DCT

2:21-cv-00520

Menicon America v. Optixon

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:21-cv-00520, D. Utah, 09/01/2021
  • Venue Allegations: Venue is alleged to be proper because the Defendant is not a resident of the United States and has engaged in infringing activity in the judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s contact lens packaging infringes patents related to space-saving, hygienic packaging for soft contact lenses.
  • Technical Context: The technology concerns single-use packaging for disposable soft contact lenses, a high-volume market where packaging cost, size, and environmental impact are significant competitive factors.
  • Key Procedural History: Plaintiff alleges sending a detailed demand letter with claim charts to Defendant's CEO on May 18, 2021, which Defendant allegedly refused and ignored, forming the basis for the willfulness allegation.

Case Timeline

Date Event
2001-08-17 Earliest Priority Date for ’137, ’002, and ’672 Patents
2010-11-09 U.S. Patent No. 7,828,137 Issues
2010-12-14 U.S. Patent No. 7,850,002 Issues
2015-02-17 U.S. Patent No. 8,955,672 Issues
2021-05-18 Plaintiff sends demand letter to Defendant
2021-09-01 Complaint Filing Date

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

U.S. Patent No. 7,828,137 - "Packaging for Disposable Soft Contact Lenses"

The Invention Explained

  • Problem Addressed: Traditional disposable contact lens packaging, typically rigid "blister packs," is described as economically and environmentally costly due to its bulk, which increases storage and transport expenses (’137 Patent, col. 1:24-29, col. 1:47-51). These packages take up a "disproportionate amount of space relative to the size of the lens" (’137 Patent, col. 13:5-7).
  • The Patented Solution: The invention proposes a smaller, slimmer, and more flexible single-use package that holds the contact lens in a "flattened or compressed state" (’137 Patent, col. 2:48-49). This is achieved by designing the package with an internal depth that is less than the natural, equilibrated "sagittal depth" of the lens itself (’137 Patent, col. 2:50-54). This design reduces material usage, saves space, and can ensure the lens is presented in a predictable orientation when opened (’137 Patent, col. 15:35-44).
  • Technical Importance: This approach challenged the conventional wisdom that contact lens packaging must be rigid to protect the lens, offering a more economical and convenient alternative for the high-volume disposable lens market (’137 Patent, col. 2:15-20).

Key Claims at a Glance

  • The complaint asserts at least independent claim 12 (Compl. ¶22).
  • Claim 12 Elements:
    • A contact lens package manufactured with a contact lens therein, wherein the package deforms the contact lens.
    • The package comprises a first space defined by a non-transmissive barrier layer.
    • The first space contains a hydration medium and the lens.
    • A maximum internal depth of the cavity is less than the natural sagittal depth of the contact lens.

U.S. Patent No. 7,850,002 - "Packaging for Soft Contact Lenses"

The Invention Explained

  • Problem Addressed: Similar to the ’137 Patent, this patent addresses the economic and practical drawbacks of bulky prior art blister packs, including cost, storage inefficiency, and environmental concerns (’002 Patent, col. 1:17-23). It also implicitly addresses the need to maintain lens hydration and sterility through autoclaving (’002 Patent, col. 1:36-39).
  • The Patented Solution: The patent describes a package, which may be a flexible "retort-type" package, comprising a non-permeable barrier layer that defines an internal space (’002 Patent, col. 4:11-13, col. 3:11-14). The key feature is that the barrier layer "engages" the soft contact lens to "prevent movement of said contact lens within said package" (’002 Patent, col. 2:42-45). This solution stabilizes the lens within a minimal, flexible package, preventing the folding or inversion that can occur in larger, rigid packages.
  • Technical Importance: By actively securing the lens within a slim package, the invention provides a way to achieve the space-saving benefits of a flexible format while improving the reliability and predictability of the lens's condition upon opening (’002 Patent, col. 15:27-44).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶22).
  • Claim 1 Elements:
    • A contact lens package comprising a non-permeable barrier layer defining an internal space.
    • A soft contact lens hermetically sealed within the space.
    • The seal is configured to withstand autoclave sterilization.
    • A free-flowing hydration medium is sealed within the space with the lens.
    • The non-permeable barrier layer engages the soft contact lens to prevent its movement within the package.

