	Complaint Filing Date

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

U.S. Patent No. 5,735,790 - Device in Hearing Aids, Issued April 7, 1998

The Invention Explained

• Problem Addressed: The patent describes drawbacks in prior art connectors for bone-anchored hearing aids, noting that metallic male-female coupling parts required high-precision machining, leading to high costs, and could cause skin irritation or create a risk of electrical shock if the user connected the hearing aid to external electronic devices (’790 Patent, col. 1:20-29, 1:59-68).
• The Patented Solution: The invention proposes a novel connector design where the implant-side female part is rigid, while the hearing-aid-side male part is radially resilient and flexible, allowing for a simple "snap-in" connection. This design enables the male part to be made from a lower-cost, electrically non-conductive material like plastic, eliminating the previously identified cost and safety issues ('790 Patent, Abstract; col. 2:50-68).
• Technical Importance: This design approach reduced manufacturing costs and enhanced patient safety by allowing for the use of plastic components in a high-precision medical device interface ('790 Patent, col. 2:60-68).

Key Claims at a Glance

• The complaint asserts independent claim 1 ('790 Patent, col. 3:40-60; Compl. ¶27).
• Claim 1 requires:
  • A substantially rigid, cylindrical, cup-shaped female coupling part with a circumferential annular bead on its inner periphery.
  • A substantially cylindrical, resilient, flexible male coupling part with a walled inner recessed portion and a circumferential groove on the outside to receive the female part's bead.
  • A vibration exciting apparatus connected to the male coupling part.
  • The male part is resilient in the radial direction to permit snap-in introduction.
  • The engagement of the bead and groove forms a signal transferring surface.
• The complaint reserves the right to assert other claims ('790 Patent, Compl. ¶39).

U.S. Patent No. 7,043,040 - Hearing Aid Apparatus, Issued May 9, 2006

The Invention Explained

• Problem Addressed: The patent addresses the treatment of single-sided deafness (unilateral hearing loss). Conventional solutions, known as CROS aids, often involved placing hardware in or on the functional ear, which could reduce its hearing ability, or used transcranial systems with poor sound quality and feedback issues ('040 Patent, col. 1:31-44).
• The Patented Solution: The invention teaches a bone-anchored hearing aid placed on the patient's deaf side. The device picks up sound on that side and transmits it as vibrations through the skull bone to the functioning cochlea on the other side of the head, leveraging the principle of bone conduction to bypass the non-functional ear entirely ('040 Patent, Abstract; col. 2:16-24).
• Technical Importance: This method provided a more effective way to treat single-sided deafness by using the skull itself as the medium for sound transmission, leaving the patient's good ear completely unobstructed ('040 Patent, col. 2:7-13).

Key Claims at a Glance

• The complaint asserts independent claim 1 ('040 Patent, col. 3:28-41; Compl. ¶30).
• Claim 1 requires:
  • A bone-conducting, bone-anchored hearing aid for sound transmission from one side of a patient's head to the cochlea on the other side for rehabilitating unilateral hearing loss.
  • A vibratory generating part that generates vibrations mechanically transmitted through the skull from a deaf side to the inner ear on the other side.
  • An implantable part to mechanically anchor the vibratory part, which is osseointegrated in the skull bone behind an external ear on the deaf side of the patient.
• The complaint reserves the right to assert other claims ('040 Patent, Compl. ¶42).

U.S. Patent No. 7,074,222 - Anchoring Element, Issued July 11, 2006

• Multi-Patent Capsule: Technology Synopsis: The patent addresses the challenge of installing anchoring implants (fixtures) into the relatively thin bone of the skull. The described solution is a self-tapping, screw-shaped implant with a main body shorter than 5 mm and featuring at least one cavity and cutting edge designed to capture bone tissue cut during insertion, thereby simplifying the surgical procedure by obviating the need for a separate pre-tapping step ('222 Patent, Abstract; col. 2:4-19).
• Asserted Claims: Independent claim 1 is asserted (Compl. ¶29).
• Accused Features: The complaint alleges that the Ponto system implants, which are described as being 3mm or 4mm long, screw-shaped, and self-tapping, infringe the ’222 Patent (Compl. ¶¶ 14, 22, 29).

