DCT

1:19-cv-14480

Bausch Health Ireland Ltd v. Emcure Pharma Ltd

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-14480, D.N.J., 06/28/2019
  • Venue Allegations: Plaintiff alleges venue is proper as Defendant is a foreign corporation, which may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's Glumetza® product constitutes an act of infringement of three patents related to controlled-release oral drug formulations.
  • Technical Context: The technology concerns gastric-retentive and controlled-release pharmaceutical tablets, which are designed to improve drug absorption and efficacy by remaining in the stomach for an extended period.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 213241 with a Paragraph IV certification, asserting the patents-in-suit are invalid or not infringed. Notably, U.S. Patent No. 6,723,340 was subject to an Inter Partes Review (IPR2014-00652), which resulted in the cancellation of independent claim 1 and claims 3-5 and 10-13, a fact that may significantly influence arguments regarding the patent's remaining claims.

Case Timeline

Date Event
2001-10-25 ’340 Patent Priority Date
2002-02-21 ’987 and ’692 Patents Priority Date
2004-04-20 ’340 Patent Issue Date
2010-08-24 ’987 Patent Issue Date
2012-12-04 ’692 Patent Issue Date
2014-04-17 IPR filed against ’340 Patent
2018-07-26 IPR Certificate issues, cancelling claims of ’340 Patent
2019-05-16 Plaintiff receives Defendant's Paragraph IV Notice Letter
2019-06-28 Complaint Filing Date

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

U.S. Patent No. 6,723,340 - Optimal Polymer Mixtures for Gastric Retentive Tablets (Issued Apr. 20, 2004)

The Invention Explained

  • Problem Addressed: The patent’s background describes the challenge of creating oral dosage forms that remain in the stomach to ensure prolonged and controlled drug release. It notes that while some polymers like poly(ethylene oxide) (PEO) can swell to achieve gastric retention, high doses may raise regulatory concerns. (ʼ340 Patent, col. 1:5-21; col. 3:10-24).
  • The Patented Solution: The invention proposes a solid tablet matrix combining PEO with hydroxypropyl methylcellulose (HPMC). This combination is described as achieving the necessary swelling for gastric retention (a key property of PEO) while using HPMC to modulate the erosion rate and control drug release, thereby allowing for a lower and potentially safer quantity of PEO. (ʼ340 Patent, Abstract; col. 3:31-58).
  • Technical Importance: This approach provided a method to balance the competing goals of gastric retention and controlled erosion in a single tablet, while addressing potential regulatory hurdles associated with high concentrations of certain polymers. (ʼ340 Patent, col. 3:59-65).

Key Claims at a Glance

  • The complaint asserts "at least one claim" of the patent (Compl. ¶30). While independent claim 1 was cancelled in an Inter Partes Review, independent claim 6 survived.
  • Independent Claim 6 (surviving):
    • A controlled-release tablet comprising a solid monolithic matrix with a drug dispersed therein.
    • The matrix comprises a combination of poly(ethylene oxide) and hydroxypropyl methylcellulose at a weight ratio that causes the matrix to swell to a size large enough for gastric retention.
    • The drug has a low water solubility (less than one part drug per ten parts water).
    • The poly(ethylene oxide) has a specified viscosity average molecular weight (100,000 to 5,000,000 daltons).
    • The hydroxypropyl methylcellulose has a specified viscosity (1,000 to 100,000 centipoise).

U.S. Patent No. 7,780,987 - Controlled Release Dosage Forms (Issued Aug. 24, 2010)

The Invention Explained

  • Problem Addressed: The patent background explains that aqueous polymeric dispersions used for drug coatings, such as Eudragit® NE30D, are often sensitive to heat. Their low glass transition temperature can cause tackiness and agglomeration during manufacturing and may lead to unstable drug release profiles over time, often addressed with impractically long curing periods. (ʼ987 Patent, col. 2:38-56).
  • The Patented Solution: The invention adds a polyglycol with a high melting point (greater than 55° C), such as polyethylene glycol (PEG) 8000, to the aqueous polymer dispersion. The coated dosage form is then cured at a temperature at or above the polyglycol's melting point. This process is described as creating a stable, controlled-release coating with short, efficient curing times, contrary to prior art teachings that advised against such high temperatures. (ʼ987 Patent, Abstract; col. 3:21-48; col. 10:46-53).
  • Technical Importance: The invention offered a manufacturing process to overcome the inherent instability and processing challenges of certain aqueous polymer coatings, enabling their use for stable, controlled-release applications with commercially viable production times. (ʼ987 Patent, col. 3:15-21).

Key Claims at a Glance

  • The complaint asserts "at least one claim" of the patent (Compl. ¶37).
  • Independent Claim 1:
    • A pharmaceutical oral dosage form coated with a stable controlled release monolithic coating.
    • The coating is applied via a process that includes curing the coated form at a temperature of at least 55° C.
    • The coating composition "consists essentially of" a neutral ester copolymer (1-35% by weight), a specific polyethylene glycol (0.1-3% by weight), a hydrophilic agent, and a pharmaceutically acceptable excipient.

U.S. Patent No. 8,323,692 - Controlled Release Dosage Forms (Issued Dec. 4, 2012)

Technology Synopsis

As a continuation-in-part of the '987 patent application, this patent claims a controlled-release oral dosage form specifically for metformin hydrochloride. The invention combines a core containing metformin and a superdisintegrant (e.g., cross-linked polyvinylpyrrolidone) with the stable monolithic coating technology from the parent patent, which uses a high-temperature cure of an aqueous dispersion containing a high-melting-point polyglycol. This structure is designed to achieve gastric retention and a specific in-vivo drug absorption profile (Tmax). (Compl. ¶43; ’692 Patent, Abstract; col. 11:1-20).

