Bausch Health Ireland Ltd v. Granules India Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Bausch Health Ireland Limited (Ireland) and Assertio Therapeutics Inc. (Delaware)
  • Defendant: Granules India Ltd. (India)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 1:19-cv-14489, D.N.J., 06/28/2019
• Venue Allegations: Venue is alleged to be proper as to Defendant, a foreign corporation, which may be sued in any judicial district.
• Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the diabetes drug Glumetza® constitutes an act of infringement of three U.S. patents related to controlled-release and gastric-retentive pharmaceutical formulations.
• Technical Context: The technology concerns oral drug delivery systems designed to prolong the release of a drug and retain it in the stomach, enhancing therapeutic effect and patient compliance for widely-prescribed medications.
• Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant’s Paragraph IV certification, which asserted that the patents-in-suit are invalid, unenforceable, or would not be infringed by its proposed generic product. Notably, an inter partes review (IPR) proceeding (IPR2014-00652) resulted in the cancellation of several claims of U.S. Patent No. 6,723,340, including independent claim 1.

Case Timeline

Date	Event
2001-10-25	U.S. Patent No. 6,723,340 Priority Date
2002-02-21	U.S. Patent Nos. 7,780,987 & 8,323,692 Priority Date
2004-04-20	U.S. Patent No. 6,723,340 Issue Date
2010-08-24	U.S. Patent No. 7,780,987 Issue Date
2012-12-04	U.S. Patent No. 8,323,692 Issue Date
2018-07-26	Inter Partes Review Certificate issues, cancelling claims of the ’340 Patent
2019-05-21	Date of Defendant’s Paragraph IV notice letter to Plaintiffs
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"

The Invention Explained

• Problem Addressed: The patent addresses the challenge of creating an oral drug tablet that can both remain in the stomach for an extended period (gastric retention) and release its active ingredient in a controlled manner (Compl. ¶ 18; ’340 Patent, col. 1:5-12). Certain polymers like poly(ethylene oxide) (PEO) swell effectively to achieve retention but may present regulatory concerns at high doses, while other polymers like hydroxypropyl methylcellulose (HPMC) offer more predictable erosion but swell less effectively (’340 Patent, col. 3:10-29).
• The Patented Solution: The invention is a drug tablet formed from a solid matrix that combines PEO and HPMC. This combination is described as providing "unexpectedly beneficial performance" by balancing the robust swelling of PEO for gastric retention with the controlled erosion of HPMC, thereby achieving reliable, prolonged drug release while using less PEO (’340 Patent, Abstract; col. 3:31-40).
• Technical Importance: This approach provided a method to formulate gastric-retentive, controlled-release dosage forms with improved performance characteristics and a potentially more favorable regulatory profile compared to formulations relying solely on high concentrations of PEO (’340 Patent, col. 3:56-65).

Key Claims at a Glance

• The complaint asserts infringement of "at least one claim" of the ’340 Patent (Compl. ¶ 30). Independent claim 1 was cancelled in an inter partes review proceeding. Independent claim 6, which remains, is presented below.
• Essential elements of independent claim 6:
  • 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 to provide gastric retention.
  • The drug has a solubility in water that is less than one part of said drug per ten parts of water.
  • The poly(ethylene oxide) has a specific viscosity average molecular weight (100,000 to 5,000,000 daltons).
  • The hydroxypropyl methylcellulose has a specific viscosity (1,000 to 100,000 centipoise).
• The complaint reserves the right to assert additional claims (Compl. ¶ 31).

U.S. Patent No. 7,780,987 - "Controlled Release Dosage Forms"

The Invention Explained

• Problem Addressed: The patent identifies stability and manufacturing issues with aqueous-based polymer coatings used for controlled-release drugs (Compl. ¶ 20). Specifically, coatings made from dispersions like Eudragit® NE30D are sensitive to high temperatures and often require long, inefficient "curing" times to achieve a stable drug release profile, complicating manufacturing (’987 Patent, col. 2:36-56).
• Patented Solution: The invention is a monolithic coating for oral dosage forms comprising an aqueous dispersion of a neutral ester copolymer (e.g., Eudragit® NE30D), a polyglycol with a melting point above 55°C (e.g., PEG 8000), and other excipients. The key inventive step is curing the coated drug form at a temperature at or above the melting point of the polyglycol. This process is described as creating a stable controlled-release profile with short, efficient curing times (’987 Patent, Abstract; col. 3:21-34).
• Technical Importance: This method offered a way to overcome the known stability and processing time limitations of certain aqueous polymer coatings, enabling more efficient and reliable manufacturing of controlled-release oral pharmaceuticals (’987 Patent, col. 3:11-20).

Key Claims at a Glance

• The complaint asserts infringement of "at least one claim" of the ’987 Patent (Compl. ¶ 37). Independent claim 1 is representative.
• Essential elements of independent claim 1:
  • A pharmaceutical oral dosage form coated with a stable controlled release monolithic coating.
  • The coating is applied via 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 specific polyethylene glycol, a hydrophilic agent, and a pharmaceutically acceptable excipient.
• The complaint reserves the right to assert additional claims (Compl. ¶ 38).

U.S. Patent No. 8,323,692 - "Controlled Release Dosage Forms"

Technology Synopsis

This patent, related to the ’987 patent, claims a controlled-release tablet for metformin hydrochloride. The technology involves a core containing metformin and a superdisintegrant, which is surrounded by the stable monolithic coating described in the ’987 patent—a neutral ester copolymer and a polyglycol, cured at a temperature at or above the polyglycol’s melting point (’692 Patent, Abstract; Claim 1). (Compl. ¶ 21).

