Sight Sciences Inc v. Ivantis Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Sight Sciences, Inc. (Delaware)
  • Defendant: Ivantis, Inc. (Delaware); Alcon Research LLC (Delaware); Alcon Vision, LLC (Delaware); and Alcon Inc. (Switzerland)
  • Plaintiff’s Counsel: Young Conaway Stargatt & Taylor, LLP; Cooley LLP
• Case Identification: 1:21-cv-01317, D. Del., 08/01/2022
• Venue Allegations: Venue is alleged to be proper in Delaware because Defendants Ivantis, Alcon Research, and Alcon Vision are incorporated in Delaware. Venue over Alcon Inc. is based on its status as a foreign corporation.
• Core Dispute: Plaintiff alleges that Defendants’ Hydrus® Microstent, a device for treating glaucoma, infringes five U.S. patents related to intraocular implants designed to maintain the patency of Schlemm's canal.
• Technical Context: The technology is in the field of minimally invasive glaucoma surgery (MIGS), which seeks to reduce intraocular pressure by restoring the eye's natural aqueous humor drainage pathways with minimal trauma.
• Key Procedural History: The complaint alleges that Defendant Ivantis was aware of the foundational patent application as early as 2008, when it unsuccessfully attempted to purchase the intellectual property rights. It further alleges that Defendant Alcon Inc. acquired Ivantis in January 2022, after the initial complaint in this lawsuit was filed, suggesting post-suit knowledge of the infringement allegations.

Case Timeline

Date	Event
2006-06-26	Priority Date for all Patents-in-Suit (based on filing of U.S. Appl. No. 11/475,523)
2007-01-01	Ivantis founded (approximate)
2007-12-27	'523 patent application published
2008-12-18	Ivantis allegedly attempts to purchase the Badawis' IP rights
2012-01-01	Ivantis commences HORIZON study for the Hydrus® Microstent (approximate)
2012-10-16	U.S. Patent No. 8,287,482 issues
2016-06-21	U.S. Patent No. 9,370,443 issues
2016-11-08	U.S. Patent No. 9,486,361 issues
2017-06-01	HORIZON study reaches its primary endpoint (approximate)
2018-08-10	FDA grants premarket approval for the Hydrus® Microstent
2019-06-11	U.S. Patent No. 10,314,742 issues
2021-09-16	Original Complaint filed by Sight Sciences against Ivantis
2022-01-07	Alcon Inc. completes acquisition of Ivantis
2022-07-19	U.S. Patent No. 11,389,328 issues
2022-08-01	Second Amended Complaint filed

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

U.S. Patent No. 8,287,482 - “Intraocular Implants and Methods and Kits Therefor”

• Issued: October 16, 2012

The Invention Explained

• Problem Addressed: The patent addresses glaucoma, a condition often caused by elevated intraocular pressure (IOP) from suboptimal drainage of aqueous humor through the eye's natural pathways, including Schlemm's canal (ʼ482 Patent, col. 1:24-62). Prior surgical treatments like trabeculectomy were highly invasive and risky, while early stents could become clogged or block the very drainage channels they were meant to open (ʼ482 Patent, col. 2:5-52).
• The Patented Solution: The invention is an implantable "support" placed within Schlemm's canal. The support is designed to prop the canal open to restore its patency, thereby facilitating the natural, transmural flow of aqueous humor out of the eye. A key aspect is that the support achieves this function while making minimal or discontinuous contact with the canal walls, thereby avoiding blockage of the trabecular meshwork or the collector channels that drain the canal (ʼ482 Patent, Abstract; col. 7:31-45).
• Technical Importance: The technology provides a minimally invasive approach to treating glaucoma that works by restoring, rather than bypassing, the eye's natural physiological drainage system (Compl. ¶¶19-21).

Key Claims at a Glance

• The complaint asserts independent claims 1 and 63 (Compl. ¶¶103-104).
• Essential elements of independent device claim 1 include:
  • A support having at least one fenestration that is longitudinally insertable into a lumen of Schlemm's canal.
  • The support having a cross-sectional dimension sufficient to at least partially prop open Schlemm's canal.
  • Wherein contact between the support and a wall of the canal is discontinuous along a perimeter of the lumen.
  • Wherein the support contacts less than 30% of the internal wall surface area of a cylindrical section of the lumen.
• The complaint reserves the right to assert additional claims.