Asserted Claims

The complaint asserts "at least one claim" (Compl. ¶44). Independent claims include 1 and 20.

Accused Features

The complaint alleges that the formulation and release characteristics of Defendant's generic metformin products, designed to be bioequivalent to Glumetza®, infringe the patent. (Compl. ¶¶ 25, 27, 44).

III. The Accused Instrumentality

Product Identification

The "Emcure ANDA Products" are the accused instrumentalities, identified as the 500 mg and 1000 mg generic versions of Glumetza® tablets described in Defendant's ANDA No. 213241. (Compl. ¶¶ 1, 25).

Functionality and Market Context

The complaint does not describe the specific formulation or technical features of the accused products. It alleges that the ANDA filing is an act of infringement under 35 U.S.C. § 271(e)(2)(A) because the products, if approved and marketed, would infringe the patents-in-suit. (Compl. ¶¶ 30, 37, 44). The ANDA is said to contain data demonstrating bioequivalence to the branded Glumetza® product, which is a treatment for type 2 diabetes. (Compl. ¶27).
No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed narrative theory of infringement mapping specific features of the accused products to the elements of the asserted claims. It makes general allegations that the submission of the ANDA constitutes infringement of at least one claim of each patent-in-suit. (Compl. ¶¶ 30, 37, 44).

  • Identified Points of Contention (’340 Patent):

    • Validity: A primary point of contention will be the validity of the surviving claims. Defendant will likely argue that the reasoning supporting the cancellation of claim 1 in the prior Inter Partes Review also renders the surviving independent claim 6 invalid.
    • Technical Questions: Infringement of claim 6 will depend on whether the active ingredient in Glumetza®, metformin hydrochloride, meets the claim’s solubility requirement of being "less than one part of said drug per ten parts of water." The precise formulation of the accused generic, particularly its use of PEO and HPMC within the claimed property ranges, will be a central factual dispute.

  • Identified Points of Contention (’987 Patent):

    • Scope Questions: Analysis will focus on whether the accused product's coating "consists essentially of" the claimed components. The presence of any unlisted excipients in the generic formulation could be argued by Defendant to materially alter the coating's properties, thereby taking the product outside the claim's scope.
    • Technical Questions: Infringement of claim 1, a product-by-process claim, will require evidence that Defendant’s manufacturing method includes the step of "curing the coated oral dosage form at a temperature of at least 55° C." This information regarding the accused manufacturing process will be a key subject of discovery.

V. Key Claim Terms for Construction

  • Term (’340 Patent, Claim 6): "a weight ratio that causes said matrix to swell...to a size large enough to provide gastric retention"

    • Context and Importance: This functional language is central to infringement, as it defines the required performance of the polymer matrix. Practitioners may focus on this term because its potential ambiguity could be a basis for a non-infringement argument or an indefiniteness challenge if the patent fails to provide an objective standard for what constitutes "large enough."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the general goal of gastric retention to prolong drug delivery in the upper GI tract, without tying the term to a specific numerical percentage of swelling. (ʼ340 Patent, col. 2:7-11).
      • Evidence for a Narrower Interpretation: The specification discloses specific embodiments that swell to "at least about 90% of its maximum weight or size within 8 hours." A party could argue that the claim term should be construed in light of these examples. (ʼ340 Patent, col. 4:46-49).

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

    • Context and Importance: This transitional phrase defines the scope of the claimed coating composition. It permits the presence of unlisted ingredients that do not materially affect the invention's basic and novel properties but excludes those that do. The entire infringement analysis for the coating may depend on the interpretation of this term and the identification of those properties.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent suggests the key novel property is achieving a stable release profile via a short, high-temperature cure. (ʼ987 Patent, col. 3:15-21). A party could argue that only additives interfering with this specific outcome are excluded.
      • Evidence for a Narrower Interpretation: The background emphasizes the sensitivity of Eudragit® NE30D to additives and processing conditions. (ʼ987 Patent, col. 2:38-56). A party could argue that because of this sensitivity, a wider range of unlisted excipients should be considered to materially affect the coating’s properties, thus narrowing the claim's scope.

VI. Other Allegations

  • Indirect Infringement: The complaint includes prospective allegations of induced and contributory infringement should Defendant engage in commercial activity post-approval. (Compl. ¶¶ 31, 38, 45). These allegations are not supported by specific facts at this stage and are secondary to the primary statutory infringement claim based on the ANDA filing.
  • Willful Infringement: Willfulness is not explicitly pleaded. However, the complaint alleges each count arises from an "exceptional" case and seeks attorneys' fees under 35 U.S.C. § 285. (Compl. ¶¶ 35, 42, 49). The basis for this allegation is not detailed but may relate to Defendant's alleged knowledge of the patents via their Orange Book listing for Glumetza®.

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

  1. Patent Viability: A threshold question for the ’340 Patent will be one of validity: can the surviving claims withstand challenges based on the same prior art or reasoning that led to the cancellation of claim 1 during Inter Partes Review?
  2. Definitional Scope: For the ’987 and ’692 patents, a core issue will be one of compositional scope: can the term "consists essentially of" be construed to read on the accused generic's specific coating formulation, or do additional excipients in the generic product materially alter its properties in a way that avoids infringement?
  3. Process Equivalence: A key evidentiary question for the ’987 and ’692 patents will be one of manufacturing proof: what evidence will emerge from discovery regarding the accused manufacturing process, specifically whether it employs the claimed high-temperature curing step essential for infringement of the asserted product-by-process claims?