DCT

2:24-cv-04404

Teva Branded Pharmaceutical Products R&D Inc v. Deva Holding As

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-04404, D.N.J., 03/29/2024
  • Venue Allegations: Venue is alleged to be proper as Defendant is a foreign corporation organized under the laws of Turkey and may be sued in any judicial district in the United States.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) for a generic version of the ProAir® HFA inhalation aerosol constitutes an act of infringement of nine U.S. patents related to metered-dose inhalers and their integrated dose-counting mechanisms.
  • Technical Context: The patents relate to mechanical dose counters for metered-dose inhalers, a critical safety and compliance feature for patients using these devices for respiratory conditions.
  • Key Procedural History: The complaint notes that Defendant sent a Paragraph IV notice letter but subsequently revoked an Offer of Confidential Access (OCA) after Plaintiffs proposed revisions to what they deemed "unreasonably restrictive terms." Consequently, Plaintiffs filed this suit under the 45-day statutory deadline without access to the confidential details of Defendant's ANDA. The complaint also certifies that this case is related to other pending or prior lawsuits involving some of the same patents against other generic manufacturers, including Amneal Pharmaceuticals and Cipla, indicating an ongoing, broad enforcement campaign for this patent portfolio.

Case Timeline

Date Event
2004-10-29 FDA approves NDA for ProAir® HFA
2007-04-02 Earliest Priority Date (’712 Patent)
2010-05-18 Earliest Priority Date (’289, ’587, ’509, ’510, ’156, ’808, ’512, ’889 Patents)
2012-03-13 U.S. Patent No. 8,132,712 Issues
2016-10-11 U.S. Patent No. 9,463,289 Issues
2017-11-07 U.S. Patent No. 9,808,587 Issues
2018-07-17 U.S. Patent No. 10,022,509 Issues
2018-07-17 U.S. Patent No. 10,022,510 Issues
2018-10-02 U.S. Patent No. 10,086,156 Issues
2020-02-18 U.S. Patent No. 10,561,808 Issues
2020-06-30 U.S. Patent No. 10,695,512 Issues
2022-07-26 U.S. Patent No. 11,395,889 Issues
2024-02-19 Defendant sends Deva Notice Letter to Plaintiffs
2024-03-29 Complaint Filed

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

U.S. Patent No. 8,132,712 - "Metered-Dose Inhaler"

The Invention Explained

  • Problem Addressed: The patent addresses the difficulty for users of manually operated metered-dose inhalers to determine when the medicament supply is nearly exhausted, creating a potentially hazardous situation where dosing becomes unreliable ('712 Patent, col. 1:11-25). Prior art dose counters were susceptible to miscounting due to the variable force and stroke length applied by users ('712 Patent, col. 2:11-20).
  • The Patented Solution: The invention provides a more robust dose-counting mechanism featuring a pawl with "at least two ratchet teeth which are radially spaced" ('712 Patent, Abstract). This design accommodates a wider range of manufacturing tolerances and actuation inconsistencies by providing alternative engagement points for the ratchet wheel, which significantly reduces the failure rate and prevents miscounting, particularly undercounting ('712 Patent, col. 5:1-11; Fig. 5).
  • Technical Importance: This multi-tooth pawl design enhanced the reliability of mechanical dose counters for manually operated inhalers, where user-to-user actuation can differ significantly.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶85).
  • The essential elements of Claim 1 include:
    • A dose counter for a metered-dose inhaler.
    • An actuator and a rotary gear.
    • A driver for advancing the rotary gear in a step-wise fashion.
    • A pawl to prevent reverse rotation of the rotary gear.
    • A display coupled to the rotary gear.
    • The pawl comprises at least two radially spaced ratchet teeth for engaging the rotary gear.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 9,463,289 - "Dose Counters for Inhalers, Inhalers and Methods of Assembly Thereof"

