Bausch Health Ireland Ltd v. Glenmark Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Bausch Health Ireland Limited (Ireland) and Assertio Therapeutics Inc. (Delaware)
  • Defendant: Glenmark Pharmaceuticals Limited (India)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 1:19-cv-12045, D.N.J., 05/01/2019
• Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendant has substantial and continuous contacts with the state, markets and sells pharmaceutical products to its residents, and will collaborate with its New Jersey-based subsidiary, Glenmark Generics Inc., USA, for the marketing and sale of the accused products. As a foreign defendant, Glenmark may also be sued in any judicial district.
• Core Dispute: Plaintiffs allege 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 four patents related to controlled-release oral dosage forms designed for gastric retention.
• Technical Context: The technology concerns pharmaceutical formulations that swell or are otherwise designed to remain in the stomach for an extended period, allowing for controlled release and improved absorption of certain drugs.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a Paragraph IV Notice Letter from Defendant, in which Defendant certified that the patents-in-suit are invalid, unenforceable, or will not be infringed by its proposed generic product. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay of FDA approval for Defendant's ANDA. An Inter Partes Review (IPR) proceeding resulted in the cancellation of several claims of the ’340 Patent, including independent claim 1.

Case Timeline

Date	Event
2000-06-20	’962 Patent Priority Date
2001-10-25	’340 Patent Priority Date
2002-02-21	’987 and ’692 Patents Priority Date
2002-12-03	’962 Patent Issue Date
2004-04-20	’340 Patent Issue Date
2010-08-04	’987 Patent Issue Date
2012-12-04	’692 Patent Issue Date
2018-07-26	’340 Patent IPR Certificate Issued, Cancelling Claims
2019-03-18	Plaintiffs Receive Glenmark's Paragraph IV Notice Letter
2019-05-01	Complaint Filing Date

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

U.S. Patent No. 6,488,962 - "Tablet Shapes To Enhance Gastric Retention of Swellable Controlled-Release Oral Dosage Forms" (Issued Dec. 3, 2002)

The Invention Explained

• Problem Addressed: The patent’s background section explains that conventional swellable tablets, even after expanding, can still pass through the stomach's pyloric sphincter if they become oriented with their longest dimension aligned with the pyloric axis, thereby negating the intended gastric retention effect (Compl. ¶16; ’962 Patent, col. 3:1-19).
• The Patented Solution: The invention proposes a specific, non-circular and non-spherical tablet shape (such as an oval or parallelogram) with two orthogonal axes of unequal length. The configuration is designed so that the shorter axis, which is initially small enough for easy swallowing, swells within an hour to a length of at least 1.2 cm. This dimension is large enough to prevent passage through the pylorus, regardless of the tablet's orientation, thus ensuring more reliable gastric retention (’962 Patent, col. 3:20-44; Abstract).
• Technical Importance: This geometric approach sought to improve the reliability of gastric-retentive drug delivery systems, a key challenge for maximizing the bioavailability and therapeutic effect of drugs preferentially absorbed in the upper gastrointestinal tract (’962 Patent, col. 1:11-25).

Key Claims at a Glance

• The complaint asserts at least one claim, and for analysis purposes, independent claim 1 is representative (Compl. ¶29).
• Essential elements of claim 1 include:
  • A controlled-release oral drug dosage form comprising a solid monolithic matrix containing a drug.
  • The matrix must be non-circular with first and second orthogonal axes of unequal length.
  • The matrix must swell in an unrestricted manner upon imbibing water.
  • The longer axis must have a maximum length of 3.0 cm in its unswollen state.
  • The shorter axis must achieve a minimum length of 1.2 cm within one hour of immersion in water.
  • The matrix shape, when projected onto a plane, must be an oval or a parallelogram.
• The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶30).

