DCT

2:23-cv-00054

IBSA Institut Biochimique SA v. Accord Healthcare Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-00054, D.N.J., 01/05/2023
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant intends to market and sell generic drugs in the district, has engaged in systematic and continuous contacts with the state, and has previously consented to jurisdiction and venue in the district in prior litigation.
  • Core Dispute: Plaintiffs allege that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs’ Tirosint®-SOL product constitutes an act of infringement of two patents related to stable, alcohol-free liquid formulations of levothyroxine.
  • Technical Context: The technology concerns pharmaceutical formulations for levothyroxine (T4), a thyroid hormone that is inherently unstable in liquid solutions and prone to degradation into a more potent hormone (T3), creating dosing challenges.
  • Key Procedural History: This is a Hatch-Waxman action filed in response to a November 22, 2022 notice letter from Defendant, which contained a Paragraph IV certification asserting that Plaintiffs' patents are invalid, unenforceable, or will not be infringed by the proposed generic product. The asserted patents are listed in the FDA’s "Orange Book" for Plaintiffs’ commercial product, Tirosint®-SOL. U.S. Patent No. 11,096,913 is a continuation of the application that led to U.S. Patent No. 10,537,538.

Case Timeline

Date Event
2016-10-18 Earliest Priority Date for ’538 and ’913 Patents
2020-01-21 U.S. Patent No. 10,537,538 Issues
2021-08-24 U.S. Patent No. 11,096,913 Issues
2022-11-22 Defendant Sends Paragraph IV Notice Letter
2023-01-05 Complaint Filed

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

U.S. Patent No. 10,537,538 - High-Stability Packaged Solutions of T4 Thyroid Hormone, issued January 21, 2020

The Invention Explained

  • Problem Addressed: The patent describes the challenge that liquid solutions of the thyroid hormone T4 are unstable and tend to prematurely convert into T3, a hormone that is 4-5 times more potent (’538 Patent, col. 2:15-26). This conversion creates dosing inaccuracies and risks patient over-dosing (’538 Patent, col. 2:26-29). Additionally, prior art solutions using alcohol to improve solubility still exhibited significant instability (’538 Patent, col. 2:36-45).
  • The Patented Solution: The invention claims to solve this problem by formulating T4 in an alcohol-free, water-glycerol solution and packaging it in a specific multi-barrier system (’538 Patent, Abstract). This system involves a primary plastic container holding the solution, which is then placed inside a secondary sealed sachet made of laminated films, separating the drug from the external environment and significantly reducing the degradation of T4 to T3 (’538 Patent, col. 2:51-61).
  • Technical Importance: The invention provides a stable, ready-to-use oral liquid formulation of a critical hormone, enabling more reliable and precise dosing than previously available liquid or solid forms (’538 Patent, col. 2:1-4).

Key Claims at a Glance

  • The complaint asserts claims 1-8 of the ’538 patent (Compl. ¶22).
  • Independent Claim 1 recites:
    • A ready-to-use pharmaceutical preparation of T4 thyroid hormone packaged in a single dose container.
    • The container is pre-filled with a liquid pharmaceutical composition consisting essentially of T4 thyroid hormone dissolved in an alcohol-free solution of 85% glycerol in water, and optionally T3 in an amount less than 2.5%.
    • The single dose container is a one-component LDPE plastic container.
    • The container is placed in a sealed sachet consisting of laminated films made of specified materials (e.g., polyethylene, aluminum, polyethylene terephthalate).

