DCT

2:20-cv-10172

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

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-10172, D.N.J., 08/07/2020
  • Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation subject to personal jurisdiction within the District of New Jersey.
  • Core Dispute: Plaintiffs allege that Defendant's Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Qvar® asthma inhaler constitutes an act of infringement of six U.S. patents directed to the mechanical dose-counting technologies used in the inhaler.
  • Technical Context: The dispute centers on the mechanical components of metered-dose inhalers that track and display the number of remaining doses, a feature critical for patient safety and adherence to treatment regimens.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 211434 and its corresponding Paragraph IV certification notice letter to Plaintiffs, dated June 24, 2020. The complaint notes a pre-suit dispute regarding the terms of Defendant's Offer of Confidential Access (OCA) to its ANDA materials.

Case Timeline

Date Event
2010-05-18 Earliest Priority Date for '289, '587, '509, '510, '156, and '808 Patents
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
2020-06-24 Cipla sends Paragraph IV Notice Letter to Teva
2020-08-07 Complaint Filing Date

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

U.S. Patent No. 9,463,289 - "Dose Counters for Inhalers, Inhalers and Methods of Assembly Thereof," issued October 11, 2016.

The Invention Explained

  • Problem Addressed: The patent describes the technical challenge of creating a reliable dose counter for manually operated metered-dose inhalers. Because the user controls the actuation, the stroke length of the medicament canister is "highly variable," which can lead to miscounts (either counting a non-administered dose or failing to count an administered one), posing a safety risk to the patient (’289 Patent, col. 2:14-24).
  • The Patented Solution: The invention proposes a specific internal geometry for the inhaler's canister housing to improve counting accuracy. The solution is a structural arrangement wherein key components—a support formation on the inner wall of the housing, the actuation member for the dose counter, and the central outlet port for the medicament—all lie within a single common plane that is coincident with the inhaler's longitudinal axis (’289 Patent, col. 5:58-67). This coplanar alignment is designed to constrain the medicament canister and prevent it from rocking side-to-side during actuation, which could otherwise cause the actuation member to misfire.
  • Technical Importance: This design purports to increase the mechanical reliability of dose counters, a critical safety feature for patients managing chronic conditions like asthma.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶62).
  • Claim 1 requires, in relevant part:
    • An inhaler for metered dose inhalation, comprising a main body, a medicament canister, and a dose counter with an actuation member.
    • The canister housing has an inner wall and a "first inner wall canister support formation" extending from it.
    • The housing has a longitudinal axis X passing through its central outlet port.
    • A key limitation requires that the "inner wall canister support formation, the actuation member, and the central outlet port" are "lying in a common plane coincident with the longitudinal axis X." (Compl. ¶19).
  • The complaint does not explicitly reserve the right to assert dependent claims, though the "at least claim 1" phrasing suggests this possibility.

U.S. Patent No. 9,808,587 - "Dose Counter for Inhaler Having an Anti-Reverse Rotation Actuator," issued November 7, 2017.

The Invention Explained

  • Problem Addressed: As with the related '289 Patent, this patent addresses the problem of inaccurate counting in manually operated inhalers, which can be caused by canister movement, or "rocking," within the housing during use (’587 Patent, col. 2:14-24).
  • The Patented Solution: The invention claims a similar structural arrangement as the ’289 Patent but adds an explicit functional requirement to the claims. Claim 1 recites the same coplanar geometry of the support formation, actuation member, and outlet port, but further requires that this arrangement functions to "protect[] against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler." (’587 Patent, Claim 1). Other independent claims recite similar functional benefits, such as protecting "against dose count errors." (’587 Patent, Claim 12).
  • Technical Importance: The patent aims to secure protection not just for the specific geometric structure but also for its functional consequence—improved counting reliability by mitigating canister rock.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claims 1, 12, and 13 (Compl. ¶72).
  • Claim 1 requires the coplanar arrangement of the support formation, actuation member, and outlet port, and adds the functional limitation that this arrangement "protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister..." (Compl. ¶23).
  • Claim 12 requires a similar structure and claims that it "protects against dose count errors by reducing rocking of the medicament canister towards or away from the actuation member." (Compl. ¶24).
  • Claim 13 requires a canister housing with an "aperture formed in the inner wall through which the portion of the actuation member extends" and that the support formation extends "from the main surface of the inner wall to the aperture." (Compl. ¶25).
  • The complaint’s use of "at least" suggests the right to assert other claims is reserved.