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 identifies challenges with single-polymer matrices for gastric retention. Using only poly(ethylene oxide) (PEO) can raise regulatory concerns at the high concentrations needed for sufficient swelling, while polymers like hydroxypropyl methylcellulose (HPMC) may not swell enough and can lead to an undesirable initial burst of drug release (’340 Patent, col. 3:10-31).
• The Patented Solution: The invention discloses a matrix combining PEO and HPMC. This blend leverages the superior swelling of PEO for gastric retention while using the erosion characteristics of HPMC to modulate the drug release rate and ensure the tablet clears the GI tract predictably. This combination allows for effective performance with lower, potentially safer, levels of PEO (’340 Patent, col. 3:32-40; Abstract). The specification describes the polymers as having "competing yet complementary actions" (’340 Patent, col. 4:49-50).
• Technical Importance: This polymer blend provided a method to achieve the dual objectives of gastric retention and controlled release with improved reproducibility and a formulation that could potentially navigate regulatory concerns associated with high concentrations of PEO (’340 Patent, col. 4:54-65).

Key Claims at a Glance

• The complaint asserts at least one claim (Compl. ¶36). Following an IPR, independent claim 1 was cancelled. Independent claim 6 is a representative surviving independent claim.
• Essential elements of claim 6 include:
  • A controlled-release tablet with a drug dispersed in a solid monolithic matrix.
  • The matrix comprises a combination of poly(ethylene oxide) and hydroxypropyl methylcellulose.
  • The weight ratio of the polymers causes the matrix to swell to a size large enough for gastric retention.
  • The drug has a low solubility in water (less than one part drug per ten parts water).
  • The PEO has a specific viscosity average molecular weight (100,000 to 5,000,000 daltons).
  • The HPMC has a specific viscosity (1,000 to 100,000 centipoise).
• The complaint reserves the right to assert other claims (Compl. ¶37).

U.S. Patent No. 7,780,987 - "Controlled Release Dosage Forms" (Issued Aug. 4, 2010)

Technology Synopsis

This patent addresses long-term stability issues associated with aqueous polymeric coatings used for controlled-release dosage forms, such as those made with Eudragit® NE30D (’987 Patent, col. 2:48-56). The invention provides a monolithic coating composition containing a neutral ester copolymer, a specific poly glycol with a melting point above 55°C (e.g., PEG 8000), and other excipients. Stability is achieved by curing the coated dosage form at a temperature at or above the poly glycol's melting point (’987 Patent, col. 4:22-34; Abstract).

Asserted Claims

The complaint asserts "at least one claim" of the patent (Compl. ¶43).

Accused Features

The complaint alleges that Defendant’s ANDA Products are controlled-release formulations that will necessarily infringe by having a composition and being manufactured in a way that meets the claim limitations (Compl. ¶43).

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

Technology Synopsis

As a continuation-in-part of the application for the ’987 Patent, this invention also relates to stable, monolithic coatings for controlled-release dosage forms. It places additional focus on formulations for high-dose drugs and achieving specific in-vivo performance criteria, such as a Tmax of 6-12 hours (’692 Patent, col. 73:60-74:3). The claimed invention combines a drug core containing a superdisintegrant (e.g., crospovidone) with a specific coating that includes a neutral ester copolymer and a poly glycol, which is then cured at a high temperature to ensure stable and reliable gastric retention and drug release (’692 Patent, col. 74:4-23; Abstract).

Asserted Claims

The complaint asserts "at least one claim" of the patent (Compl. ¶50).

Accused Features

The complaint alleges that Defendant’s ANDA Products, designed to be bioequivalent to Glumetza®, will infringe the claims covering the specific core formulation, coating composition, and resulting pharmacokinetic profile (Compl. ¶50).

III. The Accused Instrumentality

Product Identification

Defendant Glenmark’s generic versions of Plaintiffs' Glumetza® 500 mg and 1000 mg products, as described in Abbreviated New Drug Application No. 212969 ("Glenmark ANDA Products") (Compl. ¶1, ¶24).

Functionality and Market Context

The complaint alleges that the Glenmark ANDA Products are generic pharmaceutical formulations intended to be bioequivalent to the branded Glumetza® products (Compl. ¶26). As this is an ANDA case at the pleading stage, the complaint does not contain specific technical details of the accused products' formulation or manufacturing process, which are confidential within the ANDA filing. The infringement action is predicated on the legal fiction under 35 U.S.C. § 271(e)(2)(A) that filing an ANDA for a drug claimed in a patent is an act of infringement (Compl. ¶6).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed, element-by-element infringement analysis or claim charts for the asserted patents. The allegations are general, stating on information and belief that Glenmark's submission of ANDA No. 212969 for its generic Glumetza® products constitutes an act of infringement of at least one claim of each of the patents-in-suit (Compl. ¶¶ 29, 36, 43, 50). The core of the infringement allegation is that to be bioequivalent to Glumetza®, Glenmark's products will necessarily have to practice the claimed inventions.

