Detailed Analysis of the Scope and Claims of United States Patent 10,596,107
Introduction
The United States Patent 10,596,107, issued on March 24, 2020, pertains to an ophthalmic suspension composition developed by Bausch & Lomb Incorporated. This patent is crucial for understanding the formulation, application, and legal protection of ophthalmic suspensions, particularly those containing loteprednol etabonate.
Inventors and Assignee
The patent was invented by Mohannad Shawer, Eric Phillips, and Martin J. Coffey, and is assigned to Bausch & Lomb Incorporated, a leading company in the ophthalmic pharmaceutical industry[2][4].
Patent Claims
The patent includes 17 claims that define the scope of the invention. Here are the key aspects of these claims:
Formulation Composition
The patent describes an ophthalmic suspension that includes an ophthalmic active ingredient suspended in a formulation vehicle. This vehicle comprises a suspending agent and a non-ionic cellulose derivative. The active ingredient is present as particles with specific size parameters: D90 < 5 μm and D50 < 1 μm[2][4].
Ophthalmic Active Ingredient
The active ingredient, typically loteprednol etabonate, is designed to treat ophthalmic inflammatory conditions. The particle size distribution ensures effective delivery and stability of the suspension[4].
Suspending Agent and Cellulose Derivative
The suspending agent and non-ionic cellulose derivative are critical components that maintain the suspension's stability and ensure the uniform distribution of the active ingredient. These components are essential for the formulation's efficacy and patient compliance[2][4].
Scope of the Patent
The scope of the patent is defined by its claims, which determine the boundaries of what is protected under the patent.
Independent and Dependent Claims
The patent includes independent claims that broadly define the invention, and dependent claims that narrow down the scope by adding specific details. The independent claims are the broadest and most critical in defining the patent's scope. Dependent claims serve as fallback positions in case the independent claims are invalidated[3].
Claim Length and Scope
Research indicates that the length of the first claim can be a measure of the patent's scope. Generally, longer claims imply more conditions that must be met for a patent to be violated, thus indicating a narrower scope. However, the specific claims in this patent are designed to balance breadth and specificity to protect the unique formulation while allowing for some flexibility[3].
Patent Landscape
Related Patents
The patent landscape for ophthalmic suspensions includes several related patents, such as US11,534,395, which also pertains to loteprednol etabonate formulations. These patents often overlap in their claims but may differ in specific formulations, manufacturing processes, or application methods[2][5].
Patent Expiration Dates
The patent 10,596,107 is set to expire on December 23, 2036. This expiration date is significant as it marks the end of the exclusive rights granted to Bausch & Lomb Incorporated for this specific formulation. After this date, generic versions of the drug can be developed and marketed[2][5].
Competitive Environment
The ophthalmic pharmaceutical market is competitive, with multiple companies like Alcon Labs Inc. also developing and marketing loteprednol etabonate formulations under different brand names such as EYSUVIS and INVELTYS. These formulations may have different patent expiration dates and claims, influencing the market dynamics[5].
Legal and Regulatory Aspects
Drug Patents and Exclusivity
Drug patents, like the one in question, grant exclusive legal rights to the patent holder. These rights can be complemented by FDA-granted exclusivity periods, which can range from 180 days to seven years. The interplay between patent protection and exclusivity periods is crucial for maintaining market exclusivity[2].
Patent Infringement and Litigation
The scope of the patent defines what constitutes infringement. A competitor must avoid meeting every condition of the claims to avoid infringement. The complexity of patent claims and the potential for litigation highlight the importance of careful claim drafting and legal analysis[3].
Clinical and Therapeutic Implications
Treatment of Ophthalmic Inflammatory Conditions
The ophthalmic suspension composition is specifically designed to treat ophthalmic inflammatory conditions. The formulation ensures that the active ingredient is delivered effectively, providing relief from conditions such as dry eye disease and other inflammatory eye disorders[4][5].
Patient Compliance and Efficacy
The particle size distribution and the use of a suspending agent and non-ionic cellulose derivative enhance patient compliance by ensuring the suspension is stable and easy to administer. This formulation also improves the efficacy of the treatment by maintaining the active ingredient in a form that is readily absorbed by the eye[4].
Key Takeaways
- Formulation Details: The patent describes an ophthalmic suspension with an active ingredient suspended in a vehicle containing a suspending agent and a non-ionic cellulose derivative.
- Particle Size: The active ingredient particles must be less than 5 μm (D90) and less than 1 μm (D50) in size.
- Scope and Claims: The patent includes 17 claims, with independent claims defining the broad scope and dependent claims providing narrower specifications.
- Patent Expiration: The patent expires on December 23, 2036.
- Competitive Landscape: The market includes other loteprednol etabonate formulations with different patent expiration dates and claims.
- Clinical Implications: The formulation is designed to treat ophthalmic inflammatory conditions effectively.
FAQs
What is the main active ingredient in the ophthalmic suspension composition described in US Patent 10,596,107?
The main active ingredient is typically loteprednol etabonate, used to treat ophthalmic inflammatory conditions.
What are the key components of the formulation vehicle in this patent?
The formulation vehicle includes a suspending agent and a non-ionic cellulose derivative.
Why is the particle size of the active ingredient important?
The particle size ensures effective delivery and stability of the suspension, with particles less than 5 μm (D90) and less than 1 μm (D50) in size.
When does the patent 10,596,107 expire?
The patent expires on December 23, 2036.
How does this patent fit into the broader competitive landscape of ophthalmic pharmaceuticals?
This patent is part of a competitive landscape that includes other loteprednol etabonate formulations from companies like Alcon Labs Inc., each with their own patent expiration dates and claims.
Cited Sources
- United States Patent and Trademark Office, "Ophthalmic suspension composition," US Patent 10,596,107 B2, March 24, 2020.
- Drugs.com, "Generic Lotemax SM Availability," November 6, 2024.
- Boston University School of Law, "The Ways We've been Measuring Patent Scope are Wrong: How to Measure and Draw Causal Inferences with Patent Scope," October 2017.
- Google Patents, "Ophthalmic suspension composition," US Patent 10,596,107 B2.
- GreyB, "Loteprednol etabonate generic drug has transformational potential," September 18, 2023.