U.S. Patent No. 10,022,509 - "Dose Counter for Inhaler Having a Bore and Shaft Arrangement," issued July 17, 2018.

  • Technology Synopsis: This patent relates to the mechanics of a tape-based dose counter. It addresses the problem of the tape unwinding undesirably, such as when an inhaler is dropped, by claiming a specific frictional engagement mechanism between the tape's stock bobbin and its support shaft, involving a "radially extending protrusion" and a "friction edge." (’509 Patent, Abstract; Compl. ¶29).
  • Asserted Claims: Claim 1 (Compl. ¶82).
  • Accused Features: The complaint alleges on information and belief that Cipla's ANDA Products will infringe claim 1, without specifying which features of the accused products meet the claim limitations (Compl. ¶82).

U.S. Patent No. 10,022,510 - "Dose Counters for Inhalers, Inhalers and Methods of Assembly Thereof," issued July 17, 2018.

  • Technology Synopsis: This patent is directed to the information presented on the dose counter's display tape. The invention claims a tape system that includes specific, distinct markings: "dosing indicia" (numbers), "tape positioning indicia," a "tape size marker," and "priming indicia," with the priming indicia being visible in the viewing window before the first use of the inhaler. (’510 Patent, Abstract; Compl. ¶33).
  • Asserted Claims: Claims 1, 10, and 20 (Compl. ¶92).
  • Accused Features: The complaint alleges on information and belief that Cipla's ANDA Products will infringe the asserted claims, without specifying which features of the accused products meet the claim limitations (Compl. ¶92).

U.S. Patent No. 10,086,156 - "Dose Counter for Inhaler and Method of Counting Doses," issued October 2, 2018.

  • Technology Synopsis: This patent describes a ratchet-based mechanical counter and focuses on the precise sequence of operations. The invention claims an arrangement where the medicament canister fires to deliver a dose before the dose counter advances to indicate a count, thereby preventing a miscount where the counter advances but no dose is delivered. This is defined by the relative positions of an actuator pawl and a datum plane during the firing sequence. (’156 Patent, Abstract; Compl. ¶39).
  • Asserted Claims: Claim 1 (Compl. ¶102).
  • Accused Features: The complaint alleges on information and belief that Cipla's ANDA Products will infringe claim 1, without specifying which features of the accused products meet the claim limitations (Compl. ¶102).

U.S. Patent No. 10,561,808 - "Dose Counter for Inhaler Having an Anti-Reverse Rotation Actuator," issued February 18, 2020.

  • Technology Synopsis: This patent describes a dose counter mechanism that includes a "regulator" designed to prevent unintended movement of the counter display. The regulator acts upon the display to control its motion in response to user actuation, ensuring it moves in reliable, incremental steps and resists movement from accidental jolts, such as being dropped. (’808 Patent, Abstract; Compl. ¶43).
  • Asserted Claims: Claim 1 (Compl. ¶112).
  • Accused Features: The complaint alleges on information and belief that Cipla's ANDA Products will infringe claim 1, without specifying which features of the accused products meet the claim limitations (Compl. ¶112).

III. The Accused Instrumentality

Product Identification

  • The accused products are Cipla's proposed generic "0.04 MG/INH and 0.08 MG/INH Beclomethasone Dipropionate Metered Aerosol Inhalation Products" ("Cipla's ANDA Products"), for which Cipla seeks FDA approval via ANDA No. 211434 (Compl. ¶¶1, 5).

Functionality and Market Context

  • The complaint describes the accused products as a "metered aerosol inhalation for oral use" containing the active drug beclomethasone dipropionate, intended as a generic equivalent to Plaintiffs' Qvar® brand inhalers (Compl. ¶¶1, 47, 49). As this is a pre-launch ANDA action, the complaint does not provide technical details on the functionality of the accused device's dose counter. The infringement allegations are made on "information and belief" based on Cipla's ANDA filing (Compl. ¶62). The complaint states that Defendant's non-infringement contentions in its Paragraph IV notice letter lack sufficient detail for Plaintiffs to evaluate them (Compl. ¶58).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed, element-by-element mapping of the accused products to the asserted claims. The allegations are made on "information and belief" that the products described in Cipla's ANDA will infringe upon approval and commercialization.

