DCT

1:09-cv-00087

Dey L P v. Teva Parenteral Medicines Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Dey, L.P. v. Teva Parenteral Medicines, Inc., 1:09-cv-00087, N.D. W. Va., 06/23/2009
  • Venue Allegations: Plaintiff alleges venue is proper based on Defendants' continuous and systematic contacts with West Virginia, including the sale of prescription drugs, and the potential for the accused generic product to be marketed, prescribed, and dispensed in the state.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s Perforomist® inhalation solution constitutes an act of infringement of four patents related to stable, bronchodilating compositions containing formoterol.
  • Technical Context: The technology concerns aqueous formulations of formoterol, a long-acting beta-agonist used for maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), designed to remain stable for long-term storage and administration via nebulizer.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 91-141, which seeks FDA approval to market a generic product prior to the expiration of the patents-in-suit. The complaint states that Defendants filed a Paragraph IV certification asserting that the patents are invalid, unenforceable, and/or will not be infringed.

Case Timeline

Date Event
2001-04-17 Priority Date for ’344 and ’953 Patents
2003-12-23 U.S. Patent No. 6,667,344 Issues
2004-11-09 U.S. Patent No. 6,814,953 Issues
2008-03-25 U.S. Patent No. 7,348,362 Issues
2008-12-09 U.S. Patent No. 7,462,645 Issues
2009-05-12 Defendants notify Plaintiff of ANDA No. 91-141 Submission
2009-06-23 Complaint Filed

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

U.S. Patent No. 6,667,344 - Bronchodilating Compositions and Methods

The Invention Explained

  • Problem Addressed: The patent addresses the technical challenge that formoterol, a desirable bronchodilating compound, is "not adequately stable in aqueous solutions to be formulated as liquids" for inhalation therapy (Compl. Ex. A, ’344 Patent, col. 1:21-23). Powdered formulations are noted as being more difficult to administer, particularly for young and elderly patients (Compl. Ex. A, ’344 Patent, col. 1:6-10).
  • The Patented Solution: The invention is a stable, liquid pharmaceutical composition of formoterol in a "pharmacologically suitable fluid that contains water," which is suitable for long-term storage and direct administration to a patient via nebulization (Compl. Ex. A, ’344 Patent, col. 2:22-30). The stability is achieved through control of parameters such as pH, buffer concentration, and ionic strength (Compl. Ex. A, ’344 Patent, col. 9:1-col. 10:44).
  • Technical Importance: This solution provided a means to deliver formoterol as a convenient, propellant-free nebulized liquid, improving accessibility for patient populations who may struggle with dry powder inhalers (Compl. Ex. A, ’344 Patent, col. 1:6-10).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the ’344 Patent without specifying particular claims (Compl. ¶28).
  • Independent claim 1, a representative claim, includes the following essential elements:
    • A pharmaceutical composition, comprising formoterol, or a derivative thereof
    • in a pharmacologically suitable fluid
    • wherein the composition is stable during long term storage
    • the fluid comprises water
    • and the composition is formulated at a concentration suitable for direct administration to a subject in need thereof.

U.S. Patent No. 6,814,953 - Bronchodilating Compositions and Methods

The Invention Explained

  • Problem Addressed: The ’953 Patent addresses the same technical problem as the ’344 Patent: the instability of formoterol in aqueous solutions, which complicates its formulation as a liquid for nebulization (Compl. Ex. B, ’953 Patent, col. 1:22-27).
  • The Patented Solution: The invention claims a kit that combines the stable aqueous formoterol composition with the device required for its administration. Specifically, the claims recite a kit comprising the stable formoterol composition and a nebulizer, thereby providing the complete system for patient use (Compl. Ex. B, ’953 Patent, col. 17:56-62).
  • Technical Importance: This approach packages the specific drug formulation with its intended delivery device, potentially ensuring proper administration and dosage for patients using the nebulized therapy (Compl. Ex. B, ’953 Patent, Abstract).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the ’953 Patent without specifying particular claims (Compl. ¶41).
  • Independent claim 1, a representative claim, includes the following essential elements:
    • A kit, comprising:
    • (a) a pharmaceutical composition, comprising formoterol, or a derivative thereof, in a pharmacologically suitable fluid, wherein the composition is stable during long term storage, the fluid comprises water, and the composition is formulated at a concentration suitable for direct administration to a subject in need thereof; and
    • (b) a nebulizer.

U.S. Patent No. 7,348,362 - Bronchodilating β-Agonist Compositions and Methods

  • Technology Synopsis: The ’362 patent is a continuation of the application that led to the ’953 patent and is directed to the same core technology: stable aqueous solutions of formoterol for nebulization. It claims specific formulations and methods of oral administration using these compositions.
  • Asserted Claims: The complaint alleges infringement of "one or more claims" without further specification (Compl. ¶54).
  • Accused Features: The accused features are embodied in the Defendants' ANDA product, a generic version of the formoterol inhalation solution, and the act of filing the ANDA to seek approval for its manufacture, use, and sale (Compl. ¶55).