U.S. Patent No. 11,096,913 - High-Stability Packaged Solutions of T4 Thyroid Hormone, issued August 24, 2021

The Invention Explained

  • Problem Addressed: Similar to its parent patent, the ’913 patent addresses the instability of T4 in liquid solutions, particularly its premature conversion to the more potent T3 hormone, which leads to unpredictable dosing (’913 Patent, col. 2:20-33).
  • The Patented Solution: The invention is an alcohol-free and preservative-free liquid formulation of T4 in an 85% glycerol-in-water solution (’913 Patent, col. 12:63-65). The formulation is contained in a single-dose plastic container, which provides stability without requiring the specific two-part sachet system recited in the ’538 patent’s independent claim (’913 Patent, col. 13:2).
  • Technical Importance: This approach offers a stable oral liquid T4 formulation that avoids both alcohol and preservatives, which may be desirable for certain patient populations, while ensuring dose accuracy (’913 Patent, col. 5:64-66).

Key Claims at a Glance

  • The complaint asserts claims 1-9 of the ’913 patent (Compl. ¶29).
  • Independent Claim 1 recites:
    • A pharmaceutical preparation of T4 thyroid hormone comprising a container pre-filled with a liquid pharmaceutical composition.
    • The composition consists essentially of T4 thyroid hormone dissolved in an alcohol-free and preservative-free solution of 85% glycerol in water, and optionally T3 in an amount of less than 2.5%.
    • The container is a single dose plastic container.

III. The Accused Instrumentality

  • Product Identification: Accord Healthcare, Inc.’s proposed generic version of levothyroxine sodium oral solution, as identified in ANDA No. 218008 (“Accord’s Product”) (Compl. ¶¶11, 17).
  • Functionality and Market Context: Accord’s Product is an oral solution of levothyroxine sodium intended as a generic equivalent to Plaintiffs' Tirosint®-SOL (Compl. ¶1). The ANDA contains data intended to demonstrate the bioequivalence of Accord's Product to Tirosint®-SOL and seeks approval for the same dosage strengths (Compl. ¶¶17-18). If approved, the product would compete directly with Plaintiffs' branded drug (Compl. ¶1). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’538 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A ready-to-use pharmaceutical preparation of T4 thyroid hormone packaged in a single dose container which is pre-filled with a liquid pharmaceutical composition consisting essentially of: T4 thyroid hormone dissolved in an alcohol-free solution of 85% glycerol in water... Accord’s Product is alleged to be a single-dose, pre-filled oral solution of levothyroxine sodium formulated as a generic equivalent to Tirosint®-SOL, which is an alcohol-free glycerol/water solution. ¶17, ¶18, ¶22 col. 11:25-33
...and optionally T3 thyroid hormone in an amount of less than 2.5%... As a bioequivalent generic, Accord's Product is alleged to meet the same stability profile as the patented invention, including the limitation on T3 impurity levels. ¶18, ¶22 col. 11:33-35
...wherein the single dose container is a one-component LDPE plastic container... The complaint alleges that Accord’s Product will infringe this limitation but does not provide specific details about the materials used for the primary container. ¶22 col. 11:36-37
...placed in a sealed sachet consisting of laminated films made of a plurality of different materials... The complaint alleges infringement of this claim element without specifying the packaging configuration of Accord's Product. ¶22 col. 11:37-43
  • Identified Points of Contention:
    • Technical Questions: A primary factual dispute will concern the specific packaging of Accord’s Product. Infringement of claim 1 of the ’538 Patent hinges on whether Accord uses both a "one-component LDPE plastic container" and an outer "sealed sachet" made of the specified materials. The complaint does not contain facts detailing Accord's proposed packaging.

