Alcon Inc v. Gland Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Alcon Inc. (Switzerland) and Alcon Laboratories, Inc. (Delaware)
  • Defendant: Gland Pharma Limited (India)
  • Plaintiff’s Counsel: McCarter & English, LLP
• Case Identification: Alcon Inc. v. Gland Pharma Limited, 1:23-cv-00303, D. Del., 03/20/2023
• Venue Allegations: Venue is alleged to be proper because Defendant is a corporation organized under the laws of India and is subject to personal jurisdiction in the District of Delaware, and has therefore purposefully availed itself of the laws of the state.
• Core Dispute: This Hatch-Waxman action alleges that Defendant's Abbreviated New Drug Application (ANDA) to market a generic version of PATADAY® Once-Daily Relief ophthalmic solution constitutes an act of infringement of two patents covering high-concentration olopatadine formulations.
• Technical Context: The technology relates to stable, aqueous ophthalmic compositions containing a high concentration of the anti-allergy drug olopatadine, designed for enhanced, once-daily treatment of ocular allergic conjunctivitis.
• Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following a notice letter from the Defendant, dated February 7, 2023, informing the Plaintiff of its ANDA filing containing a Paragraph IV certification that the patents-in-suit are invalid, unenforceable, and/or will not be infringed.

Case Timeline

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

U.S. Patent No. 8,791,154 - "High Concentration Olopatadine Ophthalmic Composition," Issued July 29, 2014

The Invention Explained

• Problem Addressed: The patent describes the difficulty of creating ophthalmic solutions with high concentrations of the anti-allergy drug olopatadine, which is only sparingly soluble in water at a neutral pH (’154 Patent, col. 2:1-3). Higher concentrations are desirable to more effectively treat both early and, particularly, late-phase symptoms of allergic conjunctivitis with a convenient once-a-day dosage (’154 Patent, col. 1:35-45).
• The Patented Solution: The invention achieves a stable, high-concentration olopatadine solution by using a specific combination of solubilizing agents. The formulation combines olopatadine with a polyether (specifically, polyethylene glycol or PEG), a lactam polymer (polyvinylpyrrolidone or PVP), and a cyclodextrin derivative (specifically, hydroxypropyl-γ-cyclodextrin) to keep the drug dissolved in an aqueous solution suitable for ophthalmic use (’154 Patent, Abstract; col. 2:41-59).
• Technical Importance: This formulation technology enabled the development of a once-daily eye drop that provides extended relief from ocular allergy symptoms, improving patient compliance and offering enhanced efficacy against late-phase allergic reactions (’154 Patent, col. 1:49-54).

Key Claims at a Glance

• The complaint asserts at least independent claims 1 (composition) and 12 (method of use) (Compl. ¶34).
• Independent Claim 1 requires:
  • An aqueous ophthalmic solution
  • Comprising at least 0.67 w/v% olopatadine dissolved in the solution
  • PEG having a molecular weight of 300 to 500
  • polyvinylpyrrolidone
  • hydroxypropyl-γ-cyclodextrin
  • benzalkonium chloride
  • water
• The complaint reserves the right to assert other claims, which would include dependent claims (Compl. ¶34).

U.S. Patent No. 9,533,053 - "High Concentration Olopatadine Ophthalmic Composition," Issued January 3, 2017

The Invention Explained

• Problem Addressed: Like its parent ’154 patent, the ’053 patent addresses the technical challenge of solubilizing high concentrations of olopatadine in a stable aqueous formulation to improve the treatment of ocular allergies (’053 Patent, col. 2:1-12).
• The Patented Solution: The invention utilizes a multi-component system to achieve high olopatadine solubility. The solution employs a polyether (PEG), a lactam polymer (PVP), and a cyclodextrin derivative selected from a specified group, which allows for a stable, high-concentration formulation effective against allergic conjunctivitis (’053 Patent, Abstract; col. 2:50-61).
• Technical Importance: This technology provides an alternative formulation strategy for creating a high-potency, once-daily olopatadine eye drop for comprehensive allergy symptom relief (’053 Patent, col. 1:45-54).

