DCT

1:22-cv-01391

Alcon Inc v. Aurobindo Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-01391, D. Del., 10/24/2022
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Aurobindo Pharma USA, Inc. is a Delaware corporation. For Defendant Aurobindo Pharma Ltd., venue is based on its alleged business activities and purposeful availment in the district, including through its U.S. subsidiary and its history of engaging in patent litigation in Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's PATADAY® ophthalmic solution constitutes an act of infringement of two patents related to high-concentration olopatadine formulations.
  • Technical Context: The technology concerns ophthalmic formulations for treating ocular allergies, where creating a stable, effective solution with a high concentration of the active ingredient olopatadine presents significant technical challenges related to solubility.
  • Key Procedural History: The action arises from a September 12, 2022 notice letter in which Aurobindo informed Alcon of its ANDA filing (No. 217710). The letter included a Paragraph IV certification asserting that Alcon's patents-in-suit are invalid and/or will not be infringed by Aurobindo's proposed generic product, which is the statutory trigger for this Hatch-Waxman litigation.

Case Timeline

Date Event
2011-05-19 Earliest Priority Date for ’154 and ’053 Patents
2014-07-29 U.S. Patent No. 8,791,154 Issued
2017-01-03 U.S. Patent No. 9,533,053 Issued
2022-09-12 Aurobindo sends Notice Letter to Alcon regarding ANDA filing
2022-10-24 Complaint Filed

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

U.S. Patent No. 8,791,154 - "High Concentration Olopatadine Ophthamalic Composition"

  • Patent Identification: U.S. Patent No. 8,791,154, "High Concentration Olopatadine Ophthamalic Composition," issued July 29, 2014.

The Invention Explained

  • Problem Addressed: The patent addresses the difficulty of creating a stable, multi-dose ophthalmic solution containing a high concentration of the anti-allergy drug olopatadine ('154 Patent, col. 1:62-65). The specification notes that olopatadine's solubility is limited to approximately 0.18% w/v, which is insufficient to effectively treat the late-phase symptoms of allergic conjunctivitis with once-daily dosing ('154 Patent, col. 2:1-5).
  • The Patented Solution: The invention uses a specific combination of excipients to solubilize olopatadine at concentrations significantly higher than previously achievable. The solution employs a cyclodextrin derivative (e.g., hydroxypropyl-γ-cyclodextrin), a lactam polymer (e.g., polyvinylpyrrolidone or PVP), and a polyether (e.g., polyethylene glycol or PEG) to create a stable, high-concentration aqueous solution ('154 Patent, Abstract; col. 2:41-56). The patent emphasizes that this combination is critical, as other attempts using excipients like PEG and PVP alone were "incapable...of solubilizing sufficient concentrations of olopatadine" ('154 Patent, col. 2:8-11).
  • Technical Importance: This technology enabled the development of a once-daily ophthalmic solution capable of providing relief from both early- and late-phase allergy symptoms, improving patient convenience and therapeutic outcomes ('154 Patent, col. 1:43-49).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claims 1 and 12 (Compl. ¶40).
  • Independent Claim 1 (Composition): An aqueous ophthalmic solution for treating ocular allergic conjunctivitis, comprising:
    • at least .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 at least one ocular allergy symptom in humans, comprising:
    • topically applying to an eye of a human an amount of the solution of claim 4 sufficient to treat the symptom.
  • The complaint reserves the right to assert other claims, including dependent claims 2-6, 8-10, and 13-27 (Compl. ¶41).

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

  • Patent Identification: 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, the '053 patent addresses the same core problem: the difficulty of creating a stable, high-concentration aqueous formulation of olopatadine suitable for ophthalmic use ('053 Patent, col. 1:24-28, col. 2:1-13).
  • The Patented Solution: The '053 Patent claims formulations that also use a combination of a cyclodextrin, polyvinylpyrrolidone, and polyethylene glycol to achieve high olopatadine solubility ('053 Patent, col. 2:48-60). The claims of the '053 patent recite different ranges and combinations of these excipients compared to the '154 patent, such as a broader molecular weight range for PEG and a different Markush group for the cyclodextrin derivative.
  • Technical Importance: Like the '154 Patent, this invention facilitates a more effective once-daily treatment for ocular allergies by enabling higher drug concentrations.

