DCT
1:18-cv-01530
Med El Elektromedizinische Gerate GesmbH v. Advanced Bionics LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: MED-EL Elektromedizinische Geräte Ges.m.b.H (Austria) and MED-EL Corporation, USA (Massachusetts)
- Defendant: Advanced Bionics, L.L.C. (Delaware)
- Plaintiff’s Counsel: Richards, Layton & Finger, PA.
- Case Identification: 1:18-cv-01530, D. Del., 10/03/2018
- Venue Allegations: Venue is asserted in the District of Delaware based on Defendant being a limited liability company organized under the laws of Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s cochlear implant systems infringe two patents related to magnetic coupling mechanisms designed to be safe for a patient undergoing Magnetic Resonance Imaging (MRI).
- Technical Context: The technology concerns magnets in medical implants, which must hold an external device in place on the skin while also being able to safely align with powerful MRI fields to prevent patient injury or device damage.
- Key Procedural History: The complaint alleges Defendant was put on notice of the patents-in-suit on September 27, 2018, less than a week before the complaint was filed. One of the asserted patents, RE46,057, is a reissue patent, which indicates the original patent was surrendered and re-examined by the USPTO to correct an error.
Case Timeline
| Date | Event |
|---|---|
| 2002-04-01 | U.S. RE46,057 Patent Priority Date |
| 2010-04-23 | U.S. 8,634,909 Patent Priority Date |
| 2014-01-21 | U.S. 8,634,909 Patent Issue Date |
| 2016-07-05 | U.S. RE46,057 Patent Issue Date |
| 2018-09-27 | Defendant Notified of Patents |
| 2018-10-03 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Reissue Patent No. RE46,057 - "Reducing Effect of Magnetic and Electromagnetic Fields on an Implant's Magnet and/or Electronics," issued July 5, 2016
The Invention Explained
- Problem Addressed: The patent’s background describes the risks for patients with cochlear implants undergoing an MRI. A strong external magnetic field can exert torque on the implant’s fixed internal magnet, potentially twisting it out of position and injuring the patient, or demagnetizing it. (RE46,057 Patent, col. 1:58-65).
- The Patented Solution: The invention is an implantable magnet that is "freely turnable" within its housing. This design allows the magnet to passively align with an external magnetic field, such as from an MRI machine, thereby avoiding harmful torque and potential demagnetization. (RE46,057 Patent, Abstract; col. 2:50-54).
- Technical Importance: This technology allows patients with implants to undergo high-field MRI examinations without the need for additional surgery to remove and later reinsert the magnet. (RE46,057 Patent, col. 2:21-29).
Key Claims at a Glance
- The complaint asserts independent claim 19. (Compl. ¶17).
- Essential elements of claim 19 include:
- An external portion with a transmitting coil and an external holding magnet.
- An implantable portion with a receiving coil and a "cylindrical-shape implant holding magnet."
- The implant holding magnet has a "rotational cylinder axis" and is "adapted to be freely turnable within the implant housing... in response to an external magnetic field."
- The external and implant magnets magnetically cooperate to hold the external portion in place.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 8,634,909 - "MRI-Safe Disc Magnet for Implants," issued January 21, 2014
The Invention Explained
- Problem Addressed: The patent identifies a problem with prior MRI-safe solutions, such as spherical magnets, which require a "relatively large magnet much larger than the thickness of the other components of the implant," often necessitating the drilling of a recess into the patient's bone, a challenging procedure especially in young children. (’909 Patent, col. 2:1-11).
- The Patented Solution: The invention proposes a rotatable, "planar disc shaped" magnet where the magnetic dipole is oriented "parallel to the plane of the coil housing" (i.e., across its diameter, parallel to the skin). This configuration allows the magnet to align with an MRI field to avoid torque while maintaining a slim profile that is easier to implant. ('909 Patent, Abstract; col. 3:50-54).
- Technical Importance: The design provides the safety benefits for MRI compatibility in a low-profile form factor that is better suited for implantation without requiring modification of the patient's bone. ('909 Patent, col. 7:1-4).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶27).
- Essential elements of claim 1 include:
- A coil housing configured for implantation with a "planar outer surface."
- A "planar disc shaped first attachment magnet" within the coil housing that is "adapted to be rotatable therein."
- The magnet has a "magnetic dipole moment oriented across a diameter of the first attachment magnet."
- The magnet is configured so the dipole moment "remains substantially parallel to the planar outer surface of the coil housing when the first attachment magnet rotates."
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The "HiRes Ultra 3D Cochlear Implant sold with Cochlear's external headpiece for use with said implant" (collectively, the "Accused Products"). (Compl. ¶13).
Functionality and Market Context
- The Accused Products are cochlear implant systems alleged to have an external portion and an implantable portion that are held together magnetically. (Compl. ¶20-22). The core accused functionality is an implantable magnet that "can freely turn in response to an external magnetic field" to "align to the strong MRI Field." (Compl. ¶19, 21). The complaint includes a marketing image from the Defendant that shows the internal magnet assembly. (Compl. ¶31, Figure A). This image, referenced as Figure A in the complaint, depicts an array of four small, cylindrical magnets arranged in a ring. (Compl. p. 7). The complaint alleges that the parties are direct competitors in the market for cochlear implants. (Compl. ¶14).
