DCT

2:24-cv-00909

Teva Branded Pharmaceutical Products R&D Inc v. Cipla USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-00909, D.N.J., 02/16/2024
  • Venue Allegations: Venue is alleged to be proper for Cipla USA, Inc. based on its principal place of business in New Jersey, and for Cipla Ltd. based on its subjection to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs' QVAR RediHaler® product constitutes an act of infringement of twelve U.S. patents related to metered-dose inhaler devices and methods of use.
  • Technical Context: The technology concerns breath-actuated metered-dose inhalers used for the prophylactic treatment of asthma, a significant pharmaceutical market involving complex mechanical device patents.
  • Key Procedural History: The complaint notes prior litigation between the same parties involving four of the patents-in-suit (U.S. Patent Nos. 10,022,509; 10,022,510; 10,086,156; and 10,561,808), which proceeded to a final judgment in the District of New Jersey and is now pending appeal at the U.S. Court of Appeals for the Federal Circuit. Two other patents-in-suit (U.S. Patent Nos. 8,132,712 and 10,561,808) are also noted as being asserted in a separate pending case against an unrelated defendant.

Case Timeline

Date Event
2007-04-02 Priority Date for U.S. Patent No. 8,132,712
2009-06-09 Priority Date for U.S. Patent No. 8,931,476
2010-05-18 Priority Date for U.S. Patent Nos. 10,022,509; 10,022,510; 10,086,156; 10,561,808; 10,695,512; and 11,395,889
2012-03-13 Issue Date of U.S. Patent No. 8,132,712
2015-01-13 Issue Date of U.S. Patent No. 8,931,476
2017-02-14 Priority Date for U.S. Patent Nos. 11,395,888; 11,559,637; and 11,583,643
2018-01-26 Priority Date for U.S. Patent No. 10,792,447
2018-07-17 Issue Date of U.S. Patent No. 10,022,509
2018-07-17 Issue Date of U.S. Patent No. 10,022,510
2018-10-02 Issue Date of U.S. Patent No. 10,086,156
2020-02-18 Issue Date of U.S. Patent No. 10,561,808
2020-06-30 Issue Date of U.S. Patent No. 10,695,512
2020-10-06 Issue Date of U.S. Patent No. 10,792,447
2022-07-26 Issue Date of U.S. Patent No. 11,395,888
2022-07-26 Issue Date of U.S. Patent No. 11,395,889
2023-01-24 Issue Date of U.S. Patent No. 11,559,637
2023-02-21 Issue Date of U.S. Patent No. 11,583,643
2024-01-04 Date of Defendant's Notice Letter to Plaintiff
2024-02-16 Complaint Filing Date

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's background describes the difficulty for users to determine the amount of medicament remaining in an inhaler, which can be hazardous if the device becomes unreliable for dosing (’712 Patent, col. 1:52-58). Conventional dose counters can fail to provide a reliable count, for example, if the device is dropped (’712 Patent, col. 2:10-12).
  • The Patented Solution: The invention provides a dose counter with a pawl designed to prevent reverse rotation of the counter's rotary gear. The key feature is that the pawl itself has "at least two ratchet teeth" that are radially spaced, ensuring that one of the pawl's teeth engages the gear's teeth after each step-wise motion, thereby preventing miscounting even with variations in actuator stroke length (’712 Patent, Abstract; col. 4:45-51).
  • Technical Importance: This mechanical design aims to improve the reliability and safety of metered-dose inhalers by ensuring a more accurate count of remaining doses.

Key Claims at a Glance

  • The complaint asserts independent claim 1 and use claims 18 and 19 (Compl. ¶104).
  • The essential elements of independent claim 1 include:
    • A dose counter for a metered-dose inhaler, comprising an actuator, a rotary gear, and a driver.
    • The rotary gear comprises a wheel with a plurality of ratchet teeth.
    • A pawl is included to prevent reverse rotation of the rotary gear.
    • A display is coupled to the rotary gear.
    • Crucially, the pawl comprises at least two ratchet teeth, each for engaging the wheel's ratchet teeth.
    • The at least two ratchet teeth on the pawl are radially spaced such that one of them engages the wheel's teeth following each step-wise motion.