U.S. Patent No. 8,955,672 - "Packaging for Disposable Soft Contact Lenses"

  • Technology Synopsis: This patent claims a contact lens package where the package itself is defined by a "non-permeable barrier material" that "directly contacts a surface" of the lens and "deforms" it (’672 Patent, col. 26:45-51). This directly links the deformation of the lens to the barrier material itself, combining concepts of deforming the lens for space efficiency and using the package material to engage the lens surface.
  • Asserted Claims: The complaint asserts at least independent claim 1 (Compl. ¶22).
  • Accused Features: The complaint alleges that the DuoSoft® CleanPack® has a non-permeable barrier material that both directly contacts and deforms the contact lens sealed inside (Compl. ¶33).

III. The Accused Instrumentality

Product Identification

  • Defendant’s “Dewrop” brand contact lenses sold in “DuoSoft® CleanPack®” packaging (Compl. ¶9).

Functionality and Market Context

  • The complaint alleges the DuoSoft® CleanPack® is a slim, single-use contact lens package that incorporates Plaintiff's patented designs (Compl. ¶20). Defendant’s own marketing materials are cited to describe the product’s benefits, including its “eco design for earth,” “Hygienic Touch-less” technology, and “Designed with Sustainability in Mind” (Compl. ¶20).
  • Technically, the package is alleged to be manufactured with the lens inside, deforming the lens into a flattened state within a shallow cavity defined by non-permeable or non-transmissive barrier layers (Compl. ¶¶ 24, 28, 33). The complaint also alleges the package is configured for autoclave sterilization, contains a hydration medium, and uses its barrier layers to engage the lens and prevent movement (Compl. ¶¶ 29-31). The complaint provides an annotated image showing the accused package deforming a contact lens (Compl. ¶24, p. 8).
  • The product is alleged to be in direct competition with Plaintiff’s own “Miru Flat Pack” products, which embody the patented technology (Compl. ¶¶ 10, 14).

IV. Analysis of Infringement Allegations

7,828,137 Infringement Allegations

Claim Element (from Independent Claim 12) Alleged Infringing Functionality Complaint Citation Patent Citation
a contact lens package manufactured with a contact lens therein, wherein the contact lens package deforms the contact lens... The DuoSoft® CleanPack® is a package manufactured with a contact lens inside, and the packaging allegedly deforms the lens. An annotated image shows the lens in a non-natural, compressed state. ¶24 col. 2:48-49
a first space defined by a non-transmissive barrier layer, said first space containing a hydration medium, wherein the lens is disposed in the first space; The accused package is alleged to have a first space containing the lens and a hydration medium, which is defined by a non-transmissive barrier layer. A visual with callouts points to these features. ¶25 col. 4:1-4
wherein a maximum internal depth between said non-transmissive barrier layer defining said cavity is less than the natural sagittal depth of said contact lens. The complaint alleges the internal depth of the accused package's cavity (approx. 1.8 mm) is less than the natural sagittal depth of the lens (approx. 3.8 mm) and provides a diagram comparing the two depths. ¶26 col. 2:50-54

7,850,002 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a contact lens package comprising: a non-permeable barrier layer defining an internal space of said contact lens package; The DuoSoft® CleanPack® is alleged to be a package with a non-permeable barrier layer that defines an internal space. A visual with callouts illustrates the layers and the space between them. ¶28 col. 4:2-4
a soft contact lens hermetically sealed within said internal space, said seal being configured to withstand autoclave sterilization; The accused package is alleged to contain a hermetically sealed soft contact lens and is configured for autoclave sterilization, as purportedly stated in Defendant's own 510(k) Premarket Notification. ¶29 col. 1:36-39
a free flowing hydration medium sealed within said internal space with said soft contact lens; The accused package allegedly contains a free-flowing hydration medium (phosphate buffered saline) sealed with the lens, as stated in the 510(k) filing. ¶30 col. 1:33-35
wherein said non-permeable barrier layer engages said soft contact lens to prevent movement of said contact lens within said package. The non-permeable barrier layer of the accused package allegedly engages the lens surface to prevent it from moving inside the package. The complaint provides an annotated image highlighting this engagement. ¶31 col. 2:42-45