Asserted Claims

The complaint alleges infringement of "at least one claim" (Compl. ¶ 44).

Accused Features

The allegations target Defendant's proposed generic metformin hydrochloride product, which is alleged to be a controlled-release formulation that infringes by incorporating the claimed core and coating technology (Compl. ¶¶ 25, 44).

III. The Accused Instrumentality

Product Identification

The accused products are Defendant Granules’ proposed 500 mg and 1000 mg generic versions of Plaintiffs’ Glumetza® (metformin hydrochloride extended-release tablets), for which Granules filed ANDA No. 2133344 with the U.S. Food and Drug Administration (Compl. ¶¶ 1, 25).

Functionality and Market Context

The complaint alleges that the Granules ANDA seeks approval to market a generic version of Glumetza® prior to the expiration of the patents-in-suit (Compl. ¶ 6). The ANDA contains data that, according to Granules, demonstrates the bioequivalence of its product to Glumetza®, suggesting the accused product is designed to provide a similar controlled-release profile for metformin hydrochloride (Compl. ¶ 27). Glumetza® is a widely used oral medication for the treatment of type 2 diabetes.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or specific, element-by-element allegations of infringement. It alleges infringement based on Defendant's submission of its ANDA, an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶ 30, 37, 44). The implied infringement theory is that the formulation of the proposed generic product, as detailed in the confidential ANDA submission, meets all the limitations of at least one claim of each of the patents-in-suit.

No probative visual evidence provided in complaint.

Identified Points of Contention

The analysis will depend on the details of Defendant's formulation, which are not public. Key questions the litigation may address include:

• Scope Questions: For the ’340 Patent, does the polymer matrix in the accused product meet the specific compositional and functional swelling limitations of a surviving claim, such as claim 6? For the ’987 and ’692 Patents, does the product’s coating composition fall within the scope of the "consists essentially of" language, and is its manufacturing process, particularly the curing step, equivalent to that claimed?
• Technical Questions: Does the accused product utilize a combination of PEO and HPMC to achieve gastric retention as described in the ’340 Patent? Does it employ a coating of a neutral ester copolymer and a polyglycol that is cured at a temperature at or above 55°C, as required by the ’987 and ’692 Patents?

V. Key Claim Terms for Construction

’340 Patent, Claim 6

• The Term: "a weight ratio that causes said matrix to swell...to a size large enough to provide gastric retention"
• Context and Importance: This is a functional limitation that defines the required property of the polymer matrix rather than just its composition. Practitioners may focus on this term because its scope will determine whether any PEO/HPMC matrix that results in gastric retention infringes, or only those that achieve a specific, quantifiable degree of swelling taught in the patent.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue the plain language covers any weight ratio that achieves the stated function, regardless of the precise mechanism or swelling percentage, as long as gastric retention is the result.
  • Evidence for a Narrower Interpretation: The specification suggests that retention is achieved when indigestible particles exceed about 1 cm in size (’340 Patent, col. 2:9-12). Figures and examples show specific swelling profiles, with tablets increasing in mass by over 150% (’340 Patent, FIG. 2). A party could argue these disclosures limit the claim to matrices that achieve a similar, significant, and measurable size increase.

’987 Patent, Claim 1

• The Term: "consists essentially of"
• Context and Importance: This transitional phrase is narrower than "comprising" but broader than "consisting of." It restricts the coating composition to the ingredients listed in the claim and unlisted ingredients that do not materially affect the basic and novel characteristics of the invention. Practitioners may focus on this term because infringement will depend on whether any additional components in the accused coating are found to materially alter the claimed invention's stable release profile derived from the high-temperature cure.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue that minor processing aids or colorants would not materially affect the coating's fundamental controlled-release properties and thus would not preclude infringement.
  • Evidence for a Narrower Interpretation: The specification emphasizes that the invention overcomes stability problems by combining a specific copolymer and a polyglycol and using a particular curing process (’987 Patent, col. 3:11-20). A party could argue that any additional substance that affects film formation, permeability, or stability—even if not a primary release-controlling agent—materially alters this "basic and novel" characteristic and takes the accused product outside the claim's scope.

VI. Other Allegations

Indirect Infringement

The complaint includes forward-looking allegations of induced and contributory infringement should the ANDA be approved and the product be marketed in the United States (Compl. ¶¶ 31, 38, 45). The complaint does not plead specific facts supporting pre-suit knowledge or intent beyond the filing of the ANDA.

Willful Infringement

The complaint does not explicitly allege willful infringement. It does, however, assert that the case is "exceptional" and seeks an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶ 35, 42, 49).

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

Evidentiary Challenge

A central issue will be one of compositional identity: does the confidential formulation described in Defendant's ANDA contain the specific polymer matrix ('340 Patent) or the specific coating composition and curing process ('987 and '692 Patents) recited in the asserted claims? The outcome will depend almost entirely on discovery into the technical details of the accused product.

Post-IPR Viability

A key question for the ’340 Patent will be one of infringement scope: following the cancellation of broad independent claim 1, can Plaintiffs prove that Defendant's product meets all the limitations of a surviving, and potentially narrower, independent claim such as claim 6, which is limited to drugs with low water solubility?

Claim Construction Focus

For the ’987 and ’692 Patents, the dispute may turn on the definitional boundary of "consists essentially of." The court’s construction of this term will determine whether any unlisted ingredients in Defendant's coating are permissible processing aids or are instead components that materially alter the invention, thereby placing the product outside the claims' scope.