DCT

2:23-cv-00790

Bausch & Lomb Inc v. Lupin Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-00790, D.N.J., 02/10/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendants maintain a regular and established place of business in the district, specifically a manufacturing and research facility in Somerset, New Jersey. The complaint also cites Defendants' history of litigating, and submitting to jurisdiction, in the district.
  • Core Dispute: This is a Hatch-Waxman Act lawsuit in which Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's LOTEMAX® SM ophthalmic gel constitutes an act of infringement of a patent covering the drug's formulation.
  • Technical Context: The technology concerns ophthalmic suspensions, specifically gel formulations for delivering corticosteroids to the eye to treat inflammation, which are designed to improve drug residence time and bioavailability compared to traditional eye drops.
  • Key Procedural History: The litigation was triggered by Defendants' submission of ANDA No. 218087 to the FDA, seeking approval to market a generic loteprednol etabonate ophthalmic gel. As required, Defendants provided a Paragraph IV Certification notice, asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product, thereby creating the basis for this declaratory judgment action. The patent-in-suit was subject to a Certificate of Correction, which substantively amended the scope of the primary independent claim.

Case Timeline

Date Event
2015-01-26 Earliest Priority Date for U.S. Patent No. 10,596,107
2019-02-22 FDA approves NDA No. 208219 for LOTEMAX® SM
2020-03-24 U.S. Patent No. 10,596,107 Issued
2021-08-31 Certificate of Correction for U.S. Patent No. 10,596,107 Issued
2022-12-28 Date of Lupin's Paragraph IV Certification Notice Letter
2023-01-03 Plaintiff receives Lupin's Notice Letter
2023-02-10 Complaint Filed

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

U.S. Patent No. 10,596,107 - “Ophthalmic Suspension Composition,”

  • Patent Identification: U.S. Patent No. 10,596,107, “Ophthalmic Suspension Composition,” issued March 24, 2020.

The Invention Explained

  • Problem Addressed: The patent seeks to solve problems with prior methods of ocular drug delivery. It notes that simple solutions are often washed out of the eye too quickly, while ointments can cause undesirable blurred vision and a "goopy feeling." In-situ gelling systems, while improving drug residence time, can also interfere with vision and require formulation at an acidic, uncomfortable pH. (’107 Patent, col. 1:9-55).
  • The Patented Solution: The invention is a "storage-stable" ophthalmic suspension that exists as a gel but transitions to a liquid when subjected to the shear force of an eyelid blinking. It comprises an active pharmaceutical ingredient (API), such as the corticosteroid loteprednol etabonate, suspended as very fine particles (e.g., a majority of particles under 1 µm) within a specific vehicle. This vehicle combines a "carboxyvinyl polymer" (like polycarbophil) as a suspending agent with a "non-ionic cellulose derivative" to enhance stability and inhibit particle aggregation. (’107 Patent, Abstract; col. 2:21-56). The specific particle size distribution is a central feature, intended to improve therapeutic efficacy. (’107 Patent, col. 2:25-30).
  • Technical Importance: This formulation approach aims to combine the benefits of extended drug residence time on the eye's surface with improved patient comfort and vision quality, while ensuring the active ingredient remains uniformly suspended for consistent dosing. (’107 Patent, col. 1:46-55; col. 7:1-14).

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" of the ’107 patent (Compl. ¶37). The patent was subject to a Certificate of Correction that replaced the original Claim 1. The corrected independent claim is now the primary focus.
  • Corrected Independent Claim 1:
    • An ophthalmic suspension comprising an ophthalmic active ingredient suspended in a formulation vehicle,
    • wherein the ophthalmic active ingredient is loteprednol etabonate and is present as particles that have a Dv90 < 5µm and a Dv50 < 1µm,
    • and the formulation vehicle comprises a suspending agent and a non-ionic cellulose derivative,
    • wherein the suspending agent comprises a carboxyvinyl polymer,
    • and wherein the suspension is storage stable for at least one year.
  • The complaint does not specify any dependent claims but does not foreclose asserting them later.

III. The Accused Instrumentality

Product Identification

  • "Lupin's Proposed Generic LE Gel Product," which is a generic loteprednol etabonate ophthalmic gel, 0.38% (Compl. ¶¶2, 32).

Functionality and Market Context

  • The accused product is a generic drug for which Lupin is seeking FDA approval via ANDA No. 218087 (Compl. ¶29). The complaint alleges that the product is intended to be a generic version of Bausch + Lomb's LOTEMAX® SM product (Compl. ¶30). The ANDA submission necessarily contains data and information intended to demonstrate that Lupin's product is bioequivalent to LOTEMAX® SM (Compl. ¶33). The complaint alleges that upon approval, Lupin will manufacture, use, and sell this product in the United States, in direct competition with the plaintiffs (Compl. ¶¶30, 39). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not include a claim chart or detailed infringement contentions. The infringement theory is based on Defendants' filing of ANDA No. 218087, which seeks approval for a product alleged to be "the same, or substantially the same, as LOTEMAX® SM" (Compl. ¶34). The following chart summarizes the infringement allegations that can be inferred from the complaint's assertion that the proposed generic product will infringe the ’107 patent.