U.S. Patent No. 9,370,443 - “Intraocular Implants and Methods and Kits Therefor”

• Issued: June 21, 2016

The Invention Explained

• Problem Addressed: As a continuation of the same patent family, the '443 Patent addresses the same technical problem of restoring aqueous humor outflow in glaucoma patients without the risks of invasive surgery or the limitations of prior stent designs (ʼ443 Patent, col. 1:24-2:54).
• The Patented Solution: The '443 Patent similarly discloses an implantable support for maintaining the patency of Schlemm's canal. It describes various configurations, including arcuate members with a radius of curvature smaller than that of Schlemm's canal, which allows the device to exert an outward force to open the canal while ensuring a portion of the device can protrude out of the canal into the trabecular meshwork to facilitate fluid ingress (’443 Patent, col. 11:58-12:2). This design principle aims to maximize drainage while minimizing the device's footprint and contact with sensitive tissues.
• Technical Importance: This technology refines the concept of a canalicular support by introducing specific geometric configurations intended to optimize the balance between structural support and fluid dynamics within the eye's natural drainage system (Compl. ¶21).

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶109).
• The complaint does not provide the text of claim 1 of the ’443 Patent, but alleges infringement based on the same general principles as for the ’482 Patent.
• The complaint reserves the right to assert additional claims.

U.S. Patent No. 9,486,361 - “Intraocular Implants and Methods and Kits Therefor”

• Issued: November 8, 2016
• Technology Synopsis: Continuing the same inventive theme, the ’361 Patent describes intraocular supports for Schlemm's canal. It further refines the implant's structural characteristics, such as using an arcuate member with a specific radius of curvature to prop the canal open while allowing a portion to extend into the trabecular meshwork, thereby restoring the natural outflow pathway (’361 Patent, Abstract; col. 2:59-64).
• Asserted Claims: Independent claim 1 is asserted (Compl. ¶114).
• Accused Features: The complaint alleges the Hydrus® Microstent’s overall structure, dimensions, and placement within Schlemm's canal infringe the patent (Compl. ¶¶43-71, 114).

U.S. Patent No. 10,314,742 - “Intraocular Implants and Methods and Kits Therefor”

• Issued: June 11, 2019
• Technology Synopsis: This patent also relates to intraocular implants for Schlemm's canal. It claims methods for treating an eye condition that involve implanting a support comprising an arcuate member with a radius of curvature smaller than the canal's, such that a portion of the support extends out of the canal (’742 Patent, claim 1). The claims focus on the method of treatment using such a device.
• Asserted Claims: Independent claim 1 is asserted (Compl. ¶121).
• Accused Features: The complaint alleges that the implantation and use of the Hydrus® Microstent, which is alleged to have the claimed arcuate structure, infringes the method claims (Compl. ¶¶49, 72, 121).

U.S. Patent No. 11,389,328 - “Intraocular Implants and Methods and Kits Therefor”

• Issued: July 19, 2022
• Technology Synopsis: This recent addition to the patent family claims methods of reducing intraocular pressure using an introducer cannula to place a support within Schlemm's canal. The claimed method includes positioning the cannula, pushing the support distally out of it, and ensuring the implanted support has the characteristic arcuate shape with a smaller radius of curvature than the canal (’328 Patent, claim 1).
• Asserted Claims: Independent claim 1 is asserted (Compl. ¶127).
• Accused Features: The complaint alleges that the standard surgical procedure for implanting the Hydrus® Microstent using its supplied delivery system infringes this method patent (Compl. ¶¶46-47, 72, 127).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the Hydrus® Microstent and its associated delivery system and implantation methods (Compl. ¶41).

Functionality and Market Context

The Hydrus® Microstent is described as an 8mm arcuate scaffold made of nitinol, a nickel-titanium alloy (Compl. ¶¶44, 55). Its structure consists of alternating "windows" (fenestrations) and "spines" designed for structural support (Compl. ¶44). The complaint provides an image from Ivantis materials showing the device's key features, including an inlet, windows, spines, and a distal tip (Compl. ¶45, Figure 1). It is designed to be implanted longitudinally within Schlemm's canal to dilate the canal and augment the outflow of aqueous humor, spanning approximately 90 degrees of the canal's circumference (Compl. ¶¶44, 48). The device is a primary product offering for the defendants and a direct competitor to the plaintiff's products in the minimally invasive glaucoma surgery (MIGS) market (Compl. ¶¶41, 75).

IV. Analysis of Infringement Allegations

The complaint references attached claim chart exhibits that were not provided with the pleading; therefore, this analysis summarizes the narrative infringement theory presented in the body of the complaint.