The Invention Explained

  • Problem Addressed: The patent seeks to further improve the accuracy of dose counters for manually operated inhalers, where the canister's stroke length is highly variable and controlled by the user. Inconsistent actuation can cause the canister to rock within its housing, leading to improper engagement with the counter mechanism and resulting in counting errors ('289 Patent, col. 1:12-34).
  • The Patented Solution: The invention is an inhaler body that incorporates a "first inner wall canister support formation" located "directly adjacent the actuation member" of the dose counter ('289 Patent, Abstract). This structural feature acts as a guide or rail that physically stabilizes the medicament canister during its downward stroke, preventing it from rocking and ensuring consistent, reliable engagement with the dose counter's actuator mechanism ('289 Patent, col. 5:45-53; Fig. 7C).
  • Technical Importance: By integrating a stabilizing structure into the inhaler housing itself, the invention improves the mechanical interface between the user-actuated canister and the dose counter, enhancing the overall system's reliability.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶108).
  • The essential elements of Claim 1 include:
    • An inhaler for metered dose inhalation.
    • A main body with a canister housing.
    • A dose counter with an actuation member located in the canister housing.
    • The canister housing has an inner wall and a "first inner wall canister support formation."
    • The support formation, actuation member, and central outlet port lie in a common plane with the housing's longitudinal axis.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 9,808,587 - "Dose Counter for Inhaler Having an Anti-Reverse Rotation Actuator"

  • Technology Synopsis: The patent addresses the problem of dose counter inaccuracy, particularly if an inhaler is dropped or subjected to a jolt. The invention discloses a dose counter with a regulator that provides a specific resistance force (e.g., > 0.3 N) against the movement of the display tape, preventing unwanted motion of the counter display if the device is dropped ('587 Patent, Abstract; col. 2:54-63).
  • Asserted Claims: At least Claim 1 (Compl. ¶131).
  • Accused Features: The Deva ANDA Product, which is alleged on information and belief to contain a dose counter mechanism that infringes the patent (Compl. ¶¶ 130-131).

U.S. Patent No. 10,022,509 - "Dose Counter for Inhaler Having a Bore and Shaft Arrangement"

  • Technology Synopsis: This patent focuses on the mechanism for holding the tape of a dose counter. It describes a tape stock bobbin with an internal bore supported by a support shaft. At least one of the bore or shaft has a resiliently biased protrusion that creates frictional engagement, which provides good friction for the bobbin and improves tape counter accuracy ('509 Patent, Abstract).
  • Asserted Claims: At least Claim 1 (Compl. ¶154).
  • Accused Features: The Deva ANDA Product, which is alleged on information and belief to contain a dose counter with the claimed bore and shaft arrangement (Compl. ¶¶ 153-154).

U.S. Patent No. 10,022,510 - "Dose Counters for Inhalers, Inhalers and Methods of Assembly Thereof"

  • Technology Synopsis: The invention relates to a tape system for a dose counter that includes specific markings to aid in manufacturing and priming. The tape includes dosing indicia (numbers), tape positioning indicia (lines), a tape size marker (pixelated bar code), and priming indicia (a dot), which allows for automated assembly and ensures the device is correctly set up for first use ('510 Patent, Abstract).
  • Asserted Claims: At least Claim 1 (Compl. ¶177).
  • Accused Features: The Deva ANDA Product, which is alleged on information and belief to use a dose counter tape with the claimed indicia (Compl. ¶¶ 176-177).

U.S. Patent No. 10,086,156 - "Dose Counter for Inhaler and Method for Counting Doses"

  • Technology Synopsis: This patent describes a dose counter designed to count a dose only at or after the point the canister actually fires the medicament. It addresses the problem of user-controlled, variable stroke length by configuring the actuator and output member to have predetermined "fire" and "count" configurations, ensuring that an incremental count occurs reliably after medicament is dispensed ('156 Patent, Abstract).
  • Asserted Claims: At least Claim 1 (Compl. ¶200).
  • Accused Features: The Deva ANDA Product, which is alleged on information and belief to use a dose counter with the claimed fire and count configuration (Compl. ¶¶ 199-200).