U.S. Patent No. 7,409,070 - Implant Device, Issued August 5, 2008

• Multi-Patent Capsule: Technology Synopsis: The patent addresses the complexity of installing conventional two-piece hearing implants, which require the surgeon to handle and assemble a separate fixture and abutment. The invention is a pre-mounted unit where the fixture and abutment sleeve are delivered pre-assembled with the correct torque, designed to be installed in a single step using a tool that engages recesses on the abutment sleeve itself (’070 Patent, Abstract; col. 2:50-65). This simplifies the surgical procedure and reduces the risk of improper assembly (Compl. ¶28).
• Asserted Claims: Independent claim 1 is asserted (Compl. ¶28).
• Accused Features: The complaint alleges that the Ponto system is sold with a pre-mounted implant and abutment and is installed using an abutment inserter tool with spikes that engage recesses in the abutment, thereby infringing the ’070 Patent (Compl. ¶¶ 23, 26, 28). The complaint provides a visual of the accused abutment inserter. This figure shows an abutment inserter with symmetrically arranged spikes for engaging the implant (Compl. ¶26).

III. The Accused Instrumentality

Product Identification

• The accused products are Defendant's "Ponto" brand bone anchored hearing systems and related components, including implants, abutments, sound processors, and abutment extensions (Compl. ¶¶ 15, 18, 21).

Functionality and Market Context

• The Ponto system is an osseointegrated auditory implant system used for hearing rehabilitation (Compl. ¶12). It consists of a titanium implant surgically anchored into the skull, a conical, skin-penetrating abutment connected to the implant, and an external sound processor that attaches to the abutment (Compl. ¶¶ 18-19). The complaint alleges the sound processor connects to the abutment via a "snapping action" (Compl. ¶20). The figure at Complaint paragraph 20 illustrates this snapping connection between the sound processor and the abutment (Compl. ¶20). The complaint alleges that Oticon has promoted the Ponto system for treating single-sided deafness (Compl. ¶25) and has stated in FDA filings that the Ponto system is "substantially equivalent" in function to Cochlear's Baha® Divino device (Compl. ¶17). The figure at Complaint paragraph 18 shows a detailed view of the accused Ponto implant and abutment assembly (Compl. ¶18).

IV. Analysis of Infringement Allegations

'790 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a substantially rigid, cylindrical, cup-shaped female coupling part with a cop-shaped opening having a circumferential annular bead on its inner periphery about the cup-shaped opening;	The abutment for the Ponto system has a cup shape and includes an annular bead on the outer periphery that is alleged to be equivalent to a bead on the inner periphery.	¶27	col. 2:39-42
a substantially cylindrical, resilient, flexible male coupling part having a walled inner recessed portion in a first end and a circumferential groove about the outside of the recessed inner portion...	The sound processors for the Ponto system include a connector with a circumferential groove on the inside of a recessed inner portion.	¶27	col. 2:43-50
a vibration exciting apparatus connected to a second end of the male coupling party...	The connector is connected to a vibrator in the sound processor.	¶27	col. 2:12-14
wherein the male coupling part is resilient in the radial direction in order to permit snap-in introduction into the female coupling part;	The connector is resilient to snap on the abutment.	¶27	col. 2:43-45
and the annular bead and groove engagement form a signal transferring surface between said male and female coupling parts.	The connection between the annular bead and groove transfers vibrations from the sound processor to the abutment.	¶27	col. 2:34-38

• Identified Points of Contention:
  • Scope Questions: The complaint explicitly alleges infringement under the doctrine of equivalents by stating the accused product's features are "equivalent to" the claimed elements (Compl. ¶¶ 27, 39). A primary dispute will be whether the Ponto system's connector, which allegedly has a bead on the outer periphery of the female part and a groove on the inside of the male part, is equivalent to the claimed configuration of a bead on the inner periphery and a groove on the outside. This raises the question of whether the accused device performs substantially the same function in substantially the same way to achieve the same result.

