DCT

1:23-cv-01396

Sipnose Ltd v. AptarGroup Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01396, D. Del., 12/07/2023
  • Venue Allegations: Venue is alleged to be proper as Defendant AptarGroup, Inc. is a corporation organized and existing under the laws of Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s Unidose Powder Nasal Spray System, a nasal drug delivery device, infringes a patent related to the aerosolized delivery of substances to a natural orifice.
  • Technical Context: The technology concerns intranasal drug delivery devices, a field focused on non-invasive methods for achieving systemic drug absorption or direct nose-to-brain delivery.
  • Key Procedural History: The complaint alleges a history of communication between the parties, stating that Plaintiff disclosed the patent’s parent application to Defendant as early as October 2016 during discussions about a potential business collaboration. The complaint further alleges that Plaintiff notified Defendant of the application’s notice of allowance in June 2021, and sent formal notice of infringement letters in August and October 2023. These allegations form the basis for a claim of willful infringement.

Case Timeline

Date Event
2014-11-09 U.S. Patent No. 11,116,914 Priority Date
2016-10-01 Plaintiff allegedly discloses parent application to Defendant
2019-07-25 FDA approves BAQSIMI, which uses the Accused Product
2021-06-01 Plaintiff allegedly notifies Defendant of patent's Notice of Allowance
2021-09-14 U.S. Patent No. 11,116,914 Issue Date
2023-08-17 Plaintiff sends first infringement notice letter to Defendant
2023-10-23 Plaintiff sends second infringement notice letter to Defendant
2023-12-07 Complaint Filing Date

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

U.S. Patent No. 11,116,914 - "Device and Method for Aerosolized Delivering of Substance to a Natural Orifice of the Body"

  • Patent Identification: U.S. Patent No. 11,116,914, "Device and Method for Aerosolized Delivering of Substance to a Natural Orifice of the Body," issued September 14, 2021.

The Invention Explained

  • Problem Addressed: The patent’s background section identifies a need for a system that can achieve both efficient delivery of a substance to a target site (e.g., the nasal cavity) and ensure adequate absorption into and through the mucosal layer, a dual challenge that prior art devices allegedly failed to solve optimally (’914 Patent, col. 1:21-43).
  • The Patented Solution: The invention is a device that uses a pre-pressurized volume of gas to entrain and discharge a predetermined amount of a substance. The core components include a substance container, a valve mechanism, and a fluid-tight gas chamber, which work together to generate a rapid, high-velocity plume of aerosolized substance upon activation (’914 Patent, Abstract; col. 2:46-65). This controlled discharge is designed to propel the substance deep into a body cavity, such as the olfactory epithelium of the nose for direct brain delivery (’914 Patent, col. 15:45-49).
  • Technical Importance: This approach aims to provide a reproducible, user-independent delivery of a precise dose with specific aerosol characteristics (e.g., high particle velocity, narrow plume) to effectively target deep anatomical structures not easily reached by conventional sprayers (’914 Patent, col. 1:44-57).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, including independent claims 14 and 32 (Compl. ¶45).
  • Independent Claim 14 (Device) recites essential elements including:
    • A "capsule" for containing a predetermined mass (1-1000 mg) of a substance.
    • A "nozzle" with an orifice (0.2-6 mm diameter) in fluid communication with the capsule.
    • A "valve" with active and inactive configurations, reconfigurable in 200 milliseconds or less.
    • A fluid-tight chamber for a predetermined volume (1-21 ml) and pressure (1-10 barg) of gas.
    • Configuration for the pressurized gas to entrain and deliver the substance with a release time of less than 500 milliseconds, independent of the gas volume, substance volume, and pressure.
    • A resulting particle velocity in the range of 5 m/s to 50 m/s.
  • Independent Claim 32 (Method) recites steps including:
    • "Providing" a device with the core structural features of claim 14.
    • "Placing" the nozzle in proximity to a body cavity.
    • "Reconfiguring" the valve to entrain the substance with pressurized gas.
    • "Delivering" the substance and gas, and "characterizing" the resulting particle velocity to be in the range of 5 m/s to 50 m/s.