  • ’107 Patent Infringement Allegations
Claim Element (from Corrected Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An ophthalmic suspension comprising an ophthalmic active ingredient suspended in a formulation vehicle, wherein the ophthalmic active ingredient is loteprednol etabonate... The complaint alleges Lupin's ANDA is for a generic "loteprednol etabonate gel, 0.38%," which is an ophthalmic suspension. ¶¶2, 33 col. 5:36-44
...and is present as particles that have a Dv90 < 5µm and a Dv50 < 1µm... The complaint does not provide specific data on particle size but alleges the generic product is the same or substantially the same as LOTEMAX® SM, which the patent teaches is formulated with such particles. ¶¶33, 34 col. 2:25-30
...and the formulation vehicle comprises a suspending agent and a non-ionic cellulose derivative, wherein the suspending agent comprises a carboxyvinyl polymer... The complaint does not specify the excipients in Lupin's product but alleges bioequivalence, which implies a similar formulation vehicle containing the claimed polymer types to achieve the patented properties. ¶¶33, 34 col. 2:31-38
...and wherein the suspension is storage stable for at least one year. The complaint does not explicitly allege this but, as a commercial pharmaceutical product, Lupin's generic would be required to be storage stable. This property is alleged to be met by being a generic of LOTEMAX® SM. ¶34 col. 7:1-14
  • Identified Points of Contention:
    • Factual Questions: The primary question is factual: does the precise formulation detailed in Lupin's confidential ANDA actually meet every limitation of the asserted claim? The complaint lacks any direct evidence of Lupin's specific formulation, such as its particle size distribution or the identity of its excipients. This will be a central focus of discovery.
    • Scope Questions: A potential dispute may arise over the meaning of "storage stable for at least one year." The parties could contest the conditions under which stability must be measured and the metrics used to define it.

V. Key Claim Terms for Construction

The complaint does not offer a basis for claim construction analysis. However, based on the corrected Claim 1 and the technical context, the following terms may be central to the dispute.

  • The Term: "storage stable for at least one year"

  • Context and Importance: This is a functional limitation that is critical to the claim's scope but is not defined with numeric precision in the claim itself. Practitioners may focus on this term because its definition will determine what level of physical and chemical stability a generic product must exhibit to infringe. The dispute will likely center on whether this means stable under specific accelerated testing conditions or real-world commercial storage, and what degree of particle size change or degradation is permissible.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification broadly states that the term "storage-stable" means the API will "remain effectively suspended... for an extended period of time without having to stir or shake the packaged composition." (’107 Patent, col. 7:3-7). This qualitative description could support a more flexible standard.
    • Evidence for a Narrower Interpretation: The specification also links stability to the ability to "consistently deliver 90% to 110% of a predetermined dosage" without agitation and explicitly mentions a shelf-life of "at least a year" or "at least two years." (’107 Patent, col. 7:10-25). A defendant might argue these passages tie the term to specific, measurable performance metrics.

  • The Term: "particles that have a Dv90 < 5µm and a Dv50 < 1µm"

  • Context and Importance: This limitation defines the core technical characteristic of the suspended drug. Infringement will hinge on whether Lupin's product meets these specific particle size distribution values. Practitioners may focus on this term because the patent describes a specific, multi-step methodology for measuring the particle size distribution (’107 Patent, col. 11:35-51). Any deviation from this methodology could be a point of non-infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim uses the general terms "Dv90" and "Dv50," which are standard in the art. A plaintiff might argue that any standard measurement technique that yields values within the claimed ranges is sufficient to prove infringement.
    • Evidence for a Narrower Interpretation: The specification details a specific sample preparation and measurement protocol using a "Microtrac S3500 laser diffractive analyzer." (’107 Patent, col. 11:35-51). A defendant could argue that this detailed description limits the claim to particle sizes as measured by this specific method, potentially excluding results from other instruments or protocols.

VI. Other Allegations

  • Indirect Infringement: The complaint makes a conclusory allegation of induced and contributory infringement (Compl. ¶39). The basis for this appears to be the act of filing the ANDA with the intent to market a product that, if used as directed by physicians and patients, would directly infringe.
  • Willful Infringement: The complaint does not use the term "willful infringement." However, in the prayer for relief, it asks the Court to "Declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4)" and award attorney's fees (Compl. p. 12, ¶5). The factual basis for this appears to be that Lupin's filing of a Paragraph IV certification demonstrates knowledge of the ’107 patent.

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

  • A central issue will be one of factual proof: Once the formulation in Lupin's ANDA is produced in discovery, will its loteprednol etabonate particles meet the precise size distribution thresholds (Dv90 < 5µm and Dv50 < 1µm) required by the corrected Claim 1, when measured according to the methods arguably defined by the patent?
  • The case may also turn on a question of functional interpretation: How will the court construe the term "storage stable for at least one year"? Will it be defined by the general descriptions in the specification or tied to the more specific performance metrics discussed, and does Lupin's proposed product meet that standard?
  • Finally, a key question underlying the entire dispute, prompted by Lupin's Paragraph IV certification, will be the validity of the patent: Assuming Lupin's product is found to infringe, is the asserted claim of the ’107 patent valid over the prior art, or is it obvious or anticipated by earlier ophthalmic formulations?