DCT

1:19-cv-14474

Bausch Health Ireland Ltd v. Apotex Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-14474, D.N.J., 06/28/2019
  • Venue Allegations: Venue is alleged to be proper because the Defendant is a foreign corporation and may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the diabetes drug Glumetza® constitutes an act of infringement of two patents related to controlled-release pharmaceutical coatings.
  • Technical Context: The technology concerns specialized polymer coatings for oral drug tablets that control the release of the active ingredient over an extended period, enabling stable, once-daily dosage regimens.
  • Key Procedural History: This is a Hatch-Waxman action initiated after Plaintiff received a Paragraph IV Notice Letter from Defendant, dated May 14, 2019, which asserted that the patents-in-suit are invalid, unenforceable, or will not be infringed by Defendant's proposed generic product.

Case Timeline

Date Event
2002-02-21 Priority Date for ’987 and ’692 Patents
2010-08-24 U.S. Patent No. 7,780,987 Issued
2012-12-04 U.S. Patent No. 8,323,692 Issued
2019-05-14 Plaintiff Received Apotex Paragraph IV Notice Letter
2019-06-28 Complaint Filed

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

U.S. Patent No. 7,780,987 - "Controlled Release Dosage Forms," issued August 24, 2010 (’987 Patent)

The Invention Explained

  • Problem Addressed: The patent describes challenges in using aqueous polymeric dispersions for controlled-release drug coatings. Specifically, it notes that a common dispersion, Eudragit® NE30D, has a low glass transition temperature (Tg), which can cause coatings to become tacky and agglomerate during manufacturing if exposed to high heat. Achieving a stable, non-tacky final product often required impractically long curing times. (Compl., Ex. 1, ’987 Patent, col. 2:40-56).
  • The Patented Solution: The invention proposes a novel coating composition that combines the aqueous dispersion of a neutral ester copolymer (like Eudragit® NE30D) with a polyglycol having a melting point above 55°C (e.g., polyethylene glycol 8000). The coated dosage form is then cured at a temperature at or above the polyglycol's melting point. This process, contrary to prior art expectations, was found to produce a stable controlled-release film with a short curing time. (Compl., Ex. 1, ’987 Patent, Abstract; col. 3:27-34).
  • Technical Importance: This technology provided a method to make the manufacturing of aqueous-based controlled-release coatings more efficient and reliable, circumventing the safety and environmental concerns associated with organic solvents while overcoming the stability and processing issues of prior aqueous systems. (Compl., Ex. 1, ’987 Patent, col. 2:37-44).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim, and practitioners would anticipate that the primary focus will be on the independent claims (Compl. ¶25).
  • Independent Claim 1 requires, in relevant part:
    • A pharmaceutical oral dosage form coated with a stable controlled release monolithic coating.
    • The coating is formed by a process of coating and then curing at a temperature of at least 55° C.
    • The coating composition "consists essentially of" a neutral ester copolymer, a polyethylene glycol (in an amount of 0.1% to 3% by weight), and at least one other hydrophilic or pharmaceutically acceptable excipient.

U.S. Patent No. 8,323,692 - "Controlled Release Dosage Forms," issued December 4, 2012 (’692 Patent)

The Invention Explained

  • Problem Addressed: The ’692 Patent addresses the same technical challenges as its parent, the ’987 Patent: achieving stable, efficiently manufactured controlled-release coatings using aqueous polymer dispersions without the drawbacks of heat sensitivity or long curing times. (Compl., Ex. 2, ’692 Patent, col. 2:36-50).
  • The Patented Solution: The invention employs the same core technology as the ’987 Patent—a combination of a neutral ester copolymer and a high-melting-point polyglycol, cured at an elevated temperature. However, the claims of the ’692 Patent are directed more specifically to a metformin-based dosage form with particular excipients and performance characteristics. (Compl., Ex. 2, ’692 Patent, Abstract; col. 3:1-43).
  • Technical Importance: This patent refines the general coating technology for a specific therapeutic application (metformin for diabetes), claiming a formulation that achieves specific pharmacokinetic and in-vitro release profiles desirable for once-daily administration. (Compl., Ex. 2, ’692 Patent, col. 30:35-43).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶32).
  • Independent Claim 1 is significantly more detailed than in the ’987 Patent and requires, in relevant part:
    • A controlled release oral dosage form with a core comprising metformin hydrochloride and a coating surrounding the core.
    • The core must contain "cross-linked polyvinylpyrrolidone" as a "first pharmaceutically acceptable excipient."
    • The dosage form must exhibit a specific pharmacokinetic profile (Tmax of 6-12 hours) and/or a specific in-vitro dissolution profile (not more than 37% released at 2 hours and not more than 61% at 4 hours).
    • The coating must be formed from a composition comprising a neutral ester copolymer, a polyglycol with a melting point above 55° C, and other excipients, and must be cured.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant Apotex's proposed generic version of Plaintiff's Glumetza® 1000 mg product, as described in ANDA No. 213356 ("Apotex ANDA Products") (Compl. ¶1, ¶20).