Identified Points of Contention

  • Scope Questions: The infringement analysis may raise questions about the required degree of interaction for claim terms like “deforms” (’137 Patent) and “engages” (’002 Patent). For the ’002 Patent, a central question may be whether incidental contact that limits movement is sufficient to meet the "engages...to prevent movement" limitation, or if a more specific structural interaction is required.
  • Technical Questions: A factual dispute may arise over the measurement methodologies used to determine "maximum internal depth" and "natural sagittal depth" as recited in the ’137 Patent. The complaint provides specific numbers (1.8 mm vs. 3.8 mm) (Compl. ¶26); the basis for and accuracy of these measurements may be scrutinized.

V. Key Claim Terms for Construction

The Term: "deforms the contact lens" (’137 Patent, Claim 12)

  • Context and Importance: This term is fundamental to the ’137 Patent’s core concept of a space-saving package. The dispute will likely center on whether any deviation from the lens's natural shape constitutes "deformation," or if it requires the specific "flattened or compressed state" described in the specification.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain meaning of "deform" is to alter shape. Parties arguing for a broad construction may assert that any package constraining the lens from its fully equilibrated state meets this limitation.
    • Evidence for a Narrower Interpretation: The specification repeatedly describes the invention in terms of holding the lens in a "flattened or compressed state" (’137 Patent, col. 2:49) and distinguishes itself from prior art that sought to avoid deformation (’137 Patent, col. 2:42-45). This context may support a narrower construction requiring a significant, intentional flattening.

The Term: "engages said soft contact lens to prevent movement" (’002 Patent, Claim 1)

  • Context and Importance: This limitation distinguishes the invention from packages where the lens can freely float and potentially invert or fold. Practitioners may focus on this term because the mechanism and extent of "engagement" and "prevention" are not explicitly defined in the claim, creating ambiguity.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states that in the invention, the flatness of the barrier layers "will facilitate sticking of the lens to one or other of the internal surfaces" (’002 Patent, col. 22:11-13). This could support an argument that surface adhesion in a tight package constitutes "engagement."
    • Evidence for a Narrower Interpretation: The abstract states the barrier layer "engages" the lens to prevent movement. The summary notes that the package "restricts the movement of the contact lens" (’002 Patent, col. 15:26-27). A defendant may argue this implies a more active or structural restraint than mere incidental contact or "sticking" within a small space.

VI. Other Allegations

Willful Infringement

  • The complaint alleges willful infringement for all three patents-in-suit. The basis for this allegation is Defendant’s purported actual notice of the patents and infringement allegations via a detailed demand letter, including claim charts, sent on May 18, 2021. The complaint alleges that Defendant refused delivery of the physical letter and provided no response to an emailed copy, and that its infringing activity continued thereafter (Compl. ¶¶ 20-21, 37, 45, 53).

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

  • A core issue will be one of definitional scope: can the functional term "deforms," central to the ’137 patent, be met by any package that constrains a lens from its natural shape, or does it require a more specific "flattened or compressed state" as described in the patent's specification? Similarly, does the term "engages...to prevent movement" in the ’002 patent require a specific engagement mechanism, or is incidental contact within a sufficiently confined space enough?
  • A key evidentiary question will be one of factual proof: can the plaintiff demonstrate, through expert testimony and testing, that the accused DuoSoft® CleanPack® meets the specific dimensional and functional limitations of the asserted claims? This will likely involve scrutinizing the measurement of the package’s internal depth versus the lens’s sagittal depth and proving that the package's barrier layers actually function to "prevent movement" of the lens inside.