U.S. Patent No. 10,561,808 - "Dose Counter for Inhaler Having an Anti-Reverse Rotation Actuator"

  • Technology Synopsis: This patent is directed to a dose counter with a regulator that resists unwanted rotation of the display tape if the inhaler is dropped. The regulator comprises a "wavelike engagement surface" on a stock bobbin that engages with protrusions on resilient forks of a split pin, permitting incremental unwinding but resisting sudden, excessive rotation ('808 Patent, Abstract).
  • Asserted Claims: At least Claim 1 (Compl. ¶223).
  • Accused Features: The Deva ANDA Product, which is alleged on information and belief to use a dose counter with the claimed anti-reverse rotation actuator (Compl. ¶¶ 222-223).

U.S. Patent No. 10,695,512 - "Dose Counter for Inhaler Having an Anti-Reverse Rotation Actuator"

  • Technology Synopsis: This patent describes an inhaler with an integrated dose counter that is stabilized within the main body by a heat staking assembly method. A chassis for the dose counter is mounted on the body and heat staked in position, which allows for very accurate positioning and improves counting accuracy compared to snap-fit connections ('512 Patent, col. 8:1-12).
  • Asserted Claims: At least Claim 1 (Compl. ¶246).
  • Accused Features: The Deva ANDA Product, which is alleged on information and belief to be assembled using a method that results in an infringing device (Compl. ¶¶ 245-246).

U.S. Patent No. 11,395,889 - "Dose Counter for Inhaler Having an Anti-Reverse Rotation Actuator"

  • Technology Synopsis: This patent discloses an incremental dose counter with two distinct anti-back drive features. The actuator itself acts as a first anti-back drive member when not depressed, while a second, separate anti-back drive member engages when the actuator is disengaged from the output member. This dual system provides robust protection against reverse rotation of the counter mechanism ('889 Patent, col. 22:1-12).
  • Asserted Claims: At least Claim 1 (Compl. ¶269).
  • Accused Features: The Deva ANDA Product, which is alleged on information and belief to contain a dose counter with the claimed dual anti-reverse rotation features (Compl. ¶¶ 268-269).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant Deva's proposed generic version of ProAir® HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, for which it submitted ANDA No. 21-3818 to the FDA (Compl. ¶6). The product is referred to as the "Deva ANDA Product."

Functionality and Market Context

The complaint describes the product as an "inhaler" containing the active ingredient "albuterol sulphate" (Compl. ¶¶ 69-70). Its intended function, like the branded ProAir® HFA product, is for the treatment or prevention of bronchospasm (Compl. ¶21). The complaint alleges, on information and belief, that the Deva ANDA Product will include a dose-counting mechanism to track the number of remaining doses, which is the central feature for the infringement allegations (Compl. ¶¶ 85, 108). The complaint does not provide specific technical details about the design or operation of the accused product's dose counter, stating that Plaintiffs were denied confidential access to the ANDA prior to filing suit (Compl. ¶¶ 78-80).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed mapping of accused functionalities to specific claim elements, nor does it reference any claim chart exhibits. The infringement allegations for each patent are made generally on "information and belief" pending discovery (Compl. ¶¶ 85, 108).

The narrative infringement theory for the ’712 Patent is that the Deva ANDA Product will contain a dose counter that includes a pawl with at least two radially spaced ratchet teeth to prevent reverse rotation of the counter mechanism, thereby infringing at least claim 1 (Compl. ¶¶ 84-85).

The narrative infringement theory for the ’289 Patent is that the Deva ANDA Product will be an inhaler whose main body includes an inner wall canister support formation located directly adjacent to the dose counter's actuation member. This structure allegedly serves to prevent the medicament canister from rocking during use, ensuring reliable dose counting and infringing at least claim 1 (Compl. ¶¶ 107-108).