Functionality and Market Context

The complaint alleges that the Apotex ANDA Products are controlled-release oral dosage forms containing metformin hydrochloride (Compl. ¶20, ¶22). The ANDA is alleged to rely on the Glumetza® New Drug Application and contain data demonstrating bioequivalence between the Apotex ANDA Products and Glumetza® (Compl. ¶22). The act of infringement alleged is the filing of the ANDA itself, which seeks FDA approval for commercial manufacture and sale of the generic product in the United States prior to the expiration of the patents-in-suit (Compl. ¶25, ¶32).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed infringement theory or claim chart mapping elements of the accused product to the patent claims. The infringement allegation is based on the statutory act of filing an ANDA for a product that, if approved and marketed, would allegedly infringe the patents-in-suit, an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶25, ¶32). As such, a claim chart summary cannot be constructed from the complaint. No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • ’987 Patent: The central infringement question will be compositional. The analysis will focus on whether the coating of the Apotex ANDA Product contains the three required components of claim 1 (neutral ester copolymer, polyethylene glycol within the specified range, and another excipient). A significant point of contention may arise from the "consists essentially of" claim language, raising the question of whether any additional, unlisted ingredients in the Apotex coating materially alter the fundamental characteristics of the invention, thereby avoiding infringement.
    • ’692 Patent: The infringement analysis for this patent will be multifaceted. Key questions will include:
      • Core Composition: Does the core of the Apotex product contain "cross-linked polyvinylpyrrolidone" as required by claim 1? The absence of this specific excipient could be dispositive of non-infringement.
      • Functional Performance: Does the Apotex product, when tested, meet the specific Tmax and/or in-vitro dissolution rate limitations recited in claim 1? This will be an evidence-intensive inquiry likely involving competing expert testing and analysis.

V. Key Claim Terms for Construction

  • Term (’987 Patent, Claim 1): "consists essentially of"

    • Context and Importance: This term strictly limits the ingredients of the coating composition to those listed and any others that do not materially affect the "basic and novel properties" of the invention. Practitioners may focus on this term because it is a frequent and potent basis for a non-infringement defense. The determination of what constitutes a "material" effect will be central to defining the claim's scope.
    • Intrinsic Evidence for a Broader Interpretation: The specification discloses numerous additional excipients that can be included in the coating, such as anti-tacking agents, emulsifiers, and colorants, suggesting these may not be "material" to the core inventive concept. (Compl., Ex. 1, ’987 Patent, col. 9:22-45).
    • Intrinsic Evidence for a Narrower Interpretation: The patent emphasizes that the invention's novelty lies in achieving stability with short curing times, in contrast to prior art problems. (Compl., Ex. 1, ’987 Patent, col. 3:11-21). An argument could be made that any unlisted ingredient that affects stability, tackiness, or required curing time would be a "material" alteration.

  • Term (’692 Patent, Claim 1): "provides a Tmax of said metformin hydrochloride of from about 6 hours to about 12 hours"

    • Context and Importance: This is a functional limitation defining the invention by its pharmacokinetic result in the human body. The construction of this term, and how Tmax is measured and averaged across a patient population, will be critical for determining whether the Apotex product's demonstrated bioequivalence meets this specific claimed profile.
    • Intrinsic Evidence for Interpretation: The patent includes extensive clinical data showing pharmacokinetic results from its own tested formulations, which provide a clear benchmark for the claimed Tmax range. (Compl., Ex. 2, ’692 Patent, Tables 7 & 8). Parties will likely debate whether an accused product must replicate these results precisely or merely fall within the general range under standard bioequivalence testing protocols.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Apotex will induce and contribute to infringement if its ANDA is approved and it subsequently markets the product (Compl. ¶26, ¶33). In an ANDA case, the primary evidence for inducement is the proposed drug label included in the ANDA, which would instruct physicians and patients to use the drug in an allegedly infringing manner.
  • Willful Infringement: The complaint does not use the term "willful" but does allege that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶30, ¶37). The allegation is based on Apotex’s alleged knowledge of the patents via its Paragraph IV certification letter (Compl. ¶21).

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

  1. A core issue will be one of compositional scope: Can Plaintiff prove that the formulation of the Apotex generic product falls within the boundaries of the "consisting essentially of" language in the ’987 patent, or does the generic contain unlisted components that materially alter the invention's properties and thus avoid infringement?
  2. A key evidentiary question will be one of functional and structural equivalence: For the ’692 patent, does the Apotex product contain the specific "cross-linked polyvinylpyrrolidone" excipient in its core, and does it demonstrably produce the specific pharmacokinetic (Tmax) and in-vitro dissolution profiles required by the claims? This will likely devolve into a data-driven "battle of the experts."