Alcon Inc v. Alembic Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Alcon Inc. (Switzerland) and Alcon Laboratories, Inc. (Delaware)
  • Defendant: Alembic Pharmaceuticals Ltd. (India) and Alembic Pharmaceuticals, Inc. (Delaware)
  • Plaintiff’s Counsel: McCarter & English, LLP
• Case Identification: 1:23-cv-00194, D. Del., 02/22/2023
• Venue Allegations: Venue is asserted based on Defendant Alembic Pharmaceuticals, Inc. being a Delaware corporation, and on both defendants allegedly conducting systematic business in, and having substantial contacts with, the State of Delaware.
• Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of PATADAY® Once-Daily, an ophthalmic solution, constitutes an act of infringement of two patents covering high-concentration olopatadine formulations.
• Technical Context: The technology relates to pharmaceutical compositions for treating the symptoms of ocular allergies, such as allergic conjunctivitis, using a high-concentration, stable formulation of the active ingredient olopatadine.
• Key Procedural History: This patent infringement action was initiated under the Hatch-Waxman Act following a notice letter dated January 13, 2023, in which Defendant informed Plaintiff of its ANDA submission to the FDA. The complaint asserts that this notice letter triggered the 45-day period for filing suit.

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 technical challenge of solubilizing olopatadine, an anti-allergy drug, at high concentrations in a water-based ophthalmic solution. Olopatadine by itself is not very soluble at a neutral pH suitable for eye drops, which limits its effectiveness for treating more severe, late-phase allergy symptoms. (’154 Patent, col. 2:1-13).
• The Patented Solution: The invention provides a stable, aqueous formulation that successfully dissolves a high concentration of olopatadine by using a specific combination of solubilizing agents. The key components are a cyclodextrin derivative, a lactam polymer (polyvinylpyrrolidone or PVP), and a polyether (polyethylene glycol or PEG), which work together to keep the olopatadine dissolved and stable for topical delivery to the eye. (’154 Patent, Abstract; col. 2:41-59).
• Technical Importance: This formulation enabled the development of a once-daily eye drop with a higher dose of olopatadine, offering improved relief from both early-phase itching and late-phase inflammation and redness associated with allergic conjunctivitis. (’154 Patent, col. 1:33-56).

Key Claims at a Glance

• The complaint asserts infringement of at least independent claim 1 and method claim 12 (Compl. ¶40).
• Independent Claim 1 (Composition): 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; and
  • water.
• Independent Claim 12 (Method): A method of treating an ocular allergy symptom by topically applying an aqueous ophthalmic solution comprising specific concentrations of olopatadine, PEG, polyvinylpyrrolidone, and a cyclodextrin derivative selected from a specified group.

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

The Invention Explained

• Problem Addressed: As a continuation of the application leading to the ’154 patent, this patent addresses the same problem: the difficulty of creating a stable, high-concentration aqueous solution of olopatadine for ophthalmic use. (’053 Patent, col. 2:1-13).
• The Patented Solution: The invention likewise uses a combination of excipients to solubilize the olopatadine. The claims of the ’053 patent cover slightly different formulations, for example by broadening the range of molecular weights for PEG and including additional excipients like hydroxypropylmethyl cellulose. (’053 Patent, Abstract; col. 2:50-68).
• Technical Importance: This technology also provides for a high-concentration olopatadine formulation designed to offer enhanced, once-daily relief from the full range of ocular allergy symptoms. (’053 Patent, col. 1:33-56).

Key Claims at a Glance

• The complaint asserts infringement of at least independent claims 1 and 8 (Compl. ¶82).
• Independent Claim 1 (Composition): An aqueous ophthalmic solution comprising:
  • at least 0.67 w/v % olopatadine;
  • 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; and
  • water.
• Independent Claim 8 (Composition): An aqueous ophthalmic solution comprising the elements of claim 1, but with a narrower cyclodextrin group (excluding SAE-β-cyclodextrin) and the further addition of benzalkonium chloride and hydroxypropylmethyl cellulose.

III. The Accused Instrumentality

• Product Identification: Defendant's Abbreviated New Drug Application (ANDA) No. 217856 product, which is a proposed generic version of PATADAY® Once-Daily 0.7% ophthalmic solution (Compl. ¶¶1-2).
• Functionality and Market Context: The accused product is an ophthalmic solution containing olopatadine hydrochloride, intended for the treatment of ocular allergies (Compl. ¶1). The complaint alleges, based on Defendant's notice letter, that the ANDA product is a generic equivalent to the branded PATADAY® Once-Daily and contains the same active ingredient (Compl. ¶2, ¶27). The product is intended for manufacture, sale, and distribution in the U.S. market upon receiving FDA approval (Compl. ¶14). The complaint states that the ANDA product contains specific concentrations of olopatadine, PEG, polyvinylpyrrolidone, hydroxypropyl-γ-cyclodextrin, benzalkonium chloride, and water, which form the basis of the infringement allegations (Compl. ¶¶43-44, 85-86).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