'9,463,289 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An inhaler for metered dose inhalation, the inhaler comprising: a main body having a canister housing... The complaint alleges, without specific detail, that Cipla's ANDA Products are inhalers comprising a main body with a canister housing. ¶62 col. 5:29-30
a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port... The complaint alleges that Cipla's ANDA Products contain a moveable medicament canister retained in a central outlet port. ¶62 col. 5:31-35
a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister... The complaint alleges that Cipla's ANDA Products include a dose counter operated by the movement of the canister. ¶62 col. 5:36-40
wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall... The complaint alleges that the canister housing in Cipla's ANDA Products has an inner wall and an inwardly extending support formation. ¶62 col. 5:41-44
wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port, the inner wall canister support formation, the actuation member, and the central outlet port lying in a common plane coincident with the longitudinal axis X. The complaint alleges that in Cipla's ANDA Products, the specified components are arranged in a common plane coincident with the longitudinal axis. ¶62 col. 5:45-51

'9,808,587 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An inhaler for metered dose inhalation, the inhaler comprising: a main body having a canister housing... a medicament canister... a dose counter having an actuation member... The complaint alleges, without specific detail, that Cipla's ANDA Products are inhalers with these fundamental components. ¶72 col. 6:22-34
wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall... The complaint alleges that the canister housing in Cipla's ANDA Products has an inner wall and an inwardly extending support formation. ¶72 col. 6:35-38
wherein the first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane... such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister... The complaint alleges that in Cipla's ANDA Products, the specified components are arranged in a common plane and that this arrangement performs the function of protecting against unwanted actuation by reducing canister rocking. ¶72 col. 6:42-49

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: A central dispute for the '289 and '587 patents may concern the scope of the phrase "lying in a common plane coincident with the longitudinal axis X." The court will need to determine how much, if any, deviation from perfect mathematical planarity is permissible under this term, which may be informed by manufacturing tolerances and the patent's specification.
  • Technical Questions: For the '587 Patent, a key factual question will be whether the structure in the accused device actually performs the claimed function of "protect[ing] against unwanted actuation ... by reducing rocking." This raises the possibility of a dispute over whether any observed stability in the accused device is achieved through the claimed coplanar arrangement or by other, non-infringing means.

V. Key Claim Terms for Construction

  • The Term: "lying in a common plane coincident with the longitudinal axis X" (from '289 Patent, Claim 1 and '587 Patent, Claim 1).
  • Context and Importance: This term defines the core geometric innovation of the lead patents. Infringement will depend heavily on whether the components in Defendant's device meet this precise spatial relationship. Practitioners may focus on this term because its construction will determine whether minor, real-world deviations from perfect alignment fall inside or outside the scope of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification uses terms like "generally U-shaped" and "substantially perpendicular" when describing certain components, which could suggest that absolute geometric precision is not required throughout the invention and that "coincident" should be interpreted to accommodate normal manufacturing variations (’289 Patent, col. 5:35-38).
    • Evidence for a Narrower Interpretation: The claim language "lying in," "common plane," and "coincident with" is precise geometric language. Figures in the patent, such as Figure 7D, depict a clear, linear alignment of the relevant features (’289 Patent, Fig. 7D). A party might argue these specific disclosures and the precise claim language limit the scope to a strictly coplanar arrangement.

VI. Other Allegations

  • Indirect Infringement: Plaintiffs allege both induced and contributory infringement for all patents-in-suit. The allegations are based on the assertion that Defendant's proposed product labeling will instruct end-users on an infringing use of the device and that the device is "especially made or adapted for use in infringing the... patent" and is "not suitable for substantial non-infringing use" (e.g., Compl. ¶¶65-66).
  • Willful Infringement: The complaint alleges that Defendant "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. ¶68). This allegation is predicated on Defendant's filing of a Paragraph IV certification, which itself demonstrates knowledge of the patents at issue.

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

  • A core issue will be one of geometric scope: How precisely must the internal components of the accused inhaler be aligned to be considered "lying in a common plane coincident with the longitudinal axis"? The case may turn on whether this claim term permits for typical manufacturing tolerances or demands a stricter, more mathematically exact arrangement.
  • A related evidentiary question will be one of functional causality: For claims containing functional language, such as in the '587 patent, does the accused product's alleged coplanar structure actually perform the claimed function of "protect[ing] against unwanted actuation ... by reducing rocking," or is any observed stability attributable to other, unclaimed design features?
  • A threshold procedural question will be the sufficiency of the infringement allegations: Given that the complaint makes only conclusory allegations of infringement on "information and belief," an early focus of the litigation will be on discovery into Defendant's ANDA to determine whether Plaintiffs can substantiate their claims on an element-by-element basis for each of the six asserted patents.