U.S. Patent No. 7,462,645 - Bronchodilating Beta-Agonist Compositions and Methods

  • Technology Synopsis: The ’645 patent is also in the same family as the other asserted patents. It claims sterile unit dose compositions of formoterol and methods of treating bronchoconstriction by administering them.
  • Asserted Claims: The complaint alleges infringement of "one or more claims" without further specification (Compl. ¶67).
  • Accused Features: The infringement allegation centers on the Defendants' ANDA product, which is a generic formoterol inhalation solution, and the act of filing the ANDA itself (Compl. ¶68).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' generic Formoterol Fumarate Inhalation Solution, 0.02mg/2mL, referred to as the "Teva ANDA Product" (Compl. ¶20). The infringement allegation is based on the submission of Abbreviated New Drug Application (ANDA) No. 91-141 to the FDA seeking approval to market this product (Compl. ¶20).

Functionality and Market Context

The Teva ANDA Product is a generic version of Plaintiff's Perforomist® inhalation product, intended for the same therapeutic use: long-term, twice-daily administration for the maintenance treatment of bronchoconstriction in patients with COPD (Compl. ¶12, ¶18). The complaint alleges that upon FDA approval, Defendants intend to engage in the commercial manufacture, use, and sale of this product throughout the United States (Compl. ¶21). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail to construct a claim chart mapping specific features of the accused product to claim limitations. The allegations are based on the premise that the product described in ANDA No. 91-141, if approved and marketed, would be a formoterol fumarate inhalation solution that meets the limitations of the asserted claims. The summary below is based on this general allegation.

’344 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition, comprising formoterol, or a derivative thereof The Teva ANDA Product is described as a "Formoterol Fumarate Inhalation Solution" ¶20 col. 6:47-52
in a pharmacologically suitable fluid ... the fluid comprises water The accused product is an "Inhalation Solution," which is an aqueous-based formulation suitable for administration. ¶20 col. 9:1-14
wherein the composition is stable during long term storage The complaint alleges the Teva ANDA Product is a generic version of Perforomist®, implying it possesses the requisite stability for commercial distribution and use, which the patent defines as a key inventive feature. ¶12, ¶20 col. 7:30-37
formulated at a concentration suitable for direct administration The Teva ANDA Product is formulated at a specific concentration (0.02mg/2mL) intended for administration via nebulizer, consistent with the patent’s description of a composition ready for direct administration. ¶20 col. 8:16-24

’953 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A kit, comprising: (a) a pharmaceutical composition [comprising formoterol... stable during long term storage...] The ANDA filing is for a generic version of Perforomist®, which is supplied as a stable aqueous solution. The commercial sale of the Teva ANDA Product would necessarily involve packaging that constitutes a kit. ¶12, ¶20, ¶42 col. 17:57-61
and (b) a nebulizer While the complaint does not specify that Teva will co-package a nebulizer, the product's label will instruct for its use with a nebulizer. The commercial product ecosystem would thus constitute the claimed "kit" by providing the solution intended for use with a required administration device. ¶18 col. 4:1-15

Identified Points of Contention

  • Scope Questions: A primary question will be whether the product as specified in Teva's ANDA meets the claim limitation "stable during long term storage." The definition of this term, and the evidence from the ANDA regarding the proposed product's stability profile, will be central.
  • Technical Questions: For the ’953 patent, a potential point of contention is whether providing a drug solution with instructions for use with a nebulizer constitutes infringement of a claim requiring a kit that includes "(b) a nebulizer," if the nebulizer itself is not co-packaged by the defendant.

V. Key Claim Terms for Construction

The Term

"stable during long term storage"

Context and Importance

This term is the central limitation distinguishing the invention from prior art that struggled with the instability of aqueous formoterol. The outcome of the infringement analysis will likely depend heavily on whether the stability data for the proposed Teva ANDA Product falls within the scope of this term as construed by the court.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The claim language itself does not recite a specific quantitative metric for stability, which could support an argument for a more general, functional definition related to commercial viability.
  • Evidence for a Narrower Interpretation: The specification provides explicit, quantitative definitions, stating that stability refers to "greater than 80%, 85%, 90% or 95% of the initial amount of active ingredient" remaining after a specified time at a given temperature (’344 Patent, col. 7:30-37). It further provides an estimated shelf-life based on Arrhenius kinetics of "about 7.5 months at 25° C." (’344 Patent, col. 11:27-29), which may be used to argue for a specific, measurable stability requirement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Teva USA and Teva Ltd. actively induced infringement by Teva Parenteral Medicines, Inc. (TPM) by directing TPM to submit ANDA No. 91-141 (Compl. ¶35, ¶48, ¶61, ¶74). The complaint also alleges that all defendants engaged in a "cooperative venture" to submit the ANDA (Compl. ¶37, ¶50, ¶63, ¶76).
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement.

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

  • A core issue will be one of claim construction: How will the court define "stable during long term storage"? The case may turn on whether this term is construed to require meeting the specific quantitative stability metrics and shelf-life estimates disclosed in the patent specification, or if a broader, more functional definition is adopted.
  • A key evidentiary question will be one of predictive infringement: As an action under 35 U.S.C. § 271(e)(2), the dispute centers on whether the product defined in Teva’s confidential ANDA submission would infringe if commercially marketed. The analysis will depend entirely on the technical specifications, formulation details, and stability data contained within that ANDA, which will be the focus of discovery.
  • A third question concerns the scope of the kit claim in the ’953 patent: Can infringement be established by the sale of the drug product alone if its labeling and intended use require a nebulizer, or must the defendant be shown to supply both the composition and the device?