III. The Accused Instrumentality

Product Identification

The Aptar Unidose (UDS) Powder Nasal Spray System ("Unidose Powder System") (Compl. ¶27).

Functionality and Market Context

The Accused Product is a single-use, one-step device designed to deliver a powder formulation into a person's nasal cavity (Compl. ¶28). It is manufactured by Defendant Aptar and is used as the delivery device for the drug BAQSIMI, an injection-free glucagon product for treating severe low blood sugar (Compl. ¶¶26-27). The complaint alleges that operation involves inserting the device into a nostril and depressing a plunger-style actuator (Compl. ¶28). The complaint provides an image of the accused Unidose Powder System, showing the device and its separate storage container (Compl. p. 8). It also alleges, upon information and belief, that the Accused Product is a commercial embodiment of a device described in a U.S. patent application assigned to Aptar's French subsidiary (Compl. ¶29).

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,116,914 Infringement Allegations

Claim Element (from Independent Claim 14) Alleged Infringing Functionality Complaint Citation Patent Citation
at least one capsule sized and shaped for containing said predetermined mass Msub [mg] of at least one substance; wherein said predetermined mass Msub [mg] is in a range of 1-1000 mg The Unidose Powder System includes a "container or reservoir (110)" configured to hold a fixed 30 mg dose of powder, which is within the claimed mass range. ¶47 col. 2:51-55
a nozzle configured for placement in proximity to said at least one body cavity...said nozzle comprises at least one orifice, wherein a diameter D [mm] of the at least one orifice is in a range of 0.2-6 mm The system has a nasal dispenser head (120) with a dispenser orifice (121) for insertion into a nostril. The complaint alleges upon information and belief that the orifice diameter is within the 0.2-6 mm range. ¶48 col. 2:55-59
at least one valve mechanically connectable to said at least one capsule, characterized by at least two configurations: (i) an active configuration...and (ii) an inactive configuration... The system allegedly employs a mechanism with a closure element (112) and a sliding insert (115) that functions as a valve, operating in an active configuration during actuation and an inactive configuration prior to use. The complaint provides illustrations from the BAQSIMI instructions for use, depicting the device in an inactive state before the plunger is pushed and an active state as the plunger is pushed (Compl. p. 10). ¶¶16, 49 col. 2:60-65
said at least one valve is reconfigurable from said inactive configuration to said active configuration within a predetermined period of time, dT...wherein said predetermined period of time dT is less than or equal to 200 ms The complaint alleges upon information and belief that the device has a reaction time to open the valve of less than or equal to 200 ms. ¶50 col. 2:2-5
a fluid tight chamber configured to contain a predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure, Pgas [barg]... The system allegedly contains an "air expelling mechanism with a fluid tight air chamber" holding compressed air at a volume and pressure within the claimed ranges (1-21 ml and 1-10 barg, respectively). ¶51 col. 2:5-8
wherein said device is configured to deliver...such that a release time...dTdeliver, is less than 500ms, wherein the dTdeliver is maintained less than 500 milliseconds independent of the predetermined volume Vgas [ml]... The system is alleged to expel the aerosol in under 500 ms and is configured to maintain this release time regardless of the amount of force applied by the user. ¶¶53-54 col. 5:35-43
wherein a velocity of particles of the at least one substance, after exit from the device, is in a range of about 5 m/s to 50 m/s The complaint alleges upon information and belief that the device expels the aerosol at a speed within the claimed range of 5 to 50 m/s. ¶55 col. 5:50-52

Identified Points of Contention

  • Scope Questions: A central dispute may arise over the meaning of "capsule". The defense may argue that the accused product’s integrated "container or reservoir" (Compl. ¶47) does not meet the definition of a "capsule" if that term is construed to mean a separate, loadable component as depicted in some patent embodiments (e.g., ’914 Patent, Fig. 3). Similarly, the interpretation of "valve" will be critical, specifically whether the accused plunger-and-closure mechanism (Compl. p. 16) falls within the scope of the term as used in the patent.
  • Technical Questions: The complaint makes numerous allegations regarding specific numerical performance parameters (e.g., reconfiguration time, gas pressure, release time, particle velocity) on "information and belief" (Compl. ¶¶48, 50-51, 53-55). These are factual questions that will require discovery and expert testing to verify. A key technical point of contention may be the allegation that the release time is maintained "regardless of the amount of force applied by the user" (Compl. ¶54), a claim of user-independent performance that will likely demand significant evidentiary support.

