Bausch & Lomb Inc v. Sandoz Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Bausch & Lomb Incorporated (New York) and Bausch + Lomb Ireland Limited (Ireland)
  • Defendant: Sandoz Inc. (Delaware)
  • Plaintiff’s Counsel: Gibbons P.C.
• Case Identification: 2:25-cv-01167, D.N.J., 02/11/2025
• Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant resides in and maintains a regular and established principal place of business in the district, has committed acts of infringement there, and a substantial part of the events giving rise to the claim occurred there.
• Core Dispute: Plaintiff alleges that Defendant’s 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 two patents covering ophthalmic suspension compositions.
• Technical Context: The technology relates to ophthalmic gel formulations designed to improve the delivery and bioavailability of poorly soluble active ingredients for treating eye inflammation.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 218526 and its associated Paragraph IV certification. Plaintiff received a notice letter from Defendant regarding the ANDA filing on or about January 15, 2025. The patents-in-suit are listed in the FDA’s Orange Book for LOTEMAX® SM.

Case Timeline

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

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

Issued March 24, 2020

The Invention Explained

• Problem Addressed: The patent describes that conventional liquid eye drop formulations have poor residence time in the eye, as 80-99% of the active ingredient is quickly washed away, reducing therapeutic efficacy. While ointments and some gels can increase residence time, they often cause undesirable side effects like blurred vision or a "goopy feeling." (’107 Patent, col. 1:16-40).
• The Patented Solution: The invention is an ophthalmic suspension that uses a specific combination of components to create a stable gel. It suspends the active pharmaceutical ingredient (API), loteprednol etabonate, as very small particles (submicron) in a vehicle containing a suspending agent (a carboxyvinyl polymer) and a non-ionic cellulose derivative. This formulation is designed to be a gel during storage but transition to a liquid upon instillation due to shear force from blinking, thereby improving comfort and bioavailability without the drawbacks of traditional ointments. (’107 Patent, Abstract; col. 2:31-62).
• Technical Importance: This approach aims to enhance the amount of drug that penetrates key ocular tissues by using submicron drug particles, while maintaining a formulation that is stable in its package and comfortable for the patient. (’107 Patent, col. 21:39-50).

Key Claims at a Glance

• The complaint asserts infringement of at least one claim (Compl. ¶37). The primary independent claim, as corrected by the Certificate of Correction, is Claim 1.
• Independent Claim 1 (Corrected):
  • 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.

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

Issued December 27, 2022

The Invention Explained

• Problem Addressed: As a continuation of the application leading to the ’107 patent, the ’395 patent addresses the same technical problem of improving the efficacy and patient comfort of ophthalmic drug delivery for poorly soluble corticosteroids. (’395 Patent, col. 1:9-40).
• The Patented Solution: The invention is a specific ophthalmic gel suspension containing loteprednol etabonate. It claims a formulation vehicle comprising a cross-linked carboxyl-containing polymer as a suspending agent and hydroxypropylmethylcellulose as a "particle size stabilizing agent," with specific concentrations recited for a preferred embodiment. This formulation is designed to create a stable suspension of "milled particles" with a defined submicron size. (’395 Patent, Abstract; col. 2:50-64; Claim 1).
• Technical Importance: This patent claims a more specific embodiment of the technology, focusing on a particular combination of excipients and their concentrations, intended to provide a stable and effective ophthalmic gel with enhanced drug penetration. (’395 Patent, col. 21:39-50).

Key Claims at a Glance

• The complaint asserts infringement of at least one claim (Compl. ¶26). The sole independent claim is Claim 1.
• Independent Claim 1:
  • An ophthalmic suspension comprising loteprednol etabonate suspended in a formulation vehicle,
  • wherein the loteprednol etabonate is present as milled particles having D,90<5 µm and D,50<1 µm,
  • the formulation vehicle comprises a suspending agent (a cross-linked carboxyl-containing polymer) and a particle size stabilizing agent (a non-ionic cellulose derivative),
  • the non-ionic cellulose derivative is hydroxypropylmethylcellulose present at a concentration effective to provide at least moderate particle size protection,
  • the cross-linked carboxyl-containing polymer is polycarbophil,
  • and the suspension comprises specified concentrations of loteprednol etabonate (3.80 mg/mL), polycarbophil (3.75 mg/mL), hydroxypropylmethyl cellulose E4M (2.5 mg/mL), and other named excipients.

III. The Accused Instrumentality

Product Identification

• Defendant’s "Proposed Generic LE Gel Product," for which it seeks FDA approval under ANDA No. 218526 (Compl. ¶20, ¶22).