U.S. Patent No. 8,931,476 - “Inhaler”

The Invention Explained

  • Problem Addressed: The patent background explains that air inlets on breath-actuated inhalers can be accidentally covered or occluded by a patient's hand or finger during use. This blockage can prevent or influence the necessary airflow, potentially causing the breath-actuated mechanism to malfunction (’476 Patent, col. 1:58-67).
  • The Patented Solution: The invention is an inhaler housing with a specially designed air inlet. The inlet consists of an array of apertures where the opening for each aperture "extends in two different planes." This geometry ensures that if a patient's finger covers one plane of the opening, a "void space" is created, allowing air to still enter the aperture through the uncovered plane. The design also includes raised formations between apertures to further limit or prevent blockage (’476 Patent, Abstract; col. 2:38-49).
  • Technical Importance: This design enhances the reliability of breath-actuated inhalers by maintaining consistent airflow for actuation, even with variations in how a patient holds the device.

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 17 (Compl. ¶114).
  • The essential elements of independent claim 1 include:
    • An inhaler with a housing defining an air flow path.
    • The air inlet comprises an array of elongate apertures.
    • The opening of each aperture extends in two different planes.
    • This two-plane structure provides an alternate air flow path through a void space if one plane is covered.
    • A raised formation is provided on the outer surface between adjacent apertures to limit or prevent a covered opening.

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

  • Technology Synopsis: The patent describes a dose counter designed for reliability, particularly if dropped. It features a display tape on a stock bobbin that rotates on a support shaft, with a unique protrusion on one creating resilient frictional engagement with the other to regulate the unwinding of the tape (’509 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶124).
  • Accused Features: The complaint alleges that Cipla’s ANDA Product includes a dose counter with a bore and shaft arrangement that infringes the patent (Compl. ¶124).

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

  • Technology Synopsis: This patent covers an inhaler with a dose counter tape system that includes specific markings for user guidance. The tape has "dosing indicia" (numbers), "tape positioning indicia," and "priming indicia," which are visible before first use to guide the user through the initial setup of the device (’510 Patent, Abstract).
  • Asserted Claims: Independent claims 1, 10, and 20 (Compl. ¶134).
  • Accused Features: The complaint accuses the dose counter and tape marking system of Cipla’s ANDA Product (Compl. ¶134).

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

  • Technology Synopsis: This patent describes a dose counter mechanism designed to prevent counting a dose that has not actually been delivered. The actuator and ratchet wheel are arranged such that during a "canister fire sequence," the medicament fires before the dose counter reaches its "count configuration," ensuring only successfully administered doses are registered (’156 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶144).
  • Accused Features: The complaint targets the firing and counting sequence of the dose counter in Cipla’s ANDA Product (Compl. ¶144).

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

  • Technology Synopsis: The patent addresses the problem of dose counters being affected by being dropped. It discloses a "regulator" that acts upon the counter display (e.g., a tape) to regulate its motion into discrete "incremental movements," thereby preventing unwanted motion and maintaining an accurate count (’808 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶154).
  • Accused Features: The complaint targets the dose counter's display drive system and motion regulation features in Cipla’s ANDA Product (Compl. ¶154).

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

  • Technology Synopsis: This patent focuses on the assembly and stability of the dose counter within the inhaler body. The invention claims an inhaler where the dose counter's chassis is mounted to the body via a "heat staked" pin or aperture, creating a highly stable and precisely positioned assembly (’512 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶164).
  • Accused Features: The complaint alleges infringement by the method of mounting and stabilizing the dose counter chassis in Cipla’s ANDA Product (Compl. ¶164).

U.S. Patent No. 10,792,447 - “Breath Actuated Inhaler”

  • Technology Synopsis: The patent relates to the performance of a breath-actuated inhaler's pneumatic system. It describes a "pneumatic force holding unit" that retains the canister actuation force with very little degradation over time, specifically claiming that the force reduces by less than about 6% over a period of 5 minutes in its prepared configuration (’447 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 10 (Compl. ¶174).
  • Accused Features: The complaint targets the performance and stability of the pneumatic force holding system in Cipla’s ANDA Product (Compl. ¶174).

U.S. Patent No. 11,395,888 - “Inhalers and Related Methods”

  • Technology Synopsis: This patent specifies operational parameters for a breath-actuated inhaler. It claims a drive arranged to apply a specific firing force (greater than 35 N and less than 60 N) and a canister adapted to move a specific distance (between 1 and 4 mm), in combination with a vacuum chamber system that assists in regulating the firing sequence (’888 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 25 (Compl. ¶184).
  • Accused Features: The complaint accuses the specific force, travel distance, and vacuum system dynamics of Cipla’s ANDA Product (Compl. ¶184).

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

  • Technology Synopsis: This patent discloses a dose counter with a dual anti-reverse motion mechanism. The primary actuator itself is configured to act as an "anti-back drive member" when not depressed, and a second, separate anti-back member is also provided to restrict motion when the actuator is disengaged (’889 Patent, Abstract).
  • Asserted Claims: Independent claim 1 (Compl. ¶194).
  • Accused Features: The anti-reverse rotation mechanisms of the dose counter in Cipla’s ANDA Product are accused of infringement (Compl. ¶194).