IV. Analysis of Infringement Allegations
RE46,057 Infringement Allegations
| Claim Element (from Independent Claim 19) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an external portion... including... a transmitting coil... and an external holding magnet | The Accused Products comprise an external portion for placement on the skin that includes a transmitting coil and an external holding magnet. | ¶20 | col. 1:46-56 |
| an implantable portion including an implant housing containing... a receiving coil... and a cylindrical-shape implant holding magnet having a rotational cylinder axis and adapted to be freely turnable... in response to an external magnetic field | The Accused Products comprise an implantable portion with a receiving coil and an implant magnet that is "freely turnable... in response to an external magnetic field," as shown in a video where it aligns to an MRI field. | ¶21 | col. 2:50-54 |
| wherein the implant holding magnet and the external holding magnet magnetically cooperate to maintain the external portion in a fixed position on the skin | The magnets in the Accused Products cooperate to maintain position, as evidenced by marketing materials stating "Headpiece magnet aligned for optimal retention." | ¶22 | col. 1:52-56 |
8,634,909 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a coil housing configured to be implanted under the patient's skin, the coil housing having a planar outer surface... and containing a signal coil | The Accused Products comprise a coil housing configured for implantation under the skin containing a signal coil for communication. | ¶30 | col. 4:1-3 |
| a planar disc shaped first attachment magnet within the coil housing, the first attachment magnet adapted to be rotatable therein | The Accused Products have a rotatable magnet within the coil housing, which the complaint alleges is a "planar disc shaped first attachment magnet." | ¶31 | col. 4:3-5 |
| having a magnetic dipole moment oriented across a diameter of the first attachment magnet | The complaint alleges the magnet's dipole moment lies on a line from south to north pole, as depicted in Figure A of the complaint. | ¶33 | col. 4:5-7 |
| and configured within the coil housing such that the magnetic dipole moment remains substantially parallel to the planar outer surface of the coil housing when the first attachment magnet rotates | The complaint alleges that the dipole moment of the magnet remains substantially parallel to the housing's outer surface when it rotates. | ¶33 | col. 4:7-12 |
Identified Points of Contention
- Scope Questions: A primary question may be whether the accused magnet assembly, which Figure A suggests is composed of multiple smaller magnets, constitutes "a cylindrical-shape implant holding magnet" as required by claim 19 of the ’057 Patent, or "a planar disc shaped first attachment magnet" as required by claim 1 of the '909 Patent. The case may turn on whether the term "a magnet" can be construed to cover a multi-component magnetic assembly.
- Technical Questions: What evidence demonstrates that the magnetic dipole of the accused magnet assembly is "oriented across a diameter" and "remains substantially parallel to the planar outer surface" during rotation, as claimed in the ’909 Patent? The infringement allegation relies on an interpretation of a marketing graphic (Figure A). (Compl. ¶33).
V. Key Claim Terms for Construction
- The Term: "a planar disc shaped first attachment magnet" (from '909 Patent, Claim 1)
- Context and Importance: The infringement analysis for the '909 Patent hinges on this term. Practitioners may focus on this term because the accused product appears to use an array of smaller magnets, not a single disc. The construction of "a... magnet" will be critical to determining whether the accused product's structure falls within the claim's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The '909 Patent specification suggests that an attachment magnet is not necessarily a single monolithic piece, stating that "at least one of the attachment magnets may comprise a pair of complementary cylindrical attachment magnets." ('909 Patent, col. 2:51-54). This could support an argument that "a... magnet" can refer to a functional assembly of magnetic components.
- Evidence for a Narrower Interpretation: The primary embodiment shown in the '909 Patent's figures depicts a single, unitary disc-shaped magnet (Fig. 4A, element 401). ('909 Patent, Fig. 4A). The term "a planar disc shaped" itself suggests a specific, singular geometry which a defendant could argue is not met by an array of separate components.
VI. Other Allegations
- Indirect Infringement: The complaint does not contain allegations of indirect infringement (e.g., induced or contributory infringement); it pleads only direct infringement under 35 U.S.C. § 271(a). (Compl. ¶17, 27).
- Willful Infringement: The complaint alleges willful infringement based on Defendant's knowledge of the patents and their alleged infringement since "at least as early as September 27, 2018 by virtue of communications between counsel for MED-EL and Advanced bionics." (Compl. ¶15, 23, 34).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: can the term "a... magnet," as used in the asserted claims of both patents, be construed to read on the accused product's apparent use of a multi-component magnetic assembly, or is its meaning restricted to a single, monolithic structure?
- A second central issue will be factual and evidentiary: assuming the claim scope can cover a multi-component assembly, does the accused product's magnet array in fact operate as claimed? Specifically, for the '909 patent, does its effective magnetic dipole moment remain "substantially parallel" to the skin during rotation, a technical detail that will require evidence beyond the marketing materials cited in the complaint.