U.S. 8,791,154 Infringement Allegations

U.S. 9,533,053 Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The complaint alleges that Defendant's notice letter did not contest infringement for numerous claims of the patents-in-suit (Compl. ¶41, ¶83). However, the complaint also states that the notice letter included the statutory certification of non-infringement (Compl. ¶39, ¶81). This raises the question of what specific limitation(s) Defendant will argue its product does not meet. Given the direct recitation of the accused formulation in the complaint, any non-infringement argument may rely on a subtle distinction in the chemical properties or grade of one of the claimed components.
  • Technical Questions: A key technical question for the court will be whether the components of the accused ANDA product, such as "polyvinylpyrrolidone" or "hydroxypropyl-γ-cyclodextrin," are structurally and functionally identical to those required by the claims, or if there are differences in grade, purity, or molecular weight distribution that could support a non-infringement position.

V. Key Claim Terms for Construction

• The Term: "at least 0.67 w/v % olopatadine" (’154 Patent, cl. 1; ’053 Patent, cl. 1)

  • Context and Importance: This limitation defines the "high concentration" aspect of the invention, which is central to its asserted novelty over prior art formulations. The entire premise of the patents is achieving this high concentration in a stable solution. Practitioners may focus on this term because any dispute over the precise concentration or the methodology for its measurement in the accused product would be critical to the infringement analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term "at least" is open-ended and typically construed to mean the specified number or more. The specification discusses concentrations of "at least 0.50%" and higher, supporting a reading that is not limited to a single value. (’154 Patent, col. 4:49-55).
    • Evidence for a Narrower Interpretation: A party might argue for a narrower construction by pointing to specific examples in the specification that center on a 0.7% concentration, or by arguing that the term must be read in the context of what was technically feasible and described as the invention. (’154 Patent, col. 4:1-2).

• The Term: "hydroxypropyl-γ-cyclodextrin" (’154 Patent, cl. 1)

  • Context and Importance: This is a key solubilizing agent in the claimed formulation. While it is a specific chemical name, disputes in pharmaceutical cases can arise over the grade, purity, or specific structural characteristics of such excipients. Infringement requires that the accused product contains this specific cyclodextrin derivative.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party would argue for the plain and ordinary meaning of the chemical name, encompassing any commercially available version that meets the general chemical definition. The specification discusses this compound as a member of a class of cyclodextrin derivatives suitable for the invention. (’154 Patent, col. 4:30-34).
    • Evidence for a Narrower Interpretation: A party could argue that the term should be limited to the specific pharmaceutical grades or types discussed or exemplified in the patent. The specification distinguishes, for example, between commodity and purified forms of a different cyclodextrin (SAE-β-CD), suggesting that the type and source of the excipient may be a relevant technical consideration. (’154 Patent, col. 5:24-34).

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement allegation is based on the assertion that Defendant's proposed product labeling will instruct physicians and patients to administer the generic drug, thereby infringing the method of treatment claims (e.g., ’154 Patent, cl. 12). (Compl. ¶50, ¶92). Contributory infringement is alleged on the basis that the ANDA product is not a staple article of commerce and is especially made and adapted for an infringing use, with no substantial noninfringing uses. (Compl. ¶51, ¶92).
• Willful Infringement: Willfulness is alleged based on Defendant’s knowledge of the patents-in-suit, purportedly gained from their listing in the FDA's Orange Book and acknowledged via the notice letter sent to Alcon. The complaint claims Defendant acted "without a reasonable basis for believing that it would not be liable," thereby supporting a claim for enhanced damages. (Compl. ¶54, ¶70, ¶95, ¶110).

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

• A central issue will be one of evidentiary proof: As the complaint alleges the accused formulation based on Defendant’s notice letter, the primary question is whether discovery will confirm that the chemical composition of the final ANDA product matches this formulation and falls squarely within the specific component and concentration ranges of the asserted claims.
• The case may turn on a question of defense strategy: Given that the complaint alleges Defendant did not contest infringement of key claims in its notice letter, a core question is whether Defendant’s primary defense will rely on a nuanced claim construction argument for non-infringement or pivot entirely to challenging the validity of the patents as obvious or anticipated by prior art.
• A key legal question will be one of definitional precision: Can the chemical terms in the claims, such as "polyvinylpyrrolidone" or "hydroxypropyl-γ-cyclodextrin", be distinguished based on unstated properties like commercial grade, purity, or molecular weight distribution, or will they be given their broad, plain-and-ordinary meaning, likely ensuring a finding of literal infringement if the formulation is as alleged?