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 for treating ocular allergic conjunctivitis, 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; and
    • water.
  • Independent Claim 8 (Composition): An aqueous ophthalmic solution for treating ocular allergic conjunctivitis, 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 hydroxypropyl-β-cyclodextrin and hydroxypropyl-γ-cyclodextrin;
    • benzalkonium chloride;
    • hydroxypropylmethyl cellulose; and
    • water.
  • The complaint reserves the right to assert other claims, including dependent claims 2-7 and 9-13 (Compl. ¶83).

III. The Accused Instrumentality

  • Product Identification: Aurobindo's ANDA No. 217710 Product ("Aurobindo's ANDA Product"), a proposed 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, including allergic conjunctivitis (Compl. ¶24). The complaint alleges, based on information from Aurobindo's notice letter, that the product is a generic equivalent to Alcon's PATADAY® product and contains specific ingredients and concentrations that fall within the scope of the asserted patents (Compl. ¶¶2, 27).
    • Specifically, the complaint alleges Aurobindo's product contains at least 0.67 w/v% olopatadine, PEG with a molecular weight of 300 to 500, polyvinylpyrrolidone, and hydroxypropyl-γ-cyclodextrin (Compl. ¶¶43-44). It further alleges the product contains ingredients meeting the limitations of the '053 Patent, including PEG with a molecular weight of 200 to 800 and hydroxypropyl-γ-cyclodextrin (Compl. ¶¶85-86).
    • The complaint states that Aurobindo's ANDA contains bioavailability and bioequivalence data comparing its product to PATADAY® Once-Daily, positioning it to compete directly in the same market upon FDA approval (Compl. ¶¶42, 84).
  • Visual Evidence: No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,791,154 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An aqueous ophthalmic solution...comprising: at least .67 w/v% olopatadine dissolved in the solution; Aurobindo's ANDA Product is an ophthalmic solution that comprises at least .67 w/v% but no greater than 1.0 w/v% olopatadine dissolved in the solution. ¶43 col. 2:43-44
PEG having a molecular weight of 300 to 500; The ANDA Product contains PEG having a molecular weight of 300 to 500. ¶44 col. 2:55-57
polyvinylpyrrolidone; The ANDA Product contains polyvinylpyrrolidone. ¶44 col. 5:6-8
hydroxypropyl-γ-cyclodextrin; The ANDA Product contains hydroxypropyl-γ-cyclodextrin. ¶44 col. 4:49-50
benzalkonium chloride; and The ANDA Product contains benzalkonium chloride. ¶44 col. 7:45-46
water. The ANDA Product is an aqueous ophthalmic solution that contains water. ¶44 col. 3:25-26

U.S. Patent No. 9,533,053 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An aqueous ophthalmic solution...comprising: at least 0.67 w/v% olopatadine dissolved in the solution; Aurobindo's ANDA Product is an ophthalmic solution that comprises at least .67 w/v% but no greater than 1.0 w/v% olopatadine dissolved in the solution. ¶85 col. 2:49-50
PEG having a molecular weight of 200 to 800; The ANDA Product contains PEG having a molecular weight of 200 to 800. ¶86 col. 5:35-40
polyvinylpyrrolidone; The ANDA Product contains polyvinylpyrrolidone. ¶86 col. 5:2-4
a cyclodextrin selected from the group consisting of SAE-β-cyclodextrin, hydroxypropyl-β-cyclodextrin, and hydroxypropyl-γ-cyclodextrin; and The ANDA Product contains hydroxypropyl-γ-cyclodextrin. ¶86 col. 4:58-62
water. The ANDA Product is an aqueous ophthalmic solution that contains water. ¶86 col. 3:35-36
  • Identified Points of Contention:
    • Scope Questions: The complaint's allegations are based on Aurobindo's notice letter, which presumably describes the formulation submitted in the ANDA. However, Aurobindo certified non-infringement (Compl. ¶¶39, 81). This raises the central question of which specific claim limitation(s) Aurobindo contends its product does not meet. The dispute may turn on subtle distinctions, such as whether the specific grade or properties of an excipient used by Aurobindo (e.g., its "polyvinylpyrrolidone") falls outside the scope of the term as used in the patent.
    • Technical Questions: A key technical question will be one of factual correspondence. What evidence will be presented to prove the precise composition of the ANDA product? While the complaint makes direct allegations, the litigation will involve expert analysis and testing to confirm or contest the identity and concentration of each claimed component in Aurobindo's formulation.

