Bausch & Lomb Inc v. Lupin Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Bausch & Lomb Incorporated (New York) and Bausch + Lomb Ireland Limited (Ireland)
  • Defendant: Lupin Ltd. (India); Lupin Atlantis Holdings SA (Switzerland); Lupin Inc. (Delaware); and Lupin Pharmaceuticals, Inc. (Delaware)
  • Plaintiff’s Counsel: Gibbons P.C.
• Case Identification: 2:23-cv-02664, D.N.J., 05/17/2023
• Venue Allegations: Plaintiff alleges venue is proper based on Defendants maintaining a regular and established place of business in the district, committing acts of infringement in the district, and having previously submitted to the jurisdiction of the court in prior litigations.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's LOTEMAX® SM ophthalmic gel constitutes infringement of a patent covering specific ophthalmic suspension formulations.
• Technical Context: The technology relates to ophthalmic corticosteroid formulations, specifically gel suspensions designed to improve drug delivery to the eye by controlling active ingredient particle size and using a vehicle that enhances residence time.
• Key Procedural History: This action was filed in response to Defendant’s Paragraph IV certification notice, which asserts that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint notes that Defendant has previously been sued by Plaintiff in the same district concerning LOTEMAX® SM in a "Related Action."

Case Timeline

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

U.S. Patent No. 11,534,395 - "Ophthalmic Suspension Composition"

• Patent Identification: U.S. Patent No. 11,534,395, "Ophthalmic Suspension Composition", issued December 27, 2022.

The Invention Explained

• Problem Addressed: The patent describes challenges with conventional ophthalmic drug delivery, noting that liquid eye drops are often quickly washed out of the eye, reducing therapeutic effect, while ointments can cause undesirable blurred vision and a "goopy feeling" ('395 Patent, col. 1:16-36).
• The Patented Solution: The invention is an ophthalmic gel suspension that aims to improve drug bioavailability. It uses an active ingredient, such as the corticosteroid loteprednol etabonate, that is milled into very fine "submicron" particles (D,90<5 µm and D,50<1 µm). These particles are suspended in a specific vehicle containing a "suspending agent" (e.g., polycarbophil) and a "particle size stabilizing agent" (e.g., hydroxypropylmethyl cellulose, or HPMC). This combination creates a storage-stable gel that thins upon instillation in the eye, releasing the drug over an extended period without significantly impairing vision ('395 Patent, Abstract; col. 2:21-42; col. 6:46-65).
• Technical Importance: This formulation approach seeks to enhance drug penetration into key ocular tissues by using submicron particles, while the novel vehicle aims to increase residence time and stability, potentially allowing for effective treatment with a lower drug concentration or less frequent dosing ('395 Patent, col. 16:1-15).

Key Claims at a Glance

• The complaint alleges infringement of at least one claim without specifying which ones (Compl. ¶38). Independent claim 1 is representative of the invention's core.
• Essential Elements of Independent Claim 1:
  • An ophthalmic suspension comprising an ophthalmic active ingredient (loteprednol etabonate) suspended in a formulation vehicle.
  • The loteprednol etabonate is present as "milled particles that have D,90<5 µm and D,50<1 µm."
  • The formulation vehicle comprises a "suspending agent" (a cross-linked carboxyl-containing polymer, i.e., polycarbophil) and a "particle size stabilizing agent" (a non-ionic cellulose derivative, i.e., hydroxypropylmethyl cellulose E4M).
  • The suspension comprises specific concentrations of loteprednol etabonate (3.80 mg/mL), polycarbophil (3.75 mg/mL), HPMC E4M (2.5 mg/mL), and several other excipients including benzalkonium chloride, edetate disodium dihydrate, sodium chloride, poloxamer 407, glycerin, propylene glycol, and boric acid ('395 Patent, col. 23:54 - col. 24:1).
• The complaint does not explicitly reserve the right to assert dependent claims, but this is standard practice.

III. The Accused Instrumentality

Product Identification

"Lupin's Proposed Generic LE Gel Product," a 0.38% loteprednol etabonate ophthalmic gel for which Defendant Lupin has filed Abbreviated New Drug Application (ANDA) No. 218087 with the FDA (Compl. ¶¶2, 29).