U.S. Patent No. 11,559,637 - “Inhalers and Related Methods”

  • Technology Synopsis: The patent describes a specific locking system for securing the cap housing to the main body of a breath-actuated inhaler. The system uses "helical threads having non-overlapping and distinct thread segments" combined with a cooperating lock member system to achieve a "snap lock" in the locked position (’637 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 28 (Compl. ¶204).
  • Accused Features: The complaint targets the mechanism for attaching the cap housing to the main body in Cipla’s ANDA Product (Compl. ¶204).

U.S. Patent No. 11,583,643 - “Inhalers and Related Methods”

  • Technology Synopsis: This patent claims a method of metering inhalable substances to avoid inaccurate dosing caused by air trapped in the metering chamber. The method involves operating the inhaler to allow atmospheric air to enter the metering chamber for a period of time (e.g., 2 minutes to 24 hours), then orienting the device so the interior reservoir is above the chamber, allowing liquid to displace the air before administering the dose (’643 Patent, Abstract).
  • Asserted Claims: Method claims 1, 35, 36, 37, 38, 39, and 40 (Compl. ¶214).
  • Accused Features: The complaint alleges that use of Cipla's ANDA Product as directed by its proposed labeling will infringe these method claims (Compl. ¶216).

III. The Accused Instrumentality

Product Identification

  • The accused product is Cipla’s generic version of beclomethasone dipropionate inhalation aerosol, 40 mcg, for which Cipla submitted ANDA No. 219000 to the FDA (Compl. ¶1, ¶7). The product is intended as a generic equivalent to Plaintiffs' QVAR RediHaler® product for the maintenance treatment of asthma (Compl. ¶25).

Functionality and Market Context

  • The complaint alleges, upon information and belief, that Cipla’s ANDA Product is a breath-actuated metered dose inhaler (Compl. ¶25, ¶83). The complaint does not provide specific technical details regarding the design or operation of Cipla's product. Instead, it alleges that Cipla’s Paragraph IV notice letter and accompanying "Detailed Statement" contain "unsupported and unexplained assertions" of noninfringement without providing sufficient information to evaluate those assertions (Compl. ¶100). The infringement allegations are therefore based on the premise that a generic equivalent to the QVAR RediHaler® will necessarily practice the patented technologies.

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'712 Patent Infringement Allegations

The complaint does not provide sufficient detail for a side-by-side comparison of the claim elements to specific features of the accused product. The allegations are made on "information and belief" that the product, as described in the ANDA, will infringe (Compl. ¶104).

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A dose counter for a metered-dose inhaler, the counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator The complaint alleges on information and belief that Cipla's ANDA Product contains a dose counter with these fundamental components. ¶104 col. 7:29-35
the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery The ANDA Product is alleged to include a dose counter with a rotary gear implemented as a wheel with ratchet teeth. ¶104 col. 8:1-4
a pawl to prevent reverse rotation of the rotary gear The ANDA Product's dose counter is alleged to include a pawl for preventing reverse rotation. ¶104 col. 8:5-6
wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear The ANDA Product is alleged to have a pawl with the claimed two-tooth structure. ¶104 col. 8:13-16
the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear. The pawl in the ANDA Product is alleged to have its teeth radially spaced to ensure positive engagement after each actuation. ¶104 col. 8:17-22
  • Identified Points of Contention:
    • Factual/Evidentiary Question: The central dispute will be entirely factual, centering on the specific mechanical design of the pawl in Cipla’s product. The key question for the court will be whether discovery and expert analysis reveal that the accused pawl literally possesses "at least two ratchet teeth" and whether those teeth are "radially spaced" in a way that performs the claimed function of ensuring engagement after each step-wise motion.

'476 Patent Infringement Allegations

As with the '712 patent, the complaint does not provide specific details of the accused product's structure, alleging infringement on "information and belief" (Compl. ¶114).