'040 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A bone-conducting bone-anchored hearing aid apparatus for sound transmission from one side of a patient's head to the patient's cochlea on another side of the patient's head for rehabilitation of unilateral hearing loss...	Oticon Medical promotes its Ponto system for pickup of sound on the deaf side of a recipient and transfer of that sound to the recipient's functioning cochlea.	¶¶25, 30	col. 1:5-10
a vibratory generating part arranged to generate vibrations that are mechanically transmitted through the skull bone from a deaf side to the inner ear on the other side of the patient;	The sound processor in the Ponto system has a vibrator that, for single-sided deafness, is placed on the deaf side and transfers vibration to the functioning cochlea.	¶30	col. 2:18-24
and an implantable part operative to mechanically anchor the vibratory generating part, the implantable part being osseointegrated in the patient's skull bone behind an external ear at the deaf side of a patient.	The Ponto system includes an implanted screw portion that becomes osseointegrated into the patient's skull.	¶30	col. 2:16-18

• Identified Points of Contention:
  • Technical Questions: The infringement analysis will likely focus on evidence of use. A key question will be what evidence demonstrates that the Ponto system is actually used by patients as described in the claim—specifically, placed on the "deaf side" to transmit sound "to the inner ear on the other side." The complaint's allegations of Oticon's marketing and promotion for this purpose will be central to its theory of induced infringement (Compl. ¶¶ 25, 42).

V. Key Claim Terms for Construction

'790 Patent: "resilient"

• The Term: "resilient" (referring to the male coupling part)
• Context and Importance: The resilience of the male part is a core inventive concept, distinguishing it from prior art rigid metal connectors. The construction of this term will be critical to determining if the Ponto system's connector, which allegedly "snap[s] on the abutment," meets this limitation (Compl. ¶27). Practitioners may focus on this term because the degree of flexibility required by "resilient" could be a point of non-infringement for the defendant.
• Intrinsic Evidence for a Broader Interpretation: The specification suggests "resilient" can be inherent to the material itself, stating the part can be made from "an elastically resilient material, such as plastics" ('790 Patent, col. 2:51-52).
• Intrinsic Evidence for a Narrower Interpretation: The specification also describes adding features to increase resiliency, such as providing "axial slots 19 in the material" ('790 Patent, col. 2:45-46). This could support an argument that "resilient" requires more than just the inherent properties of a material like plastic and implies a specific structural design for flexibility.

'040 Patent: "deaf side"

• The Term: "deaf side"
• Context and Importance: This term defines the specific application and patient population targeted by the patent: individuals with unilateral hearing loss. Its definition is central to the infringement analysis, as the entire claim is premised on placing the device on the "deaf side" to stimulate the contralateral ear.
• Intrinsic Evidence for a Broader Interpretation: The patent defines the patient population as having "a profound hearing loss in the inner ear on the other side of the head" ('040 Patent, col. 1:8-10), suggesting "deaf side" refers simply to the location of the non-functioning ear.
• Intrinsic Evidence for a Narrower Interpretation: The term is consistently used in the context of "rehabilitation of patients with unilateral hearing loss" ('040 Patent, col. 1:7-8). A defendant could argue this context limits the term to a specific, diagnosed medical condition, potentially excluding other uses or patient types.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for all four patents. The inducement allegations are based on Oticon's promotion, marketing, sales, and instructions that allegedly encourage customers and medical professionals to use the Ponto system in an infringing manner, such as for single-sided deafness (Compl. ¶¶ 39, 42, 46, 50).
• Willful Infringement: Willfulness is alleged for all four patents. The complaint bases this on Oticon's alleged knowledge of the patents stemming from a 2010 license agreement between Cochlear and Oticon's parent company (Compl. ¶37), as well as the alleged affiliation between Oticon and the named inventor of the '040 and '222 patents (Compl. ¶16).

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

• A central issue for the ’790 patent will be one of structural equivalence: as the complaint appears to concede a lack of literal infringement, can the Ponto system's connector—with its allegedly reversed placement of the bead and groove—be proven to infringe under the doctrine of equivalents?
• A key evidentiary question for the ’040 patent will be one of infringing use and intent: what evidence will be presented to show that Oticon actively induced infringement by promoting its Ponto system for the specific cross-skull application for single-sided deafness, and that the product's function when used as promoted meets the claim limitations?
• A significant threshold legal battle may involve assignor estoppel: will the court find that the doctrine bars Oticon from challenging the validity of the ’040 and ’222 patents due to its relationship with the patents' sole inventor, a former employee of Cochlear's predecessor?