’913 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical preparation of T4 thyroid hormone comprising a container pre-filled with a liquid pharmaceutical composition consisting essentially of: T4 thyroid hormone dissolved in an alcohol-free and preservative-free solution of 85% glycerol in water... Accord’s Product is alleged to be a pre-filled, single-dose solution that, as a generic of the preservative-free Tirosint®-SOL, is formulated in an alcohol-free and preservative-free glycerol/water solution. ¶17, ¶18, ¶29 col. 12:60-65
...and optionally T3 thyroid hormone in an amount of less than 2.5%... Accord's Product is alleged to be bioequivalent and therefore to meet the claimed stability and T3 impurity limits. ¶18, ¶29 col. 12:65-13:1
...wherein the container is a single dose plastic container. The complaint alleges Accord’s Product is a single-dose formulation and will be packaged in a single-dose plastic container. ¶17, ¶29 col. 13:2
  • Identified Points of Contention:
    • Technical Questions: A key question is whether Accord’s formulation is genuinely "preservative-free". The presence of any substance that could be characterized as a preservative, even if it has other functions, could form the basis of a non-infringement defense.
    • Scope Questions: The term "single dose plastic container" is broader than the packaging claimed in the ’538 Patent. The litigation may explore the intended scope of this term and whether it covers the specific container chosen by Accord.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of" (’538 Claim 1, ’913 Claim 1)

    • Context and Importance: This transitional phrase is present in the independent claims of both asserted patents. Its construction is critical because infringement will depend on whether any unlisted ingredients in Accord's formulation materially alter the "basic and novel properties" of the claimed invention—namely, the stability of T4 in an alcohol-free (and, for the ’913 patent, preservative-free) solution.
    • Intrinsic Evidence for a Broader Interpretation: A plaintiff may argue that the core inventive concept is the stable, alcohol-free glycerol-water system, and that the presence of common, inert pharmaceutical excipients that do not affect this stability falls within the claim scope (’538 Patent, col. 2:49-54).
    • Intrinsic Evidence for a Narrower Interpretation: A defendant may point to the specification's emphasis on the simple formulation and the stability achieved without other agents, arguing that any additional unlisted component (e.g., a buffer or chelating agent) inherently alters the formulation's characteristics beyond what is permitted by the claims (’913 Patent, col. 5:55-66).

  • The Term: "preservative-free" (’913 Claim 1)

    • Context and Importance: This negative limitation is central to the infringement analysis for the ’913 patent. A dispute may arise over the definition of a "preservative" and whether any component in Accord's formulation, regardless of its primary purpose, has a preservative effect.
    • Intrinsic Evidence for a Broader Interpretation: The patent does not provide an explicit definition. A plaintiff would likely argue for the common understanding of antimicrobial agents added to prevent spoilage, and that the term does not exclude substances with incidental, secondary preservative effects.
    • Intrinsic Evidence for a Narrower Interpretation: The specification highlights that the "preservative-free formulation is particularly indicated for chronic use", suggesting a very high standard of purity (’913 Patent, col. 5:64-66). A defendant could argue that any substance with a known preservative function, even a weak one, places the formulation outside the claim's scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Accord is liable for contributory infringement, stating that Accord’s Product is "especially adapted for a use that infringes" and that there is "no substantial non-infringing use" for the product (Compl. ¶¶23, 30). The basis for inducement would be the product's labeling and instructions, which would allegedly encourage direct infringement by end-users.
  • Willful Infringement: The complaint does not explicitly allege willfulness. However, it requests a finding that the case is "exceptional" and an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶¶26, 33). The factual basis for this request is not detailed in the complaint.

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

  • A core issue will be one of factual correspondence: Does the specific formulation and packaging of Accord's proposed generic product, as detailed in its confidential ANDA, align with the claim limitations of the asserted patents? This will turn on whether the product is packaged in the two-part "LDPE container" and "sealed sachet" system of the ’538 patent and whether its formulation is truly "preservative-free" as required by the ’913 patent.
  • A key legal battle will be over claim scope: How will the court interpret "consisting essentially of"? The viability of the infringement case may depend on whether unlisted excipients in Accord’s product are found to materially alter the stability of the T4 hormone, thereby placing the product outside the bounds of the claims.
  • Finally, the case presents a question of patent strategy: The broader claim language of the continuation ’913 patent (reciting only a "single dose plastic container") relative to the narrower parent ’538 patent suggests an attempt to capture variations in generic packaging. A central question is whether this broadening is sufficient to read on Accord's chosen container, even if the more specific packaging system of the ’538 patent is not used.