United States Patent 9,254,286: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,254,286, titled "Ophthalmic formulations of cetirizine and methods of use," is a significant patent in the field of ophthalmic medications, particularly for the treatment of allergic conjunctivitis and allergic rhinoconjunctivitis. This patent, assigned to Aciex Therapeutics, Inc., provides insights into the formulation, composition, and application of cetirizine in ophthalmic treatments.
Patent Overview
The patent was issued on February 9, 2016, and is set to expire on July 9, 2032. It covers stable topical formulations of cetirizine designed for comfortable instillation in the eye and effective in treating allergic conjunctivitis and allergic rhinoconjunctivitis[2][4].
Scope of the Patent
The scope of the patent is broad yet specific, focusing on the following key aspects:
Formulation Composition
The patent describes ophthalmic formulations of cetirizine, with the active ingredient present in concentrations ranging from 0.01% to 1.0% (w/v), preferably between 0.05% and 0.5% (w/v). Cetirizine can be in the form of cetirizine hydrochloride or dihydrochloride[4].
Stability and Comfort
The formulations are designed to be stable and comfortable when instilled in the eye, achieved without the use of cyclodextrins or other solubilizing compounds. This is a significant improvement over previous formulations that required such additives[4].
Combination Formulations
The patent also covers combination formulations of cetirizine with other active agents, such as fluticasone, which provide comprehensive treatment benefits for rhinoconjunctivitis that cannot be achieved by single agents alone[4].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the inventors while defining the boundaries of their intellectual property.
Independent Claims
The patent includes independent claims that describe the ophthalmic formulations of cetirizine as the sole active ingredient or in combination with other agents. These claims specify the concentration ranges, forms of cetirizine, and the absence of certain solubilizing compounds[4].
Dependent Claims
Dependent claims further elaborate on the independent claims, detailing specific aspects such as the use of mucoadhesive vehicles, polymeric suspending agents (e.g., dextrans, polyethylene glycol, polyvinylpyrolidone), and cross-linked carboxy-containing polymer systems (e.g., Noveon AA-1, Carbopol®, DuraSite®)[4].
Patent Landscape
The patent landscape surrounding US 9,254,286 is complex and influenced by several factors:
Related Patents
Other patents related to ophthalmic formulations of cetirizine, such as US 8,829,005 and US 20210299121A1, also contribute to the broader intellectual property landscape. These patents cover similar formulations and methods of use, with varying expiration dates and specific claims[2][4].
Patent Expiration Dates
The patent is set to expire on July 9, 2032. This expiration date is crucial for understanding the timeline during which the patent holder enjoys exclusive rights and when generic or competing products might enter the market[2].
Regulatory and Legal Considerations
The patent's validity and scope are subject to regulatory and legal scrutiny. The Federal Circuit's stance on genus claims, as discussed in the context of pharmaceutical and biotechnology patents, can impact the breadth and enforceability of such patents. The requirement for a written description and enablement under 35 U.S.C. § 112(a) is particularly relevant[3].
Impact on the Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry, particularly in the development and commercialization of ophthalmic medications.
Innovation and Competition
The patent protects innovative formulations that provide comfort and efficacy, discouraging direct competition during its term. However, the expiration of the patent will open the market to generic versions, potentially increasing competition and reducing costs for consumers[2].
Market Expansion
The market for therapeutic ophthalmic formulations is expanding, driven by increasing demand for effective treatments for allergic conjunctivitis and other eye conditions. This patent contributes to the growth of this market by providing a stable and effective treatment option[3].
Key Takeaways
- Stable Formulations: The patent covers stable ophthalmic formulations of cetirizine without the need for solubilizing compounds.
- Combination Therapies: The patent includes combination formulations with other agents like fluticasone for comprehensive treatment benefits.
- Patent Expiration: The patent expires on July 9, 2032, marking the end of exclusive rights for the patent holder.
- Regulatory Considerations: The patent's scope is subject to regulatory and legal scrutiny, particularly under 35 U.S.C. § 112(a).
- Industry Impact: The patent influences innovation and competition in the pharmaceutical industry, especially in ophthalmic medications.
FAQs
What is the primary focus of United States Patent 9,254,286?
The primary focus is on stable topical formulations of cetirizine for treating allergic conjunctivitis and allergic rhinoconjunctivitis.
What are the key components of the cetirizine formulations described in the patent?
The formulations include cetirizine hydrochloride or dihydrochloride at concentrations between 0.01% and 1.0% (w/v), without the use of cyclodextrins or other solubilizing compounds.
Can the cetirizine formulations be used in combination with other active agents?
Yes, the patent covers combination formulations, particularly with fluticasone, for enhanced treatment benefits.
When does the patent expire?
The patent expires on July 9, 2032.
How does the Federal Circuit's stance on genus claims affect this patent?
The Federal Circuit's rigid position on genus claims under 35 U.S.C. § 112(a) could impact the patent's scope and enforceability, requiring a detailed written description and enablement.
Cited Sources
- US20210299121A1 - Cetirizine ophthalmic compositions - Google Patents
- Generic Zerviate Availability - Drugs.com
- Eviscerating Patent Scope - DigitalCommons@NYLS
- US9254286B2 - Ophthalmic formulations of cetirizine and methods of use - Google Patents
