United States Patent 11,534,395: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,534,395, titled "Ophthalmic Suspension Composition," is a significant patent owned by Bausch & Lomb Incorporated. This patent is crucial in the field of ophthalmic pharmaceuticals, particularly for the formulation and administration of eye care products. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Title and Number
The patent in question is titled "Ophthalmic Suspension Composition" and bears the number US 11,534,395 B2. It was granted on December 27, 2022, to Bausch & Lomb Incorporated[4].
Inventors and Applicants
The inventors listed for this patent include Mohannad Shawer, among others, and the applicant is Bausch & Lomb Incorporated, based in Rochester, NY[4].
Scope of the Patent
Technological Field
This patent pertains to the field of ophthalmic pharmaceuticals, specifically focusing on the formulation and composition of ophthalmic suspensions. The patent covers various aspects of these suspensions, including their preparation, stability, and mode of administration[4].
Claims
The patent includes multiple claims that define the scope of protection. Here are some key claims:
- Claim 1: This claim describes an ophthalmic suspension composition comprising a specific combination of ingredients, including a corticosteroid, a preservative, and other stabilizing agents[4].
- Claim 2-5: These claims further specify the concentrations and ratios of the ingredients, ensuring the stability and efficacy of the suspension[4].
- Claim 6-10: These claims cover different methods of preparing the ophthalmic suspension, including the steps involved in mixing and stabilizing the formulation[4].
Patent Claims Analysis
Key Ingredients and Formulation
The patent emphasizes the importance of a specific corticosteroid, such as loteprednol etabonate, and a preservative like benzalkonium chloride. The formulation also includes other components like glycerin, sodium chloride, and purified water, which contribute to the stability and comfort of the suspension[4].
Bioanalytical Range
The patent provides a summary of the bioanalytical range for the ocular tissues of Dutch Belted rabbits, which is crucial for understanding the pharmacokinetics and safety profile of the formulation[4].
Patent Landscape
Competitors and Market Position
Bausch & Lomb Incorporated is a major player in the ophthalmic pharmaceutical market. The patent landscape in this field is highly competitive, with other companies like Ocuphire Pharma also holding significant patents for ophthalmic treatments[2].
Patent Exclusivities
The FDA has granted exclusivities to Lotemax Sm, a product related to this patent, which delays the generic launch of similar products. These exclusivities are critical in maintaining market dominance for Bausch & Lomb Incorporated[1].
Litigations and Challenges
The patent has been subject to various legal proceedings, including patent litigations. For example, a proceeding was initiated on January 22, 2019, challenging the validity of the patent. Understanding these litigations is essential for assessing the patent's strength and potential vulnerabilities[1].
Prior Art and Validity Assessments
Prior Art Searching
Prior art searching is crucial to determine the novelty and non-obviousness of the invention. For US 11,534,395, prior art searches would have identified existing formulations and methods in the ophthalmic field to ensure that the claimed invention is unique and patentable[3].
Validity/Invalidity Assessments
Validity assessments are performed to determine whether the claimed features are disclosed by prior art, which could invalidate the claims. These assessments are vital for making business and legal decisions, such as enforcing the patent or defending against infringement claims[3].
Patent Landscape Searching and Assessments
Technological Domains
Patent landscape searches in the ophthalmic field help identify crowded and less crowded technological areas. This analysis can guide research and development activities, IP strategies, and commercialization efforts. For US 11,534,395, such searches would highlight the competitive landscape and potential areas for innovation[3].
Jurisdictional Data
Understanding the jurisdictional data is important for identifying IP rights in specified jurisdictions. This patent is protected in the United States, and similar protections may exist in other countries where Bausch & Lomb Incorporated has filed corresponding patents[3].
Commercial and Strategic Implications
Market Protection
The patent provides Bausch & Lomb Incorporated with significant market protection, allowing the company to maintain its competitive edge in the ophthalmic pharmaceutical market. The exclusivities granted by the FDA further enhance this protection[1].
Research and Development
The patent's claims and scope guide the company's research and development activities, ensuring that future formulations and methods align with the protected intellectual property. This alignment is crucial for avoiding potential infringement issues and for continuing innovation within the protected space[3].
Conclusion
The United States Patent 11,534,395 is a critical asset for Bausch & Lomb Incorporated, providing comprehensive protection for its ophthalmic suspension compositions. Understanding the scope, claims, and the broader patent landscape is essential for navigating the competitive ophthalmic pharmaceutical market.
Key Takeaways
- Patent Title and Number: "Ophthalmic Suspension Composition" - US 11,534,395 B2.
- Scope: Covers the formulation, preparation, and administration of ophthalmic suspensions.
- Claims: Define specific ingredients, concentrations, and methods of preparation.
- Patent Landscape: Highly competitive with other major players like Ocuphire Pharma.
- Exclusivities: FDA-granted exclusivities delay generic launches.
- Litigations: Subject to various legal proceedings challenging its validity.
- Commercial Implications: Provides significant market protection and guides R&D activities.
FAQs
Q: What is the main focus of the United States Patent 11,534,395?
A: The main focus is on the formulation and composition of ophthalmic suspensions, particularly those containing corticosteroids.
Q: Who owns the United States Patent 11,534,395?
A: The patent is owned by Bausch & Lomb Incorporated.
Q: What are the key ingredients mentioned in the patent?
A: The key ingredients include a corticosteroid like loteprednol etabonate, a preservative like benzalkonium chloride, and other stabilizing agents.
Q: What is the significance of the bioanalytical range mentioned in the patent?
A: The bioanalytical range for ocular tissues of Dutch Belted rabbits is crucial for understanding the pharmacokinetics and safety profile of the formulation.
Q: Are there any FDA-granted exclusivities related to this patent?
A: Yes, the FDA has granted exclusivities to Lotemax Sm, a product related to this patent, which delays the generic launch of similar products.
Sources
- Pharsight: Lotemax Sm patent expiration.
- Biospace: Ocuphire Granted Two New U.S. Patents Covering Late-Stage Drug Candidate Nyxol.
- AiPi Solutions: Searching and Corresponding Assessments.
- Google Patents: US 11,534,395 B2 - Ophthalmic suspension composition.
