DCT
8:18-cv-00620
Glaukos Corp v. Ivantis Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Glaukos Corporation (Delaware)
- Defendant: Ivantis, Inc. (Delaware)
- Plaintiff’s Counsel: Irell & Manella LLP
- Case Identification: 8:18-cv-00620, C.D. Cal., 04/14/2018
- Venue Allegations: Venue is asserted based on Defendant Ivantis having a regular and established place of business in the district, specifically its principal place of business and manufacturing facility in Irvine, California, where alleged infringing activities have occurred.
- Core Dispute: Plaintiff alleges that Defendant’s Hydrus Microstent, a device for treating glaucoma, infringes two patents related to ocular shunt devices that create a drainage pathway within the eye.
- Technical Context: The technology relates to Micro-Invasive Glaucoma Surgery (MIGS), a class of medical devices designed to reduce intraocular pressure by creating a bypass for aqueous humor to drain into the eye's natural outflow system, Schlemm's canal.
- Key Procedural History: The complaint alleges that U.S. Patent 6,626,858 has been repeatedly cited during the prosecution of Defendant's own patent applications. The second patent, U.S. Patent 9,827,143, is a continuation of the same parent application as the first, suggesting a shared technical foundation.
Case Timeline
| Date | Event |
|---|---|
| 1999-04-26 | Earliest Priority Date for '858 and '143 Patents |
| 2003-09-30 | '858 Patent Issued |
| 2004-01-01 | Glaukos begins work with FDA on clinical trial protocol |
| 2006-12-12 | Glaukos acquires rights to the Asserted Patents |
| 2007-01-01 | Ivantis founded |
| 2012-01-01 | Glaukos obtains FDA approval for its iStent device |
| 2017-11-28 | '143 Patent Issued |
| 2017-11-30 | Glaukos issues press release regarding '143 Patent |
| 2018-01-01 | Ivantis begins "Limited International Launch" of Hydrus |
| 2018-04-14 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent 6,626,858 - "Shunt Device and Method for Treating Glaucoma"
- Patent Identification: U.S. Patent 6,626,858, issued September 30, 2003. (Compl. ¶34).
The Invention Explained
- Problem Addressed: The patent describes glaucoma as a condition of elevated intraocular pressure caused by abnormally high resistance to the outflow of aqueous humor through the eye's natural drainage pathway. (’858 Patent, col. 1:49-2:10). It notes that prior surgical treatments, like trabeculectomy, divert fluid to the external surface of the eye, which can lead to serious complications such as scarring, infection, and hypotony (excessively low pressure). (’858 Patent, col. 3:13-4:11).
- The Patented Solution: The invention is a shunt surgically placed to divert aqueous humor from the eye's anterior chamber directly into Schlemm's canal, bypassing the site of outflow resistance (the trabecular meshwork) while utilizing the natural, downstream drainage system. (’858 Patent, Abstract; col. 5:12-23). This is intended to avoid the complications of external drainage. Key embodiments, such as the one in Figure 1A, depict a "T-shaped" device with a proximal portion for the anterior chamber and a bi-directional distal portion that sits within and holds open Schlemm's canal. (’858 Patent, Fig. 1A).
- Technical Importance: This approach represented a shift toward a more physiologic method for treating glaucoma, aiming to restore the natural outflow pathway rather than creating an artificial external one, thereby seeking to reduce long-term complication rates. (’858 Patent, col. 5:1-11).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1. (Compl. ¶¶1, 4, 36-38).
- Independent Claim 1:
- An aqueous humor shunt device to divert aqueous humor from the anterior chamber into Schlemm's canal;
- Comprising a distal portion sized to be received within Schlemm's canal and a proximal portion sized to be received within the anterior chamber;
- The device permits fluid communication between the proximal and distal portions; and
- The proximal portion intersects the distal portion, and the distal portion "branches in two opposite directions from the intersection," permitting fluid communication along Schlemm's canal. (’858 Patent, col. 12:12-24).
- The complaint reserves the right to assert additional claims. (Compl. ¶4).
U.S. Patent 9,827,143 - "Shunt Device and Method for Treating Ocular Disorders"
- Patent Identification: U.S. Patent 9,827,143, issued November 28, 2017. (Compl. ¶42).