Functionality and Market Context

The accused product is intended to be a generic version of Bausch & Lomb's LOTEMAX® SM product (Compl. ¶30). The complaint alleges that Lupin’s ANDA contains data to establish its bioequivalence to the branded product (Compl. ¶34). The functionality is therefore the topical treatment of ophthalmic inflammatory conditions. The complaint alleges the accused product is the "same, or substantially the same, as LOTEMAX® SM" (Compl. ¶35).

IV. Analysis of Infringement Allegations

The complaint pleads infringement under 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA as a technical act of infringement. The core allegation is that the product described in Lupin's ANDA, if commercially manufactured and sold, would infringe the '395 patent (Compl. ¶¶38-39). The complaint does not contain a detailed claim chart. The following table summarizes the infringement theory based on the allegations that the accused product is a generic version of LOTEMAX® SM.

No probative visual evidence provided in complaint.

'395 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: A central dispute may involve the claim term "particle size stabilizing agent." The question will be whether the excipient used by Lupin in its formulation performs this specific function as described in the patent, or if it is merely a conventional viscosity agent that falls outside the claimed scope.
• Technical Questions: The primary technical question, to be resolved through discovery of Lupin's confidential ANDA, is one of compositional identity: does Lupin's formulation actually contain every excipient at the concentrations required by Claim 1? A second key question will be whether the loteprednol etabonate particles in Lupin's product meet the specific D,90 and D,50 size limitations recited in the claim.

V. Key Claim Terms for Construction

• The Term: "particle size stabilizing agent"
• Context and Importance: This term is critical because the patent distinguishes its invention from the prior art not just by particle size, but by the specific formulation vehicle that maintains that size. The patent presents experimental data suggesting that HPMC is particularly effective at this function, while other agents are not ('395 Patent, Table 2, col. 14:35-46). The infringement analysis will depend heavily on whether the agent used in Lupin's formulation meets this functional definition.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A plaintiff may argue that the term is defined by its function—any non-ionic cellulose derivative that is shown to inhibit nucleation and stabilize sub-micron particles would be covered, regardless of its specific grade or other properties. The patent claims the agent "comprising" a non-ionic cellulose derivative, which may suggest other components could be included.
  • Evidence for a Narrower Interpretation: A defendant may argue that the specification defines this term by example, strongly pointing to HPMC, and specifically high-viscosity grades like HPMC E4M, as the solution ('395 Patent, col. 14:11-23). The patent contrasts the successful performance of HPMC with the failure of other agents like PVP and CMC, suggesting the term is not a generic descriptor for any thickener but is limited to agents with the specific stabilizing properties demonstrated by HPMC in the patent's examples.

VI. Other Allegations

• Indirect Infringement: The complaint includes standard allegations of induced and contributory infringement (Compl. ¶40). This is predicated on the eventual commercialization of Lupin's product, where its package insert and marketing materials would allegedly instruct physicians and patients to use the product in an infringing manner.
• Willful Infringement: The complaint does not contain a separate count for willfulness. However, it establishes that Lupin had knowledge of the '395 patent, at the latest, upon receipt of information that led to its sending of the Paragraph IV notice letter dated March 2, 2023 (Compl. ¶32). This allegation of pre-suit knowledge, combined with the prayer for a declaration of an "exceptional case" (Prayer for Relief ¶5), lays the groundwork for a potential claim of willful infringement based on post-filing conduct.

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

This ANDA litigation will center on a comparison between the specific formulation disclosed in Lupin's confidential regulatory filing and the limitations of the '395 patent's claims. The key questions for the court will likely be:

• A central issue will be one of factual infringement: Does the precise formulation detailed in Lupin's ANDA—specifically its list of excipients, their concentrations, and the resulting particle size distribution of the active ingredient—fall within the literal scope of the asserted patent claims?
• A key legal question will be one of claim construction: Can the term "particle size stabilizing agent," which the patent links to the specific performance of HPMC, be construed broadly to cover the excipient used in Lupin's formulation, or is its meaning limited by the specification to the specific embodiments that were shown to be effective?