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An inhaler for delivering medicament to a patient, the inhaler comprising a housing for holding the medicament and having an air inlet means and a medicament delivery port which together define an air flow path The complaint alleges Cipla's ANDA product is an inhaler with these fundamental components. ¶114 col. 10:23-28
wherein the air inlet means comprises an array of elongate apertures formed in the housing The ANDA Product's housing is alleged to feature an air inlet made of an array of elongate apertures. ¶114 col. 10:29-31
wherein the opening of each aperture extends in two different planes such that, if at least a part of the opening is covered...a void space is created...to provide an air flow path The openings of the apertures in the ANDA Product are alleged to have a multi-planar geometry that creates an alternative airflow path when partially obstructed. ¶114 col. 10:35-43
wherein a raised formation is provided in the outer surface of the housing between adjacent apertures to either limit or prevent a covered opening. The ANDA Product's housing is alleged to include raised formations between the air inlet apertures. ¶114 col. 10:44-47
  • Identified Points of Contention:
    • Scope and Factual Question: The analysis will focus on the physical geometry of the air inlets on Cipla's device. Key questions will be: (1) What is the scope of the term "extends in two different planes" as used in the patent? and (2) Does the physical structure of the accused product's air inlet openings meet that definition? This will likely require expert testimony and analysis of the physical product or its design specifications.

V. Key Claim Terms for Construction

For the '712 Patent

  • The Term: "radially spaced"
  • Context and Importance: This term defines the structural relationship between the "at least two ratchet teeth" on the pawl, which is the core of the asserted inventive concept for preventing miscounting. The infringement analysis for claim 1 will hinge on whether the teeth on the accused pawl are arranged in a manner that falls within the scope of this term.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself does not require a specific distance or angle, only that the teeth are spaced in a way that allows one to engage after each step. This may support an argument that any non-identical placement of the teeth along the radius of the pawl's rotation meets the limitation.
    • Evidence for a Narrower Interpretation: The specification states that this spacing allows the pawl to provide "alternative positions for engaging the ratchet teeth" to accommodate manufacturing tolerances (’712 Patent, col. 5:1-4). This purpose-driven language may support a narrower construction requiring a spacing sufficient to actually compensate for such tolerances in a meaningful way, not just any de minimis separation.

For the '476 Patent

  • The Term: "extends in two different planes"
  • Context and Importance: This phrase describes the essential geometric feature of the air inlet openings designed to prevent occlusion. Whether the accused product infringes will depend directly on how this structural limitation is construed and applied to the physical device.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: An argument could be made that any continuously curved surface technically "extends in two different planes" and would meet the limitation literally.
    • Evidence for a Narrower Interpretation: Asserted independent claim 17, which relates to a similar embodiment, explicitly requires the two planes to define "an angle of at least 45 degrees to each other" (’476 Patent, col. 11:1-4). This provides strong intrinsic evidence that the patentee contemplated a distinct angular relationship, not merely a curve, which could be used to argue for a narrower construction of the term in claim 1 as well.

VI. Other Allegations

  • Indirect Infringement: For each patent, the complaint alleges active inducement of infringement on the basis that Cipla "plans and intends to" have its ANDA Product used in an infringing manner upon approval, and that Cipla's proposed product labeling will direct end-users to perform the infringing acts (e.g., Compl. ¶107, ¶117). Contributory infringement is alleged on the basis that Cipla knows its product is "especially made or adapted for use in infringing" the patents and is "not suitable for substantial non-infringing use" (e.g., Compl. ¶108, ¶118).
  • Willful Infringement: The complaint alleges that Cipla has acted with "full knowledge" of the patents-in-suit and "without a reasonable basis for believing that it would not be liable for infringing" (e.g., Compl. ¶110, ¶120). Knowledge is predicated on the patents' listing in the FDA's Orange Book and Cipla's submission of the Paragraph IV certification notice letter (e.g., Compl. ¶235). The prayer for relief seeks a judgment of willful infringement and enhanced damages (Compl. p. 72, ¶(g)).

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

  • A primary issue will be one of evidentiary proof: As is typical in ANDA litigation initiated before the generic product is marketed, the complaint is based on information and belief. The case will turn on factual questions revealed in discovery, namely whether the specific mechanical components and operational characteristics of Cipla's device—from the geometry of its air inlets to the functional timing of its dose counter—fall within the scope of the claims of Teva's twelve patents.
  • A second core issue will be one of claim scope and interpretation: With a dozen patents covering discrete mechanical features and methods, disputes over the meaning of key claim terms will be central. For example, can the term "extends in two different planes" (’476 Patent) be interpreted to read on the specific geometry of the accused inhaler's air vents, and do the instructions for use in Cipla's proposed labeling direct a method of use that meets the steps of the "metering" claims (’643 Patent)?
  • A final question will be the impact of prior litigation: Given that the same parties have previously litigated four of the asserted patents through a final judgment at the district court level, a threshold issue may be the preclusive effect of any claim constructions or findings from that earlier case, especially in light of the pending appeal at the Federal Circuit.