The Invention Explained
- Problem Addressed: Like its parent, the '143 Patent addresses the need for a safer and more effective surgical treatment for glaucoma by targeting the natural drainage pathway. (’143 Patent, col. 1:35-2:54).
- The Patented Solution: The invention is an implant, specifically described as having a non-tubular, "at least partially open" channel, such as a "trough-like" shape. (’143 Patent, col. 12:9-12). This elongate, flexible implant is positioned within Schlemm's canal to act as a stent, holding the canal open, while its open structure and portals facilitate fluid flow from the anterior chamber and into the eye's collecting channels. (’143 Patent, col. 4:51-62; Fig. 3D).
- Technical Importance: By using a non-tubular, open-channel design, the invention may enhance drainage by maximizing the surface area available for fluid to exit into the collector channels located along the outer wall of Schlemm's canal, a potential refinement over a simple enclosed tube. (’143 Patent, col. 8:56-65).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 5. (Compl. ¶¶1, 4, 44-46).
- Independent Claim 5:
- An implant to relieve intraocular pressure;
- Comprising a flexible, elongate body of biocompatible material with a curved "channel" for positioning within Schlemm's canal;
- The channel is "at least partially open along its length" to facilitate fluid flow from Schlemm's canal into collecting channels; and
- The channel has "one or more portals oriented to allow flow of aqueous humor from an anterior chamber" into Schlemm's canal. (’143 Patent, col. 12:5-18).
- The complaint reserves the right to assert additional claims. (Compl. ¶4).
III. The Accused Instrumentality
Product Identification
- The Ivantis Hydrus Microstent ("Hydrus"). (Compl. ¶1).
Functionality and Market Context
- The Hydrus is described as an 8 mm long, crescent-shaped shunt device made of biocompatible nitinol, a flexible metal alloy. (Compl. ¶28). It is designed with a proximal inlet portion that resides in the anterior chamber of the eye to collect aqueous humor and a distal portion that is placed circumferentially within Schlemm's canal. (Compl. ¶29).
- Ivantis allegedly refers to the distal portion as a "scaffold" designed to be inserted into Schlemm's canal. (Compl. ¶29). The complaint alleges that Ivantis's website contains animations showing fluid flowing from the anterior chamber through the Hydrus and exiting through openings into the collecting channels. (Compl. ¶30). The Hydrus is positioned as a direct competitor to Glaukos's iStent, targeting the same patient population and allegedly seeking to leverage the market developed by Glaukos. (Compl. ¶¶19, 23).
IV. Analysis of Infringement Allegations
'858 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An aqueous humor shunt device...comprising a distal portion...to be received within a portion of Schlemm's canal and a proximal portion...to be received within the anterior chamber of the eye... | The Hydrus is an "aqueous humor shunt device" with a distal portion "designed to be received and retained at least partially circumferentially within a portion of Schlemm's canal" and a proximal portion received by the anterior chamber. | ¶¶27, 29 | col. 5:50-62 |
| wherein device permits fluid communication from the proximal portion...to the distal portion... | Animations on the Ivantis website allegedly depict aqueous humor flowing from the proximal portion of the Hydrus in the anterior chamber through to the distal portion in Schlemm's canal. | ¶30 | col. 5:58-62 |
| wherein the distal portion branches in two opposite directions from the intersection with the proximal portion... | The Hydrus is described as a single 8 mm long, crescent-shaped device. The complaint does not allege a specific corresponding structure but asserts infringement "literally or under the doctrine of equivalents." | ¶¶28, 36 | col. 8:52-57 |
'143 Patent Infringement Allegations
| Claim Element (from Independent Claim 5) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a flexible, elongate body of biocompatible material for implantation in a living human eye comprising a curved channel... | The Hydrus is an 8 mm long, crescent-shaped device made of nitinol (a flexible, biocompatible material). An image from Defendant's website shows the Hydrus device from two angles, revealing a trough-like channel with multiple openings. (Compl. ¶31). | ¶¶28, 31 | col. 8:56-65 |
| wherein the channel is at least partially open along its length to facilitate flow of aqueous humor from Schlemm's canal into one or more collecting channels | The complaint alleges that the Hydrus's distal portion comprises an "at least partially open trough-like channel open posteriorly toward the collecting channels." | ¶31 | col. 8:40-45 |
| the channel further having one or more portals oriented to allow flow of aqueous humor from an anterior chamber of the eye into Schlemm's canal | The Hydrus includes a "proximal inlet portion" that resides in the anterior chamber where "aqueous humor enters the body of the device," and Ivantis animations allegedly depict this flow. | ¶29, 30 | col. 4:51-62 |
- Identified Points of Contention:
- Structural Mismatch ('858 Patent): A primary dispute for the '858 Patent will likely concern the limitation "the distal portion branches in two opposite directions." The complaint describes the Hydrus as a single crescent-shaped body, which does not appear to literally meet this T-shaped structural requirement. The case for infringement of claim 1 may therefore depend heavily on the doctrine of equivalents and whether the function of the single elongate Hydrus body is equivalent to the claimed bi-directional branches.