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Factual & Evidentiary Questions: As the complaint was filed without detailed information from the ANDA, the primary point of contention will be factual: what is the actual mechanical structure and principle of operation of the dose counter in the Deva ANDA Product? The case will depend on whether discovery reveals mechanisms that correspond to the specific claim limitations of the nine asserted patents.
    • Scope Questions ('712 Patent): A key question will be whether the specific anti-reverse rotation mechanism in the accused device, once revealed, falls within the scope of a "pawl" comprising "at least two ratchet teeth" that are "radially spaced," as those terms are construed by the court.
    • Technical Questions ('289 Patent): The analysis will focus on whether the accused inhaler housing incorporates a structure that functions as an "inner wall canister support formation" and whether its placement is "directly adjacent" to the actuator, raising questions of both structural correspondence and the interpretation of spatial claim terms.

V. Key Claim Terms for Construction

  • The Term: "pawl...comprises at least two ratchet teeth...radially spaced" (from '712 Patent, Claim 1)
  • Context and Importance: This phrase captures the core of the asserted invention in the ’712 Patent. The construction of this multi-part term will be central to determining whether the defendant's mechanism for preventing reverse rotation of the counter infringes, as it defines a specific structural solution to the problem of counter unreliability.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the open-ended term "comprises" suggests the pawl could include other, unnamed components. The specification describes the function as providing "alternative positions for engaging the ratchet teeth," which may support a construction covering any structure that achieves this functional outcome ('712 Patent, col. 5:2-4).
    • Evidence for a Narrower Interpretation: The figures and detailed description show a specific embodiment where the two teeth (64, 66) are part of a single, forked member (60) ('712 Patent, Fig. 5; col. 6:53-57). A party may argue that "pawl" should be construed as being limited to such a singular component rather than separate, non-integral structures.
  • The Term: "first inner wall canister support formation located directly adjacent the actuation member" (from '289 Patent, Claim 1)
  • Context and Importance: This term defines the key structural relationship alleged to improve dose counter accuracy. The interpretation of the spatial term "directly adjacent" will be critical, as it dictates how close the support structure must be to the actuator for a finding of infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent describes the function of the support as preventing the canister from "rocking too much" ('289 Patent, col. 5:48-52). This functional language may support a broader construction where any sufficiently close support structure that achieves this anti-rocking function is covered.
    • Evidence for a Narrower Interpretation: The figures depict the support formation (144) as a rail immediately next to the aperture (74) for the actuation member, with no intervening structures ('289 Patent, Fig. 7C; col. 8:33-37). A party could argue that "directly adjacent" requires this immediate, contiguous placement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant will actively induce infringement by providing product labeling that instructs end-users to operate the Deva ANDA Product in an infringing manner (Compl. ¶¶ 87-88). It further alleges contributory infringement on the basis that the accused product is especially made for use in an infringing way and is not suitable for substantial non-infringing use (Compl. ¶89).
  • Willful Infringement: Willfulness is alleged based on Defendant's knowledge of the patents-in-suit, as evidenced by its submission of a Paragraph IV certification, allegedly without a reasonable basis for believing it would not be liable for infringement (Compl. ¶¶ 91, 114).

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

Given the procedural posture of the case, where the complaint was filed to meet a statutory deadline without access to the ANDA, the dispute will be shaped almost entirely by facts revealed in discovery. The central questions for the court are likely to be:

  • A core issue will be one of mechanical correspondence: What are the precise mechanical structures and operational principles of the dose counter within Deva's proposed generic inhaler? Specifically, does its anti-reverse rotation mechanism utilize a "pawl" with "at least two...radially spaced" teeth as claimed, or does it employ a distinct, non-infringing design?
  • A key evidentiary question will be one of structural arrangement: Does the physical design of the Deva product's canister housing include an "inner wall...support formation" that is "directly adjacent" to the dose counter's actuator? The resolution of this will depend on a factual comparison of the accused device against the claim language as construed by the court.
  • The outcome of the case may turn on the cumulative effect of multiple patented features: With nine patents asserted covering distinct but related aspects of the dose counter—from its anti-rotation pawl and canister support rails to its tape bobbin friction and assembly methods—a central question will be whether the accused product manages to avoid all of these claimed features or if it incorporates one or more of the patented solutions to achieve reliable dose counting.