V. Key Claim Terms for Construction

  • The Term: "capsule"

  • Context and Importance: This term appears in independent claim 14 ("at least one capsule sized and shaped for containing said predetermined mass"). The complaint identifies the corresponding feature in the accused device as a "container or reservoir (110)" (Compl. ¶47). Practitioners may focus on this term because if "capsule" is construed narrowly to require a physically separate and disposable component, the accused product's integrated reservoir design might be found non-infringing.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent specification suggests the terms can be interchangeable, stating, "It is another object of the present invention to disclose the device, wherein said volume is a container. It is another object of the present invention to disclose the device, wherein the container is a capsule..." (’914 Patent, col. 3:15-18). This language may support an interpretation where "capsule" encompasses any structure that contains the substance, including an integrated one.
    • Evidence for a Narrower Interpretation: The specification frequently depicts the capsule as a discrete component loaded into the main device (e.g., element 21 in Fig. 3). A defendant could argue that these specific embodiments define the term, limiting its scope to structures that are physically separate from the delivery device's main body.

  • The Term: "valve"

  • Context and Importance: Claim 14 requires "at least one valve mechanically connectable to said at least one capsule." The complaint alleges a mechanism involving a "closure element (112)" and a sliding "insert (115)" meets this limitation (Compl. p. 16). The definition of "valve" is critical because the infringement case depends on this plunger-like assembly being legally equivalent to the claimed term.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent broadly defines the valve by its function: a component "characterized by at least two configurations: (i) an active configuration in which said at least one valve enables delivery...and (ii) an inactive configuration, in which said at least one valve prevents delivery..." (’914 Patent, col. 4:60-65). A plaintiff may argue that any structure performing this binary open/close function meets the claim.
    • Evidence for a Narrower Interpretation: A defendant may point to more conventional valve structures disclosed in the patent's detailed description (e.g., pinch valves) to argue that the term requires something more than the alleged simple mechanical displacement of a closure. The complaint's own description of an "insert (115) that slides during actuation to expel the closure element" (Compl. p. 16) could be used by a defendant to distinguish the mechanism from a traditional valve.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement theory is based on Aptar allegedly encouraging end-users to perform the patented method by providing instructions for use that direct the infringing acts (Compl. ¶¶57-58). The contributory infringement allegation is based on the sale of the Unidose Powder System, which is allegedly "specifically made or adapted for use in infringing the '914 patent" and has no substantial non-infringing use (Compl. ¶34).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged pre-suit knowledge of the patent and its infringing activity. The basis includes alleged discussions regarding the parent patent application as early as October 2016, notification of the patent's allowance in June 2021, and formal infringement notice letters sent in August and October 2023 (Compl. ¶¶37-41, 60).

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

  • A core issue will be one of definitional scope: can the term "capsule," which is depicted in some patent embodiments as a discrete component, be construed to cover the integrated "container or reservoir" of the accused Unidose Powder System? The resolution of this and the related construction of the term "valve" will be fundamental to the infringement analysis.
  • A key evidentiary question will be one of functional proof: can Plaintiff produce sufficient evidence, likely through expert testing, to demonstrate that the accused device operates within the specific quantitative parameters (e.g., release time <500 ms, particle velocity of 5-50 m/s) recited in the asserted claims?
  • A central technical question will be one of performance characteristics: does the accused device achieve a delivery time that is "independent" of user-applied force and other variables as required by claim 14, or does its performance vary in a way that creates a mismatch with the claim language?