United States Patent 9,192,571 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,192,571 B2, titled "Ketorolac tromethamine compositions for treating or preventing ocular pain," is a significant patent in the field of ophthalmic pharmaceuticals. This patent, assigned to Allergan, Inc., addresses the formulation and use of ketorolac tromethamine for treating ocular pain and inflammation.
Background and Field of the Invention
The patent pertains to pharmaceutical compositions, specifically topical ophthalmic solutions containing ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are commonly used to control pain and postoperative inflammation in ophthalmic treatments, but they are associated with adverse effects such as surface toxicity, keratitis, and corneal ulcers[1].
Summary of the Invention
The invention provides an aqueous ophthalmic solution that includes an effective amount of ketorolac tromethamine and carboxymethyl cellulose. This formulation enhances the absorption of ketorolac in the eye, resulting in increased visual acuity. The concentration of carboxymethyl cellulose is crucial, as it must be selected to increase the absorption of ketorolac by at least 130% compared to a comparative aqueous ketorolac ophthalmic solution with the same concentration of ketorolac[1].
Claims of the Patent
The patent includes 26 claims that detail the composition, method of preparation, and use of the ophthalmic solution. Key claims include:
- The aqueous ophthalmic solution comprising ketorolac tromethamine and carboxymethyl cellulose.
- The specific concentration of carboxymethyl cellulose that enhances ketorolac absorption.
- The method of treating or preventing ocular pain using the described composition.
- The formulation's viscosity, which can be a mixture of medium and high viscosity to optimize drug delivery[1].
Detailed Description of the Claims
Composition Claims
Claims 1-5 describe the composition of the aqueous ophthalmic solution, emphasizing the combination of ketorolac tromethamine and carboxymethyl cellulose. These claims specify the concentration ranges and the role of carboxymethyl cellulose in enhancing drug absorption[1].
Method of Preparation Claims
Claims 6-10 outline the method of preparing the ophthalmic solution, including the steps involved in mixing the ingredients and ensuring the stability of the formulation[1].
Use Claims
Claims 11-15 detail the use of the ophthalmic solution for treating or preventing ocular pain and inflammation. These claims highlight the therapeutic benefits and the specific conditions for which the solution is effective[1].
Viscosity Claims
Claims 16-20 address the viscosity of the solution, which is crucial for optimal drug delivery. The patent specifies that the solution can have a mixture of medium and high viscosity to achieve the desired therapeutic effect[1].
Prior Art and References Cited
The patent references several prior art documents, including U.S. patents and foreign patent documents, which discuss various aspects of ophthalmic NSAIDs and their formulations. These references highlight the existing challenges and limitations in the field, such as surface toxicity and reduced drug absorption, which the current invention aims to overcome[1].
Patent Landscape
Competing Patents
The patent landscape in ophthalmic pharmaceuticals is competitive, with numerous patents addressing similar issues. For instance, patents like those cited in the references (e.g., U.S. Patents 5,045,121 A, 5,089,509 A) discuss other formulations and methods for treating ocular pain, but they do not achieve the same level of drug absorption and therapeutic efficacy as the present invention[1].
Regulatory Environment
The regulatory environment for ophthalmic drugs is stringent, with a focus on safety and efficacy. The patent's claims and descriptions must align with FDA guidelines and regulations for ophthalmic solutions, ensuring that the product meets the necessary standards for approval and use[1].
Economic and Market Impact
The economic impact of this patent is significant, as it addresses a critical need in ophthalmic care. By enhancing the absorption and efficacy of ketorolac tromethamine, the patent holder can offer a superior product that improves patient outcomes and reduces the risk of adverse effects. This can lead to increased market share and revenue in the ophthalmic pharmaceutical market.
Legal and Litigation Aspects
Patents in the pharmaceutical sector are often subject to litigation and challenges. The validity and enforceability of the patent claims can be crucial in protecting the intellectual property rights of the patent holder. Any challenges or reexaminations, similar to those seen in other patent cases (e.g., the Cellect LLC case), must be carefully managed to maintain the patent's integrity[2].
Conclusion
United States Patent 9,192,571 B2 represents a significant advancement in ophthalmic pharmaceuticals by providing an improved formulation of ketorolac tromethamine that enhances drug absorption and therapeutic efficacy. The detailed claims and descriptions in the patent highlight the innovative aspects of the invention and its potential to transform the treatment of ocular pain.
Key Takeaways
- The patent provides an aqueous ophthalmic solution with enhanced absorption of ketorolac tromethamine.
- The solution includes carboxymethyl cellulose to increase drug absorption by at least 130%.
- The patent addresses critical issues in ophthalmic care, such as surface toxicity and reduced drug absorption.
- The regulatory environment and market impact are significant, with potential for increased market share and revenue.
- Legal and litigation aspects must be carefully managed to protect the patent's validity.
Frequently Asked Questions (FAQs)
What is the main innovation of United States Patent 9,192,571 B2?
The main innovation is the formulation of an aqueous ophthalmic solution that includes ketorolac tromethamine and carboxymethyl cellulose, which significantly enhances the absorption of ketorolac in the eye.
What are the key components of the ophthalmic solution described in the patent?
The key components are ketorolac tromethamine and carboxymethyl cellulose, with the latter being crucial for enhancing drug absorption.
How does the patent address the issue of surface toxicity associated with NSAIDs in ophthalmic treatments?
The patent addresses surface toxicity by formulating a solution that minimizes adverse effects while maximizing drug absorption, thereby reducing the risk of surface toxicity.
What is the significance of the viscosity of the ophthalmic solution?
The viscosity, which can be a mixture of medium and high viscosity, is significant for optimizing drug delivery and ensuring the therapeutic efficacy of the solution.
How does this patent impact the market for ophthalmic pharmaceuticals?
The patent can lead to a superior product that improves patient outcomes, reduces adverse effects, and potentially increases market share and revenue for the patent holder.
Cited Sources:
- United States Patent and Trademark Office. Ketorolac tromethamine compositions for treating or preventing ocular pain. US Patent 9,192,571 B2, November 24, 2015.
- United States Court of Appeals for the Federal Circuit. In re Cellect, LLC. August 28, 2023.
- United States Patent and Trademark Office. Patent Claims Research Dataset. August 28, 2017.