V. Key Claim Terms for Construction

  • The Term: "dissolved in the solution"

  • Context and Importance: This term appears in the preamble of the olopatadine limitation in both asserted patents (e.g., '154 Patent, Claim 1). Its construction is important because a defense to infringement could be that not all of the olopatadine is "dissolved," or that it does not remain dissolved under certain conditions, thereby avoiding literal infringement. Practitioners may focus on this term because it qualifies the required concentration of the active ingredient.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification repeatedly describes the invention's purpose as achieving "solubilization" of high concentrations of olopatadine ('154 Patent, col. 2:2-3, 2:12-13). A party could argue this context implies the term should be understood practically, meaning the solution is clear and free of visible precipitate under normal storage and use, rather than requiring absolute molecular dissolution.
    • Evidence for a Narrower Interpretation: The specification contrasts the invention with formulations that "will typically begin to precipitate" ('154 Patent, col. 5:53-54). A party could argue this sets a high bar for stability and that "dissolved" requires the complete absence of any undissolved particles, even at a microscopic level, for the product's full shelf life.

  • The Term: "a cyclodextrin selected from the group consisting of..."

  • Context and Importance: This Markush group defines a critical solubilizing agent in the claimed invention ('053 Patent, Claim 1). Aurobindo's non-infringement defense might argue that its chosen cyclodextrin is a different chemical entity not explicitly recited in the group.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification introduces the cyclodextrins with language like "more particularly, a γ-cyclodextrin derivative and/or a β-cyclodextrin derivative" ('053 Patent, col. 2:50-52). A party might argue this phrasing suggests the listed members are exemplary rather than exhaustive, potentially opening the door to arguments about equivalents.
    • Evidence for a Narrower Interpretation: Markush group claim language is typically interpreted as closed, meaning it is limited to the members explicitly listed. The patent's specific recitation of "SAE-β-cyclodextrin, hydroxypropyl-β-cyclodextrin, and hydroxypropyl-γ-cyclodextrin" could be used to argue that any other type of cyclodextrin, even if functionally similar, falls outside the literal scope of the claim.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement, stating that Aurobindo knows its ANDA product is especially adapted for infringing use and that its proposed product labeling will instruct physicians and patients to use the product in a manner that directly infringes the method claims (e.g., claim 12 of the '154 Patent) (Compl. ¶¶50-51, 65-67, 92).
  • Willful Infringement: The complaint alleges willful infringement based on Aurobindo's knowledge of the patents-in-suit, which are listed in the FDA's Orange Book for PATADAY® (Compl. ¶¶37, 79). The complaint asserts that Aurobindo proceeded with its ANDA filing "without a reasonable basis for believing that it would not be liable for infringement" (Compl. ¶¶54, 95).

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

  • A central issue will be one of factual infringement: Does the precise chemical formulation of Aurobindo's ANDA product, as it will be manufactured and sold, meet every limitation of at least one asserted claim? Given Aurobindo’s non-infringement certification, the case will likely devolve into a "battle of the experts" over the chemical identity, properties, and concentration of one or more excipients in the accused generic product.
  • A second key question will concern invalidity: Can Aurobindo prove by clear and convincing evidence that the claimed formulations were obvious or anticipated by the prior art? The dispute will likely focus on whether it would have been obvious to a person of ordinary skill in the art to combine the specific claimed ingredients—a cyclodextrin, PVP, and PEG—in the claimed concentrations to solve the known problem of olopatadine's poor solubility.