• Identified Points of Contention:
  • Scope Questions: A primary dispute will concern whether the specific formulation detailed in Glenmark's confidential ANDA falls within the scope of the asserted claims. For the ’962 Patent, this may involve whether the accused tablet has the claimed non-circular shape and swells in the prescribed manner. For the ’340 Patent, the question will be whether the formulation uses the claimed combination of PEO and HPMC with the specified molecular weights and viscosities to achieve gastric retention. For the ’987 and ’692 Patents, the dispute may turn on whether the accused product's coating contains the claimed poly glycol and whether its manufacturing process includes the claimed curing step.
  • Technical Questions: A central evidentiary question will be what Glenmark’s confidential ANDA filing reveals about its product's precise formulation and manufacturing process. Discovery will be required to determine if there is a technical match between that formulation and every limitation of the asserted claims. For instance, does the generic formulation achieve bioequivalence through a different, non-infringing technical pathway?

V. Key Claim Terms for Construction

’962 Patent

• The Term: "solid monolithic matrix" (from claim 1)
• Context and Importance: This term defines the fundamental structure of the dosage form. The dispute may center on whether the accused product constitutes a single, uniform "monolithic" structure as claimed, or if it could be characterized as a multi-component or layered system that falls outside the claim's scope.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification frequently uses terms like "tablet" and "dosage form" interchangeably with "matrix," suggesting the term could be construed broadly to cover any single-unit solid dosage form (’962 Patent, col. 3:9-11).
  • Evidence for a Narrower Interpretation: The detailed description specifies that the dosage form is "preferably a polymeric matrix in which the drug is dispersed," which could support a narrower construction limited to structures where the drug is physically distributed throughout a polymer (’962 Patent, col. 3:51-53).

’340 Patent

• The Term: "a weight ratio that causes said matrix to swell upon contact with gastric fluid to a size large enough to provide gastric retention" (from claim 6)
• Context and Importance: This functional language links the composition (the polymer ratio) to a required outcome (swelling for retention). Infringement analysis will depend on whether this limitation requires not only the presence of the claimed polymers but also proof that their specific ratio is the reason the tablet swells sufficiently for gastric retention.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: Plaintiffs may argue that any product containing the claimed polymers in a ratio that results in a tablet swelling to a size generally understood in the art to be retained in the stomach (e.g., >1 cm) meets this limitation.
  • Evidence for a Narrower Interpretation: A defendant may argue that the term is limited to polymer ratios that produce swelling profiles similar to those described in the patent's specific examples and figures (’340 Patent, FIGS. 2, 5). The cancellation of other claims during IPR may also be cited to support a narrower construction of the surviving claims.

VI. Other Allegations

• Indirect Infringement: The complaint includes standard allegations that if Glenmark commercially manufactures, uses, or sells the ANDA products, it will induce and contribute to infringement by others (e.g., patients and doctors) (Compl. ¶¶ 30, 37, 44, 51).
• Willful Infringement: The complaint does not use the word "willful" but alleges for each count that the case is "exceptional" and seeks an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶ 34, 41, 48, 55). The factual basis for pre-suit knowledge is Glenmark's filing of the Paragraph IV certification, which required it to analyze the patents-in-suit (Compl. ¶25).

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

• A central factual question, typical of ANDA litigation, will be one of formulation equivalence: Does the specific combination of active ingredients, polymers, excipients, and coatings detailed in Glenmark's confidential ANDA filing read on every limitation of the asserted claims, particularly the geometric and swelling requirements of the ’962 patent, the specific polymer blends of the ’340 patent, and the coating-and-curing process of the ’987 and ’692 patents?
• A key issue of claim construction and infringement will be one of functional performance: For claims reciting functional outcomes (e.g., a ratio that "causes" swelling for retention), what is the evidentiary standard to prove that Glenmark’s bioequivalent product, if sold, would necessarily perform these specific patented functions, and can Glenmark argue it achieves bioequivalence via a technically distinct, non-infringing mechanism?