- Definitional Scope ('143 Patent): For the '143 Patent, the analysis may focus on claim construction. A key question is whether the Hydrus structure, which Ivantis allegedly calls a "scaffold," falls within the scope of the term "channel" as used in the patent. The outcome will depend on whether the term is interpreted broadly based on its function or more narrowly based on the specific "trough-like" embodiments shown in the patent's figures.
V. Key Claim Terms for Construction
The Term: "branches in two opposite directions" (’858 Patent, Claim 1)
- Context and Importance: This term appears to define the core "T-shaped" geometry of the primary embodiment of the '858 Patent. As the accused Hydrus device is described as a single crescent-shaped body, the construction of this term is critical to the literal infringement analysis and will frame any argument under the doctrine of equivalents.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not appear to provide an explicit definition that would broaden the term beyond its plain meaning. A party might argue it should be read functionally to cover any structure that extends circumferentially within the canal from a central inlet.
- Evidence for a Narrower Interpretation: The specification consistently illustrates this concept with drawings of a T-junction, where two distinct arms extend from a central proximal stem (e.g., Figs. 1A, 2, 3B). (’858 Patent, col. 12:21-22). The plain meaning of "branches" suggests a division into multiple paths, supporting a narrow construction limited to such a T-shaped structure.
The Term: "channel" (’143 Patent, Claim 5)
- Context and Importance: This term defines the primary fluid conduit of the '143 Patent's implant. Practitioners may focus on this term because the complaint notes that Ivantis sometimes refers to its product as a "scaffold," raising the question of whether a "scaffold" is a "channel." (Compl. ¶29). The resolution will determine if the Hydrus's core structure is covered by the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the structure in various ways, including as "trough-like" and "at least partially open," suggesting "channel" is a broad term for a fluid pathway and not limited to a specific geometry. (’143 Patent, col. 8:40-45, col. 12:9-10).
- Evidence for a Narrower Interpretation: A party could argue the term should be limited by the embodiments shown in the figures, which depict specific open, trough-like structures. (’143 Patent, Figs. 3A, 3D). This could be used to argue that the Hydrus's specific "scaffold" geometry falls outside the scope of the claimed "channel."
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced infringement and contributory infringement for both patents. (Compl. ¶¶37-38, 45-46). The inducement allegations are based on Ivantis's alleged encouragement of infringing use through marketing materials, published studies, conference presentations, and demonstrative videos. (Compl. ¶32).
- Willful Infringement: Willfulness is alleged for both patents. The complaint asserts that Ivantis had pre-suit knowledge of Glaukos's technology and patents based on: the '858 Patent being cited during the prosecution of Ivantis's own patent applications; Ivantis's public statements acknowledging the market created by Glaukos; industry analyst reports discussing the patents; and Ivantis's website referencing one of the co-inventors. (Compl. ¶¶19, 20, 21, 22, 39, 47).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of structural equivalence: Does the accused Hydrus Microstent, a single crescent-shaped device, infringe claims of the '858 Patent that explicitly require a distal portion that "branches in two opposite directions," a feature the patent illustrates as a distinct T-shaped structure? This question will likely hinge on the doctrine of equivalents.
- A second central question will be one of claim scope: Can the term "channel" in the '143 Patent, described in the specification as "trough-like," be construed to read on the accused Hydrus device, which Defendant Ivantis allegedly markets as a "scaffold"? The court's construction of this term will be pivotal.
- Finally, a key factual dispute will concern willfulness: Does the evidence cited in the complaint, particularly the prior citation of the '858 patent in Ivantis's own patent prosecution, establish that any infringement was "deliberately and consciously" committed, potentially exposing Defendant to enhanced damages?