The complaint's central infringement theory across all asserted patents is that the Hydrus® Microstent is a "support" that meets the patents' key structural and functional limitations. The complaint alleges the device is longitudinally inserted into Schlemm's canal and has a cross-sectional dimension sufficient to prop it open (Compl. ¶¶43, 50). A primary focus of the allegations is on limitations requiring minimal and discontinuous contact with the canal wall. The complaint alleges that the Hydrus® Microstent's window-and-spine structure inherently creates discontinuous contact points (Compl. ¶60, ¶65). The complaint includes a scanning electron microscope image from a third-party publication, overlaid with an outline of the Hydrus device, to visually support the allegation of intermittent contact points with the canal wall (Compl. ¶61).

Crucially, the complaint dedicates significant analysis to the quantitative limitation present in claims of the ’482 Patent, which requires the support to contact "less than 30% of the internal wall surface area" of the canal section it occupies (Compl. ¶¶54-71). To support this, the complaint presents a detailed calculation based on publicly available dimensions of the Hydrus® Microstent and the typical dimensions of Schlemm's canal, concluding that the potential contact area is approximately 27%-28% of the internal wall surface area (Compl. ¶70). The infringement theory for method claims in the later patents (’742, ’328 Patents) rests on the allegation that the standard, instructed use of the Hydrus® Microstent and its delivery system directly practices the claimed steps of implantation (Compl. ¶¶72, 121, 127).

Identified Points of Contention

• Scope Questions: The dispute may turn on the construction of the term "support" and whether it reads on the accused "scaffold" device. A central point of contention will be the methodology for calculating the "less than 30%" surface area contact limitation, raising questions about the assumptions used in the complaint's calculations (e.g., modeling the canal as a perfect cylinder).
• Technical Questions: A key factual question will be whether the evidence demonstrates that the Hydrus® Microstent's structure results in "discontinuous contact" as defined by the claims. The complaint's reliance on third-party studies and calculations will likely be challenged by competing expert analyses from the defendants.

V. Key Claim Terms for Construction

Term: "support"

• Context and Importance: This term is foundational to all asserted claims. The infringement analysis depends entirely on whether the accused Hydrus® Microstent, marketed as a "scaffold," falls within the scope of a "support" as contemplated by the patents.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification discloses a wide array of configurations for the "support," including unitary structures, beads on a thread, and open networks, suggesting the term is not limited to a specific form but rather to its function of maintaining canal patency (’482 Patent, col. 7:31-35; Figs. 6A-8H).
  • Evidence for a Narrower Interpretation: The abstract and summary consistently describe the support as one that "maintains the patency of the canal without substantially interfering with transmural fluid flow" (’482 Patent, Abstract). Defendants may argue this functional requirement narrows the term to exclude devices that operate differently.

Term: "contact...is discontinuous along a perimeter of the lumen"

• Context and Importance: This limitation is central to distinguishing the patented invention from prior art stents that may have had continuous wall contact. The complaint alleges the Hydrus® Microstent's window-and-spine design literally meets this element.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification illustrates numerous embodiments with clear gaps in contact, such as spaced beads or supports with fluted edges, suggesting that any regular interruption of contact would satisfy the "discontinuous" requirement (’482 Patent, Figs. 7D, 8E).
  • Evidence for a Narrower Interpretation: Defendants may argue that "discontinuous" requires a specific degree of separation or pattern that is absent in the accused device, or that incidental points of contact along the device's length do not render the overall contact "discontinuous" in the claimed sense.

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement based on Defendants’ marketing materials, Instructions For Use (IFU), surgeon training, and the publication of a "Coding and Billing Guide" that allegedly instruct medical professionals to use the Hydrus® Microstent in an infringing manner (Compl. ¶¶92, 104, 115).

Willful Infringement

Willfulness is alleged based on a long history of pre-suit knowledge. The complaint asserts that Ivantis was aware of the parent patent application in 2008 when it attempted to purchase the IP rights (Compl. ¶¶32-33). It further alleges that Ivantis and its counsel monitored and cited the patents-in-suit during the prosecution of their own patents (Compl. ¶¶35-39). Finally, it alleges that Alcon had knowledge of the present lawsuit when it proceeded to acquire Ivantis, and thereafter continued the accused activities (Compl. ¶¶83-84).

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

• A core issue will be one of quantitative analysis and claim construction: The dispute will likely center on the proper methodology for calculating the "less than 30% of the internal wall surface area" contact limitation from claim 1 of the ’482 Patent. The outcome may depend on a "battle of the experts" over the technical assumptions and measurement techniques used to determine if the accused device meets this precise numerical threshold.
• A second key question will be one of willfulness and damages: The complaint presents extensive allegations of Defendants' long-standing knowledge of the asserted patents, including a 2008 offer to purchase the foundational IP and Alcon's acquisition of Ivantis post-suit. A judicial finding of willful infringement based on these facts could expose Defendants to the possibility of enhanced damages, significantly raising the financial stakes of the litigation.