Functionality and Market Context

• The complaint alleges that the accused product is a generic version of Plaintiff’s LOTEMAX® SM, a 0.38% loteprednol etabonate ophthalmic gel (Compl. ¶20, ¶22).
• The complaint further alleges, upon information and belief, that the accused product is the "same, or substantially the same, as LOTEMAX® SM" and that the ANDA contains data demonstrating its bioequivalence to the branded product (Compl. ¶23, ¶24). The complaint does not provide independent technical details of the accused product's formulation beyond these allegations of equivalence.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or detailed infringement contentions. The infringement analysis is predicated on the allegation that the accused generic product is the same or substantially the same as the branded LOTEMAX® SM product (Compl. ¶24).

'395 Patent Infringement Allegations

'107 Patent Infringement Allegations

Identified Points of Contention

• Factual Questions: The central dispute will be factual: does the formulation described in Sandoz’s ANDA actually meet every limitation of the asserted claims? This includes the specific particle size distributions (D,90 < 5µm and D,50 < 1µm), the precise concentrations of excipients listed in Claim 1 of the ’395 patent, and the one-year storage stability required by Claim 1 of the ’107 patent.
• Scope Questions: How will the term "milled particles" in the ’395 patent be construed? Does it require a specific manufacturing process (e.g., bead milling as described in the specification) or does it simply refer to particles that have been reduced in size by any method?

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

"storage stable for at least one year" (’107 Patent, Claim 1)

• Context and Importance: This limitation is a functional requirement for the final product. Infringement will depend on whether Defendant's product can be proven to meet this stability standard. Practitioners may focus on this term because its definition is not a simple structural feature but a performance characteristic that must be tested over time.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue the term should be given its plain and ordinary meaning in the context of pharmaceutical formulations, without being limited to a specific test.
  • Evidence for a Narrower Interpretation: The specification provides a potential definition: "the API will remain effectively suspended... without having to stir or shake the packaged composition... the storage-stable ophthalmic suspensions of this invention will consistently deliver 90% to 110% of a predetermined dosage of pharmaceutical active per eye drop, without a patient having to agitate the suspension in its container." (’107 Patent, col. 7:4-16). A party may argue this passage defines the claim term.

"milled particles" (’395 Patent, Claim 1)

• Context and Importance: This term appears in the ’395 patent but not the parent ’107 patent, suggesting a potential distinction. The infringement analysis may turn on whether Sandoz's manufacturing process constitutes "milling."
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue "milled" is a general descriptor for particles that have undergone a size-reduction process and is not limited to any specific technique.
  • Evidence for a Narrower Interpretation: The specification extensively discusses "bead milling" and "microfluidizer" techniques to achieve the desired particle size (’395 Patent, col. 11:4-12:53). A party could argue that "milled particles" should be construed as particles produced by one of the specific processes detailed in the specification.

VI. Other Allegations

Indirect Infringement

• The complaint alleges that upon approval, Defendant will contributorily infringe and induce infringement of the asserted patents (Compl. ¶28, ¶34, ¶39, ¶45). The factual basis for these allegations is not detailed beyond the act of filing the ANDA and the intent to market the generic product for the same approved uses as LOTEMAX® SM.

Willful Infringement

• The complaint does not use the word "willful," but it requests a declaration that the case is "exceptional" under 35 U.S.C. § 285, which can be based on willful infringement (Prayer for Relief, ¶6). The alleged basis for knowledge is Defendant’s submission of the Paragraph IV certification and its associated notice letter, which demonstrate knowledge of the patents-in-suit prior to the filing of the lawsuit (Compl. ¶21).

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

• A central issue will be one of factual proof: Will discovery of Sandoz's confidential ANDA submission reveal that its proposed generic product meets every specific quantitative and qualitative limitation of the asserted claims, particularly the submicron particle size distributions and, for the ’395 patent, the exact concentrations of the listed excipients?
• A key legal question will be one of claim scope: Can Plaintiff successfully argue for a construction of "storage stable for at least one year" (’107 patent) that is both definite and met by the accused product? Similarly, will the court construe "milled particles" (’395 patent) broadly to cover any particle reduction method, or will it be limited to the specific methods detailed in the patent?
• An underlying strategic question will be one of equivalence: Given that this is an ANDA case based on alleged bioequivalence, the dispute will likely focus on whether the formulation choices made by Sandoz to achieve bioequivalence also force it to fall within the literal scope of the asserted patent claims.