Key Claims at a Glance

• The complaint asserts at least independent claims 1 and 8 (both composition claims) (Compl. ¶76).
• Independent Claim 1 requires:
  • An aqueous ophthalmic solution
  • Comprising at least 0.67 w/v% olopatadine dissolved in the solution
  • PEG having a molecular weight of 200 to 800
  • polyvinylpyrrolidone
  • a cyclodextrin selected from the group consisting of SAE-β-cyclodextrin, hydroxypropyl-β-cyclodextrin, and hydroxypropyl-γ-cyclodextrin
  • water
• The complaint reserves the right to assert other claims (Compl. ¶76).

III. The Accused Instrumentality

• Product Identification: Defendant’s ANDA Product (ANDA No. 213514), which is a generic version of PATADAY® Once-Daily Relief 0.7% ophthalmic solution (Compl. ¶¶ 1-2).
• Functionality and Market Context: The accused product is an ophthalmic solution intended for the treatment of ocular allergies, such as allergic conjunctivitis (Compl. ¶18). The complaint alleges, based on Defendant's notice letter, that the ANDA product is a generic equivalent containing the "same or equivalent ingredients in the same or equivalent amounts" as the branded PATADAY® product and includes bioavailability and bioequivalence data to that effect (Compl. ¶¶ 2, 36, 78). Defendant seeks to market this product as a lower-cost generic alternative to Plaintiff's branded drug (Compl. ¶1).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’154 Patent Infringement Allegations

’053 Patent Infringement Allegations

• Identified Points of Contention: The complaint alleges that Defendant's notice letter did not contest infringement of numerous claims of both patents, including the independent claims charted above (Compl. ¶¶ 35, 77). The primary point of contention, therefore, appears to be validity, as Defendant's Paragraph IV certification asserts the patents are invalid and/or unenforceable (Compl. ¶¶ 33, 75). The complaint does not detail the basis for these invalidity contentions. A central question for the court will be whether the combination of known pharmaceutical excipients to achieve a high-concentration olopatadine solution was non-obvious at the time of the invention.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail to identify specific claim construction disputes, particularly as it alleges that infringement itself was not contested for many claims. However, in formulation cases, the specific properties of claimed components can become relevant.

• The Term: "polyvinylpyrrolidone" (’154 Claim 1; ’053 Claim 1)
• Context and Importance: This term is recited without limitation as to its molecular weight or other properties. Practitioners may focus on this term because the patents’ specifications disclose preferred embodiments using a specific grade of PVP with a particular average molecular weight. The scope of this term could become critical if prior art discloses using a different grade of PVP in similar formulations.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language itself simply recites "polyvinylpyrrolidone" without any qualifiers. A party could argue this term should be given its plain and ordinary meaning, covering all forms of PVP suitable for ophthalmic use.
  • Evidence for a Narrower Interpretation: The specifications for both patents describe a preferred embodiment using PVP with an average molecular weight of approximately 50,000 (’154 Patent, col. 6:16-23; ’053 Patent, col. 6:28-34). A party could argue that the invention is limited to PVP within or near this disclosed range, potentially leveraging this disclosure to narrow the claim scope away from prior art.

VI. Other Allegations

• Indirect Infringement: The complaint alleges active inducement, stating that Defendant intends for its product to be used in an infringing manner and that its proposed product labeling will instruct physicians and patients to apply the infringing solution to the eye (Compl. ¶¶ 44, 86, 101). The complaint also alleges contributory infringement, asserting the ANDA product is not a staple article of commerce and lacks substantial noninfringing uses (Compl. ¶¶ 45, 61).
• Willful Infringement: Willfulness is alleged based on Defendant’s "full knowledge" of the patents-in-suit, stemming from the patents’ listing in the FDA’s Orange Book and the formal notice provided through the ANDA process (Compl. ¶¶ 48, 89). The complaint alleges Defendant acted "without a reasonable basis for believing that it would not be liable for infringement" (Compl. ¶¶ 48, 64, 89, 104).

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

• A core issue will be one of patent validity: Given that the complaint alleges the accused generic formulation contains all elements of the asserted claims, the case will likely center on Defendant's assertion that the patents are invalid. The key question for the court will be whether combining these known pharmaceutical ingredients to achieve a stable, high-concentration olopatadine solution was obvious in view of the prior art.
• A critical question is one of infringement defense: Since the complaint alleges Defendant did not contest infringement of many claims in its notice letter, on what basis will Defendant now build its non-infringement case? The discovery process will need to reveal the specific technical or legal arguments underpinning the non-infringement portion of its Paragraph IV certification.